The UK government have told kidney cancer patients that new drugs cannot be offered on the National Health Service. Roche's Avastin, Bayer's Nexavar, Pfizer's Sutent and Wyeth's Torisel were not cost-effective. The drugs -- known generically as bevacizumab, sorafenib, sunitinib and temsirolimus -- should therefore not be a treatment option for advanced and/or metastatic kidney cancer, NICE said.
Cancer Research UK said it raised questions about whether NICE's system of appraisal was appropriate for all types of drugs, especially when there were few alternative treatments. NICE argues it has to make tough choices when deciding which drugs should be paid for and which not.
Modern targeted drugs are revolutionising cancer care, yet they often increase survival by only a few months. Drug companies argue they need to charge a high price for them to make a return on risky research investment. The high price of treatment with the kidney drugs means it would cost GBP71,500 to GBP171,300 ($139,800-335,000) for every year of healthy life gained, NICE calculated.
Today there are an estimated 24.6 million people in the world living with cancer. The World Health Organisation (WHO) has predicted that the worldwide incidence will rise by 50% between 2000 and 2020. Cancer is becoming increasingly common in developing and developed countries, with significant potential for market expansion in both regions. Worldwide, there remain significant unmet needs in cancer treatment, with great opportunities for companies who can develop safer and better-targeted treatments. Our new report Oncology Market Leaders - Analyses and Outlook, 2008-2023, will help you to understand those developments and their significance.
According to IMS, sales data for 2007, the oncology area ranked as the fifth-largest therapeutic class worldwide. In 2007, the anti-cancer drug market generated sales of $66.8bn, up by 17% in comparison with $57bn in 2006. MabThera/Rituxan, Herceptin and Avastin - leading products of biotechnology and pharmacogenomics - are currently amongst the most prominent drugs in cancer therapy. Furthermore, the cancer pipeline remains strong. Current and future R&D is likely to produce significant therapeutic advances, especially when combined with pharmacogenomic medicine, particularly theranostics.
Oncology Market Leaders - Analyses and Outlook, 2008-2023, examines the product portfolios of the leading companies in oncology critically, with in-depth analysis, especially market forecasting and qualitative analyses of market drivers and restraints. This report also contains primary research from our survey of experts in the field. The result is a comprehensive market-based report with detailed analyses and informed opinion
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Clay Christensen on Disrupting Health Care
An acclaimed author and expert on the development and commercialization of technological and business innovation, HBS professor Clayton Christensen has written a new book aimed at changing our national conversation about health care. In The Innovator's Prescription: A Disruptive Solution for Health Care (read an excerpt), Christensen and his coauthors, the late Jerome Grossman and Jason Hwang (MBA '06), focus not on how the United States will pay for health care in the coming decades, but rather on targeting innovations that will make health care both more affordable and more effective in the future.
Deborah Blagg: "Disruptive innovation" is a term you've used in your analyses of other industries, but what does it mean in the context of the health-care industry?
Clayton Christensen: People think they know what disruptive innovation means, but I've found it's often misunderstood. The simplest way to describe it-in a way that applies to health care or any industry-is innovation that transforms a product or service that historically has been very complicated and expensive into something that is affordable and simple to use.
Q: In your book, you identify fee-for-service reimbursement as a "runaway reactor" in accelerating the rise in health-care costs. Why is this system such a problem?
A: By some estimates, 50 percent of all health care is driven by physician and hospital supply, not by patients' needs. Today's doctors work in a system where they are rewarded by Medicare and insurance companies for the number and cost of the services they provide rather than by the value of those services in helping patients. In short, medical professionals make money when their patients become sick.
Here's one example of how the problem plays out in practice. In our research, we came across a book by George Halverson, the CEO of Kaiser Permanente. In making the argument for flat-fee reimbursement (which his company employs), Halverson notes that even though there is an affordable sealant that is almost 100 percent effective in protecting children's teeth against decay, only about one-third of kids get it. By contrast, in the minority of dental plans that provide comprehensive care for a yearly fixed fee, nearly all children are treated with the sealant. Now why might this be? Because in the fixed-fee system, filling cavities is a cost, not a revenue opportunity. So the financial incentive supports preventive care.
Q: So a system where health providers offer comprehensive care for a fixed fee is the disruptive innovation that will bring down costs?
A: It's a key component, but one reason why health-care reform is such a tough problem is that the challenges are complicated and interrelated. People who have studied this industry for a long time have come up with a number of feasible ideas to get at the cost problem, including high-deductible insurance and health savings accounts. But until we make sure that the treatments and services consumers are getting are effective and affordable, changing the way we consumers pay for the services doesn't fix anything.
What we need is a system of new value networks that will disrupt the old business models in this industry. We need a new approach not just to insurance and reimbursement, but also to the places where medical services are delivered, the way we use technology, the way pharmaceuticals are developed, the way we educate medical professionals, and who performs what kinds of services. These things are all connected, and changing one piece, or plugging an isolated innovation into an existing framework, will not solve the larger problem.
Q: You mentioned that the places where health care is delivered are part of the outmoded business model. Could you elaborate?
A: You can't make CT scans more affordable by changing the way big hospitals are run. But if you take procedures that once had to be performed at Mass General [Massachusetts General Hospital], for example, and you make them available at lower-cost, focused hospitals, that saves money. And as the technology evolves and becomes more portable, some procedures that took place in a focused hospital might move right into the doctor's office or clinic. It's by making lower-cost venues of care more capable that health care becomes affordable, not by expecting large hospitals to charge less.
Q: Could you give an example of a technological innovation that you think will have great impact?
A: The advantages of electronic medical records, which make patient information accessible and portable, have been talked about for a long time. One hurdle to progress on this relates, again, to the existing business model, which makes it difficult for information stored on one health-care provider's software system to merge with information from other facilities. There's a new disruptive technology in the works, personal electronic health records (PEHRs), an open-source tool that collects data from all providers and gives patients access over the Internet or by mobile phone.
