The Top Ten Specialty Pharmaceutical Companies: Positioning, performance and SWOT analyses

Specialty pharmaceutical companies focus the majority of their efforts upon one or two therapeutic areas that are served by specialized physicians. Their traditional mode of operation is to acquire under-promoted branded products from Big Pharma companies that are generating lower sales and significantly increase revenues through the application of targeted marketing and promotional activities. However, the dynamics of the industry are changing. Rising costs for in-licensing and acquiring late stage/approved products have driven companies to develop products internally in order to remain competitive.

‘The Top Ten Specialty Pharmaceutical Companies’ is a report published by Business Insights that explores the global competitive landscape of the specialty pharmaceutical industry. The latest key trends and evolving business models in the specialty pharmaceutical market are identified and the leading companies in this sector are profiled in detail. For each of the top ten specialty pharma companies, this report provides a detailed examination of geographic and therapeutic focus, major currently marketed products and growth strategies in the form of key acquisitions and divestments. The opportunities and threats facing each of these leading players are also assessed.

Discover the key trends and growth drivers of the specialty pharma market, compare the strategies and perfomance of the top ten companies and evaluate their future prospects with this report.

Some key findings from this report

• The global specialty pharma market reached an overall value of $61.6bn in 2007, an increase of 15.7% from 2006. The ten leading companies represented 36.4% of the total market in 2007.

• Servier currently leads the worldwide specialty pharma industry. The company had a market share of 7.0% in 2007, representing sales of $4.3bn, an increase of 20.3% over 2006.

• Gilead intend to maintain its current dominance in the HIV/AIDS treatment market by accelerating the discovery, development and marketing of antiretroviral drugs and by establishing a foothold in the economies of emerging markets.

• Many drug delivery companies are changing focus to become specialty pharma companies, by using their drug delivery technologies to develop improved formulations of existing molecules. Alza was the first drug delivery company to complete this transition.

• Cephalon has a strong late-stage pipeline and anticipates several product approvals and launches during 2008–10. The company expects four FDA approvals within its oncology and pain management franchises in 2008, in addition to the launch of two new onclogy products before 2010.

Top reasons to order your copy today
• Identify the market dynamics of the global specialty pharma industry over the 2006-07 period, understand the potential benefits of emerging business models and identify the latest industrial trends across the UK, Japan, France, Germany, Italy, Spain and the US.

• Evaluate the performance and strategies of the top 10 players in the global specialty pharma market with this report’s examination of the geographic and therapeutic focus and currently marketed product portfolios of Servier, Gilead, Forest, Shire, Biogen Idec, Cephalon, Sepracor, Lundbeck, Endo Pharma and CSL.

• Assess the future prospects of the top ten specialty pharma companies with this report’s analysis of each firm’s strengths, weaknesses, opportunties and threats, in addition to an examination of growth strategies via product acquistions and divestments.

• Measure the progress of leading specialty pharma companies outside of the top ten by anlaysing the portfolios and therapeutic/geographic focus of Covidien, Allergan, ONO, Genzyme, Gruenenthal, Warner Chilcott, Ferring, Stiefel Labs, Bracco and Leo Pharma.

Key issues examined in this report
• Genericization of specialty products. Specialty pharma products with orphan drug status become vulnerable to genericization once this status has expired. Biogenerics are increasing as a result of favourable EU legislation.

• Cannibalization of product sales. Intense competition has forced specialty pharma companies to reformulate or recombine their products at a high rate. This ‘cannibalization’ has resulted in a shortening of individual product lifecycles.

• Lack of incentives in Europe. Pricing and reimbursement pressures in Europe have created greater boundaries to innovation, leading to fewer undervalued late-stage products. As a result, traditional specialty companies are likely to face future difficulties in this region.

• CNS treatments dominate the specialty sector. CNS is the largest therapeutic area for the leading specialty pharma companies, with half of the top ten companies focused on CNS and neurology treatments.

Your questions answered
• How fast is the global market for specialty pharmaceutical treatments expanding?

• What are the trends in the global specialty pharmaceutical market?

• Who are the top 10 players in the industry and how much of the market do they control?

• Which growth strategies have proven most effective?

• Which business models have been adopted by leading companies to gain competitive advantage and enhance market share?

• What are the strengths, weaknesses, opportunties and threats facing each of the top 10 players?

• Where are the most exciting growth opportunities for leading specialty pharmaceutical companies?

The Promotional Landscape in the US and Europe: Benchmarking promotional ROI and optimizing detailing and journal spend relationships

Promotional activities within the pharma industry operate through various sales and promotional channels with the aim of convincing physicians, patients and payors about the value and efficacy of products. Return on investment (ROI) is the critical measure of success for such initiatives. However, a clear understanding of the ROI generated across various market and lifecycle settings is essential for companies attempting to optimize their detailing and journal advertising strategies in the future.

‘The Promotional Landscape in the US and Europe’ is a report published by Business Insights that provides detailed strategic guidance for the preparation and execution of successful promotion strategies. This report examines a number of case studies of recent high profile promotional strategies and their associated sales data to provide a comprehensive analysis of the key success factors for detailing and journal advertising across various stages of the product lifecycle. The impact of market and product-level influences on promotional returns are assessed and the most effective methods of measuring promotional performance are also identified.

Improve the effectiveness of your promotional strategies by examining the key factors affecting associated ROI and compare the promotional activities of leading companies with this report.

Some key findings from this report

• US detailing spend has fallen from 4.4% of promoted sales in 2005 to 3.9% in 2007. The proportion of sales revenues allocated to promotional activities is relatively higher amongst EU5 countries than the US, amounting to 8.4% in 2007 compared with 4.2% in the US.

• Returns from detailing in the US have increased from 18.4 to 20.5 over the period 2005-2007. Returns from journal advertising have recorded greater gains, rising from 11.2 to 19.1 in the same period.

• Promotional spend during a product’s launch year typically constitutes over 50% of first year sales in the US. This proportion falls to less than 15% in year two and less than 5% by year seven.

• Merck & Co invested the greatest proportion of sales into promotional activities out of the top 10 pharma companies in 2007. This was largely due to new product launches, such as the vaccine Gardasil and diabetes treatment Januvia. Eli Lilly and Novartis were the next largest promotional spenders.

Top reasons to order your copy today
• Assess returns from pharmaceutical promotion in the US and EU5 with this report’s detailed breakdown of the ROI levels associated with detailing and journal spend on promoted retail sales by therapeutic category, relative innovation, price level and lifecycle stage.

• Compare how successfully leading companies have executed their promotional strategies with this report’s analysis of total retail sales and proportional promotional spend in the US and EU for major players including Pfizer, GSK, AstraZeneca, J&J and Merck & Co.

• Evaluate the most effective promotional strategies for new product launches with this report’s case study analysis that includes a high profile launch into a new product category, the introduction of a new drug class, the redefining of an established product category and the launch of a second-generation product.

• Identify the most effective promotional strategies for mature products with this report’s case study analysis of the promotional effectiveness of detailing and journal advertising spend for products facing patent expiry, including lifecycle management strategies involving reformulations, line extensions and fixed dose combinations.

Key issues examined in this report
• Effectiveness of detailing. Product detailing continues to be the most effective promotional channel despite increasingly restricted access to physicians. However, improving effectiveness and utilizing channels such as eDetailing will continue to offer incremental returns.

• Promotion across product lifecycles. Although it is necessary for companies to generate significant promotional activity in the early stages of the product lifecycle, the ability to balance these initiatives across various portfolios over time is of great importance.

• New product promotions. New products require significant educational promotion, particularly those launched into new treatment settings such as Gardasil or Champix/Chantix.

• Protecting products close to patent expiry. The classic game theory response to impending patent expiry involves maximizing sales prior to expiry through continued aggressive promotion before restricting all promotional efforts post patent expiry. Brand-level promotion in light of new competition with therapeutic equivalency and a significant price discount is rarely considered to be of value.

Your questions answered

• What is the most appropriate measure for pharmaceutical promotional returns?

• How do promotional strategies evolve across the product lifecycle?

• What key market/product characteristics have the greatest impact on promotional returns?

• Which companies are currently achieving above average promotional returns and why?

• How can promotional activities help to establish market share for new product launches?

• To what extent can promotional activities help to safeguard market share following patent expiry?

• What are the key benchmarks/guidance available from real life case studies that can be applied directly to my current portoflio?

The Dermatology Market Outlook to 2013: Competitive landscape, pipeline analysis and growth opportunities

The dermatology market remains highly competitive, with developers ranging from Big Pharma to biotechnology and specialty pharmaceutical firms. In recent years levels of innovation in the area have dwindled, allowing generic competition to erode the market share of several leading brands across major drug classes. As leading players continue to lose ground to smaller, specialised players, opportunities are being created for companies that can implement effective lifecycle management and identify lucrative niches.

‘The Dermatology Market Outlook to 2013’ is a report published by Business Insights that provides comprehensive coverage across key dermatology markets, with analysis of major currently marketed and pipeline drugs. The growth drivers and competitive dynamics of the area are assessed, with revenue and epidemiological forecasts provided for the period 2008-13. This report assesses the 10 leading companies in the dermatology market, examining their product portfolios and R&D pipelines to provide forecasts of their future competitive positions. This report also assesses prevalence rates across the seven major markets in addition to highlighting key trends across the global dermatology area, with coverage of over 95% of the total market.

Discover the key trends and growth drivers of the market for dermatology treatments, assess the competitive dynamics of leading companies and evaluate the future prospects of major products.

Some key findings from this report
• Increased safety concerns will restrict future growth for topical immunosuppressants such as Novartis’ Elidel and Astellas’ Protopic. Both these products have a declining market presence due to the FDA’s black box label warning in 2005 for potential cancer risk.

• Major branded oral acne treatments including Roaccutane will face growing generic competition over the 2008-2013 period. Leading brands in the topical acne treatment market are only expected to achieve marginal growth, while the total market for acne treatments is expected to amass $3b of revenue in 2013.

• The market for psoriasis treatments is forecast to register strong growth between 2008-2013, driven by the performances of key drugs such as Raptiva, Taclonex, Soriatane.

• The corticosteroid market is estimated to value $3.7b by 2013. Reformulated combination corticosteroid/anti-infective brands will continue be integral to the treatment of psoriasis and dermatitis and will continue to be the primary growth drivers within the area.

• Leo Pharma is believed to feature the strongest R&D pipeline in the dermatology market, with five projects currently in the mid to late stages of development. However, most leading companies have sparsely populated pipelines.

Top reasons to order your copy today
• Assess the epidemiology and forecast prevalence of major dermatological disorders including acne, psoriasis, dermatitis, rosacea across key geographies including the UK, Japan, France, Germany, Italy, Spain and the US.

• Evaluate the performances and strategies of major dermatology developers by examining the sales focus by drug class, currently marketed products and R&D portfolios of Bayer Schering, Galderma, GSK, Leo Pharma, Novartis, J&J, Roche, Sanofi-Aventis, Schering-Plough and Stiefel Labs.

• Examine the market dynamics for the global dermatology area and assess key trends and growth drivers across major treatment classes including corticosteroids, topical anti-infectives, acne and psoriasis.

• Forecast revenues for major currently marketed and pipeline dermatology products over 2008-13, with this report’s sales forecasts across major indications, treatment classes and company portfolios.

• Identify the strategies that offer the greatest potential for success in the future, measure the impact of recent key events in the dermatology area and understand the latest issues affecting R&D.

Key issues examined in this report
• Generics threaten branded oral acne treatments. The majority of anti-acne brands, excluding Roaccutane and Diane, are based on generic molecules and formulations. This is expected to cause a shift in developmental focus to topical acne treatments and lead to a collapse in the value of the branded oral acne market.

• The future of corticosteroids. Triple combination products and reformulations are continuing to revive the sales of corticosteroid brands following poor performance in 2006. However, widespread genericization is threatening to stifle future growth in this class.

• Competition intensifies for psoriasis treatments. New molecular entities are largely focused upon psoriasis indications. The market is likely to witness strong growth in the forecast period as anti-TNF therapies such as Enbrel and Humira maintain strong performances.

• Shift in competitive landscape. With large pharma companies apparently neglecting their dermatology pipelines, small specialist players can build a market presence through strong lifecycle management strategies and targeted drug development.

Your questions answered
• What will be the major growth indications and drivers in the dermatology area between 2008-13?

• How will the competitive landscapes for acne, psoriasis, dermatitis, rosacea, viral, bacterial and fungal dermatological infection treatments change by 2013?

• Which companies will become the key players in the dermatology market over the period 2008-2013?

• How have recent launches from companies such as GSK, Galderma and Leo Pharma/Warner Chilcott performed?

• Which pipeline products will be the growth drivers of the future?

• How significant is the threat of generics to the global market?

• What key trends and developments will influence the global dermatology market over 2008-13?

Biotech M&A Trends: Deal assessments, trends and future prospects

M&A activity in the pharma industry continues to gain momentum as a growing number of companies seek to replenish drug pipelines through biotechnology acquisitions. M&As between biotech companies are also growing in number, stimulated by the drive to strengthen product portfolios and expand participation in the growing global biotech market. Such deal activity is expected to become an increasingly prominent feature in the biotech sector over the next few years. Over 68% of respondents to Business Insights' recent proprietary survey carried out for this report believe that M&A initiatives will be integral to the continued success of their company.

‘Biotech M&A Trends: Deal assessments, trends and future prospects’ is a report published by Business Insights that analyses trends in biotech M&A deals valued below $1bn across mid/small-sized pharma and biotech companies, including niche biopharma players and diagnostics/medical technology businesses. Trends in the value, volume and geographical distribution of deals are examined based on M&A activity since 2003 and a proprietary Business Insights survey reveals how over 130 industry executives perceive the future of biotech M&As. This report identifies the key factors influencing transactions with an evaluation of over 50 recent deals, in addition to providing a comprehensive case study analysis detailing the strategies behind five major M&A’s.

Some key findings from this report

• US companies accounted for 42% of acquiring companies and 41% of targets in global biotech M&A deals over the 2003-2008 period. UK companies were the second most active as acquirers and targets.
• 4% of M&A deals since 2003 have been valued at more than $500m, while 70% were for less than $100m. The average deal value for the five year period was $94m. Figures are based upon the 378 M&A deals during this period for which values were disclosed.
• Marketed products and technology access continue to be the key drivers of M&A. Of recent M&A deals, 46% have been founded upon targets with commercialized products, while 34% were geared to harness technology platforms.
• Cash is the main payment mechanism for M&A deals. Of the 50 most recent deals for which values are known, 54% were cash-only, while a further 18% were for cash and future milestone payments.
• M&A will be an important source of future company growth. 45% of respondents to a proprietary Business Insights survey expect over 20% of their company’s future growth to stem from M&A.

Top reasons to order your copy today
• Identify the latest trends in M&A activity with this report’s detailed analysis of deal values and volumes over the 2003-2008 period and a geographical breakdown of target and acquirer locations.
• Understand the critical factors influencing M&A transactions, discover the key selection criteria when assessing potential biotech targets and determine the main M&A payment mechanisms by using this report’s examination of 50 biotech M&A deals since 2007.
• Benchmark M&A strategies used to successfully expand product portfolios and geographical presence with this report’s case study analysis of 5 major recent M&A deals including Actelion/Axovan & CoTherix, Antisoma/Xanthus, Forest Labs/Cerexa, Solvay Pharma/Innogenetics, Avant Immunotherapeutics/Celldex Therapeutics.
• Evaluate the future landscape for biotech M&A’s and discover the key influences that will drive future biotech M&A transactions with this report’s assessment of trends in M&A combinations and therapeutic area targeting in addition to the potential impact of reverse mergers.

Key issues examined in this report
• Economic gloom is driving M&A activity. The current economic climate has contributed to an increasingly cautious investment market that has driven trade sales by biotech investors. Biotech acquistions are more attractive to pharma companies than complex licensing deals which can cost as much as gaining total control through acquisition.
• Shifting trends in acquirers and targets. Chinese firms are an appealing target for companies seeking to access the rapidly growing Asian biopharmaceutical market. Indian companies are becoming aggressive acquirers, having accounted for 12% of deals in 2008.
• Acquirer priorities. Approved or late-stage products and technology platforms are priorities for acquiring companies. Products in the early stages of development typically attract smaller acquisition values.
• Influence of personalized medicine. Pharma firms will increasingly target diagnostic companies as part of efforts to advance their product development activities with molecular techniques. In this way, personalized medicine and targeted therapies will begin to blur the boundaries between pharmaceuticals and diagnostics.

Your questions answered
• What are the key selection criteria when assessing potential biotech targets?
• How important are M&A initiatives in relation to company success in the short to mid-term future?
• Why are M&A strategies attractive to a growing number of companies?
• What are the main challenges in M&A dealmaking and how can these be overcome?
• How can biotech companies maximize their value prior to an acquisition?
• What are the current trends in M&A deals valued at less than $1bn?
• Which recently adopted M&A strategies have proven to be the most effective?

Successful Pharma-Biotech Alliance Strategies: Driving synergies, avoiding failure and managing relationships

"The average value of pharma-biotech deals will almost treble by 2015 as pharma companies focus on gaining exclusive access to high potential technologies via large equity investments..."
In recent years, alliances between pharma and biotech companies have become increasingly common.The potential synergistic benefits to both parties have resulted in over 30% of drugs in clinical trials now being a direct product of such alliances. However, poor deal structure and implemenation continue to contribute to the failure of almost half of these relationships.

‘Successful Pharma-Biotech Alliance Strategies’ is a report published by Business Insights that provides a detailed examination of the current alliance landscape and analyses the underlying factors that can determine their success or failure. Recent major joint ventures, acquistions and licensing deals are evaluated and the latest trends and developments affecting alliance management are assessed. This report also examines 9 case studies that profile varying approaches to deal structuring and relationship management, and charts the current and future alliance activities of the top ten pharmaceutical companies. Volume and value forecasts for pharma-biotech deals to 2015 are also provided.

Explore the landscape for pharma-biotech alliances and identify the most successful approaches to deal structuring and relationship management...

Use this new report to...
• Benchmark 9 case studies of key alliance management strategies to help you optimize your drug development alliances by identifying successful and unsuccessful approaches across the areas of deal structure, relationship management and monitoring and deal renegotiation.

• Identify the factors that are pivotal to the success or failure of alliances by measuring the influence of a host of variables including management structure, therapeutic area focus, partner locations, drug development stage and manner of partner introduction.

• Assess the competitive positions of potential pharma/biotech partners with this report’s analysis of current and future biotech positions of the top ten pharmaceutical companies and a detailed evaluation of recent major joint ventures, acquistions and licensing deals.

• Understand the future landscape for pharma-biotech alliances with this report’s analysis of the latest trends and developments influencing relationship management in addition to deal trends that include volume and value forecasts for pharma-biotech deals to 2015.

The CNS Market Outlook to 2013: Competitive landscape, pipeline analysis and growth opportunities

"The global CNS disorders market expanded by 8.0% from 2006, to reach total sales of $77.3bn in 2007. This growth has been primarily driven by treatments for AD, ADHD and Parkinson’s Disease."

The CNS disorders market is one of the largest and fastest growing markets in the pharmaceutical industry. Reimbursement terms continue to be favorable within the area, despite the relatively high risks associated with product development. This is largely due to significant levels of unmet medical need and the clinical specificity of many CNS drugs. High levels of investment have contributued to a rich product pipeline, with an estimated 600 clinical candidates currently under development, and companies are widely engaged in licensing novel/clinically differentiated CNS products. The sector has struggled recently however, with previously dominant product classes coming under increasing pressure from generic competition and safety concerns. ‘The CNS Market Outlook to 2013’ is a new report published by Business Insights that provides comprehensive coverage of the major markets within the global CNS disorders market, incorporating a detailed epidemiological analysis of major indications and key factors impacting their prevalence. This report profiles the factors and underlying trends shaping the market landscape and identifies the most promising areas of potential growth. Current leading brands of treatment within each indication are assessed and ten of the market’s leading players are profiled. Sales forecasts for currently marketed and key pipeline products over the 2008-13 period are also provided. Discover the key trends and growth drivers of the CNS market, assess the competitive dynamics of leading companies and evaluate the future prospects of pipeline products with this report...

Assess the competitive dynamics of leading companies and evaluate the future prospects of pipeline products within the CNS disorders market...

Use this new report to...

Assess epidemiology, treatment trends and sales patterns for treatment markets including depression, schizophrenia, AD, migraine, epilepsy, PD, insomnia and ADHD across major countries including the UK, Japan, France, Germany, Italy, Spain and
the US.

Measure the market performance and strategic positioning of major CNS developers with this report’s evaluation of the franchises and market shares of AstraZeneca, Eli Lilly, Eisai, Forest, GSK, J&J, Novartis, Pfizer, Sanofi Aventis and Wyeth.

Understand the market dynamics of the global CNS disorders area and identify the impact of recent key events by assessing major market trends, growth drivers and the latest issues affecting R&D.

Predict revenues for major currently marketed and pipeline CNS products over 2008-13, with this report’s sales forecasts across major indications, treatment classes and company portfolios.

Discover the strategies that offer the greatest success potential for CNS developers in the future and understand the challenges currently facing companies within this therapeutic area.

The Future of RNAi Therapeutics: Drug pipelines and prospects

"The total RNAi therapy market is estimated to value $580m by 2012. This forecast is based upon current treatments, levels of market satisfaction and five new Phase II/III RNAi agents profiled in this report."

RNA interference continues to offer significant promise for a host of therapeutic treatments. Potentially any disease-causing gene, cell type or tissue can be targeted with RNAi, including those not ‘druggable’ with small molecules or protein-based therapies. Pharma companies are increasingly investing in siRNA optimization or examining siRNA alternatives, in addition to staking out proprietary positions in lipid-based, nanotransporter-based and alternative delivery technologies. The development and licensing of such platforms will become crucial for developers over the coming years. ‘The Future of RNAi Therapeutics: Drug pipelines and prospects’ is a report published by Business Insights that provides an in-depth assessment of recent progress and future opportunities for RNAi players in major therapeutic areas including infectious diseases, cancer, inflammation/immune dysfunction, CNS disorders and cardiology/metabolism. The latest trends in RNAi therapeutics are examined, focusing on the main areas of clinical need, general/proprietary technologies and company pipelines, and the activities and strategies of 37 RNAi-based developers are profiled. This report also provides forecasts for market growth to 2012 across major RNAi market segments. Identify the developmental status of key RNAi agents, review the latest advances in RNAi technologies and assess the competitive landscape with this report’s analysis of 37 companies across major therapeutic areas.

Measure the developmental progress of 97 RNAi agents, review the latest advances in delivery technologies and evaluate 37 RNAi-based companies across major therapeutic areas...

