 | Datamonitor's Biotechnology: Global Industry Guide is an essential resource for top-level data and analysis covering the Biotechnology industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis on a global, regional and country basis. |
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| In 2008, seven major market sales of anticonvulsants reached $13.6 billion, making it one of the largest therapeutic drug classes in the Pharmaceutical sector. However, generic incursion of second generation anticonvulsants will continue to increase the barrier to entry for prospective players, although viable commercial opportunities exist to optimize returns from this lucrative drug class market. |
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| With current blockbuster brands facing generic competition, Datamonitor forecasts the antidepressant market to decline at a compound annual growth rate of -2.0% (20082018). However, an antidepressant with a novel mechanism of action has huge commercial potential and the most promising candidate to date is Servier and Novartis's melatonin agonist and serotonin antagonist Valdoxan (agomelatine). |
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| Datamonitor expects the antidiabetics market to reach $38 billion, across the seven major markets, by 2018. The growth will be driven by the launch of new drug classes, notably the DPP-IV inhibitors and GLP-1 agonists, and large growth in patient numbers. However, patent expiries of the glitazone (TZDs) class will restrain market growth. |
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| Datamonitor expects the Australian antidiabetics market to reach $416m by 2018. The growth will be driven by the launch of new drug classes, notably the incretin mimetics, and large growth in patient numbers. Although strongest growth is expected in the non-insulin market, the insulin market will continue to dominate, generating revenues of $224m 10 years from now. |
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| Since the 1960s, hormonal contraceptives have been widely used as effective birth control in the developed world. Although they are mainly used to prevent pregnancies, they can be used for treating other conditions such as acne, endometriosis, and polycystic ovarian syndrome. In 2008, the hormonal contraceptives market was worth $6.2 billion across the seven major pharmaceutical countries. |
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| The Parkinson's disease market is approaching maturity, with the threat of generic incursion evident in each drug class. Although growth will be stifled by generic launches, relatively successful lifecycle management strategies and new product launches see the Parkinson's disease market grow at a compound annual growth rate (CAGR) of 2.6% over the next 10 years (20082018). |
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| Datamonitor's Generics: Global Industry Guide is an essential resource for top-level data and analysis covering the Generics industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis on a global, regional and country basis. |
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| Since the 1960s, hormonal contraceptives have been widely used as effective birth control in the developed world. Although they are mainly used to prevent pregnancies, they can be used for treating other conditions such as acne, endometriosis, and polycystic ovarian syndrome. In 2008, the hormonal contraceptives market was worth $6.2 billion across the seven major pharmaceutical countries. |
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| With the pharmaceutical industry reducing its focus on the primary care blockbuster model, Big Pharma is now looking towards the development and commercialization of more niche, high value, often biologic therapies, for the treatment of smaller patient populations. |
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| Datamonitor's Orthopedics: Global Industry Guide is an essential resource for top-level data and analysis covering the Orthopedics industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis on a global, regional and country basis. |
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| The Parkinson's disease market is approaching maturity, with the threat of generic incursion evident in each drug class. Although growth will be stifled by generic launches, relatively successful lifecycle management strategies and new product launches see the Parkinson's disease market grow at a compound annual growth rate (CAGR) of 2.6% over the next 10 years (20082018) |
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Drugs with new mechanisms, in particular Pfizer’s oral JAK inhibitor CP-690,550 and Chugai/Roche’s Actemra (tocilizumab), will launch for rheumatoid arthritis and should offer advantages over current therapies, but do not come without some safety signals. Late-stage pipeline launches will be a major contributor to market growth from $7.4 billion in 2008 to $11.5 billion in 2018. |
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| Three new partnerships are reshaping the competitive environment in HIV. Most notably, Tibotec/Johnson & Johnson is linking up with Gilead to combine their Phase III drug rilpivirine with Truvada to create a new gold standard fixed dose combination for treatment-naïve patients. Addressing Atripla's shortcomings, Datamonitor expects this product to dominate the market. |
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The drug therapy of acute myeloid leukemia (AML) and adult acute lymphoblastic leukemia (ALL) is largely based on chemotherapy regimens that have changed little in the past few decades. Patient outcomes for both diseases remain poor, particularly for elderly and high-risk patients. As the limits of cytotoxic chemotherapy are being reached, an unmet need remains for novel, improved therapies. |
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The cancer therapies market offers a high level of commercial reward to a handful of companies including Roche, Sanofi-Aventis, AstraZeneca, Novartis and Eli Lilly. Cancer therapy sales totaled over $38 billion in the seven major pharmaceutical markets in 2008, growing at a CAGR of 17.4% between 2005 and 2008. |
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| The report provides a comprehensive financial and strategic analysis of the mAb market, forecasting its commercial evolution out to 2014 and assessing trends by product, company, therapy area, geography, technology and target type. It also provides an insight into the direction of mAb technology evolution and an analysis of pipeline dynamics. |
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| Over the past decade, vaccines have resurfaced as an attractive commercial proposition for Pharma. The developed world has been the initial focus of vaccine makers due to the better healthcare infrastructure and higher price levels. However, facing increasingly saturated markets in the West, companies are looking to expand into new geographies, such as Asia's emerging markets.
Scope
Strategic analysis of key domestic vaccine companies as well as the position of major international playersThorough assessment of the market environment for vaccines in India, China, Taiwan and KoreaReview of existing vaccine recommendations, coverage rates and promising future indicationsIn-depth discussion of strengths, weaknesses, opportunities and threats for each market from a vaccine maker's perspective
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| Introduction
As the developed markets are becoming increasingly mature, Pharma is turning to the emerging markets, where long-term growth can be sustained. Of particular interest are Indonesia and the Philippines, which are currently going through major reforms to expand their healthcare systems; however there are key differences between these two markets. |
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| In 2008, seven major market sales of antipsychotics reached $18.2 billion. Datamonitor forecasts the market value to peak in 2011 when it will then succumb to generic erosion, particularly in the US where incursion is the most rapid. However, the commercial opportunity still exists for developers who can differentiate their antipsychotics with reformulation and indication expansion strategies.
