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BioJournal - Datamonitor
http://www.bioportfolio.com/cgi-bin/acatalog/Datamonitor.html
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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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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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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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Significant barriers to entry into the biosimilars market exist. High
up-front investment and the need for specific expertise favor big players.
Understanding of the marketplace is critical for success acceptance by key
stakeholders is crucial for market uptake of biosimilars and achieving
preferential reimbursement status through constant review of the pricing
strategy is desirable. |
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In 2007, more than 3 million new cases of solid tumors are forecast to
be diagnosed across the seven major pharmaceutical markets, obviously
representing an enormous market potential. Lower incidence tumor types are
becoming increasingly attractive to drug developers, due to high levels of
unmet need which can result in significant financial rewards. |
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The PD market is set to continue to grow over the next 7 years, reaching
over $2.37 billion in 2013, a 39% increase from 2006 levels. Combinations,
reformulations, and indication expansions will drive the majority of this
growth, with key brands expected to be Novartis/Orion's Stalevo,
GlaxoSmithKline's (GSK's) Requip Modutab, and UCB-Schwarz's Neupro. |
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NICE is one of the most advanced cost effectiveness assessment bodies
operating in the major pharmaceutical markets. Since it was established it
has had an increasing impact on the availability of new drugs in England and
Wales, but has also generated considerable attention globally |
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The neuropathic pain market is forecast to double from 2006 to reach
over $7 billion by 2016. At this time, the current late-stage neuropathic
pain pipeline is forecast to take only 18% of the total market share,
highlighting an opportunity for better pipeline drugs that demonstrate
improved pain management. The most promising and closest pipeline drug to
market is UCB's Vimpat (lacosamide). |
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With the seven triptan brands continuing to dominate acute migraine
treatment and Ortho-McNeil's Topamax (topiramate) driving sales in the
prophylactic market, 7MM revenues of anti-migraine drugs increased by 8.1%
from 2005 to $3.7 billion in 2006. The US accounted for 80% of the 7MM total
in 2006, Whilst in the 5EU, France is the largest market for
migraine-specific drug sales. |
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"IntroductionThis report provides a comprehensive strategic analysis of
the mAb market out to 2012 by company. It identifies four 'established' and
four 'emerging' players within the mAb sector which are forecast to play the
most commercially significant role within this market. |
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The long-standing unmet need of the osteoporosis market has been for
improved adherence to treatment. Two pipeline products, Amgen's Denosumab
and Novartis' Aclasta (zoledronate), have answered this demand with
intermittent dosing schedules and consequently are expected to generate
blockbuster revenues. This will rejuvenate the market which is otherwise
stalling under multiple patent expiries. |
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Europe serves as a model for other countries looking to define their own
regulatory approval criteria. The US is on the brink of passing legislation
to establish a statutory pathway for biosimilars approval but the opposing
interests of biosimilar and innovative companies may result in further
delays. Development of biosimilars presents many challenges and potential
pitfalls. |
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The Hospital antibacterials market accounted for $9.9bn of the total $41bn
anti-infectives market. Increasingly resistant and problematic pathogens
make this an attractive target for premium priced products outside of the
largely genericized Community market. However, high concentrations of patent
expiries and similarly targeted product launches imply a highly competitive
commercial landscape. |
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Social media are shifting the way that the global economy operates.
Internet journals and communities have enabled consumers to communicate
their experiences with companies' products and services to other consumers.
A consequence of consumer-generated marketing is that relationship
management throughout the lifecycle of a product is taking the place of mass
marketing in consumer-driven industries. |
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The diabetes epidemic has contributed in the growth of the antidiabetics
market the past few years. Since the prevalence of diabetes continues to
increase, the market will further expand. While early therapy is dominated
by generically available agents, and the later stages by insulin, the number
of unmet needs in the diabetes treatment, warrants that novel agents will
have a place in the market. |
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With fewer truly novel products entering the market, combined with
increasing developmental time and spend, and declining ROI, successful
launches have never been more important for pharmaceutical companies.
Therefore, to ensure a successful launch, manufacturers must employ a
multitude of timely strategies to ensure their product enter the market as
soon and as smoothly as possible. |
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Datamonitor expects few new products to emerge from a week pipeline for
both acute and chronic heart failure. Sales in the seven major markets will
be modest with all the new drugs being add-on therapies to current standard
regimes. Significant unmet patients needs will remain in both acute and
chronic heart failure. |
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Waves of technological advancements have powered significant evolution
in R&D from serendipitous drug discovery, through to rational drug design.
However, as the low-hanging fruit has been picked, and recent technological
advances have failed to yield high numbers of new therapies, the search is
on to identify R&D strategies to improve R&D productivity |
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Female sexual dysfunction (FSD) affects an estimate 84 million women
across the seven major pharmaceutical markets and represents a significant
opportunity for investment. Despite its high prevalence, FSD is poorly
understood and defined. Currently there is just one product approved for the
treatment of FSD; P&G's Intrinsa (testosterone) is marketed in Germany,
France and the UK. |
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The pediatric and adolescent vaccines market encompasses many different
classes. DTP and MMR combinations continue to form the mainstay of childhood
immunization; however, their growth potential is limited. The key
opportunities lie in novel, innovative additions to established schedules,
particularly pneumococcal (Prevnar), conjugated meningococcal (Menactra) and
HPV (Gardasil) vaccines. |
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Datamonitor has identified the key trends and events that drive patient
empowerment and impact the pharmaceutical industry. These range from the
increased access to information via internet and the rising pressures of
cost containment through to how patient empowerment is affecting access to
drugs as well as changing pharmaceutical marketing strategies and their
public image. |
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Datamonitor expects the antihypertensives market to reach almost $40
billion, across the seven major markets, by 2016. 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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The restrictive, highly competitive antidyslipidemic market is going to
become even further genericized, which will add to the challenges that drug
makers are facing. Despite over 300m people being eligible for
antidyslipidemic treatment, there is still a lot of under-diagnosis and
under-treatment, but it will be a major issue capturing all the eligible
population. |
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Detailed analysis of the Asthma and COPD market. 10 year sales forecast
for all major drugs brands in these indications, taking into account new
treatment trends, clinical trial data, patent expirations and key new
product launches in the 7 major markets. |
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Detailed analysis of the antiretroviral therapy market. 10 year sales
forecast for marketed drugs and key pipeline compounds, factoring in
clinical trial results, new product launches and patent expiries.
Scope of this report
* In-depth analysis of the current HIV market across the major US and EU
markets
* Thorough assessment of underlying commercial and clinical factors shaping
the antiretroviral market
* Detailed sales forecasts for the three major antiretroviral classes,
molecules and brands in each of the six major markets
* Case study analysis of the entry inhibitor class focusing on the
competitive environment and critical success factors |
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Gastroesophageal reflux disease (GERD), functional dyspepsia (FD) and
peptic ulcer disease (PUD) represent a group of common gastrointestinal (GI)
conditions, which can be referred to collectively as upper GI disorders.