Use this report to...

Analyze emerging RNAi agents and delivery technologies and examine new molecular targets and pipeline antisense drugs.

Evaluate 97 RNAi compounds in development for infectious and inflammatory diseases, cancer and other major disease categories.

Assess 37 competitors and potential collaborators developing RNAi technologies and examine the latest RNAi-related patenting trends.

Identify potential growth segments and develop future strategies with this report’s forecasts for the global RNAi therapy market to 2012.

Innovative Strategies and Models for R&D Success: The evolving networked pharma company

Report overview
Many pharma companies are currently engaged in wide-scale R&D restructuring, adopting a biotechnological approach to drug development by establishing disease-focused R&D units, R&D spin-offs, strategic partnerships and joint ventures. This trend has been reinforced by the emergence of public/private partnerships, co-operatives and open-source research initiatives that have encouraged companies to target previously neglected disease areas such as biotherapeutics and vaccines. Emerging markets are also driving change throughout R&D, with companies increasingly internationalizing their processes to take advantage of tax incentives, government investment, cheap labor and technology specialists.

‘Innovative Strategies and Models for R&D Success’ is a new report published by Business Insights that explores how the latest pharma R&D strategies are improving productivity and containing costs. The effectiveness of new and emerging approaches to drug discovery and development are assessed, with over 40 detailed case studies of partnerships, alliances, collaborations, outsourcing and in-licensing opportunities. This report also explores the potential benefits and disadvantages of key offshore markets including China, India and Russia and examines the recent internal restructurings of major companies such as AstraZeneca, GlaxoSmithKline, Pfizer and Roche.

Use over 40 detailed case studies to assess new R&D approaches, and identify which strategies are most effective for different company sizes, therapeutic area focus, product portfolios and geographical locations.

Key findings
• The pharma industry is migrating towards fully-integrated networked pharmaceutical companies (FINPCos) that can improve productivity and effectively exploit the cost-savings associated with R&D internationalization. This model maximizes investment returns through the use of innovative partnerships and strategic alliances.

• Major companies including AstraZeneca, GSK, Roche and Pfizer have recenty undertaken major R&D restructuring. Changes have typically involved strategic risk-sharing partnerships, collaborations, joint ventures, spin-offs and contract agreements.

• Big Pharma are increasingly engaging in a range of risk-sharing partnerships with academics, federal agencies, contract providers, biotechs and other pharma players. Such alliances alleviate the risks of drug discovery and can improve R&D efficiency.

• Up to 30% of clinical studies are currently outsourced, and this figure will rise to 50% by 2010. This growth will be driven by companies consolidating their focus upon core competencies while contracting out secondary R&D programs to specialists.

• Virtual pharma models can reduce drug development costs by at least 25% and development times by up to 50%. Niche pharma companies have emerged to add value through strategic outsourced clinical developments that are out-licensed to established players.

Key questions answered
• What are public private partnerships and how can they be used to expand R&D programs?

• How will private federal partnerships improve technology transfer to the industry?

• To what extent can R&D outsourcing reduce development times and contain costs?

• Who are the key contract service providers in the emerging markets and what R&D related services do they offer?

• Which alternative R&D strategies are being used to attract investment and drive product development?

• How can pharma companies most effectively ensure shareholder value in the future?

Key issues examined by this report
• Benefits of R&D restructuring. The redesign of pharma R&D models within large companies is creating an entrepreneurial environment that enhances the flow of information and facilitates faster decision-making during product development. Strategic networking is also helping companies to expand their portfolios and develop a new generation of progressive blockbusters.

• New R&D approaches reduce consolidation. Innovative R&D strategies such as risk-sharing partnerships and strategic/tactical outsourcing are helping to combat the declining levels of productivity that are driving industrial consolidation.

• Role of ‘R&D spin-offs’. R&D spin-offs enable pharma companies to streamline their portfolios and reduce overheads, whilst retaining the option to license back successful candidates at a future date. The speed of product development can also be significantly improved away from internal pharma processes.

• Influence of emerging markets. Offshore R&D investments in emerging countires are becoming increasingly attractive following the lifting of WTO restrictions, tightened IP protections, infrastructure improvements and tax exemptions. India, China and Russia offer the most significant cost advatages.

Innovations and Pipelines for Respiratory Disorders: Niche markets, new products and future developments

The market for respiratory disorder treatments is continuing to experience rapid expansion as healthcare payors increasingly acknowledge the high treatment costs associated with chronic indications. A shift in developmental focus has become the driving force for market transformation, with research efforts now targeting the causative disease pathway in an effort to prevent symptom presentation and pathological decline. In the short term, a number of impending product launches will satisfy unmet demand within high-value market niches by addressing issues of patient compliance and targeting patients at the more severe end of the disease spectrum.

‘Innovations and Pipelines for Respiratory Disorders’ is a new report published by Business Insights that examines the future of the respiratory disorders market and explores the dynamics and drivers for current and emerging treatments. This report assesses leading mechanisms of action in drug development pipelines based upon clinical/preclinical results, potential market positioning and sales success in addition to identifying associated investment opportunities. The major trends and issues affecting new product development are highlighted and the future potential of leading innovations is evaluated. This report also identifies major areas of unmet market need and provides a detailed assessment of the currently marketed portfolios and developmental products of key companies within the sector.

Explore the latest trends and innovations in respiratory treatments, assess the performances of currently marketed medications and evaluate the potential of leading pipeline candidates with this report.

Some key findings from this report...
• The respiratory and pulmonary product market expanded at a CAGR of 9.3% over the period 2003-07. Growth has been most prominent in the sale of anti-asthma and COPD products, which accounted for 55% of global respiratory revenues in 2007.

• Anti-asthma and COPD treatments are predominantly comprised of innovative products, which accounted for 64.9% of total product revenues in 2007. Revenue growth in this category is being driven by the sale of both plain, inhaled anticholinergics and inhaled combination products (B2 stimulants and corticosteroids).

• GlaxoSmithKline is the global market leader for respiratory product sales. GSK’s dominance will be reinforced by a strong R&D portfolio that includes a number of phase II combination candidates.

• Research into treatments for cystic fibrosis are currently concentrated on methods of non-viral gene transfer. The successful launch of gene therapy innovatives is not expected until 2030.

• Real-time PCR is a significant development in the treatment of respiratory tract infections, allowing rapid/accurate pathogen identification through genotyping. This will create market potential for targeted, pathogen-specific first line anti-infective treatments.

Top five reasons to order your copy today
• Assess patient potential, treatment trends and sales patterns across the global respiratory market with this report’s analysis of countries including Japan, France, Germany, Italy, Spain, the UK and the US.

• Discover which respiratory indications have the greatest potential to provide franchise growth and profile the key drivers of growth and innovation across Asthma, COPD, Cystic Fybrosis, Pulmonary Hypertension, Respiratory Allergies and Respiratory tract infections.

• Compare the product pipelines, therapy area investments and growth metrics of key players in the respiratory disorders market with this report’s assessment of major companies including GSK, Merck & Co., Boehringer Ingelheim, and AstraZeneca.

• Examine the major unmet needs within the global respiratory disorders market, identify the latest key events and understand the most important issues affecting major companies within this sector.

• Evaluate leading mechanisms of action under development and discover which have the potential to fill current market niches, with this report’s analysis of clinical/preclinical results, potential market positioning, sales performance and investment activity.

Key issues examined in this report...
• Shifting R&D focus. The majority of currently marketed therapies are aimed at treating presenting symptomology, however new disease models have identified biomarkers involved in pathological disease progression which may act as targets for pipeline drug candidates.

• Increased regulatory scrutiny. Stringent analysis of datasets and increased requirements for dataset submission has put pressure on drug developers to focus their pipelines around leading candidates.

• Drive for innovation. The success of leading companies is heavily reliant upon a small number of branded products (eg. Singulair accounts for 99.86% of Merck & Co's respiratory portfolio revenues). Many leading players are now aiming to expand their portfolios by developing new drug candidates with novel mechanisms.

• COPD/Asthma development potential. The most significant opportunities for drug developers remain within the COPD and asthma patient populations, where present treatment regimens are largely inadequate and convenient dosing regimens are required.

Your questions answered...
• What are the leading existing marketed innovatives and how has their success been achieved?

• What are the most exciting compounds currently in development for the different respiratory disease indications?

• What is the forecast sales potential of these products?

• How will novel products be positioned to maximize their potential?

• How do the product pipelines of leading respiratory companies compare and what are their investment and growth strategies?

• What are the differences between the treatment models of leading companies in terms of clinical development?

• Which companies are best positioned to succeed over 2008-12 based on their pipeline clinical candidates?

The Anti-Infectives Market Outlook to 2013
The market for anti-infectives related disorders is set to become increasingly challenging as growing numbers of infectious pathogens become resistant to existing therapies. The resultant shift in R&D strategies has become a driving force behind market transformation, with many manufacturers now focused on developing drugs to counter resistance. Developmental focus has also shifted away from the anti-fungal and anti-bacterial markets due to increasing levels of genericization and comparatively shorter treatment regimens compared to other indications. By contrast, the anti-viral market contains large patient populations with chronic infections that require lifelong treatment, in addition to existing therapies that fail to provide adequate treatment.
‘The Anti-Infectives Market Outlook to 2013’ is a report published by Business Insights that provides comprehensive coverage of the major markets in the global anti-infectives area, incorporating a detailed epidemiological analysis of the four major indications and key factors impacting their prevalence. This report profiles the factors and underlying trends that are driving market transformation and identifies the most promising areas of potential growth. Current leading brands of treatment within each indication are assessed and ten of the market’s leading players are profiled. Sales forecasts for currently marketed and key pipeline products over the 2008-13 period are also provided.
Discover the key trends and growth drivers of the anti-infectives market, assess the competitive dynamics of leading companies and evaluate the future prospects of major products with this report...
Assess leading developmental products within each indication, identify potential growth opportunities and assess leading companies within the anti-infectives market with this report...

Some key findings from this report...
• The global anti-infectives market is forecast to expand at a CAGR of 5.7% between 2008-13. Sales of anti-virals and vaccines are forecast to grow by 7.5% and 9.0% respectively, comfortably outperforming overall market growth during this period.
• The ten leading companies in the anti-infectives market accounted for 53.8% ($37.3bn) of total revenues in 2007. The competitive landscape remains highly fragmented, with market leaders Merck and GSK controlling a combined market share of only 21.4%.
• Anti-bacterials accrued sales of $36.3bn in 2007, accounting for 52.3% of total market revenues. Major growth drivers in this drug class are the cepahalosporins and fluroquinolones, which amassed combined sales of $16.0bn, 45% of total anti-bacterial revenues.
• Anti-fungals were the only drug class to experience a decline in sales over the 2006–2007 period, with a reduction of 2.7%. This is largely attributable to fewer new product launches and toxicity concerns relating to major marketed drugs.
• Market leader GSK is forecast to report a 2% decline in revenue share between 2008-13 due to upcoming patent expirations and a weak developmental pipeline for HIV treatments.

Top reasons to order your copy today
• Assess the epidemiology and forecast prevalence of anti-fungal, anti-bacterial, anti-viral and vaccine markets across major countries including the UK, Japan, France, Germany, Italy, Spain and the US.
• Measure the market performance and strategic positioning of major anti-infectives developers with this report’s evaluation of the franchises and market shares of Abbot, BMS, Gilead Sciences, GSK, J&J, Merck, Novartis, Pfizer, Sanofi-Aventis and Wyeth.
• Identify the market dynamics for the global anti-infectives area and understand the impact of recent key events by assessing major market trends, growth drivers and the latest issues affecting R&D.
• Predict revenues for major currently marketed and pipeline anti-infective products over 2008-13, with this report’s sales forecasts across major indications, treatment classes and company portfolios.
• Discover the strategies that offer the greatest success potential for anti-infectives developers in the future and understand the challenges currently facing companies within this therapeutic area.

Key issues examined in this report...
• Shifting R&D focus for vaccines. The arrival of vaccines that can treat HPV and Herpes Zoster will act as a catalyst for transition within the R&D pipeline. Potential further launches of groundbreaking novel vaccines will help to maintain robust market growth.
• Opportunities in anti-virals. The anti-virals market bears significant future commercial opportunity, with growth in the sector being fuelled by the constant threat of drug resistance, unmet medical need, large patient markets and sub-optimal standards of care.
• Hepatitis C therapies fuel growth. New drug classes in development have the potential to offer significant improvements in efficacy, convenience and tolerability over existing treatment regimens.
• Emerging anti-bacterial trends. Growing concerns over infections caused by gram-negative organisms such as acinetobacters has driven sales of currently marketed products and also catalyzed a shift in R&D focus amongst anti-bacterial developers.

Your questions answered...
• What will be the major growth indications and drivers within the anti-infectives market between 2008-13?
• What are the major current trends within anti-fungals, anti-bacterials, anti-virals and vaccines across the seven major markets?
• How have recent launches from companies such as GSK, Merck, and Pfizer performed?
• What is the forecast commercial potential of the most promising compounds in clinical development?
• What is the forecast market size and growth rate of major anti-infective indications?
• How significant is the threat of generics to the global market?
• Which major pipeline developments will shape future strategies?
• How will the competitive landscape of the global anti-infectives market change over 2008-13?

The Top 10 Generic Pharmaceutical Companies: Positioning, performance and SWOT analyses

The global generics market grew at a faster pace than the global pharma market in 2007, with a CAGR of 16.4% during 2004–2007. Regular patent expirations of blockbuster drugs are the primary growth driver of the industry.
Rising healthcare expenditure has also contributed to industry expansion, with governments coming under growing pressure to provide low cost alternatives to branded drugs. However, the generics market is changing due to the threat from authorized generics, competition from players in emerging countries and increasing consolidation. Teva’s acquisition of Barr Pharmaceuticals is the latest example of companies attempting to improve their market strength and geographical reach via divestments and acquisitions.
‘The Top 10 Generic Pharmaceutical Companies’ is a new report published by Business Insights that analyzes the size, structure and competitive landscape of the global generics market. The top 10 generics companies are assessed based on their market shares, product performances, therapeutic focus and future outlook, and the key issues and challenges facing these companies are examined. The latest industrial trends and developments are assessed across the generics markets of the UK, France, Germany, Italy, Spain and the US. This report also evaluates the strengths and weaknesses of the leading players and provides insights into the opportunities and threats that face them.
Assess the structure, competitive landscape and latest developments in the global generics market, compare the performances and portfolios of leading companies and benchmark their strategies with this report...
Compare the performances and growth strategies of leading generics companies and discover the business models that hold the key to future growth with this report...

Some key findings from this report...
• The global generics market reached $90.7m in 2007, representing a three-year CAGR of 12.1%. Sales of generic drugs are expected to increase by 14–15% in 2008, as compared with branded pharmaceutical growth of 6–7%. Much of this growth will be driven by the introduction of pro-generic reforms to major markets.
• The top 10 generics companies accounted for 28.5% of the global market in 2007. Many leading players are actively updating their product portfolios, seeking growth opportunities in emerging markets, pursuing cost optimization and investing in R&D capabilities.
• The US attained generics sales worth $25.4m in 2007, accounting for 26.3% of global market. However, the generics markets of EU countries have a higher growth rate than the US, and accounted for 14.2% of the global sales in 2007.
• Generics companies are currently facing a number of major challenges including continued pricing pressure, authorized generics, a lack of patient awareness and distrust among healthcare prescribers.
• The nervous system (NS) and cardiovascular system (CVS) were the largest generics therapy areas among the top 10 companies in this report, with a 2007 market share of 31% and 28% respectively.

Top reasons to order your copy today
• Benchmark the top 10 generic companies over the 2004-07 period, and use detailed company analysis to measure the performances and outlooks of major players including Novartis, Teva, Mylan, Apotex, Ratiopharm, Pfizer, Sanofi-Aventis, Watson, Bayer and Stada.
• Assess the market dynamics, sales volumes, growth drivers within major generics markets with this report’s analysis of countries including France, Germany, Italy, Spain, the UK and the US.
• Evaluate the strategies of leading generics companies by using this report to measure the success of their currently marketed products and identifying their geographic expansion, product innovation tactics, major acquisitions and divestments and new product launches.
• Identify the therapeutic focus of the top 10 generics companies, understand how company product portfolios are evolving and examine future growth opportunities within key therapeutic areas.
• Measure the industrial impact of the latest trends and issues including the implications of patent expirations and the future potential of emerging generics markets such as Brazil, Russia, India and China.

Key issues examined in this report...
• Growing presence of branded companies. Branded Pharma companies are increasingly involved in generics production to win back revenues that would otherwise be lost due to patent expiry. After launching their own authorized generics, branded companies are able to delay and inhibit the entry of pure generic players by undercutting price and market share during the exclusivity period.
• Rising pressure on pricing. The long term sustainability of generic pharmaceutical companies is coming under threat after government initiatives to promote low cost generics have contributed to product devaluation and reduced profit margins.
• Increased consolidation. Generic manufacturers are consolidating in order to compete with rising numbers of specialty pharma companies who possess greater scale and R&D capabilities. The regulatory framework for authorized generics also provides easy market access for specialty developers, forcing pure generic players to consolidate in order to achieve greater vertical integration, scale and R&D skills.

Your questions answered...
• What are the latest trends and developments in the major generics markets of the UK, France, Germany, Spain, Italy and the US?
• Who are the top 10 global generic pharmaceutical companies and what are their market shares?
• Which therapy areas have become the focus of the global top 10 generic companies?
• What are the strengths, weaknesses, opportunities and threats facing each of the leading players?
• What are the drivers and resistors of growth across major generics markets?
• What are the key strategies of the leading generics companies and how do these strategies drive revenue and market share?
• What is the future outlook for the global generics industry?

Valuing Pharmaceutical Innovation: Pricing and reimbursement for innovative therapies
"Pricing and reimbursement strategies for innovative new drugs require significant evidence of beneficial clinical and economic outcomes using cost effectiveness and budget impact models..."

Developing, manufacturing and marketing innovative

New pharmaceutical drugs is highly complex and involves significant investment. Market access must be maximized at the highest possible price to generate sufficient sales revenue an acceptable return on investment. However, limited payor budgets and increased competition from other therapies has increased downward pressure on drug prices across the pharma industry.

'Valuing Pharmaceutical Innovation' is a new report published by Business Insights that explores the latest issues and developments surrounding innovative therapy reimbursement. The main supply and demand side factors influencing pricing, market access and reimbursement decisions across a number of major markets are closely examined and the key trends and economic requirements of major therapeutic categories are assessed. This report also identifies the most successful pricing and market access strategies across each category of innovation with a detailed case study analysis of the pricing challenges encountered by both recently launched innovative therapies and those in late stage development.

Use this report’s case study analysis to benchmark the pricing strategies of leading innovative products and evaluate the reimbursement environments of major markets and therapeutic categories...

Use this new report as a platform to:
• Enhance your market access strategies for upcoming products by comparing the regulatory mechanisms influencing reimbursement decisions across countries including Japan, France, Germany, Italy, Spain, the US and the UK.

• Understand the latest challenges and issues facing various
categories of innovation including ‘new market’, ‘redefining the category’, ‘second-generation’, ‘incremental therapeutic’ and ‘incremental formulation’ innovations.

• Assess the innovative drug reimbursement environments of major therapeutic areas by identifying the current trends, unmet medical need and economic requirements of a range of disease categories including oncology, HIV, autoimmune diseases and diabetes.

• Leverage innovative new market access programs to protect prices for novel therapies in cost constrained reimbursement settings.

• Benchmark the reimbursement strategies of leading products by using detailed case studies of recently launched and upcoming innovative therapies across each type of innovative category.

Obesity Drug Markets in the US and EU: Analysis of product pipelines and competitive environment

The rising prevalence of obesity is a growing problem in developed countries, with 32% of Americans and 17% of EU residents considered obese in 2008. The condition is associated with a range of severe co-morbidities, the most significant of which include asthma, cardiovascular disease, cancer, diabetes, hypertension and kidney disease. Obesity-related treatments cost healthcare payors billions of dollars each year, and the market for medications is steadily expanding as incidence of obesity continues to increase. Stringent regulations have restricted the amount of medications currently available, however many currently marketed products are failing to meet consumer needs.

‘Obesity Drug Markets in the US and EU: Analysis of product pipelines and competitive environment’ is a report published by Business Insights that explores the dynamics and drivers of the market for current and emerging obesity treatments. This report evaluates the performances and attributes of currently marketed products and highlights the most effective strategies for securing future success in this therapeutic area. The potential of leading obesity drug candidates is assessed and over 100 compounds are identified across pre-clinical, Phase I, Phase II and Phase III development. Forecasts of future sales are also provided, based upon trends in obesity drug usage, projected prevalence rates and the approval potential of emerging products.

Explore the latest trends and innovations in obesity treatments, assess the performances of currently marketed medications and evaluate the potential of leading pipeline candidates with this report.

Some key findings from this report
• An estimated 17% (85m people) of the EU population are obese and a further 32% (160m people) are overweight. The average rate of obesity in the US is forecast to reach 40% by 2010.

• US sales of obesity drugs more than tripled in 2007 to reach $421m following the introduction of Alli, which accounted for 71% of total revenue. Strong support from GlaxoSmithKline will stimulate further expansion for Alli in both the US and EU.

• The majority of weight loss products currently marketed have proven to be ineffective, with only a small proportion of consumers having been able to achieve and maintain weight loss.

• The US and European obesity drug markets will expand at a combined CAGR of 23.3% between 2008-2012. This growth will be driven by the launch of several products currently in late stage development, and increase revenues to an estimated $3.1b by 2012.

• A large number of novel obesity medications are currently under development, many of which represent novel approaches to the treatment of obesity and new drug classes such as CB1 antagonists and serotonin receptor agonists.

Top five reasons to order your copy today
• Examine the major issues surrounding obesity in the US and EU with this report’s detailed analysis of co-morbidities, prevalence rates by sub-population, socioeconomic impacts, regulatory trends and the latest medical intelligence from this rapidly evolving treatment area.

• Evaluate the relative safety, efficacy and cost of currently marketed obesity drugs with this report’s comparative analysis of Rx and OTC medications including Alli, Meridia, Xenical and Accomplia.

• Explore emerging obesity treatments with details and descriptions of 146 drugs at various stages of pipeline development and assess the safety, efficacy and cross-indication potential of leading obesity drug candidates such as Lorcaserin hydrochloride, Lepislim, Taranabant, Contrave, CP-945,598 and Qnexa.

• Forecast sales for obesity medications in the US and EU through to 2013, measure the performances of currently marketed drugs in each region and discover how competitive dynamics will change in the future.

• Identify the strategies that offer the greatest success potential within the expanding market for obesity treatments and understand the challenges currently facing companies within this therapeutic area.

