Rheumatoid Arthritis Therapeutics - A Global Strategic Business Report

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
II. EXECUTIVE SUMMARY
1.INDUSTRY OVERVIEW & OUTLOOK
Global Pharmaceutical Industry Hit by Economic Downturn
Credit Crunch to Affect Biological Drug Pipeline
Biotech Bankruptcies Rife in the Current Economic Downturn
Economic Downturn Takes Toll on R&D
Autoimmune Disease Therapeutics – An Ever Flourishing Market
Rheumatoid Arthritis – A Chronic, Debilitating Disease
Incidence and Prevalence Higher in Urban and Developed Regions
Rheumatoid Arthritis - Market Overview
A Look At Arthritis Market Sales Data
Table 1: World Arthritis Market – Value Sales of Drug Classes for 2006 and 2007 (USD billion) (includes corresponding Graph/Chart)
Table 2: World Arthritis Market – Value Sales of Anti- TNF Biologics for 2007 (USD billion) (includes corresponding Graph/Chart)
Table 3: World Arthritis Market –Value Sales of Select NSAIDs for 2007 (USD billion) (includes corresponding Graph/Chart)
Table 4: World Arthritis Market – Value Sales of COX-2 Inhibitors for 2007 (USD billion)
Market Outlook
Global Market Estimates and Forecasts
2.MARKET DYNAMICS AND TRENDS
Anti-TNF Biologic Therapies – The Market Leading RA Drugs
Table 5: World Rheumatoid Arthritis Market – Value Sales* of Biologic Response Modifiers: 2007 and 2008 (in US$ Billion) (includes corresponding Graph/Chart)
Biologics Continue to Gain Market Share
Expensive Biologics to Drive Value Growth
Year of Approval of Leading Biologics in Rheumatoid Arthritis Therapy
New Products to Drive Market Growth
Superior Outcomes to Enhance Adoption of Biologics
Efficacy and Convenience – Key Factors Driving Physician’s Decision
Non-Anti-TNFs, Orencia to Gain Strength
Patent Expiry – A Mid- to Long-term Threat
Year of Expected Generic Market Entry of Leading Biologics in Rheumatoid Arthritis Therapy
Competitive Landscape
Table 6: Comparative Analysis of Leading Biologic Rheumatoid Arthritis Drugs based on ACR Scores by End Point (includes corresponding Graph/Chart)
High Prices and Safety Concerns
3.RHEUMATOID ARTHRITIS: THE DISEASE AND TREATMENT
Arthritis
Rheumatoid Arthritis
The Disease Progression
The Age Factor
Causes and Diagnosis
Signs and Symptoms
Treatment
Non-steroidal Anti-inflammatory Drugs
Side Effects Profile
Cyclo-Oxygenase-2 Inhibitors
Celecoxib
Others
Anti-rheumatic Steroids
Side Effects Profile
Corticosteroids
Glucocorticoids
Disease-modifying Anti-rheumatic Drugs (DMARDs)
D-penicillamine
Gold Salts
Hydroxychloroquine
Leflunomide
Methotrexate
Sulfasalazine
Others
Biological Response Modifiers
Adalimumab (Humira)
Etanercept
Infliximab
Anakinra
Abatacept
Rituximab
Tocilizumab
4.DRUG DEVELOPMENT FOCUS
The Rheumatoid Arthritis Pipeline
List of Select RA Drug Candidates in Various Clinical Pipeline Phases: 2008-09
Opportunities Aplenty for New Oral Agents in RA Treatment
5.RESEARCH & DEVELOPMENT
Velcura to Commence Clinical Trials for Lead Rheumatoid Arthritis Compound
Biogen Announces Phase II Trial Results for Baminercept in Rheumatoid Arthritis
Genentech, Biogen Announce Encouraging Phase III Results of Rituxan
Chelsea Announces Encouraging Preclinical Results for RA Drug Candidate
Medarex Commences Phase II Trials for Rheumatoid Arthritis Treatment Drug
ChemoCentryx Launches Phase I Clinical Trial for CCR1 Inhibitor
Chelsea Commences Phase II Trial for CH-1504
Arana Therapeutics Initiates Phase II Trial of ART621 in Rheumatoid Arthritis
VGX Pharma Initiates Follow-on Phase I Study for VGX-1027
