Table of Contents
- 1 Methodology and Executive Summary
- 1.1 Report Objectives
- 1.2 Research Methodology
- 1.3 Executive Summary
- 2 An Introduction to Autoimmune Diseases
- 2.1 Prevalence and Demographics of Autoimmune Diseases
- 2.2 Causes of Autoimmune Diseases
- 2.3 Types of Autoimmune Diseases
- 2.4 Workings of the Immune System
- 2.5 Unmet Need in Autoimmune Diseases
- 3 Multiple Sclerosis
- 3.1 Disease Overview
- 3.2 Pathogenesis
- 3.3 Symptoms
- 3.4 Types of MS
- 3.5 Causes
- 3.6 Risk Factors
- 3.7 Global Impact of MS and Patient Population
- 3.8 Financial Costs Associated with MS
- 3.9 An Overview of Treatment Options for MS
- 3.10 Biological Response Modifiers (BRMs) and the MS Therapy Market
- 3.10.1 Avonex
- 3.10.2 Betaseron
- 3.10.3 Rebif
- 3.11 Key Clinical Trial Results and Ongoing Trials Impacting Global
Sales
- 3.12 The Role of Neutralizing Antibodies and MS Therapy Efficacy
- 3.13 Market Analysis
- 3.13.1 Sales Data for Leading MS Therapies
- 3.13.2 SWOT Analysis for Key Products
- 3.13.3 Market Share
- 3.13.4 Geographic Market Analysis
- 3.14 How Do the BRMs Compete with Other MS Therapies?
- 3.14.1 Copaxone
- 3.14.2 Novantrone
- 3.15 Tysabri After the Fall: Will it Regain its Foothold?
- 3.15.1 Market Prospects for Tysabri Going Forward
- 3.16 New Delivery Methods as Competitive Tools
- 3.16.1 Room Temperature Formulations
- 3.16.2 Pre-filled Pre-mixed Syringes
- 3.17 R & D Trends
- 3.17.1 Emerging Therapies
- 3.17.1.1Leustatin
- 3.17.1.2Fampridine
- 3.17.1.3Teriflonomide
- 3.17.2 Key Biologic Therapies in Development for Multiple Sclerosis
- 3.17.2.1ABT 874
- 3.17.2.2Rituxan
- 3.17.2.3Campath
- 3.17.2.4Zenapax
- 3.17.2.5MLN1202
- 3.17.3 Future Alternatives for MS Therapy
- 3.18 Forecasting Future Sales of the BRMs
- 3.18.1 Avonex
- 3.18.2 Betaseron
- 3.18.3 Rebif
- 3.19 The Future of the MS Market
- 4 Rheumatoid Arthritis
- 4.1 Disease Overview
- 4.2 Etiology of Rheumatoid Arthritis
- 4.3 The Impact of Rheumatoid Arthritis
- 4.4 Treatment of Rheumatoid Arthritis
- 4.5 How are the Biological Response Modifiers Changing the Face
of RA Therapy?
- 4.6 With What Drugs Are the Biological Response Modifiers
Competing?
- 4.6.1 Arava: Competitive with BRMs?
- 4.7 The Cost of RA Biologics
- 4.8 Medicare Reform in the US: Impact on RA Market
- 4.8.1 Medicare Self-Injectable Demo Project: A Challenge to
Remicade
- 4.8.2 The New Prescription Drug Bill's Impact on RA Therapy
Competition
- 4.9 Profiling the Biologic DMARDs
- 4.9.1 Remicade
- 4.9.1.1 Clinical Efficacy
- 4.9.1.2 Market Position and Sales
- 4.9.2 Enbrel
- 4.9.2.1 Clinical Efficacy
- 4.9.2.2 Market Position and Sales
- 4.9.3 Humira
- 4.9.3.1 Clinical Efficacy and Dosage
- 4.9.3.2 Market Position and Sales
- 4.9.4 Kineret
- 4.9.4.1 Clinical Efficacy and Dosage
- 4.9.4.2 Market Position and Sales
- 4.9.5 Orencia
- 4.9.5.1 Clinical Efficacy and Dosage
- 4.9.5.2 Market Position and Sales
- 4.9.6 Rituxan
- 4.9.6.1 Clinical Efficacy and Dosage
- 4.9.6.2 Market Position and Sales
- 4.9.7 Predicting Future Sales of the Biologic Class in RA Treatment
- 4.9.7.1 Remicade
- 4.9.7.2 Enbrel
- 4.9.7.3 Humira
- 4.9.7.4 Orencia
- 4.9.7.5 Rituxan
- 4.10 Overall Market Forecast for Biologic Treatment of RA 2006-2010
- 4.11 Emerging Biologics for RA
- 4.11.1 CDP-870
- 4.11.2 Actemra
- 4.11.3 AMG 714
- 4.11.4 Eculizumab
- 4.11.5 IDEC-151
- 4.11.6 AMG 719
- 4.11.7 TAK 715
- 4.11.8 Golimumab
- 4.11.9 Denosumab
- 4.11.10 Pegsunercept
- 4.11.11 SCIO 469
- 4.11.12 BMS 561392
- 4.11.13 Belimumab
- 4.11.14 Neumega
- 4.11.15 Belatacept
- 4.11.16 VX 702
- 4.11.17 Denileukin
- 4.12 Research and Development Pipeline Highlights
- 4.13 The Future of Rheumatoid Arthritis Treatment
- 5 Systemic Lupus Erythematosus (SLE)
- 5.1 Disease Overview
- 5.2 Etiology and Epidemiology
- 5.3 The Difficulties of Diagnosing SLE
- 5.4 The Economic Impact of SLE
- 5.5 Current Treatment Options for SLE Patients
- 5.6 Therapy Regimens
- 5.7 Unmet Need in SLE
- 5.8 The Importance of Biomarkers and the Development of New Drugs
for Lupus
- 5.9 New Biologics: How Will They Fit Into Therapeutic Regimens?