Key issues examined in this report...
• Full pipelines reflect demand. Increasing proportions of both US andEU populations are becoming overweight, obese, morbidly obese orsuper obese, creating a growing need for treatments in this field. Alarge number of pharma companies are currently developing suchtreatments, most of which are in the early stages of development.

• Consumer dissatisfaction. Consumers are largely dissatisfied withcurrent obesity products, as most require significant lifestyle changes(ie. diet and exercise) that can often prove difficult to accomodate.

• Rising regulatory scrutiny. Heightened scrutiny, particularly at theFDA, is causing approval delays and denials for all drug candidates.Sanofi-Aventis’s new obesity drug, Acomplia, is widely availableoutside the US but was rejected by the FDA on safety concerns.

• Non-prescription availability. Alli’s switch from Rx to OTC usage in2007 reinvigorated the US market for obesity treatments.GlaxoSmithKline is currently pursuing a similar switch in Europe withapproval expected during 2009 at the latest.

Your questions answered
• How can the rising trend of obesity in the US and EU be countered effectively?
• Which approaches to obesity management will experience the most growth through to 2012?
• Why was Alli able to achieve significantly more OTC sales than Xenical?
• Why are there relatively few advanced-stage drug candidates for obesity?
• How will the competitive dynamics of leading obesity medications change in the US and EU over the 2008-2012 period?
• Why is the approval late-stage obesity drugs under threat?
• Which newly identified condition is obesity related to?

Innovations in the Management of Diabetes: Next generation treatments and market dynamics

Diabetes has become the fifth leading cause of death across developed markets, and cases of the disease are forecast to grow by 7.1% across the globe by 2013. The market for innovative diabetes treatments will be driven by this projected rise in prevalence, together with the substantial unmet need for drugs that can effectively halt or reverse disease progression. Although extended lifecycle management for existing antidiabetic therapies may offer sales growth in the short term, the development of new drugs from novel classes will become increasingly important in the future. However, the potential introduction of stricter regulations for diabetes drug development and recent setbacks for novel products have increased speculation about the potential of innovative treatments.
‘Innovations in the Management of Diabetes: Next generation treatments and market dynamics’ is a report published by Business Insights that analyzes the emerging drug classes, novel drug delivery technologies and future growth drivers of the diabetes market. This report explores the major trends and issues affecting the development of novel products and assesses the future potential of leading innovations. The major areas of unmet need in the market are identified and the currently marketed portfolios and developmental compounds of key companies operating within the sector are assessed. This report also examines recent concerns about the safety profiles of marketed products and the possible implementation of stricter FDA regulations.
Explore the latest trends and innovations in diabetes treatments, assess the currently marketed portfolios and pipelines of leading players and identify future market opportunities with this report.

Some key findings from this report

• The global diabetes market value was $24,275mn in 2007, having increased by 13.8% since 2006. The market has maintained steady growth in recent years, with a CAGR of 13.2% over 2003-07.
• OAD drugs and non-invasive insulin drug delivery technologies continue to offer significant potential for market expansion, despite several innovative introductions within new drug classes, such as GLP-1 agonists and DDP-IV inhibitors.
• A number of pharma companies are re-focusing on co-morbidities such as hypertension, dyslipidemia and obesity for innovative product development. Sanofi-Aventis’ Acomplia (rimonabant) is a first-in-class CB-1 antagonist indicated for the treatment of overweight patients with associated Type 2 diabetes or dyslipidemia risk factors.
• Metabolic syndrome has become a focal area for drug developers. The syndrome refers to a clustering of CVD risk factors whose underlying pathophysiology is related to insulin resistance.
• The FDA is considering the implementation of stricter standards when testing diabetes drugs for related cardiovascular risks. The possibility of stricter controls in diabetes drugs development will be a difficult obstacle for several emerging agents.

Top five reasons to order your copy today
• Forecast sales growth for the global diabetes market to 2012 and assess the epidemiology and prevalence rates of Type 1/ Type 2 diabetes with this report’s detailed analysis across Japan, France, Germany, Italy, Spain, the UK and the US.
• Examine the major unmet needs within the global diabetes market, identify the latest key events and understand the most important trends and issues affecting major companies operating in this sector.
• Discover which innovations and new compounds have the greatest potential to catalyze portfolio growth by gaining insights into future growth drivers, emerging drug classes and novel delivery technologies.
• Compare the currently marketed portfolios and product pipelines of key players in the diabetes market and understand how competitive dynamics will change with this report’s assessment of companies including Novo Nordisk, Takeda, Sanofi-Aventis, GSK and Lilly.
• Evaluate the potential of leading competitive strategies with this report’s examination of lifecycle management, diversification, franchise development and new market entry.

Key issues examined in this report...
• The diagnosis/treatment gap. With prevalence rates of diabetes continuing to increase globally, it is estimated that only 50% of Type 2 diabetes patients across the seven major markets have been diagnosed, with only 80% of these patients receiving treatment.
• Inhaled insulin failure. The market withdrawal of SanofiAventis/Pfizer’s Exubera has been compounded by the suspension of NovoNordisk’s AERx iDMS, following claims that the product lacks the potential to offer significant benefits over injected formulas. Lilly/Alkermes ceased development of AIR in March 2008 on the same grounds.
• New drug classes. The diabetes treatment paradigm may potentially be altered following the introduction of several new drugs that target the underlying causes of diabetes rather than the symptoms.
• Potential for innovatives. The global diabetes market is forecast to grow significantly over the next five years, driven by an increasing global prevalence creating expanded patient populations and the continued launch of novel drugs. Immense market potential exists for companies who address combined risk factors effectively.

Your questions answered...
• Which markets will experience an increase in the prevalence of diabetes?
• What are the latest technological developments in this field?
• Which treatment areas have become the focus of R&D investment?
• Are currently marketed innovatives satisfying demand?
• What are the drivers and resistors to growth for new products?
• Which pharma companies are implementing lifecycle management strategies for their diabetes portfolios?
• What are the implications of stricter FDA regulations for product approvals?
• How can companies most effectively prepare for impending changes to the market for innovative treatments?

Leading Drug Delivery Companies and Technologies: Competitive landscape, company profiles and technological developments

Over the last decade, the drug delivery industry has evolved to become a key area in the development of value-added pharmaceutical products. The global market grew from $15bn to $40bn during 2000–2006 as companies increasingly turned to drug delivery technologies as a means of expanding product lifecycles, enhancing drug efficacy and maximizing revenues. Although the market is still dominated by the oral drug delivery system, a number of novel technologies are emerging across all systems of delivery. However, the pure drug delivery company model is rapidly becoming extinct as leading players attempt to consolidate their strategic opportunities by expanding their focus towards manufacturing, a trend that is expected to accelerate over the next five years.

‘Leading Drug Delivery Companies and Technologies’ is a report published by Business Insights that examines the current and future trends that are shaping the drug delivery market and reviews the key emerging technologies across major systems of drug delivery. This report identifies the product portfolios and targeted therapeutic areas of leading drug delivery companies in addition to assessing their technology platforms to provide guidance over their applicability, regulatory implications and developmental progress. This report also evaluates the opportunities and threats facing each of the companies profiled and provides a comparative analysis of the growth strategies used to facilitate successful deals and collaborations.

Identify key trends and developments in the global drug delivery market, assess the performances and portfolios of leading drug delivery companies and benchmark their strategies with this report...

Some key findings from this report...
• The oral delivery system continues to dominate the drug delivery market due to convenient usage, cost-effectiveness and low frequency of administration. Needleless injectables, PEGylation technologies and micro-electromechanical devices are among the novel technologies with the greatest growth potential.

• The market for parenteral drugs and solutions sold in prefilled syringes and premixed IV systems will grow, due to the ease of administration and resistance to infections associated with these methods. The needle-free delivery sector will rise to $3bn by 2010.

• Pulmonary delivery technologies are increasingly prevalent in pain management, cystic fibrosis and diabetes. Pulmonary-based delivery vehicles are currently the focus of a number of major companies including Nektar, Aradigm, 3M, and Alkermes.

• Dry powder inhalers will secure the largest share of sales within the asthma market, as demand for treatments in this therapy area continues to expand. However, MDI products will experience a relatively higher rate of growth due to consistent improvements in particle size and safe propellant delivery.

Top reasons to order your copy today
• Discover the key issues and trends in the global drug delivery market with this report’s analysis of market size and growth, the commercial value of drug delivery systems and the extended strategic focus of growing numbers of drug delivery companies.

• Identify the dynamics of major drug delivery systems by evaluating the latest market developments and technological innovations in oral, pulmonary, injectable and transdermal delivery platforms.

• Assess the leading players in the drug delivery market with this report’s review of the opportunities and threats, financial performances and R&D expenditures of Biovail, Elan, SkyePharma, Alkermes, Bioject, QLT, Nektar, Aradigm, Antares, Noven, Alza and 3M.

• Benchmark the strategies of leading drug delivery companies by evaluating their product portfolios and pipelines, deals and alliances, targeted therapeutic areas and technology platforms

Key issues examined in this report...

• Technology driving growth. Drug delivery technologies are being used to boost revenues and enhance product efficacy by developing future commercial opportunities and expanding product lifecycles.

• Expanding strategic focus. A growing number of drug delivery companies are evolving into specialty pharma companies. Widening the core business to incorporate manufacturing is a strategy increasingly used to enhance revenues.

• Stagnant R&D investment. The companies featured in this report recorded an average growth in R&D expenditure of just 6% during 2003–2007. This low growth in R&D spend is likely to inhibit the discovery and development of new products in the short term.

• Inhaled insulin setback. The development of inhaled insulin has been the focus of many companies operating in the pulmonary drug delivery field. However, a high number late-stage terminations have raised doubts over the commercial potential of this delivery vehicle.

Your questions answered...
• What are the major issues surrounding drug delivery within the global pharma industry?

• What are the latest innovations and developments in different drug delivery vehicles?

• What are the market dynamics for oral, injectable, pulmonary and transdermal drug delivery systems?

• What are the key technologies and growth strategies of leading drug delivery companies?

• What are the product portfolios, pipeline candidates, financial performances and R&D expenditures of these leading companies?

• What opportunities and threats will drug delivery companies face in the future?

Contract Manufacturing Strategies

Drug manufacturing now typically accounts for 25% of company costs and achieving agility in the production process has become essential for pharma companies hoping to align their supply chains with constant shifts in global product demand. In addition to offering efficiencies in cost, capacity and time-to-market, contract manufacturing organizations (CMOs) can provide innovative, state-of-the-art process and production technologies to support the rapid technical transfer of products from R&D to commercial manufacturing. However, the effective management of the CMO/sponsor relationship is critical not only in satisfying regulatory requirements amid growing concerns over quality control, but also in meeting the overall commercial aim of the project.
‘Contract Manufacturing Strategies: Market developments, technology transfer and key success factors’ is a report published by Business Insights that explores the future of the contract manufacturing market with a detailed analysis of emerging drivers and restraints, business models and production strategies. The potential benefits and risks of contract manufacturing are assessed and the key strategies for effective CMO selection and successful relationship management are identified. This report also reviews the latest FDA contract legislation to determine the most effective measures in ensuring regulatory compliance and assesses the rapidly expanding markets of India and China to discover their growth potential and regulatory outlook.
Understand how the CMO market will develop over 2008-2013, identify emerging manufacturing strategies/regulatory issues and assess the outsourcing growth potential of India and China with this report...

Some key findings from this report...
• The global CMO market will be worth $20.5bn by the end of 2008, having expanded from $12.8bn in 2002. Steady growth in this sector is set to continue, with a projected CAGR of 10%.
• Contract Research and Manufacturing Organization (CRAMs) have emerged as key future business models, engaging in both contract research and manufacturing. These hybrids can offer molecule synthesis from the milligram to the multi-hundred-tonne scale.
• 29% of all manufacturing output is expected to be produced via third parties by 2010, as large companies continue to scale back on production and focus on core competencies. Major players including AstraZeneca, Roche, Pfizer and Schering are currently undertaking manufacturing strategy reviews to enhance profitability.
• Asia-based CMOs increased their contract service revenues by 44% over the 2006-2007 period. Low-cost competition from Asia will be a key influence on the CMO industry over the next 5-10 years.
• Biologicals manufacturing has become a focus area for CMOs. The number of new biotechnology-based drugs progressing through development far exceeds the number of conventional drugs

Top five reasons to order your copy today
• Assess future outsourcing trends and manufacturing strategies with this report’s analysis of the changing CMO industry structure, emerging business model capabilities and five year market growth forecasts.
• Discover the outsourcing potential of India and China and measure the impact of low cost manufacturing by using this report’s assessment of future growth potential, regulatory frameworks, recent patent and safety issues and a case study of Heparin producers in China.
• Identify the latest FDA contract manufacturing legislation and understand the how to ensure regulatory compliance by examining current regulatory requirements for both sponsors and contract manufacturers.
• Understand the key success factors for establishing successful CMO partnerships with this report’s detailed analysis of the multi-step sourcing process for CMOs and determine the essential criteria for CMO selection and effective relationship management.
• Evaluate the major risks and challenges of contract manufacturing projects by gaining insights into potential downsides and costs.

Key issues examined in this report...
• Importance of tech-transfer/scale-up. Effective technology transfer is a key component in the success of a contract-manufacturing project, but it is engulfed in uncertainty. Timelines and costs both vary dramatically, and together with scale-up capabilities, this constitutes a deciding factor in determining the fit between a client and a CMO.
• Ensuring regulatory compliance. The client company is deemed to be responsible for the manufacturing process, whether it be external or internal. All facilities involved in the manufacturing/testing of a drug product must adhere to the cGMPs that apply to their operations.
• Effective risk management. Although the risk of drug failure is assumed by the client company, the CMO business model is not designed to absorb high levels of risk. It is therefore critical for the client company to implement a wide array of risk-mitigation tactics.
• Offshoring to India/China. Asia continues to expand it’s outsourcing capabilities to offer high cost-savings and revenue-growth opportunities, however many CMOs in the region are still failing to demonstrate the levels of regulatory compliance expected by clients.

Your questions answered...
• How will the CMO market develop over the period 2008-11?
• What are the key factors influencing ‘buy vs. make’ decisions in biomanufacturing?
• Which are the current market drivers and constraints of the contract biomanufacturing market?
• What is the forecast global manufacturing capacity and growth rates for microbial fermentation and mammalian cell culture expression
systems over 2006-2011?
• What kind of risks and challenges are inherent in an outsourced manufacturing project?
• What are the key selection criteria and success factors for contract manufacturing organizations?
• What are the critical issues affecting technology transfer & scale-up?
• How will India and China influence the global CMO market?
• What is the long-term future of in-house manufacturing?

Emerging Role of Postmarketing Clinical Research: Regulatory Compliance, Product Differentiation and Key Issues

Report overview

The pharmaceutical industry has recently endured intense speculation and negative publicity as a result of high profile product withdrawals caused by inadequate safety profiles. Regulatory bodies have responded swiftly; the FDA now requires mandatory surveillance data submission for drugs under increased scrutiny, and the EMEA is close to implementing similar strategies as part of drug policy harmonization initiatives for phase IV trials. Postmarketing clinical research has also become a key feature of product lifecycle management. Phase IIIb/IV trials are increasingly being used in company specific initiatives to provide strategic guidance in areas such as payor approval and reimbursement, indication expansion, franchise development and marketing.

‘Emerging Role of Postmarketing Clinical Research’ is a report published by Business Insights that uses detailed case studies and market scenarios to examine the latest issues surrounding phase IV trial applications. The potential to leverage competitive advantage with postmarketing research is assessed by measuring the implications for formulary access, product marketing, indication expansion and reimbursement coverage. This report also explores the regulatory issues and requirements affecting mandatory postmarketing trial conduct and identifies the key components of effective phase IV trial design and completion.

Identify the latest regulatory developments affecting postmarketing clinical research, use case studies to evaluate recent phase IV trial implementations and understand the competitive potential of successful trial designs...

Key findings...

• US Government initiatives have almost doubled the number of post-approval commitments since 2003-2004, following growing numbers of black box warnings and late-stage drug withdrawals.
• The EMEA and FDA will continue to harmonize regulatory approaches for phase IV monitoring and study commitments in areas of common interest, including pandemic vaccines, medicines for children, rare diseases and cancer medicines.
• Big Pharma companies conducted 145 (75%) of the 243 industry trials publicly registered with the FDA between 1998-2007. Of these trials, 109 were independently undertaken by big pharma as strategic initiatives. Average Big Pharma patient numbers (1743) far exceeded those of mid-tier biopharma companies (952).
• The implementation of a networked model of stakeholder involvement has become crucial to the success of drug developers by enabling access to new development platforms and facilitating effective trial management/sponsorship
• Active controls featured in 71 industry-sponsored trials, the majority of which were conducted under randomized, open label, parallel assignments. Of the 14 registered trials for medical devices, seven were undertaken with active control comparators in an interventional setting.

Key questions answered...
• How will the rising significance of postmarketing research cause pharma and biotech companies to restructure?
• How can phase IIIb/IV trials be used to successfully manage product lifecycles and market positioning?
• To what extent will the increased regulatory demands over postmarketing data collection and submission impact the pharma industry?
• What are the precise requirements for clinical data submission and how are these relevant to company-specific initiatives?
• How can market competition influence trial design and conduct?
• How has the FDA Amendment Act of 2007 affected prescription drug regulations and postmarketing commitment criterion?

Key issues examined...
• Revised R&D resource allocation. As regulators and companies increasingly apply postmarketing surveillance to justify product positioning and long term safety/efficacy profiles, financial investment in phase IIIb/IV trials will grow at a relatively higher rate than other stages of clinical development.
• New regulatory policies. The FDA will soon require mandatory submission of phase IV surveillance data over a large patient population. In addition, products approved on the grounds of accelerated procedures, or those which incorporated surrogate endpoints/biostatistical modelling techniques in early phase data, will require further commitment studies after conditional approval.
• Impact on lifecycle management. Marketing and product labelling companies are under pressure to justify claims through postmarketing study data submission, whilst indication expansion development strategies require postmarketing product data submission to support applications for extended approval.
• Importance of trial design/management. With multiple applications for trial data, trial design and management is crucial in identifying potential issues or adjustments as early as possible. Proactive adaptive designs and electronic data capture techniques are necessary for the ongoing analysis of collated datasets.

Top reasons to purchase this report

• Assess the industry impact of recent regulatory developments in postmarketing commitment trials and surveillance studies

• Use detailed case studies to understand the influence of phase IV trials upon lifecycle management, indication expansion and reimbursement

• Identify how postmarketing strategies can enhance product differentiation, market development and formulary coverage

• Evaluate the operational objectives and trial management/outsourcing trends for phase IV trials across key industry sectors

Innovative Clinical Trial Design and Management: Trends, success stories and impact upon R&D budgets
Report overview
The costs associated with developing drugs have risen dramatically over the past decade and fewer drugs are obtaining regulatory approval. The pharmaceutical industry is continually exploring new ways of improving drug developments and one area of focus is adaptive clinical trial designs. These innovative clinical trial designs use accumulating data to guide potential modifications to the study as it progresses, without undermining the validity and integrity of the trial. The advantages of such designs include the reduced length and cost of clinical trials, lower patient numbers and the ability to stop a trial early where a drug has not shown efficacy.

‘Innovative Clinical Trial Design and Management’ is a new report published by Business Insights that explores the major types of adaptive design and their role in dose-finding. The report investigates seamless Phase 2/3 trials and adaptive trials in pharmacogenomics, assesses the logistical implications of adaptive trial implementations and reviews the current regulatory standpoints of the FDA and EMEA. Detailed case studies of recent adaptive clinical trials are provided and the companies offering statistical expertise in this area are profiled. This report also includes a breakdown of the potential cost and time savings that innovative trial designs can offer throughout the clinical development process.

Use detailed case studies to explore recent adaptive trial implementations, identify the companies pioneering and supporting innovative designs and understand the most effective planning and logistics strategies... 15

Key findings...

Major pharma companies are implementing adaptive trials to improve dose-finding in the Phase 2 setting. The use of adaptive clinical trials will increase across the industry over the next 2-3 years.

Adaptive clinical trial designs are more effective than traditional designs in cases where there is uncertainty surrounding the dose, effect size and variability, clinical endpoint or patient populations.

The planning and execution of adaptive designs is more complex than the traditional approach. Successful implementations require teams of statisticians, data managers, clinicians and drug supply and logistics managers to work together as early as possible.

Predictive biomarkers have been found to require detailed prospective analysis far earlier in the clinical development process, and with the same clarity as traditional drug approvals. Post-hoc correlations were previously thought to be good enough for identifying the biomarkers used to predict the patients most likely to respond well to a new treatment.

Regulatory authorities are supportive of adaptive trials, particularly in the Phase 2 setting. However, there are concerns over the confidentiality of data and companies have been asked to demonstrate that the parties involved in running the study will remain unaware of ongoing adaptations.

Key questions answered...
• How can adaptive trials improve the success rates of clinical drug projects?
• How are pharma companies implementing adaptive trials and what major hurdles can prevent such implementations?
• What is the position of the FDA and EMEA in regards to different types of adaptive trial?
• How can logistical and strategic planning be managed most effectively?
• Which companies are offering services to support adaptive clinical trials?
• Which companies are co-developing drugs and diagnostic products?

Key issues examined by this report...

• Adaptive trial implementations. The aim of adaptive trials is to improve the information value of clinical trials whilst maintaining their integrity and validity. The use of adaptive trials in the early phases of drug development should yield better information and lead to the earlier termination of unsuccessful compounds.

• Dose finding improvements. The availability of new Bayesian study designs that acknowledge prior information and allow for the testing of a wider range of doses has enabled more accurate dose-finding. This may have important consequences for the success of future Phase 3 clinical programs

• Seamless trial speed. Major pharma companies are interested in the prospect of combining drug development phases into ‘seamless trials’, with the potential to reduce the length of clinical development programs in the Phase 2b/3 setting

• Regulatory issues. Engaging with the FDA/EMEA during the protocol design stages of an adaptive trial is important, especially for studies intended for use in packages of pivotal clinical data. The EMEA’s current position on adaptive clinical trial design is summarized within a reflection paper published in October 2007, while draft FDA guidance is expected in 2008.

