Therapeutic Monoclonal Antibodies Report 2008-2023

1 Executive Summary
1.1 Aims of This Report
1.2 A Brief Overview of the Chapters
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 Timeline for Monoclonal Antibodies in Therapy
2.3 There are 21 FDA Approved Therapeutic Monoclonals
2.4 Monoclonal Antibodies are a Thriving Part of the Biotech Market
2.4.1 MAbs Lead the Market
2.5 The Monoclonal Antibody Market is Taking Off
3 World Market for Therapeutic Monoclonal Antibodies
3.1 Summary of Key Findings
3.2 Therapeutic Monoclonal Antibodies Generated Over $21bn in 2007
3.3 World Therapeutic Monoclonal Antibodies Market Forecast 2008-2023
3.4 Market Analysis of the Leading Products – the ‘Big 5’
3.4.1 Remicade is Leading the Pack, but Will it Last?
3.5 Market Forecast by Therapeutic Analysis
3.5.1 Oncology Drugs Dominate in the Monoclonal Antibody Market
3.5.1.1 Over Half of Monoclonal Antibody Revenues are from Oncology Products
3.5.1.2 Cancer Drugs will Drive the Market
3.5.2 AIID is Second in Line
3.5.2.1 AIID Narrows the Gap
3.5.3 Other Therapeutic Areas are also Growing Quickly
3.5.3.1 Other Therapeutic Areas Represent 10% of the Market
3.6 Market Forecast by Technology Analysis
3.6.1 Chimeric Antibodies Retiring from the Spotlight
3.6.2 Humanised Antibodies Moving to Centre Stage
3.6.3 Fully Human Antibodies Set to Become the Next Star
3.6.4 A Change of Guard in Technology Forerunners
4 Forces Affecting the Therapeutic Monoclonal Antibodies Market
4.1 SWOT Analysis of the Therapeutic Monoclonal  Antibodies Market
4.2 Monoclonal Drugs Constitute a Thriving Market
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 There is a Lower Risk of Adverse Events for Monoclonals
4.2.5 Monoclonal Antibodies Avoid Biogeneric Competition
4.2.6 Rising Expenditures of Prescription Drugs Stimulate Market Growth
4.3 Pipeline Developments in Monoclonal Antibody Therapies are Very Promising
4.3.1 New Production Methods Will Reduce Costs
4.3.2 Flexible Formats to Fill Unmet Needs in Oncology
4.3.3 Innovative Combination Uses of Existing Products
4.4 Weaknesses and Threats Will Hold Back the Monoclonal Market to Some Degree
4.4.1 Big and Expensive: Developmental 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 Fierce for Many Prime Targets
5 Leading Marketed and Pipeline Products for Therapeutic Monoclonal Antibodies
5.1 The ‘Big 5’ Will Continue to Dominate the Market
5.1.1 Remicade (Johnson and Johnson)
5.1.1.1 Doubts Linger Around Remicade
5.1.2 Rituxan/MabThera (Roche/Genentech)
5.1.2.1 Rituxan Grows to $6.4bn by 2013
5.1.3 Herceptin (Roche/Genentech)