Gastric acid suppression remains the cornerstone of therapy in upper GI
disorders, with particular focus on reducing symptoms and eradicating H.
pylori, if present. |
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Sales of the Top 20 cancer therapy brands in each of the seven major
markets totaled $24.5 billion in 2006 and are forecast to grow at a CAGR of
6.6% to $45.9 billion by 2016. Four newly marketed drugs are expected to
become part of the Top 20 cancer therapy brands during the forecast period
and are set to increase the 2016 sales of the existing Top 20 cancer therapy
brands to $52.7 billion. |
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Failure to take medication as prescribed significantly increases the
risk that patients will experience complications resulting in injury or
death, and propagate higher healthcare costs overall. The medical
establishment's approach to adherence is changing as it becomes clear that
the responsibility of achieving adherence is not solely the patient's, but
rather is shared among stakeholders. |
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Incidence of primary brain cancer across the seven major markets in 2007
is estimated to be 47,000. Over half of these cases will be glioblastoma
multiforme, for which survival prospects are dismal. The median survival for
this group of patients is 1.2 years and only 27% of patients are alive after
two years. The level of unmet need is therefore high in this disease. |
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Novel pipeline drugs, lifecycle management of the current branded
antidepressants, and development of atypical antipsychotics for depression
are set to grow the depression market through to 2010 when it will peak at
$14.6 billion. Thereafter, however, generic incursion of the atypical
antipsychotics and the remaining branded antidepressants will see the
depression market value drop to 2016. |
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Ambien has remained the clear leader in the insomnia market for over a
decade, with 2006 sales of over $2.3 billion across the seven major markets.
The success of Ambien is attributable to a favorable side-effect profile and
half-life. However, due to recent patent expiries in the US and Japan,
Ambien's leadership status is finally under threat and the market is
undergoing some dramatic changes. |
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The dynamic MS market continues to grow unabated; seven major market
revenues increased 14.7% from 2005 to $4.6 billion in 2006. Growth is driven
by the highly successful beta-interferon brands, Teva's Copaxone (glatiramer
acetate), and the recent relaunch of Tysabri; the first launch of a new MS
treatment for six years. |
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The osteoporosis market is due a major upheaval when market leader
Fosamax (alendronate) loses its US patent. The resultant heightened
competition will force market players to implement radical lifecycle
management strategies to safeguard their franchise revenue. New market
entrants provide further complexity to the competitive landscape but will
also drive market growth over the next ten years. |
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The report provides a comprehensive financial and strategic analysis of
the mAb market, forecasting its commercial evolution out to 2012 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 telehealth market will continue to grow as the population,
particularly the elderly and chronically ill, and technology adoption
increase. |
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The telehealth market will continue to grow as the population,
particularly the elderly and chronically ill, and technology adoption
increase. |
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Irritable bowel syndrome (IBS) is a common disease affecting 1020% of
the total adult population, particularly women, in which recurrent abdominal
pain or discomfort is associated with defecation or changes in bowel habit.
The majority of sufferers have never consulted a physician about their
symptoms and remain undiagnosed. |
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Supportive care can be defined as those products used to prevent and/or
treat the adverse side effects that arise as a result of the tumor itself or
administration of anticancer therapies, in particular cytotoxic
chemotherapy. While the antihormonal therapies and novel molecular targeted
therapies do not exist without some toxicity, these are not as severe as
those associated with chemotherapy. |
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The close association with hepatitis means that hepatocellular carcinoma
(HCC) is common in developing countries where hepatitis B and C infections
are endemic. However, the increasing prevalence of hepatitis in the West
means that incidence of HCC in the US and Europe is expected to increase
significantly over the coming years. |
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The Canadian pharmaceutical market is the 8th largest globally and as
such represents an important market for generics manufacturers. Although
historically dominated by domestic generics companies, mergers and
acquisitions over the last five years have increased the dominance of
foreign players. |
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Patients in a clinical population receive drug and non-drug therapy for
female sexual dysfunction, yet a third remain refractory to treatment,
highlighting a need for a formally approved product for FSD. There is a low
level of satisfaction with the classification guidelines, further limiting
diagnosis, already hampered by embarrassment, lack of physician awareness
and an unclear referral system. |
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Mainly affecting women, fibromyalgia syndrome affects six million people
in the US alone. This relatively common yet poorly understood syndrome is
characterized by widespread muscle pain and fatigue and remains
substantially underserved by the medical profession and the pharmaceutical
industry. Currently, there are no drugs licensed to treat fibromyalgia in
the US, Japan or Europe. |
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The treatment of Rheumatoid Arthritis (RA) has been rapidly evolving
over the last decade. The success of the next wave of novel RA therapies
depends on their ability to address the key issue of cost effectiveness, as
the patient population for anti-TNF's is reaching a maximum and competition
moves to anti-TNF failure patients. |
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The launch of serotonin antagonists which are largely aimed at treating
sleep maintenance is set to make a substantial impact on the insomnia
market, which will increase in value across the seven major markets from
$6.1 billion in 2006 to $7.7 billion in 2016. |
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With declining returns from drug development pipelines, preservation of
branded revenues is key for manufacturers. Inevitably though, once the core
product patent of a pharmaceutical drug expires, generic companies will
launch their own, cheaper versions of the drug, encouraging product
switching and eroding the revenues of branded pharmaceuticals. |
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Novel oral anticoagulants and antiplatelet agents will have a profound
impact on the antithrombotics market. Datamonitor expects Bayer's
rivaroxaban and Sankyo/Eli Lilly's prasugrel to achieve blockbuster status.
Parenteral anticoagulants are not expected to be large revenue generators,
due to low clinical unmet need in this market segment and strong competition
from current gold standard agents. |
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At present, despite the availability of numerous agents for the
treatment of dyslipidemia, there is significant scope for expanding the
market by improving diagnosis and treatment of dyslipidemia patients.
