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.
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
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?
Scope:
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
Executive Summary
Autoimmune Biologics Market
Unmet Needs and Key Opportunities
The Pipeline
Pricing and Reimbursement Strategies
1. Introduction
2. Unmet Needs and Key Opportunities in the Autoimmune Biologics Market
Introduction
Unmet Needs Overview: Physician Survey Results
Rheumatology
Rheumatoid Arthritis High Unmet Need: Therapies with Greater
Disease-Modifying Ability
Rheumatoid Arthritis Unmet Need: Predictors to Treatment Response to
Biologics
Psoriasis Unmet Need: Systemic Agents with Improved Safety Profiles
Gastroenterology
Crohn' s Disease Unmet Need: More-Effective Maintenance Therapies
Ulcerative Colitis Unmet Need: More-Effective Maintenance Therapies
with Sustained Long-Term Efficacy for Moderate to Severe Disease
The Need for Safer Biologics
The Need for Biomarkers and Diagnostics
Addressing Challenges in the Development of Biomarkers and Diagnostics:
Physician Survey Results
Proteomics 101
Rheumatology
Rheumatoid Arthritis
Ankylosing Spondylitis
Osteoarthritis
Dermatology
Systemic Lupus Erythematosus
Psoriasis
Gastroenterology
Crohn' s Disease
Ulcerative Colitis
Dealmaking Analysis in Biomarkers and Diagnostics for Autoimmune Disorders
Deal Type
Partnering Companies/Research Institutions
Considerations for Future Growth
3. The Autoimmune Biologics Pipeline
Introduction
A Competitive Review of the Autoimmune Biologics Pipeline
Autoimmune Disease Background
Surveyed Specialists' Patient Populations and Biologics Prescribing
Habits
Patient Populations
Biologics Prescribing Habits
Scope of This Section
Agents in Development
Beyond MAbs: Antibody Variants
Companies
Pfizer
Amgen
Abbott Laboratories
Market Statistics and Market Outlook
Autoimmune Biologics Market Statistics
Autoimmune Biologics Market Outlook
Rheumatology
Dermatology
Gastroenterology
4. Pricing and Reimbursement Strategies
Introduction
International Price Comparisons for Autoimmune Biologics
United States
General Environment
Healthcare Reform
Formulary Positioning
Cost-Containment Measures
Physician Survey
Physicians' Acceptance of Different Types of Health Insurance
Physicians' Prescribing Behavior
Distribution Restrictions Imposed by Health Plans
Affordability of Biologics
Increasing Cost-Containment Pressures
Prospects for Biosimilars
Reimbursement Prospects for New Immune Biologics
Suggested Industry Actions to Improve Access to Immune Biologics
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
France
General Environment
Health Insurance
Pharmaceutical Reimbursement
Cost Containment
Hospital Prescribing
National Guidelines for the Appropriate Use of Expensive and
Innovative Drugs
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
Germany
General Environment
Health Insurance and Pharmaceutical Reimbursement
Cost Containment
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
Italy
General Environment
Health Insurance
Pharmaceutical Reimbursement
Cost Containment
Hospital Prescribing
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
Spain
General Environment
Health Insurance
Reimbursement
Cost Containment
Hospital Prescribing
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
United Kingdom
General Environment
Health Insurance Coverage
Pharmaceutical Pricing and Reimbursement
Health Technology Assessment
Cost Containment
Hospital Prescribing
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
Japan
General Environment
Health Insurance
Pharmaceutical Reimbursement
Cost Containment
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
Outlook and Implications for the Pharmaceutical Industry
Tables and Figures
Table 2-1 Worldwide Sales of Leading Autoimmune Biologics, 2010
Table 2-2 Autoimmune Diseases and Select Associated Biomarkers
Table 2-3 Ongoing and Recently Completed Safety Trials of Biologics for
Autoimmune Diseases
Table 2-4 Autoimmune Biologics-Specific Dealmaking Involving Biomarkers
and Diagnostics, January 2005-May 2011
Table 3-1 Descriptions of Select Autoimmune Diseases
Table 3-2 Biologics Drug Classes Commonly Used to Treat Autoimmune Diseases
Table S1 Protein Therapies: Polymers and Peptides
Table 3-3 Companies with Leading Autoimmune Biologics Pipelines, Number of
Agents by Phase
Table 3-4 Companies with Leading Autoimmune Biologics Pipelines, Number of
Agents by Indication
Table 3-5 Pfizer' s Autoimmune Biologics Pipeline
Table 3-6 Amgen' s Autoimmune Biologics Pipeline
Table 3-7 Worldwide Sales of Leading Autoimmune Biologics, 2010
Table 3-8 Market-Leading Companies by Autoimmune Biologics Sales, 2010
Table 3-9 Worldwide Sales of Leading Autoimmune Biologics, 2017
Table 3-10 Market-Leading Companies by Autoimmune Biologics Sales, 2017
Table 4-1 Leading Immune Biologics
Table 4-2 Ex-Manufacturer Prices of Leading Immune Biologics in Major