Scope
In-depth analysis of the current and future antipsychotic drug class market across the US, Japan, France, Germany, Italy, Spain and the UK.Country-specific total brand sales forecasts for key products, generics and pipeline agents across the seven major markets to 2018.Assessment and appreciation of the numerous opportunities and threats present in the antipsychotic market, with analysis of emerging markets trends.Case study evaluation of the strategies employed by key players in the antipsychotic market, including Johnson & Johnson, AstraZeneca and Eli Lilly.
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| Introduction
CRC incidence will be over 490,000 cases by 2018 in the seven major markets. This large patient base will translate into a high commercial potential for the development of novel, more effective therapies. Currently, there are 77 agents in development for CRC, 4 of which are in late-phase development. Collectively, they are forecast to achieve sales of $1,398m by 2018.
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| Datamonitor's Healthcare: Global Industry Guide is an essential resource for top-level data and analysis covering the Global Healthcare industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis with distinct chapters for Health Care Equipment, Health Care Supplies and Orthopedics |
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| The opioids market is set to grow from $9.6 billion in 2008 to $11.9 billion in 2018 across the seven major markets. However, the number and diversity of products in late-stage development will limit the commercial potential of individual brands simply due to saturation and price competition in each opioids market.Reasons to Purchase*Analysis of the likely impact that recent events will have on the future opioids market*Includes forecasts for the key brands, generics, and pipeline agents in the seven major markets to 2018*Identification of future market events that are expected to affect opioid revenues. |
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| Tuberculosis is a major cause of illness and death worldwide, but despite 14.4 million prevalent cases, 9.2 million new cases and 1.7 million deaths in 2006, the small and rapidly declining burden of disease in the seven major markets has limited drug and vaccine development activities until recently. |
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| Back pain can restrict activity and quality of everyday life and in some cases is a potentially chronic and even crippling condition. Therefore, back pain exerts a large economic impact on society. Due to the high prevalence of back pain, Datamonitor believes that the condition represents a commercially attractive target to pharmaceutical companies with an interest in the pain market. |
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| Despite an explosion in the number of drugs and treatment strategies available, pulmonary arterial hypertension is still a rapidly fatal condition for a small, hard to identify patient group. A small clinical elite is currently leading the way in advancing treatment outcomes, and is central to determining which new treatment strategies are used. |
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| With a considerable patient population and continued government focus on lowering national smoking rates, the nicotine dependence market represents a lucrative opportunity for pharmaceutical companies. With strong uptake since launch in 2006 of Pfizer's Chantix (varenicline), the seven major prescription nicotine dependence market was estimated to total $1.35 billion in 2008. |
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| The opioids market is set to grow from $9.6 billion in 2008 to $11.9 billion in 2018 across the seven major markets. However, the number and diversity of products in late-stage development will limit the commercial potential of individual brands simply due to saturation and price competition in each opioids market. |
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| Only 15-20% of pancreatic cancer patients have resectable disease, therefore most receive systemic therapy. Gemzar (gemcitabine; Eli Lilly) forms the current standard of care for advanced disease. Despite this, no treatment is truly effective, with five-year survival at 5% for all stages of disease. Significant unmet needs therefore remain, with ample commercial opportunities for drug developers. |
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| Not only is Pharma facing a continued slow down in sales growth in the seven major markets, but erosion of branded drugs by generics follow patent expiry is increasing, driven by evolving payer initiatives to incentivize generic use. |
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| Patient perception of disease severity drives treatment-seeking behavior in psoriasis. New therapeutic options targeting specific mechanisms are set to reshape severe psoriasis therapy. However, current biologics have not undermined first-line topical therapy. In addition to efficacy, reimbursement plays a crucial role in physicians' prescribing decisions. |
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| With cystic fibrosis patients still dying prematurely and only two products currently approved for the treatment of this disease, the market is wide open for new entrants. Not only will novel symptomatic treatments and re-formulations lead to improved treatment paradigms, truly disease-modifying compounds are in late-stage development and will significantly change the market. |
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| Factors influencing a prescribing decision can diverge from clinical facts. In the highly competitive autoimmune area, misconceptions and physician habits can result in loss of sales. Targeted detailing of specialist physicians, differentiating by indications is the key to success. Datamonitor has surveyed gastroenterologists, rheumatologists and dermatologists on attribute and brand perceptions |
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| Datamonitor's Orthopedics: Global Industry Guide is an essential resource for top-level data and analysis covering the orthopedics industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis on a global, regional and country basis. |
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| Datamonitor's Biotechnology: Global Industry Guide is an essential resource for top-level data and analysis covering the biotechnology industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis on a global, regional and country basis. |
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| Over 11.5 million women suffer from infertility in the seven major markets. Although prevalence rates are stable, the trend towards later parenthood is inducing an increasing demand for infertility treatments. As cost of therapy is the major barrier access, the raise in demand puts increased pressure on healthcare payers to reimburse these treatments across the seven major markets. |
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| The antithrombotic market is expected to grow to $22 billion by 2017. The growth will mainly be due to the introduction of new agents onto the market, such as prasugrel and rivaroxaban, which will offer significant improvements over the current standards of care (Plavix (clopidogrel) and warfarin, respectively). |
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 | PharmaVitae universe Rx sales are forecast to expand at a 2007-13 CAGR of 2.4%, down 7.6 percentage points from 2001-07. The underlying cause of this falling rate is the much-discussed genericization of small molecule products. However, not all sectors are equally exposed, prompting a shake-up of the industry and an increasing pursuit of cost savings to sustain operating profit growth rates. |
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| Datamonitor forecasts that total sales for the seven major rheumatoid arthritis markets will grow from $7 billion in 2007 to over $12 billion in 2017. The sustained uptake of anti-TNFs combined with the launch of several new biologic products will drive growth in the short-and mid-term. However, biosimilar entry will cause a small contraction in market value at the end of the forecast period. |
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| The Hepatitis C market was worth $2.3 billion in 2007, declining at a CAGR of -2.8% from 2004-2007. Despite this recent slump, Datamonitor forecasts sales to grow to $4.5 billion by 2017, driven primarily by the launch of the new protease inhibitors. The US and EU will remain the largest markets, generating $1.9 billion and $1.7 billion respectively in 2017. |