- 5.10 New SLE Drugs in Development
- 5.10.1 Riquent
- 5.10.2 Rituxan
- 5.10.3 LymphoStat-B
- 5.10.4 ETI-201
- 5.10.5 AMG 412
- 5.10.6 AMG 623
- 5.10.7 Abatacept
- 5.10.8 TACI-lg
- 5.10.9 Actemra
- 5.10.10 TRX-1
- 5.10.11 TV-4710
- 5.11 Key Research and Development Trends in SLE Therapy
- 5.12 New Alternatives to SLE Biologics
- 5.12.1 Competition from Non-Biologics in SLE Drug Development
- 5.12.1.1Prestara
- 5.12.1.2CellCept
- 5.12.1.3Linomide
- 5.13 Future of the Lupus Therapy Market
- 6 Inflammatory Bowel Disease
- 6.1 Disease Overview
- 6.2 Crohn's Disease vs Ulcerative Colitis: What Distinguishes the
Two Diseases?
- 6.3 Etiology of IBD
- 6.4 Symptoms and Diagnosis of IBD
- 6.5 The Demographic Impact of IBD
- 6.6 The Economic Impact of IBD
- 6.7 Traditional Therapies: What They Do and Don't Do
- 6.8 Surgery as an Option
- 6.9 Can Biologics Begin to Meet Unmet Need in IBD?
- 6.9.1 Remicade in More Detail: A Revolution in the Treatment of
Crohn's Disease
- 6.9.1.1 Clinical Efficacy
- 6.10 New Products and New Indications in IBD Therapy
- 6.10.1 Humira
- 6.10.2 Kremezin
- 6.10.3 Neumega
- 6.10.4 Tetomilast
- 6.10.5 CDP-870
- 6.10.6 Tysabri
- 6.10.7 Prograf
- 6.10.8 Leukine
- 6.10.9 Alicaforsen
- 6.10.10 MLN-02
- 6.10.11 PDL BioPharma's Three New Drugs
- 6.10.12 Rebif
- 6.10.13 RDP58
- 6.11 Do Research and Development Trends Favor Biologic Therapy?
- 6.12 Key Biologic Research and Development Trends in IBD Therapy
- 6.13 What are the Threats to the Biologics Class?
- 6.14 IBD Therapy Market Forecast
- 7 Psoriasis
- 7.1 Disease Overview
- 7.2 Psoriasis Types
- 7.3 The Demographic Impact of Psoriasis
- 7.4 Lifestyle and Economic Impact of Psoriasis
- 7.5 Traditional Pharmacological Treatment for Psoriasis
- 7.6 Why Are Biologic Therapies Emerging?
- 7.7 What Are the New Biologics and How Are They Influencing the
Market?
- 7.7.1 Amevive
- 7.7.1.1 Clinical Efficacy
- 7.7.1.2 Market Competition and Future Sales
- 7.7.1.3 Future Sales of Amevive
- 7.7.2 Raptiva
- 7.7.2.1 Clinical Efficacy
- 7.7.2.2 Market Competition and Future Sales
- 7.7.3 Enbrel
- 7.7.3.1 Clinical Efficacy
- 7.7.3.2 Market Competition and Future Sales
- 7.8 What are the Emerging Biologics for Psoriasis?