It's not hard to imagine how PEHRs can help us manage our own health care, but the technology is transformative in lots of unexpected ways. In some areas of sub-Saharan Africa, for example, PEHR technology in the hands of health-care workers has already helped reduce the transmission of mother-to-child HIV. For many pharmaceutical companies, complete and accurate patient data would help in screening participants in drug trials and make it possible to track and troubleshoot unexpected problems that show up after a drug is introduced into the general population, like what happened with Vioxx. The potential of this technology is far-reaching.
Q: Your prescription calls for widespread, coordinated change. Who is responsible for leading the way?
A: We hope policymakers in Washington will give our approach consideration, but to transform a complicated industry like this, you need buy-in from a broad range of people, including executives of provider organizations, as well as hospital, insurance, drug, retail, and medical device companies; deans of medical schools; and employers, who pay the bulk of health-care costs. All these parties interact in an interdependent way inside the current system and need to work together to bring about real change.
Q: Is this change happening, and if so, where are we on the transition timeline?
A: System problems require a systemic solution. You need what the great [HBS professor] Al Chandler called "the visible hand of managerial capitalism." When this kind of change happened in personal computers, IBM weighed in and orchestrated the creation of a new business ecosystem.
That's what we need in health care. Right now, only 5 percent of health care in America is provided by integrated institutions such as Kaiser, Intermountain, and Geisinger, but 95 percent of health care is still provided by disintegrated, specialized providers. And if those providers don't start to integrate as competitors in the health-care market, they will be the losers
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The opioids market was estimated to be worth $9.6 billion across the seven major pharmaceutical markets (7MM) in 2008, and strong historical sales means it could reach $11.9 billion by 2018.
The launch of several branded products are expected to be the main growth drivers with long-acting and short and rapid-acting opioids forecasted to be the most dynamic over 2009 - 2018. However, the number and diversity of products in late-stage development could limit the commercial potential of individual brands, with the market seeing significant saturation and price competition.
Even so, the conventional opioids market still represents a large volume of prescriptions and with several new products on the horizon such as Tapentadol (Johnson & Johnson) and Acurox (King Pharmaceuticals), it possesses growth potential.
This new report includes:
A strategic analysis of the likely impact recent events will have on the future opioids market.
Analysis of historical growth trends in the short and rapid-acting markets (Actiq, Fentora), including promotional spend.
Sales forecasts for the opioids market, sub-markets and key brands in the 7MM to 2018.
A comprehensive evaluation of the demand for anti-abuse opioids.
An analysis of the growth trends in key markets outside of the 7MM.
An Excel dataset containing forecasts for the key brands, generics and pipeline agents in the 7MM to 2018. Volume and value forecasts are presented for each of the following levels: country/region, class, molecule and product.
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Inflammatory Bowel Diseases:
World Market Report 2009-2024
This brand new in-depth market analysis examines the current and future prospects of the inflammatory bowel diseases (IBD) market. The world market for intestinal anti-inflammatories was worth over $2400 million in 2008, and had grown at 9% over the previous year.
The value of other types of drugs used to treat IBD, including immunosuppressants and monoclonal antibodies, approached $12000m. Visiongain predicts the market for intestinal anti-inflammatories and IBD drugs to continue expanding, based on rising disease rates and evolving diagnostic methods. Currently, IBD is under-diagnosed, especially in developing countries. As governments and health services address chronic illnesses like IBD, this market will expand into previously untreated regions. Continuing studies and surveys indicate that IBD is spreading globally, and has an especially high prevalence rate in India. In addition, the Latin American countries experienced 14% sales growth last year, and are set to account for an increasingly large share of the world market in years to come.
This report - Inflammatory Bowel Diseases: World Market 2009-2024 - discusses and analyses the major drug categories used in the treatment of IBD. This report forecasts the top brand-name and generic drugs used for IBD, including monoclonal antibody therapies. How much of an impact will monoclonal antibodies have on sales of other IBD-related therapies, for example? You should know and ths report will tell you. This report also analyses the major markets worldwide, discussing the principal national markets in detail, in addition to the world market. Through this report, you will discover how the leading markets will perform in the future, and how the relative values of each region will change over time. The US was the largest market in 2008, but will it retain its leading market share until 2024? How will the European market share compare with the Asian market share in 2014, 2019 and 2024?
Drug types analysed and forecasted in this report - Inflammatory Bowel Diseases: World Market 2009-2024 - include:
• Aminosalicylate acid / 5-ASA
• Corticosteroids
• Immunomodulators
• Antibiotics
• Biologic therapies
• Monoclonal antibodies.
• Includes unique primary material unavailable elsewhere
This report covers disease and therapy distinctions between the two major types of IBD: Crohn's disease and ulcerative colitis. It discusses these diseases and addresses aetiological theories that impact upon treatment. We provide the information you need to assess the future of those diseases and of the relevant markets. Sources consulted include industrial databases, commercial information, published economic research and market-specific interviews with experts in the IBD field. The result is a comprehensive market- and industry-based report with detailed analyses and informed opinion that you will not find anywhere else.
In particular, Inflammatory Bowel Diseases: The World Market 2009-2024 focuses on the following essential aspects of that market:
• Forecast of the overall world IBD market from 2009 to 2024
• Forecasts of the current leading drugs' sales from 2009 to 2024
• Assessments of pipeline developments
• Analyses of short- and long-term drivers in the market
• Analyses of how disease theories impact upon treatment procedures
• Sales forecasts for the leading regional markets from 2009 to 2024, including discussions of specific country markets
• Discussion of the importance of generics in the IBD market
• Discussion of why the market contains so many types of drugs, and what that means for future developments
• Assessments of opportunities and threats in the IBD market worldwide
• Analyses of the impact monoclonal antibodies will have on the IBD market, present and future.
Why you should buy this report:
• To receive a comprehensive assessment of the complex IBD market, including the various types of therapies
• To receive a comprehensive analysis of the sales prospects for existing and new IBD drugs from 2009 to 2024
• To discover which types of therapies are most likely to succeed over the short- and long-term, and why each will succeed
• For a thorough assessment of the current and future market at global and regional levels
• To find out where the market is heading, both technologically and commercially
• For a logical analysis of the multifaceted treatment options for IBD, including market drivers and restraints.
