Autoimmune Disease Therapeutics

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

• Study Reliability and Reporting Limitations
• Disclaimers
• Data Interpretation & Reporting Level
• Quantitative Techniques & Analytics
• Product Definition and Scope of Study
• Rheumatoid Arthritis
• Multiple Sclerosis
• Psoriasis
• Crohn' s disease

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW & OUTLOOK

• Autoimmune Disease Therapeutics Market Continues to Flourish
• 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
• Global Market Estimates and Forecasts
• Analysis by Region
• Analysis by Segment

2. MARKET DYNAMICS AND TRENDS

• Biologics Continue to Gain Market Share
• New Products to Drive Market Growth
• Biogenerics to Expand Adoption of Biological Drugs
• New Indications to Fuel Market Growth
• Superior Outcomes to Enhance Adoption of Biologics
• Efficacy and Convenience - Key Factors Driving Physician' s Decision

3. DISEASE OVERVIEW

• Immunity and Immune System
• Autoimmune Diseases
• Women- Highly Susceptible to Autoimmune Diseases
• Table 1: Percentage Breakdown of Incidence of Autoimmune Diseases in Men and Women (includes corresponding Graph/Chart)
• Complexity in Manifestations Renders Difficulty in Understanding the Conditions
• Etiology of Autoimmune Diseases
• Genetic Predisposition
• Environmental Factors
• Autoimmune Diseases - A Social and Health Burden
• Regulatory Glitches and High Costs Hinder Biogenerics
• Types of Autoimmune Diseases
• Incidence and Prevalence
• Diagnosis and Treatment of Autoimmune Diseases
• Overview on Select Biologic Drugs
• Remicade
• Humira
• Rituxan(r) (rituximab)
• Cimzia
• Cimzia to Face Stiff Competition in Rheumatoid Arthritis Market
• Psoriasis - A Promising Market for Cimzia
• Actemra
• Enbrel