5.1.3.1 Herceptin Faces Tough Competition
5.1.4 Avastin (Roche/Genentech)
5.1.4.1 Avastin to Drive the Growth and Innovation of Therapeutic Antibodies
5.1.5 Humira (Abbott)
5.1.5.1 Humira Has Immense Opportunities
5.2 Market Analysis of the Emerging Products - The Three Other Blockbusters
5.2.1 Erbitux (Merck/ImClone)
5.2.1.1 Erbitux Does Not Have Enough to Overtake Avastin
5.2.2 Lucentis (Roche/Genentech)
5.2.2.1 Growth Flattens for Lucentis
5.2.3 Synagis (AstraZeneca)
5.2.3.1 Pessimism Surrounds Synagis
5.3 Top Seven Products to Watch
5.3.1 Cimzia (UCB)
5.3.2 Golimumab (Johnson and Johnson)
5.3.3 Denosumab (Amgen)
5.3.4 Numax (AstraZeneca/MedImmune/Applied Molecular Evolution)
5.3.5 Bapineuzumab (Elan/Wyeth)
5.3.6 ABT-874 (Abbott)
5.3.7 Ustekinumab (Johnson and Johnson)
6 Therapeutic Monoclonal Antibodies Market Dynamics
6.1 Therapeutic Monoclonal Antibodies Market Finds Success Outside of the Traditional  
      Blockbuster Model
6.2 Therapeutic Monoclonal Antibodies - a High-Value Market with a High Barrier of
      Entry
6.3 Big Pharma is Moving into the Market
6.4 Strategic Alliances Help to Accelerate Market Growth
6.5 Roche and Genentech's Partnership Follows a Winning Business Blueprint
6.6 A Market Monopolised by Three Giants
6.6.1 Roche/Genentech Has Absolute Control in the Market
6.6.1.1 Marketed Monoclonal Antibody Therapies
6.6.1.2 Pipeline Analysis
6.6.1.3 Strategic Analysis
6.6.2 Johnson and Johnson Looking to Secure Leadership in Autoimmune Antibodies
6.6.2.1 Marketed Monoclonal Antibody Therapies
6.6.2.2 Pipeline Analysis
6.6.2.3 Strategic Analysis
6.6.3 Abbott Ties its Future to Humira
6.6.3.1 Marketed Monoclonal Antibody Therapies
6.6.3.2 Pipeline Analysis
6.6.3.3 Strategic Analysis
6.7 Emerging Player to Watch
6.7.1 Amgen Bets on Bone Diseases
6.7.1.1 Marketed Monoclonal Antibodies Therapies
6.7.1.2 Pipeline Analysis
6.7.1.3 Strategic Analysis
7 Therapeutic Monoclonal Antibodies in the Leading Pharmaceutical Markets
7.1 Sales of Therapeutic Monoclonal Antibodies in the US
7.1.1 Increasing Prevalence of Cancer Will Drive Sales in the US Market
7.1.2 High Economic Cost of Cancer and Autoimmune Diseases Will Drive Sales of
         Monoclonal Antibodies
7.2 The European Market for Monoclonal Antibodies Will Increase Moderately
7.3 Developing Countries are Thriving
7.4 China and India Rise Up
8 Interviews with Industry Experts: Therapeutic Monoclonal Antibodies - Current and Future Trends
8.1 Interview 1: Professor Joe Cummins, Professor Emeritus of Genetics, University of
      Western Ontario, Canada.