However, for new agents, gaining a secure foothold on the market will be
challenging, but their chances can be improved through targeting niche
patient populations and conducting outcome trials. |
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The influenza vaccine market, sized at approximately $2.2 billion in
2006, yields many challenges. Demand is highly variable, and only large
players are able to cope with the need for annual updates and the costly
manufacturing process. However, driven by the increasing pandemic threat,
the market is growing fast and is predicted to more than double in size by
2016. |
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Unmet needs across the hematological malignancies remain high, with most
traditional therapies conferring low levels of specificity and high
toxicity. Pipeline candidates classified as molecular targeted therapies,
cytotoxic therapies and immunotherapeutic agents, may offer attractive
therapeutic additions and Datamonitor's insight into their clinical and
commercial potential is provided. |
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The launch of five novel orally administered disease-modifiers is set to
revolutionize the multiple sclerosis (MS) market, which will more than
double in value across the seven major markets from 2006 to reach $10.7
billion in 2016. |
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The roll-out of Part D in January 2006 represented a significant leap
forward, since it provided coverage for outpatient drugs for Medicare
patients for the first time. A high number of both patients and insurance
providers are now involved in the program, as a result of strong patient
enrollment. |
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An estimated 34 million people are diagnosed with asthma in the major
markets. The disease can be broken down into various phenotypes,
differentiated by severity, trigger, or predominant inflammatory type. These
phenotypes may have important consequences for future approaches to treat
asthma in a more targeted fashion, doing away with the one-size-fits-all
approach. |
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Datamonitor believes that companies developing pipeline drugs for the
depression market should concentrate resources on targeting third-line
depression patients, a market with significant sales volume and few viable
treatment options. GSK's gepirone ER is likely to be the first pipeline drug
to enter the market and exploit this opportunity, with forecast sales of
$615m in 2016. |
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In the US and Europe, an estimated 510% of patients are expected to
develop an infection during their hospital stay. The four main types of
infections that occur within the hospital setting are urinary tract
infections, hospital acquired pneumonia, surgical site infections and
blood-stream infections, accounting for approximately 35%, 15%, 14% and 10%
respectively. |
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Technology has been used to either inform or expedite the prescribing
process in most modern healthcare systems for over two decades. Recently,
market forces - including greater regulatory intervention, increased
investment from stakeholders and decreased resistance from end-users - have
begun to converge to set the stage for widespread adoption of truly
integrated ePrescribing solutions. |
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Atopic dermatitis is a skin disorder characterized by intense itch, dry
skin and redness. Often considered a benign disease, it actually impacts
very negatively on quality of life, sometimes more than psoriasis and
diabetes. Through opinion leader interviews, Datamonitor has identified a
high level of unmet need in atopic dermatitis treatment and believe that a
number of market opportunities exist |
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SCLC accounts for one-fifth of all lung tumor types. More than 80,000
new cases are expected to be diagnosed in 2007 in the seven major markets,
although it is set to decrease due to changing smoking habits. Mesothelioma
is rarer, although incidence is expected to increase in the coming years in
Europe and Japan given the heavy use of asbestos in the 1970s and long
latency period of the disease. |
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Globally, esophageal cancer is the ninth most common tumor type and
seventh leading cause of cancer-related death, however, its incidence
fluctuates widely depending on geographical area. While relatively uncommon
in Western countries, 50% of patients still present with locally advanced
unresectable or distant metastatic disease, where treatment is complicated
and chances of a cure are reduced. |
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Datamonitor has identified the key trends and events that impacted the
pharmaceutical market on a macro-environmental and corporate strategy level
in 2006. These range from the continuation of long term trends such as the
focus on cost containment to more recent impacts such as the effects of
Medicare Part D and the increasing power of the Democratic part in the US. |
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An understanding of the present and future market trends surrounding
eHealth is vital in order for the pharmaceutical industry to develop
effective multi-channel marketing strategies. It is advisable for
stakeholders to invest in targeted initiatives that meet the specific
information needs and support the decision making processes of the large
numbers of physician and consumer groups online. |
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The HIV market generated $7.4 billion of sales in 2005 and experienced a
CAGR of 13.3% from 2001-2005, making it one of the fastest growing
infectious diseases sub sectors. Despite the antiretroviral market's
relative immaturity, many older flagship products such as Combivir are
expected to lose patent protection before 2015. |
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There is no cure for psoriasis, which profoundly affects sufferers
quality of life, physical and social functioning. There is a particular
unmet need for effective long-term therapies for psoriasis. Prevalence is
the highest of the autoimmune diseases at 16 million in 2006, but this is
deceptive in terms of market size, as the treated and severe patient
populations are comparatively small. |
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The 2004 withdrawal of Vioxx from the global market had a negative
effect on the COX-2 class, with a 44% fall in Celebrex sales for
osteoarthritis in 2005. However, as patients sought an alternative to the
COX-2s, there was positive growth in traditional NSAIDs, non-narcotic
analgesics, narcotic analgesics, corticosteroids and HA viscosupplements,
leading to a 1.1% increase in total market value. |
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Atherosclerosis generally begins in childhood and manifests clinically
in mid-to-late adulthood. While the mortality from atherosclerotic
conditions has declined significantly, in developed countries cardiovascular
disease accounts for nearly 50% of all deaths, and within the next 15-20
years, is projected to surpass infectious diseases to become the leading
cause of death worldwide. |
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The disease-modifying drugs are considered by physicians to represent a
significant advance for the management of MS. However, none is fully
effective and there are problems with regards to side effects, dosing
regimens and cost. Tysabri, a novel once-monthly drug is expected to be an
improvement in terms of efficacy; however, there remains a concern over side
effects and long-term safety. |
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The erectile dysfunction market grew 3.5% from 2005 to be worth $1.95
billion in 2005 and is almost entirely composed of sales from three brands:
Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil). Despite
the dominance of these products, several opportunities exist for a
successful market entry. |
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Melanoma comprises just 5% of all skin cancers but it is the most
deadly. In 2006, more than 100,000 cases of the disease are expected to be
diagnosed in the seven major pharmaceutical markets. High unmet needs still
persist for this tumor type and despite three decades of extensive R&D,
five-year survival of advanced patients remains below 20%. |
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RSV mostly causes upper respiratory tract infections (URTI), resulting
in the common cold. However, in certain risk groups, RSV can cause more
severe lower respiratory tract infections (LRTI) leading to bronchiolitis.
These risk groups include elderly people, patients with underlying pulmonary
or cardiac disease, premature infants, children under four years old and
immunocompromised patients. |
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CRM is a business strategy by which a company seeks to maximize the
value of its products by managing the customer relationship, with specific
aims to boost customer retention and increase market share, while reducing
the costs of sales, marketing and customer fulfillment. CRM is made
necessary because of advances in Web-enabled technologies, which have
changed the dynamics of sales and marketing. |
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Based on an analysis of 46 companies and 1,000+ products, Datamonitor
forecasts that pharmaceutical industry ethical sales will increase at a
modest 4.9% CAGR 200511. 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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With increasing regulatory clarity and the expiries of key patents
covering innovator biologics, the development of biosimilars for a range of
recombinant protein classes is becoming increasingly attractive. Although
many companies are targeting the market, 12 companies dominate. These
include established generics companies, leading biosimilars developers, plus
emerging biosimilar developers. |
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Datamonitor predicts a somewhat enthusiastic uptake of two agents
currently in development by 2015. However, reimbursement is critical to the
uptake of new medication, due to the high cost of therapy. If the
reimbursable status is not achieved, the expansion of the market will not
match the rate of growth of the obese population and the great potential of
the obesity market will remain untapped. |
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The global antibacterial market, valued at $25.5 billion in 2005, is
highly mature. Modest growth (CAGR 2001-2005: 5.1%) is fuelled by ageing,
immunosuppression and emerging resistances, especially in the hospital and
former niche markets (e.g. MRSA). The community market, however, is facing a
value loss following the patent expiries of several blockbusters (e.g.
Pfizer's Zithromax) in 2005. |
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Unmet needs across the cancer market remain high, with most therapies
conferring low levels of specificity and high toxicity. Therapeutic cancer
vaccines offer an attractive therapeutic addition, delivering treatment of
high specificity, low toxicity and prolonged activity. However, despite
years of R&D, a reproducible survival benefit has proved elusive, leaving
the market wide open. |
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A lack of prescriber adherence to both marketing licenses and
pharmacoeconomic guidelines represents both a challenge and opportunity for
pharmaceutical companies marketing current Alzheimer's disease drugs.
Indication expansion between disease severities may not be a viable
commercial option; conversely, stricter guidelines by bodies such as the
UK's NICE will not necessarily threaten the market. |
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The Chinese pharmaceutical market, although only positioned ninth
globally, has experienced pronounced and rapid expansion in recent years,
driven by the growth of both Chinese and Western manufacturers.