4. OVERVIEW OF SELECT AUTOIMMUNE DISEASES

• Rheumatoid Arthritis
• Disease Overview
• Low Penetration to Sustain growth of Anti-TNF Drugs
• Incidence and Prevalence Higher in Urban and Developed Regions
• Diagnosis
• Treatment of Rheumatoid Arthritis
• BRMs Revolutionize RA Treatment
• Drugs Used in Treating Rheumatoid Arthritis
• Table 2: Leading Biologic Drugs for Rheumatoid Arthritis Worldwide (2007): Value Sales for Enbrel, Remicade, Humira, Orencia, Rituxan and Kineret (US$ Million)
• Year of Approval of Leading Biologics in Rheumatoid Arthritis Therapy
• Key Drugs In Late Stage Development for Rheumatoid Arthritis Treatment
• Competitive Landscape
• Table 3: Comparative Analysis of Leading Biologic Rheumatoid Arthritis Drugs based on ACR Scores by End Point
• High Prices and Safety Concerns
• Multiple Sclerosis
• Etiology
• Types of Multiple Sclerosis
• Table 4: Prevalence of Different Types of Multiple Sclerosis
• Pathology
• Prevalence of Multiple Sclerosis High in Women
• Facts About Multiple Sclerosis
• Treatment
• Interferon Drugs - High Efficacy Drugs in Existing MS Therapies
• Beta Interferon Drugs in Multiple Sclerosis Treatment
• Non-Interferon Drugs
• Non-Interferon Drugs in Multiple Sclerosis Treatment
• Trends in Multiple Sclerosis Market
• High Unmet Need and Rich Pipeline to Expand MS Market
• Interferon-based Drugs Lead Multiple Sclerosis Drug Market
• Oral Drugs in Pipeline to Alter Market Dynamics in MS Therapies
• Dip in Sales Inevitable for Current Therapies
• Tough Times Ahead for Betaseron
• Competitive Landscape
• Table 5: Leading Multiple Sclerosis Drugs Worldwide (2007) by Sales: Avonex, Rebif, Copaxone, Betaseron and Tysabri (includes corresponding Graph/Chart)
• Table 6: Leading Multiple Sclerosis Drugs Worldwide (2000, 2003 and 2006): Market Shares for Avonex, Rebif, Copaxone, Betaseron and Tysabri (includes corresponding Graph/Chart)
• Multiple Sclerosis Drug Pipeline - An Overview
• Drugs Under Development for Treating Multiple Sclerosis
• FTY 720 (Fingolimod)
• Mylinax
• Laquinimod
• Campath (Alemtuzumab) - Trials Marred with Side Effects
• Teriflunomide
• Fampridine-SR
• BG-12 (Oral Fumarate)
• MN-166
• Psoriasis
• Prevalence
• Available Treatment Options
• Biological Drugs Lead the Fray
• Table 7: Leading Psoriasis Drugs Worldwide (2005): Market Share by Value Sales for Biologics (Enbrel, Raptiva and Amevive), Systemic Drugs, and Topicals (includes corresponding Graph/Chart)
• Inflammatory Bowel Diseases
• Crohn' s disease
• Stages of the Disease
• Prevalence
• Diagnosis
• Treatment
• Global Crohn' s Disease Therapeutics Market: Leading Biological Drugs and their Worldwide
• Year of Approval for Leading Drugs in Crohn' s Disease Treatment
• Ulcerative Colitis
• Diagnosis and Treatment
• Other Diseases
• Systemic Lupus Erythematosus (SLE)
• Prevalence and Epidemiology
• Treatment
• Sjogren' s Syndrome
• Prevalence and Epidemiology
• Diagnosis and Treatment
• Type-1 Diabetes Mellitus
• Types of Diabetes Mellitus
• Type 1 or Insulin Dependent Diabetes Mellitus
• Type 2 or Non-Insulin Dependent Diabetes Mellitus
• Insulin - Vital for Blood Glucose Management
• Etiology
• Prevalence
• Diabetes in Children - A Growing Concern
• Diagnosis and Treatment
• Autoimmune Hepatitis
• Disease Categories
• Treatment
• Side Effects
• Juvenile Rheumatoid Arthritis
• Symptoms
• Diagnosis
• Scleroderma
• Prevalence
• Etiology
• Diagnosis
• Management
• Vasculitis Syndeomes
• Haematologic Autoimmune Diseases
• Ankylosing Spondylitis

5. PRODUCT INTRODUCTIONS/APPROVALS

• Cimzia(r) Receives FDA Approval for Treating Rheumatoid Arthritis
• Simponi(tm) Receives FDA Approval for Treating Rheumatoid Arthritis
• HUMIRA(r) Obtains EU Approval for Polyarticular Juvenile Idiopathic Arthritis
• Cimzia(r) Receives FDA Nod for Treating Crohn' s Disease
• HUMIRA(r) Obtains Approval from Japanese Ministry for Rheumatoid Arthritis
• HUMIRA(r) Receives FDA Clerance for Polyarticular Juvenile Idiopathic Arthritis
• Abbott Receives EU Marketing Authorization for Humira in Psoriasis Treatment
• Xian-Janssen Introduces Remicade, Branded infliximab in China
• HUMIRA(r) Obtains EU Approval for Treating Crohn' s Disease
• HUMIRA(r) Obtains FDA Approval for Crohn' s Disease
• Remicade(r) Obtains Approval for Use in PsA and Early RA in Australia
• Tysabri(tm) Receives Health Canada Approval for Use in Multiple Sclerosis
• Rituxan(r) Gets FDA Approval for Use in RA
• Humira(r) Obtains FDA Approval for Treating AS
• Betaseron(r) Receives FDA Approval for Use in First Clinical Episode of MS
• Abbott Receives FDA Clearance for HUMIRA Pen
• Remicade Obtains FDA Approval for Treating Pediatric Crohn`s Disease