Genmab to Commence Phase I/II Trial of Ofatumumab in RA Patients
Can-Fite Announces Seikagaku’s Proposed Phase I Trial for CF101 in Japan
Hollis-Eden Pharma Initiates Phase I/II Trial of Triolex in RA Patients
Trubion Pharma Announces Initiation of Phase 1 Trial of SBI-087
Micromet and Nycomed Initiate Formal Preclinical Safety Studies
6.RECENT INDUSTRY ACTIVITY
GlaxoSmithKline Forms Strategic Alliance with Archemix
Cypress Bioscience Acquires Proprius Pharmaceuticals
Biotie to Takeover German Company, elbion
Roche to Acquire UK Company, Piramed
Pipex Acquires Rheumatoid Arthritis Drug Candidate, dnaJP1
Latona Signs Two Agreements to Acquire Orphan Drug Status and Patent Rights
MorphoSys, Galapagos Sign Alliance to Co-Develop Antibody Therapies
Nycomed Inks Agreement with Immunomedics for Veltuzumab
Affitech Signs Antibody Discovery and Development Deal with Omeros
Entelos Signs Research Agreement with UCB Pharma
Novo Nordisk and VLST Form Partnership to Develop Therapeutic Targets
Maxygen Enters into Agreement with Astellas for MAXY-4
GlaxoSmithKline Forms Global Alliance with Regulus Therapeutics
Can-Fite Signs License Agreement with Korean Company for RA Drug
Amgen, Wyeth Announce U.S. Prescribing Information Update for Enbrel
Galapagos Secures Grant for Rheumatoid Arthritis Drug Development
MorphoSys and University of Melbourne to Receive U.S. Patent
Merrimack Acquires Funds for Developing Biologics
Galapagos Announces GT146 Milestone Achievement
Amgen Acquires Avidia
Iroko Acquires Two Pharmaceutical Products from Merck
EvoGenix to Merge with Peptech
Eli Lilly and MacroGenics Tie Up for Developing Teplizumab
Pharmacopeia and Wyeth Sign R&D Agreement to Develop JAK3 Inhibitors
Nuon Enters into Strategic Agreement with Kissei Pharmaceutical
Roche and Toyama Enter into Licensing Agreement for T-5224
GSK and Genmab Sign Partnership Agreement for HuMaxCD20
7.PRODUCT APPROVALS / APPLICATIONS
UCB Receives FDA Approval for Cimzia for Treating Rheumatoid Arthritis
Centocor Announces FDA Approval of Simponi™ for Rheumatoid Arthritis
Chugai Announces Japanese Approval of Actemra for RA Treatment
Abbott Secures Japanese Approval for Humira for RA Treatment
Chugai and Roche Secure Swiss Approval for RoACTEMRA
Chugai and Roche Announce Further FDA Guidance on BLA for Actemra
Roche, Chugai Announce CHMP’s Positive Recommendation for RoActemra
Roche’s Actemra Recommended for Approval by FDA Advisory Committee
Centocor, Schering-Plough Submit MAA for Golimumab Approval
UCB Submits MAA to the EMEA for Approval of Certolizumab Pegol
Abbott Secures FDA Approval for Humira for Polyarticular JIA Treatment
Xian-Janssen Introduces Remicade, Branded infliximab in China
Abbott Files for Humira Approval as JRA Treatment in the US and Europe
Roche Receives NICE Approval for MabThera as Severe RA Treatment
8.FOCUS ON SELECT PLAYERS
Abbott Laboratories, Inc. (USA)
Amgen, Inc. (USA)
Biogen Idec, Inc. (USA)
Bristol-Myers Squibb Company (USA)
F. Hoffmann-La Roche AG (Switzerland)
Chugai Pharmaceutical Co., Ltd. (Japan) – A Member of Roche Group
Genentech Inc. (USA)
Genmab AS (Denmark)
GlaxoSmithKline PLC (UK)
Johnson & Johnson Services, Inc. (USA)
Schering-Plough Corp. (USA)
UCB S.A. (Belgium)
Wyeth (USA)
9.GLOBAL MARKET PERSPECTIVE
Table 7: World Recent Past, Current & Future Analysis for Rheumatoid Arthritis Therapeutics (Biologics) by Geographic Region – US, Japan, Europe, Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