Increasingly, there is a shift towards a research-based industry, focused on
generating new, innovative therapies, supported by improving intellectual
property regulations. |
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The ageing of the population will result in an increased incidence of
coronary artery disease, heart failure and stroke. In addition to these
epidemiological forces, the antithrombotics market will be sustained by the
forthcoming launch of innovative novel agents whose sales revenue is
expected to dampen the commercial impact of generic incursion in blockbuster
proceeds. |
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|
After the launch of Trexima in 2007, triptan genericization coupled with
a weak late-stage pipeline will result in a major shift in market dynamics,
and will result in the migraine market value decreasing to $3.2 billion in
2015. The market remains receptive to superior prophylactics however, with
innovation being essential for the progression of the acute market,
post-triptan era. |
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|
The oncology market has shown remarkable growth in recent years, driven
by the advent of targeted therapy and the high level of unmet needs in the
disease, and it is poised for further expansion. While this will provide
companies with opportunities, a key hurdle for novel cancer drugs will be
the increasing pharmacoeconomic vigilance that prevails within cash-strapped
healthcare systems. |
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Cases of endometrial cancer are set to rise in developed countries due
to an increase in risk factors such as obesity. In contrast, while incidence
of cervical cancer is set to decrease in developed countries following the
implementation of anti-HPV immunization with Merck & Co's Gardasil and
GlaxoSmithKline's Cervarix, it will remain a major cause of cancer-related
death in the developing world. |
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|
The drive for increased cost savings by healthcare providers is increasing
the focus on boosting the biosimilar market. With a regulatory approval
pathway in place in Europe and substantial guidelines to support biosimilar
development, the European biosimilars market is significantly more advanced
than the US, where plans for a biosimilar regulatory approval pathway have
stalled. |
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|
Datamonitor's Drug Delivery: Global Industry Guide is an essential
resource for top-level data and analysis covering the drug delivery
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. |
|
|
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. |
|
|
Today, consumers are taking a more proactive approach to managing their
health and the prevention of diet-related diseases, such as obesity,
diabetes, cardiovascular and bone and joint diseases. Many of these diseases
are at epidemic levels, and this combined with increasing patient power
makes the prevention of these lifestyle diseases attractive markets for both
the food and pharmaceutical industries to exploit. |
|
|
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. |
|
|
The environment in which pharmaceutical companies promote their products
has become increasingly tough over recent years as a number of trends and
factors drive changes. As the effects of shrinking pipelines and rising R&D
costs impact companies, they are under increasing pressure to deliver
greater productivity from their sales forces. |
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Ulcerative colitis and Crohn's disease are the primary constituents of
Inflammatory Bowel Disease, which is estimated to affect approximately 1.8
million people in the seven major markets. Eight years after the launch of
Remicade in Crohn's disease the next generation of anti-TNF's are poised for
approval, but the anti-TNF class will soon be under attack from novel
cytokine therapies. |
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In the US, approximately 88 million people are diagnosed with a
respiratory tract infection in an average year. Of these, a total of 66
million patients suffer from one of the three major diagnoses: acute
bacterial sinusitis (ABS), acute exacerbation of chronic bronchitis (AECB)
and community-acquired pneumonia (CAP). |
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|
Internet-enabled information communication technologies, such as
computers, mobile phones and PDAs have had a significant impact on the
physician-patient relationship by allowing for the efficient and
cost-effective management of large volumes of information, as well as by
supporting communications between individuals that would otherwise be
prohibited by time or geography. |
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|
In spite of generic Actiq competition, Cephalon’s reign of the
breakthrough pain market will be secured in the short-term with sales of its
follow-on brand Fentora. From 2008, however, a number of fast-acting
analgesics will enter the arena and battle for market share; this and other
growth drivers will see the market more than double from 2005 to reach an
estimated $2.5 billion in 2016. |
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|
Osteoarthritis (OA) is characterized by the progressive destruction of
articular joints and is a major cause of pain in Western populations.
Osteoarthritis is the most common form of arthritis and severely impacts the
physical function and day-to-day quality of life of an individual. It also
impacts heavily on the economy and it is believed to cost the US alone an
estimated $60 billion per year. |
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|
The government has relied on simple P&R tools to contain rising
healthcare costs and provide a reasonable level of healthcare. However,
factors such as a healthier elderly population are masking healthcare system
inefficiencies, boosting healthcare costs and increasing the focus on cost
containment. Although the rise in drug spending is slowing down, it remains
a visible cost containment target. |
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|
The hormonal contraceptive market grew by 4.2% from 2004 to $5.0 billion
in 2005. Market growth was driven in part by the strong uptake of Schering
AG's Yasmin and Organon's NuvaRing which fulfill key strategies: additional
indications and alternative delivery modes. Market growth is not expected to
falter if companies employ these lifecycle strategies which promote uptake
in a competitive market. |
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The oncology therapy area is unlikely to be spared from the heightened
conservatism currently sweeping the regulatory environment. This is
evidenced by the increased scrutiny with which the FDA appraises accelerated
approval applications, particularly in light of the 2005 withdrawal of
AstraZeneca's Iressa. |
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|
NSCLC comprises over 75% of all lung cancers. In 2006, more than 338,000
cases of the disease are expected to be diagnosed in the seven major
pharmaceutical markets. High unmet needs still persist for this tumor type
and despite two decades of extensive R&D and chemotherapy use, the median
overall survival of NSCLC patient's remains below 12 months. |
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|
Drug delivery is one of the most dynamic and fast growing sectors of the
pharmaceutical industry. The high level of innovation in this sector is
evolving at a fast pace with products such as Pfizer’s inhaled insulin,
Exubera, gaining US approval in January 2006. |
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|
The total asthma and COPD population in 2006 is estimated to be 44.8 million
and 28.8 million respectively. While the majority of patients are well
controlled with current therapies, the remaining unmet needs are twofold:
first, to find better options for the 1.7 million patients with severe
asthma; second, to identify effective anti-inflammatory drugs in COPD. |
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|
Slow generic uptake, reformulations, follow-on products and new market
entrants will ensure steady long-term growth of the epilepsy market despite
several high profile patent expiries. UCB has emerged as the number one
epilepsy company, and is set to strengthen their epilepsy pipeline if the
proposed acquisition of Schwarz is confirmed. |
|
|
Until a decade ago, 5FU/leucovorin formed the mainstay of colorectal
cancer treatment but Camptosar and Eloxatin quickly established themselves
as components of gold-standard therapy. The advent of Avastin and Erbitux
heralded a new era in the disease management, and the emergence of other
molecular targeted agents should further push survival to an unprecedented
level in the coming years. |
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|
Cancer treatment continues to embrace the inclusion of molecular
targeted therapies (MTT) 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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|
Datamonitor estimates that there are over 11 million atrial fibrillation
patients in the seven major markets. Despite high unmet needs and