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| Datamonitor research points to this sector, beleaguered by patent expiries, barriers to market entry and uptake, becoming increasingly inclement towards branded drugs. Generic incursion has taken a heavy toll on the market at a number of levels. The volume of key brands facing generic competition makes it even harder for remaining products to court large revenues in the community sector. |
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| The transplant immunosuppressant market has seen considerable growth in recent years, but this is expected to slow down. Two factors combine to cause a decline in the market from 2011, the limited availability of donor organs and patent expiries of several key products. Neither the shift to once-daily formulations nor the launch of novel biologic therapies will prevent the contraction. |
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| Long being regarded as an unattractive market, vaccines have re-emerged as successful growth driver for Big Pharma. The launch and rapid uptake of novel, high-price products such as Wyeth's Prevnar or Merck & Co's Gardasil, along with the emergence of novel vaccine technologies and favourable legislation have brought vaccines back into the main focus of pharmaceutical and biotech companies. |
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| The depression market was valued at around $11.04 billion in 2007 across the seven major markets. Following marginal growth to 2011 ($12.01 billion), the market is forecast to decline in value through to 2017 ($9.81 billion) when brand erosion due to generic incursion affecting all major drug classes used to treat depression finally outweighs the success of reformulations and follow-on products. |
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| Led by the seven triptan brands and Topamax's (topiramate; Johnson & Johnson) continued uptake, seven major market migraine revenues grew strongly at an annual rate of 12.6% to total $4.1 billion in 2007. |
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| Driven primarily by continued uptake of UCB's market leading anticonvulsant, Keppra (levetiracetam), seven major market epilepsy revenues grew strongly at a compound annual growth rate of 11.7% to reach almost $3.8 billion in 2007. |
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| Psoriatic arthritis and ankylosing spondylitis form part of the group of diseases known as the spondyloarthropathies. Psoriatic arthritis is a form of inflammatory arthritis associated with psoriasis, whilst ankylosing spondylitis causes arthritis of the spine and sacroiliac joints. Moderate-severe disease for both patient groups is frequently treated with similar therapies, including biologics. |
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| Sarcomas are a diverse group of rare connective tissue tumors that are categorized as soft tissue sarcomas or bone sarcomas. Although sarcomas represent only 1% of all adult and 15% of all childhood cancers, the development of metastatic disease is a major clinical problem as cure is less likely, particularly for soft tissue sarcomas. |
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| The face of ACS continues to change. The ageing population and pressure of growing risk factors have made a significant impact on the management strategies in ACS. This report extends the previous year report and unveils the true picture through in-depth analysis of data on over 29,000 ACS patient records in the 5 major European pharmaceutical markets (France, Germany, Italy, Spain and the UK). |
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| In 2008, the six tumor types covered in this report are forecast to account for over 961,000 new cases of cancer. Collectively, the 32 different drugs in Phase III development for the six tumor types are forecast to achieve $4,789m in sales by 2017. This constitutes a significant proportion of the oncology market, thus representing ample commercial opportunities for drug developers. |
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 | Since the financial meltdown, the relationship between Pharma and Biotech has been turned on its head. Previously, pharma companies had no choice but to license Biotech drugs at high prices in order to fill their sparse late stage pipelines. |
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| Narcolepsy is a chronic sleep disorder, which affects fewer than 500,000 sufferers across the seven major markets (7MM). The narcolepsy market value has grown considerably since 2004 to reach $230m in 2007 driven largely by the significant penetration of Provigil (modafinil; Cephalon) and Xyrem (sodium oxybate; Jazz Pharma) and the associated increase in the awareness of the disorder. |
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| Pharmaceutical companies are now divesting non-core assets such as medical devices and manufacturing plants in an effort to cut costs and focus on core strategies, primarily drug development. However, while some Pharma companies are narrowing their focus, targeting specific disease areas for future growth, others are taking a broader approach in an effort to spread risk and return on investment. |
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 | With the Asia-Pacific markets growing rapidly, they are becoming increasingly attractive for Pharma to enter. However, a number of key P&R developments and reforms are set to change the healthcare environment in the next few years, as healthcare is made more accessible to the poor and elderly. |
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| This report focuses on the challenges of diverse and uncoordinated treatment paradigms for diabetes and the movement to rationalize efforts and establish best practice. Datamonitor uncovers the unique dynamics of the two largest diabetes markets in the GCC; including the impact of regulatory processes such as the healthcare reforms currently being undertaken. |
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| Datamonitor's Generics: Global Industry Guide is an essential resource for top-level data and analysis covering the generics industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis on a global, regional and country basis. |
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| Datamonitor's Health Care Equipment & Supplies: Global Industry Guide is an essential resource for top-level data and analysis covering the health care equipment & supplies industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis on a global, regional and country basis. |
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| Prevalence of diabetic renal disease is on the rise. Current treatment focuses on the management of hypertension and glycemic control, but is unable to address the deterioration of renal function. An unmet need exists for therapies fully reversing disease progression. Early diagnosis can help to prevent the disease progression but lack of early diagnostic markers makes this option rather remote. |
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| Datamonitor expects incretin mimetics to emerge as a major new therapeutic class in non-insulin antidiabetics, driven by an explosion in the patient population, safety fears surrounding established therapies and significant unmet patient needs. |
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| RNA therapies have been in development for a number of years, but are yet to achieve any notable commercial success. Improvements have been made following initial attempts and the technology may finally be coming to fruition. |
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| The mature pain market has experienced a turbulent 4-year period during which the estimated seven major market sales value has fallen from an all-time high in 2004 down to $24.29 billion in 2007. However, through the growing use of non-traditional analgesics and the emergence of a number of opioid reformulations, the market is set to consolidate in a new phase of growth and prosperity. |
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| M&As have been the preferred growth strategy by a majority of Pharma companies. Although mega-mergers certainly create economies of scale and boost pipelines, the long-term effects may not be as favorable as desired. Current trends show the mega-mergers of the past are now a long gone strategy, as now companies are seeking to buy smaller companies for a smaller fee. |
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| The antidyslipidemic market is increasingly governed by cost concerns which appear to be more pressing than the safety and efficacy concerns. Cost-saving initiatives together with the continuing genericization are going to bring the antidyslipidemic revenues down by 25% from $26.6 billion in 2007 to $19.9 billion in 2017. |