6. RECENT INDUSTRY ACTIVITY

• Novo Nordisk and VLST Collaborate on Therapeutic Targets Development
• Actemra' s Approval Gets Delayed
• Apitope Raises Financing for Developing Multiple Sclerosis Compound
• CalciMedica to Acquire Rights to STIM1 from TorreyPines
• Roche Acquires ARIUS Research, Inc.
• Astellas Inks Agreement with Maxygen for MAXY-4 Candidates
• Carna and Caliper Life Sciences Ink Collaborative Supply Agreement
• Isotechnika Gets Back Worldwide Rights to Transplant Drug, Voclosporin
• Boehringer In-licenses Two Drug Targets from BioFocus
• Bionomics Enters into a Development and Licensing Agreement with Merck Serono
• Nycomed Inks Agreement with Immunomedics for Veltuzumab
• EpiVax Receives Grants from National Institutes of Health to Advance Epi-13
• Boehringer to Takeover Actimis
• Antisoma Acquires Xanthus Pharmaceuticals
• Merrimack Acquires Funds for Developing Cancer and Autoimmune Disease Biologics
• BioSeek and Merck Sign Collaboration Agreement for Compound Evaluation
• Questcor Amends Distribution Contract with US Distributor of Acthar
• ANP Completes Phase IIa Trial for Multiple Sclerosis Drug
• Insert and Calando Merge to Form Calando Pharmaceuticals
• Codon Inks Research & Development and Licensing Deal with Merrimack
• Debiopharm Inks licensing Deal with Airmid for Debio 0824 ShK Peptide
• Chelsea Acquires Global Rights to I-3D Range of DHODH Inhibiting Compounds
• Cypress Bioscience Acquires Proprius
• J&J PRD Grants Milestone Payment to Sunesis Pharmaceuticals
• GlaxoSmithKline Acquires License to Market Vaccinex' s Antibody
• Teva to Takeover CoGenesys
• Hadasit, HMS and BWH to Co-develop Oral Therapy for Autoimmune Diseases
• Anthera Acquires Rights to Develop and Market AMG 623 from Amgen
• Can-Fite Enters into Two Cooperation Agreements to Develop CF102 Drug
• Source MDx Inks an Agreement with Pfizer
• Cambridge Inks an Antibody Development Agreement with Medarex
• Pfizer to Acquire Coley Pharma
• GSK Joins Hands with Tolerx to Develop and Commercialize otelixizumab
• Amgen Acquires Avidia
• Eli Lilly and MacroGenics Tie Up for Developing Teplizumab
• MorphoSys and Genesis Ink Antibody R&D Deal
• arGentis Enters into a License Agreement with UTRF
• Eden Biodesign to Investigate Novel Drug Candidate for Autoimmune Diseases
• Nuon and Kissei Team up for Tranilast
• Organon and Dyax Team Up for Developing Therapeutic Antibodies
• Medarex Joins Hands with Mitsubishi for Monoclonal Antibody Development
• Merck and Archemix Collaborate
• Genzyme Takes Over Bioenvision
• Organon and Medarex Ink Drug Development Deal
• CalciMedica Secures Exclusive Rights for CBR' s Autoimmune Drug Target
• Xanthus Secures Exclusive Patent Estate Rights for FLT3 Pathway
• Eisai Corporation Acquires Morphotek
• TIRC Changes Name to Orchestra Therapeutics
• Abbott Files HUMIRA(r) for Psoriasis in the US and EU (USA/Europe)
• Accentia Secures Exclusive Global Rights to Revimmune
• Medarex and Compugen Ink Collaborative Agreement for Therapeutic Antibody
• SRI and Telik Sign License Agreement for Drug Development
• China Biopharma Signs Agreement with Chinese Biopharmaceutical Firm
• Kirin and Astellas Ink Licensing Agreement for Anti-CD40 Antagonistic mAb
• QSV and Artielle Sign Contract to Produce RTL-1000
• JDRF and MacroGenics Form Partnership
• GSK and Genmad Sign Partnership Agreement for HuMaxCD20
• Biocon Enters into Joint Venture Agreement with Neopharma
• Pipex Pharmaceuticals Acquires Remaining Stake in Effective Pharmaceuticals
• Astellas Acquires Worldwide Rights for Amevive(r)
• Biogen Acquires Fumapharm
• Biogen and UCB Join Hands for Oral Multiple Sclerosis Therapy

