関節リウマチ治療：市場動向と研究開発

Abstract

The market for rheumatoid arthritis therapeutics has experienced remarkably strong growth during the past five years due to the introduction of the biological response modifiers (BRMs) to treatment regimens. The value of this market will reach nearly $13 billion by 2011. Sales of both Remicade and Enbrel continue to grow, while the introduction of Humira in 2003 has been a major stimulus to the market. All three of these products are now approved in both the US and Europe for rheumatoid arthritis. Added to this mix in 2006 was Rituxan and Orencia, which will both have an impact in the patient population unresponsive to other BRMs. As half-year 2006 revenues clearly indicate, revenues from the sales of all of these products will continue to trend positively in 2007.

The rheumatoid arthritis pipeline today is replete with biologic therapies designed to modify the course of the disease. There are a number of follow-on biologic products being developed, which, like Remicade, Enbrel and Humira, target TNF-a. Additionally, though, companies are investing in candidates which target other cytokines that have been implicated in disease development.

Rheumatoid Arthritis Therapeutics: Market Trends and R&D Insights is arranged to provide readers with an analytically-based overview of the market for rheumatoid arthritis therapies as well as an assessment of therapeutics currently in clinical development. The report focuses primarily on the class of rheumatoid arthritis therapeutics known as the biological response modifiers (BRMs). These drugs currently account for the vast majority of sales in this therapeutic area and will continue to make a strong impact in the coming years.

Key features of this report:

• An assessment of the current status of key products on the market and emerging products with significant growth potential.
• Analysis of key clinical trials as a means of determining future success in the market
• Forecast financial growth of this sector as a whole as well as provide revenue forecasts for key products in the field (all forecasts through 2011)
• Identification of trends and issues that will have a significant impact on the rheumatoid arthritis market
• Important background about the disease, its etiology, patient population and financial impact of RA

Table of Contents

1. Executive Summary

• 1.1 Scope and Methodology
• 1.2 Market Growth
• 1.3 Market Trends

2. Rheumatoid Arthritis: Scientific Background

• 2.1 Disease Overview
• 2.2 Etiology of Rheumatoid Arthritis
  • 2.2.1 Genetic Factors
• 2.3 The Immune Response
  • 2.3.1 Cytokines
  • 2.3.2 Helper T-Cells and RA
  • 2.3.3 Leukocytes
• 2.4 Symptoms
• 2.5 Diagnosis
  • 2.5.1 Diagnostic Criteria
    • 2.5.1.1 Blood/Serum Tests
    • 2.5.1.2 Markers
    • 2.5.1.3 Imaging
• 2.6 Risk Factors

3. The Financial and Demographic Impact of Rheumatoid Arthritis

• 3.1 The Prevalence and Incidence of Rheumatoid Arthritis
  • 3.1.1 Worldwide
  • 3.1.2 US
• 3.2 The Financial Impact of Rheumatoid Arthritis

4. Current Treatment Options for Rheumatoid Arthritis

• 4.1 NSAIDs
• 4.2 Corticosteroids
• 4.3 DMARDs
• 4.4 Biological Response Modifiers
  • 4.4.1 Key Biological Response Modifiers
    • 4.4.1.1 Remicade
    • 4.4.1.1.1Clinical Efficacy and Dosage
    • 4.4.1.2 Enbrel
    • 4.4.1.2.1Clinical Efficacy and Dosage
    • 4.4.1.3 Humira
    • 4.4.1.3.1Clinical Efficacy and Dosage
    • 4.4.1.4 Kineret
    • 4.4.1.4.1Clinical Efficacy and Dosage
    • 4.4.1.5 Orencia
    • 4.4.1.5.1Clinical Efficacy and Dosage
    • 4.4.1.6 Rituxan
    • 4.4.1.6.1Clinical Efficacy and Dosage
• 4.5 Surgical Treatments

5. Major Issues Affecting the RA Market

• 5.1 How are the Biological Response Modifiers Changing the Face of RA Therapy?
• 5.2 With What Drugs Are the Biological Response Modifiers Competing?
• 5.3 The High Cost of RA Biologics
• 5.4 Medicare Reform in the US: Impact on RA Market
  • 5.4.1 Medicare Self-Injectable Demo Project: A Challenge to Remicade
  • 5.4.2 The New Prescription Drug Bill's Impact on RA Therapy Competition