The global IBD market is highly complex, with multiple drugs being used simultaneously and/or sequentially for therapy. The market can therefore accept a large number of drugs, but the market is already fairly saturated, with several similar drugs on the market. What does such saturation mean for the futures of existing drugs? What does this mean for the pipeline? If, as visiongain's interviewees say, IBD current drugs are less efficacious than they could be, what then are the promising future treatments that could fill therapeutic gaps? This report covers those important matters, amongst others.
As inflammatory bowel disease rates continue to rise, as too public awareness spreads and more-thorough diagnostic procedures expand the number of patients, the demand for IBD drugs will increase. What drugs and which companies will meet these therapeutic needs successfully in the future? Can new and future therapies compete successfully with established treatments? This report answers those and other important questions, to enable you to take advantage of this expanding market.
- PRICING -
- Individual report pricing - single user copies of this report are available for only GBP £1499
- Departmental copies (this entitles up to 5 individual users in your department) of this report are available for only GBP£2999. This is not suitable for library usage.
- Allow your whole company to have access to this information for only GBP£4999. Company-wide License allows your whole company access and intranet use on CD Rom and in PDF form. Suitable for library storage and use.
- Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only GBP£6999
(The 15% VAT is not included)
-ORDERING-
Ordering is simple! All you need to do, to order this report is contact me on e-mail address:
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You can either call JANA on TEL: +44 (0)207 549 9971
If you buy one report this year make sure it is the report that will guarantee your success for the forthcoming years. Order this report now.
Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.
By ordering your copy of this Report TODAY you can ensure your companies success in the market tomorrow.
I look forward to receiving your order.
Kind Regarts,
Jana Jankova
Emarketing Executive
Visiongain Ltd.