8.1.1 Safety Concerns for Therapeutic Monoclonal Antibodies
8.1.2 Excitement Surrounding Therapeutic Monoclonal Antibodies
8.1.3 Prospects of Fully Human Antibodies
8.1.4 Prospects of the Therapeutic Monoclonal Antibodies Market
8.2 Interview 2: Dr Martin Wiles, Vice President of Business Development,    
      BioInvent, Sweden
8.2.1 Greatest Obstacles to Market Growth
8.2.2 Prospects of Fully Human Antibodies
8.2.3 Prospects of Therapeutic Monoclonal Antibodies Market
8.2.4 Most Promising Products
8.2.5 Long-Term Collaborative Partnership between BioInvent and ThromboGenics
9 Future Trends for Therapeutic Monoclonal Antibodies
9.1 Are Magic Bullets Back in Vogue?
9.1.1 Immunogen's TAP System Attracts Attention
9.1.2 Seattle Genetics ADC Technology Shows Promise
9.2 Nanobodies, BiTEs and TandAbs - New Takes on the Monoclonal
9.2.1 BiTEs Can Thwart CD8 Negative Tumours
9.2.2 TandAbs Specialise in Tumour Killing
9.2.3 NanoBodies - Heavy Chain Only Technology
9.3 Diagnostic Tests Will Be Integral to Future Success
9.3.1 Lack of Low Hanging Fruit Will Force Integration
10 Conclusion: the Monoclonal Antibodies Market is Growing Strongly and Will
     Become a Leading Therapeutic Technology
10.1 The Monoclonal Antibodies Market is One of the Strongest Areas in the
        Pharmaceutical Industry
10.2 Oncology is the Key Driver to Market Growth
10.3 Humanised Monoclonal Antibodies Will Dominate the Market in the Short-Term,
        but Fully Human Antibodies are the Focal Point of Research Interest
10.4 Monoclonal Antibody Therapies Will Reach More Countries
10.5 The Market Will Be Restrained by Competition and Price Restrictions
10.6 Monoclonal Antibodies Will Become the Mainstream Therapeutic Technology in
        the Industry
10.7 Outlook for the Future

List of Tables
Table 2.1 FDA-Approved Therapeutic Monoclonal Antibodies, 2008
Table 2.2 Leading Biotech Drugs Based on Monoclonal Antibodies, 2007
Table 3.1 Leading Therapeutic Monoclonal Antibodies, Sales ($m) and Market Share (%), 2007
Table 3.2 Global Sales ($bn) by Therapeutic Area, 2007
Table 3.3 Statistics of Key Oncology Indications and Their Monoclonal Antibody Therapies, 2007
Table 3.4 Prevalence of Key AIID Indications and Their Monoclonal Antibody Therapies, 2007
Table 4.1 SWOT Analysis of the Monoclonal Antibody Market, 2008
Table 4.2 Targets and Indications for Selected Approved Antibodies
Table 4.3 Modes of Administration for Leading Monoclonal Antibody Drugs
Table 5.1 Global Market for the Emerging Three, Sales ($bn) and Market Share (%), 2007-2013
Table 6.1 Key Mergers and Acquisitions of the Monoclonal Antibody Market
Table 6.2 Near-Term Opportunities in the Roche Group's Pipeline, 2008
Table 6.3 Near-Term Opportunities in Johnson and Johnson's Pipeline, 2008
Table 6.4 Near-Term Opportunities in Abbott's Pipeline, 2008
Table 6.5 Near-Term Opportunities in Amgen's Pipeline, 2008
Table 7.1 Leading Regions of the Therapeutic Monoclonal Antibodies Market, Sales ($m) and Market Share (%), 2007 and 2013
Table 9.1 Examples of Conjugated Monoclonal Drugs in the Pipeline, 2008
Table 9.2 Immunogen's Product Pipeline, 2008
Table 9.3 Other Monoclonal-based Drugs in Development Using the TAP System, 2008
Table 9.4 Seattle Genetics Pipeline, 2008
Table 10.1 Global Monoclonal Antibodies, Sales ($bn) and  Growth (%), 2007-2013
Table 10.2 Global Monoclonal Antibodies Market, Key Therapy Areas, Sales ($bn) and CAGR (%), 2007-2013
Table 10.3 Leading Geographical Markets for Monoclonal  Antibodies, 2007, 2013, 2018, and 2023

List of Figures
Figure 2.1 Structure of an Antibody
Figure 3.1 Leading Therapeutic Monoclonal Antibodies, Sales ($m), 2007
Figure 3.2 Leading Therapeutic Monoclonal Antibodies, Market Share (%), 2007
Figure 3.3 Leading Monoclonal Therapeutic Antibodies, Sales Growth (%), 2007
Figure 3.4 World Therapeutic Monoclonal Antibodies, Sales ($bn), 2007-2013
Figure 3.5 Global Therapeutic Monoclonal Antibodies, Sales Growth (%), 2008-2013
