The Future of Monoclonal Antibodies - Market Forecasts to 2015, Competitive Benchmarking, Product Pipeline and Deals Analysis

1 Table of Contents 4
1.1 List of Tables 8
1.2 List of Figures 10
2 Global Monoclonal Antibodies Market: Introduction 12
3 Global Monoclonal Antibodies Market: Market Characterization 14
3.1 Introduction 14
3.2 Revenue Forecasts for the Global MAbs Market Potential 14
3.2.1 MAbs Treatment Potential 14
3.2.2 Drug Prices 16
3.2.3 Market Potential 17
3.2.4 Market Potential Segmentation 18
3.3 Revenue Forecasts of Global MAbs Market - Actual Market 19
3.3.1 MAbs Actual Treatment Population 19
3.3.2 Actual Sales 20
3.3.3 Actual Sales Segmentation 21
3.4 Treatment Usage Patterns 23
3.5 Global MAbs Trends 24
3.5.1 Market Trends 24
3.5.2 Technology Trends 25
3.6 Product Trends 25
3.6.1 Research and Development Focus Shifted Towards Humanized and Fully Humanized MAbs 25
3.7 Global MAbs Market Drivers 26
3.7.1 Gradual Growth in the Uptake of MAbs Have Driven the Monoclonal Antibody Sales Growth 26
3.7.2 Improved Side-effect Profiles and Tolerance of MAbs Therapy 26
3.7.3 Lack of Effective Conventional Therapies Accelerates Utilization of MAbs 26
3.7.4 Expanded Indications Opens up New Potential Patient Group 27
3.7.5 Lack of Generics Augmented the Sales Growth of MAbs 27
3.8 Global MAbs Market Restraints 27
3.8.1 High Cost of MAbs Hampering the Growth of Treatment Population 27
3.8.2 Adverse Effects - Generation of Antibodies against MAbs in Patients Receiving Monoclonal Antibody Therapy 27
3.8.3 Industry Challenges - Majority of MAbs Receive Approvals as Last Option Therapies 28
3.9 Unmet Needs 28
3.9.1 The High Cost of MAb Therapies is the Major Unmet Need and it is Also Responsible for Low Utilization by Patients 28
3.9.2 MAbs Do Not Cure the Disease; They either Treat Signs and Symptoms or Decelerate Cell Proliferation 28
4 Global MAbs Market Potential: Therapeutic Distribution 29
4.1 MAbs Market Potential in HER2 Breast Cancer (Adjuvant and Metastatic) 29
4.1.1 Introduction 29
4.1.2 Prescription Population 31
4.1.3 Annual Cost of Therapy 32
4.1.4 Market Potential 33
4.2 MAbs Market Potential in Bone Metastases and Bone Loss Due to Cancer Therapy 34
4.2.1 Introduction 34
4.2.2 Prescription Population 35
4.2.3 Annual Cost of Therapy 36
4.2.4 Market Potential 37
4.3 MAbs Market Potential in Relapsing-remitting Multiple Sclerosis (RRMS) 38
4.3.1 Introduction 38
4.3.2 Prescription Population 40
4.3.3 Annual Cost of Therapy 41
4.3.4 Market Potential 42
4.4 MAbs Market Potential in Metastatic Non-Small Cell Lung Cancer (NSCLC) 43
4.4.1 Introduction 43
4.4.2 Prescription Population 45
4.4.3 Annual Cost of Therapy 45
4.4.4 Market Potential 46
4.5 MAbs Market Potential in Rheumatoid Arthritis 47
4.5.1 Introduction 47
4.5.2 Prescription Population 49
4.5.3 Annual Cost of Therapy 50
4.5.4 Market Potential 51
5 Global MAbs Market: Pipeline Analysis 53
5.1 Introduction 53
5.2 MAbs Nomenclature 53
5.3 Monoclonal Antibody Technology 54
5.4 Applications of MAbs 55
5.4.1 Detection Assays 55
5.4.2 Purification Techniques 55
5.4.3 Gene Identification 55
5.4.4 Applied Chemistry 55
5.4.5 Disease Therapy 56
5.5 Therapeutic Applications in Oncology 56
5.5.1 Introduction 56
5.5.2 Marketed Therapies 56
5.5.3 Therapies in Late Stage Pipeline 62
5.6 Therapeutic Applications in Autoimmune and Inflammatory Diseases 66
5.6.1 Introduction 66
5.6.2 Marketed Therapies 66
5.6.3 Therapies in Late Stage Pipeline 71