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| Rapid economic growth on the back of a strong export drive has contributed to making South Korea one of the largest markets in Asia, after Japan, China and India. The country's pharmaceutical market is beginning to open up to multinationals, a trend set to gather momentum as regulatory and IP changes take hold, potentially putting the domestic industry under threat. |
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| Schizophrenia is a chronic and severe mental health disorder affecting around 4.6 million schizophrenia sufferers across the seven major markets. Currently led by oral branded atypical antipsychotics, the schizophrenia market will undergo some big changes over the period 20082017. Prospective players can expect to face stiff competition from generic versions of all currently branded drugs. |
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| The traditional sales force model is no longer effective as doctors are no longer the key prescribing decision makers. Governments and payers are implementing cost cutting initiatives and promoting generic use in an attempt to control escalating healthcare costs. This has made it increasingly difficult for sales representatives to promote expensive branded drugs to doctors. |
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| Almost 100 million post-menopausal women suffer from osteopenia and osteoporosis in the seven major markets. Those diagnosed are often identified through screening for low bone mineral density or after presenting with a fracture. Although not all guidelines are clear on when to initiate pharmacological treatment, most base their assessment of the type of drug to treat with on cost-benefit analyses |
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| With growing competition, Pharma companies are under increased pressure to deliver additional value for key stakeholders through their portfolios. Companies with comprehensive portfolios offering more to physicians, patients, payers and pharmacists will have the competitive edge. |
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| Pharma is experiencing tough times, facing both economic and regulatory pressures, with increasing demands for improved safety data and comparative efficacy studies. Consequently, the duration, size, complexity and ultimately cost of clinical trials is on the increase, while simultaneously, the success of late-stage clinical trials is declining. |
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| In 2008, the six tumor types covered in this report are forecast to account for over 1.2m new cases of cancer. Collectively, the 36 different drugs in Phase III development for the six tumor types are forecast to achieve $7,049m in sales by 2017. This constitutes a significant proportion of the oncology market, thus representing ample commercial opportunities for drug developers. |
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| Adjuvants are coming increasingly into focus for vaccine developers since many novel split- and subunit vaccines are insufficiently immunogenic on their own. Adjuvants offer a solution: they can accelerate, enhance and prolong the immune response to vaccination but also enable the use of antigen-sparing formulations. This makes them an attractive option for prophylactic and therapeutic vaccines. |
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| Stimulated by evidence of disease slowing with Teva/Lundbeck's Azilect (rasagiline), and successful reformulation of leading dopamine agonists, the Parkinson's disease market value is set to grow by an compound annual growth rate (CAGR) of 10% over the next 5 years (20072013), peaking at $3.1 billion in 2013. |
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| Several product launches and indication expansion caused substantial sales growth in the seven major inflammatory bowel disease markets from $1.7 billion in 2004 to $2.7 billion in 2007. Datamonitor forecasts the IBD market will grow with a CAGR (200717) of 4.6% to reach $4 billion in 2017 and success will depend on brands demonstrating patient convenience and improved compliance. |
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| The antidyslipidemic market is expected to fall to $20 billion in 2017. The decline will be driven by the deep genericization of the market, further exacerbated by the patent expiries of the top antidyslipidemic, Pfizer's Lipitor, as well as by the recent negative messages from the ILLUMINATE and ENHANCE clinical trials. |
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| Despite high unmet need, the market for the small molecules used to manage conditions such as genital and oral herpes, genital warts, cytomegalovirus retinitis and pneumonia or shingles has been neglected compared with the successfully promoted immunizations for varicella in children, zoster in adults, or human papilloma virus in adolescents. |
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| Datamonitor expects the antidiabetics market to reach $29 billion, across the seven major markets, by 2017. The growth will be driven by the launch of new drug classes, notably the DPP-IV inhibitors and GLP-1 agonists, and large growth in patient numbers. However, patent expiries of the glitazone (TZDs) class will restrain market growth. |
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| With sales growth rates expected to fall below their historic levels, Big Pharma must act to bolster its performance out to 2012 if it is to maintain the investment community's valuation of its stocks. One mechanism for plugging the sales growth rate gap and fulfilling investors' 'growth imperative' is M&A activity. |
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 | In 2007, HIV drugs achieved sales of $9.3 billion in the 7MM, growing faster than the overall market at a CAGR of 11.3% from 2004-2007. Due to patent expirations, Datamonitor expects the market's growth to slow down somewhat, reaching total sales of $15.1 billion in 2017. Among the ROW, the Canadian HIV market in 2007 was worth $272 million, achieving a CAGR of 24% from 2004-2007. |
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 | After 3 years of steady growth, the value of the insomnia market across the seven major markets (7MM) slumped by 12% to $4.1 billion in 2007 due to rapid generic erosion of Sanofi-Aventis's market leader Ambien (zolpidem) in the US. However, this downturn will be short-lived and the market will regain growth from 2009 to $6.9 billion in 2017 driven by the launch of new treatments across the 7MM. |
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 | Antihormonal therapies are a class of cancer therapeutics that generated branded drug sales of $5.8 billion in the seven major pharmaceutical markets in 2007. However, the relative maturity of the market means that it is has become a highly genericized therapeutic class. Even still, the lack of innovation within this saturated market helps many leading brands retain their success. |
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 | Cancer therapy brand sales totaled over $30 billion in the seven major markets in 2007, growing by 20.1% since 2006. The high growth of this market makes it attractive to companies keen to emulate the blockbuster status achieved by several brands. However, with several impending patent expiries due, companies will need to work hard to maximize their return throughout the lifecycle of their brands. |
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 | Spurred by uptake of Biogen Idec and Elan's Tysabri (natalizumab) and continued revenue growth for the three beta-interferon brands and Teva's Copaxone (glatiramer acetate), the seven major multiple sclerosis market value increased 15.1% from 2006 to $5.3 billion in 2007. |
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 | The respiratory market will continue to grow with the same rate over the next few years, with a slight dip between 2012 and 2015 due to the patent expiries of leading products. Growth is driven by the expansion of sales in existing classes, the launch of major new products with safety and convenience advantages, and the results of several landmark trials. |
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| Although Europe is leading the way, the biosimilar industry is very much in its infancy, with the perception of key decision makers critical to the initial rate of uptake. The opinion of key stakeholders, and the influence they wield, will therefore inform the strategy of both the branded and biosimilar contingents, in what is likely to become a battle to gain trust. |