The Convergence of Biomarkers and Diagnostics: Therapy area analyses, key products and future trends

In recent years, there have been concerted efforts to enhance the precision of disease diagnosis and monitoring as the hetrogeneity of conditions becomes increasingly understood. Targeting broad patient populations in a ‘one-pill-fits-all’ approach has begun to attract criticism, with the average efficacy of such drugs being estimated at 50% or less. In the current climate, biomarkers have emerged as key tools in the realisation of personalised medicine by characterizing specific diseases and treatment responses at the DNA, RNA, protein, or metabolite level.
‘The Convergence of Biomarkers and Diagnostics’ is a report published by Business Insights that provides a detailed assessment of recent developments and future opportunities for biomarker companies in all major therapeutic areas. This report analyzes the markets for diagnostic biomarkers, including currently marketed products and products in development, and examines current trends in the discovery, validation and clinical application of biomarkers. Advances in biomarker detection technologies are profiled and the strategies of companies involved in biomarker discovery or diagnostic development are assessed. This report also forecasts growth in biomarker and diagnostic segments to 2012.
Identify the latest developments in diagnostic biomarkers, examine biomarker-related patent trends and benchmark the strategies used to identify and validate novel biomarkers with this report.

Key findings...
• The biomarker market was worth $5.5bn in 2007 and is forecast to grow at a CAGR of 17.6% to $12.4b in 2012. Rapid growth in the cardiovascular segment will result in this area becoming the leading category by sales volume in 2012.
• Cancer has more biomarker patent claims than any other indication based on analysis from patent documents in the World Intellectual Property Organization (WIPO) database.
• A large number of cardiovascular-based biomarkers are under investigation for inclusion in multimarker panels, including those indicative of inflammation, plaque instability and rupture, thrombosis and ischemia.
• Genotyping tests (primarily for viral infections) are currently worth an estimated $104mn. Business Insights forecast that this will grow to $686m in 2012 to become the fastest growing segment in the biomarker market, with an CAGR of 45.8%.
• Specialist companies use a variety of strategies and technologies to discover and validate new diagnostic biomarkers, with many bioinformatics companies now supporting biomarker discovery.

Key questions answered...
• What types of molecules can serve as diagnostic biomarkers?
• Which in-vitro biomarker detection platforms are currently available?
• Where has progress been most evident in cancer, CNS, Alzheimer's and cardiovascular disease profiling?
• What are the latest developments in the search for new diagnostic biomarkers?
• Why are multimarker assays being developed?
• What is the outlook for the biomarker-based diagnostics market?

Key issues examined by this report...
• Rise of omic technologies. There is growing interest in the application of high-throughput omic technologies to biomarker discovery. Recent advances have provided a large inventory of candidate DNA, RNA, and protein biomarkers with potential for risk assessment, screening, diagnosis, prognosis, and selection.
• Advances in diagnostics. Transcriptomic, proteomic and metabolomic profiling represents a revolutionary approach to molecular diagnostics. It is anticipated that proteomic profiling will result in better tests to diagnose HBV infection.
• Biomarker-based targeting. With increasing numbers of drugs failing when aimed at broad populations, biomarkers are being used to differentiate between patient groups. This will help
pharma companies revive the fortunes of poor performing products and develop new targeted drugs.
• Multiple biomarkers. There is an growing consensus that multiple biomarkers convey the multi-dimensional nature of a disease state more accurately, with panels of biomarkers expected to become the norm in the future. Researchers are also increasingly turning to biomedical imaging as a tool to track disease progress and improve patient outcomes.

Top reasons to purchase this report…
• Identify developments and opportunities in biomarker-based diagnostics across cancer, CNS, infectious and cardiovascular diseases.
• Review the technologies used in biomarker discovery and validation and those enabling the translation of biomarker discoveries into clinical assays.
• Identify the main segments of the biomarker-based diagnostics market and forecast market growth to 2012.
• Assess the strategies of companies who are active in biomarker discovery and diagnostic test development.

Drug Approval Trends at the FDA and EMEA

Drug safety has become a major industry concern following the market withdrawal of Merck’s Vioxx in 2004 and several other discontinuations of COX-2 inhibitors. Although adverse reactions were previously considered a relatively minor risk compared to a drug’s wider benefit, both newly approved and established drugs are now under intense scrutiny.

Drug approvals in the US and Europe have become subject to approval delays, rising requests for further clinical data, and greater chances of rejection. Regulators are currently attempting to reconfigure review processes in order to minimize delays in recognition of the potential mass benefit of new applications. Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and industry response is a new report published by Business Insights that provides a comprehensive review of current drug approval trends in the US and Europe with case studies highlighting successful and unsuccessful applications. Emerging regulatory developments and process improvements are examined and the strategic measures implemented by developers to enhance the approval potential of their drugs are assessed. This report also evaluates the future regulatory landscapes of the FDA and EMEA, with a review of anticipated developments through to 2012.

Understand the changing landscape for FDA and EMEA drug approvals, discover the implications of process changes upon your drug applications and anticipate future regulatory developments with this report...

Some key findings from this report...
• The FDA and EMEA are asking for more data in drug applications that pose heightened safety concerns, although there have been no official changes in overall drug approval standards.

• The number of new molecular entities approved in the US each year has declined from 36 to 18 since 2004, despite a sustained increase in the amount of clinical trials conducted.

• The EMEA is approving fewer products than the FDA even though processing speed and volume have been significantly improved. System reforms include reduced review times, faster approvals for innovative drugs and relaxed requirements in pediatric trials.

• Information about new drug candidates is being increasingly shared by the FDA and EMEA as globalization continues throughout the pharma industry. Such convergence is prominent in the orphan drugs area, where evaluations require considerable resources.

• Biosimilar approval structures in the EMEA are significantly more comprehensive than those of the FDA. Europe is now becoming the global center for biosimilar development and production.

Top five reasons to order your copy today
• Examine the latest developments in US and European drug approval processes with this report’s detailed analysis of the key regulatory issues surrounding new molecular entities, generic drug applications, indication expansions and drug safety.

• Understand the implications of rising adverse drug reactions by exploring the issues surrounding safety failures and measuring the potentially affected patient populations of recent discontinuations.

• Measure the future impact of drug approval trends on R&D programs using this report’s extensive review of anticipated changes to FDA and EMEA approval frameworks over the 2008-12 period.

• Evaluate the strategies that companies are using to accelerate drug approvals by understanding the latest industrial approaches to safety test improvements, outsourcing, repositioning and the management of clinical study results and data reporting.

• Benchmark successful drug applications and avoid approval delays with this report’s case studies featuring numerous profiles for issues such as risky drug applications, biosimilar approvals and Rx-to OTC switches.

Key issues examined in this report...
• Delayed approvals. Regulators are requesting more data to validate or refute conclusions about product risks. This is creating a rise in the size and number of clinical trials as well as overall research budgets.

• Rising R&D costs. Drug developers are continually increasing their R&D expenditures to generate approvable drug applications, despite rising financial pressures in the industry. Emerging technologies such as stem cells, genomics and proteomics are among the most prevalent initiatives being used to identify appropriate drug candidates.

• US generics focus. The FDA is allocating resources to generic drug approvals in an attempt to speed these products to market. However, although Europe has recently developed a clear regulatory path for generic versions of biologicals, this is yet be achieved in the US.

• Regulatory process improvements. Regulators are enhancing their drug review processes with new technologies such as electronic drug applications and technology-based standards for drug review.

Your questions answered...
• Why are new molecular entities experiencing growing approval delays?

• How is the FDA responding to allegations that reviewers are being influenced by the intense pressure to approve new products?

• In which therapy areas are the FDA currently showing the greatest flexibility for novel product approval?

• How will the FDA encourage Rx-to-OTC switches of novel medicines?

• What technologies are drug makers utilizing to help speed the drug development process?

• What new processes has the EMEA recently established to significantly speed drug approvals?

• What emerging trends are companies using to bypass early-stage drug testing?

• How has the convergence of FDA and EMEA approaches benefited European drug marketers?

The Fastest Growing Biotechnology Companies
In recent years, the biopharmaceutical industry has emerged as one of the most important sectors in the Healthcare field. Advances in life sciences have resulted in the drug discovery process becoming more science-intensive, with an increasing emphasis on cross-company collaborations and the exchange of information. However, growing commercial pressures and rising R&D costs have prompted many biotech companies to seek financial support from global Big Pharma corporations through licensing and collaborative R&D deals. Progressive enhancements in integration have subsequently led to traditional pharma companies becoming increasingly dependant upon the technology platforms and approaches adopted by biotech companies.
The Fastest Growing Biotechnology Companies: Growth strategies, comparative analyses and company profiles is a new report published by Business Insights that examines the structure and organization of the biopharmaceutical industry with a detailed analysis of the fastest growing biotechnology companies. This report provides a comparative analysis of growth strategies and reviews the methods used to improve operational efficiency in light of cost pressures, generic competition, complex pricing, regulations, and globalization. This report also explores the levels of interaction and integration between biopharma companies and the wider pharma industry.
Use key indicators to assess the performances of the fastest growing biotech companies, benchmark their most successful strategies and understand major industrial issues with this new report.

Top five reasons to order your copy today
• Identify the fastest growing biotech companies over the 2002-06 period, and use detailed company analysis to measure the performances and outlooks of major players including Theravance, ISTA, Palatin, Pharmion, Amylin, Trimeris, ViroPharma, NPS, SIGA and Idenix.
• Discover which therapeutic areas have been targeted by the fastest growing biotech companies and determine which strategies they have used to exploit proprietary technologies and intellectual property.
• Review the progress of biotech development programs and understand the regulatory status of new products in development, patents held and the current status of marketed products.
• Benchmark the strategies of the fastest growing biotech companies with this report’s assessment of the effectiveness and wider implications of a host of leading strategic implementations.
• Understand how biopharma drug discovery programs are being improved to develop more efficient methods in the screening of new chemical entities (NCEs).

Key issues examined in this report...
• Biotech losses. Only eleven of the world’s top twenty biotechnology companies currently attain a positive net income. This trend is a key industry-wide issue, with companies now attempting to stabilize financial performance.
• Developmental uncertainty. Biotherapeutic developments continue to face a high level of uncertainty. A wide array of factors can contribute to the delay or late-stage failure of promising products.
• External investment. Time-consuming, risky and expensive biopharma product developments require high levels of investment and investor patience, as market-generated revenues are often late in materializing. Investors often pursue milestone payments, joint ventures, out-licensing deals, or M&A as alternative exit strategies.
• Partnership trends. The majority of dedicated biotech companies have attempted to establish strategic alliances, joint ventures and even mergers between themselves and major pharma companies.

Some key findings from this report...
• Theravance, Inc. is the fastest growing biotechnology company in the world, with a growth rate of 12,456% over the 2002-06 period. However, Theravance also has one of the highest levels of net losses within the industry, highlighting the need to sustain more stable, predictable and stronger financial performance.
• ISTA Pharmaceuticals, Inc is the world’s second fastest growing biotechnology company, with a growth rate of 11,773% between 2002-06. Palatin Technologies, Inc. is in third position with a growth rate of 6,928% during the same period.
• Amylin Pharmaceuticals, Inc. recorded the greatest sales gains over 2002-2006, with an increase of $497.4mn during this period.
• The top 10 fastest growing biotechnology companies had a combined R&D expenditure of $734mn in 2006. This constitutes an increase of $324.7mn since 2002, and a five year growth rate of 179%.
• Flexible or adaptive clinical trial designs and proprietary Internet applications are helping to bring products to market faster by improving the efficiency of clincial trials. A prominent example of this is MetaTrial’s Electronic Data Capture (EDC) software.

Your questions answered...
• Who are the fastest growing biotechnology companies in the world?
• What is their level of R&D expenditure and how does this compare to their revenues?
• What proportion of biotech company revenues are accounted for by marketed products?
• What license agreements, joint ventures and partnerships have been established by the fastest growing biotech companies?
• How profitable is the biopharmaceutical industry?
• What key strategic tactics are being adopted by the fastest growing biotech companies in R&D, product commercialization, cost containment, manufacturing and screening/development of NCEs?
• What are the strengths, weaknesses, opportunities and threats to each of the companies profiled within this report?
• What is the product pipeline status of major biotech companies?

Impact of Pharmacogenomics on Public Healthcare Policy

Immense advances in genetic code decipherment over the last decade have recently led to personalized medicine, or ‘the right drug for the right person’, becoming an achievable concept. Pharmacogenomics (PGx) embodies the principles of personalized medicine by combining pharmacology with genetic information to improve drug safety and efficiency. The pharma industry is currently applying PGx throughout its R&D processes to enhance decision making, streamline clinical trial design and reduce drug failures and product withdrawals. Companies are also attempting to increase the impact of PGx by engaging in strategic alliances and collaborations. However, it is crucial that governments and regulators provide sufficient rewards for developers if innovation in this field to continue. This can be achieved by establishing suitable incentives, regulatory frameworks and reimbursement environments.
Impact of Pharmacogenomics on Public Healthcare Policy: Educating patients, payors and regulators is a new report published by Business Insights that examines how PGx implementations can help to improve efficiency and productivity within the industry, across the fields of pharma, biotech and diagnostics. The PGx strategies of major companies are profiled and recent alliances and licensing opportunities are highlighted. This report discusses how reimbursement issues may influence the uptake of PGx and assesses major regulatory issues in Europe, Japan and the US. The current market trends, future challenges and opportunities facing PGx are also investigated.
Discover the potential value of pharmacogenomic tests and products to your R&D program, identify the latest regulatory and reimbursement issues and benchmark PGx implementation strategies with this report.

Top five reasons to order your copy today
• Identify how companies are implementing PGx technologies with this report’s analysis of key strategies, alliances and licensing opportunities for major pharma, biotech and diagnostics companies.
• Discover how PGx can create cost-savings through improved decision-making and reduced development times by examining the challenges and opportunities facing this technology and assessing the realistically attainable benefits.
• Understand the latest reimbursement issues influencing coverage, coding and payment in the PGx field by using this report’s profile of key reimbursement drivers and analysis of the cost-effectiveness and commercial viability of PGx tests and technologies.
• Assess the extent to which changes in the regulatory landscape may influence future applications of PGx with this report’s analysis of influential white papers currently under review and major developments in the regulatory environments of Europe, Japan and the US.
• Evaluate stakeholder importance in the uptake of PGx products and tests and understand how education and patient consent will affect PGx utilization in the drive towards personalized medicine.
Some key findings from this report...
• Pharmacogenomics (PGx) can improve drug safety and efficiency to increase success rates in pharma R&D. Although the biotech and diagnostic industries have been quick to adopt this technology, the pharma industry has been the slowest to realize the potential benefits.
• Regulators in the US, Europe and Japan are beginning to engage in the collection, submission and analysis of PGx data through a newly established regulatory framework. However, there are concerns that regulations that may stifle innovation in this rapidly evolving field.
• Pharma, biotech and diagnostics companies have adopted a variety of PGx strategies in their R&D programs, and in some cases have active companion diagnostic programs that run in parallel.
• The pharma industry continues to fight for cost-effectiveness and fair reimbursement in PGx tests and products. PGx testing is generally not mandatory prior to drug prescription and approval does not currently guarantee reimbursement.
• The patent landscape will become more complex as companies seek to develop personalized medicines in an effort to improve the proprietary status of approved and novel drugs.

Key issues examined in this report...
• Productivity improvements. PGx technologies aim to alleviate the current productivity crisis in the biopharma industry, specifically in terms of regulatory approvals, reimbursement, containment of R&D costs and accurate stratification of patient populations.
• Industrial consolidation. Reductions in productivity have been one of the key factors driving consolidation within the pharma industry. The application of new technologies such as PGX testing and patient stratification is helping to address this issue.
• Go/no-go decision-making. The additional information and resources associated with PGx applications can be used to make go/no-go decisions earlier in the drug development process, reducing the financial liability of potential drug failures.
• Toxicology and safety. Effective PGx implementations can result in the earlier identification of toxicology and safety issues in late-stage R&D. Clinical trials can then be adapted to reposition the drug candidate, significantly reducing the prospect of negative publicity.

Your questions answered...
• What is PGx and how is it being applied in the industry?
• Which of the leading companies adopting PGx and how are they applying it to their development programs?
• What are the opportunities and challenges facing PGx?
• Which strategies are diagnostic companies using to develop PGx tests?
• What reimbursement hurdles do PGx tests and products have to overcome in order to reach the market?
• How is the r evolution of PGx changing the reimbursement environment?
• How will regulatory frameworks provide incentives for the adoption of PGx technologies in the future?
• What is the current IP landscape within the PGx field?

The Future of Targeted Therapeutics

In recent years, the maximization of blockbuster revenues has been compromised by generic price erosion and a decline in new drug approvals. Large pharmaceutical companies are coming under pressure to explore new R&D strategies and implement more cost-effective sourcing methods for innovative new molecules. The biotechnology industry is emerging as a hub of innovation for biomarker and new chemical entity (NCE) identification, and has become a vital component in the preclinical development of new drug technologies. As therapeutic focus shifts to treating the causal pathway of disease and not merely symptomology, the majority of emerging targeted therapeutics are large molecule biologics while monoclonal antibody therapies represents one of the fastest-growing segment within the pharmaceutical industry.
The Future of Targeted Therapeutics: Key technologies, new therapy area applications and leading players is a new report published by Business Insights that examines various types of targeted therapies within Pharma pipelines, highlighting the molecules of greatest significance to major therapy areas. The key revenue drivers and product focus within targeted technology markets are also assessed. This report also measures the impact of the new model of targeted therapeutic development upon stakeholder demand and health economics.
Discover the most promising targeted molecules within each therapeutic area, identify the pipeline potential of leading companies and align your R&D strategies with the latest innovations and development models.

Top five reasons to order your copy today
• Understand stakeholder incentives in the future of targeted therapeutics, including public and private payors, regulatory bodies, physicians, patients and healthcare providers.
• Discover the strategic initiatives used by various biopharmaceutical companies in the development of targeted therapies within the areas of Oncology, CNS, Cardiovascular and Anti-Infectives.
• Assess the current stages of development and clinical potential of key molecular targeted drugs by technology type and therapy area.
• Identify and view key examples of the different types of molecules that are strengthening pipelines for targeted therapeutics and understand their mechanisms of action.
• Assess unmet needs within different therapy areas that are promoting the development of new targeted therapies and anticipate how such therapies will compete with currently marketed treatments.

Key issues examined in this report...
• Declining blockbuster revenues. Blockbuster-generated revenues grew by a mere 5.1% over 2005-06, well below the 7.0% total growth registered by the global pharma market. This trend has been heavily influenced by patent expiration and generic entry, which typically result in blockbuster prices falling to 70-90% of their original value.
• Patient populations and drug focus. Patient compliance issues and the variable efficacy and bioavailability of therapies in different patient populations is driving segmentation within therapy markets.
• Clinical trial failures. NCE approval rates have experienced an overall decline which has been compounded by drug application failures across all industry sectors; for every FDA drug approval during 2005-07, 1.6 phase III failures were recorded.
• Reimbursement and health economics. At present rates of development, costs per treatment for innovative small molecule drugs and biologics will exceed those witnessed during the blockbuster era.

Your questions answered...
• Which treatment areas offer the greatest patient potential and future value for targeted therapies?
• What are the key targeted therapies currently in development for major disease areas related to cancer, cardiovascular and CNS?
• How have markets been affected by targeted therapy launches?
• To what extent will existing treatment models and plans need modification?
• What are the implications for health economics?
• Which biotechnology companies are creating advanced proprietary technologies to develop targeted therapies?
• How can the barriers to successful targeted therapy launches be overcome to maximize revenues?

The Cardiovascular Market Outlook to 2012
The cardiovascular therapeutic area has historically provided the largest single source of revenue for the pharmaceutical industry. The outlook for the market remains robust, driven by high patient populations and a widespread focus on preventative treatment. However, low growth rates in established indications will prevail due to the growing availability of effective generic medicines and an overall scarcity of innovative new drug launches. Major pharma companies are now primarily focusing efforts upon compliance and protection against the generic threats posed by line extensions and combination treatments. Changes in the competitive positions of leading companies will become inevitable as new revenue sources continue to decline and established portfolios underperform. The Cardiovascular Disorders Market Outlook to 2012 is a new report published by Business Insights that provides comprehensive coverage of every class of drugs across all major cardiovascular indications. Detailed insights into recent key events and future market leaders are also provided, in addition to epidemiological analysis and forecasts for major products over the period 2007-12. With coverage of over 90% of the total market for cardiovascular products, this report profiles the underlying trends and factors driving the market and identifies the most promising areas of potential growth.

Some key findings from this report...
• Zetia, Diovan, Crestor and Lipitor were the strongest performing major products of 2006-07. Each of these brands is forecast to maintain patent protection over the short to medium-term.
• The cardiovascular portfolios of Novartis and AstraZeneca are best positioned for high levels of future growth. Conversely, it is forecast that current market leaders Pfizer,Merck and Sanofi-Aventis will struggle to preserve their market shares over the 2008-12 period.
• The cardiac therapy area is the only segment forecast to experience a decline in net sales during the forecast period. However, generic competition to Lipitor may also result in the Dyslipidemia market suffering a fall in sales over 2011-12.
• Thrombosis will be the major growth driver of the cardiovascular area throughout the short-term, whilst heart failure has the most favourable dynamics of any indication for rapid market growth.
• Heart failure and thrombosis represent the most active areas of current drug development. Increasing competition in these traditionally less competitive therapeutic areas is forecast to become a major trend over the period up to 2012.

Top five reasons to order your copy today
• Assess patient potential, treatment trends and sales patterns across major cardiovascular indications with this report’s analysis of epidemiological studies, unmet medical need, and economic imperatives for stakeholders.
• Measure the market performance and strategic positioning of major pharmaceutical corporations with this report’s evaluation of the franchises and market shares of AstraZeneca, BMS, Daiichi Sankyo, GSK, Merck, Novartis, Pfizer, Sanofi-Aventis and Servier.
• Discover the market dynamics of the cardiovascular area and understand the impact of recent key events by assessing major market trends, growth drivers and the latest issues affecting R&D.
• Compare the future prospects of key players and forecast sales of leading products across major indications to 2012 with this report’s analysis of sales focus by drug class, currently marketed portfolios, R&D pipelines, and trends in promotional spend for key brands.
• Identify the strategies that offer the greatest success potential within the future cardiovascular market and understand the challenges currently facing companies within this therapeutic area.

Key issues examined in this report...
• Cardiac therapies. Heart failure treatments have become a focal point for cardiovascular drug developments. However, doubts remain over whether the marginal benefits offered by such medicines will be sufficient to generate and sustain high levels of revenue.
• Combination drugs. Although combination drugs failed to accrue strong sales growth in 2007, the growing acceptance of combination dyslipidemic therapies amongst payors and physicians will favour Merck’s Vytorin/Inegy and Novartis’ newly launched combination product Exforge (amlodipine/valsartan)
• Empty pipelines. Currently marketed portfolios have taken on greater importance in light of weak late stage pipelines among players such as Merck, BMS and AstraZeneca. This lack of new revenue sources is forecast to depress future growth in the cardiovascular market.
• Market leaders. Few leading companies are expected to retain their presence in the cardiovascular market, with some major players set to experience drastic declines in revenue over the forecast period.