BSG House,
226-236 City Road,
London / EC1V 2QY
Tel: +44 (0) 20 7549 9971
Table of Contents
1 Executive Summary
1.1 Inflammatory Bowel Diseases (IBD) Market Trajectory
1.1.1 Visiongain's Prediction for the IBD Market
1.1.2 Prevalence Rates Rising Worldwide
1.2 Aims, Scope and Format of the Report
1.2.1 Chapter Outline
1.3 Complexities of the IBD Market: Assessing Multiple Drug Categories
1.4 Research Methods
2 What Is Inflammatory Bowel Disease?
2.1 Definition and Diagnosis
2.2 Signs, Symptoms and Secondary Conditions
2.2.1 Bleeding Ulcers, Fistulae, Bowel Perforations, Toxic Megacolon
2.2.2 Pyoderma Gangrenosum
2.2.3 Primary Sclerosing Cholangitis
2.2.4 Malnutrition, Poor Nutrient Absorption and Stunting
2.3 Ulcerative Colitis
2.4 Crohn's Disease
2.5 Indeterminate Colitis: Distinguishing Crohn's Disease from Ulcerative Colitis
2.6 Causes / Aetiology of Inflammatory Bowel Disease
2.7 Prevalence
2.8 Socioeconomic Costs
2.8.1 The Individual Cost of IBD
3 Autoimmune Disorders
3.1 Brief Overview of the Immune System
3.2 What are Autoimmune Diseases / Disorders?
3.3 What Causes Autoimmune Disorders?
3.4 Why are Autoimmune Diseases Spreading in Developed Countries, but Not in Developing Countries?
3.4.1 The Hygiene Hypothesis
3.5 What Inflammation is and Why Inflammation is Dangerous
3.5.1 What is Inflamed in Inflammatory Bowel Disease?
3.5.2 The Costs and Consequences of Non-Treatment
4 Treatments for Inflammatory Bowel Diseases
4.1 The Goals of IBD Treatment
4.1.1 Producing Remission
4.1.2 Maintaining Remission
4.2 Drug Categories and their Mechanisms of Action
4.2.1 Aminosalicylates / 5-ASA / Mesalazine / Mesalamine
4.2.2 Corticosteroids
4.2.3 Immunomodulators
4.2.4 Antibiotics
4.2.5 Biologic Therapies / Monoclonal Antibodies
4.3 Surgical Treatments
4.3.1 Surgery for Ulcerative Colitis
4.3.2 Surgery for Crohn's Disease
4.4 The Leading Alternative Treatments: Hygiene Theory, Helminthic Therapy and Faecal Bacteriotherapy
4.4.1 Helminthic Therapy
4.4.2 Faecal / Fecal Bacteriotherapy / Human Probiotic Infusions (HPI)
4.4.3 Smoking
5 World IBD Market: Market Projection, Top Drug Projections
5.1 World Inflammatory Bowel Diseases Market, 2009-2024
5.1.1 The 5 Types of IBD Drugs
5.1.2 Other Drugs Cross-Indicated for IBD: Accounting for Monoclonal Antibodies
5.2 Lialda: Easier to Use, Growing in Significance
5.2.1 Unique Selling Point: Lialda is Lactose-Free
5.2.2 Lialda's Downside
5.3 Asacol
5.4 Entocort
5.4.1 Steroid Side Effects and Entocort EC
5.5 Pentasa
5.5.1 Excellent Safety Profile Assisting Pentasa's Sales
5.6 Salofalk
5.6.1 Salofalk Once-Daily
5.6.2 Salofalk and China Medical Sales Agreement
5.7 Budenofalk: 22% growth last year
5.7.1 Sales to be Boosted by New Sales Deal with Salix
5.8 Colazal: Losing Ground
5.9 Monoclonal Antibodies Forecasts
5.10 Remicade
5.10.1 Label Expansion Assisting Remicade's Sales
5.11 Humira
5.11.1 Label Expansion Behind Humira's Growth
5.11.2 Registered for Crohn's in US and EU; In Phase III for Crohn's in Japan
5.12 Cimzia
5.12.1 Challenged by the Committee for Medicinal Products for Human Use
5.13 Tysabri
5.13.1 Still Under Scrutiny for Liver Toxicity
6 Crucial Pipeline Developments: New Drug Targets, Innovative Delivery Technologies, and Cutting-Edge Treatments
6.1 Traficet-EN
6.2 Alicaforsen: Approved for Pouchitis, Cancelled for Crohn's, Under Assessment for UC
6.3 Rifaxamin
6.4 Myoconda: Is this the Cure for IBD?
6.5 Bupropion (Wellbutrin)
6.6 Abatacept (Orencia)
6.7 Polyketals: Technology to Deliver Drugs to Internal Inflammation
6.8 Extracorporeal Photopheresis (Light Therapy Outside of the Body): Uvadex (Methoxsalen)
6.9 A New Monoclonal Antibody Indicated for Crohn's Disease: Ustekinumab (Stelara)
6.10 Interleukins: Promising New Drug Targets (with a Table of Pipeline Interleukin Drugs)
6.11 Stem Cells: Prochymal by Osiris Therapeutics
7 Leading Companies
7.1 Procter & Gamble: 27% of the IBD Market
7.2 Ferring: Drug Originator and Innovator, but Limited Late-stage Pipeline
7.3 Shire
7.3.1 Lialda's Success and its Potential
7.3.2 Shire's Share of Pentasa
7.4 Dr. Falk
7.5 Prometheus Laboratories: Significance through IBD Drugs and Tests
7.5.1 Prometheus's Diagnostic and Genetic Analysis Tests: Frontiers of IBD Treatment
7.5.2 Serology Retrospective Results
7.5.3 Prometheus and Monoclonal Antibodies
7.6 Salix: Losing Colazal, Gaining US License to Budenofalk
7.7 Cosmo Pharmaceuticals / Cosmo Technologies: Watch this Company!
7.7.1 MMX Revenues
8 World Markets by Region
8.1 Changing Regional Market Share
8.2 North America: Slower Growth, Market Share in 2024 Compared with 2009
8.3 Europe: Retaining Market Share in the Long Term?
8.3.1 United Kingdom
8.3.2 Germany
8.3.3 Poland: Increasing in Market Relevance
8.4 Africa, Asia, Australasia: Growing Markets
8.4.1 The Incidence and Prevalence of IBD in Asia
8.4.2 Japan
8.4.3 Australia
8.4.4 China
8.4.5 India
8.5 Latin America
9 Strengths, Weaknesses, Opportunities and Threats of the IBD Market
9.1 Strengths
9.1.1 Monoclonal Antibodies: a Threat to Intestinal Anti-Inflammatories?
9.2 Weaknesses
9.2.1 Genotyping: A Dead End?
9.3 Opportunities
9.4 Threats
9.4.1 Cures and/or Vaccines?
9.4.2 Market Saturation
9.4.3 The World Economic Climate - Will this Limit Uptake of New IBD Drugs in a Nearly-Saturated Market?
10 Visiongain Interviews with Relevant Key Opinion Leaders
10.1 Interview with Marco Greco, Chairman of the European Federation of Crohn's and Ulcerative Colitis Associations (EFCCA).
10.1.1 Public Awareness
10.1.2 Differences Between European Countries
10.1.3 Drug Companies' Involvement in Awareness Campaigns
10.1.4 Unmet Medical Needs
10.2 Interview with Dr. Alan Fraser, Associate Professor of Medicine, University of Auckland, Director for Clinical Examinations at Auckland Hospital.
10.2.1 Autoimmunity vs. Infection Theories
10.2.2 Monoclonal Antibodies
10.2.3 Genotyping
10.2.4 Remaining Therapeutic Gaps
10.2.5 Future Treatments
10.3 Interview with Professor Thomas Borody, MD, PhD, Director of the Centre for Digestive Diseases (Sydney), and Executive Director and Chief Medical Officer of Giaconda Limited
10.3.1 Mycobacterium avium paratuberculosis (MAP) Infection and IBD Aetiology
10.3.2 IBD and HIV/AIDS
10.3.3 Monoclonal Antibodies and Immunosuppressant Treatments
10.3.4 Potential Cure(s)
10.3.5 Remicade and MAP
10.3.6 Genotyping
10.3.7 Crohn's vs. Colitis
10.3.8 Future Therapies
10.3.9 Potential and Future of Myconda
11 Conclusions
11.1 IBD Market Sales Forcasts
11.2 The Market will be Stimulated by New Delivery Technologies and New Drug Targets
11.3 Many Drugs and Generics on the Market, but Poor Disease Management Means High Potential Drug Uptake
11.4 The IBD Market - Will Sales Growth Continue Steadily from 2009 to 2024?
List of Tables
Table 3.1 The Most Common Autoimmune Disorders, by Type
Table 4.1 IBD Drugs by Type, Chemical Name and Brand Name
Table 5.1 World Intestinal Anti-Inflammatories Sales Forecasts, 2009-2024
Table 5.2 Lialda Sales Forecast, 2009-2024
Table 5.3 Asacol Sales Forecast, 2009-2024
Table 5.4 Entocort Sales Forecast, 2009-2024
Table 5.5 Pentasa Sales Forecast, 2009-2024
Table 5.6 Salofalk Sales Forecast, 2009-2024
Table 5.7 Budenofalk Sales Forecast, 2009-2024
Table 5.8 Colazal Sales Forecast, 2009-2024
Table 5.9 Autoimmune-Indicated Monoclonal Antibodies Forecasts, 2009-2024
Table 5.10 Remicade Sales Forecast, 2009-2024
Table 5.11 Humira Sales Forecast, 2009-2024
Table 5.12 Cimzia Sales Forecast, 2009-2024
Table 5.13 Tysabri Sales Forecast, 2009-2024
Table 6.1 Interleukin-targeted Drugs Pipeline, by Phase and Company, 2008
Alaven Pharm
Amgen
AstraZeneca
Atlantic Healthcare
Biogen Idec
Biovail
Biovitrum
Bristol-Myers Squibb
Center for Digestive Diseases (Sydney)
Centocor
ChemoCentryx
Committee for Medicinal Products for Human Use (CHMP)
Conaris Research Institute AG
Cosmo Pharmaceuticals, S.p.A.
Cosmo Technologies, Ltd.