limitations of all the current treatment options, achievement of regulatory
approval is becoming increasingly difficult. This means that a very limited
number of novel treatments are expected to be introduced in the near future. |
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|
Supportive care is used to prevent or treat the adverse effects that
arise as a result of cancer treatment, particularly chemotherapy. While
newer molecular targeted therapies do not exist without some toxicity, this
is not as severe as that associated with traditional cytotoxics. A rising
incidence of cancer worldwide will mean that supportive care market will
increase both size and relevance. |
|
|
The orthopedic joint replacement market is at a crossroads between
time-tested conventional procedures and advanced implant materials and
surgical techniques. Demand driven by an aging population and an increasing
number of younger patients undergoing replacement procedures together with
improved implant materials and surgical techniques are contributing to
growth in this mature market. |
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|
Combined drug sales in the five major European markets represent the
second-biggest market globally after the US. Unlike the US, which is
dominated by a wide range of private payers, governments are the major
payers in Europe. The monopsonistic nature of these markets provides
governments with significant leverage and they use extensive P&R controls to
contain spiralling healthcare costs. |
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|
Product lifecycle management (LCM) is an integral part of portfolio
continuation and preservation. With R&D productivity stalling, and profit
margins increasingly eroded by cost-containment initiatives, maximizing the
return on investment (ROI) of in-line brands is a key objective for
pharmaceutical companies. |
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|
Traditionally, the treatment of respiratory infections has largely
involved antibiotics from the macrolide class. Advanced Life Sciences'
cethromycin, along with Sanofi-Aventis' Ketek, is a ketolide, a
second-generation class of macrolides with activity against bacterial
strains resistant to macrolides. Data from two Phase III trials in
community-acquired pneumonia are expected in early 2007. |
|
|
Datamonitor expects the antihypertensive market to exceed $40bn by 2015
across the seven major markets, with novel treatments and the market-leading
ARBs delivering much of this value. However, significant hurdles exist, and
pharmaceutical companies need to carefully design marketing campaigns and
pricing structures for their products. |
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|
Datamonitor expects the continuously growing prevalence of diabetes to
drive growth in diabetes drug spending, potentially benefiting market uptake
of novel insulin therapies. A set of novel, non-injectable insulins are
poised to become available to patients in the next five years. By 2010, the
market will thus have to absorb Pfizer's Exubera and at least three other
inhalable insulins. |
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|
More people than ever are living with HIV and AIDS in North America and
Western Europe. Over the next five years, a great variety of new HIV drugs
are expected to reach the market early stage therapies will be simplified by
new products that will transform the market. For those with few treatment
options left, new pipeline products will redefine late stage therapy. |
|
|
Rheumatoid arthritis is a debilitating and life-long disease that is
estimated to affect approximately 5 million people in the seven major
markets. The launch of anti-TNF products over six years ago and more recent
novel target biologic therapies have added significantly to the treatment
options, but have resulted in a crowded market for moderate to severe
patients. |
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|
Palatin Technologies' bremelanotide (PT-141) is a novel melanocortin
receptor agonist that is believed to be the only agent currently in
development for the treatment of both erectile dysfunction (ED) and female
sexual dysfunction (FSD). |
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|
Digital imaging products and CEREC form the basis for growth for Sirona
Dental Systems, while accounting for nearly two-thirds of revenues, and will
therefore be essential to the newly formed combination of Schick
Technologies and Sirona. |
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|
There are no FDA-approved second-line chemotherapy options for hormone
refractory prostate cancer, indicating a great unmet need, with a large
potential market for an agent such as Spectrum's satraplatin, which could
offer key advantages due to its oral administration profile. |
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|
Stimulated by sales of atypical antipsychotics for bipolar depression,
and despite the launch of generic risperidone, the global bipolar disorder
market will grow until 2011, when revenues will peak at $6.6 billion. The
market will begin to decline thereafter owing to the launch of generic
versions of the leading atypical antipsychotics, quetiapine, olanzapine, and
ziprasidone from 2011 onwards. |
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ASCO features key presentations in the oncology area, and is generally
the most important week of the year for oncology. Presents Datamonitor's
comments on the most important events at the 2006 conference. |
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|
ASCO features key presentations in the oncology area, and is generally
the most important week of the year for oncology. Presents Datamonitor's
comments on the most important events at the 2006 conference. |
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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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|
Launched in the US in 1999 as the only topical lidocaine patch, Lidoderm
has demonstrated very strong growth year-on-year, with annual growth of 114%
in 2003, 73% in 2004, and 36% in 2005. Lidoderm’s continued growth in both
labeled and off-label indications is highly important to the company’s
future success. |
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|
The lack of differentiation between overactive bladder agents has led
manufacturers to turn to large-scale marketing efforts in an attempt to gain
market share. Given the relatively small marketing capabilities of IDEV and
Esprit, they may have difficulty penetrating high-prescribing urology and
primary care practices compared to its larger rivals, thus slowing Sanctura
XR's near-term potential. |
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Renovis and AstraZeneca's NXY-059 is viewed as the most promising
neuroprotectant currently in development for stroke, however, much of its
potential is dependent upon its ability to demonstrate a benefit in the
recently enrolled SAINT-II trial. |
|
|
Following the lackluster 2004 launch of an oral suspension formulation
of Santarus' lead product, Zegerid (a fast-acting proton pump inhibitor)
much of Santarus' future success is tied to the commercial potential for the
recently launched Zegerid oral capsule formulation to drive near-term
revenues. |
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|
The diabetes epidemic has contributed to growth in the antidiabetics
market over the past few years. Since the prevalence of diabetes continues
to increase, the market will further expand. While early therapy is
dominated by generically available agents, and the later stages by insulin,
the number of unmet needs in the diabetes treatment warrants that novel
agents will have a place in the market. |
|
|
The pharma industry is facing a crisis over R&D productivity, as
reflected by the low level of new drug approvals despite companies investing
the highest ever amounts in R&D. As a result, companies are seeking novel
ways to drive growth, with many opting to increase their reliance on third
parties - through licensing, collaborative and outsourcing agreements - in
an attempt to achieve this. |
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|
According to Datamonitor's eHealth Consumer Insight Survey, consumers in the
US, Western EU and Japan access search engines more frequently than any
other type of online or offline information resource when looking for health
information. As a result, consumers' requests for medication based on
information obtained online have become an increasingly influential factor
in the prescribing process. |
|
|
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. |
|
|
The respiratory market will continue to experience strong growth for the
next 6 years, 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 studies. Despite patent expiries of three
leading products, from 2010, the market will avoid a collapse like the one
seen for oral antihistamines. |
|
|
Commercial Insight: Antidyslipidemics explores current trends and key
future issues in the management of dyslipidemia and the effects of generic
competition and healthcare reforms on the main drug classes in this market.
