Monoclonal Antibodies in Cancer Therapy 2009-2024

1. Executive Summary

• 1.1 Aims of this Report
• 1.2 Brief Overview of the Chapters in this Report

2. Monoclonal Antibodies for Cancer Therapy

• 2.1 Oncology is the Fifth-Largest Therapeutic Class Worldwide by Total Sales
• 2.2 The Oncology Market is Expanding
• 2.3 Monoclonal Antibodies
  • 2.3.1 What are Monoclonal Antibodies?
  • 2.3.2 How do Monoclonal Antibody Therapies Work?
• 2.4 Categories of Monoclonal Antibodies for Therapeutic Use
  • 2.4.1 Murine Antibodies
  • 2.4.2 Chimeric and Humanised Antibodies
  • 2.4.3 Human Antibodies
  • 2.4.4 Immunogenicity
• 2.5 Current Monoclonal Antibody Cancer Therapies
  • 2.5.1 Rituxan/MabThera
  • 2.5.2 Avastin
  • 2.5.3 Herceptin
  • 2.5.4 Erbitux
  • 2.5.5 Vectibix
  • 2.5.6 Campath
  • 2.5.7 Mylotarg
  • 2.5.8 Zevalin and Bexxar
  • 2.5.9 The Market Shares of Naked vs. Conjugated Monoclonal Antibodies
  • 2.5.10 The Market for Monoclonal Antibody Therapies is Growing.

3. Total World Market 2009-2024

• 3.1 Summary of Key Findings
• 3.2 Biotech is a Rapidly-Expanding Market
• 3.3 Monoclonal Antibodies are a Central Part of the Biotech Market
• 3.4 Oncology - A Major Sales Driver in the Mab Sector
• 3.5 Total World Market in 2008
• 3.6 Predicted Sales from 2009-2024
• 3.7 The Big Three
• 3.8 Generic Competition
• 3.9 Chimeric Antibodies in Decline
• 3.10 The Shift Towards Human Antibodies

4. Key Products Analysis

• 4.1 Overview: Strong Pipeline Means Competition Will Increase
• 4.2 Roche/Genentech Dominated the Market in 2008
• 4.3 Rituxan/MabThera (Roche/Genentech)
  • 4.3.1 Will Rituxan Continue Steady Growth over the Next Five Years?
• 4.4 Avastin (Roche/Genentech)
  • 4.4.1 Broadened Profile and Patient Base
  • 4.4.2 Continued Growth Despite Competition
• 4.5 Herceptin (Roche/Genentech)
  • 4.5.1 Strong Competition in the R&D Pipeline
• 4.6 Erbitux (Merck/Imclone)
  • 4.6.1 Aiming for the Top Three
• 4.7 Vectibix (Amgen)
  • 4.7.1 The K-RAS Issue
• 4.8 Campath (Bayer Schering AG)
  • 4.8.1 Future Increase in Revenue?

5. SWOT Analysis for the Monoclonal Antibody Oncology Therapies Market

• 5.1 Principal Drivers
  • 5.1.1 Increasing Prevalence and High Economic Costs of Cancer
  • 5.1.2 MAb Therapy Presents Lower Risk of Adverse Effects
  • 5.1.3 Combining Existing Products
  • 5.1.4 Biologicals vs. Chemically-Derived Pharmaceutical Products
  • 5.1.5 Promising Pipelines
  • 5.1.6 Improvements in Accessibility
  • 5.1.7 New Production Methods will Reduce Costs
• 5.2 Principal Restraints
  • 5.2.1 Development Costs - a High Barrier of Entry
  • 5.2.2 Mode of Administration is a Limiting Factor
  • 5.2.3 Insufficient Efficacy as a Single Agent
  • 5.2.4 Immunogenicity - the Rise of Humanised and Human Monoclonal Antibodies
  • 5.2.5 Financial Limitations in Research and Development
  • 5.2.6 Adverse Events - Safety Concerns
  • 5.2.7 Competition for Prime Drug Targets