Crohn's and Colitis Foundation of America (CCFA)
Dong A
Dr. Falk Pharma
Elan (Ireland)
European Federation of Crohn's and Colitis Associations (EFCCA)
European Medicines Agency (EMEA)
Faes Farma
Ferring
Food and Drug Administration (FDA)
Genmat
Genzyme
Giaconda
Giuliani
GlaxoSmithKline
Isis Pharmaceuticals
Johnson & Johnson
Medarex
Merck
Novartis
Osiris Therapeutics
Pediatric Inflammatory Bowel Disease Center at Cedars-Sinai Medical Center in Los Angeles
Pfizer
Probiotic Therapy Research Center, Sydney
Procter & Gamble
Prometheus Laboratories
Salix
Santarus
Santen
Schering-Plough
Shire
Stanford University
Synergen
Therakos
University of Washington
Wyeth
ZymoGenetics
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Statins: The World Market Report
2009-2024
from visionagain
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Report Details
The world statins market is changing, with patent expires and maturity of the landmark product Lipitor (atorvastatin). Statins are at the forefront of strategies to combat dyslipidaemia, being pivotal in the prevention of coronary heart disease. Consequently, those drugs are one of the most widely-prescribed and most lucrative sectors of the pharmaceutical industry, with total revenues exceeding $26 billion in 2008. Importantly, the world statins market is poised to undergo a period of rapid and dynamic change, with the generic statin sector growing particularly strongly in the years ahead. When will annual sales of generic statins exceed those of branded statins? Which branded statin will continue to achieve year-on-year sales growth during the coming waves of generic competition? Statins: The World Market, 2009-2024 answers these vital questions - amongst others - and provides the essential information that you need to take advantage of opportunities in the changing statin drugs market from 2009 onwards.
Statins: The World Market, 2009-2024 provides a comprehensive analysis of the world statins market, compiled using a wealth of research tools - including interviews with key opinion-leaders, examination of commercial databases, company reports, policy documents, industry news and filings. This original study provides extensive sales forecasting, market shares present and future, informed opinion, as well as detailed analysis of unmet needs, pipeline developments and commercial opportunities for statin drugs.
Highlights of Statins: The World Market, 2009-2024 include:
• Forecasts to 2024 for the overall world statin market, the generic statin market, the branded statin market and the dyslipidaemia market, including all statin types, the leading statin brands, leading manufacturers, country markets and combination statin drugs
• Interviews with key-opinion leaders in the field
• Examination of strengths, weakness, opportunities and threats facing major stakeholders in the sector - the market drivers and restraints
• Analysis and forecasts for the leading statin markets in the US, Japan and Canada, together with leading European and emerging national markets
• Analysis of the R&D pipeline for new statins, as well as other lipid-lowering drug types.
With full market forecasts for all the major generic statins, this new visiongain report reveals the significant commercial opportunities in new sectors of the statin market. However, significant opportunities exist for original branded products too. With relatively few single statins currently in development, new product developments in statins will mainly focus on statin combination drugs, visiongain predicts. In addition, strong growth in the statins sector will occur in emerging national markets - most notably in China and India - driving global sales. There are vast and expanding existing and potential patient populations for those drugs worldwide.