The growth potential of the leading classes is discussed, and case studies
are used to highlight possible strategies to maximize future growth for
lipid management franchises. |
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|
Neurontin (gabapentin) has finally been knocked off the top spot as a result
of fierce generic incursion. However, Pfizer's follow-on Lyrica
(pregabalin), Lilly's Cymbalta (duloxetine) and Endo/Elan's Lidoderm
(lidocaine patch 5%) are re-establishing market growth and laying the
groundwork for new entrants. |
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|
The changing nature of CME has caused the pharmaceutical industry to
reassess its investment in CME. While more restrictive guidelines and
increased oversight may persuade many companies to decrease their
investments in CME, Datamonitor recommends that stakeholders seize this
opportunity to invest in educational programs that produce positive results
in physician behavior and patient health. |
|
|
Breast cancer is the leading cause of cancer-related mortality among
women worldwide. In 2006, more than 447,000 cases of the disease are
expected to be diagnosed in the seven major pharmaceutical markets. High
unmet needs still persist for this tumor type. Despite recent drug approvals
in the adjuvant and metastatic setting, the overall survival remains below
five years. |
|
|
The 11 tumor types covered in this report will account for over 2.3
million new cases of cancer in 2006 in the seven major pharmaceutical
markets. Despite the emergence of targeted therapies, major unmet needs
remain. NSCLC and breast cancer attract the highest R&D interest, but niche
tumors with high unmet needs are gaining significant interest from
pharmaceutical and biotech companies. |
|
|
The global schizophrenia market will continue to grow until 2010, when
revenues will reach $3.8 billion. However, despite the launch of numerous
pipeline schizophrenia drugs, the market will begin to decline thereafter
owing to the US launch of generic risperidone in 2007, followed by generic
versions of olanzapine, quetiapine and ziprasidone from 2011 onwards. |
|
|
Parkinson's disease (PD) is a progressive, degenerative condition of the
central nervous system (CNS), caused by the degeneration of dopaminergic
neurons in the substantia nigra of the midbrain. The PD market grew by 6.9%
to $1.8 billion between 2004 and 2005. In the absence of conclusive evidence
for a neuroprotective compound, the focus on the market remains on
symptomatic treatment. |
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|
> Overview of the role that blockbusters have played in shaping and
driving market growth
> Identification of which niche disease markets to target, to maximize value
from the nichebuster model
> Examination of how a range of different drivers such as regulatory
initiatives are incentivizing the nichebuster model
> Identification of trends underlying R&D collaborations or licensing deal
activity in allowing Big Pharma to access novel technologies and markets |
|
|
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. |
|
|
Despite being the most common cause of death from gynecological tumors,
ovarian cancer has not traditionally attracted the same level of R&D
interest as other female cancers. Nevertheless, nearly 60,000 cases of
ovarian cancer being diagnosed in the seven major markets each year is, by
no means, small and therefore, it remains an important secondary indication
for existing and pipeline drugs. |
|
|
The Top 20 cancer therapeutics generated sales of $20.1 billion in 2005
across the seven markets, set to reach $27.4 billion by 2015. Cytotoxics
currently constitute the majority, due to their long history in oncology and
their key role in current treatment. By 2015, the majority of the Top 20
will consist of targeted therapies, whose place in cancer therapy will
become increasingly established. |
|
|
Systemic Lupus Erythematosus is a chronic, life-long and potentially
fatal autoimmune disease characterized by multiple system distress and
unpredictable flares. High unmet need makes this an attractive market but
dispute over patient numbers and clinical trial difficulties are significant
hurdles for new entrants to overcome. |
|
|
In 2005, over 50.000 solid organ transplants were conducted in the seven
major markets. In order to prevent the patient's immune system from
rejecting the transplanted organ, immunosuppression therapy is required for
the lifetime of the graft with a base maintenance drug (either Calcineurin-
or mTOR inhibitors) and adjunctive therapies (antimetabolites, steroids). |
|
|
An estimated 10 million people in the seven major markets have chronic
HCV. The current standard of care, pegylated interferon (Peg-IFN) plus
ribavirin (RBV), achieves long-term disease remission in approximately half
of those receiving treatment. More efficacious therapies are required to
improve treatment success in difficult-to-treat patients, in particular
patients with HCV genotype 1. |
|
|
The dynamics of the contract manufacturing landscape in the
pharmaceutical industry are changing. With the increasing globalization of
the contract manufacturing market, particularly regarding on-patent
biologics and APIs, companies need to position themselves to be able capture
the cost savings Asian countries have to offer. |
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|
The generics market is undergoing significant change, with intense
merger and acquisition activity, a raft of upcoming patent expiries and new
legislation being enacted to promote generic prescription in the major
markets. In addition, key issues, such as authorized generics, the first
biosimilars approvals and increasing competition within the market are also
affecting growth dynamics. |
|
|
The US is the leading global drugs market in terms of sales and profit
margin. However, drug companies are facing an unprecedented number of
challenges in maintaining revenue growth: fewer drugs are being approved, a
wide number of blockbusters are facing patent expiry, and payers are
implementing stringent cost-containment policies in the face of
sky-rocketing healthcare costs. |
|
|
Mid Pharma companies are EU/US based pharmaceutical companies with 2005
annual revenues of <$10bn. An integral component of the Mid Pharma business
model is securing access to promising new drugs through in-licensing and
acquisition. |
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|
Although there are many marketed treatments for overactive bladder,
there are few available for stress urinary incontinence or interstitial
cystitis. Furthermore, despite available treatments for overactive bladder,
many are associated with side effects leading to poor treatment compliance.
With significant unmet needs remaining in these markets, there are clear
opportunities for new entrants. |
|
|
The current focus on biomarker discovery is a result of an improved
understanding of the biologic basis for carcinogenesis. The increasing
number of potential drug targets and a plethora of diverse, new
developmental agents have stimulated the search for biomarkers that can
reduce the time, cost and attrition rates prevalent in oncology drug
development. |
|
|
Datamonitor believes that RSD1235 (iv) has the potential to have a
significant impact on the treatment of atrial fibrillation. In addition,
P&G's Stedicor and Sanofi-Aventis' Multaq also offer advances on current
treatments, with improvements in efficacy and safety therein. |
|
|
Biologics are forecast to be the fastest growing segment of the
pharmaceutical market out to 2010 (12.2% CAGR). However, biologics face the
emergence of bio-similars and increasing numbers of competitor products,
both factors that intensify the commercial need for next-generation
biologics with superior product characteristics. DMEa method for optimizing
biologicsdirectly addresses this need. |
|
|
'Big Pharma' (non-biotech companies with annual revenues >$10bn) has
historically focused on small molecules. However, this is set to change,
with around 60% of revenue growth forecast to come from biologic products
(therapeutic proteins and monoclonal antibodies): by 2010, annual sales of
biologics will have increased by $26bn, compared to a $13bn increase for
small molecules. |
|
|
The generics industry has undergone significant change over the last
five years, with a wave of consolidation altering the competitive landscape.
Indeed, the intense merger and acquisition activity has lead to more diverse
companies, both on a product level and geographically, with pure generics
companies becoming increasingly rare. |
|
|
Since the beginning of this decade, parallel trade levels of
pharmaceutical drugs in the US and Europe have risen to some of the highest
levels ever seen, exerting additional pressure on the profitability of
pharmaceutical companies. As a result, it has become ever more important for
pharmaceutical companies to take action to limit the impact of this. |
|
|
Dry Overactive Bladder (dry OAB) is considered part of the overactive
bladder syndrome. However, unlike wet overactive bladder (or urge urinary
incontinence), it is normally only associated with urinary urgency and
frequency, and not incontinence. Even so, recent studies suggest that these
symptoms bother patients, with unpredictable urges disrupting daily
activities and quality of life. |
|
|
Urge urinary incontinence (UUI) is a relatively common disorder which
can affect all age groups but becomes increasingly prevalent with old age.