6. MAbs in the Leading Pharmaceutical Markets

• 6.1 USA
• 6.2 Europe
• 6.3 Other Countries
  • 6.3.1 India and China

7. The Monoclonal Antibody Cancer Therapies Pipeline

• 7.1 New Technology - Monoclonal Antibody Fragments
  • 7.1.1 Bispecific T-Cell Engagers
  • 7.1.2 Tandabs
• 7.2 Conjugated vs. Naked Antibodies
• 7.3 The Future of Human MAbs
• 7.4 Competition for Prime Drug Targets
  • 7.4.1 Tailored Medicine
• 7.5 Solid Pipeline
• 7.6 Products to Watch
  • 7.6.1 Roche' s Winning Pipeline
  • 7.6.2 Genmab and GlaxoSmithKline' s Arzerra/HuMax-CD20
  • 7.6.3 Amgen' s AMG 162

8. Visiongain Interviews with Relevant Experts

• 8.1 Dr Janice M. Reichert, Tufts University and Editor-in-Chief of the Journal mAbs
  • 8.1.1 Major Challenges and Opportunities for Monoclonal Antibody Cancer Therapies
  • 8.1.2 Future Developments and Pipelines
  • 8.1.3 The Effect of Biosimilars
• 8.2 Dr David Blakey, AstraZeneca
  • 8.2.1 The Future of Humanised and Fully-Human Antibodies
  • 8.2.2 Therapeutic Antibody Fragments vs. Full-Length IgGs
  • 8.2.3 Major Opportunities in Monoclonal Antibody Cancer Therapies

9. Conclusions

• 9.1 The MAb Market is Strong and Expected to Grow Stronger
• 9.2 Expansion into New Markets
• 9.3 Personalised Treatments Emerging
• 9.4 Growth Will Eventually Slow as Expansion of the Market Drives Prices Down
• 9.5 Outlook for the Future

• Table 2.1 Summary of Types of Monoclonal Antibodies for Cancer Therapy
• Table 2.2 Targets and Indications for Selected FDA-Approved Antibodies
• Table 3.1 Top Selling FDA Approved Antibodies, 2008
• Table 3.2 Leading Monoclonal Antibodies for Oncology Therapies, Sales ($bn) and Market Shares (%), 2008
• Table 3.3 Predicted Sales ($bn) for the World Market, 2009-2024
• Table 3.4 Predicted Growth Rate (%) for the World Market, 2009-2024
• Table 3.5 World Sales ($bn) and Market Shares (%) for the Different Types of Oncology Monoclonal Antibodies, 2008
• Table 3.6 Market Shares (%) for Chimeric, Humanised and Human Monoclonal Antibodies, 2014-2024
• Table 4.1 Predicted Sales ($bn) for the World Market, 2009-2016
• Table 4.2 Predicted Sales ($bn) for the World Market, 2017-2024
• Table 4.3 Market Shares (%) and CAGR (%) for Selected Products, 2008 and 2014
• Table 5.1 SWOT Analysis, 2009-2024
• Table 5.2 Side Effects of Monoclonal Antibody Therapy
• Table 6.1 Leading Regions of the Monoclonal Antibody Anticancer Therapies Market, Sales ($bn) and Market Shares (%), 2008 and 2014
• Table 7.1 Selected Phase III and Pre-Registration Anticancer Monoclonal Antibodies, 2008
• Table 9.1 Global Monoclonal Antibody Anticancer Therapies, Sales ($bn) and Growth (%), 2008-2014