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Table of Contents
1 Executive Summary
2 Dyslipidaemia and Coronary Heart Disease
2.1 Cholesterol and Triglycerides
2.2 Lipoproteins Transport Cholesterol and Triglycerides
2.3 Dyslipidaemia and Atherosclerosis
2.4 Cholesterol Risk Levels
2.5 The Fredrickson/World Health Organization (WHO) Classification of Dyslipidaemia
2.6 Cardiovascular Disease
2.7 CHD Risk Factors
2.8 Cholesterol Testing
2.9 Primary and Secondary Prevention of Atherosclerosis
3 Statins and Other Lipid-Lowering Drugs
3.1 Statins: Mechanism of Action and Types
3.2 Lovastatin
3.2.1 Lovastatin Indications
3.2.2 Lovastatin Brands and Generic Manufacturers
3.3 Simvastatin
3.3.1 Simvastatin Indications
3.3.2 Simvastatin Brands and Generic Manufacturers
3.4 Pravastatin
3.4.1 Pravastatin Indications
3.4.2 Pravastatin Brands and Generic Manufacturers
3.5 Fluvastatin
3.5.1 Fluvastatin Indications
3.5.2 Fluvastatin Brands and Generic Manufacturers
3.6 Atorvastatin
3.6.1 Atorvastatin Indications
3.6.2 Atorvastatin Brands and Generic Manufacturers
3.7 Rosuvastatin
3.7.1 Rosuvastatin Indications
3.7.2 Rosuvastatin Brands and Generic Manufacturers
3.8 Pitavastatin
3.9 Statin/Other Lipid-Lowering Drug Combinations
3.9.1 Lovastatin/Nicotinic Acid
3.9.2 Simvastatin/Nicotinic Acid
3.9.3 Simvastatin/Ezetimibe
3.9.4 Atorvastatin/Fenofibrate
3.9.5 Atorvastatin/Ezetimibe
3.9.6 Atorvastatin/Ezetimibe/Fenofibrate
3.10 Statin/Other Cardiovascular Drug Combinations
3.10.1 Caduet (Atorvastatin/Amlodipine)
3.10.2 Pravadual (Pravastatin/Aspirin)
3.10.3 Generic Statin/Other Cardiovascular Drugs
3.11 Other Dyslipidaemia Drugs
3.11.1 Anion-Exchange Resins
3.11.2 Ezetimibe
3.11.3 Fibrates
3.11.4 Nicotinic Acid
3.11.5 Omega-3-Acid Ethyl Esters
4 The World Statin Market
4.1 Statins Dominate the Lipid-Lowering Drug Market
4.1.1 The World Lipid-Lowering Drug Market
4.1.2 World Lipid-Lowering Drug Market Forecast, 2009-2024
4.2 The World Statin Market, 2009-2024
4.2.1 The World Statin Market, 2008
4.2.2 Scope for Further Growth: World Statin Market Forecast, 2009-2011
4.2.3 The Impact of Atorvastatin Genericisation on the World Statin Market, 2011-2014
4.2.4 Further Generic Opportunities: World Statin Market Forecast, 2014-2019
4.2.5 What are the Prospects for the World Statin Market from 2019 to 2024?
4.2.6 Statin Type Market Forecast, 2009-2024
4.3 The Branded and Generic Statin Markets
4.3.1 The Branded and Generic Statin Markets, 2008
4.3.2 By 2018 Sales of Generic Statins Will Exceed Branded Revenues
4.4 Atorvastatin
4.4.1 The Atorvastatin Market in 2008
4.4.2 Atorvastatin Market Forecast, 2009-2024
4.4.3 Lipitor Market Forecast, 2009-2011
4.4.4 The Ultimate Patent Cliff: Lipitor Market Forecast, 2011-2014
4.4.5 The Fate of Lipitor: Market Forecast, 2014-2024
4.4.6 Generic Atorvastatin Market Forecast, 2009-2024
4.5 Rosuvastatin
4.5.1 The Rosuvastatin Market in 2008
4.5.2 Rosuvastatin Market Forecast, 2009-2024
4.5.3 Bucking the Trend of Other Branded Statins: Crestor Market Forecast, 2009-2014
4.5.4 What are Crestor’s Prospects During 2014-2024?
4.5.5 Generic Rosuvastatin Market Forecast, 2009-2024
4.6 Simvastatin
4.6.1 The Simvastatin Market in 2008
4.6.2 Simvastatin Market Forecast, 2009-2024
4.6.3 Zocor Market Forecast, 2009-2024
4.6.4 Generic Simvastatin Market Forecast, 2009-2024
4.7 Pravastatin
4.7.1 The Pravastatin Market in 2008
4.7.2 Pravastatin Market Forecast, 2009-2024
4.7.3 Mevalotin/Pravachol Market Forecast, 2009-2024
4.7.4 Generic Pravastatin Market Forecast, 2009-2024
4.8 Fluvastatin
4.8.1 The Fluvastatin Market in 2008
4.8.2 Fluvastatin Market Forecast, 2009-2024
4.8.3 Lescol/Lochol Market Forecast, 2009-2024
4.8.4 Generic Pravastatin Market Forecast, 2009-2024
4.9 Pitavastatin
4.9.1 The Pitavastatin Market in 2008
4.9.2 Pitavastatin Market Forecast, 2009-2024
4.10 Lovastatin
4.10.1 The Lovastatin Market in 2008
4.10.2 Lovastatin Market Forecast, 2009-2024
4.11 Statin/Non-Statin Combination Drugs
4.11.1 The Statin/Non-Statin Combination Drug Market in 2008
4.11.2 Launch of new Statin Combination Drugs Will Drive Growth During 2009-2014
4.11.3 Genericisation in the Statin/Non-Statin Combination Sector, 2014-2024
4.11.4 Vytorin/Inegy Market Forecast, 2009-2013
4.11.5 Vytorin/Inegy Market Forecast, 2014-2024
4.11.6 Caduet Market Forecast, 2009-2024
4.12 Leading Statin Manufacturers
4.12.1 Leading Statin Manufacturers, 2008: Seven Players Control 85% of the Market
4.12.2 Pfizer’s Statin Revenues Forecast, 2009-2014
4.12.3 A New Leading Statin Manufacturer by 2013
4.12.4 Merck & Co./Schering-Plough Statin Revenues Forecast, 2009-2014
5 Issues Affecting the Statin Industry
5.1 SWOT Analysis of the Statin Industry
5.2 Patient Compliance
5.2.1 Patients on Statins Exhibit Poor Patient Compliance
5.2.2 Effective Contact Between Patients and Healthcare Practitioners is the Key to Improving Patient Compliance
5.2.3 Developments in Cholesterol Testing
5.2.4 Diagnostic Testing for Genetic Markers May Increase Patient Compliance
5.2.5 Increasing Use of Web-Based Information Technology Will Improve Patient Compliance
5.3 Generic Statins
5.3.1 Expected Patent Expiries in the Statin Market
5.3.2 Governments and Insurers Will Favour Generic Statins
5.4 Statin Clinical Trials
5.5 Safety of Statins
5.6 Statin OTC Switching
5.6.1 The Rationale for OTC Switching
5.6.2 Statin OTC Switching in the UK
5.6.3 Statin OTC Switching in the US
5.6.4 What are the Worldwide Prospects for Statin OTC Switching?
5.7 Prevalence of Coronary Heart Disease
5.7.1 Coronary Heart Disease is the Leading Cause of Death Worldwide
5.7.2 Future Projections for Prevalence of Coronary Heart Disease
5.7.3 The Economic Cost of Coronary Heart Disease
5.8 Promising Non-Statin Lipid-Lowering Pipeline
5.8.1 Statins Cannot Treat All Forms of Dyslipidaemia
5.8.2 Developments in Existing Rivals for Statins
5.8.2.1 Novel Nicotinic Acid Formulations
5.8.2.2 New Formulation of Fibrates
5.8.2.3 Omega-3 Fatty Acids
5.8.2.4 Functional Foods and Nutritional Supplements
5.8.3 Novel Lipid-Lowering Agents
5.8.3.1 CETP Inhibitors
5.8.3.2 Cholesterol Absorption Inhibitors
5.8.3.3 Antisense Oligonucleotides
5.8.3.4 PPAR-Alpha Agonists
5.8.3.5 MTP Inhibitors
5.8.3.6 Phospholipase A2 Inhibitors
5.8.3.7 Nicotinic Acid Receptor Agonists
5.8.3.8 Human Antibodies
6 Expert Opinion on Methods to Improve Patient Compliance
6.1 Statin Patient Compliance: Humayun J. Chaudhry, D.O., M.S., FACP, Commissioner of Health Services, Suffolk County, New York
6.1.1 Improving Patient Compliance in Statin Therapy
6.1.2 The Future of Cholesterol Testing
6.1.3 Web-Based Information Technology in Statin Prescribing
6.2 Genetic Markers to Improve Patient Compliance: Thomas White, Ph.D., Chief Scientific Officer and Vice President of Research and David P. Speechly, PhD Vice President Corporate Affairs, Celera