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| Datamonitor expects the antihypertensives market to reach $37 billion, across the seven major markets, by 2017. The growth will be driven by the uptake of Novartis's Tekturna, as well as increased use of ARBs, and their combinations. However, the expiries of some key patents, particularly Pfizer's Norvasc and Merck's Cozaar, will restrain market growth. |
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| In 2008, the six tumor types covered in this report are forecast to account for over 666,000 new cases of cancer, obviously representing an enormous market potential. However, it is the higher-incidence tumor types that continue to attract drug developers, with lower-incidence cancers potentially suffering due to unfulfilled unmet needs via a lack of R&D activity. |
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| Targeted therapies are the top selling class of cancer drug, reaching sales of nearly $15 billion in the seven major pharmaceutical markets in 2007. The high growth of this therapy class makes it attractive to drug developers, resulting in 10 new entrants to the market since 2005. More drugs are likely to gain approval in the near future, contributing to a rapidly changing competitive landscape. |
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| Cytotoxic therapies are the second largest class of cancer therapeutics, generating branded drug sales of over $10 billion in the seven major pharmaceutical markets in 2007. Patent expiries for a number of agents that have achieved blockbuster sales over the years, means that the market continues to attract a considerable amount of generic competition. |
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| As competitive pressures from the entry of generics post-patent expiry and new brands are growing, product lifecycles are evolving for the worst. Effective lifecycle management is becoming a must for Pharma looking to maximize their return on investment, regardless of which stage of the lifecycle a drugs is in. However such strategies are becoming most prominent immediately before patent expiry. |
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| Alternative delivery methods under development have so far failed to live up to expectations. In many cases the technical difficulties associated with the delivery technique have not been overcome, leading to a return to injection based therapies. Big Pharma have all but exited the development of new insulin therapies leaving the field to small niche players. |
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 | As advances in omics technologies enable the development of high value molecular diagnostics, neurological conditions represent an attractive target for diagnostic companies. In this report, Datamonitor identifies the diseases in which early detection with a biomarker could significantly benefit the patient, gain payer approval, and ultimately expand the pharmaceutical market. |
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| At the forefront of novel technologies; momentum is steadily building for the development of stem cell products to address cardiovascular disease. The most active areas are those with high clinical unmet need heart failure, cardiomyopathy and ishemic heart disease. |
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| With a considerable patient potential and large medical unmet need, the untapped fibromyalgia market represents a lucrative opportunity for pharmaceutical companies. Estimated to total around $650m in 2007 in the seven major markets, Datamonitor forecasts the market to grow to over $2.4 billion in 2017. |
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| Vaccines have re-emerged as successful revenue generators for Big Pharma, with adults and the elderly now increasingly coming into focus as the next big opportunity in this sector. An aging population, rising disease awareness and new technologies to overcome the scientific hurdles linked to the weakened immune response in the elderly are all contributing factors. |
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| Asthma is managed using a step-wise approach, with bronchodilators to relieve symptoms of airflow limitation and controller medications to target underlying inflammation. Datamonitor's research shows that almost all patients (even those with mild intermittent asthma) receive some type of controller medication as their baseline treatment, which is in line with international management guidelines. |
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 | The report provides a comprehensive financial and strategic analysis of the mAb market, forecasting its commercial evolution out to 2013 and assessing trends by product, company, therapy area, technology and target type. It also provides an insight into the direction of mAb technology evolution and an analysis of pipeline dynamics. |
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| The neuropathic pain market is forecast to almost triple to over $6.3 billion by the end of the forecast period in 2017. The growth in the market is spurred on by the uptake of Pfizer's Lyrica (pregabalin), forecast to reach almost $3 billion in sales by 2017. Vimpat is the most promising pipeline drug, forecast to take some $480m by 2017. |
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| The treatment of menopausal symptoms is a common clinical challenge, with vasomotor symptoms affecting an estimated 75% of women aged over 50 years. Hormone replacement therapy (HRT) has formed the mainstay of treatment for almost 60 years and is highly efficacious. However, concerns surrounding the safety of HRT have led to an increase in demand for non-hormonal alternatives. |
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| With the growing cost of developing novel drugs, combined with the fact that fewer such drugs are gaining regulatory approval, the use of lifecycle management is playing an ever-more important role in the increasingly cost-conscious pharma industry. Rx-to-OTC switching is one such strategy employed to either enhance existing franchise revenues or protect branded revenues from generic competition. |
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| Drug repositioning has several advantages over traditional discovery-reduced cost, risk and time to market-compared with traditional discovery, providing an attractive prospect for Big Pharma, scrambling to fill pipelines in an increasingly harsh market environment. As competition to inlicense candidates drives the price of this strategy up, repositioning presents a cost effective alternative. |
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| With several recent non-approvable decisions in the osteoarthritis market since 2006, Datamonitor has updated its forecast to account for the effect on the market. We have revised the market outlook over the next 10 years using the latest IMS data. We expect the market to grow steadily, with a CAGR from 2007 to 2017 of 3.2%, to reach sales of nearly $5.5 billion in 2017. |
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| Stroke is one of the top three causes of death and its incidence in the seven major markets is expected to increase in the next ten years because of an aging population. Long term disability caused by stroke is a major economic burden on healthcare systems, current treatment options are limited and general awareness of stroke is poor. |
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| With the rising costs, length and complexity of clinical trials, drug development is subject to huge delays, translating into delays in getting a drug to market and millions of dollars in lost sales. Optimizing the recruitment process through web-based technologies can cut delays in clinical trials and can also be used to maintain relationships with patients to improve the clinical trial process. |
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| Datamonitor expects incretin mimetics to emerge as a major new therapeutic class in non-insulin antidiabetics, driven by an explosion in the patient population, safety fears surrounding established therapies and significant unmet patient needs. |
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| Governments and payers across the seven major markets are implementing cost-cutting initiatives to combat escalating healthcare costs, putting even greater pressure on pharma companies. In addition to the credit crunch, ever fewer novel products are coming to market, contributing to the declining return on investment. |
