NEW YORK, March 28, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Antibody Drugs: Technologies and Global Markets
INTRODUCTION
STUDY GOALS AND OBJECTIVES
The aim of this report is to provide a range of information—from detailed analysis through industry trends—to quantify and qualify the rapidly growing market for therapeutic monoclonal antibody (mAb) drugs. Forecasts and trends are gleaned from industry sources, analyst reports, and company forecasts, as well as from assessment of available and emerging technologies.
The report develops forecasts for sales of the mAb market by individual antibody, by therapeutic antibody target (epidermal growth factor receptor [EGFR], cluster of differentiation [CD] 20, tumor necrosis factor [TNF] alpha, etc.), and by major disease applications from 2011 through 2016. Additionally, we examine strategies employed by biopharmaceutical firms to develop and market products in this explosive market sector.
Our main objective is to present a comprehensive analysis of the current market for therapeutic mAb disease-modifying products and to forecast this market's future direction through 2016.
REASONS FOR DOING THE STUDY
Therapeutic mAbs represent the largest and one of the fastest-growing classes of biopharmaceutical products by sales in the U.S. and throughout the world. Of the top 20 drugs by sales throughout the world today, five are mAbs.
During our forecast period from 2011 through 2016, eight new mAbs are forecast to enter the market, and sales of therapeutic mAbs are estimated to grow from approximately $43 billion in 2010 to nearly $58 billion in 2016. Sales of humanized and fully human antibodies for autoimmune/inflammatory diseases such as rheumatoid arthritis, ulcerative colitis, and multiple sclerosis are forecast to experience the fastest sales growth.
This period of dynamic growth for humanized and fully human antibodies plus the continued rollout of antibody-drug conjugates (ADCs), also called immunoconjugates, is expected to result in stagnating sales of chimeric antibodies from 2011 through 2016.
INTENDED AUDIENCE
This study will be of interest to those working in the biotechnology and pharmaceutical industries and related life science, drug discovery, and diagnostic test manufacturing companies, as well as all those interested or actively working in drug research.
Both individuals looking for a comprehensive listing of mAbs in human clinical-stage development and individuals looking at how the mAb drug marketplace is expected to change (in terms of sales and technology) in the coming years will find this report extremely useful.
SCOPE OF REPORT
This report analyzes and assesses therapeutic applications of mAbs in human medicine. Covered in this report are mAbs exclusively, including the combination of mAbs when they are attached to a cytotoxic agent such as with ADCs.
Excluded from this report are diagnostic uses of mAbs (such as for imaging purposes) and therapeutic antibodies for veterinary use. Also excluded are research applications of mAbs.
The scope of the study is global. The "Overview" section provides a discussion of the importance and advantages of antibody-based products, valuation of antibody product sales, patent issues and differences in applicability of mAbs products versus polyclonal antibodies (pAbs), and other competing agents such as small molecule therapeutics.
The "Technology and Technical Issues" section discusses new directions in antibody research, the types of antibodies used as therapeutics, the challenges in antibody production, and other approaches—in particular transgenic sources—of antibody production.
The "Products" section provides a synopsis of more than 60 mAb drugs, including those currently marketed and those in late-stage development. Comparative product and sales analyses are provided for individual products. Tables include current and forecasted sales by individual product, sales by target and technology (for mAb-based drugs), as well as global market size and growth estimates for therapeutic mAbs.
The "Applications" section provides an overview of the leading indications for available and emerging antibody-based therapeutics. These include selected indications for autoimmune diseases (specifically rheumatoid arthritis, psoriasis, and Crohn's disease), cancer indications (specifically the most common solid tumor types, leukemias, and lymphomas) cardiovascular diseases, infectious diseases, ophthalmic indications, and respiratory diseases.
The "Industry Structure" section provides an overview of the antibody industry as well as a discussion of the pending huge impact of genomics and the emergence of biotechnology firms into the mainstream market.
The "Company Profiles" section emphasizes companies that lead the biotechnology and pharmaceutical industry in the research and development of antibody drugs and the innovative products that those companies have launched or have in development.
INFORMATION SOURCES
The information in this report was derived from the review of more than 200 biotechnology and pharmaceutical companies developing mAbs and the review of journal articles related to mAb therapeutics. Sources of information include PubMed, ClinicalTrials.gov, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and company presentations and annual reports.
TABLE OF CONTENTS
CHAPTER ONE: INTRODUCTION 1
STUDY GOALS AND OBJECTIVES . 1
REASONS FOR DOING THE STUDY 1
INTENDED AUDIENCE 2
SCOPE OF REPORT 2
INFORMATION SOURCES . 3
ANALYST CREDENTIALS 3
RELATED REPORTS . 3
BCC ON-LINE SERVICES . 4
DISCLAIMER . 4
CHAPTER TWO: SUMMARY 5
SUMMARY TABLE GLOBAL SALES OF THERAPEUTIC MONOCLONAL ANTIBODIES, THROUGH 2016 ($ MILLIONS) 5
SUMMARY FIGURE GLOBAL SALES OF THERAPEUTIC MONOCLONAL ANTIBODIES, 2009-2016 ($ MILLIONS) . 6
CHAPTER THREE: OVERVIEW 7
DEFINITIONS 7
DEFINITIONS (CONTINUED) . 8
THE IMPORTANCE OF ANTIBODY DRUGS AND DIAGNOSTICS . 9
THE IMPORTANCE OF ANTIBODY … (CONTINUED) 10
INTELLECTUAL PROPERTY ISSUES AND PATENT LICENSING 11
THE HISTORY OF THE COMMERCIALIZATION OF MONOCLONAL ANTIBODY PRODUCTS . 11
TABLE 1 TIMELINE TO COMMERCIALIZATION OF MONOCLONAL ANTIBODY PRODUCTS . 11
ADVANTAGES OF MONOCLONAL ANTIBODY DRUGS 12
WHY DO MONOCLONAL ANTIBODY PRODUCTS HAVE SO MANY APPLICATIONS COMPARED WITH POLYCLONAL ANTIBODY PRODUCTS? 13
VALUATION OF ANTIBODY PRODUCT SALES . 14
CHAPTER FOUR: TECHNOLOGY AND TECHNICAL ISSUES . 15
OVERVIEW . 15
OVERVIEW (CONTINUED) . 16
TABLE 2 MONOCLONAL ANTIBODIES VERSUS SMALL MOLECULE DRUGS . 17
TABLE 2 (CONTINUED) . 18
TABLE 3 MONOCLONAL ANTIBODIES VERSUS POLYCLONAL ANTIBODIES . 18
THE HAMA PROBLEM AND ITS RESOLUTION . 19
PHAGE DISPLAY AND POLYSOME DISPLAY 20
PHAGE DISPLAY AND POLYSOME … (CONTINUED) 21
DIRECTED EVOLUTION 22
ANTIBODY CLASSES 22
TABLE 4 ANTIBODY TYPES AND DESCRIPTIONS . 23
ANTIBODY FORMS IN PRODUCTS 23
TABLE 5 GLOBAL SALES OF THERAPEUTIC MONOCLONAL ANTIBODIES BY ANTIBODY TECHNOLOGY TYPE, THROUGH 2016 ($ MILLIONS) . 24
TABLE 6 ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY
ANTIBODY FORM (NUMBER/%) 25
TABLE 7 ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY TECHNOLOGY FORM AND STAGE OF DEVELOPMENT 25
TABLE 8 ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY TARGET . 26
ABTIDES 26
ANTIBODY-DRUG CONJUGATES / IMMUNOCONJUGATES 26
ANTISERUMS . 27
BISPECIFIC ANTIBODIES 28
CAMOUFLAGED ANTIBODIES 28
CHIMERIC ANTIBODIES 29
HUMANIZED ANTIBODIES 29
Humanized Antibodies (Continued) . 30
FULLY HUMAN ANTIBODIES 31
PROGENITOR STEM CELLS . 32
SINGLE-CHAIN ANTIBODIES 32
SYNTHETIC ANTIBODIES 33
SOURCES OF MONCLONAL ANTIBODIES ON THE MARKET 34
TABLE 9 MARKETED MONOCLONAL ANTIBODY PRODUCTS AND THEIR SOURCES 34
TABLE 9 (CONTINUED) . 35
TABLE 9 (CONTINUED) . 36
THE SPECIAL CASE OF ENBREL. 36
ANTIBODY TECHNOLOGIES IN DEVELOPMENT 37
AFFIBODIES . 37
DOMAIN ANTIBODIES 37
NANOBODIES . 38
TABLE 10 MONOCLONAL ANTIBODIES IN PHASE 3 DEVELOPMENT 39
TABLE 10 (CONTINUED) . 40
