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
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.
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-αinhibitors 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
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
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
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.
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.
Table of Contents
Table of Contents
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
Rheumatoid Arthritis High Unmet Need: Therapies with Greater
Rheumatoid Arthritis Unmet Need: Predictors to Treatment Response to