6. The Global Market for RA Therapies

• 6.1 Commercial Market Size
  • 6.1.1 US Revenues
  • 6.1.2 Non-US Revenues
• 6.2 Key Products Driving Growth
  • 6.2.1 Remicade: Market Position and Revenues
  • 6.2.2 Enbrel: Market Position and Revenues
  • 6.2.3 Humira: Market Position and Revenues
  • 6.2.4 Kineret: Market Position and Revenues
  • 6.2.5 Orencia: Market Position and Revenues
  • 6.2.6 Rituxan: Market Position and Revenues
• 6.3 Market Share
  • 6.3.1 Product
  • 6.3.2 Country/Region

7. The R&D Pipeline for RA Therapies

• 7.1 Unmet Need
• 7.2 Key Clinical Trial Endpoints
• 7.3 R&D Trends in RA Therapy
• 7.4 Phase III Products Nearing Approval
  • 7.4.1 Cimzia (CDP-870)
    • 7.4.1.1 Clinical Efficacy
    • 7.4.1.2 Market Assessment
  • 7.4.2 Actemra
    • 7.4.2.1 Clinical Efficacy
    • 7.4.2.2 Market Assessment
  • 7.4.3 CellCept
    • 7.4.3.1 Clinical Efficacy
    • 7.4.3.2 Market Assessment
  • 7.4.4 CNTO 148
    • 7.4.4.1 Clinical Efficacy
    • 7.4.4.2 Market Assessment
• 7.5 Selected Phase II Products in Development
  • 7.5.1 AMG 714
  • 7.5.2 HuMax-CD 20
  • 7.5.3 R1594
  • 7.5.4 Eculizumab
  • 7.5.5 AMG 108
  • 7.5.6 Denosumab
  • 7.5.7 P38 MAP Kinase Inhibitor
  • 7.5.8 BMS 561392
  • 7.5.9 Lymphostat-B
  • 7.5.10 VX 702

8. The Financial Outlook of the RA Therapy Market

• 8.1 Financial Forecasts for Key Products
  • 8.1.1 Remicade
  • 8.1.2 Enbrel
  • 8.1.3 Humira
  • 8.1.4 Orencia
  • 8.1.5 Rituxan
• 8.2 Overall Market Forecast for RA Market 2006-2011

Tables

• Table 3.1 Prevalence of Chronic Conditions Causing Disabilities
• Table 5.1 Approved DMARDs for Rheumatoid Arthritis
• Table 5.2 Profiles of the Leading DMARDs and BRMs
• Table 5.3 Out-of-Pocket Costs Associated with Demonstration Drug Project
• Table 6.1 Sales of Key BRMs for Rheumatoid Arthritis, 2000-2006
• Table 6.2 US Sales of Leading RA Therapies 2000-2006
• Table 6.3 Non-US Sales of Leading RA Therapies 2000-2006
• Table 6.4 Sales of Remicade 2000-2006, US, Japan, Europe + Rest of World
• Table 6.5 Global Sales of Enbrel, US & Canada, Rest of World 2000-2006
• Table 6.6 Global Sales of Humira, US, Rest of World 2003-2006
• Table 7.1 New Rheumatoid Arthritis Drugs in Development
• Table 8.1 RA Therapy Market Financial Forecast 2006-2011

Graphs

• Graph 3.1 Prevalence of RA in Various Countries
• Graph 6.1 Global Sales of Leading RA Therapies 2000-2005, by product
• Graph 6.2 US Sales of Leading RA Therapies 2000-2005, by product
• Graph 6.3 Non-US Sales of Leading RA Therapies 2000-2005, by product
• Graph 6.4 Remicade Market Share, by Country/Region 2005
• Graph 6.5 Enbrel Market Share, by Country/Region 2005
• Graph 6.6 Humira Market Share, by Country/Region 2005
• Graph 6.7 Global Market Share of Leading RA Therapies by Product, 2005
• Graph 6.8 US Market Share of Leading RA Therapies by Product, 2005
• Graph 6.9 Non-US Market Share of Leading RA Therapies by Product, 2005
• Graph 6.10 RA Therapy Market Share, by Country/Region 2005
• Graph 8.1 Sales Forecast for Remicade 2006-2011
• Graph 8.2 Sales Forecast for Enbrel 2006-2011
• Graph 8.3 Sales Forecast for Humira 2006-2011
• Graph 8.4 Sales Forecast for Orencia 2006-2011
• Graph 8.5 Sales Forecast for Rituxan 2006-2011

Diagrams

• Diagram 4.1 Rheumatoid Arthritis Treatment Guidelines
• Diagram 4.2 The American College of Rheumatology Criteria (ACR) Criteria