Your questions answered...
• Which indications will experience the greatest growth in the global cardiovascular market over the period 2007-12?
• How will generic competition influence the future of branded products and which defensive strategies provide the most effective protection?
• How have recent major product launches performed?
• What is the forecast market size and growth rate over the period 2007-2012 across the major cardiovascular indications?
• Which pipeline products offer the highest growth potential?
• What will be the competitive landscape of hypertension, thrombosis, dyslipidemia and arrhythmia in 2012?

Launching Combination Products: Brand extension and franchise development

Combination pharmaceutical products, or fixed-dose combinations (FDC’s), offer benefits to many drug classes due to the additive nature of therapeutic effect and the reduced level of side-effects associated with their use. Their core advantage however is an improvement in convenience that stems from reducing prescription numbers and their associated administrative costs. Although fixed-dose combination drugs have historically attracted disapproval from physicians, who typically prefer to determine the components and ratios of drug applications at their own discretion, a widespread acknowledgement and acceptance of these therapies has now been established. This is largely due to their effectiveness in areas such as HIV and asthma, but the successful positioning of combination products remains difficult in therapeutic areas where combination therapies only provide marginally incremental benefits. Launching Combination Products is a new report published by Business Insights that provides detailed strategic guidance for the preparation and successful execution of combination product launches. This report performs a comprehensive examination of current competitive pressures, best practices and future developments in key therapeutic areas including cardiovascular, respiratory, HIV and women’s health. Detailed case studies also provide unique insights into the brand extension and franchise development strategies of leading companies and help to identify the key success factors behind recent combination product launches.

Some key findings from this report...
• Key cardiovascular combination product launch strategies are focused upon developing franchises within individual indications. Seven of these projects are currently in late-stage development, while three are poised to expand into other risk factors such as diabetes.
• Major diabetes combination product launch strategies are concentrated in franchise development across multiple indications, two of which are currently in late-stage development. However, oral diabetes drugs will continue their expansion with brand extensions.
• Single pill, fixed dose combinations will be introduced to the HIV market as dosing regimens for new therapies become established and replace current market leading combinations. Presently however, the market is still characterized by significant pill burdens.
• The success of combination products is largely dependant upon the implementation of effective branding, pricing and positioning objectives. Although such issues are the primary concern of the product manager, this responsibility should be shared amongst associated product managers, therapy area heads, R&D leads, corporate planning and pricing managers, and sales and marketing.

Top five reasons to order your copy today
• Understand the competitive environment for combination product launches with this report’s detailed analysis of recent, leading and future launches in key therapy areas including cardiovascular, respiratory, HIV and women’s health.
• Benchmark the successful strategies of leading companies using this report’s case studies that detail a range of combination product launch tactics applied across a variety of drugs.
• Formulate effective therapy area-specific combination product launch strategies with this report’s analysis of high value opportunities across a number of therapy areas.
• Assess the differences between brand extensions and franchise developments and understand the strategic rationale that will determine which implementation is most effective for your company.
• Develop defensive counter-strategies against combination products with this report’s examination of impending launches and explore the repositioning initiatives offered by combination strategies.

Key issues examined in this report...
• Patient compliance. Fixed dose combinations provide essential convenience for patients, most notably for chronic diseases involving high pill burdens. However, improved patient compliance is more evident in some treatment settings than in others.
• Cardiovascular risk factor combinations. Combinations in late stage development are attempting targeting a number of cardiovascular risk factors, such as hypertension, dyslipidemia and diabetes. Their potential impact on this broad therapeutic category remains unknown.
• Cancer combinations. The use of multiple drug ‘combinations’ in the treatment of cancer is well established, most prominently with monoclonal antibody and chemotherapies. However, fixed dose combinations are difficult to establish when drugs from different classes are combined into different formulations.
• HIV combinations. There are currently no leading combination therapies in late stage development for HIV, and it will take time for new therapies to be integrated into established treatment paradigms.

Your questions answered...
• What are the key issues influencing combination products and successful therapy area launches?
• How do combination brand strategies vary by therapy area?
• What are the therapeutic and commercial drivers for developing fixed-dose combination products?
• What are the differences between brand extension and franchise development strategies?
• To what extent have established combination product launches affected key therapy areas?
• What impact will future combination product launches have upon key therapy areas?
• What are the leading combination product opportunities within key therapy areas?

Innovations in Bioinformatics: Emerging tools for drug discovery and development

Report overview
R&D laboratories are co-ordinating the analysis of increasing volumes of disparate biological data, largely comprised of gene and protein sequences. Bioinformatics-enabled data management has enabled companies to improve productivity within their R&D programmes by identifying new drug targets, diagnostic biomarkers and biomarkers of drug efficacy and toxicity. From a systems biology approach, bioinformatics combine data into interactive models to highlight disease pathways and aid the discovery of on/off-target effects of compounds. Knowledge management solutions are crucial in both instances, enabling project teams to make informed decisions about potential new drugs. ‘Innovations in Bioinformatics’ is a new report published by Business Insights that provides a detailed analysis of bioinformatic developments and applications. This report examines the bioinformatic tools used to manage high-throughput data from omic technologies, systems biology modelling and biomarker discovery. Knowledge management solutions are reviewed and the provisions of major bioinformatics contributors are highlighted. This report also provides forecasts for bioinformatic tools and services to 2011.

Key findings...

• The bioinformatics market is forecast to grow at a CAGR of 23% to $4.5bn by 2011, from a value of $1.6bn in 2006. The US led the geographical market with a share of 45% in 2006, but Europe’s CAGR of 24.6% will narrow the gap over the forecast period.
• Bioinformatics-enabled protein biomarker discovery will enable the development of safer and more effective drugs, targeted therapies and molecular diagnostics.
• Systems biology modelling is forecast to grow at a rate of 35% over the next five years, the highest growth of any bioinformatics sector. The potential for widespread integration throughout all stages of drug discovery will act as a catalyst for this expansion.
• Knowledge management is currently the leading bioinformatics market segment. This lead will be strengthened by mass adoption of Semantic Web technology and the increasing availability of software through the internet.
• Software for next-generation sequencing has vastly reduced time and cost constraints of DNA-sequencing. The miniaturization of reactions has increased their quality and density, subsequently lowering per-reaction costs.

Key questions answered
• What are the major segments of the bioinformatics market?
• How can bioinformatics tools be used in genomics/proteomics?
• How is enterprise knowledge managed and how are the contributions of modelling providers changing?
• What are the services and strategies of key companies in the fields of knowledge management, systems biology and high-throughput genotyping?
• Which segments are forecast to dominate the bioinformatics market in 2011?
• How are these dominant segments likely to evolve?

Key issues examined by this report
• R&D improvements. Emerging bioinformatics tools that promise to improve productivity in drug R&D are creating new opportunities for pharma companies, as pressure from declining pipelines and patent protection expiries continues to mount.
• Data efficiencies. Bioinformatics solutions enable users to manage and interpret research data far more effectively than by attempting to traverse the deluge of heterogeneous data provided by omics technologies.
• Compound failures. The use of bioinformatics tools can help to detect potential toxicity earlier in the drug discovery and development process, drastically reducing toxicity and safety related compound failures during full clinical development.
• Impact of biomarkers. The utility of bioinformatics in biomarker discovery and validation has made them integral to the new, cost effective model of drug discovery and development which emphasises the use of biomarkers throughout the process.
• Internet dominance. As growing numbers of knowledge management solutions leverage open web standards, the internet is set to become the dominant bioinformatics platform and broad adoption of Semantic Web technology is anticipated.

Medicines in the cancer therapeutic area account for the third largest source of revenue within the pharma industry. The cancer market has experienced significant innovative change in recent years, creating attractive opportunities for a range of new and established biotechnology players as well as established pharma companies. Although new product development continues to involve substantial levels of risk, innovation is the key driving force in the market, and has led to the competitive exclusion of several of the industry’s traditional competitors. With successful launches now being applied to multiple indications faster than ever before, subsequent increases in product sales volumes are rapidly changing the competitive landscape of the cancer market. The Cancer Market Outlook to 2012 is a new report published by Business Insights that provides comprehensive coverage of the major markets in the global cancer area, incorporating a detailed epidemiological analysis of the nine major indications and key factors impacting their prevalence. Current leading brands of treatment within each cancer indication are analysed and eight of the market’s leading players are profiled. With coverage of over 9 % of the total market for cancer products, this report profiles the factors and underlying trends that are driving market transformation and identifies the most promising areas of potential growth. Forecasts for currently marketed and key pipeline products over the 2 6-12 period are also provided. Discover the key market trends and growth drivers of the cancer market, assess the competitive dynamics of leading pharma companies and evaluate the future prospects of major products with this report.

Nanotechnologies have already attracted over $3bn of global government funding as part of efforts to enhance a range of disciplines including pharmaceuticals, drug delivery and healthcare monitoring. Advances in nanomaterials, nanostructures and nanosystems are expected to drive the value of the global nanotehnology market to over a trillion dollars by 2015, but many companies are remaining cautious, preferring to monitor developments in academia prior to making substantial investments. Despite such trepidation, the pharma industry is beginning to adopt nanotools throughout the R&D process to facilitate the high throughput screening of drug repositories, the identification of new drug targets and biomarkers for preclinical and clinical studies and the development of diagnostics and imaging agents. ‘Nanotechnology’ is a new report published by Business Insights that provides a comprehensive review of nanotechnology and it’s role in the development of next-generation nanomedicines. The nanotools and detection systems currently driving nanotechnology are profiled and the applications of nanotechnologies within the R&D process are assessed. This report measures the impact of nanotechnologies currently being applied to target cancer, cardiovascular disease and CNS disorders and also explores the implementation strategies of leading pharmaceutical, healthcare and nanotechnology start-ups. Use this new report to assess the future of nanotechnology within pharma R&D, identify the innovations driving growth within the market and examine the implementation strategies of leading companies.

Declining industrial productivity has forced companies to urgently address the areas of drug development that are most likely to lead to the failure of a new compound. Innovations are required that can support the earlier termination of drugs which will be toxic in humans and cause rare events that are unlikely to be identified in clinical trials. Major pharma companies have subsequently begun to implement an array of new technologies for drug safety prediction into the discovery phases of research.

‘Early Stage Drug Safety Strategies and Risk Management’ is a report published by Business Insights that identifies the new predictive technologies which can facilitate the earlier termination of potentially unsuccessful compounds. Emerging approaches in key areas such as hepatotoxicity, nephrotoxicity and cardiotoxicity are examined, and the collaborative efforts of academia and technology developers in driving the discovery of safety predictive methods and biomarkers are reviewed. This report evaluates the latest innovative predictive technologies being introduced into pre-clinical and early clinical development phases and also explores the potential cost savings and challenges associated with their implementation.

Key Findings

Future improvements in drug discovery will include the modeling of a wider range of toxicities, such as hepatotoxicity, and formations of reactive metabolites that might lead to idiosyncratic toxicity. Developments in high-throughput technologies, systems biology and bioinformatics have also enabled virtual modeling for whole organs.

High-content screening is increasingly important for identifying toxicity endpoints in a drug discovery setting. The methods use automated microscopy with image analysis to measure the effects of compounds on cell health. Improvements are required in the cell types used and the number of toxicity endpoints that can be studied reliably.

Novel in vivo models are now available including zebrafish screens, which are suited for use at the lead optimization stage or earlier. Humanized rodent models, in which key enzymes responsible for metabolism have been replaced by their human counterparts, may also be suitable for use in candidate selection.

Pharmacometric modeling and simulation and novel study methods such as adaptive designs are increasingly being applied in drug development to make the most of the data collected and to guide the choice of dose for clinical application.

Use this report to

• Assess key technologies for predicting drug safety in the earliest stages of discovery and clinical development with this report’s comprehensive analysis of emerging approaches across in silico, in vitro and in vivo preclinical technologies.
• Identify which companies are leading the field in safety prediction for new drugs, understand the strategic implementations for large pharma companies and examine the role of public-private consortia in solving key issues within this field of predictive safety.
• Discover the extent to which predictive safety technologies can provide potential cost savings and improvements in attrition rates and assess the challenges and risks associated with the implementation.
• Understand the latest strategies to improve safety evaluation in early clinical development with this report’s analysis of the latest approaches in exploratory and Phase I clinical trials.

Explore issues including

The impact of failure; Declining productivity in the pharma industry has intensified the need to create innovative solutions to reduce new compound failures. The current likelihood of a project progressing from Phase 1 to approval is roughly 20%, although in some therapeutic areas this may be as low as 8%.

The importance of collaboration; Sharing information and expertise across companies can drive the field forward in a way that is impossible for these organizations individually. Biomarker data from some of the major consortia has been submitted to regulators, and this represents significant progress, most notably within the field of renal toxicity.

Better predictive animal models; Rodent and non-rodent models used in drug development are expensive and the results do not always translate well to the human situations. A survey carried out in 1999 reported a true positive concordance rate between animal and human data of 71% for rodent and non-rodent species (63% for non-rodents and 43% for rodents alone).

The need for early assessment of key clinical attributes; Exploratory trials are particularly useful for gaining early insight into human ADME characteristics including mass balance, metabolite and absolute bioavailability parameters that would not traditionally be collected until Phase 2 or later. These studies use microdoses and can explore more candidates at a lower cost than a traditional ‘First in Man’ study.

Discover

• Which technologies are leading the way in predicting potential safety problems in the earliest stages of drug discovery and development as possible?
• What are the contributions of in silico, in vitro, and in vivo methods in the non-clinical stages of drug development?
• What are the goals of public-private consortia in driving the discovery of methods and biomarkers and how much have they achieved to date?
• How can the data collected in early human clinical trials be improved to better inform decision-making about potentially safe candidates?

Biologics continue to outperform the global pharma market, driven by premium priced therapies for conditions that cannot be managed by conventional drugs. The rapid penetration of novel biologics and the gradual expiry of their patents will create significant market opportunities for biosimilars developers through to 2016. In the short term, biosimilar market growth will be driven by drug classes including erythropoietin, filgrastim, human growth hormone (hGH) and insulin. ‘The Top 10

Biosimilars Players: Positioning, performance and SWOT analyses’ is a report published by Business Insights that examines the competitive landscape of the global biosimilars industry. The latest key issues and evolving business models in the biosimilars market are identified and the leading companies in this sector are profiled in detail. This report examines the portfolio sales performances, pipelines and growth strategies of each of the top 10 biosimilars companies. The opportunities and threats facing each of these leading players are also assessed. This report also examines the size, growth and major trends of the global biosimilars industry, in addition to providing to an assessment of leading biosimilars companies outside of the top 10.

Key findings

The global biosimilars market reached $1bn in 2007, representing an increase of 5.9% over 2006. The increasing use of biologics in disease areas such as cancer, auto-immunity and orphan diseases, in addition to healthcare cost containment, has driven this growth.

Novartis (Sandoz) leads the global biosimilars market with a market share of 4.1% and sales of $23m in 1H 2008. The company is expanding its portfolio to exploit the opportunities arising from branded biologics going off-patent in the US and EU.

An estimated $25bn worth of biologics will lose patent protection by 2016, creating a significant market opportunity for biosimilars. Monoclonal Antibodies (mAb) such as Herceptin and Rituxan/Mabthera are among a number of major biologics going off-patent during this period.

Teva is the third largest company in the global biosimilars market, with a share of 2.1% based on sales of $12m in 1H 2008. The company is investing in R&D and manufacturing capabilities to accelerate biosimilar development. The 2008 acquisition of Barr has substantially strengthened its market position, having provided access to Barr’s substantial expertise in the field.

Use this report to

• Compare the performances of the top 10 players in the global biosimilars market with this report’s analysis of marketed product sales for Biocon, Bioton, Emcure (Gennova), Hospira, Intas Biopharma, LG Life Sciences, Novartis (Sandoz), Ranbaxy, Teva, Wockhardt.

• Identify the market dynamics of the global biosimilars industry over the 2006-07 period, examine the drivers and resistors to industrial growth and understand the key trends that are shaping the future of the biosimilars market.

• Assess the future prospects of the top 10 biosimilars companies with this report’s analysis of each firm’s strengths, weaknesses, opportunities and threats, in addition to an examination of their product pipelines and growth strategies.

• Measure the progress of other leading biosimilars companies by evaluating the financial performances, marketed products and pipelines of 3SBio, Bharat Biotech, Dr Reddy’s, MJ Biopharm, Panacea Biotech, Pharmaclon, Shantha Biotech, Shenzhen Neptunus Interlong, Shreya Life Sciences and Stada.

Explore issues including

The safety and efficacy of biosimilars. Technological and manufacturing complexities make it difficult to produce exact replicas of biologics, raising concerns over the safety/efficacy of biosimilars. Such perceptions, combined with an unwillingness to switch from sophisticated branded biologics, mean that the market acceptance of biosimilars is likely to be slow.

The erosion of biosimilar price differentials. The cost of biosimilar development is rising due to regulatory agencies seeking additional clinical studies to ensure patient safety. This is reducing the price advantage of biosimilars against their reference drug. Price discounts are subsequently expected to amount to only 25%-35% initially, due to high costs and limited competition.

Significant regulatory hurdles to overcome. The complex structure of biosimilars demands stringent regulation to ensure patient safety. Europe was the first among regulated pharma markets to create a biosimilars approval pathway in 2006. This legislation provides 10 years of patent protection to biologics against biosimilars and hybrids, and calls for extensive testing to ensure safety. The difference between a similar biological medicinal product and the reference product must be justified with appropriate studies and clinical trials on a case-by-case basis, in addition to post-marketing monitoring.

Discover

• Which major trends are currently shaping the global biosimilars market?
• Who are the top 10 players in the market?
• What is the market share of each of the global leaders by company?
• What are the key growth strategies of leading companies?
• What are the strengths and weaknesses of the industry’s top players?
• Which factors are considered when creating biosimilar regulations across Europe, the US, Canada, India and China?
• How are the dynamics of the biosimilars market different from generics?

The pharmaceutical contract manufacturing (PCM) industry continues to grow at a steady pace, driven by cost pressures, stringent regulatory requirements and patent expiries. The highly competitive nature of the industry has been driving consolidation and companies are increasingly offshoring to emerging markets to reduce costs. As a result, players in key outsourcing destinations have been improving their manufacturing infrastructure to increasing their global competitiveness. ‘Key Players in Pharmaceutical Contract Manufacturing’ is a report published by Business Insights that examines the competitive landscape of the global PCM industry. The latest key issues and developments in the contract manufacturing market are identified and leading companies in this sector are profiled in detail. For each of the top 10 CMO companies, this report provides a detailed examination of financial performance by business segment, manufacturing and R&D capacity, growth strategies and key acquisitions/divestments. This report also examines the size and growth of the global CMO industry, with analysis of major market drivers and trends in CMO destinations.

Key Findings

The global PCM market was worth $26bn in 2007 and is expected to grow at a CAGR of 11.4% to reach $40bn by 2011.
Catalent is the largest CMO in the world, with revenues of $1.8bn in 2007. The PCM market is highly fragmented, with the top ten players in the market holding less than 30% of total market share.
Contract manufacturing in India and China is forecast to expand at a CAGR of 20% through to 2011. Big Pharma are increasingly outsourcing manufacturing to low cost destinations due to cost and margin pressures, and India and China offer skilled manpower and a robust manufacturing infrastructure.
Piramal is the largest CMO in India, and its contract manufacturing revenues increased by 33.3% in dollar terms between 2007-2008. The primary contributor to this growth was it’s PMS segment.
Biopharmaceutical manufacturing is forecast to have increased by 15% in 2008, driven by sales growth of biologics. Lonza, a leading player in this field, registered revenue growth of 75.9% in 2007.

Use this report to...
• Compare the performances of the top 10 CMO companies across key business segments with this report’s analysis of Catalent, Lonza, Boehringer Ingelheim (BI), DSM, Patheon, Evonik, Piramal, Jubilant, Aenova, Fareva.
• Identify the market dynamics of the global PCM industry over the 2003-07 period, discover which emerging markets are becoming the CMO destinations of the future and understand the major issues affecting key industry players.
• Assess the future prospects of the top 10 CMO companies with this report’s analysis of each firm’s manufacturing and R&D capability, growth strategies and M&A activity.
• Measure the progress of other leading CMO companies by evaluating the financial performances of Nipro, Siegfried, Haupt, Divi’s Laboratories (Divi’s), Cambrex, Recipharm, Archimica, Vetter, Famar and NextPharma.

Explore issues including...
Increased offshore outsourcing. Although Europe remains the biggest market for pharmaceutical outsourcing, Asia Pacific will expand rapidly over the coming years due to significant advantages over Eastern Europe and emerging countries such as Brazil, Taiwan and Korea.
Stringent regulatory requirements. CMOs must receive approval from international regulatory bodies such as the FDA in order to establish credibility. Such approvals are difficult to obtain and require compliance with a number of stringent norms.
Growth of biopharma manufacturing. Biopharmaceutical contract manufacturing is the fastest growing segment of contract manufacturing, and players in this field are expanding capacities to meet the rising demand.
Industry consolidation. The PCM industry is experiencing a significant amount of M&A activity due to the presence of a large number of small players. Indian companies in particular have engaged in aggressive M&A activity, with Jubilant’s acquisition of DRAXIS and Hollister-Stier and Piramal’s acquisition of Avecia Pharmaceuticals.

Discover...
• What are the key trends in the global PCM industry?
• Which countries are the hotspots for contract manufacturing?
• Who are the top 10 players in the industry?
• How are the top 10 players positioned?
• How will consolidation change the dynamics of the industry?
• What are the key strategies of the leading CMO companies?
• Which regions and segments offer the greatest growth opportunities?
• What is the future outlook for the industry

The Scandinavian Pharma Market Outlook to 2013: Policy environment, market structure, pipeline analysis and growth opportunities

The Scandinavian healthcare system and pharmaceutical market is well regulated, with the state bearing responsibility for a large proportion of an individual’s pharmaceutical expenses. Solidarity and equality are the ideological basis of these welfare states, and a significant public commitment exists towards ensuring access to high quality health care for all citizens. Sweden and Denmark have been the two biggest pharma and biotech markets in Scandinavia, while regional players such as Novo Nordisk have laid the foundations for this industry in the region.
‘The Scandinavian Pharmaceutical Market Outlook to 2013’ is a report published by Business Insights that explores the healthcare systems and policy environments of Denmark, Norway, Sweden and Finland. This report examines the region’s market potential by assessing historic epidemiological data, sales trends, competitive intelligence and clinical data across each major country. The growth drivers of the region are identified and forecasts for major prescription drugs and markets are provided for the period 2009-13. The competitive landscape of the Scandinavian market is also evaluated, with the region’s five leading companies being assessed based upon their marketed product portfolios and R&D pipelines in order to forecast their future competitive positions.