• Figure 2.1 Sales ($bn) of Naked vs. Conjugated Monoclonal Antibodies, 2008
• Figure 3.1 Market Shares (%) for the Main Categories of the Monoclonal Antibody Market for 12 Months up to Q3 2008
• Figure 3.2 Sales ($bn) for the Top Three Monoclonal Antibody Oncology Therapies, 2005-2008
• Figure 3.3 Sales ($bn) for Monoclonal Antibody Oncology Therapies for 12 Months up to Q3 2008
• Figure 3.4 Market Shares (%) for Monoclonal Antibody Oncology Therapies for 12 Months up to Q3 2008
• Figure 3.5 Predicted Sales ($bn) for the World Market, 2009-2024
• Figure 3.6 Predicted Growth (%) of the World Market, 2009-2014
• Figure 3.7 Predicted Sales ($bn) for the Big Three: Rituxan, Avastin and Herceptin, 2009-2014
• Figure 3.8 Sales ($bn) for Different Types of Monoclonal Antibodies for Oncology, 2008
• Figure 3.9 Market Shares (%) for Different Types of Monoclonal Antibodies for Oncology, 2008
• Figure 3.10 Pipeline Drugs (Phase II and III) by Antibody Type, 2008
• Figure 3.11 Predicted Market Shares (%) for Chimeric, Humanised and Human Monoclonal Antibodies, 2014-2024
• Figure 4.1 Market Shares (%) for Companies in the Monoclonal Antibody Oncology Therapies Area, 2008
• Figure 4.2 Sales ($bn) for Rituxan, 2005-2008
• Figure 4.3 Sales ($bn) for Rituxan, 2009-2014
• Figure 4.4 Market Share (%) for Rituxan, 2009-2014
• Figure 4.5 Sales ($bn) for Rituxan/MabThera, 2009-2024
• Figure 4.6 Sales ($bn) for Avastin and Rituxan, 2009-2024
• Figure 4.7 Sales ($bn) for Avastin, 2005-2008
• Figure 4.8 Market Share (%) for Avastin, 2009-2014
• Figure 4.9 Sales ($bn) for Avastin, 2009-2024
• Figure 4.10 Sales ($bn) for Herceptin, 2005-2008
• Figure 4.11 Sales ($bn) for Herceptin, 2009-2024
• Figure 4.12 Market Share (%) for Herceptin, 2008-2014
• Figure 4.13 Sales ($bn) for Erbitux, 2005-2008
• Figure 4.14 Sales ($bn) for Erbitux, Herceptin and Rituxan, 2009-2024
• Figure 4.15 Sales ($bn) for Erbitux, 2009-2024
• Figure 4.16 Market Share (%) for Erbitux, 2009-2014
• Figure 4.17 Sales ($bn) for Vectibix, 2009-2014
• Figure 4.18 Market Share (%) for Vectibix, 2009-2014
• Figure 4.19 Sales ($bn) for Vectibix, 2009-2024
• Figure 4.20 Sales ($bn) for Campath, 2005-2008
• Figure 4.21 Sales ($bn) for Campath, 2009-2024
• Figure 4.22 Market Share (%) for Campath, 2009-2014
• Figure 6.1 Leading Pharmaceutical Markets, Sales ($bn), 2008, 2014, 2019 and 2024
• Figure 6.2 Leading Pharmaceutical Markets, Market Shares (%), 2008, 2014, 2019 and 2024
• Figure 6.3 Leading Pharmaceutical Markets, CAGR (%), 2008-2014
• Figure 6.4 Comparisons of the US, European, Chinese and Indian Markets, Market Shares (%), 2008-2024
• Figure 7.1 Pipeline Drugs (Phase II) by Indication, 2008
• Figure 7.2 Pipeline Drugs (Phase III) by Indication, 2008

• Abbott Laboratories
• Affimed Therapeutics
• AstraZeneca
• American Cancer Society
• Amgen
• Bayer Schering Pharma
• Biogen-Idec
• Bradmer Pharmaceuticals
• Bristol-Myers Squibb
• Dr. Reddy' s Laboratories
• Elan Pharmaceuticals
• Eli Lilly
• Esteve
• EMEA
• Fresenius SE
• Genentech
• Genmab
• Genzyme (ILEX Oncology)
• GlaxoSmithKline
• GlycArt Biotechnology
• ImClone Systems
• International Agency for Research on Cancer
• Johnson & Johnson
• Menarini Merck & Co.
• Micromet
• Millennium Pharmaceuticals
• Novartis
• Paladin Labs
• Pfizer
• Roche
• TeGenero
• Trion Pharma
• Tufts University
• US FDA
• Viventia Biotech
• World Health Organisation
• Wilex
• Wyeth Pharmaceuticals