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Antibody Drugs: Technologies and Global Markets
Date:3/21/2012

NEW YORK, March 21, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Antibody Drugs: Technologies and Global Markets

http://www.reportlinker.com/p0801344/Antibody-Drugs-Technologies-and-Global-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical

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

More  Market Research Report

Check our  Industry Analysis and Insights

Nicolas Bombourg

Reportlinker

Email: nbo@reportlinker.com

US: (805)652-2626

Intl: +1 805-652-2626 


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