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| While drug eluting stents have been successful in reducing the rate of restenosis following percutaneous coronary intervention, there have been safety scares over a new problem: “in-stent thrombosis”. Opinion leaders are divided over the gravity of this problem, but positive safety data are required to restore physician confidence in drug eluting stents. |
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| The market for CNS drugs across the 7MM was worth a substantial $95.5 billion, accounting for a 21.4% share of the total pharmaceutical market value in 2007. Despite stalling R&D productivity and the genericization of the majority of leading CNS blockbuster brands, the market continues to offer a wealth of lucrative opportunities for all types of drug manufacturer. |
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| In 2007, the market value of HRT for menopausal symptoms saw its first upturn since the Women’s Health initiative (WHI) study results in 2002; highly publicized findings which linked HRT to cancer and cardiovascular safety risks. The recent growth of the market is due in part to the increasing price of HRT products but can only be sustained by a similar increase in volume sales. |
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| As the reimbursement status for the cost of hospital-acquired infections is under pressure by payors, interest in preventing these complications at the outset is growing. Nosocomial vaccines offer one route of prevention. This report assesses the clinical pipeline candidates five key nosocomial pathogens and their potential market environment including target population size estimates. |
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| Non-small cell lung cancer accounts for about 80% of all lung cancers. In 2008, the incidence of NSCLC is forecast to exceed 367,000 new cases in the seven major pharmaceutical markets. The high incidence of the disease and the large unmet need make NSCLC an attractive market for new drug development. |
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| Advanced heart failure is a growing issue. Existing pharmacological strategies increase the survival rates of acute heart failure patients, providing a growing source of patients with advanced disease. In view of long waiting lists for heart transplantation and the growing lack of donors, cardiac resynchronization and mechanical circulatory support devices have demonstrated promising results. |
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| Incidence of breast cancer in the seven major markets will total 455,000 in 2008, while 115,000 women will die from the disease. Despite advances in treatment over the past decade, significant unmet needs remain. This level of demand and the large patient potential make breast cancer a relatively attractive indication for drug developers. |
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| The ADHD market is currently valued at $3.85 billion and is set to increase over the next 10 years at a CAGR of 1.2%. Despite the continuing dominance of stimulant drugs, the 2002 launch of Strattera, the first non-stimulant treatment for ADHD, and the 2006 launch of Daytrana have served to open up the market, giving patients and physicians a greater choice of treatment options. |
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| An overview ofthe market for portable inhalers, looking at market shares,usefulness as tools for franchise protection and -expansion. Patient- and physician preferences are being analyzed as well as suitablility of molecules and inhaler types., |
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| The Critical Care Community is currently at its most organized, and motivated, and on a mission to improve outcomes in sepsis. This is driving a rigorous assessment of care strategies which is gathering speed and showing results. This will yield many opportunities for developing products, but current interventions' roles will change, with impacts on how they are measured, used and valued. |
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| The opioid market is currently valued at $7.7 billion and is set to increase over the next 10 years at a CAGR of 2.4%. Despite this market being exclusively comprised of old genericized molecules, novel formulations and delivery methods have stimulated growth over the last 5 years. This growth is set to continue as current market players instigate lifecycle management strategies to retain value. |
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| With the AD market entering a pivotal phase, Datamonitor has conducted several scenario forecasts in order to explore the possible market outlook over the next 10 years. Several pioneering Phase III disease slowing therapies offer blockbuster potential. However, should these drugs fail Phase III trials, generic competition of current therapies will see the market value decline. |
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| Antibody-based agents represent a novel approach to the treatment and prophylaxis of infectious diseases. In recent years, considerable interest has been expressed in their further development, driven by advances in technology that improve manufacturing cost and tolerability: fully human antibody reagents avoid the toxicities associated with traditional human- or animal-derived serum therapy. |
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| Ideally drug supply should be a simple and transparent chain that connects the manufacturer and patient in as few steps as possible, however in practice it can be a highly circuitous one that includes several intermediaries before reaching a pharmacy. This increases the risk of counterfeit drugs and facilitates parallel trade, both leading to lost sales for the manufacturer. |
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| SLE is a chronic, life-long and potentially fatal autoimmune disease characterized by multiple system distress and unpredictable flares. Therapy is largely off-label and a huge demand exists for new SLE therapies because of the potential for serious side effects from drugs currently used in the management of the disease. |
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| Today, pharma companies face growing competition from generics and me-too drugs, combined with increasingly tough P&R, a clamp down on healthcare spending, and the need to treat patients for longer due to the aging population. These factors threaten both current and future revenues prompting Pharma to adopt a range of corporate strategies to respond to the changing market dynamics. |
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| Bone metastases are a complication of some advanced cancers including cancers of the breast, lung, prostate, kidney and thyroid. The incidence of bone metastases across these tumor types in the seven major markets is forecasted to total 225,174 in 2008. While treatment with bisphosphonates reduces the risk of skeletal complications, they do not improve survival in the majority of patients. |
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| Latin American countries have attracted a lot of attention recently. With their economies currently stable, their geographic location and low-cost is ideal for investors. In addition, having such a high and varied population eases recruitment for clinical trials, and the demographics show there is a very high need for pharmaceuticals. |
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| Datamonitor's OTC Pharmaceuticals: Global Industry Guide is an essential resource for top-level data and analysis covering the OTC pharmaceuticals industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis on a global, regional and country basis. |
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| Datamonitor's Pharmaceuticals: Global Industry Guide is an essential resource for top-level data and analysis covering the pharmaceuticals industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis on a global, regional and country basis. |
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| Non-Hodgkin's lymphoma (NHL) is the most common hematological malignancy and is comprised of around 30 different disease subtypes. Each of these present with a distinct set histological, genetic and clinical characteristics. Treatment options in NHL include chemotherapy, targeted therapies, stem cell transplantation and radiotherapy. |
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| Prostate cancer is one of the four most common tumor types, and is the most common cancer and second most common cause of cancer-related death to affect men. Prostate cancer is curable when localized and frequently responds to treatment at an advanced stage. The rate at which prostate tumors grow varies between patients, with some achieving prolonged survival even with metastatic disease. |
