Therapeutic Monoclonal Antibodies Report 2008-2023

Table of Contents

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