Therapeutic Monoclonal Antibodies, 2006-2011 - Maximising the Growth Potential of a Stocked Pipeline

1. Executive Summary
1.1 Aims of This Report
1.2 Chapter Summaries

2. Introduction
2.1 What is a Monoclonal Antibody?
2.1.1 Structure of Antibodies
2.1.2 Function of Antibodies
2.2 History of Therapeutic Monoclonal Antibody Development
2.2.1 Different Types of Therapeutic Antibody
2.2.2 Time line
2.3 There are 19 FDA Approved Therapeutic Monoclonals
2.4 Monoclonal Antibodies are a Thriving Part of the Biotech Market
2.4.1 The Biotech Industry is Strong
2.4.2 MAbs Lead the Market
2.5 The Monoclonal Antibody Market is Taking Off

3. World Market For Monoclonal Antibodies
3.1 The World Market is Worth Over $13bn
3.1.1 There are Eleven Leading Monoclonal Antibody Treatments
3.1.2 Two Drugs Generate Almost 50% of All Revenues
3.1.3 Growth is High for Monoclonal Antibody Drugs
3.1.4 Visiongain Forecasts High Revenues in the Future But Growth Will Slow
3.2 Oncology Drugs Dominate in the Monoclonal Antibody Market
3.2.1 Half of Monoclonal Antibody Revenues Are From Oncology Products
3.2.2 Cancer Drugs Will Drive the Market
3.3 Roche/Genentech Lead the Monoclonal Market

4. SWOT, Drivers and Restraints
4.1 Strengths, Weaknesses, Drivers and Restraints for the Monoclonal Antibodies Market, 2006
4.2 Monoclonal Drugs are Thriving
4.2.1 Monoclonal Technology Allows a Wide Range of Targets
4.2.2 Cancer Drugs Lead the Monoclonal Market
4.2.3 Chronic and Niche Diseases Generate High Revenues
4.2.4 Monoclonal Antibodies Do Not Face Biogeneric Competition
4.3 The Future Looks Bright for New Developments
4.3.1 Monoclonal Drugs are a Significant Part of Biotech Pipelines
4.3.2 New Production Methods Will Reduce Costs
4.3.3 Flexible Formats to Fill Unmet Needs in Oncology
4.4 Weaknesses and Threats Will Hold Back the Monoclonal Market to Some Degree
4.4.1 Big and Expensive: Development Costs Limit Growth
4.4.2 Injections are the Main Mode of Administration
4.4.3 The Challenge of Immunogenicity Looms Large
4.4.4 High Profile Safety Cases Increase Regulatory Concerns
4.4.5 Competition is High for Many Prime Targets

5. Therapeutic areas for Monoclonal Antibodies
5.1 Oncology
5.1.1 Rituxan/MabThera
5.1.2 Herceptin
5.1.3 Avastin
5.1.4 Erbitux
5.1.5 Campath
5.2 Arthritis and Other Inflammatory Conditions
5.2.1 Enbrel and Amevive Mimic Monoclonal Action
5.2.2 Remicade
5.2.3 Humira
5.3 Other Therapeutic Areas
5.3.1 Synagis/Numax
5.3.2 ReoPro
5.3.3 Xolair
5.4 The Key For Monoclonal Antibody Success is the Growth of Indications
5.4.1 Herceptin's Expanding Indications Drive High Growth 8 Years from Launch
5.4.2 Can Monoclonals Deliver The Holy Grail - A Pipeline in a Product?