7. FOCUS ON SELECT GLOBAL PLAYERS

• Abbott Laboratories (USA)
• Amgen Inc. (USA)
• Bayer Schering Pharma AG (Germany)
• Biogen Idec Inc. (USA)
• Bristol-Myers Squibb Company (USA)
• Elan Corporation, plc (Ireland)
• Eli Lilly And Company (USA)
• F. Hoffmann-La Roche AG (Switzerland)
• Chugai Pharmaceutical Co., Ltd. (Japan)
• Genentech, Inc. (USA)
• GlaxoSmithKline plc (UK)
• Johnson & Johnson, Inc. (USA)
• Merck Serono SA (Switzerland)
• Novartis AG (Switzerland)
• Sanofi-aventis SA (France)
• Schering-Plough Corporation (USA)
• Shire Pharmaceuticals Group plc (Ireland)
• Teva Pharmaceuticals Industries Limited (Israel)
• UCB Pharma (Belgium)

8. GLOBAL MARKET PERSPECTIVE

• Table 8: World Recent Past, Current & Future Analysis for Autoimmune Disease Therapeutics by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 9: World 10-year Perspective for Autoimmune Disease Therapeutics by Geographic Region - Percentage Breakdown of Dollar Sales for US, Japan, Europe and Rest of World Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)
• Table 10: World Recent Past, Current & Future Analysis for Rheumatoid Arthritis Therapeutics by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 11: World 10-year Perspective for Rheumatoid Arthritis Therapeutics by Geographic Region - Percentage Breakdown of Dollar Sales for US, Japan, Europe and Rest of World Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)
• Table 12: World Recent Past, Current & Future Analysis for Multiple Sclerosis Therapeutics by Geographic Region - US, Japan, Europe and Rest of World- Markets Independently Analyzed with Annual Sales in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 13: World 10-year Perspective for Multiple Sclerosis Therapeutics by Geographic Region - Percentage Breakdown of Dollar Sales for US, Japan, Europe and Rest of World Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)
• Table 14: World Recent Past, Current & Future Analysis for Psoriasis Therapeutics by Geographic Region - US, Japan, Europe and Rest of World- Markets Independently Analyzed with Annual Sales in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 15: World 10-year Perspective for Psoriasis Therapeutics by Geographic Region - Percentage Breakdown of Dollar Sales for US, Japan, Europe and Rest of World Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)
• Table 16: World Recent Past, Current & Future Analysis for Crohn' s Disease Therapeutics (Biologics) by Geographic Region - US, Japan, Europe and Rest of World- Markets Independently Analyzed with Annual Sales in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 17: World 10-year Perspective for Crohn' s Disease Therapeutics (Biologics) by Geographic Region - Percentage Breakdown of Dollar Sales for US, Japan, Europe and Rest of World Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)
• Table 18: World Recent Past, Current & Future Analysis for Other Autoimmune Disease Therapeutics by Geographic Region - US, Japan, Europe and Rest of World- Markets Independently Analyzed with Annual Sales in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 19: World 10-year Perspective for Other Autoimmune Disease Therapeutics by Geographic Region - Percentage Breakdown of Dollar Sales for US, Japan, Europe and Rest of World Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

