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Therapeutic Monoclonal Antibodies Markets

Antibodies are proteins in the immune system that help the body defend against foreign invasion, particularly from pathogens and toxins.

As such, a human-engineered therapeutic monoclonal antibody (mAb) is protein derived from the immune system through recombinant DNA technology that has the ability to combine specifically with a target protein that plays a role in a disease process.

With this unique ability to specifically target diseased cells while leaving healthy cells unaffected, monoclonal antibodies can serve to diagnose and treat a wide range of medical conditions.

Areas such as breast cancer therapy have benefited greatly since the advent of drugs like Herceptin (trastuzumab) that interferes with the HER2/neu receptor. Indeed, the field of therapeutic monoclonal antibodies potentially has far-reaching and paradigm-shifting implications for biology, drug discovery, and medical treatment of disease.

The discipline has already yielded discoveries that have been used for drug delivery and diagnostic purposes, and other exciting new therapeutic applications.

This report reviews the market for medical products based on emerging therapeutic monoclonal antibodies. It defines the dollar volume of sales in the U.S. and worldwide, and it analyzes the factors that influence the size and the growth of the market segments.

The study goes on to discuss in detail the trends that have developed which have stimulated this market and surveys many of the companies marketing, manufacturing or developing monoclonal antibodies therapies.

Monoclonal antibodies for non-therapeutic purposes--used primarily in life science and research applications--are not discussed in this review. Moreover, antibody process technology is not covered.

Special effort was made to include mention of smaller companies that are or potentially could have an impact on their industry far in excess of their current size. Each company is discussed in depth with a section on the history of the company, the product line, business and marketing analysis, and a subjective commentary of the position of the company in its market.

Table of Contents

TABLE OF CONTENTS

1. Introduction 5

• 1.1 Statement of Report 5
• 1.2 Objectives of this Report 5
• 1.3 Scope of the Report 6
• 1.4 Methodology 7
• 1.5 Executive Summary 8

2. Introduction: The State of Therapeutic Monoclonal Antibody Technology 10

• 2.1 State of the Pharmaceutical Industry 10
• 2.2 Antibodies as an Alternative Pharmaceutical Agent 16
• 2.3 Current Status of Antibody Therapeutics 19
• 2.4 Demands of Antibody Therapeutics Development 22

3. Recent Technology Trends 24

• 3.1 Classic Design of Antibodies 24
  • 3.1.1 Chimeric Monoclonal Antibodies 25
  • 3.1.2 Humanized Monoclonal Antibodies 25
  • 3.1.3 Totally Human Antibodies 26
  • 3.1.4 Monoclonal Antibody Processing 26
• 3.2 Monoclonal Antibodies Therapeutics 26
  • 3.2.1 Naked Monoclonal Antibodies 26
  • 3.2.2 Conjugated Monoclonal Antibodies 27
• 3.3 Synthetic Antibodies, Unique Scaffolds 28
• 3.4 Screening and Selection of Antibodies 28
• 3.5 Novel Antibody Modifications: Glycosylation, Pegylation, Polymer Conjugations 29
  • 3.5.1 Miniaturizing and Delivering Antibody Drugs 30
  • 3.5.2 Recombinant Polyclonals 30
• 3.6 Monoclonal Antibody Purification 31

4. Industry Challenges 32

• 4.1 Introduction: Challenges Affecting the U.S. Therapeutic Monoclonal Antibodies Market 32
• 4.2 Increasing Costs and Complexities of Clinical Trials 33
• 4.3 Long-term Safety and Efficacy 33
• 4.3.1 Post-marketing Surveillance of Monoclonal Antibodies 34
• 4.4 High Cost of Monoclonal Antibodies 34
• 4.5 Restricted Government Healthcare Spending 35
• 4.6 Intellectual Property Thicket 35
• 4.7 Government Regulation 36
• 4.8 Third-party Reimbursement Environment 37

5. Pipeline Analysis 38

• 5.1 Overview of the Monoclonal Antibodies Pipeline 38
  • 5.1.1 Anti-Cancer Antibodies 41
  • 5.1.2 Profiles of Important Monoclonal Antibodies in Oncology 41
    • 5.1.2.1 Avastin 42
    • 5.1.2.2 Phase I Trials of Anti-EpCAM Antibody Adecatumumab (MT201) in Combination with Chemotherapy 44
    • 5.1.2.3 Adecatumumab (MT201) in Combination with Chemotherapy 44
    • 5.1.2.4 Herceptin 44
    • 5.1.2.5 Pertuzumab, a HER2 Dimerization Inhibitor 47
    • 5.1.2.6 Cetuximab 48
    • 5.1.2.7 Prostate Cancer: Will Vaccines Lead the Way? 48
    • 5.1.2.8 Recent Trial of an Anti-prostate Cancer Monoclonal Antibody 48
    • 5.1.2.9 Anti-melanoma Antibodies 49
    • 5.1.2.10 Other Anti-cancer Monoclonal Antibodies 49
  • 5.1.3 Monoclonal Antibodies in Autoimmune and Inflammatory Disorders 49
    • 5.1.3.1 Type 1 Diabetes 49
    • 5.1.3.2 Rheumatoid Arthritis 50
  • 5.1.4 Monoclonal Antibodies in Organ Transplants 50
  • 5.1.5 Monoclonal Antibodies in Cardiovascular Disorders 51
    • 5.1.5.1 Ablynx 51
    • 5.1.5.2 ThromboGenics/BioInvent International 51
    • 5.1.5.3 Pexelizumab: A Recombinant Humanized Single Chain Monoclonal Antibody 51
  • 5.1.6 Monoclonal Antibodies in Infectious Diseases 51
  • 5.1.7 Monoclonal Antibodies in Miscellaneous Indications 52
    • 5.1.7.1 Alzheimer’s Disease 52
    • 5.1.7.2 Parkinson’s Antibody Therapy 52
• 5.2 U.S. Therapeutic Monoclonal Antibodies Market 53
• 5.2.1 Market Dimensions 53

6. Short-term Market Predictions 54

• 6.1 Total Revenue Forecasts 54
• 6.2 Segment Revenue Forecast 55
  • 6.2.1 Oncology, Arthritis, Immune and Inflammatory Disorders (AIID) 55
• 6.3 Competitive Analysis Forecast 56
  • 6.3.1 Competition between Similar Products 56
  • 6.3.2 Competitive Factors 58
• 6.4 Conclusions 58
  • 6.4.1 A Rocky Road 58
  • 6.4.2 The Only Solution to High Medical Costs is Research 59

7. Antibody Technology Companies: Profiles 61

• 7.1 Abbott Laboratories 61
• 7.2 Abgenix 62
• 7.3 Ablynx 62
• 7.4 Aeres 62
• 7.5 Affimed Therapeutics AG 63
• 7.6 Affitech AS 63
• 7.7 Agensys 63
• 7.8 Alexion Pharmaceuticals 63
• 7.9 Amgen 64
• 7.10 Antisoma 65
• 7.11 ApoLife, Inc. 65
• 7.12 Applied Molecular Evolution, Inc. 66
• 7.13 Arana Therapeutics 66
• 7.14 Astellas Pharma 66
• 7.15 AstraZeneca plc 67
• 7.16 Biogen Idec, Inc. 68
• 7.17 BioInvent International AB 69
• 7.18 Biosite Discovery 70
• 7.19 Biovation Ltd. 70
• 7.20 BioWa 70
• 7.21 Boehringer Ingelheim 70
• 7.22 Cambridge Antibody Technology Group 71
• 7.23 Celltech 71
• 7.24 Corixa 71
• 7.25 Crucell NV 71
• 7.26 Cytogen 72
• 7.27 Dyax 72
• 7.28 Eisai Co., Ltd. 73
• 7.29 Elan Corporation 73
• 7.30 Eli Lilly 74
• 7.31 Elusys Therapeutics 75
• 7.32 Enzon Pharmaceuticals 75
• 7.33 Genentech 76
• 7.34 Genmab A/S 84
• 7.35 Genovac GmbH 84
• 7.36 Genzyme Corporation 85
• 7.37 GlaxoSmithKline plc 86
• 7.38 GlycArt 86
• 7.39 ILEX Oncology 86
• 7.40 ImClone Systems 87
• 7.41 ImmunoGen 87
• 7.42 Immunomedics 89
• 7.43 InNexus Biotechnology, Inc. 91
• 7.44 Johnson & Johnson 91
• 7.45 Lexigen 92
• 7.46 Medarex 92
• 7.47 MedImmune 94
• 7.48 Merus BV 95
• 7.49 Micromet 95
• 7.50 Millegen 95
• 7.51 Millennium Pharmaceuticals 96
• 7.52 MorphoSys AG 96
• 7.53 Novartis 96
• 7.54 Peregrine Pharmaceuticals, Inc. 97
• 7.55 PDL BioPharma 98
• 7.56 Philogen 99
• 7.57 Philotec 100
• 7.58 Phylos 100
• 7.59 Roche 100
• 7.60 Sanofi-Aventis 101
• 7.61 Scil Proteins 103
• 7.62 Seattle Genetics 104
• 7.63 Symphogen A/S 105
• 7.64 Tanox 105
• 7.65 ThromboGenics NV 105
• 7.66 Trion Pharma 106
• 7.67 Viventia Biotech, Inc. 106
• 7.68 Wyeth 106
• 7.69 Xcellerex 107
• 7.70 Xencor, Inc. 107
• 7.71 Xoma Ltd. 107