- 7.8.1 Humira
- 7.8.1.1 Clinical Efficacy
- 7.8.1.2 Anticipated Market Position
- 7.8.2 Remicade
- 7.8.2.1 Clinical Efficacy
- 7.8.2.2 Anticipated Market Position
- 7.9 Competition from Non-Biologics
- 7.9.1 Avandia
- 7.9.2 Prograf
- 7.10 Future Sales of the Biologic Class in Psoriasis
- 7.11 Research and Development Trends in Psoriasis Therapy
- 8 Asthma
- 8.1 Disease Overview
- 8.2 Epidemiology
- 8.3 Economic Impact
- 8.4 Classifications
- 8.5 Current Therapeutic Options for Asthma
- 8.5.1 Bronchodilators
- 8.5.2 Anti-Inflammatories
- 8.5.3 Dietary Supplements
- 8.6 Biologic Targets in Asthma Therapy
- 8.7 Xolair: The First Biologic for Asthma - Will it Alter Market
Dynamics?
- 8.7.1 How Does Xolair Work?
- 8.7.2 Clinical Efficacy
- 8.7.3 Market Penetration and Strategies
- 8.8 Research and Development Trends
- 8.8.1 R411
- 8.8.2 Zenapax
- 8.8.3 IL-4/13 Trap
- 8.8.4 Mepolizumab
- 8.8.5 SCH 55700
- 8.9 Key Research and Development Trends in Asthma Therapy
- 8.10 Threats to the Biologics Class
- 8.11 The Future for Biologics in Asthma Treatment
- Tables
- Table 3.1 Major Symptoms of Multiple Sclerosis
- Table 3.2 Multiple Sclerosis Patient Population, by type
- Table 3.3 Incidence of MS in Countries/Regions of High Prevalence
- Table 3.4 Key Therapies for Multiple Sclerosis
- Table 3.5 Leading MS Therapy Delivery Routes and Dosage
- Table 3.6 Global Sales of Leading MS Therapies, 2000-2005 ($ mn)
- Table 3.7 Future Sales of Tysabri 2006-2010
- Table 3.8 New Multiple Sclerosis Drugs in Development
- Table 3.9 Biologics in Clinical Development for MS
- Table 3.10 Future Sales of Avonex 2005-2010 ($ mn)
- Table 3.11 Future Sales of Betaseron ($ mn)
- Table 3.12 Future Sales of Rebif ($ mn)
- Table 4.1 Prevalence of Chronic Conditions Causing Disabilities
- Table 4.2 Sales of Biologics for Rheumatoid Arthritis, 1999-2005
($ mn)
- Table 4.3 Approved DMARDs for Rheumatoid Arthritis
- Table 4.4 Profiles of the Leading DMARDs
- Table 4.5 Out-of-Pocket Costs Associated with Demonstration Drug
Project
- Table 4.6 Sales of Remicade 2000-2005 ($ mn)
- Table 4.7 Global Sales of Enbrel 2000-2005 ($ mn)
- Table 4.8 Global Sales of Humira 2003-2005 ($ mn)
- Table 4.9 Financial Growth Forecast of the Biologics in the RA
Market 2006-2010 ($ mn)
- Table 4.10 New Rheumatoid Arthritis Drugs in Development
- Table 5.1 New Systemic Lupus Erythematosus Drugs in Development
- Table 5.2 Forecast SLE Market 2006-2010 ($ mn)
- Table 6.1 Principal Alternatives in the Differential Diagnosis
of Inflammatory Bowel Disease
- Table 6.2 Criteria of Trulove and Witts for Assessing Disease
Activity in Ulcerative Colitis
- Table 6.3 Prevalence of Crohn's Disease by Age in the United
States
- Table 6.4 PDL BioPharma's IBD Pipeline
- Table 6.5 Inflammatory Bowel Disease Drugs in Development
- Table 6.6 Forecasting Growth in the IBD Therapy Market 2006-2010
($ mn)
- Table 7.1 Estimated Demographic Impact of Psoriasis in the US
- Table 7.2 Amevive Sales 2003-2005 ($ mn)
- Table 7.3 Forecasted Sales of Amevive 2006-2010 ($ mn)
- Table 7.4 Raptiva Sales 2003-2005 ($ mn)
- Table 7.5 Forecasted Sales of Raptiva 2006-2010 ($ mn)
- Table 7.6 Psoriasis Drugs in Development
- Table 8.1 Best-Selling Asthma Drugs, 2000-2005 ($ mn)
- Table 8.2 New Biologic Medications Under Development for Asthma
- Table 8.3 Asthma Therapies Under Development (Phase I and II)
- Graphs