• A. Market Analysis
• Current and Future Analysis
• Autoimmune Diseases Fact Sheet
• Table 20: Prevalence of Key Autoimmune Diseases in the US for 2006 (in Millions) (includes corresponding Graph/Chart)
• Market Trends
• Biologic Drugs Lead the Fray
• Biologics To Add Further Impetus to the Market
• Rheumatoid Arthritis Drugs Lead the Market
• Enbrel and Humira Continue to Gain Share in the Anti-TNF Market
• Increased Incidence and Rise in Drug Prices to Drive Growth in MS Market
• Table 21: US Multiple Sclerosis Drug Market (2006): Percentage Breakdown of Number of Dispensed Prescriptions for Avonex, Copaxone, Rebif, Betaseron and Tysabri (includes corresponding Graph/Chart)
• Incidence of Type 1 Diabetes Mellitus Endemic in White Youth
• Lialda' s Share Gaining Momentum in Ulcerative Colitis Drugs Market
• Key Ulcerative Colitis Drugs Market in the US (2006)
• Table 22: US Ulcerative Colitis Drugs Market (2007 & 2008): Percentage Breakdown of Prescriptions Dispensed Ranked by Leading Drugs for Asacol, Pentasa, Lialda, Canasa, Sulphasalazine, Colazal, Other Drugs and Generics (includes corresponding Graph/Chart)
• Product Launches/ Approvals
• Strategic Corporate Developments
• Key Players
• B. Market Analytics
• Table 23: US Recent Past, Current & Future Analysis for Autoimmune Disease Therapeutics by Disease Segment - Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Crohn' s Disease (Biologics) and Other Autoimmune Diseases Independently Analyzed with Annual Sales in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 24: US 10-year Perspective for Autoimmune Disease Therapeutics by Disease Segment - Percentage Breakdown of Dollar Sales for Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Crohn' s Disease (Biologics) and Other Autoimmune Diseases for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

2. JAPAN

• A. Market Analysis
• Current and Future Analysis
• Product Launches/Approvals
• Key Players
• B. Market Analytics
• Table 25: Japanese Recent Past, Current & Future Analysis for Autoimmune Disease Therapeutics by Disease Segment - Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Crohn' s Disease (Biologics) and Other Autoimmune Diseases Independently Analyzed with Annual Sales in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 26: Japanese 10-year Perspective for Autoimmune Disease Therapeutics by Disease Segment - Percentage Breakdown of Dollar Sales for Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Crohn' s Disease (Biologics) and Other Autoimmune Diseases for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

3. EUROPE

• A. Market Analysis
• Current and Future Analysis
• Europe - A Burgeoning Market for Autoimmune Disease Therapeutics
• Increasing Awareness to Drive Market Growth
• Low Penetration to Fuel Growth in European MS DMDs Market
• Table 27: Prevalence of Key Autoimmune Diseases in Europe for 2006 in Millions (includes corresponding Graph/Chart)
• Lower Treatment Rate Bodes Huge Potential for the UK MS Drug Market
• Drugs Hindering Disease Progression to Gain Prominence
• Product Launches/Approvals
• Strategic Corporate Developments
• Key Players
• B. Market Analytics
• Table 28: European Recent Past, Current & Future Analysis for Autoimmune Disease Therapeutics by Disease Segment - Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Crohn' s Disease (Biologics) and Other Autoimmune Diseases Independently Analyzed with Annual Sales in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 29: European 10-year Perspective for Autoimmune Disease Therapeutics by Disease Segment - Percentage Breakdown of Dollar Sales for Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Crohn' s Disease (Biologics) and Other Autoimmune Diseases for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

4. REST OF WORLD

• A. Market Analysis
• Current and Future Analysis
• Canada
• Canada - Highest Prevalence Rates for Multiple Sclerosis
• Sales of Biologics on the Rise in Canadian Rheumatoid Arthritis Drugs Market
• Asia-Pacific
• Autoimmune Diseases Market in Asia-Pacific - An Overview
• Incidence of Multiple Sclerosis in India on the Rise
• Overview of Rheumatoid Arthritis in Australia
• Table 30: Percentage Breakdown of Prevalence of Rheumatoid Arthritis in Australia by Age Group (includes corresponding Graph/Chart)
• Table 31: Percentage Breakdown of Prevalence of Rheumatoid Arthritis in Australia by Sex (includes corresponding Graph/Chart)
• Overview of Irritable Bowel Diseases in Australia
• Product Launches/Approvals
• Strategic Corporate Developments
• B. Market Analytics
• Table 32: Rest of World Recent Past, Current & Future Analysis for Autoimmune Disease Therapeutics by Disease Segment - Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Crohn' s Disease (Biologics) and Other Autoimmune Diseases Independently Analyzed with Annual Sales in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 33: Rest of World 10-year Perspective for Autoimmune Disease Therapeutics by Disease Segment - Percentage Breakdown of Dollar Sales for Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Crohn' s Disease (Biologics) and Other Autoimmune Diseases for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE