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Strategic Overview of the Autoimmune Biologics Market

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This publication has been discontinued on July 17, 2013.

Abstract

Introduction:

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.

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.

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
      • Psoriatic Arthritis Unmet Need: Additional Disease-Modifying Agents
    • Dermatology
      • Systemic Lupus Erythematosus Unmet Need: Steroid-Sparing Therapies
      • 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 3-18 Worldwide Autoimmune Biologics Market Growth, 2006-2017
  • 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
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