Figure 3.6 Leading Therapeutic Monoclonal Antibodies, Market Share (%), 2007 and 2013
Figure 3.7 Leading Monoclonal Antibody Therapies, Sales ($m), 2007-2013
Figure 3.8 Global Monoclonal Antibodies Market by Therapeutic Area, Sales ($bn), 2007
Figure 3.9 Global Monoclonal Antibodies Market by Therapeutic Area, Market Share (%), 2007
Figure 3.10 Global Monoclonal Antibodies Market by Therapeutic Area, Sales ($bn), 2007-2013
Figure 3.11 Leading Monoclonal Antibody Therapies for Oncology, Sales ($m), 2007
Figure 3.12 The Oncology Sector of Monoclonal Antibodies Market, Sales ($bn), 2007-2023
Figure 3.13 Leading Monoclonal Antibody Therapies for AIID, Sales ($m), 2007
Figure 3.14 The AIID Sector of Monoclonal Antibodies Market, Sales ($bn), 2007-2023
Figure 3.15 Other Leading Monoclonal Antibody Therapies, Sales ($m), 2007
Figure 3.16 Other Therapeutic Areas of Monoclonal Antibodies Market, Sales ($bn), 2007-2023
Figure 3.17 Global Monoclonal Antibodies Market by Technology, Sales ($bn), 2007
Figure 3.18 Global Monoclonal Antibodies Market by Technology, Market Share (%), 2007
Figure 3.19 Global Chimeric Monoclonal Antibodies Market, Market Share (%), 2007
Figure 3.20 Global Chimeric Monoclonal Antibodies Market, Sales ($bn), 2007-2023
Figure 3.21 Global Humanised Monoclonal Antibodies, Market Share (%), 2007
Figure 3.22 Global Humanised Monoclonal Antibodies, Sales ($bn), 2007-2023
Figure 3.23 Global Fully Human Monoclonal Antibodies Market, Market Share (%), 2007
Figure 3.24 Global Fully Human Monoclonal Antibodies Market, Sales ($bn), 2007-2023
Figure 3.25 Global Therapeutic Monoclonal Antibodies by Technology, Sales ($bn), 2007-2023
Figure 5.1 Sales of Global Monoclonal Antibodies and the Big Five ($bn), 2007-2013
Figure 5.2 Global Market Forecast for Remicade, Sales ($m), 2007-2023
Figure 5.3 Global Market Forecast for Rituxan/MabThera, Sales ($m), 2007-2023
Figure 5.4 Global Market Forecast for Herceptin, Sales ($m), 2007-2023
Figure 5.5 Global Market Forecast for Avastin, Sales ($m),  2007-2023
Figure 5.6 Global Market Forecast for Humira, Sales ($m),  2007-2023
Figure 5.7 Global Market Forecast for Erbitux, Sales ($m),  2007-2023
Figure 5.8 Global Market Forecast for Lucentis, Sales ($m), 2007-2023
Figure 5.9 Global Market Forecast for Synagis, Sales ($m), 2007-2023
Figure 6.1 Leading Companies, Total Market Share  in the World Monoclonal Antibodies Market (%), 2007
Figure 6.2 Leading Companies, Total Sales ($bn) in the World Monoclonal Antibodies Market, 2007
Figure 6.3 Roche/Genentech's Therapeutic Monoclonal Antibodies, Market Share (%) and Sales ($m), 2007
Figure 6.4 Johnson and Johnson's Marketed Portfolio, Market Share (%) and Sales ($bn), 2007
Figure 7.1 Leading Pharmaceutical Markets, Market Share (%), 2007, 2013, 2018 and 2023
Figure 7.2 Leading Pharmaceutical Markets, Sales ($m), 2007, 2013, 2018 and 2023
Figure 7.3 Leading Pharmaceutical Markets, Growth Rates (CAGR %), 2007-2013
Figure 9.1 Antibody Formats
Figure 10.1 Global Therapeutic Monoclonal Antibodies by Technology, Sales ($bn), 2007-2023

Companies Listed

Abbott Laboratories   
Abgenix   
Abylnx   
Aeterna   
Affimed   
Agensys   
Alexion   
Alfacell   
Amgen   
Antisoma
Applied Molecular Evolution   
AstraZeneca   
Biogen-Idec   
BioInvent   
Biotest   
Bradmer Pharmaceuticals   
Bristol-Myers Squibb   
Cambridge Antibody Technology   
Cancer Research UK   
Centocor   
Chugai   
Corixa   
Cura-Gen   
Daiichi Sankyo   
Eisai   
Elan
Eli Lilly   
Genentech   
GenMab 
GlaxoSmithKline 
IDEC Pharmaceuticals   
ImClone   
Immunogen   
Immunomedics   
Jansen-Cilag   
Johnson and Johnson   
Medarex   
MedImmune   
Merck   
Merus   
Micromet   
MorphoSys   
National Institute of Health (NIH)   
Novartis   
PDL BioPharma   
Peregrine   
Pfizer   
Roche   
Sanofi-Aventis   
Schering AG   
Seattle Genetics   
Sloane Kettering Institute   
Symphogen   
Tanabe   
Targa Therapeutics   
Thrombogenics   
UCB   
Viventia Biotech   
Wyeth   
Xoma