5.7 Therapeutic Applications in Respiratory Diseases 74
5.7.1 Introduction 74
5.7.2 Marketed Therapies 74
5.7.3 Therapies in Late Stage Pipeline 75
5.8 Therapeutic Applications in Infectious Diseases 75
5.8.1 Introduction 75
5.8.2 Marketed Therapies 76
5.8.3 Therapies in Pipeline 76
5.9 Therapeutic Applications in Organ Transplantation 77
5.9.1 Introduction 77
5.9.2 Marketed Therapies 78
5.10 Therapeutic Applications in Cardiovascular Diseases 79
5.10.1 Introduction 79
5.10.2 Marketed Therapies 80
5.10.3 Therapies in Pipeline 81
5.11 New Indications 81
5.11.1 Central Nervous System 82
5.11.2 Diabetes 83
5.12 Insights into Most Promising Drugs 83
5.12.1 Denosumab 83
6 Global MAbs Market: M&A Landscape 86
6.1 Overview 86
6.1.1 Emergent BioSolutions acquires Avanir Pharmaceuticals 86
6.1.2 MacroGenics acquires Raven Biotechnologies 86
6.1.3 Thermo Fisher acquires Affinity BioReagents 87
6.2 R&D Licensing Agreements 87
6.2.1 Deals by Phase 87
6.2.2 Deals by Geography 87
6.2.3 Deals by Licensing Type 88
6.2.4 Deals by Value ($) 88
6.2.5 Preclinical 89
6.2.6 Phase I 90
6.2.7 Phase II 91
6.2.8 Phase III 92
6.2.9 Approved 92
7 Global MAbs Market: Competitive Landscape 94
7.1 Evolving competitive landscape 94
7.1.1 Major players 94
7.1.2 Key MAbs in the Market 95
7.2 Company Benchmarking Analysis 96
7.3 Roche/Genentech 98
7.3.1 Key Monoclonal Antibody Drugs 100
7.3.2 Key Indications of Interest 102
7.3.3 Pipeline Analysis 103
7.4 Abbott 104
7.4.1 Key MAbs 105
7.4.2 Key Indications of Interests 106
7.4.3 Pipeline Analysis 106
7.5 Johnson & Johnson 106
7.5.1 Key MAbs 107
7.5.2 Key Indications of Interest 108
7.5.3 Pipeline Analysis 108
7.6 Biogen Idec. 109
7.6.1 Key MAbs 110
7.6.2 Key Indications of Interest 111
7.6.3 Pipeline Analysis 111
7.7 Merck/Schering Plough 112
7.7.1 Key MAbs 113
7.7.2 Key Indications of Interest 113
7.7.3 Pipeline Analysis 114
7.8 AstraZeneca 115
7.8.1 Key MAbs 115
7.8.2 Key Indications of Interest 116
7.8.3 Pipeline Analysis 116
7.9 Bristol-Myers Squibb 117
7.9.1 Key MAbs 118
7.9.2 Key Indications of Interest 118
7.10 Elan 119
7.10.1 Key MAbs 120
7.10.2 Key Indications of Interest 120
7.10.3 Pipeline Analysis 121
7.11 Eli Lilly 122
7.11.1 Key Monoclonal Antibody Drugs 123
7.11.2 Key Indications of Interests 123
7.11.3 Pipeline Analysis 124
7.12 Amgen 124
7.12.1 Key Monoclonal Antibody Drugs 125
7.12.2 Key Indications of Interest 126
7.12.3 Pipeline Analysis 127
8 Global MAbs Market: Appendix 128
8.1 Research Methodology 128
8.2 Geographical Scope 128
8.3 Coverage 128
8.4 Secondary Research 129
8.5 Primary Research 129
8.6 Forecasts 129
8.6.1 Epidemiology-based Forecasting 129
8.7 Expert Panel Validation 131
8.8 Contact Us 132
8.9 Disclaimer 132

1.1 List of Tables
Table 1: MAbs Market, Global, MAbs Treatment Potential, 2000-2008 15
Table 2: MAbs Market, Global, MAbs Treatment Potential, 2008-2015 15
Table 3: MAbs Market, Global, Annual Cost of Therapy ($), 2000-2008 16
Table 4: MAbs Market, Global, Annual Cost of Therapy ($), 2008-2015 17
Table 5: MAbs Market, Global, MAbs Market Potential ($ bn), 2000-2008 18
Table 6: MAbs Market, Global, MAbs Market Potential ($ bn), 2008-2015 18
Table 7: MAbs Market, Global, MAbs Actual Treatment Population, 2000-2008 20
Table 8: MAbs Market, Global, MAbs Actual Treatment Population, 2008-2015 20
Table 9: MAbs Market, Global, Actual Sales ($ bn), 2000-2008 21
Table 10: MAbs Market, Global, Actual Sales ($ bn), 2008-2015 21
Table 11: MAbs Market, Global, Actual Sales Segmentation ($ bn), 2000-2008 23
Table 12: MAbs Market, Global, Actual Sales Segmentation ($ bn), 2008-2015 23
Table 13: MAbs Market, Global, HER2+ Breast Cancer, Prescription Population, 2000-2008 31
Table 14: MAbs Market, Global, HER2+ Breast Cancer, Prescription Population, 2008-2015 32
Table 15: MAbs Market, Global, HER2+ Breast Cancer, Annual Cost of Therapy ($), 2000-2008 32
Table 16: MAbs Market, Global, HER2+ Breast Cancer, Annual Cost of Therapy ($), 2008-2015 32
Table 17: MAbs Market, Global, HER2+ Breast Cancer, Market Potential ($ bn), 2000-2008 33
Table 18: MAbs Market, Global, HER2+ Breast Cancer, Market Potential ($ bn), 2008-2015 33
Table 19: MAbs Market, Global, Bone Metastasis and Bone Loss, Prescription Population,
2009-2015 36
Table 20: MAbs Market, Global, Bone Metastasis and Bone Loss, Annual Cost of Therapy ($), 2009-2015 37
Table 21: MAbs Market, Global, Bone Metastasis and Bone Loss, Market Potential ($ bn),
2009-2015 38
Table 22: MAbs Market, Global, RRMS, Treatment Options, 2008 40
Table 23: MAbs Market, Global, RRMS, Prescription Population, 2000-2008 41
Table 24: MAbs Market, Global, RRMS, Prescription Population, 2008-2015 41
Table 25: MAbs Market, Global, RRMS, Annual Cost of Therapy ($), 2000-2008 42
Table 26: MAbs Market, Global, RRMS, Annual Cost of Therapy ($), 2008-2015 42
Table 27: MAbs Market, Global, RRMS, Market Potential ($ bn), 2000-2008 42
Table 28: MAbs Market, Global, RRMS, Market Potential ($ bn), 2008-2015 43
Table 29: MAbs Market, Global, Metastatic NSCLC, Treatment Options, 2008 44
Table 30: MAbs Market, Global, Metastatic NSCLC, Prescription Population, 2000-2008 45
Table 31: MAbs Market, Global, Metastatic NSCLC, Prescription Population, 2008-2015 45
Table 32: MAbs Market, Global, Metastatic NSCLC, Annual Cost of Therapy ($), 2000-2008 46
Table 33: MAbs Market, Global, Metastatic NSCLC, Annual Cost of Therapy ($), 2008-2015 46
Table 34: MAbs Market, Global, Metastatic NSCLC, Market Potential ($ bn), 2000-2008 47
Table 35: MAbs Market, Global, Metastatic NSCLC, Market Potential ($ bn), 2008-2015 47
Table 36: MAbs Market, Global, Rheumatoid Arthritis, Prescription Population, 2000-2008 50
Table 37: MAbs Market, Global, Rheumatoid Arthritis, Prescription Population, 2008-2015 50
Table 38: MAbs Market, Global, Rheumatoid Arthritis, Annual Cost of Therapy ($), 2000-2008 51
Table 39: MAbs Market, Global, Rheumatoid Arthritis, Annual Cost of Therapy ($), 2008-2015 51
Table 40: MAbs Market, Global, Rheumatoid Arthritis, Market Potential ($ bn), 2000-2008 52
Table 41: MAbs Market, Global, Rheumatoid Arthritis, Market Potential ($ bn), 2008-2015 52
Table 42: MAbs Market, Global, Monoclonal Antibody Nomenclature 54
Table 43: MAbs Market, Global, Licensing Agreements for Drugs in the Preclinical Stage,
2008-2009 90
Table 44: MAbs Market, Global, Licensing Agreements for Drugs in the Phase I, 2008-2009 91
Table 45: MAbs Market, Global, Licensing Agreements for Drugs in the Phase II, 2008-2009 92
Table 46: MAbs Market, Global, Licensing Agreements for Drugs in the Phase III, 2008-2009 92
Table 47: MAbs Market, Global, Licensing Agreements for Approved Drugs, 2008-2009 93
Table 48: MAbs Market, Global, Top 5 Companies Sales ($m), 2006-2008 95
Table 49: MAbs Market, Global, Top 10 MAbs ($m), 2006-2008 98
Table 50: MAbs Market, Global, Roche/Genentech Revenue ($ m), 2006-2015 100
Table 51: MAbs Market, Global, Abbott Revenue ($ m), 2006-2015 105
Table 52: MAbs Market, Global, Johnson & Johnson Revenue ($ m), 2006-2015 107
Table 53: MAbs Market, Global, Biogen Idec Revenue ($ m), 2006-2015 110
Table 54: MAbs Market, Global, Merck/Schering Plough Revenues ($ m), 2006-2015 113
Table 55: MAbs Market, Global, AstraZeneca Revenues ($ m), 2006-2015 115
Table 56: MAbs Market, Global, Bristol-Myers Squibb Revenues ($ m), 2006-2015 118
Table 57: MAbs Market, Global, Elan Revenues ($ m), 2006-2015 120
Table 58: MAbs Market, Global, Eli Lilly, Revenues ($ m), 2006-2015 122
Table 59: MAbs Market, Global, Amgen Revenues ($ m), 2006-2015 125

1.2 List of Figures
Figure 1: MAbs Market, Global, Major Factors Influencing the Global MAbs Market, 2008 14
Figure 2: MAbs Market, Global, MAbs Treatment Potential, 2000-15 15
Figure 3: MAbs Market, Global, Annual Cost of Therapy ($), 2000-2015 16
Figure 4: MAbs Market, Global, MAbs Market Potential ($ bn), 2000-2015 17
Figure 5: MAbs Market, Global, Market Segmentation by Disease, 2008 and 2015 19
Figure 6: MAbs Market, Global, MAbs Actual Treatment Population, 2000-2015 20
Figure 7: MAbs Market, Global, Actual Sales ($ bn), 2000-2015 21
Figure 8: MAbs Market, Global, Actual Sales Segmentation ($ bn), 2008 and 2015 22
Figure 9: MAbs Market, Global, Actual Sales Segmentation ($ bn), 2000-2015 23
Figure 10: MAbs Market, Global, Treatment Population Trends, 2000-2015 24
Figure 11: MAbs Market, Global, MAbs Segmented by Origin, 1992-2009 25
Figure 12: MAbs Market, Global, Market Share of Key Indications, 2008 29
Figure 13: MAbs Market, Global, HER2+ Breast Cancer, Prescription Population, 2000-2015 31
Figure 14: MAbs Market, Global, HER2+ Breast Cancer, Annual Cost of Therapy ($), 2000-2015 32
Figure 15: MAbs Market, Global, HER2+ Breast Cancer, Market Potential ($ bn), 2000-2015 33
Figure 16: MAbs Market, Global, Bone Metastasis and Bone Loss, Prescription Population, 2009-2015 36
Figure 17: MAbs Market, Global, Bone Metastasis and Bone Loss, Annual Cost of Therapy ($), 2009-2015 37
Figure 18: MAbs Market, Global, Bone Metastasis and Bone Loss, Market Potential ($ bn), 2009-2015 38
Figure 19: MAbs Market, Global, Multiple Sclerosis, Diseased Population, 2008 39
Figure 20: MAbs Market, Global, RRMS, Prescription Population, 2000-2015 40
Figure 21: MAbs Market, Global, RRMS, Annual Cost of Therapy ($), 2000-2015 41
Figure 22: MAbs Market, Global, RRMS, Market Potential ($ bn), 2000-2015 42
Figure 23: MAbs Market, Global, Metastatic NSCLC, Prescription Population, 2000-2015 45
Figure 24: MAbs Market, Global, Metastatic NSCLC, Annual Cost of Therapy ($), 2000-2015 46
Figure 25: MAbs Market, Global, Metastatic NSCLC, Market Potential ($ bn), 2000-2015 47
Figure 26: MAbs Market, Global, Rheumatoid Arthritis, Prescription Population, 2000-2015 50
Figure 27: MAbs Market, Global, Rheumatoid Arthritis, Annual Cost of Therapy ($), 2000-2015 51
Figure 28: MAbs Market, Global, Rheumatoid Arthritis, Market Potential ($ bn), 2000-2015 52
Figure 29: MAbs Market, Global, Pipeline Segmentation by Disease, 2009 53
Figure 30: MAbs Market, Global, Oncology Pipeline, 2009 56
Figure 31: MAbs Market, Global, Autoimmune Diseases Pipeline, 2009 66
Figure 32: MAbs Market, Global, Respiratory Diseases Pipeline by Phase of Development, 2009 74
Figure 33: MAbs Market, Global, Infectious Diseases Pipeline by Phase of Development, 2009 76
Figure 34: MAbs Market, Global, Organ Transplantation Pipeline by Phase of Development, 2009 78
Figure 35: MAbs Market, Global, Cardiovascular Pipeline by Phase of Development, 2009 80
Figure 36: MAbs Market, Global, Other New Indications in Pipeline, 2009 82
Figure 37: MAbs Market, Global Major M&A Deals, 2008-2009 86
Figure 38: MAbs Market, Global, Major Licensing Agreements by Phase, 2008-2009 87
Figure 39: MAbs Market, Global, Major Licensing Agreements By Geography, 2008-2009 88
Figure 40: MAbs Market, Global, Major Licensing Agreements By Deal Value, 2008-2009 88
Figure 41: MAbs Market, Global, Top Three Companies, 2008 94
Figure 42: MAbs Market, Global, Top 5 Companies Sales Trend, 2006-2008 95
Figure 43: MAbs Market, Global, Key Target Therapies Launched, 1997-2009 96
Figure 44: MAbs Market, Global, Company Market Share Analysis, 2008 96
Figure 45: MAbs Market, Global, Company Benchmarking Analysis, 2008 97
Figure 46: MAbs Market, Global, Top 10 MAbs, 2006-2008 98
Figure 47: MAbs Market, Global, Roche/Genentech Revenue Segmentation, 2008 99
Figure 48: MAbs Market, Global, Roche/Genentech Revenue ($ m), 2006-2015 100
Figure 49: MAbs Market, Global, Roche/Genentech R&D Pipeline by Therapeutic Area, November 2009 103
Figure 50: MAbs Market, Global, Roche/Genentech Pipeline Analysis by Phase, November 2009 104
Figure 51: MAbs Market, Global, Abbott Revenue Segmentation, 2008 104
Figure 52: MAbs Market, Global, Abbott Revenue ($ m), 2006-2015 105
Figure 53: MAbs Market, Global, Abbott Pipeline Analysis by Phase, November 2009 106
Figure 54: MAbs Market, Global, Johnson & Johnson Revenue ($ m), 2006-2015 107
Figure 55: MAbs Market, Global, Johnson & Johnson R&D Pipeline by Therapeutic Area, November 2009 108
Figure 56: MAbs Market, Global, Johnson & Johnson Pipeline Analysis by Phase, November 2009 109
Figure 57: MAbs Market, Global, Biogen Idec Revenue Segmentation, 2008 109
Figure 58: MAbs Market, Global, Biogen Idec Revenue ($ m), 2006-2015 110
Figure 59: MAbs Market, Global, Biogen Idec R&D Pipeline by Therapeutic Area, November 2009 111
Figure 60: MAbs Market, Global, Biogen Idec Pipeline Analysis by Phase, November 2009 112
Figure 61: MAbs Market, Global, Merck/Schering Plough Revenues ($ m), 2006-2015 113
Figure 62: MAbs Market, Global, Merck/Schering-Plough R&D Pipeline by Therapeutic Area, November 2009 114
Figure 63: MAbs Market, Global, Merck/Schering-Plough Pipeline Analysis by Phase, November 2009 114
Figure 64: MAbs Market, Global, AstraZeneca Revenues ($ m), 2006-2015 115
Figure 65: MAbs Market, Global, AstraZeneca R&D Pipeline by Therapeutic Area, November 2009 116
Figure 66: MAbs Market, Global, AstraZeneca Pipeline Analysis by Phase, November 2009 117
Figure 67: MAbs Market, Global, Bristol-Myers Squibb Revenues ($ m), 2006-2015 118
Figure 68: MAbs Market, Global, Bristol-Myers Squibb R&D Pipeline by Phase, November 2009 119
Figure 69: MAbs Market, Global, Elan Revenues ($ m), 2006-2015 120
Figure 70: MAbs Market, Global, Elan R&D Pipeline by Therapeutic Area, November 2009 121
Figure 71: MAbs Market, Global, Elan Pipeline Analysis by Phase, November 2009 121
Figure 72: MAbs Market, Global, Eli Lilly, Revenues ($ m), 2006-2015 122
Figure 73: MAbs Market, Global, Eli Lilly R&D Pipeline by Therapeutic Area, November 2009 123
Figure 74: MAbs Market, Global, Eli Lilly Pipeline Analysis by Phase, November 2009 124
Figure 75: MAbs Market, Global, Amgen Revenues ($ m), 2006-2015 125
Figure 76: MAbs Market, Global, Amgen R&D Pipeline by Therapeutic Area, November 2009 127
Figure 77: MAbs Market, Global, Amgen Pipeline Analysis by Phase, November 2009 127