Although several pharmacological therapies are available for treating this
distressing condition, patients' reluctance to present to a physician and
incorrect diagnosis of the different overactive bladder subtypes limit the
potential of this market. |
|
|
Stress urinary incontinence (SUI) is the most common type of urinary
incontinence in women. Up until recently there were no globally developed or
widely approved pharmacological treatments for this disorder leaving women
with few treatment optionsnon-invasive (e.g. pelvic floor exercises) or
invasive (i.e. surgery) non-pharmacological therapy. |
|
|
Mixed Urinary Incontinence (MUI) affects over 10% of women, with women
suffering from unpleasant symptoms of both urge urinary incontinence (UUI)
and stress urinary incontinence (SUI). At present, no pharmacological agent
is able to effectively treat the symptoms of both UUI and SUI. |
|
|
Interstitial cystitis (IC) is considered a rare disorder and poor
understanding of the underlying causes of the disorder have made diagnosis
and management difficult. Moreover, this has impacted on the development of
effective drugs for this disorderthere are few available treatments for IC
and as a result, significant unmet needs exist. |
|
|
Allergic rhinitis affects between 15% and 20% of the population in the
seven major markets. Currently available treatments focus on symptom relief;
however, a significant number of allergic rhinitis patients with
uncontrolled symptoms remain. Shorter, safer, and more convenient therapies
currently in development may lead to a substantial market expansion. |
|
|
Disease management is not a new concept in the healthcare industry and
despite the heterogeneity that characterizes this field, such programs are
becoming an important part of the healthcare sector. As the vendor industry
continues to evolve through mergers and acquisitions, technology and
consumer forces will shape future disease management offerings. |
|
|
Datamonitor estimates that there are nearly 86 million Metabolic
Syndrome patients in the six major markets. Although the patient pool in
need of treatment for Metabolic Syndrome is large, the lack of an approved
indication for Metabolic Syndrome, the lack of a consensus definition and
the aversion of physicians to pharmacotherapy limit the size of the
Metabolic Syndrome market, considerably. |
|
|
Major Depressive Disorder (MDD) is estimated to affect over 34 million
individuals yearly across the seven major markets. Only a fraction of this
patient population is treated adequately, resulting in lost productivity,
unnecessary patient suffering and unfulfilled revenue potential for
manufacturers. |
|
|
In 2005, around 30,000 renal transplants were conducted in the seven
major markets. In order to prevent the patient’s immune system from
rejecting the transplanted organ, daily immunosuppression therapy is a
necessity for the lifetime of the graft with a base maintenance drug
(cyclosporine, tacrolimus, sirolimus) combined with adjunctive therapies
(azathioprine, mycophenolate mofetil, steroids). |
|
|
Non-small cell lung cancer comprises over 75% of all lung cancers. In 2006,
more than 338,000 cases of the disease are expected to be diagnosed in the
seven major pharmaceutical markets. High unmet needs still persist for this
tumor type and despite two decades of extensive R&D and chemotherapy use,
the overall survival of NSCLC patients remains below 12 months. |
|
|
Despite declining incidence rates, gastric cancer remains the second
most common tumor type and second cause of cancer-related death worldwide.
Gastric cancer occurs nearly five times more frequently in Japan than in the
West. While early diagnosis and encouraging survival rates are common in
Japan, the disease confers greater mortality in the West, thus representing
a significant health burden. |
|
|
While existing treatment strategies for adult acute leukemia may yield
satisfactory remission- induction rates, a major clinical concern is the
high rate of disease relapse despite attempts to optimize post-remission
consolidation therapy. This is acutely problematic among elderly patients
who are frequently unable to tolerate the rigors of more intensive treatment
approaches. |
|
|
Osteoarthritis offers a very attractive commercial target in terms of
patient potential, and the explosion in new disease modifying drugs in
rheumatoid arthritis has highlighted the possibilities for OA. However,
controversy in the Cox-2 class, preconceptions about alternative treatments
and even debate around the definition of OA make this a more difficult
market to break into than first thought. |
|
|
The global anxiety disorders market is set to decline from $4.5 billion
in 2006 to $2.6 billion by 2015 (CAGR 2006 15 -6.0%). This will be primarily
due to the launch of numerous generic anxiety drugs from 2006 onwards, which
will offset the revenue growth derived from existing drugs seeking
additional anxiety indications, and the launch of several novel anxiety
drugs. |
|
|
Despite modest improvements in blood pressure control, effective blood
pressure control for all still seems to be an elusive goal. As such, the
promotion and use of combination therapies has increased, explaining much of
the current R&D activity in this area where many developers are studying
novel combinations of currently marketed drugs rather than discovering
innovative treatments |
|
|
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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Despite a tough year in 2005 in terms of the regulatory environment and
public opinion, with the withdrawal of Vioxx still at the forefront of
peoples' minds, a number of leading pharmas continued to drive impressive
growth. Biologicals continued to lead the market in terms of growth with
Genentech's cancer focused portfolio driving the fastest growth in 2005 and
forecast to do the same in 2006. |
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Urinary incontinence and overactive bladder disorders are estimated to
affect more than 10% of the female population. However, presentation,
diagnosis and treatments rates are poor. In the US, the employment of
Continence Nurses provides an ideal opportunity to ensure that patients are
able to gain access to expert advice and treatment. |
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Disease management (DM) is becoming an important topic not only within
the US health care agenda, but also globally. Forces driving the disease
management market include a world-wide aging population and increasing
healthcare costs. Additionally, because ROI studies on DM programs have been
limited or inconclusive these programs have failed to gain significant
traction. |
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The majority of physicians surveyed in Italy and Spain access the
Internet for work-related purposes five hours per week or less. The
viability of using Internet-enabled applications to reach physicians is
dependent largely on both the level of access physicians have to an Internet
connection both at work and at home, as well as the time physicians have
available to go online during their workday. |
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Although only 5% of asthma suffers have severe asthma, these patients
account for a disproportionately high percentage of healthcare spending, as
asthma-related hospitalizations and emergency room visits are two of the
costliest outcomes, which highlights the significant unmet need in this
market. |
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Approximately 50,000 cystic fibrosis patients worldwide still await a
cure of their disease (WHO, 2004). Gene therapy experienced its first
failure in 2005 therefore focusing attention on new strategies such as ion
channel modulation. In the meantime, the administration of current drugs is
improving, which should advance general patient-compliance. |
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Caregivers are taking a more proactive role in providing healthcare to
themselves and others, using online tools and services to find information,
and influencing physician prescribing decisions by requesting particular
medication or discussing specific products. By providing online resources
for caregivers, pharma companies can increase brand loyalty among
caregivers, and potentially, physicians. |
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Datamonitor expects the global pulmonary arterial hypertension (PAH)
market to grow from $636m in 2004 to just over $2 billion by 2014, as new
product and formulation launches in the US and a healthy late-stage pipeline
drive sales growth. With this increased interest, combined with increased
awareness and R&D activity, treatment for this orphan disease is set to
enter a new era |
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The Internet has played a key role in changing the patient-physician
relationship. Time constrains and productivity pressures are driving
physicians to the Internet to keep abreast of medical knowledge. At the same
time, physicians are becoming accustomed to the role of patients as
consumers. Physician behavior is changing in response to this consumerism
trend in healthcare. |
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Gaining access to influential healthcare professionals is difficult
because physicians often do not have time to see drug reps during the
working day. Furthermore, drug reps often fail to make the most of the
limited time they do have with prescribers. Over time this has caused drug
reps to lose influence to patient requests during the prescribing process. |
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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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Increased prevalence of diabetes, obesity, and cardiovascular disease,
all causal factors of renal disease, drives growth of the end-stage renal
disease (ESRD) sector. On average, an ESRD patient uses >$7,000 of
drugs/year, representing a significant opportunity for pharmaceutical
companies in treating the symptoms, comorbid conditions and treatment side
effects of ESRD. |
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Influenza is a highly infectious disease which globally infects 10-20%
of the population every year causing up to 500,000 deaths. Although all
persons are at risk, the elderly and the young are the most vulnerable. For
decades, trivalent prophylactic vaccines produced in chicken eggs have been
used to reduce the burden of influenza with approximately 300 million doses
produced globally. |
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The antidyslipidemics market is driven by the statins, which account for
87% of it. However, as many statins are expected to face patent expiry in
the coming decade their role is expected to change from a driver to that of
almost a resistor. Manufacturers are looking to novel products to protect
their franchise, such as Pfizer's atorvastatin/torcetrapib. |
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A meager 20% of metastatic RCC tumors respond to standard cytokine
therapy, thus rendering 80% of advanced RCC patients without any effective
treatment. Further, with up to 50% of stage one to three patients relapsing
following nephrectomy and an increasing incidence of this disease, RCC
represents a lucrative commercial opportunity for the developers of novel,
effective pharmacotherapy. |
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Datamonitor expects the antihypertensive market to exceed $50bn by 2014
across the seven major markets, with novel treatments and the market-leading
ARBs delivering much of this value. However, significant hurdles exist, and
pharmaceutical companies need to be savvy regarding marketing and pricing
structures for their products, as only the most cunning and aggressive
companies look set to survive. |
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Postoperative pain can be caused by many different surgical procedures,
each involving a variety of complications and physician specialties. Pain is
a subjective experience for patients and it would seem that prescribing is
driven by physicians' subjective preferences. Patients frequently have to
suffer with their pain and request treatment before medication is initiated. |
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Hepatitis is a major health problem in China, which is home to one third
of hepatitis B patients and one quarter of hepatitis C patients globally.