6. Assessment of the Monoclonal Pipeline
6.1 The Monoclonal Pipeline
6.1.1 Oncology Drugs Dominate the Monoclonal Pipeline
6.1.2 A Wide Variety of Targets in the Pipeline
6.2 There is Competition for Prime Drug Targets
6.3 TNF Binding Antibodies Compete for Slice of Large Market
6.3.1 UCB's Cimzia is Ahead of the Pack
6.3.2 Segard Aims for Separate Market but Struggles to Convince
6.3.3 Golimumab to Follow in Remicade's Footsteps
6.3.4 Applied Molecular Evolution Provides Promising Anti-TNF Candidate
6.4 Competition is High for Next Generation Rituxan
6.4.1 GenMab's HuMax Technology Hopes to Add Advantage
6.4.2 Companies Seek to Build on Rituxan's Success
6.4.3 Immunomedics Aim to Compete on Stability
6.5 New Targets Present Opportunities and Risk
6.5.1 CD22 Products in Race to Launch
6.5.2 Could CEA be the Next Breakthrough for Oncology Treatments?
6.5.3 CTLA4 is Another Promising Target
6.6 Other Novel Targets in the Late Pipeline

7. Future Trends for Therapeutic Monoclonal Antibodies
7.1 Are Magic Bullets Back in Vogue?
7.1.1 Immunogen's TAP System Attracts Attention
7.1.2 Seattle Genetics ADC Technology Shows Promise
7.2 Nanobodies, BiTEs and TandAbs - New Takes on the Monoclonal
7.2.1 BiTEs Can Thwart CD8 Negative Tumours
7.2.2 TandAbs Specialise in Tumour Killing
7.2.3 NanoBodies - Heavy Chain Only Technology
7.3 Diagnostic Tests Will Be Integral to Future Success
7.3.1 Lack of Low Hanging Fruit Will Force Integration

8. Conclusion: The Monoclonal Antibody Market is Strong and Will Get Stronger
8.1 The Monoclonal Antibody Market is One of The Strongest Areas of the Pharmaceutical Industry
8.2 Pipelines are Bursting with Monoclonals
8.3 The Market Will be Restrained by Competition and Price Restrictions
8.4 Could Monoclonals be the Answer to Big Pharma's Woes?


Figures:
Figure 2.1 Structure of an Antibody
Figure 2.2 World Revenue Forecast for the World Biotech Market 2004-2011
Figure 2.3 The Biotechnology Market by Technology Class, 2005
Figure 2.4 World Revenues for Remicade, 2002-2005
Figure 2.5 World Revenues for Rituximab, 2002-2005
Figure 3.1 World Revenues for the Leading Monoclonal Antibody Drugs, 2004-2005 ($m)
Figure 3.2 Monoclonal Antibody Market by Drug, 2005
Figure 3.3 Growth Rates (%) for Leading Monoclonal Antibody Drugs, 2005
Figure 3.4 World Revenue ($m) Forecast for Monoclonal Antibody Drugs, 2005-2011
Figure 3.5 Growth Rate Forecast for Monoclonal Antibody Drugs, 2005-2011
Figure 3.6 Market Share by Therapeutic Area, 2005
Figure 3.7 World Monoclonal Antibody Market Forecast by Therapeutic Area, 2005-2011
Figure 3.8 Market Share by Therapeutic Area, 2011
Figure 3.9 Market Share by Company, 2005
Figure 4.1 Technology Classes in the Biotech Pipeline, 2006
Figure 4.2 Different Technology Classes in the Biotech Pipeline, 2006
Figure 4.3 Number of FDA Approved Monoclonal Drugs by Year, 2001-2004
Figure 5.1 World Revenues ($m) for Leading Monoclonal Antibody Oncology Treatments, 2004-2005
Figure 5.2 Growth Rates (%) for Monoclonal Antibody Oncology Treatments, 2004-2005
Figure 5.3 World Revenue Forecast for Rituxan, 2004-2011
Figure 5.4 World Revenue Forecast for Herceptin, 2004-2011
Figure 5.5 World Revenue Forecast for Avastin, 2004-2011
Figure 5.6 World Revenue Forecast for Erbitux, 2004-2011
Figure 5.7 World Revenue Forecast for Campath, 2004-2011
Figure 5.8 World Revenues ($m) for Monoclonal Antibody Based Treatments for Arthritis, 2004-2005
Figure 5.9 Growth Rates (%) for Monoclonal Antibody Based Treatments for Arthritis, 2004-2005
Figure 5.10 World Revenues ($m) for Monoclonal Antibody Treatments for Psoriasis, 2004-2005
Figure 5.11 Growth Rates (%) for Monoclonal Antibody Treatments for Psoriasis, 2004-2005
Figure 5.12 World Revenue Forecast for Remicade, 2004-2011
Figure 5.13 World Revenue Forecast for Humira, 2004-2011
Figure 5.14 World Revenues ($m) for Monoclonal Antibody Treatments for Other Therapy Areas, 2004-2005
Figure 5.15 Growth Rates (%) for Monoclonal Antibody Treatments for Other Therapy Areas, 2004-2005
Figure 5.16 World Revenue Forecast for Synagis, 2004-2011
Figure 5.17 World Revenue Forecast for ReoPro, 2004-2011
Figure 5.18 World Revenue Forecast for Xolair, 2004-2011
Figure 5.19 Growth Rates (%) for Herceptin, 2000-2006
Figure 6.1 Indications for Monoclonal Antibodies in the Development Pipeline, 2006
Figure 6.2 Indications for Monoclonal Antibodies in the Mid-Late Development Pipeline (Phase II-III), 2006
Figure 7.1 Antibody Formats
Figure 8.1 Growth Rates for the Biotech, Monoclonal and Pharmaceutical Markets, 2005