- Graph 2.1 Prevalence of Major Autoimmune Diseases in Women
versus Men
- Graph 2.2 Autoimmune Disease Prevalence, by Specific Disease (in
thousands)
- Graph 3.1 Global Sales of Leading MS Therapies 2000-2005 ($ mn)
- Graph 3.2 Global Sales of Leading Four MS Therapies, US vs Rest
of World 2000-2005 ($ mn)
- Graph 3.3 Sales of Avonex 2000-2005 US vs Rest of World ($ mn)
- Graph 3.4 Sales of Betaseron 2000-2005 US vs Rest of World ($ mn)
- Graph 3.5 Sales of Rebif 2000-2005 US vs Rest of World ($ mn)
- Graph 3.6 Sales of Copaxone 2000-2005 US vs Rest of World ($ mn)
- Graph 3.7 Market Share of Leading MS Therapies, 2004
- Graph 3.8 Market Share of Leading MS Therapies, 2005
- Graph 3.9 Market Share of Leading MS Therapies, United States
2004
- Graph 3.10 Market Share of Leading MS Therapies, Rest of World 2004
- Graph 3.11 Market Share of Leading MS Therapies, United States 2005
- Graph 3.12 Market Share of Leading MS Therapies, Rest of World 2005
- Graph 3.13 Future Sales of BRMs in the Global MS Market 2006-2010
($ mn)
- Graph 4.1 Growth of the Biologics in Rheumatoid Arthritis
2000-2005 ($ mn)
- Graph 4.2 Global Sales of Leading RA Therapies 2000-2005 ($ mn)
- Graph 4.3 Market Share of Leading RA Therapies, 2005 (estimated)
- Graph 4.4 Market Share of DMARDs: Traditional vs Biologics, 2005
- Graph 4.5 Sales of Remicade 2000-2005 ($ mn)
- Graph 4.6 Sales of Remicade US vs Rest of World ($ mn)
- Graph 4.7 Global Sales of Enbrel, 2000-2005 ($ mn)
- Graph 4.8 Sales of Enbrel, 2003-2005, US vs Rest of World ($ mn)
- Graph 4.9 Global Sales of Humira, 2003-2005 ($ mn)
- Graph 4.10 Humira Sales by Geographical Region 2003 ($ mn)
- Graph 4.11 Sales Forecast for Remicade 2006-2010 ($ mn)
- Graph 4.12 Sales Forecast for Enbrel 2006-2010 ($ mn)
- Graph 4.13 Sales Forecast for Humira 2006-2010 ($ mn)
- Graph 4.14 Sales Forecast for Orencia 2006-2010 ($ mn)
- Graph 4.15 Sales Forecast for Rituxan 2006-2010 ($ mn)
- Graph 4.16 Financial Growth Forecast of the Biologics in the RA
Market 2006-2010 ($ mn)
- Graph 4.17 Annual Growth of Rheumatoid Arthritis Biologics
2006-2010, by CAGR
- Graph 5.1 SLE Death Rates Among Women
- Graph 5.2 Sales Forecast for Biologics for Lupus 2006-2010 ($ mn)
- Graph 6.1 Prevalence of Crohn's Disease by Age/Percentage in the
United States
- Graph 6.2 Sales of Remicade 1998-2005
- Graph 6.3 Forecasting Sales in the IBD Therapy Market 2006-2010
($ mn)
- Graph 6.4 Forecast Annual Growth in the IBD Therapy Market
2006-2010
- Graph 7.1 Amevive Sales 2003-2005 ($ mn)
- Graph 7.2 Forecasted Sales of Amevive 2006-2010 ($ mn)
- Graph 7.3 Raptiva Sales 2003-2005 ($ mn)
- Graph 7.4 Future Sales of Raptiva 2006-2010 ($ mn)
- Graph 7.5 Forecasted Sales of Enbrel* 2006-2010 ($ mn)
- Graph 7.6 Anticipated Revenue from Psoriasis Biologics 2006-2010
($ mn)
- Graph 7.7 Market Share of Leading Psoriasis Therapies, 2005
(estimate)
- Graph 8.1 Annual Growth of Best-Selling Asthma Drugs, 2000-2005
- Graph 8.2 Sales of Xolair 2003-2005 US vs Rest of World ($ mn)
- Graph 8.3 Financial Forecast for Xolair 2006-2010 ($ mn)
- Graph 8.4 Sales Forecast for Biologics for Asthma 2006-2010 ($
mn)
- Graph 8.5 Annual Percentage Growth Forecast in the Asthma
Biologics Therapy Market 2006-2010
- Diagrams
- Diagram 3.1 Course of Multiple Sclerosis, by Type
- Diagram 6.1 Principal Differences Between Ulcerative Colitis and
Crohn's Disease
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