Key Findings
The Scandinavian pharma market recorded sales of $10.1bn in 2007, a 16% increase over 2006. Sweden had the largest market share (38%), followed by Finland (23%), Denmark (22%), and Norway (17%). These countries possess developed infrastructures, advanced technologies, R&D support and business friendly cultures. Pfizer led the Scandinavian market in 2007 with sales of $696m, a 6.3% increase over 2006.

Pfizer has a significant presence in all four Scandinavian markets and in the leading therapeutic areas of the region. Drugs for the treatment of CNS disorders are the largest product class in Scandinavia, with a market share of 20.7% in 2007. Cancer and cardiovascular diseases are the next largest therapeutic categories in the region.

Well-developed biotech and life sciences clusters across the Scandinavian region enable world-class research and provide pools of well-educated personnel and versatile facilities to support start-up companies.

Parallel trade has become a major concern for the profitability of Scandinavia-based Pharma companies in recent years. Factors driving this include lower prescription drug expenditures sought by payors and parallel traders’ strategies benefit from price differentials for drugs across different countries.

Use this report to...
• Compare the healthcare markets of key Scandinavian countries with this report’s macroeconomic analysis of infrastructure, per capita health expenditure and Pharma sales growth vs. GDP growth across Sweden, Finland, Denmark and Norway.
• Understand how healthcare policy environments vary across the region with this report’s examination of drug approval processes, pricing regulations and reimbursement policies in each major country.
• Identify which indications have the greatest potential to provide franchise growth with this report’s evaluation of major therapy/sub-therapy areas and leading brands, including forecast sales over the period 2009-2013.
• Measure the performances and prospects of leading companies in the Scandanavian area with this report’s strategic analysis of leading pharma corporations based on sales focus by drug class, currently marketed products and R&D pipeline portfolios.

Explore issues including...
The threat to EU health spending. Pharma activity in the Scandinavian market is focused around cost containment, but in recent years the consumption of generics and parallel imports has slowly increased. A new pricing regime linked to other European countries has also had a moderating effect on price levels in Scandinavian countries over recent years.

Higher licensing deal values. Competition for promising projects (particularly drugs that have established solid proof-of-concept data) has not only boosted the deal values overall, but also increased the quantity and average value of deals in the early stages of product development.

Parallel trade influencing pricing. The prevalence of parallel trade is having a significant impact upon state expenditure on drugs and consumer prices. In Sweden, parallel imports have been included as substitutable products in accordance with the generic substitution policy, giving significant boost to parallel imported products in the country.

Support for generic substitution of patented drugs. A report by the National Trade Estimate of the United States Trade Representative (USTR) made special mention of Finland, due to the country’s Pharma Pricing Board not always waiting for the expiry of the analogous process patent before taking action.

Discover...
• What will be the major growth drivers in the Scandinavian pharma market over 2009-13?
• Which companies were the winners and losers in the Scandinavian pharma market in 2007?
• Which companies will become key players over 2009 -13?
• Which products will be affected by generic competitors over the period 2009-13?
• Which pipeline products will be the growth drivers of the future?
• Which therapy areas and indications have the highest market potential over 2009-13?
• How will the Scandinavian pharma market’s competitive landscape change by 2013?

The Canadian pharmaceutical market is one of the fastest growing markets in the world, however strong generic erosion is expected over the next five years due to upcoming patent expiries for leading products. Although the product pipeline currently lacks the potential to offset these sales losses, the TRIPS compliant 20-year patent period and recent amendments to the Patented Medicines Regulations are expected to drive the revenues of branded drugs.

‘The Canadian Pharmaceutical Market Outlook to 2013’ is a report published by Business Insights that provides comprehensive coverage of the Canadian pharma market, including a detailed analysis of regulatory, pricing and reimbursement frameworks that govern the country’s policy environment. The structure of the market is examined with a breakdown of pharma distribution networks, licensing trends and sales by province/territory. Sales trends amongst leading brands, therapy areas and companies are also identified. This report evaluates the competitive landscape of the region, with an analysis of the portfolios and pipelines of leading branded, generics and biotechnology companies. The potential of key pipeline compounds is also assessed, and revenue/epidemiological forecasts are provided for the period 2009-13.

Key findings

The Canadian pharma market grew by 13.0% during 2006–07, generating revenues of $16.9bn. The market was driven by the strong growth of cancer and musculoskeletal treatments resulting from the success of novel targeted therapies and the availability of several new high-value biologic treatments.
Cardiovascular drug sales accounted for 23.2% of the Canadian pharma market in 2007, accruing revenues of $3.9bn. Lipitor remained the market leading statin with sales of $1.0bn in 2007, however the availability of generic simvastatin has resulted in increased therapeutic substitution and reduced sales.
Generic drug companies such as Apotex and Novopharm are continuing to demonstrate impressive growth, with revenue increases of 26% and 52% respectively in 2007. Pfizer dominated the market with a share of 12.4% in 2007, following sales of $2.1bn.
Pfizer’s market position was supported by strong sales of Lipitor and Norvasc, which together accounted for 65.6% of the company’s sales.
The Canadian biopharmaceutical industry is facing funding challenges due to administrative and tax barriers. These hurdles are forcing companies to partner their innovations with major companies prematurely, and they subsequently fail to maximize their revenue potential.

Use this report to

• Examine the forecast prevalence of major disorders in the Canadian pharma market over 2009-13 with this report’s analysis of indications including arthritis, asthma, COPD, hypertension, heart diseases, HIV/AIDS, Parkinson’s/Alzheimer’s disease and cancer.
• Evaluate the policy environment of the Canadian healthcare system with this report’s examination of the latest trends and developments in pharmaceutical regulation, pricing and drug coverage/reimbursement.
• Assess the competitive landscape of the Canadian pharma market with this report’s analysis of the portfolio sales and therapy area focus of leading manufacturers including AstraZeneca, GSK, J&J, Novartis, Pfizer, Apotex and Novapharm.
• Predict revenues for currently marketed and pipeline products in the Candian pharma market over 2009-13, with this report’s sales forecasts across major indications, treatment classes and company portfolios.

Explore issues including...

Impending patent expiries for leading products. The patent expiries of major brands such as Pfizer’s Lipitor and Norvasc, Nycomed’s Pantoloc, AstraZeneca’s Crestor and Nexium and J&J’s Pariet will result in generic competition eroding more than $2bn of sales by 2013.
Tighter regulations increase pricing pressure. Governmental policies are shifting towards a ‘price control’ model due to rising healthcare costs. Such restrictive policy scenarios are escalating pricing pressures and the bargaining power of payor groups.
Weak pricing framework for generics. Despite provincial legislation limiting generic product prices to 50% of the original brand prices, the actual price of generics in Canada can occassionally be twice as high as US prices due to shortcomings in policy design.
Widespread generic substitution. Generic substitution is compulsory in hospitals reimbursed by Medicare, while pharmacists in British Columbia retain the mandate for generic substitution. Additionally, some drug coverage plans require generic prescriptions.
Direct-to-customer advertising prohibited. Health Canada prohibits pharma manufacturers from advertising the preventive and curative properties of their products to the general public.

Discover

• What will be the major growth drivers in the Canadian pharma market over 2009-13?
• Which leading companies are best positioned for growth over the period 2009-13?
• Which products will be affected by generic competitors through to 2013?
• Which therapy areas and indications have the highest market potential over 2009-13? • Which pipeline products will be the growth drivers of the future?
• How will the Canadian pharma market’s competitive landscape change by 2013?
• Which major market/pipeline developments will define future corporate strategies?
• How do government polices on pharmaceutical regulation, pricing and reimbursement impact the industry?

The Asian Cardiovascular Market Outlook to 2013
Regional and therapeutic analysis, pipeline impact and growth opportunities

Report Overview

The Asian cardiovascular market continues to grow at significant pace, having registered growth of 19.9% over 2006/07. This is in stark contrast to the global cardiovascular market, where the patent expiries of leading products and subsequent generic competition has slowed growth to 2.6%. Anti-hypertensives are the key drivers of Asian market growth, while anti-dyslipidemics and anti-thrombotics are the fastest growing therapeutic areas. Although Asian markets have lower per capita healthcare expenditures than the US and EU, they are widely regarded as the future growth markets of the health services industry.

‘The Asian Cardiovascular Market Outlook to 2014’ is a new report published by Business Insights that provides comprehensive coverage of the Asian cardiovascular market, with analysis of major currently marketed and pipeline drugs. The key trends and growth drivers of the area are assessed, with revenue and epidemiological forecasts provided for the period 2009-14. This report analyses regional healthcare and licensing trends, and examines regulatory frameworks across the 10 major Asian markets. This report also evaluates the product portfolios, R&D pipelines and competitive positioning of leading companies in the area, with forecasts for key brands and therapy areas for the period 2009–14.

Key Findings

Hypertension was the most common cardiovascular risk factor across Asia in 2007, with an estimated prevalence rate of 15.9%.

Dyslipidemia was the second most prevalent disorder in the region, with a rate of 11.7%. The Asian cardiovascular market generated revenues of $7.5bn in 2007, having expanded by 19.9% between 2006–07. The original brands segment has the strongest penetration in the developed markets of South Korea and China, accounting for $2.3bn of sales in 2007.

The total diabetic population of the Asian market amounted to 126m in 2007. India is forecast to have 91m diabetes sufferers by 2014. Pfizer retained its regional market leader status in 2007, with a market share of 8.4%.

Pfizer’s position was strengthened by strong performances from Lipitor and Norvasc, which together accounted for 85.7% of the company’s sales. The 10 leading companies in Asia represented only 35.9% of the market in 2007, with total sales of $2.7bn.

Plavix leads a highly fragmented cardiovascular market, after revenues grew by 24.2% to reach $288m in 2007. The top ten brands accounted for a mere 20% of total market sales in 2007.

Use this report to...

• Assess the epidemiology and forecast prevalence of major cardiovascular disorders over 2009-14 across countries including China, South Korea, India, Taiwan, Thailand, Philippines, Indonesia, Malaysia, Hong Kong and Singapore.

• Understand the market dynamics of the Asian cardiovascular market and evaluate major trends, growth drivers and sales forecasts for major treatment classes including anti-hypertensives, anti-dyslipidemics, cardiac therapies, anti-thrombotics and hematologicals.

• Examine the competitive landscape of the Asian cardiovascular market with this report’s country/ therapy area focus breakdown, portfolio sales analysis and pipeline evaluation for Pfizer, Sanofi-Aventis, AstraZeneca, Novartis, Merck, Bayer, GSK, Servier, Roche, Boehringer Ingelheim.

• Predict revenues for currently marketed and pipeline cardiovascular products in the Asian area over 2009-14, with this report’s sales forecasts across major indications, treatment classes and company portfolios.

Explore issues including...

Major patent expiries to have minimal impact. The patent expiries of key brands such as Pfizer’s Lipitor and Norvasc, Sanofi- Aventis’ Plavix and Novartis’ Diovan will result in minimal sales erosion, in contrast to the losses witnessed in the seven major markets.

Tighter regulations increase pricing pressure. Governmental policies are slowly shifting towards a ‘price control’ model due to an alarming rise in healthcare costs. Such restrictive policy scenarios are combining with the low economic status of the mainstream population to further escalate pricing pressures.

Widespread generic penetration. Generic penetration is highest in countries such as India where patents have not been registered. The availability of generic versions of therapeutically significant cardiovascular compounds and an under-privileged patient population are encouraging physicians to prescribe these cheaper therapy options.

Importance of brand loyalty and marketing strategies. Brand loyalty is a key cardiovascular market driver within developed economies such as South Korea, Malaysia, Hong Kong and Singapore. Other nations with developing economies are driven by marketing strategies that influence physician preferences.

Discover...

• What are the major trends in cardiovascular therapies across Asian markets?

• What are the leading drug classes, brands and companies in the 10 major Asian markets?

• Which companies are best positioned to succeed over the period 2009-14?

• Which products will be affected by generic competition during 2009-14?

• What are the most promising compounds currently in clinical development?

• Which therapy areas and indications have the highest market potential over 2009-14?

• How will the competitive landscape change by 2014?

The Future of Biobanks: Regulation, ethics, investment and the humanization of drug discovery

Report Overview

Biobanks collect and store human biospecimens, playing a vital role in the development of novel drugs and diagnostics. In recent years, large population-based biobanks have been established which monitor the health status of participants over time to assess the natural occurrence and progression of common diseases. Hundreds of disease-based biobanks are located around the world, which are a valuable resource for biomarker discovery as well as for studying progression, mortality and responses to treatment.

‘The Future of Biobanks’ is a report published by Business Insights that examines major trends in the biobanking industry and identifies the key initiatives to upgrade the biobanking infrastructure. This report explores the applications of biobanks and provides examples of how large sets of high-quality biosamples are creating new ways to diagnose, prevent and treat diseases. The activities of over 180 US biobanks are assessed to illustrate how the scale and scope of biobanking is changing. This report also evaluates the limitations of biobanks, in addition to reviewing the unique legal, regulatory and ethical issues that surround this new frontier of biomolecular research.

Key Findings

• A number of new, high-quality biobanks will accelerate the development of personalized diagnostics and therapeutics over the next decade.
• Increased co-operation between biobanks can advance this progression, although many scientific and political barriers must be overcome.
• An estimated $1bn has been invested in the biobanking industry within the last ten years. The first advances are expected to result in the improved treatment of cancer, and progression for a range of other common diseases will follow.
• Recently established biobanks have reached unprecedented levels of scale, particularly the Taizhou project in China. Studies conducted on the entire population of a country may soon be possible.
• At least 179 biobanks with 345,000 donors exist in the US, most of which were established in the last 10 years.
• As biotechnology companies’ biobanking assets mature in terms of the number of samples collected their R&D productivity and the number of products available for outsourcing will increase

Use this report to...

• Assess the strengths and limitations of biobanks and understand their scientific and commercial relevance with this report’s analysis of biobank-enabled targeted therapeutics and diagnostic/prognostic tests.
• Analyze growth in disease-based biobanks by using this report’s unique review of 180 US-based biobanks by disease type and gain insights into the collaborative networks that can leverage greater sample sizes.
• Evaluate major founder/national population biobanks and gain insights into private sector biobanking with this report’s examination of contract service providers, biomarker discovery companies, pharma collections and research collaborations.
• Review developments in the regulatory framework for biobanking and understand ethical issues including informed consent, withdrawal and ownership, confidentiality and commercialization.

Explore issues including...

• Biobanking expansion. The falling cost of genomic technologies is expanding the scale and scope of biobanking research. This has already resulted in the development of several new diagnostic tests that can improve risk assessment and treatment decisions.
• Potential for personalised medicine. Very few personalized medicines exist, but the creation of large sets of high-quality biosamples should widen the clinical application of new personalized products and services.
• Legal and ethical issues. Although the legal and ethical frameworks that govern biobanking are still evolving, many major issues such as ownership and commercialization are now largely addressed during the consent process.
• Cost of national biobanks. National biobanks have been established in several countries, although their value has been questioned. Conducting large-scale population studies requires significant investment, due to the extremely large collections of biosamples and data involved (including relevant medical history, lifestyle and environmental information).

Discover...

• Why are biobanks a critical resource?
• Which types of biobank are most common?
• What are the most common disadvantages of biobanks?
• Which major drug developers have invested in biobanks?
• What are the major uncertainties surrounding the future of biobanks?
• What growing trend could boost biobanking?
• When will the benefits of biobanking be realized?

The Top 10 Contract Research Organizations: Positioning, performance and SWOT analyses

Cost containment and regulatory pressures within the pharma industry are driving R&D outsourcing across the globe. Clinical obstacles to approval have become more significant due to the growing availability of existing generic treatments, and the trend to adopt Health Economics Outcomes Research (HEOR) assessments is increasing the complexity of clinical research. As a result, the scope of the CRO industry is expanding, and the global market is predicted to value $35bn by 2013.
‘The Top 10 Contract Research Organizations’ is a report published by Business Insights that examines the competitive landscape of the global CRO industry. The latest key issues and evolving business models in the CRO market are identified and the leading companies in this sector are profiled in detail. For each of the top 10 CRO companies, this report provides a detailed examination of financial performance by business segment and growth strategies in the form of key acquisitions and divestments. The opportunities and threats facing each of these leading players are also assessed. This report also examines the size and growth of the global CRO industry, with analysis of major market drivers and trends in CRO destinations.

Key Findings

The global CRO industry valued $18bn in 2008, an increase of 14% over 2007. The CRO market will grow at an annual rate of 14% over the 2009–13 period.

Quintiles leads the global CRO market having accrued a market share of 16.9% in 2007, equivalent to sales of $2.7bn. There are over 1,100 players in the industry, and the top 10 players only accounted for 56.1% of the global market in 2007.

The fragmented structure of the CRO industry has led to an increase in strategic alliances, acquisitions, joint-ventures and other partnership deals as companies attempt to expand their service offerings and geographical presence.

Covance is the second largest global CRO, having registered revenues of $1.5bn 2007, representing a market share of 9.7%. Covance is building global capabilities, with many clinical trials now being conducted in emerging markets.

Biomarkers have the potential to become an integral part of clinical research, after the FDA recommended their usage throughout clinical trials to demonstrate desired clinical activity and safety.

Use this report to...

• Compare the performances of the top 10 CRO companies across key business segments with this report’s analysis of Quintiles, Covance, Pharmal Product
Development, Charles River Labs, ICON, Parexel, MDS, Kendle, PharmaNet
Development and PRA International
• Identify the market dynamics of the global CRO industry over the 2007-08 period, discover which emerging markets are becoming the CRO destinations of the future and understand the latest industrial trends across the UK, Japan, France, Germany,
Italy, Spain and the US.
• Assess the future prospects of the top 10 CRO companies with this report’s analysis of each firm’s strengths, weaknesses, opportunities and threats, in addition to an examination of growth strategies via acquisitions and divestments.
• Measure the progress of other leading CRO companies by evaluating the financial performances of Aptuit, Life Sciences Research, Omnicare, SGS, CMIC, WuXi
Pharmatech, Galapagos (Biofocus), LAB Research, United BioSource and Bio-Imaging.

Explore issues including...

Industrial consolidation. Globalization and the need to provide a wider breadth of services to meet customer needs across the drug development process is driving consolidation.
Budget pressures for biopharma. The economic slowdown has limited the availability of funds for ‘risky’ businesses such as biotechnology. This has led to many projects being suspended.
Consolidation in client industry. Consolidation in the pharma industry has led
to the creation of larger entities with better bargaining power. This is beginning to impact upon contract payment terms.
Demand for CRO services. Regulatory pressures are creating a need for larger trials
and increasing development timelines. Regulatory delays and phase IV monitoring requirements are also fuelling demand for CRO services.
Influx of private equity players. A number of factors are driving the participation of private equity players, including the nature of the service-based business model and recent shifts in the CRO industry led by globalization and the demand for full-service offerings.

Discover...

• Which countries are attracting offshore investment?
• What are the trends in the global CRO industry?
• Who are the top 20 players in the industry?
• What is the market share of each of the global leaders by company?
• What are the drivers and resistors of growth in the CRO industry ?
• How is consolidation expected to change the dynamics of the industry?
• What are the key strategies of the leading CRO companies?
• What are the strengths and weaknesses of the industry’s top players?
• Which phases of clinical research are driving the industry?

The Autoimmune Market Outlook to 2013: Competitive landscape, pipeline analysis and growth opportunities

Autoimmune disorders have been one of the most prominent growth segments in the pharma industry over the last decade. A growing patient population and high levels of unmet need are the main drivers of market growth, and novel biologics are increasingly helping to fulfill patient need, with their high cost helping to drive market sales. Study findings have also shown that the early use of anti-TNF drugs can help to halt/reverse disease progression. This has further expanded patient populations and prompted the use of these drugs in early-stage treatment. ‘The Autoimmune Market Outlook to 2013’ is a report published by Business Insights that provides comprehensive coverage of major markets within the global autoimmune area, incorporating a detailed epidemiological analysis of key indications and the main factors impacting their prevalence. Current leading brands of treatment within each indication are analysed and eight of the market’s leading players are profiled. With coverage of over 95% of the total market for autoimmune products, this report reviews the factors and underlying trends that are shaping the market and identifies the most promising areas of potential growth. Forecasts for currently marketed and key pipeline products over the 2009-13 period are also provided.

Key Findings

-The global autoimmune market generated sales of $31.9bn in 2007, an increase of 14.4% over 2006 sales. The market is forecast to grow at a CAGR of 8.1% to reach a total value of $51.0bn in 2013.
-Immunosuppressant drugs dominate the automimnune market, with four products from this class accounting for 40.3% of total market sales. The highest selling immunosuppressant drug was J&J/Schering-Plough’s Remicade, with 42.1% of total sales in this class.
-Pfizer’s Celebrex dominated the COX-II market with a share of 81.3% in 2007. Celebrex maintained blockbuster status despite the earlier withdrawals of major blockbuster COX-II inhibitors such as Vioxx and Bextra.
-Roche’s Actemra is expected to be launched in the US during Q1 2010, in view of the FDA’s request for additional data and Roche’s risk mitigation strategy. Actemra is forecast to generate sales of $680m in 2013.
-Amgen is the global autoimmune market leader, having accrued a market share of 11.2% ($3.6bn) in 2007. This was driven almost entirely by Enbrel ($3.5bn) which had a sales increase of 12.2%.
-Novartis' developmental MS drug ‘fingolimod’ (FTY-720) is one of the strongest competitors to Biogen Idec's MS franchise due to its potency and convenience of once daily oral dosing.

Use this report to:

• Assess patient potential, treatment trends and sales patterns of major autoimmune indications over the period 2009-13, with this report’s coverage of osteoarthritis, rheumatoid arthritis, crohn’s disease, systemic lupus erythematosus, ulcerative colitis and multiple sclerosis markets across Japan, France, Germany, Italy, Spain, the UK and the US.
• Discover the market dynamics of the autoimmune area and understand the impact of recent events by assessing key market trends, growth drivers and the latest issues affecting product development.
• Compare the market performance and strategic positioning of major pharma companies’ autoimmune portfolios with this report’s evaluation of the franchises and market shares of Amgen, Abbott, J&J, Pfizer, Novartis, Wyeth, Roche and Astellas. • Evaluate the autoimmune pipeline compounds of leading companies with this report’s detailed analysis of clinically
• Evaluate the autoimmune pipeline compounds of leading companies with this report’s detailed analysis of clinically differentiated pipeline products by indication, and sales forecasts for key R&D pipeline products to 2013. sclerosis markets across Japan, France, Germany, Italy, Spain, the UK and the US.