TABLE 11 MONOCLONAL ANTIBODIES IN PHASE 2 DEVELOPMENT 40
TABLE 11 (CONTINUED) . 41
TABLE 11 (CONTINUED) . 42
TABLE 11 (CONTINUED) . 43
TABLE 11 (CONTINUED) . 44
TABLE 11 (CONTINUED) . 45
TABLE 11 (CONTINUED) . 46
TABLE 11 (CONTINUED) 47
TABLE 12 MONOCLONAL ANTIBODIES IN PHASE 1 DEVELOPMENT 47
TABLE 12 (CONTINUED) 48
TABLE 12 (CONTINUED) . 49
TABLE 12 (CONTINUED) . 50
TABLE 12 (CONTINUED) . 51
TABLE 12 (CONTINUED) . 52
NEW DIRECTIONS IN ANTIBODY RESEARCH 53
THE MARKET OPPORTUNITY FOR TRANSGENIC PRODUCTION OF ANTIBODY PRODUCTS 53
THE MARKET OPPORTUNITY FOR …(CONTINUED) 54
THE HIGH COST OF PRODUCING ANTIBODIES AND OTHER PROTEIN DRUGS . 55
THE GROWING CRISIS IN MEETING PRODUCTION DEMANDS FOR PROTEIN DRUGS 56
THE TRANSGENIC ADVANTAGE . 56
TRADITIONAL PRODUCTION METHODS 57
MICROBIAL FERMENTATION . 58
MAMMALIAN CELL CULTURE 58
THE ENBREL SHORTAGE . 59
THE CRUNCH IN CAPACITY. 59
REASONS FOR THE NEED TO INCREASE PROTEIN DRUG PRODUCTION 60
GENOMICS AND GENE DISCOVERY DRIVE THE EXPANDING DEVELOPMENT OF PROTEIN DRUGS 61
PRODUCTION OF ANTIBODIES IN ANIMALS . 62
PRODUCTION OF ANTIBODIES … (CONTINUED) . 63
GOATS AS MONOCLONAL ANTIBODIES FACTORIES 64
PRODUCTION OF ANTIBODIES IN PLANTS 64
PLASTIDS 64
TARGETING AND COMPARTMENTALIZING 65
TRANSGENIC SEEDS FOR ANTIBODY STORAGE 65
CHAPTER FIVE: PRODUCTS 66
OVERVIEW . 66
MARKETED PRODUCTS 66
TABLE 13 GLOBAL SALES OF MONOCLONAL ANTIBODIES, BY
PRODUCT THROUGH 2016 ($ MILLIONS) . 67
TABLE 14 U.S. SALES OF MONOCLONAL ANTIBODIES, BY
PRODUCT THROUGH 2016 ($ MILLIONS) . 68
TABLE 15 REST OF WORLD SALES OF MONOCLONAL ANTIBODIES, BY PRODUCT THROUGH 2016 ($ MILLIONS) . 69
GEMTUZUMAB OZOGAMICIN (MYLOTARG) 70
DACLIZUMAB (ZENAPAX) 71
Daclizumab (Zenapax) (Continued) 72
TABLE 16 DACLIZUMAB CHOICE STUDY RESULTS . 73
CATUMAXOMAB (REMOVAB) 74
TOCILIZUMAB (ACTEMRA, ROACTEMRA, RG1569) . 75
TRASTUZUMAB (HERCEPTIN, RG597) . 76
Trastuzumab (Herceptin, RG597) (Continued) 77
BEVACLIZUMAB (AVASTIN, RG435) . 78
Bevaclizumab (Avastin, RG435) (Continued) 79
Bevaclizumab (Avastin, RG435) (Continued) 80
CETUXIMAB (ERBITUX) . 81
Cetuximab (Erbitux) (Continued) . 82
PANITUMUMAB (VECTIBIX) 83
Panitumumab (Vectibix) (Continued) . 84
IBRITUMOMAB TIUXETAN (ZEVALIN) 85
Results of Trials . 86
Sales of Zevalin 87
ALEMTUZUMAB (LEMTRADA, CAMPATH, MABCAMPATH) 88
Alemtuzumab (… (Continued) 89
Alemtuzumab (… (Continued) 90
NATALIZUMAB (TYSABRI) . 91
TABLE 17 TYSABRI SENTINEL AND AFFIRM STUDY RESULTS 92
Natalizumab (Tysabri) (Continued) 93
TOSITUMOMAB-I (BEXXAR) 94
Tositumomab-I (Bexxar) (Continued) . 95
OFATUMUMAB (ARZERRA) 96
Ofatumumab (Arzerra) (Continued) . 97
RITUXIMAB (RITUXAN, MABTHERA, RG105) . 98