HBV vaccination, together with HBV and HCV screening have helped to reduce
transmission, but continued transmission from mother to child (for HBV) and
transmission via blood transfusions (HCV) means that HBV and HCV are likely
to remain a problem. |
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The global Rheumatoid Arthritis (RA) market has experienced
extraordinary growth over the last decade. This market valued at $4.14
billion in 2004, shows no hint of decline. The explosion in new disease
modifying drugs since the late 1990's has resulted in a competitive and
rapidly evolving market. However, the recent events in the COX-2 market will
continue to impact all arthritis drugs. |
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Until recently, the insomnia market has been dominated by Ambien,
Sonata, and Imovane, and the older hypnotics such as benzodiazepines.
However, the global insomnia market is set to grow from $3.7 billion in 2005
to $5.5 billion by 2014 (CAGR, 5.6% 200514), driven primarily by the launch
and up-take of Lunesta, Rozerem and Ambien CR as well as pipeline drugs from
2006 onwards. |
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Over the next 10 years a significant number of key oncology products,
some with blockbuster status, will lose patent protection, thus exposing
billions of dollars to generic erosion. While obviously a major threat to
the key pharmaceutical players and sales of their branded products, this
presents significant opportunities to potential generic manufacturers. |
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There have been several drug safety scares over the last five years,
most notably the withdrawal of Vioxx and the problems with the SSRI
antidepressants. With growing public and physician awareness of safety
issues, and new PhRMA guidelines for direct-to-consumer advertising drawn up
in response to the withdrawal of Vioxx, companies face new challenges when
planning future promotional campaigns. |
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Opioid abuse is a growing medical challenge, yet few developments have
been made in its treatment in recent years. The market requires
clarification of the goals of therapy - to remove the addictive behavior or
to just manage the addiction and modify the impact on the abuser's life? |
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COPD is a deadly disease of the elderly, with patients suffering years
of progressive discomfort and disability with no pharmacological
interventions able to slow the progressive decline in lung function. A
large, increasing patient population demands the development of truly novel
COPD-focused therapies which must be coupled with improved disease awareness
and diagnosis. |
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Juvenile arthritis is the next indication due for approval for
blockbuster biologic therapies Remicade (infliximab) and Humira
(adalimumab). Pediatric rheumatology is a growing specialty that offers high
unmet need in terms of effective well-tested treatments. |
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Therapeutic vaccines have faced numerous setbacks in recent years. The
only three vaccines to reach the market have had insignificant sales, while
the pipeline has seen numerous high-profile failures and no new product
launches in three years. |
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Currently driven by the needs of the expanding respiratory market, the
inhalable drug delivery sector has also been invigorated by the promise of
growth through the systemic delivery of drugs via the lungs as the first
inhalable insulin nears the market. |
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Hypertension is a deadly disease and an important global public health
challenge. Datamonitor estimates that there are currently 192m people with
hypertension in the seven major markets, and this number is set to rise to
212m by 2015. |
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Endocrinologists play an important role in many of today's pressing
healthcare issues, with diseases such as diabetes and obesity on the rise
globally. Pharmaceutical companies can build brand equity by providing the
eHealth tools that are most in demand from endocrinologists, as they rely
increasingly on the Internet as a means to access information and improve
patient care. |
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A series of high profile safety concerns, such as the withdrawal of
Vioxx (rofecoxib) and the link between antidepressants and suicidal thoughts
in children over the last two years has made drug safety a major issue for
governments, regulatory authorities and the pharma industry. |
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The value of the Indian pharmaceutical industry grew 11% in 2004 from
2003; with the top 10 Indian pharmas accounting for 46% of the market, and
R&D spend increasing by 36%. Compliance with international intellectual
property protection and an increasing threat of foreign players moving into
India are factors currently changing the dynamics of the market. |
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The imminent introduction of Medicare Part D will take place with the US
drug market in a transitional period. Negative sentiment towards high prices
in the US market has gained currency in recent years, while growth in
generics continues to outstrip branded drug sales. |
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There is a clear need for new treatments for heart failure, as mortality
and morbidity rates, although improving, remain high. Heart failure already
represents the leading cause of hospitalization for patients over the age of
65 in Western markets and the aging population in these markets will surely
lead to growth in the prevalence of the disease and an increase in
healthcare expenditure. |
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Datamonitor's Drug Delivery: Global Industry Guide is an essential
resource for top-level data and analysis covering the drug delivery
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. |
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Inefficient patient recruitment slows the progress of many clinical
trials. Online recruitment has the potential to alleviate some of the
current delays. However, the success of this approach depends upon
consumers' comfort levels with the clinical trial process. |
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The Internet is becoming a major source of healthcare and treatment
information in Japan. In fact, Datamonitor research shows that surveyed
consumers in Japan spend the most time online compared to surveyed consumers
in the US and Europe. |
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The global incidence of STIs is estimated at several hundreds of
millions cases per year, and due to the asymptomatic nature of most
infections, underreporting is likely to mask the real incidence. |
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There is a positive outlook for the respiratory market over the next
five years, which will experience a sustained period of growth driven by the
expansion of sales in existing classes, the launch of major new products,
and the results from several landmark studies. |
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As consumer use of the Internet for personal reasons increases, the
influence of consumers on physicians and their prescribing decisions is also
increasing. This PowerPoint presentation identifies current consumer usage
and their preferences for online health information and services as well as
emerging technologies that are impacting consumers' relationships with their
physicians. |
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The socio-economic consequences of diabetes and its complications make
it a major public health issue. Patients with diabetes have a 25% reduction
in life expectancy compared with the general population, mainly due to
cardiovascular deaths. |
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Alzheimer's patients remain poorly treated and are growing in number.
Currently, cholinesterase inhibitors and the more recent NMDA-receptor
antagonists provide only moderate and temporary symptomatic benefit. By the
end of the decade, however, drugs with the ability to slow the rate of
disease progression are expected to be launched - most notably, the f |
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