Explore issues including
-Reduced commercial opportunity for Coxibs. The commercial opportunity for the COX-II inhibitor class has been substantially reduced due to cardiovascular safety concerns. The US withdrawals of Vioxx and Bextra, in addition to the non-approvals of Arcoxia and Prexige, are likely to restrict the growth prospects of this class in the near future.
-Impact of high value biologic treatments. Orencia, for use in DMARD failures, has yet to significantly affect the growth of existing agents. BMS’s Orencia and Roche’s Actemra target rheumatoid arthritis patients refractory to anti-TNFs, a population estimated to be between 20-40% of moderate/severe RA patients.
-Cost of MS treatments. Research has shown that the cost of being diagnosed with MS in the UK is nearly £17,000 per person. The research also found that among 2,000 people surveyed from across the UK, half stated that they had to leave work due to MS, which increased the potential cost to over £25,000 per person when lost employment productivity is added.
-Importance of arthritis disease management. Although several novel artrhitis treatments have been launched in recent years, it is possible for many patients to acheive effective disease control from the better use of existing medications.

Discover...

• What will be the major growth indications in the autoimmune market over 2007–13?
• Which companies were the winners and losers in this market in 2007?
• How have major launches from companies such as Amgen, Roche, Abbott and J&J performed?
• Which companies will become key players in the autoimmune market over 2007–13?
• Which products will be affected by generic competitors over the period 2007–13?
• Which pipeline products will be the growth drivers of the future?
• Which indications have the highest levels of market potential over the period 2007–13?
• What will be the competitive landscape in osteoarthritis, rheumatoid arthritis, crohn’s disease, lupus, ulcerative colitis and multiple sclerosis in 2013?

The Top 10 Global In-Vitro Diagnostics Companies: Positioning, performanceand SWOT analyses

The in-vitro diagnostics (IVD) market continues to grow at a steady pace, driven by new fields such as molecular diagnostics and a growing consumer awareness surrounding disease management. There is also an increasing focus on emerging markets, where healthcare infrastructures are improving. The industry is highly competitive and continues to witness large scale consolidation. Major in-vivo players are beginning to enter the in-vitro market and the regulatory environment is becoming even more stringent, increasing the time to approval for new products.
‘The Top 10 Global In-Vitro Diagnostics Companies’ is a report published by Business Insights that explores the global competitive landscape of the IVD industry. This report analyses the size and structure of the market and identifies the latest developments in service offerings, new technologies, strategic approaches and competitive dynamics amongst leading companies. This report assesses the opportunities and threats facing the top 10 IVD companies in the future, and examines their current structure, financial performance, growth strategies and R&D activity. Growth forecasts for key products and regions are also provided.

Key Findings

The global in-vitro diagnostics (IVD) market is forecast to grow at a rate of 6% to reach $50.0bn in 2012. The market has been growing at a rate of 5-6% in recent years, reaching a value of $36.5bn in 2007.

Roche is the largest player in the market with a share of 20%. It is followed by Siemens and Abbott, who both hold 12% of the market. The IVD market is highly consolidated, with the top ten players holding close to 80% market share.

Molecular diagnostics, diabetes care, and emerging markets are the key growth drivers of the IVD industry. Theranostics is an emerging field with great promise and a number of players are making extensive efforts in the area.

Abbott’s IVD revenues increased by 10.8% to reach $4.4bn in 2007. However, Abbott’s diagnostics margins have been falling and it has recently announced a cost-cutting plan to improve the operating margin of its diagnostics unit. Abbott has also been faced with regulatory issues, with its diagnostics business coming under FDA supervision.

A number of large in-vivo players have entered the IVD market recently, signalling the convergence of the two diagnostic fields. Siemens Healthcare is a prominent example of this trend, following their acquisition of DPC, Bayer Diagnostics and Dade Behring.

Use this report to...

• Compare the performances of the top 10 IVD companies across key business segments and geographies with this report’s analysis of Roche Diagnostics, Siemens Healthcare, Abbott, J&J, Beckman Coulter, Becton Dickinson, bioMerieux, Bayer Diabetes, Sysmex and Bio-Rad.

• Understand the market dynamics shaping the global IVD industry, forecast key growth areas by product/region and identify deal-making patterns across clinical trials phases and key therapeutic areas.

• Evaluate the future prospects of major IVD players with this report’s examination of R&D expenditure, M&A activity, growth strategies and SWOT analyses for each of the top 10
companies.

• Measure the progress of other leading IVD companies by analysing the financial performances of Inverness, Chiron (Novartis), Olympus, Gen Probe, Hologic/Cytyc, Qiagen, Arkray, DiaSorin, Radiometer, Werfen.

Explore issues including...

Industry consolidation. The IVD market is consolidating further due to a large number of smaller companies striving to increase their market share through M&A activity. Big Pharma is also entering the IVD market through acquisitions.

Growth of molecular diagnostics. Molecular diagnostics is one of the fastest growing segments of the IVD market and is expected to grow at a CAGR of 14% over the next five years.

Stringent regulatory environment. Regulation within the IVD market is becoming increasingly stringent, particularly in the US where the FDA is intensifying its scrutiny on diagnostics companies.

Emergence of theranostics. Advances in the field of genomics are leading to the emergence of theranostics and personalized healthcare. Theranostics uses diagnostic testing to tailor disease treatment to individual needs through the application of molecular diagnostics. A number of players are currently conducting R&D and launching new products in the fields of
theranostics and personalized healthcare.

Discover...

• What are the key trends and issues within the global IVD industry?
• Who are the top 10 companies in the IVD market?
• How do the leading companies compare in terms of financial performance, R&D capabilities and coverage by country and category?
• Who are the leading companies outside of the top 10?
• Which regions and segments offer the greatest growth opportunities for leading companies?
• What are the key strategies of the leading IVD companies and how do these strategies drive revenue and market share?
• What is the future outlook of the global IVD industry?

Key Trends in Offshoring Pharmaceutical R&D: Company strategies, emerging markets and impact on ROIs

Offshoring and outsourcing have become an increasingly critical contributor to pharma and biotech R&D strategies in recent years. They enable companies to focus on core competencies such as drug discovery or technology development whilst contracting out non-core processes to experts, often at lower costs. As offshore investments begin to mature and provide returns on investment, the opportunity to migrate individual components or whole segments of R&D portfolios will continue to rise.
‘Key Trends in Offshoring Pharmaceutical R&D’ is a report published by Business Insights that evaluates the offshore R&D strategies that can reduce development times and improve productivity, with analysis of a variety of strategic partnerships, academic collaborations, and outsourcing opportunities. This report identifies emerging areas of technological and scientific significance across the globe and examines the offshore strategies and investments of the top 20 pharma and biotech companies across Asia, Australia, Central and Eastern Europe, Latin America and the Far East. This report also provides a financial and managerial valuation of leading companies based on their P/E ratio, return on assets (ROA) and return on investment (ROI) and measures company performance against the healthcare industry, pharmaceutical and biotechnology sectors and leading shares of the S&P500.

Key Findings
-Companies that have allocated over 60% of their R&D expenditure offshore have displayed greater shareholder return, operating margins, market capital growth and return on assets.
-The US currently attracts 53% of total industry R&D spend, however it is forecast that 20% of this expenditure will migrate to Asia Pacific by 2010.
Australia, China and Singapore are emerging as key areas for scientific and technological investment.
-Leading pharma and biotech companies have undergone major R&D restructuring over the last five years and now adopt a focused, streamlined global approach which is increasingly reliant on offshore strategic partnerships, academic collaboration and outsourcing to establish networks of scientific expertise.
-Scientific and technological excellence within emerging economies is a key incentive for offshore investment, enabling companies to enhance innovation and productivity within their R&D programs.
-Managerial expertise is a critical factor driving the success of offshore investments, helping leading pharma and healthcare companies to outperform their peers and the S&P 500 index in 2008.

Use this report to...
• Assess the offshore R&D strategies of the top 20 pharma and biotech companies with this report’s analysis of offshore investment and deal trends over the last five years.
• Discover which geographic regions have the greatest potential for offshore R&D
investment by identifying key areas of technological, scientific and academic expertise across Asia Pacific, Australia, Eastern Europe, Latin America, the Middle East and South Africa.
• Measure how the offshore strategies of the top 20 pharma and biotech companies have influenced their R&D productivity and efficiency with this report’s financial and managerial performance review, comparative analysis of healthcare/pharma/biotech sectors and S&P500 index assessment.
• Identify the key drivers and opportunities for offshore investment with this report’s analysis of major offshoring trends and R&D developments.

Explore issues including...

Shifting focus of R&D strategies. The industry has become more globalized in its R&D approach as part of efforts to improve productivity and efficiency. Networks of offshore partnerships and academic collaborations are now enabling companies to harness external expertise on a project by project basis.
Offshore investment in emerging economies. Companies are increasingly turning to emerging countries to counter the slowing growth of US and European markets. Investing in offshore R&D facilities provides companies with local expertise and a greater understanding of local economies.
Offshore opportunities in tertiary economies. The success of commercial opportunities in emerging markets has expanded the regional scope of investment, with Australia, Israel and Singapore all seen to provide labour arbitrage and access to specialists.
Focused managerial directives are critical. Successful R&D performance is underpinned by a streamlined R&D strategy which is well managed by a team of scientists, technologists and non-scientists which can guide global networks ensuring early go/no go decision making which builds on the core competencies of both internal and external researchers.

Discover...
• Which countries are attracting offshore investment?
• Which areas of research and technology are attracting offshore investment?
• How are the leading pharma and biotech companies changing their R&D programs?
• Which major companies and academic institutions have attracted offshore investment?
• What factors are driving offshore investment?
• What is the financial performance of the leading pharma and biotech companies based on P/E ratio compared to their peers and the S&P500?
• Which companies have delivered the best return on assets and return on investment during the last five years?
• How will offshore investment influence R&D productivity in the future?

Evolving Trends in Biopharmaceutical Licensing: Deal assessments, drivers and resistors

Large Pharma companies have become heavily dependant upon alliances and in-licensing to gain access to technologies/new molecular entities from Biopharma. This reliance has strengthened Biopharma’s bargaining position, and is reflected in negotiation tactics which aim to expand their role beyond product discovery and development towards an active participation in the the future of their products. This is emphasized by the growing complexity of licensing deals, as Biopharma attempts to secure marketing and commercialization rights within partnership deals.
Furthermore, recent increases in internal Biopharma consolidation are an indicator of the ability of well-established Biopharma companies to effectively compete against traditional big Pharma.
‘Evolving Trends in Biopharmaceutical Licensing’ is a report published by Business Insights that provides a detailed analysis of licensing strategies in the biopharmaceutical industry over the 2001-08 period. This report examines the growth of the biopharmaceutical industry, deal-making trend data, drivers and challenges facing biopharmaceutical licensing, and profiles of biopharmaceutical licensing among leading companies. The future prospects of the industry are assessed and the potential impact of political/regulatory factors upon licensing and alliances is identified. This report also investigates the influence of the recent upsurge in M&A activity and provides recommendations on the strategies that can sustain future growth.

Key Findings
-Several top-ranked Biopharma companies have matched the consistent sales growth of major traditional pharma companies. A key component of this success has been the increasing reliance of big Pharma to improve R&D productivity and rejuvenate sales of marketed portfolios through licensing and partnership deals.
-Big Pharma has been acquiring Biopharma companies at an increasing rate, resulting in this becoming the fastest-growing M&A sector in 2008 with deal values up 87%. Intense competition and financial uncertainty has also prompted a surge in biopharma consolidation, with 52 biopharma/biopharma deals in 2007.
-Considerable potential for Biopharma licensing deals still exists, particularly within the OAD class of drugs and non-invasive insulin drug delivery technologies.
-The total deal size of early-stage alliances with biopharma has increased six-fold, with total deal values in 2007 estimated at $18bn. This has been driven by the relatively lower costs of discovery and lead development, despite the higher risk of failure.
-Co-development/co-promotion deals accounted for 30% of licensing deals over 2006-07. Licensing deals will continue to become more complex due to biopharma’s desire to remain involved in their product lifecycle beyond the stages of discovery and development

Use this report to...
• Examine the licensing landscape of the biopharma industry with this report’s analysis of Biopharma and Pharma licensing and alliance activity and an examination of specific approaches utilized by both sectors.
• Discover the drivers and challenges facing Biopharma licensing, understand how
Biopharma companies are preparing to exploit new opportunities and assess deal-making trends across clinical trials phases and key therapeutic areas.
• Evaluate the strategies of leading companies involved in biopharmaceutical licensing with this report’s analysis of deal activities amongst leading players and identify the changing dynamics of Biopharma/Pharma partnerships.
• Assess the future prospects of the Biopharma industry and how current market and political/regulatory factors will impact the dynamics of licensing and alliances, as well as potential strategies for sustaining growth.

Explore issues including...
Biopharmas reduced reliance on Pharma. Biopharma is sustaining its efforts to increase its role outside of product development/discovery to become actively engaged in the future of their products. As such, it is becoming increasingly difficult to differentiate big Pharma from major Biopharma companies.
Optimizing revenue potential. Biopharma are increasingly targeting high value therapy areas, such as oncology and inflammatory disease, bringing them into direct competition with major Pharma.
Future competitive strategies. With licensing deals increasing in value and complexity, Biopharma companies are looking to increase their involvement by forming long-term, partnership-based relationships. This active engagement in licensing deals will typically involve the negotiation of equity investment and the co-promotion and co-marketing of a drug that allows Biopharma to generate additional downstream revenues.
Drug development potential. The emergence of several new Biopharma companies with innovative technology platforms has created immense potential for intra-Biopharma licensing trends to continue developing novel drugs that can successfully differentiate themselves within the marketplace.

Discover...
• How will the increasing competition for attractive Biopharma licensing candidates affect deal terms and values?
• How can Biopharma companies improve their licensing strategies to ensure future growth?
• What have been the major trends in licensing agreements between Biopharma and Pharma over 2001-08?
• Which strategies have Biopharma used to reduce their reliance on Pharma?
• How has the value, volume and competition for Biopharma licensing deals changed over 2001-08?
• What have been the strategies of successful Biopharma and Pharma deal-makers?
• Why are Biopharma and Pharma increasingly adopting M&A strategies instead of entering into licensing agreements?

Technology Transfer Strategies: Maximizing returns from new technologies

Report Overview

Technology transfer is a long-established part of early-stage research within the pharmaceutical and biotechnology industries. Although technology transfer offices have traditionally been associated with inefficiency and a lack of commercial judgment, recent trends have shown improvements in staffing, expertise and service levels. However, the tech transfer function has recently suffered from ‘funding gaps’ for promising new technologies. A clear disparity exists between current service offerings and demand levels amongst investors/industry partners, while the lack of an established model for effective technology transfer function and significant regional variations are major obstacles to future progress.

‘Technology Transfer Strategies’ is a uniquely themed report published by Business Insights that provides a comprehensive examination of the major trends in technology transfer activity in the US, Canada and Europe. The report provides a detailed country-level analysis of technology transfer and associated intellectual property technology regulations, in addition to evaluating the key approaches to office structuring and strategies to negotiate the ’funding gap’. A series of in-depth interviews also document the experiences and insights of 11 tech transfer experts, and their recommendations for successful technology transfer strategies are revealed.

Key Findings

The number of new technology transfer licensing agreements ‘earned’ for every $1 billion of research expenditure has fallen from 115 to 109 between 2004 and 2006. However, the rate of return for licensing revenues per $1 million research expenditure has increased over the same period, from $34,806 to $40,837.

The efficiency of technology transfer outcomes varies across major regions. The UK produces the highest rate of invention disclosures, licensing agreements and new start-ups. The US produces the greatest rate of new patent grants, while Canada generates the most new patent applications. US institutions also generate the greatest technology licensing returns from research investments.

A common industry complaint about interactions with technology transfer offices is ‘a lack of understanding about customer needs’. Tech transfer executives are often viewed to better understand the merits of scientific over commercial solutions.

Generating a successful initial public offering (IPO) has become more difficult, putting increased pressure on associated royalty rates and spin-out terms. As venture capitalists become more conservative, moving new technologies from federal funding to proof-of-concept is increasingly challenging.

Use this report to...

• Identify the latest trends in technology transfer and compare the relative efficiencies of different regions with this report’s detailed survey data of technology transfer performances in the US, Canada and Europe.

• Compare the progress of leading peer-group universities and institutions by using this report’s league table assessment of leading technology transfer offices including healthcare patent data and overall technology transfer outcomes.

• Benchmark the best practices of leading technology transfer offices in the US and Europe by using in-depth case studies that examine successful strategies and approaches to office structuring.

• Assess the strategic recommendations and future predictions of technology transfer specialists based on insights from interviews with eleven experts from universities, hospitals, research institutions and independent companies, in addition to contributions from venture capital and pharmaceutical industry executives.

Explore issues including.

The funding gap. The difficulty of translating basic research to commercial licensing opportunities has never been greater, particularly as VCs and industry clients become more risk averse.

Defensive strategies. Moving technologies beyond basic research to proof of concept is expensive but has become a necessary step in the current technology transfer environment

Cultural differences. Technology transfer offices are positioned between the academic and business worlds, and must balance the non-profit and for-profit worlds accordingly.

Integration vs independence. Recent trends, particularly in the UK, have seen a move towards establishing independent technology transfer offices in order to facilitate greater levels of professionalism and commercialism.

Discover...

• How do intellectual property rights differ by geography?
• How does the availability of potential collaborators and licensing partners differ by geography?
• How does the availability of human resources vary by geography?
• What are the alternative models for delivering technology transfer?
• What impact does each model of tech transfer delivery have upon commercial returns, operational effectiveness and culture/process?
• What are the key lessons from current technology transfer best-practices?
• How does the funding gap influence returns from technology transfer?
• What strategies can effectively combat the funding gap?

Negotiating the Emerging Biosimilars Landscape: Key developments in the regulatory environment

As regulatory obstacles to biosimilars development have become increasingly resolved, a growing number of opportunities have been created for generics companies in the biopharmaceutical market, which according to IMS data was valued at $85.9 billion in 2007. Conservative projections estimate that sales of biopharmaceutical products will exceed $135 billion by 2011. With some of the earliest biopharmaceuticals having already lost patent protection, the originators of biopharmaceutical products are facing intense competition from generics developers. In response, originators are resorting to a range of defensive tactics, including the reformulation of existing products to improve efficacy, the implementation of more efficient delivery systems and the pursuit of high-level intellectual property (IP) battles.

‘Negotiating the Emerging Biosimilars Landscape’ is a report published by Business Insights that examines the structure of the biopharmaceutical industry and the strategic approaches taken to alleviate the threat posed by the biosimilar market. The key factors affecting market access within the biosimilars market are assessed and the latest issues surrounding bioequivalence are examined. This report also provides a comprehensive review of the current legislative and regulatory positions of key geographic regions in addition to evaluating their anticipated future legislative changes and outcomes.

Key Findings

European Union guidelines have been prepared which authorise the use of specific therapeutic biopharmaceutical medicines as biosimilars. However, despite the range of current European guidelines produced by the EMEA, many European governments have issued laws prohibiting the automatic substitution of original products.

No approval pathway for biosimilars (FOB) exists in the USA, and one is unlikely to exist before 2010. A complex range of Acts and Bills have failed to resolve a number of outstanding legal and regulatory issues.

India’s biopharmaceutical industry is projected to grow to almost $5 billion by the end of 2010, representing annual growth in excess of 30%. However, despite WTO membership and recent advances in compliance with international regulatory/intellectual property laws, there remains no formal regulatory framework for biosimilars in India or China.

Health Canada has not yet publicly announced a legal or regulatory framework for biosimilar approval, and no legal framework for biosimilars currently exists in Japan. New regulatory frameworks and biosimilar guidelines are currently under development in both countries.

Use this report to...

• Identify and respond to the challenges and threats posed by the emergence of the biosimilars industry with this report’s examination of key trends and strategic approaches used by the biopharmaceutical industry to protect market share and intellectual property.
• Examine details of expired patents or impending patent expiries for first-gen biopharmaceuticals derived from recombinant DNA such as interferons, human insulin and insulin analogs, monoclonal antibodies (Mab) growth hormone and epoietins.
• Evaluate the legislative and regulatory requirements for biosimilars across key geographic regions including Europe, the US, Japan, Australia, Canada as well as the strategically important emerging markets of China and India.
• Assess the factors affecting biosimilar market access with this report’s analysis of the drivers and restraints to biosimilar approval, use and uptake, in addition to an investigation of the problems associated with determining bioequivalence.

Explore issues including...

Impending patent expiries. The critical challenge facing the biopharmaceutical industry is the expiry or pending expiry of patents for first generation biopharmaceuticals derived from recombinant DNA such as interferons, growth hormone and epoietins.

Defensive strategies. As part of efforts to protect the market share of products with impending patent expiries, originator biopharmaceutical companies have begun to protect intellectual property and engage in strategic alliances, joint ventures and mergers between themselves and major pharma companies.

Geographical disparities in biosimilar legislation. Different geographic regions have varying legislative approaches to the regulation and/or approval of biosimilars. Such discrepancies often lead to misunderstandings and can result in complexity and complication during the approval process.

Discover...

• Which biopharmaceutical companies are at risk from product patent expires?
• What is the status of the analytical techniques used for determining bioequivalence?
• What tactics prove most effective for originator biopharmaceutical companies who wish to protect their market position?
• What effect the market entry of second generation biopharmaceuticals by originator companies have on the biosimilars market?
• What are the growth drivers and restraints of the biosimilars market?
• How are global healthcare costs influenced by biosimilar market entry prospects?
• What is the current legislative and regulatory status of biosimilars in Europe and the US?
• How will China and India influence the biopharmaceutical and biosimilars market in the future?

The Cardiovascular Market Outlook to 2013

The cardiovascular therapy area spans a range of treatment classes including anti-hypertensives, anti-dyslipidemics, anti-thrombotics, hematological preparations and cardiac therapies. Each sub-therapy area is facing a different set of issues and challenges, such as the current generic threat for dyslipidemics and competition from novel therapies in thrombosis. Leading products in these sub-therapy areas have proven to be significant growth drivers for Big Pharma, such as Pfizer’s Lipitor, Sanofi’s Plavix and Lovenox, and Amgen’s Aranesp. The recent emergence of smaller players and increased competition from generics has prompted leading players to engage in alliances and agreements for key drugs to keep pace with the changing market landscape.

‘The Cardiovascular Market Outlook to 2013: Competitive landscape, global market analysis and pipeline analysis’ is a report published by Business Insights that provides comprehensive coverage of every class of drugs across major cardiovascular indications. Detailed insights into recent key events and future market leaders are also provided, in addition to epidemiological analysis and forecasts for major products over the 2007-13 period. With coverage of over 90% of the total market for cardiovascular products, this report profiles the underlying trends and factors driving the market and identifies the most promising areas of potential growth.

Discover the key market trends and growth drivers of the cardiovascular market, assess the competitive dynamics of leading companies and evaluate the future prospects of major products with this new report...

Some key findings from this report...
• Anti-hypertensives were the highest selling sub-therapeutic category in 2007, with global sales of $52.9bn. Norvasc was the leading anti-hypertensive, with sales of $3.3bn.

• The global market for anticoagulants will experience significant activity over the next two years with the introduction of new drugs including Boehringer Ingelheim’s Pradaxa/Rendix, Bayer- Schering/J&J’s Xarelto, BMS/Pfizer’s apixaban and Eli Lilly/Daiichi’s Effient.

• Crestor has been steadily gaining market share and positive JUPITER trial results will help to further improve its market position. The positive trial data is likely to result in recommended cholesterol treatment goals becoming lowered, and Crestor will be well positioned to capture more patients and expand the market.

• GlaxoSmithKline’s (GSK) acquisition of Reliant Pharma will contribute to GSK having the highest growth amongst the leading players through to 2013. The addition of key drugs such as Lovaza to GSK's portfolio will drive this growth.

• The anti-arrhythmic market is expected to remain a relatively small opportunity, as drug therapy has significant limitations. Multaq from Sanofi-Aventis may become the therapeutic standard in the first-line treatment of chronic atrial fibrillation.

Top five reasons to order your copy today

• Assess patient potential, treatment trends and sales patterns across major cardiovascular diseases over the period 2007-13 within the subtherapy areas of hypertension, dyslipidemia, thrombosis and stroke.

• Measure the market performance and strategic positioning of major pharmaceutical corporations with this report’s evaluation of the franchises and market shares of AstraZeneca, Amgen, BMS, Daiichi Sankyo, GSK, Merck, Novartis, Pfizer and Sanofi-Aventis.

• Discover the market dynamics of the cardiovascular area and understand the impact of recent key events by assessing major market trends, growth drivers and the latest issues affecting R&D.

• Compare the future prospects of key players and forecast sales of leading products across major indications to 2013 with this report’s analysis of sales focus by drug class, currently marketed portfolios, R&D pipelines, and strategy/growth assessments.

• Identify the strategies that offer the greatest success potential within the future cardiovascular market and understand the challenges currently facing companies within this therapeutic area.

Key issues examined in this report...

• Leading cholesterol-lowering drugs show declining sales. Patent expirations have been off-setting positive drivers of growth including recent trial results that support aggressive LDL lowering in broader patient populations. The availability of generic simvastatin has resulted in increased therapeutic substitution and declining brand share.

• Stalling growth of leading hypertension drugs. Angiotensin receptor blockers or ARBs have become the most prescribed antihypertensive class. However after several years of gaining market, growth in the branded ARB category appears to be stalling. A number of studies have shown ARBs to be no more effective than generic ACE inhibitors, most recently the ONTARGET study published in April, 2008

• Novel oral anti-thrombotics threaten leading drugs. Novel drugs in the thrombosis market pipeline are expected to strongly compete with the current market leader Lovenox . The new drugs are orally formulated and are expected to substantially expand the market. Trial data has shown these drugs to be more efficacious without presenting a huge inrease in the risk of bleeding.

Your questions answered...
• Which indications will experience the greatest growth in the global cardiovascular market over the period 2008-13? • Which companies will become the key players in the cardiovascular area over the period 2009 -13?

• How have recent major product launches from companies such as Gilead and Novartis performed?

• What is the forecast market size and growth rate over the period 2008-2013 across the major cardiovascular indications?

• Which pipeline products offer the highest growth potential? • What will be the competitive landscape of hypertension, dyslipidemia, thrombosis, hematology and cardiac therapies in 2013?

Delivery Mechanisms for Large Molecule Drugs Successes and failures of leading technologies and key drivers for market success

Emerging drug delivery technologies aim to improve measures of safety, efficacy, convenience and compliance in both new and existing drug candidates and products. For currently marketed products, reformulations with new delivery technologies will extend the period of patent protection. New formulas will be key to boosting sales volume of large molecule products in chronic diseases where patient compliance surrounding dosing strategies and ease of administration are limitations on market growth. In R&D pipelines, novel applications of delivery technologies will expose new methods to reformulate failed or discontinued drugs and mask their unfavorable effects, expanding the market of potential drug candidates.
‘Delivery Mechanisms for Large Molecule Drugs’ is a report published by Business Insights that examines the future of the drug delivery technologies market, and the short, mid, and long-term growth dynamics which will underpin investment decisions. This report will measure the performance of leading drug delivery technologies applied within clinical R&D pipelines and identify when specific therapy area populations are set to benefit from emerging innovations. The market success of new technologies is forecast by their ability to fulfill unmet medical need, the maturity of the technology in clinical application, and the level of commercial interest and investment landscape.

Key Findings

Nanotechnology will have the greatest impact on the drug delivery market. However, the immaturity of the technology is likely to delay marketed presence over the next 7-10 years.

Antibody fragmentation and PEGylation technologies are the leading targeted large molecule particle engineering formulas with marketed drug product presence. However, antibody fragments have suffered 33 candidate failures compared with 12 PEGylated products.

Active transdermal technologies have generated the greatest number of technologies and devices amongst large molecule delivery innovations, with 16 clinical and 8 preclinical drug/device combination products and 49 stand-alone devices.

Electronic delivery is set to have the greatest impact upon the device industry. Electronic device control is more advanced within the field of pulmonary delivery than transdermal delivery, with the average pulmonary-based product in early clinical phase I compared to late-stage preclinical investigation for transdermal. There are, however, 25 transmembrane electroporation technologies currently being developed,
in comparison to 12 for electronic active pulmonary delivery.

Use this report to...

• Understand the drivers of new delivery platform developments with this report’s analysis of therapy area growth drivers, clinical development spend and unmet clinical need.
• Identify the risks and opportunities associated with emerging delivery technologies by measuring the risk potential and maturity of innovative platforms.
• Evaluate the latest developments in systemic targeting technologies by using this report’s analysis of innovations and pipeline progress for the latest active and passive targeting techniques.
• Discover which technologies have the greatest potential within large molecule product markets in the future with this report’s comparative analysis of growth metrics for leading platforms and an evaluation of their established clinical drug application.
• Assess recent innovations in pulmonary delivery technologies and needle-free
transdermal delivery with this report’s analysis of clinical and preclinical developments and commercial potential.

Explore issues including...
High failure rates for new technologies. The high failure rates of drugs to which pioneering delivery techniques have been applied have made investors cautious.
Unknown clinical safety and efficacy profiles have made it harder to determine appropriate parameters for success in clinical application.
Immaturity of technologies. Many of the technology platforms profiled in this report are in the early stages of application to clinical drug candidates. Those that have achieved success in marketed drug candidates already have ‘next generation’ alternatives in technology pipelines.
Unknown clinical pharmacokinetics. Many of these platforms remain in such an immature stage that they have yet to be applied to drug candidates. In vivo
experimental use in drug candidates can never accurately predict success once a technology has reached maturity. Even for those technologies with established use in R&D pipelines, long-term clinical efficacy remains unknown.
Regulation of the new technologies. While the clinical performance of new particle engineered drug molecules or active delivery devices remain unknown, regulatory bodies only have existing data-measure demands on which to benchmark their expectations. This framework will be shifted in line with emerging clinical performance datasets.

Discover...
• Which delivery technologies will have the greatest impact on the large molecule market in the short, mid, and long-term?
• How mature are the different delivery technologies and what is their pipeline presence in terms of application to R&D drugs?
• Will particle engineering technologies drive injectable formulas to dominate the market?
• Which therapy areas will benefit most from growth in the different technologies?
• How can the risk-profiles associated with clinical use be most effectively minimized?
• What are the leading novel platforms?
• Who are the targets for out-licensing and co-development of platforms for clinical use?
• What are the leading technology platforms within different classifications and how have they achieved their growth?

Intellectual Property and Outsourcing in China: Minimizing risk whilst maximizing return on investment

The pharma outsourcing industry in China has experienced over 35% year on year growth in the past few years. Increasingly, the sophisticated service offer of multinational CROs/CMOs is being challenged by improving Chinese players importing Western expertise, experience and business models to this fast growth market. However, there are still wide variations in service quality and capability from domestic outsourcing providers and many pharma and biotechs in Western markets are still reluctant to transfer parts of the drug development process to China.

Their concerns largely stem from issues around intellectual property rights (IPR), copyright infringements and counterfeiting. At both a corporate and governmental level, this weakness has been recognized and several key changes have been made to Chinese patent law, while service providers have also sought to improve their IPR protection processes and service standards. Nonetheless, key differences in secure IPR protection standards and service capability remain among domestic players.

‘Intellectual Property and Outsourcing in China’ is a report published by Business Insights that explores the expanding pharma outsourcing market in China to discover how large pharma, small-sized pharma and biotech can most effectively utilize the country’s service offerings and capabilities. It examines the latest outsourcing trends and service provisions across all stages of the drug discovery process and profiles the leading domestic CRO/CMOs. This report provides an in-depth investigation of the changing IPR protection landscape in China and analyses the strategies which can minimize infringement risks. Case studies are used to illustrate the success of recent CRO/CMO partnerships with Western companies and key criteria for selecting suitable service providers are also identified.

Some key findings from this report...

• China is the world’s most attractive destination for Pharma outsourcing based on an analysis of patient pools, cost efficiency, regulatory conditions, available expertise and infrastructure.

• There were 694,153 patent applications in China in 2007, a CAGR of 22.5% on the number of applications in 2003 (308,487). At this rate, China will be the world’s largest patent-filing jurisdiction by 2012.

• China’s service capabilities are strong, with full-scale medicinal chemistry services currently available from 26 CROs. Services include structure-based rational drug design, structure-activityrelationship (SAR)-based activity/potency optimization, and the optimization of pharmacological properties for lead compounds.

• In the next 3 to 5 years, the service capabilities of many China-based service providers will develop quickly and change the IP risk profile. Currently, the domestic industry is highly proficient in large-scale manufacturing but relatively weak in preclinical and clinical drug development, and as providers’ capabilities increase the need for verification of effective IP protection protocols will intensify.

• The market will experience high growth of around 35% year on year to 2011. During this period, the industry will likely see investment in targeting, identification and validation capabilities.

Top reasons to order your copy today

• Understand how large pharma, small-sized pharma and biotech companies can benefit from the Chinese pharma market with this report’s analysis of the number of companies involved, levels of industry maturity, and existing/projected service offering capabilities.

• Assess the the risk factors associated with outsourcing decisions and measure the suitability of China-based CROs and CMOs with this report’s examination of each class of service provider and the key criteria for selecting the most appropriate company, including IPR protection protocols, service quality/capability, cost and geographic location.

• Understand how the IPR protection environment in China is evolving by evaluating the latest regulatory developments and patent application trends for domestic and multinational companies, in addition to this report’s market forecasts for outsourcing industry growth to 2015.

• Identify how IPR protection varies across each stage of the R&D process and use case studies of partnerships between Chinese CROs/CMOs and Western companies to measure the success of recent endeavours.

Key issues examined in this report...

• Variable service offerings. Many Chinese pharma companies that have API manufacturing skills only offer their services on a seasonal basis. They are not professional CMO providers, as their service offerings are largely dependent upon spare production capacity levels.

• Inflated service claims. Although many CROs/CMOs claim a broad service scope to attract business, their actual service skills are limited to only a couple of areas. Specifically, scientific staff often lacks sufficient experience, training and deliverability guidelines.

• Inconsistent IPR protection system. IPR protection is no longer a serious issue amongst top-tier service providers but may still be weak in lower tier domestic companies and those operating in rural areas.

• IPR infringement cases and counterfeit drugs: Drug counterfeiting is still a real problem and most IPR infringement cases are related to trademark/copyright violations. However, there have been no reported cases of infringement of a western pharma or biotech’s IPR by a Chinese company during their outsourcing collaborations.

Your questions answered...

• How does China compare to other outsourcing destinations?

• What services are offered by the CRO and CMO industry in China?

• What are the advantages of outsourcing different stages of the R&D process by large/small-sized pharma and biotech companies?

• What are the government’s development priorities for the industry?

• How has medical infrastructure supported region-specific growth in outsourcing and will this trend continue?

• What is the strongest sector of China’s pharma outsourcing industry in terms of both number of companies and strength of their services?

• Who are the major Chinese players in contract research and in which areas do they specialize?

• Which multinational companies have projects outsourced to China?

• What actions are the government taking to strengthen IPR protection?

The Cancer Market Outlook to 2013: Competitive landscape, pipeline analysis and growth opportunities

The market for cancer treatments is one of the largest and fastest growing areas in the pharma industry. Most innovation in oncology over the past 10 years has been driven by scientific advances, particularly in the genomics, transcriptomics and proteomics sciences. Successful oncology players of the future will be those that can anticipate protocol evolution and design the most relevant clinical trials. More recently, biotech companies have been driving innovation in oncology more than ever before. Partnering with biotech companies is an important but expensive source of innovation for many pharma companies, with approximately 75% of phase II, III and pre-registration innovative drugs are of biotech origin.
‘The Cancer Market Outlook to 2013’ is a report published by Business Insights that provides comprehensive coverage of the major markets in the global cancer area, incorporating a detailed epidemiological analysis of the nine major indications and key factors impacting their prevalence. Current leading brands of treatment within each cancer indication are analysed and eight of the market’s leading players are profiled. With coverage of over 90% of the total market for cancer products, this report profiles the factors and underlying trends that are driving market transformation and identifies the most promising areas of potential growth. Forecasts for currently marketed and key pipeline products over the 2007-13 period are also provided.
Discover the key market trends and growth drivers of the cancer market, assess the competitive dynamics of leading pharma companies and evaluate the future prospects of major products with this report.

Assess leading brands of treatment for each indication, identify potential growth opportunities and compare the outlooks of leading companies within the cancer market with this new report...

Some key findings from this report...
• Antineoplastic mAbs accrued sales of $11.3bn in 2007, amassing a market share of 34.1%. The most prominent contributors to market share in this class were MabThera (32.8%), Herceptin (28.8%), Avastin (25.2%) and Erbitux (10.2%). The total antineoplastics market is forecast to be valued at $43.0bn in 2013.
.• Amgen’s blockbuster brands Neulasta (pegfilgrastim) and Neupogen (filgrastim) dominated the immunostimulant market in 2007, with sales of $3.5bn and $1.4bn respectively. Forecast sales for the immunostimulants market are estimated to reach $17.6bn in 2013.
• Roche is the leader in the global market for cancer treatments, with a market share of 34.9% (equivalent to $13bn sales) in 2007. Roche has recently bolstered its position through portfolio expansion, with the purchase of majority stakes in both Genentech and Chugai.
• A definitive merger between Eli Lilly and ImClone will increase Eli Lilly’s flow of high-quality, innovative therapies. This will enable the company to offer physicians/patients a complementary portfolio of leading agents/targeted therapies including Gemzar, Alimta & Erbitux.
• Pfizer has a robust R&D pipeline with eight molecules in phase II and thirteen molecules in phase I, the highest among all the top ten companies in global cancer market.

Top five reasons to order your copy today
• Assess patient potential, treatment trends and sales patterns of major cancer indications over the period 2007-13, with this report’s coverage of lung, breast, colorectal, ovarian cancer markets across Japan, France, Germany, Italy, Spain, the UK and the US.
• Measure the market performance and strategic positioning of major pharmaceutical corporations with this report’s evaluation of the franchises and market shares of Roche, Amgen, Sanofi-Aventis, Merck KgaA, Novartis, Pfizer, Schering-Plough and Eli Lilly.
• Discover the market dynamics of the cancer area and understand the impact of recent key events by assessing major market trends, growth drivers and the latest issues affecting product development.
• Compare the cancer pipeline compounds of leading companies with this report’s detailed analysis of clinically differentiated pipeline products by indication, in addition to sales forecasts for key R&D pipeline products in the global cancer market to 2013.
• Understand which indications are likely to generate franchise growth and examine major classes of cancer treatments including antineoplastics, immunostimulants and cytotoxic hormone therapies.

Key issues examined in this report...
• Reimbursement for cryoablation treatments. The new 2008 CMS rates for prostate cryoablation (in outpatient hospitals), under APC code 674, were raised from $6,685 to $7,816, an increase of 16.9%. The cryoablation rates for ambulatory surgical centers, known as ASC code 55873, were raised from $1,339 to $6,219, an increase of 364%.
• Plant-based cancer vaccine. Researchers are developing a plantbased vaccine which can be created more quickly and at far less expense than the animal-based version. The antibodies produced may also trigger a stronger immune response than in mammalian cells.
• Novel inhibitor of human microRNA. The Wistar Institute team have identified a small molecule that blocks the pathway of miR-21, which is implicated in brain cancer, as well as lung, colon, breast, and ovarian cancer. With further development, the molecule has the potential to boost patient response to existing chemotherapies.
• NICE guidance on kidney cancer drugs. The availability of high cost cancer drugs is one of the most pressing issues for the NHS. Drug makers are developing proposals which may reduce future drug costs.

Your questions answered...
• Which indications will experience the greatest growth in the global cancer market over the period 2008-13?
• How have recent major product launches from companies such as Roche, Amgen, Pfizer and Merck KGaA performed?
• What is the forecast market potential of the most exciting compounds currently in development for cancer indications?
• Which companies are best positioned for future success?
• What is the forecast market size and growth rate over the period 2007-2013 across the major cancer indications?
• How will generic competition influence the future of branded products and which defensive strategies provide the most effective protection?
• Which pipeline products offer the highest growth potential?
• What will be the competitive landscape of lung, breast, colorectal, ovarian, prostate, lymphoma and pancreatic cancer in 2013?

The Pharmaceutical Market Outlook to 2018: Key threats and opportunities for Big Pharma and its responses to them

The pharmaceutical industry must respond to a number of key challenges over the next ten years in order to sustain recent levels of growth. Falling levels of R&D productivity and the exposure of an increasing amount of blockbuster drugs to generic competition as a result of patent expiries are among the most notable concerns for pharma players. Recent strategies have seen a rise in outsourcing and the restructuring of R&D processes, with a movement away from internally driven R&D organizations with Centers of R&D Excellence and Disease Focused R&D Centers. Turbulence in the global economy is also having a significant impact upon the biotech industry, where externally funded companies are particulary vulnerable to investment downturns.

‘The Pharmaceutical Market Outlook to 2018’ is a report published by Business Insights that explores the key threats and opportunities facing the pharma industry over the next ten years. This report analyses how leading companies including Pfizer, Roche, GSK, and Merck & Co. are optimizing their approaches and growth strategies to succeed in the changing market landscape. The performances of the top 10 pharma companies over the past five years are also assessed and a proprietary Business Insights survey evaluates the views of industry executives as to future market growth, biotech M&A activity, personalised medicine and pipeline developments.

Identify key trends and developments in the global pharma landscape over the next ten years, compare the strategic responses of leading players and evaluate competitor sales, pipelines and prospects.

Some key findings from this report
• Global sales of biotech drugs rose by 12.5% in 2007 to over $75bn, despite the financial challenges faced by the pharma market. However biotech funding has been notably affected, having fallen to half of its 2007 level following investment of only $12bn in 2008 (YTD).

• Lilly saw the second highest sales growth in 2007 amongst the leading pharma companies, a 13% increase over 2006 revenues. This performance can be largely attributued to the steady sales of Zyprexa ($5bn in 2007), the 6th highest selling drug globally in 2007.

• Total pharma R&D spend has been increasing by 15% per annum to a total of $70bn in 2007, and is forecast to reach $85bn in 2009. Similarly, biotech R&D spend reached $13bn in 2007. Despite this increased spending, the number of NMEs being approved by the FDA has continued to fall, with only 18 NME approvals in 2007.

• Pfizer’s Lipitor achieved sales of $13.5bn in 2007, however revenues are forecast to fall below $7bn over the next five years following the loss of patent protection.

• Global expenditure on CRO services is forecast to reach over $26bn by 2010, accounting for 22% of the pharma budget. Much of this outsourcing will be focused upon Phase III and drug discovery.

Top reasons to order your copy today
• Discover the key threats and opportunities facing the pharma industry over the next ten years with this report’s detailed evaluation of R&D challenges, increasing generic competition, biotech developments, new technologies and emerging markets.

• Assess the competitive landscape of the global pharma market with this report’s analysis of the top 10 pharma companies based on total pharma sales, branded pharma revenues, product/therapy area mixes and a breakdown of leading developmental products.

• Compare how leading pharma companies are adapting to the evolving pharma market by examining the individual challenges, growth strategies, M&A initiatives and pipeline prospects of major players including Pfizer, GlaxoSmithKline, Merck & Co. and Roche.

• Identify how the global pharmaceutical market is likely to change over the next ten years by using this report’s analysis of a Business Insights’ proprietary survey which reveals the opinions and expectations of industry executives in relation to the future pipeline, marketed products, business strategies and alliances.

Key issues examined in this report

• Restructuring R&D processes. Many leading pharma players have restructured R&D processes by establishing Centers of R&D Excellence and Disease Focused R&D Centers. In addition, there has been a drive to increase the utilization of CRO’s both locally and internationally to discover, optimize and clinically assess new candidates.

• Shift towards ‘nichebuster’ drugs. The ‘one size fits all’ approach to drug development is being replaced by a more targeted, innovative approach to develop treatments for small patient groups with complicated diseases such as cancer, rheumatoid arthritis and immune disorders. Such ‘nichebusters’ are expected to exploit new technologies such as biomarkers and theranostics and will support the continued development of personalized medicine.

• Importance of developing (pharmerging) markets. Emerging markets such as China and India will stimulate significant growth in the pharma market over the next five years. These ‘pharmerging’ markets have grown more rapidly than the seven major markets in the past five years, with sales rising by 15.79% compared to 5.62% in the 7MM.

Your questions answered
• What are the key emerging opportunities for companies in the pharmaceutical industry?

• How did leading pharma companies perform over the last five years?

• Which growth strategies are being used by major pharma players including Pfizer, Gsk, Merck & Co and Roche?

• How has the current economic environment affected the relationship between biotech companies and pharma companies?

• To what extent has the therapy area mix changed amongst the portfolios of leading pharma companies?

• How is the therapy area mix likely to change in future?

• Which geographic areas will become integral to the future of the global pharma market?