6.2.1 Patient Compliance for Statins is Poor
6.2.2 Genetic Markers: The KIF6 Risk Allele
6.2.3 Genetic Markers Could Improve Patient Compliance
6.2.4 Diagnostic Tests for Genetic Markers
6.2.5 Evidence for Genetic Marker Tests Increasing Patient Compliance
6.2.6 Effect of Genetic Marker Diagnostic Effects on Future Statin Prescribing Patterns
6.2.7 The Future of Cholesterol Testing
6.2.8 Effect of Genetic Markers on Clinical Trials Involving Statins
6.2.9 Web-Based Technologies to Improve Patient Compliance
7 Statin Country Markets
7.1 Leading Country Markets in 2008
7.2 Leading Country-Market Forecasts, 2009-2024
7.3 The US Statin Market
7.3.1 The US Statin Market in 2008
7.3.2 US Statin Market Forecast, 2009-2014
7.3.3 US Statin Market Forecast, 2014-2024
7.4 The Japanese Statin Market
7.4.1 The Japanese Statin Market in 2008
7.4.2 Japanese Statin Market Forecast, 2009-2024
7.5 The Canadian Statin Market
7.6 European Statin Markets
7.7 Emerging Statin Markets: China and India
8 The Statin Pipeline
8.1 The Statin Pipeline Lacks New Products
8.2 New Statins and Statin Combination Drugs in Development
8.2.1 Crestor/TriLipix
8.2.2 Crestor for Patients with Elevated CRP
8.2.3 Simvastatin and Nicotinic Acid/Laropiprant
8.2.4 Pravastatin and Fenofibrate Combination Therapy
8.2.5 Simvastatin and Fenofibrate Combination Therapy
8.2.6 Vytorin for Kidney Disease and Acute Coronary Syndrome.
8.2.7 Simvastatin/Rosiglitazone
8.2.8 PPD Statin/RBx 10558
8.2.9 Simvastatin/Aspirin/Lisinopril/Hydrochlorothiazide
8.2.10 Simvastatin/Aspirin/Ramipril
8.2.11 NCX 6560
8.2.12 Atorvastatin/Ezetimibe
9 Conclusions
9.1 The Statin Market in 2008
9.2 Future Challenges for the Statin Industry
9.3 Rise of the Generics: World Statin Market Forecast, 2009-2024
9.4 Leading Statin Manufacturers and Country Markets
List of Tables
Table 2.1 Risk Levels for Total Cholesterol
Table 2.2 Risk Levels for LDL Cholesterol
Table 2.3 Risk Levels for HDL Cholesterol
Table 2.4 Risk Levels for Triglycerides
Table 2.5 The Fredrickson/WHO Classification of Dyslipidaemia
Table 3.1 Leading Generic Lovastatin Manufacturers
Table 3.2 Leading Generic Simvastatin Manufacturers
Table 3.3 Leading Generic Pravastatin Manufacturers
Table 3.4 Branded Fibrates
Table 3.5 Leading Prescription Omega-3 Acid Products
Table 4.1 World Lipid-Lowering Drug Market, 2008
Table 4.2 Non-Statin Lipid-Lowering Drug Market, 2008
Table 4.3 World Lipid-Lowering Drug Market Forecasts, 2009-2014
Table 4.4 World Lipid-Lowering Drug Market Forecasts, 2015-2024
Table 4.5 Leading Statin Types and Brands, 2008
Table 4.6 Statin Type Market Forecasts, 2009-2014
Table 4.7 Statin Type Market Forecasts, 2015-2024
Table 4.8 The Branded and Generic Statin Markets, 2008
Table 4.9 Branded and Generic Statin Market Forecasts, 2009-2014
Table 4.10 Branded and Generic Statin Market Forecasts, 2015-2024
Table 4.11 Atorvastatin Market, 2008
Table 4.12 Atorvastatin Drugs Forecasts, 2009-2014
Table 4.13 Atorvastatin Drugs Forecasts, 2015-2024
Table 4.14 Rosuvastatin Market, 2008
Table 4.15 Rosuvastatin Drugs Forecasts, 2009-2014
Table 4.16 Rosuvastatin Drugs Forecasts, 2015-2024
Table 4.17 Simvastatin Market, 2008
Table 4.18 Simvastatin Drugs Forecasts, 2009-2014
Table 4.19 Simvastatin Drugs Forecasts, 2015-2024
Table 4.20 Pravastatin Market, 2008
Table 4.21 Pravastatin Drugs Forecasts, 2009-2014
Table 4.22 Pravastatin Drugs Forecasts, 2015-2024
Table 4.23 Fluvastatin Market, 2008
Table 4.24 Fluvastatin Drugs Forecasts, 2009-2014
Table 4.25 Fluvastatin Drugs Forecasts, 2015-2024
Table 4.26 Pitavastatin Drugs Forecasts, 2009-2014
Table 4.27 Pitavastatin Drugs Forecasts, 2015-2024
Table 4.28 Lovastatin Drugs Forecasts, 2009-2014
Table 4.29 Lovastatin Drugs Forecasts, 2015-2024
Table 4.30 Statin and Statin/Non-Statin Combination Drug Sales, 2008
Table 4.31 Statin/Non-Statin Combination Drug Market, 2008
Table 4.32 Statin/Non-Statin Combination Drugs Forecasts, 2009-2014
Table 4.33 Statin/Non-Statin Combination Drugs Forecasts, 2015-2024
Table 4.34 Leading Statin Manufacturers, 2008
Table 4.35 Leading Statin Manufacturers’ Revenue Forecasts, 2009-2014
Table 5.1 SWOT Chart for the Statins Industry, 2009-2024
Table 5.2 Expected Statin Patent Expiry Dates, 2009-2024
Table 5.3 Novel Lipid-Lowering Drugs in Development
Table 7.1 Leading Statin Country Markets, 2008
Table 7.2 Leading Statin Country-Market Forecasts, 2009-2014
Table 7.3 Leading Statin Country Market Forecasts, 2015-2024
Table 8.1 The Statins Pipeline
List of Figures
Figure 4.1 World Lipid-Lowering Drug Market, 2008
Figure 4.2 World Lipid-Lowering Drug Market Forecast, 2009-2024
Figure 4.3 Statin Type Market Share, 2008
Figure 4.4 Leading Statin Brand Market Share, 2008
Figure 4.5 World Statin Market Forecast, 2009-2024
Figure 4.6 Statin Type Market Forecast, 2009-2024
Figure 4.7 Statin Type Market Share, 2014
Figure 4.8 Statin Type Market Share, 2019
Figure 4.9 Statin Type Market Share, 2024
Figure 4.10 Branded and Generic Statin Market Forecasts, 2009-2024
Figure 4.11 Atorvastatin Drugs Forecasts, 2009-2024
Figure 4.12 Rosuvastatin Drugs Forecasts, 2009-2024
Figure 4.13 Simvastatin Drugs Forecasts, 2009-2024