INFLIXIMAB (REMICADE) 99
Infliximab (Remicade) (Continued) . 100
DENOSUMAB (PROLIA, XGEVA) . 101
IPILIMUMAB (YERVOY, MDX-010) 102
ADALIMUMAB (HUMIRA) . 103
GOLIMUMAB (SIMPONI) 104
CANAKINUMAB (ILARIS, ACZ885) 105
ECULIZUMAB (SOLIRIS) . 106
PALIVIZUMAB (SYNAGIS) 107
ABCIXIMAB (REOPRO) 108
Abciximab (ReoPro) (Continued) . 109
Abciximab (ReoPro) (Continued) . 110
RANIBIZUMAB (LUCENTIS) . 111
Ranibizumab (Lucentis) (Continued) 112
MUROMONAB (ORTHOCLONE OKT3) 113
OMALIZUMAB (XOLAIR) . 113
USTEKINUMAB (STELARA, CNTO 1275) 114
Ustekinumab (Stelara, CNTO 1275) (Continued) 115
CERTOLIZUMAB PEGOL (CIMZIA) . 116
BASILIXIMAB (SIMULECT) 116
Basiliximab (Simulect) (Continued) 117
BELIMUMAB (BENLYSTA) . 118
NIMOTUZUMAB . 119
PRODUCTS IN DEVELOPMENT . 119
TANEZUMAB (RN624) 119
VEDOLIZUMAB (MLN0002). 120
LY2127399 121
OTELIXIZUMAB . 121
MEPOLIZUMAB (BOSATRIA) 122
TEPLIZUMAB (MGA031, HOKT3-GAMMA1) . 122
BAPINEUZUMAB (AAB-001) . 123
GANITUMAB (AMG 479) 124
OBINUTUZUMAB (AFUTUZUMAB, GA101, RG7159) 125
ZANOLIMUMAB (FORMERLY HUMAX-CD4) . 126
RESLIZUMAB (CINQUIL) 127
BLINATUMOMAB (MT103) 128
FARLETUZUMAB (MORAB-003) . 128
EPRATUZUMAB 129
GIRENTUXIMAB (RENCAREX) 129
INOTUZUMAB OZOGAMICIN (CMC-544) 130
BRIAKINUMAB (ABT-874) . 131
ELOTUZUMAB 132
SILTUXIMAB (CNTO 328) 133
TRASTUZUMAB EMTANSINE (T-DM1, RG3502) 133
INOLIMOMAB (LEUKOTAC) . 134
ITOLIZUMAB (T1H, ANTI-CD6) 134
NAPTUMOMAB ESTAFENATOX (ANYARA) . 135
NECITUMUMAB (IMC-11F8) . 135
PERTUZUMAB 136
RAMUCIRUMAB (IMC-1121B, LY3009806) 137
RAXIBACUMAB 138
MK-3415, MK-6072, AND MK-3415A . 138
MK-3415, MK-6072, and MK-3415A (Continued) 139
CHAPTER SIX: APPLICATIONS 140
OVERVIEW . 140
TABLE 18 MONOCLONAL ANTIBODIES ON THE MARKET, BY
INDICATION 2011 (NUMBER/%) 140
TABLE 19 GLOBAL SALES OF THERAPEUTIC MONOCLONAL
ANTIBODIES, BY APPLICATION, THROUGH 2016 ($ MILLIONS) . 141
TABLE 20 MONOCLONAL ANTIBODIES IN CLINICAL STAGE DEVELOPMENT, BY INDICATION, 2011 (NUMBER/%) . 141
TABLE 20 (CONTINUED) . 142
AUTOIMMUNE DISEASES 142
CROHN'S DISEASE 143
PSORIASIS . 144
RHEUMATOID ARTHRITIS . 145
TABLE 21 SALES OF MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF INFLAMMATORY DISEASES (NOT INCLUDING MS), THROUGH 2016 ($ MILLIONS) . 145
SOLID TUMORS 146
U.S. CANCER STATISTICS 146
TABLE 22 INCIDENCE, MORTALITY, AND SURVIVAL RATES FOR COMMON CANCERS IN THE U.S., 2011 . 147
TABLE 23 CANCER PREVALENCE RATES IN THE U.S., 2008 (IN THOUSANDS) . 148
BREAST CANCER . 149
COLORECTAL CANCER 149
HEAD AND NECK CANCER 149
KIDNEY CANCER . 149
LIVER CANCER 149
LUNG CANCER . 150
MALIGNANT MELANOMA 150
OSTEOSARCOMA . 151
OVARIAN CANCER 151
PANCREATIC CANCER . 152