Table 8: World 10-Year Perspective for Rheumatoid Arthritis Therapeutics (Biologics) by Geographic Region - Percentage Breakdown of Dollar Revenues for the US, Japan, Europe, Latin America and Rest of World Markets for 2006, 2009 & 2015 (includes corresponding Graph/Chart)
III. MARKET
1.THE UNITED STATES
A. Market Analysis
Current & Future Analysis
Rheumatoid Arthritis – Prevalence
Table 9: US Rheumatoid Arthritis Patient Group Breakdown for 2008 (includes corresponding Graph/Chart)
Table 10: US Moderate to Severe Rheumatoid Arthritis Patient Group Breakdown by Therapy for 2008 (includes corresponding Graph/Chart)
Market Overview
Market Trends
Biologic Drugs Lead the Fray
Table 11: US Rheumatoid Arthritis Therapeutics Market –Breakdown of Value Sales of Leading Biologic Therapies for 2007 (includes corresponding Graph/Chart)
Enbrel and Humira Continue to Gain Share in the Anti-TNF Market
Research and Development
Strategic Corporate Developments
Product Approvals
Select Players
B. Market Analytics
Table 12: US Recent Past, Current & Future Analysis for Rheumatoid Arthritis Therapeutics (Biologics) – Annual RevenueFigures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
2.JAPAN
A. Market Analysis
Current & Future Analysis
Market Overview
Table 13: Japanese Rheumatoid Arthritis Patient Group Breakdown for 2008 (includes corresponding Graph/Chart)
Research and Development
Strategic Corporate Developments
Product Approvals
Select Player
B. Market Analytics
Table 14: Japanese Recent Past, Current & Future Analysis for Rheumatoid Arthritis Therapeutics (Biologics) – Annual Revenue Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
3.EUROPE
A. Market Analysis
Current & Future Analysis
Rheumatoid Arthritis – Prevalence
Table 15: European Rheumatoid Arthritis Patient Group Breakdown for 2008 (includes corresponding Graph/Chart)
Market Overview
Research and Development
Strategic Corporate Developments
Product Approvals
Select Players
B. Market Analytics
Table 16: European Recent Past, Current & Future Analysis for Rheumatoid Arthritis Therapeutics (Biologics) – Annual Revenue Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
4.LATIN AMERICA
A. Market Analysis
Current & Future Analysis
B. Market Analytics
Table 17: Latin American Recent Past, Current & Future Analysis for Rheumatoid Arthritis Therapeutics (Biologics) by Region – Brazil and Rest of Latin America Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
Table 18: Latin American 10-Year Perspective for Rheumatoid Arthritis Therapeutics by Region - Percentage Breakdown of Dollar Revenue for Brazil and Rest of Latin America Markets for 2006, 2009 & 2015
5.REST OF WORLD
A. Market Analysis
Current & Future Analysis
Canada
Canadian Rheumatoid Arthritis Therapeutics Market
Australia
Overview of Rheumatoid Arthritis in Australia
Table 19: Percentage Breakdown of Prevalence of Rheumatoid Arthritis in Australia by Age Group (includes corresponding Graph/Chart)
Table 20: Percentage Breakdown of Prevalence of Rheumatoid Arthritis in Australia by Gender (includes corresponding Graph/Chart)
Research and Development
Strategic Corporate Developments
Product Launch
B. Market Analytics
Table 21: Rest of World Recent Past, Current & Future Analysis for Rheumatoid Arthritis Therapeutics (Biologics)– Annual Revenue Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 103 (including Divisions/Subsidiaries - 110)
Region/CountryPlayers
The United States
Canada
Japan
Europe
France
Germany
The United Kingdom
Rest of Europe
Asia-Pacific (Excluding Japan)