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Strategic Overview of the Autoimmune Biologics Market
Decision Resources, Inc, September 2011
Autoimmune disorders comprise a myriad of diseases - including various rheumatologic, dermatologic, and gastroenterological (GI) disorders - in which the body’s immune system mistakenly attacks healthy body tissues. Premium-priced autoimmune biologics, such as the tumor necrosis factor (TNF)-a inhibitors - Amgen/Pfizer/Takeda’s Enbrel (etanercept), Janssen Biotech/Merck & Co./Mitsubishi Tanabe’s Remicade (infliximab), Abbott/Eisai’s Humira (adalimumab), Janssen Biotech/Merck & Co./Mitsubishi Tanabe/Janssen’s Simponi (golimumab), and UCB/Otsuka’s Cimzia (certolizumab pegol) - have been successful in treating many patients with certain autoimmune disorders. However, a considerable percentage of autoimmune patients do not respond to available biologics, and these agents carry a risk of serious side effects. More-effective, safer therapies are urgently needed, and drug developers are understandably interested in developing biologics to compete in this lucrative market.
To help understand clinical perspectives and trends in this market, Decision Resources fielded a survey in April 2011 to 78 U.S. physicians (25 dermatologists, 26 rheumatologists, and 27 gastroenterologists) who had an average of 15 years of practice. This physician insight drives the analysis of the pipeline, the unmet needs and opportunities, and market access and reimbursement issues relevant to the autoimmune biologics market.
Questions answered in this report:
- A growing prevalent patient population and a handful of blockbuster agents are fueling a robust autoimmune biologics market. What is the size of this market, and what is its growth trend? Which companies are the leaders based on 2010 sales? Will those rankings change? What opportunities are available to these and other contenders in this space?
- Agents in the autoimmune biologics pipeline aim for a wide array of drug targets. What are the most common drug targets? Why are drug manufacturers aiming for these targets instead of others?
- Despite the success of the TNF-a inhibitors and other biologics, significant unmet needs remain for many autoimmune indications. What autoimmune indications could benefit most from newer biologics? What unmet needs are most striking in these autoimmune indications, according to surveyed physicians?
- Understanding biological pathways and discovering biomarkers are keys to future success in the autoimmune disease markets. What are the barriers and opportunities in this arena for more-robust prescribing of biologics? What do rheumatologists, dermatologists, and gastroenterologists say about the use of biomarkers and diagnostics for autoimmune/inflammatory diseases?
- An analysis of dealmaking activity shows that large- and small-capital-backed companies appear to have similar strategic goals when it comes to use of biomarkers in autoimmune biologics development. What other strategic trends are revealed for other company types after an analysis of 46 transactions performed across 71 entities over 65 months?
- In the United States, almost half of all commercial insurance plans assign most immune biologics to tier 2 or 3 of their formularies. Which leading drugs have the most and least favorable formulary placement? How do Medicare plans compare with commercial plans in their tier positioning of immune biologics? Which coverage restrictions are most commonly applied to immune biologics?
- A recent Decision Resources survey of 27 gastroenterologists, 26 rheumatologists, and 25 dermatologists in the United States found widespread concern about barriers to access to immune disease therapies. To what extent do out-of-pocket costs restrict patients’ access to and compliance with immune disease therapies? What impact do coverage restrictions have on access to immune biologics? What changes in cost containment are likely in the next five years?
- The French healthcare system reimburses a substantial proportion of the cost of immune disease therapies. What is the standard reimbursement rate for drugs in this therapeutic area? For which immune disorders can patients qualify for exemption from out-of-pocket costs for medications? What restrictions are imposed on the distribution of immune biologics in France?
Introduction to the autoimmune biologics market: Market size, market growth, market drivers, product sales, unmet needs.
Indications covered: Rheumatology (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis), gastroenterology (Crohn’s disease and ulcerative colitis), and dermatology (psoriasis and systemic lupus erythematosus).
Primary research: Insight from a physician survey of 78 specialists (27 gastroenterologists, 26 rheumatologists, and 25 dermatologists) fielded by Decision Resources in April 2011; includes data from ongoing clinical trials as reported in clinicaltrials.gov; additional research analysis from ChartTrends: Rheumatoid Arthritis 2010, a report by BioTrends Research Group, a Decision Resources, Inc., company.
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan, and rest of world.
Emerging therapies: Phase I: 31 drugs; Phase II: 36 drugs; Phase III: 7 drugs.
Dealmaking assessment: Analysis of 46 deals featuring 71 unique companies/entities between 2005 and May 2011.
Historical and projected autoimmune biological therapy sales: 2006-2017 sales; leading drug classes; current and projected market-leading companies.
Pricing: International comparison of the ex-manufacturer prices of leading immune biologics.
Reimbursement: Detailed Fingertip Formulary data on the formulary status and coverage restrictions of leading immune biologics in commercial and Medicare plans in the United States; reimbursement policies in France, Germany, Italy, Spain, United Kingdom, and Japan.
General market access environment: Concise overviews of health insurance coverage, pharmaceutical reimbursement, and cost containment trends that impact the market for immune biologics in each country under review.
Exhibits: 96 data-rich tables and figures.
Autoimmune Biologics Market
Unmet Needs and Key Opportunities
Pricing and Reimbursement Strategies
2. Unmet Needs and Key Opportunities in the Autoimmune Biologics Market
Unmet Needs Overview: Physician Survey Results
The Need for Safer Biologics
The Need for Biomarkers and Diagnostics
Addressing Challenges in the Development of Biomarkers and Diagnostics: Physician Survey Results
Dealmaking Analysis in Biomarkers and Diagnostics for Autoimmune Disorders
Partnering Companies/Research Institutions
Considerations for Future Growth
3. The Autoimmune Biologics Pipeline
A Competitive Review of the Autoimmune Biologics Pipeline
Autoimmune Disease Background
Surveyed Specialists’ Patient Populations and Biologics Prescribing Habits
Scope of This Section
Agents in Development
Market Statistics and Market Outlook
Autoimmune Biologics Market Statistics
Autoimmune Biologics Market Outlook
4. Pricing and Reimbursement Strategies
International Price Comparisons for Autoimmune Biologics
Outlook and Implications for the Pharmaceutical Industry
About the Author
- Abbott Laboratories
- Acetylon Pharmaceuticals
- Amira Pharmaceuticals
- Astellas Pharma
- Becton Dickinson
- Biogen Idec
- Biotica Technology
- Boehringer Ingelheim
- Boule Diagnostic
- Bristol-Myers Squibb
- Burnham Institute
- Caliper Life Sciences
- Caprion Pharmaceuticals
- CBR Institute for Biomedical Research
- Centenary Institute of Cancer Medicine and Cell Biology
- Centocor Ortho Biotech
- China Institute of Strategy and Management Lanmeng Investment
- Columbia University
- Corridor Pharmaceuticals
- Dainippon Sumitomo Pharma
- Eli Lilly & Co.
- Emergent BioSolutions
- Forest Laboratories
- Fox Chase Cancer Center
- Gilead Sciences
- Halozyme Therapeutics
- Human Genome Sciences
- Janssen Biotech
- Johnson & Johnson
- Lee Laboratories
- MD Biosciences
- Medisyn Technologies
- Merck & Co.
- Merck Serono
- Millennium Pharmaceuticals
- Mitsubishi Tanabe Pharma
- Novo Nordisk
- Noxxon Pharma
- Ono Pharmaceutical
- Provid Pharmaceuticals
- Synta Pharmaceuticals
- TcLand Expression
- University of Cologne, Ludwig Boltzmann Institute
- Zeus Scientific