Figure 4.14 Pravastatin Drugs Forecasts, 2009-2024
Figure 4.15 Fluvastatin Drugs Forecasts, 2009-2024
Figure 4.16 Pitavastatin Drugs Forecasts, 2009-2024
Figure 4.17 Lovastatin Drugs Forecasts, 2009-2024
Figure 4.18 Statin Combination Drugs Forecasts, 2009-2024
Figure 4.19 Leading Statin Manufacturers, 2008
Figure 4.20 Leading Statin Manufacturers’ Revenue Forecasts, 2009-2014
Figure 7.1 Statin Market Share by Country, 2008
Figure 7.2 Statin Market Share by Country, 2014
Figure 7.3 Statin Market Share by Country, 2019
Figure 7.4 Statin Market Share by Country, 2024
Figure 7.5 US Statin Market Forecast, 2009-2024
Figure 7.6 Japanese Statin Market Forecast, 2009-2024
Figure 7.7 Canadian Statin Market Forecast, 2009-2024
Figure 7.8 French, UK, Chinese and Indian Statin Market Forecasts, 2009-2024
Figure 9.1 World Statin Market Forecast, 2009-2024
List of Organisations Mentioned in the Report
Abbott
Actavis
Aegerion
Almirall
Alter [Spain]
Amarin
American Heart Association
American Medical Association [US]
Apotex
Arena Pharmaceuticals [US]
Astellas
AstraZeneca
Atherotech
Bagó [Argentina]
Bayer
Berkeley HeartLab (part of Celera)
BioInvent [Sweden]
Bristol-Myers Squibb
Celera
Center for Cardiovascular Disease in Women at Brigham and Women's Hospital
Centro Nacional de Investigaciones Cardiovasculares (National Centre for Cardiovascular Research, CNIC) [Spain]
Chiesi
Choongwae [South Korea]
CINFA [Spain]
Cobalt Laboratories
Cobalt Pharmaceuticals
Covidien
Daiichi Sankyo
Dr. Reddy's Laboratories
European Medicines Agency (EMEA)
European Society of Cardiology
Ferrer
Food and Drug Administration (FDA)
Galephar Pharmaceutical Research
Gedeon Richter
Genentech
Genfit
Genzyme
GlaxoSmithKline (GSK)
Human Genome Sciences (HGS)
Intas
Isis
Japan Tobacco
Johnson & Johnson
Kissei
Kowa
Krka
Kyorin
LifeCycle Pharma
Liposcience
Lupin
Medicines and Healthcare products Regulatory Agency (MHRA) [UK]
Medley [Brazil]
Menarini
Merck & Co.
Merck/Schering-Plough Pharmaceuticals [joint venture between Merck & Co. and Schering-Plough]
Micro Labs
Mitsubishi Tanabe
Mochida
Mylan
Nichi-Iko [Japan]
NicOx
Nissan Chemical
Novartis
Par
Pfizer
Pharmaceutical Product Development (PPD)
Pierre Fabre
Polpharma
Public Citizen [US]
Ranbaxy
Ratiopharm
Recordati
Roche
Sanofi-Aventis
Sawai [Japan]
Schering-Plough
Sciele [wholly owned subsidiary of Shionogi]
Sepracor
Servier
Shionogi
Sigma Pharmaceuticals [Australia]
Sigma-Tau
SkyePharma
Solvay
Stada
Teva
University of Auckland
Watson
World Health Organization (WHO)
Zentiva
Zydus Cadila
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Emerging drug delivery technologies aim to improve measures of safety, efficacy, convenience and compliance in both new and existing drug candidates and products. For currently marketed products, reformulations with new delivery technologies will extend the period of patent protection. New formulas will be key to boosting sales volume of large molecule products in chronic diseases where patient compliance surrounding dosing strategies and ease of administration are limitations on market growth. In R&D pipelines, novel applications of delivery technologies will expose new methods to reformulate failed or discontinued drugs and mask their unfavorable effects, expanding the market of potential drug candidates.
‘Delivery Mechanisms for Large Molecule Drugs' is a new report published by Business Insights that examines the future of the drug delivery technologies market, and the short, mid, and long-term growth dynamics which will underpin investment decisions. This report will measure the performance of leading drug delivery technologies applied within clinical R&D pipelines and identify when specific therapy area populations are set to benefit from emerging innovations. The market success of new technologies is forecast by their ability to fulfill unmet medical need, the maturity of the technology in clinical application, and the level of commercial interest and investment landscape.
Nanotechnology will have the greatest impact on the drug delivery market. However, the immaturity of the technology is likely to delay marketed presence over the next 7-10 years.
Antibody fragmentation and PEGylation technologies are the leading targeted large molecule particle engineering formulas with marketed drug product presence. However, antibody fragments have suffered 33 candidate failures compared with 12 PEGylated products.
Active transdermal technologies have generated the greatest number of technologies and devices amongst large molecule delivery innovations, with 16 clinical and 8 preclinical drug/device combination products and 49 stand-alone devices.
Electronic delivery is set to have the greatest impact upon control is more advanced within the field of pulmonary delivery average pulmonary-based product in early clinical phase I compared transdermal. There are, however, 25 transmembrane electroporation in comparison to 12 for electronic active pulmonary delivery.
From Delivery Mechanisms for Large Molecule Drugs
Successes and failures of leading technologies
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