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)-αinhibitors - 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 our analysis of the pipeline, the unmet needs and opportunities, and market access and reimbursement issues relevant to the autoimmune biologics market.
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.