References 111


INDEX OF FIGURES

• Figure 2.1: Worldwide Pharmaceutical Sales and R&D Expenditures, 2000-2013 11
• Figure 2.2: International Per Capita Healthcare Spending by Country 13
• Figure 2.3: Total Spending on Healthcare in the U.S., 1960-2007 15
• Figure 2.4: Percentage Breakdown of U.S. Healthcare Spending, 2008 15
• Figure 3.1: Basic Structure of the Antibody Molecule 25
• Figure 5.1: Global Market for Protein Therapeutics, 2007-2013 53
• Figure 6.1: Sales of the Five Leading Antibodies, 2008 56

INDEX OF TABLES

• Table 2.1: Number of New Drug Applications to the FDA, 2000-2008 11
• Table 2.2: New Drug Approvals from FDA, 2000-2008 12
• Table 2.3: Percentage of GDP Healthcare Spending by Country, 2008 13
• Table 2.4: Life Expectancy Rate by Country, 2008 14
• Table 2.5: Development Time for Major Drugs for Top U.S. Pharmaceutical Companies 16
• Table 2.6: Number of FDA “Black-box” Warnings, 2003-2007 20
• Table 2.7: Collaboration and Mergers 21
• Table 2.8: Worldwide Spending of Specialty Pharmaceuticals, 2003-2010 21
• Table 2.9: New Drug Development from Existing Drugs 22
• Table 3.1: Timeline of Immunological Discoveries 24
• Table 3.2: Antibody Screening and Selection Technologies 29
• Table 3.3: FDA-Approved Rapid HIV Antibody Screening Tests 29
• Table 4.1: Currently Approved Therapeutic Antibodies 32
• Table 5.1: Therapeutic Antibodies in the Development Pipeline 38
• Table 5.2: Currently Approved Anti-Cancer Antibodies 41
• Table 5.3: Status of Clinical Studies Involving Avastin 42
• Table 5.4: Market for Avastin Therapeutic Antibodies, 2006-2012 43
• Table 5.5: Rise in Herceptin Sales, 1998-2008 46
• Table 5.6: Monoclonal Antibodies in Clinical Trials for Cardiovascular Diseases 51
• Table 6.1: Projected World Market for Therapeutic Monoclonal Antibodies, 2008-2012 54
• Table 6.2: Market Record and Outlook for Oncological Therapeutic Antibodies, 2006-2012 55
• Table 6.3: Recorded and Anticipated Sales Growth for Anti-inflammatory Monoclonal Antibodies, 2006-2012 55
• Table 7.1: Genentech’s Operating Revenue, 2004-2008 76
• Table 7.2: Genentech’s Product Sales, 2006-2008 78
• Table 7.3: Genentech’s Product Licensee Products 80
• Table 7.4: Genentech’s Products in Development 80

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