Markets as a Percentage of U.S. Prices, 2010
Table 4-3 U.S. Commercial Health Plans' Formulary Positioning of Leading
Immune Biologics, by Percentage of Plans, July 2011
Table 4-4 U.S. Commercial Health Plans' Formulary Positioning of Leading
Immune Biologics, by Percentage of Covered Lives, July 2011
Table 4-5 U.S. Medicare Plans' Formulary Positioning of Leading Immune
Biologics, by Percentage of Plans, July 2011
Table 4-6 U.S. Medicare Plans' Formulary Positioning of Leading Immune
Biologics, by Percentage of Covered Lives, July 2011
Table 4-7 Percentage of U.S. Commercial Health Plans That Subject Leading
Immune Biologics to Prescribing Restrictions, July 2011
Table 4-8 Percentage of U.S. Medicare Plans That Subject Leading Immune
Biologics to Prescribing Restrictions, July 2011
Table 4-9 U.S. Physicians' Views on Actions Payers Might Take in the Next
Five Years to Control the Cost of Immune Biologics
Table 4-10 Assessment of Select Immune Biologics by France' s Transparency
Commission
Table 4-11 Distribution Controls on Leading Immune Biologics in France
Table 4-12 Supplementary Payments for Immune Biologics Prescribed in
German Hospitals, 2011
Table 4-13 Distribution Controls on Leading Biologics in Spain
Table 4-14 Biologics Approved by the National Institute for Health and
Clinical Excellence (NICE) for Immune Disorders
Figure 2-1 Survey Question (Rheumatologists): Please rate the following
rheumatic autoimmune disorders according to the level of unmet treatment need
Figure 2-2 Survey Question (Gastroenterologists): Please rate the
following rheumatic autoimmune disorders according to the level of unmet
treatment need
Figure 2-3 Survey Question (Rheumatologists): Please rank the following
unmet needs in rheumatoid arthritis, from greatest unmet need to lowest unmet
need
Figure 2-4 Survey Question (Rheumatologists): Please rank the following
unmet needs in psoriatic arthritis, from greatest unmet need to lowest unmet
need
Figure 2-5 Survey Question (Dermatologists and Rheumatologists): Please
rank the following unmet needs in systemic lupus erythematosus, from greatest
unmet need to lowest unmet need
Figure 2-6 Survey Question (Dermatologists): Please rank the following
unmet needs in psoriasis, from greatest unmet need to lowest unmet need
Figure 2-7 Survey Question (Gastroenterologists): Please rank the
following unmet needs in Crohn' s disease, from greatest unmet need to lowest
unmet need
Figure 2-8 Survey Question (Gastroenterologists): Please rank the
following unmet needs in ulcerative colitis, from greatest unmet need to
lowest unmet need
Figure 2-9 Physician Survey Results: How Biomarkers Can Help Reduce Unmet
Needs in Patients with Autoimmune Disease
Figure 2-10 Ongoing Clinical Trials Evaluating Biomarker Activity for
Biologics in Autoimmune Diseases
Figure 2-11 Physician Survey Results: Top Two Autoimmune Diseases That
Would Benefit the Most as a Result of Biomarker-Based Diagnostic Tests
Figure 2-12 Physician Survey Results: Frequency of Using Biomarker-Based
Diagnostic Tests to Differentially Diagnose Autoimmune Diseases
Figure 2-13 Physician Survey Results: Top Three Barriers to Using
Biomarkers and Diagnostics in Diagnosing and/or Managing Autoimmune Diseases
Figure 2-14 ChartTrends Results: Correlation Between Common Rheumatoid
Arthritis Biomarkers and Biologics
Figure 2-15 Physician Survey Results: Delays in Diagnosis of Rheumatoid
Arthritis
Figure 2-16 Physician Survey Results: Delays in Diagnosis of Ankylosing
Spondylitis
Figure 2-17 Physician Survey Results: Delays in Diagnosis of Systemic
Lupus Erythematosus
Figure 2-18 Physician Survey Results: Delays in Diagnosis of Inflammatory
Bowel Diseases
Figure 2-19 Number of Biomarker and Diagnostics Deals in Autoimmune
Disease from January 2005 Through May 2011
Figure 2-20 Number of Biomarker and Diagnostics Deals in Autoimmune
Disease from January 2005 Through May 2011, by Deal Type
Figure 2-21 Percentage of Biomarker and Diagnostics Deals in Autoimmune
Disease from January 2005 Through May 2011, by Company Type
Figure 2-22 Number of Biomarker and Diagnostics Deals in Autoimmune
Disease from January 2005 Through May 2011, by Company Type
Figure 3-1 Survey Question (Rheumatologists): In a typical 30-day period,
how many patients with each of the following conditions do you treat or
monitor?
Figure 3-2 Survey Question (Dermatologists): In a typical 30-day period,
how many patients with each of the following conditions do you treat or
monitor?
Figure 3-3 Survey Question (Gastroenterologists): In a typical 30-day
period, how many patients with each of the following conditions do you treat
or monitor?
Figure 3-4 Survey Question (Rheumatologists): How many prescriptions for
the following biologics do you write in a typical 30-day period?
Figure 3-5 Survey Question (Dermatologists): How many prescriptions for
the following biologics do you write in a typical 30-day period?