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| In May 2006 Bausch & Lomb's ReNu with MoistureLoc contact lens solution was permanently withdrawn from markets worldwide due to an outbreak of a fungal eye infection. For a large market player, the loss of a new revenue driver and the negative publicity surrounding the event is likely to have a significant impact on future success, as well as implications for other companies in the sector. |
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| Existing sales and marketing models are considered unsustainable. Pharma has been slow to adapt and take advantage of the marketing opportunities offered by the internet. Meanwhile customers are increasingly using the web to source information. Pharma needs to evolve and engage with their customers online, or risk being left behind. |
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| With dwindling growth rates observed in the major developed markets many pharmaceutical companies are turning towards emerging market countries in order to sustain their revenue growth. While some countries, with double digit growth rates present tremendous opportunities, there are also many obstacles that need to be overcome. |
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| A total of 11 companies make up the top five across each of the four ID sectors, their core competencies ranging from a single disease area to generics prowess, producing a comprehensive portfolio to providing a specific offerings corresponding to highest unmet need. This report characterises the key players in each sector, and their approach to maximising their returns from a pressurised sector. |
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| The face of ACS is changing. The ageing population and pressure of growing risk factors have made a significant impact on the management strategies in ACS. This report unveils the true picture through in-depth analysis of data on over 21,000 ACS patient records in the 5 major European pharmaceutical markets (5EU; France, Germany, Italy, Spain and the UK). |
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| Type 2 diabetes is an emerging epidemic driven by the escalating prevalence of obesity and by an ageing population. Diagnosis rates will continue to increase as improved awareness raises the public profile of the disease. Despite several established classes of oral anti-diabetic agents an unmet need for a safe, efficacious agent which can halt or reverse long-term disease progression remains. |
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| The UI market is set to continue to grow over the next 6 years, reaching over $2.5 billion in 2012, a 68% increase from 2006. Lifecycle management strategies, novel formulations and follow-on products will drive the majority of this growth, with key brands expected to be Pfizer's Detrol LA (tolterodine) and Toviaz (fesoterodine), GSK's Vesicare (solifenacin), and Novartis' Enablex (darifenacin). |
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| The autoimmune disease market will be rapidly growing due to a high number of competitive brands currently on the market and a full pipeline. Company strategies include expanding the treatment algorithm by pursuing approval for 'early' disease stages, launching easy-to-use devices to make up for downsides of injectable drugs, and developing fully human monoclonal antibodies as follow-on products. |
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| The generics market is growing, driven by rising healthcare costs and fed by a steady stream of patent expiries. Levels of generic uptake vary widely across the 7 major markets, with important implications for industry strategy. |
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| Counterfeit medicines are a global problem costing patient's their health and the pharmaceutical industry and governmental organizations millions of dollars per year. Although there is no one preventative strategy, there are several measures that can be employed simultaneously to reduce the risk of fake medicines entering the pharmaceutical supply chain. |
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| Research and Development activity in the Hepatitis C arena continue to be high. The market still holds many areas of unmet medical needs: while existing therapies provide good efficacy for about half of the patient population, side effects and limited efficacy in other patients offer much room for improvement. Several development setbacks over the past 18 months highlight the obstacles in R&D. |
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| Myelodysplastic syndromes (MDS) are a heterogeneous group of hematopoietic stem cell disorders. With a forecast incidence of 36,769 across the seven major markets in 2007, they are one of the most common hematological malignancies. Currently, the only potentially curative option is hematopoietic stem cell transplantation but this is only suitable for a small subset of patients. |
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| Non-Hodgkin's lymphoma (NHL) is the most common hematological malignancy and is comprised of around 30 different disease subtypes. Each of these present with a distinct set histological, genetic and clinical characteristics. Treatment options in NHL include chemotherapy, targeted therapies, stem cell transplantation and radiotherapy. |
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| The incidence of multiple myeloma is forecast to total 40,885 cases across the seven major pharmaceutical markets in 2007. Current drug therapy is planned around stem cell transplantation. The recent approval of three new agentsThalomid (thalidomide; Celgene), Revlimid (lenalidomide; Celgene) and Velcade (bortezomib; Millenium/Johnson & Johnson)has significantly advanced treatment. |
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| Endometriosis is a painful, menstrual-related disorder that is thought to affect approximately 10% of the female population of reproductive age. Despite this large patient potential, growth of the endometriosis market has been limited by low levels of investment, poor awareness among physicians and the public, problematic diagnosis, and lack of effective therapies. |
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| Based on an analysis of 43 companies and 1,200+ products, Datamonitor forecasts that pharmaceutical industry ethical sales will increase at a modest 3.2% CAGR 2006 to 2012. However, behind this industry average figure there are strategic segments of the market that offer double-digit growth rates through barriers against generic competition and the opportunity for aggressive indication broadening. |
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| Peripheral artery disease, sometimes also referred to as peripheral vascular disease, is atherosclerosis in peripheral regions, which can lead to loss of blood flow to the limbs, and can result in loss of life, limb amputation and cardiovascular events. The current pharmacological treatment options are limited, and there are large unmet needs associated with the disease. |
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| The continued uptake of existing brands and the launch of two opioid antagonists will cause the market to grow at a compound annual growth rate of 13.5% from 2006 to reach $304m across the seven major markets by 2016. The alcohol dependence market requires a paradigm shift away from the public perception that it is a behavioral disorder towards being regarded as a treatable medical condition. |
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| The ALS market was worth $148m in 2006 across the seven major markets. With the only approved treatment for ALS, Sanofi-Aventis's Rilutek (riluzole), facing generic incursion in 201213, future growth in this market is dependent on the success of pipeline drugs. |
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| Treatment of HIV has come a long way since the discovery of the virus. Although no real cure has been found yet, the last few decades have seen the introduction of many classes of drugs that suppress the replication of the virus. As therapeutics have improved dramatically in terms of efficacy, safety and convenience, the bar for new drugs has been raised considerably. |
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| Parkinson's disease (PD) is a progressive, degenerative condition of the central nervous system that affects the way the brain coordinates body movements, including walking, talking and writing. PD affects less than 1% of the population in the seven major markets (7MM); with patients typically being diagnosed in their early sixties and living for over 18 years after the onset of first symptoms. |