Tables:
Table 2.1 FDA Approved Monoclonal Antibodies for Therapeutic Use
Table 2.2 Top Ten Biotech Drugs, 2005
Table 3.1 Leading Monoclonal Antibody Treatments, 2006
Table 4.1 SWOT Analysis of the Monoclonal Antibody Market, 2006
Table 4.2 Targets and Indications for Approved Antibodies
Table 4.3 Modes of Administration for Leading Monoclonal Antibody Drugs
Table 4.4 Immunogenicity of Selected Monoclonal Antibodies
Table 5.1 Monoclonal Antibody Oncology Treatments, 2006
Table 5.2 World Revenue Forecast for Rituxan, 2004-2011
Table 5.3 World Revenue Forecast for Herceptin, 2004-2011
Table 5.4 World Revenue Forecast for Avastin, 2004-2011
Table 5.5 World Revenue Forecast for Erbitux, 2004-2011
Table 5.6 World Revenue Forecast for Campath, 2004-2011
Table 5.7 Monoclonal Antibody Based Anti-inflammatory Drugs, 2005
Table 5.8 World Revenue Forecast for Remicade, 2004-2011
Table 5.9 World Revenue Forecast for Humira, 2004-2011
Table 5.10 Monoclonal Antibody Drugs in Other Therapeutic Areas, 2005
Table 5.11 World Revenue Forecast for Synagis, 2004-2011
Table 5.12 World Revenue Forecast for ReoPro, 2004-2011
Table 5.13 World Revenue Forecast for Xolair, 2004-2011
Table 5.14 Selected Marketed Monoclonal Products with New Indications in the Pipeline
Table 6.1 Targets for Monoclonal Antibodies in the Pipeline
Table 6.2 Prime Targets for Monoclonal Antibodies
Table 6.3 Anti-TNF-a Monoclonal Antibodies in the Pipeline
Table 6.4 Anti-CD20 Monoclonal Antibodies in the Pipeline
Table 6.5 Anti-CD22 Monoclonal Antibodies in the Pipeline
Table 6.6 Anti-CEA Monoclonal Antibodies in the Pipeline
Table 6.7 Anti-CTLA4 Monoclonal Antibodies in the Pipeline
Table 6.8 Other Antibodies in the Late Pipeline
Table 7.1 Examples of Conjugated Monoclonal Drugs in the Pipeline
Table 7.2 Immunogen's Product Pipeline, 2006
Table 7.3 Other Monoclonal-based Drugs in Development Using the TAP System
Table 7.4 Seattle Genetics Pipeline, 2006
Table 8.1 Summary of the Pipeline for Monoclonal Antibodies, 2006