Figure 3-6 Survey Question (Gastroenterologists): How many prescriptions
for the following biologics do you write in a typical 30-day period?
Figure 3-7 Autoimmune Biologics Pipeline, by Indication
Figure 3-8 Autoimmune Biologics Pipeline, by Target
Figure 3-9 Autoimmune Biologics Pipeline, by Drug Class
Figure 3-10 Autoimmune Biologics Pipeline, by Formulation
Figure 3-11 Autoimmune Biologics Pipeline, by Clinical Development Phase
Figure 3-12 Survey Question: If Eli Lilly' s LY-2127399 were approved,
would you prescribe it to your patients with autoimmune disorders?
Figure 3-13 Survey Question: If GlaxoSmithKline/Tolerx' s otelixizumab were
approved, would you prescribe it to your patients with autoimmune disorders?
Figure 3-14 Survey Question: If Novartis' s secukinumab (AIN-457) were
approved, would you prescribe it to your patients with autoimmune disorders?
Figure 3-15 Survey Question: If Takeda' s vedolizumab were approved, would
you prescribe it to your patients with autoimmune disorders?
Figure 3-16 Autoimmune Biologics Pipeline, by Company
Figure 3-17 Autoimmune Biologics Pipeline, Development Activity by Company
Size
Figure 3-19 Worldwide Autoimmune Biologics Market Growth, by Region,
2006-2017
Figure 3-20 Worldwide Sales of Autoimmune Biologics, by Type, 2010 and 2017
Figure 3-21 Survey Question (Rheumatologists): Which of the following
biological agents do you most often prescribe for each of the autoimmune
diseases?
Figure 3-22 Survey Question (Dermatologists): Which of the following
biological agents do you most often prescribe for each of the autoimmune
diseases?
Figure 3-23 Survey Question (Gastroenterologists): Which of the following
biological agents do you most often prescribe for each of the autoimmune
diseases?
Figure 4-1 Diagnosed Prevalent Populations of Common Immune Disorders in
Seven Mature Markets, 2010 and 2020
Figure 4-2 Drug-Treatment Rates for Common Immune Disorders in Seven
Mature Pharmaceutical Markets, 2010 and 2020
Figure 4-3 Average Ex-Manufacturer Prices of Leading Immune Biologics in
Major Markets as a Percentage of U.S. Prices, 2010
Figure 4-4 Health Insurance Coverage of the U.S. Population, 1999-2009
Figure 4-5 U.S. Residents' Sources of Prescription Drug Benefits, July 2010
Figure 4-6 Sources of Funding for Drug Therapy for Select Immune Disorders
in the United States, 12 Months to June 2010
Figure 4-7 Average Positioning of Leading Immune Biologics in the
Formularies of U.S. Commercial Health Plans, July 2011
Figure 4-8 Average Positioning of Leading Immune Biologics in the
Formularies of U.S. Medicare Plans, July 2011
Figure 4-9 U.S. Employers' Use of Common Utilization Management Tools,
2007-2010
Figure 4-10 Percentage of U.S. Dermatologists, Gastroenterologists, and
Rheumatologists Who Accept Patients With Various Types of Health Insurance or
No Insurance
Figure 4-11 Percentage of Patients With Various Types of Health Insurance
or No Insurance Who Are Denied Treatment by U.S. Dermatologists,
Gastroenterologists, and Rheumatologists
Figure 4-12 Average Number of Prescriptions for Leading Biologics Written
by U.S. Rheumatologists, Dermatologists, and Gastroenterologists in a 30-Day
Period
Figure 4-13 Biologics Most Often Prescribed by U.S. Rheumatologists for
Common Immune Disorders
Figure 4-14 Biologics Most Often Prescribed by U.S. Dermatologists for
Common Immune Disorders
Figure 4-15 Biologics Most Often Prescribed by U.S. Gastroenterologists
for Common Immune Disorders
Figure 4-16 Frequency of Off-Label Prescribing of Biologics by U.S.
Rheumatologists, Dermatologists, and Gastroenterologists
Figure 4-17 U.S. Physicians' Views on the Extent to Which Cost Restricts
Patients' Access to Immune Biologics
Figure 4-18 U.S. Physicians' Estimates of the Percentage of Patients
Unable to Afford Out-of-Pocket Payments for Biologics
Figure 4-19 U.S. Physicians' Estimates of the Percentage of Patients Who
Discontinue Biologic Therapy on Financial Grounds
Figure 4-20 U.S. Physicians' Expectations Regarding the Likelihood That
Payers Will Take Action in the Next Five Years to Increase Reimbursement
Restrictions on Immune Biologics
Figure 4-21 U.S. Physicians' Expectations Regarding How Often They Would
Prescribe Immune Biosimilars
Figure 4-22 U.S. Physicians' Reservations Regarding the Use of Biosimilars
Figure 4-23 U.S. Physicians' Views Regarding the Likely Importance of
Various Attributes in Securing Favorable Reimbursement Status for New Immune
Biologics
Strategic Overview of the Autoimmune Biologics Market published by Decision Resources, Inc. in September 29, 2011. This report price starts from US $ 4600.