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| Inflammatory bowel disease (IBD) is a chronic inflammatory condition that affects the gastrointestinal tract causing a number of distressing symptoms such as bleeding, diarrhea and abdominal pain. IBD includes key subsets Crohn's disease and ulcerative colitis, both of which can significantly impact on the quality of life of an individual. |
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| As a result of market dominance by agents such as leuprolide, and AstraZeneca’s Zoladex (goserelin) and Casodex (bicalutamide), there is little space in the antihormonal therapies market for new competition unless significant clinical superiority or a unique selling point is demonstrated. While Taxotere-based chemotherapy is the established first-line standard for hormone-refractory prostate cancer, many patients are still precluded from treatment due to toxicity concerns. This, coupled with a lack of second-line standard therapy, indicates a major gap in the market that could be potentially lucrative for drug developers. Enthusiasm has been shown by key opinion leaders regarding certain late-phase pipeline products, however, during the time of writing, publication of negative clinical trial data has meant a dampening of this optimism. It will therefore be some time before the high unmet needs in the hormone-refractory prostate cancer market are satisfied. |
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| Despite being one of the most common hereditary diseases among Caucasians, low physician awareness and a lack of disease-modifying drugs have led to massive underdiagnosis of the condition. the resulting perceived small number of patients and restricted market is a major obstacle for the development of new treatments.Understand the epidemiology of alpha-1 antitrypsin deficiency and assess the untapped patient potential. Evaluate current strategies for the diagnosis and treatment of this disease. Assess the potential for new drugs and their potential for additional uses Gain an understanding of some of the principal challenges in the treatment of alpha 1 antitrypsin deficiency as defined by key opinion leaders. |
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| Key issues in head and neck cancer including disease overview and epidemiology, current treatment patterns and controversies, unmet needs and key stakeholder opinions. The clinical pipeline and profiles of the late-phase products are also included. |
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| The systemic antifungals market accounts for $3.1bn of the total $41bn anti-infectives market. A wave of new products coinciding with patent expiry of two widely used compounds will shake up the market for systemic infections, further polarizing between winners and losers. Key changes are forcing a rethink of management strategies and clinical trial design. |
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| The current Huntington’s disease market is comprised of off-label prescriptions of psychotropic drugs. In the near term, two pipeline drugs are set to enter the market, demonstrating the viability of this disease as a primary marketing indication. In the longer term, with a strong genetic link and reliable diagnostic test, prophylactic treatment with a disease modifying drug could prove lucrative. |
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| With Pharma struggling to maintain its pipelines and portfolios with products developed in-house, companies are increasingly turning to licensing. However, the search for late-stage developmental products is becoming tougher and more expensive, and companies are now looking towards licensing earlier-stage compounds. |
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| The high prevalence of nicotine dependence, strong uptake of Pfizer’s Chantix (varenicline), and the launch of new innovative therapies will cause the nicotine dependence prescription drug market to grow to $4.6 billion across the seven major markets by 2016. Innovative therapies are set to offer patients a convenient dosing regimen and thereby carrying the potential for improved compliance. |
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| Fuelled by an increasing disease awareness, the growing use of new, expensive drugs as well as combination therapy, the HBV drugs market, sized at $431m in 2006 across the seven major markets, will nearly triple in size by 2016. Rapid growth until 2011 will slow down in the following years as a result of genericization and the beginning impact of routine HBV vaccination. |
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| Datamonitor expects the cardiovascular market to remain stable with sales only showing negligible growth between 2006 and 2016, below the 3% growth predicted for the SU sold. Generic products will become increasingly important as the majority of products will have lost IP protection, accounting for 30% of cardiovascular sales and 65% of SU sold in 2016. |
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| Approaches to cancer treatment continue to incorporate molecular targeted therapies into standard treatment regimens. With an increasing number of candidates gaining approval, and with a dynamic developmental pipeline, further clinical, commercial and strategic challenges are continuing to emerge. |
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| Drug targets are the critical link between drugs and their role in the treatment of medical disorders. By grouping drug targets into key protein families, this report provides a comprehensive analysis of the prescription pharmaceutical market by not just molecule type and therapy area, but also by target family. |
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| Stroke is one of the top three leading causes of death worldwide and an area of high unmet needs. TPA is limited to a low number of ischemic stroke patients due to a short therapeutic time window, but it is still the best therapy available. TPA is responsible for major changes and advances in the way stroke patients are cared for, which is expected to evolve further. |
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| In the 7 major markets, Datamonitor estimates that the incidence of RCC in 2007 will total 86,800 cases. Around 25% of all RCC patients are diagnosed with Stage IV disease; the 2-year survival rate for these patients is around 23%. This low survival rate and the fact that a significant proportion of Stage IIII patients relapse with Stage IV disease mean there is significant unmet need in RCC. |
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| Datamonitor expects the antithrombotics market to peak at just over $20 billion in 2012, across the seven major markets. The growth will be driven by the uptake of the novel oral anticoagulants - Bayer's Xarelto and BI's Rendix - which are expected to launch simultaneously, in 2008. |
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| The market for infertility drugs is a complex and dynamic arena shaped by numerous factors such as changing social attitudes, national legislation, and prescriber preferences. Brand strength and diverse portfolios have allowed Organon, Merck Serono and Ferring to secure a firm foothold in the market, worth over $1 billion in 2006, and represent tough competition. |
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| The allergic rhinitis market will continue to decline over the next few years, after which it will resume limited growth due to the introduction of new compounds and combination products. These will drive the expansion of sales in existing classes as they exhibit safety and convenience advantages. Meanwhile, immunotherapy is expected to move from its niche position into mainstream therapy. |
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| The upper GI market, defined as gastroesophageal reflux disease (GERD), peptic ulcer disease (PUD) and dyspepsia indications, achieved sales of just over $19 billion in 2006, with minimal growth since 2005. All major PPI brands will lose patent protection in the next 10 years, resulting in a major increase in generics and a declining market value. |
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| Despite several developments in efforts to tackle the spread of HIV, the total number of people living with HIV has continued to increase across the 6MM. However, significant advances in HIV disease understanding, treatment and management mean that the outlook for patients has considerably improved. |
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