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

List of Tables
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

List of Figures
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


Companies Listed
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