PROSTATE CANCER 152
STOMACH CANCER . 153
ANTIBODY PRODUCTS ON THE MARKET FOR THE TREATMENT OF CANCER . 153
TABLE 24 SALES OF MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF SOLID TUMORS, BY REGION, THROUGH 2016 ($ MILLIONS) . 153
LYMPHOMAS AND LEUKEMIAS 153
NON-HODGKIN LYMPHOMA . 154
LEUKEMIAS 154
Leukemias (Continued) . 155
CARDIOVASCULAR DISEASES 156
PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY 157
INFECTIOUS DISEASES 158
CYTOMEGALOVIRUS INFECTION 159
HEPATITIS 160
RESPIRATORY SYNCYTIAL VIRUS INFECTION 160
TABLE 25 SALES OF MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF INFECTIOUS DISEASES, BY REGION, THROUGH 2016 ($ MILLIONS) . 161
MULTIPLE SCLEROSIS . 161
TABLE 26 SALES OF MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF MULTIPLE SCLEROSIS, BY REGION, THROUGH 2016 ($ MILLIONS) . 162
OPHTHALMIC DISEASES 162
MACULAR DEGENERATION 162
OTHER THERAPEUTIC APPLICATIONS . 163
TABLE 27 SALES OF MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF OTHER DISEASES, BY REGION, THROUGH 2016 ($ MILLIONS) . 163
CHAPTER SEVEN: INDUSTRY STRUCTURE . 164
OVERVIEW . 164
ORIGINATORS . 164
COMMERCIAL DEVELOPERS . 165
VENDORS . 166
MANUFACTURERS . 166
TECHNOLOGY INNOVATORS. 167
PRICING FORECASTS 168
THE REGULATORY ENVIRONMENT 168
THE REGULATORY ENVIRONMENT (CONTINUED) . 169
GENOMICS AND MONOCLONAL ANTIBODIES: A MATCH FOR SUCCESS . 170
GENOMICS AND MONOCLONAL … (CONTINUED) . 171
GENOMICS AND MONOCLONAL … (CONTINUED) . 172
COMPANY SALES AND MARKET SHARE . 173
TABLE 28 SALES OF MARKETED ANTIBODIES BY
MANUFACTURER, THROUGH 2016 ($ MILLIONS) 174
TABLE 29 MANUFACTURERS OF ANTIBODIES BY MARKET SHARE, 2011 AND 2016 (%) 175
TABLE 30 MONOCLONAL ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY COMPANY . 176
COMPANY PROFILES 176
ABBOTT LABORATORIES . 176
ALEXION PHARMACEUTICALS 177
AMGEN 178
ASTRAZENECA . 179
AstraZeneca – U.S. Headquarters 179
BAYER AG . 180
Bayer (U.S. Location) 180
BIOGEN IDEC . 181
BRISTOL-MYERS SQUIBB 182
BTG . 183
DAIICHI SANKYO . 183
ELAN 184
EMERGENT BIOSOLUTIONS . 185
EISAI 185
ELI LILLY 186
GENMAB 186
Genmab (U.S. Location) 187
GLAXOSMITHKLINE . 187
GlaxoSmithKline (U.S. Location) 187
HUMAN GENOME SCIENCES 188
JOHNSON & JOHNSON . 188
KALOBIOS PHARMACEUTICALS 189
MERCK KGAA (MERCK SERONO) . 190
MORPHOSYS . 191
NOVARTIS . 191
PFIZER . 192
ROCHE . 193
To order this report:
Biopharmaceutical Industry: Antibody Drugs: Technologies and Global Markets
Check our Industry Analysis and Insights
CONTACT:
Nicolas Bombourg
Reportlinker
Email: [email protected]
US: (805)652-2626
Intl: +1 805-652-2626
SOURCE Reportlinker
Share this article