Biologic Therapeutic Drugs: Technologies and Global Markets

  • January 2013
  • -
  • BCC Research
  • -
  • 142 pages

INTRODUCTION

STUDY GOALS AND OBJECTIVES

This study provides a comprehensive analysis of biologics, or biopharmaceuticals, on a global basis. Its aim is to provide a range of information, from detailed product analyses within disease subsegments to overall industry trends, in order to quantify and qualify the market for therapeutic drug products in the biologics segment. Segments are forecast on a global basis. Forecasts and trends are developed from a cross-reference of data points, gleaned from proprietary industry sources, company publications, industry benchmarking and other divergent data sources to arrive at a cogent and coordinated forecast.

REASONS FOR DOING THE STUDY

The biologics, or biopharmaceutical, therapeutic market is wide ranging and has important implications for the future of medicine and industry advancement. For companies with an effective strategy, market opportunity awaits. Importantly, the ability to develop an effective strategy begins with where opportunity exists and ends with how to effectively execute to capture profit from opportunity.Market growth has been spurred by the need for a more extensive pipeline by drug companies, attractive targets against challenging diseases, a push by companies to pursue biosimilars and enabling manufacturing technologies that reduce the cost to produce profitable products.This study deeply investigates one of the most important market drivers: individual products. Specific product reviews of key drug programs that are expected to dominate the biopharmaceutical marketplace in the coming years are reviewed.This report seeks to address the critically important topics of analyzing a changing market dynamic, emerging players and technologies, strategies for accessing emerging markets, and specific disease segments and geographies in order to allocate resources and make effective decisions.

SCOPE OF REPORT

Current and projected product forecasts during the forecast period (2012 to 2017) are discussed. As well, new products approved in 2009 and 2012 by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) and those products expected to be approved within the forecast period are projected within their respective segment. Figures for 2012 are projected estimates, except where actual results have been reported due to the release timing of the report. For large markets segments such as mAb, therapeutic proteins and vaccines, specific mechanisms of action are discussed in detail.

For example, the trend of increased use of vascular endothelial growth factor (VEGF) inhibitors as a first-line therapy for multiple disease states such as colorectal cancer and the ophthalmic disease wet age-related macular degeneration (AMD) are discussed.The report includes analysis of leading and emerging competitors in the current worldwide market. Profiles of manufacturers of leading products as well as biotechnology companies with novel products in development are analyzed to define their specific product strategies employed. This report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. The competitive environment is examined with a special focus on how new products and technologies are influencing the current standard of care. Detailed profiles of current market leaders are discussed, as well as companies with innovative products poised to advance within the forecast period.Market figures are based on revenues at the manufacturers' level and are projected at 2012 dollar value. Inflation is not computed into the projection figures.

Trends are assessed based on projected sales for existing products, new product introductions, expanded indications for existing products, and projected changes in the prevalence, diagnosis, and scripting rates for certain diseases.Included in this report are forecasts by product, product category and by company from 2009 through 2017. The study is arranged to offer an overview of the biologics market accompanied by product, company, geography and mechanism of action with forecasts broken down and covered by geographic region or country. Virtually the entire globe is covered to include prevalence data for each disease subsegment.Excluded from this report are over-the-counter (OTC) medications and other consumables that do not require a physician’s prescription.Sales figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of revenue change. Revenue figures do not account for variation in local currencies.All market share data presented are on a global basis unless specifically noted.

INTENDED AUDIENCE

This report is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investors, investor consultants, and anyone interested in the biologics market, its products, its industry participants and its future.The importance of identifying overall market trends, product opportunities, emerging geographies, merger and acquisition (M&A) opportunities, and insights that provide guidance for sales growth or defensive moves cannot be overstated for a variety of constituents, including:
- Established companies in the industry shall benefit from the contents, including corporate strategy, sales and marketing, business development, and research and development (R&D).
- Emerging biopharma and biotechnology players in the segment must understand specific opportunities for out-licensing, originating from the elements of differentiation of their therapeutic drug as compared to leading, competitive and emerging therapies. As well, market forecasts can support investment, provided a thorough and detailed substantiation is provided for the market forecast, as is found in this study.
- Investment firms evaluating candidates for venture capital or hedged investments will gain insights as to the opportunity and risks that are being encountered in the industry in a product and company specific analysis.
- Equity analysts are provided detailed forecasts for the next five years, substantiated by quantitative analysis that can support further analysis to product and company forecasts over the short and long run.

METHODOLOGY AND INFORMATION SOURCES

Both primary and secondary research methodologies were used in preparing this report. In-depth interviews were conducted with leading experts in the field who are executives in companies, industry analysts and leading medical practitioners in the field.Information to prepare this report was obtained from participating and emerging companies in the biologics area; various institutes of the National Institutes of Health (NIH) and published data in medical journals such as Nature Biotech, Genetic and Engineering News, Journal of Experimental Medicine, European Journal of Immunology, Oncology, Clinical and Diagnostic Laboratory Immunology, Immunobiology, Nature Immunology, and many others. Other information was from the World Health Organization and other government agencies, literature searches, and others. Population estimates are based on those reported by the international database of the U.S. Census Bureau.Current and historical revenue figures for individual products have been sourced from company disclosures that exist in the public domain; annual reports, 10Ks, investor briefings or from government sources.

ANALYST'S CREDENTIALS

Jackson Highsmith is a life sciences research consultant with more than 16 years of research experience. Jackson has been consulting with specialty pharmaceuticals and large pharmaceutical industry players since 2007. Prior to that, he worked at a large research consultancy where he focused on in-depth research; he also has worked at a large pharmaceutical company in a wide range of medical therapeutics in early and midstage drug development.

REPORT HIGHLIGHTS

This report provides:
- An overview of the global market for biologic therapeutic drugs
- Analyses of global market trends, with data from 2011, estimates for 2012, and projections of compound annual growth rates (CAGRs) through 2017
- Coverage of large market segments such as monoclonal antibodies (mAb), therapeutic proteins, and vaccines
- Examination of the competitive environment with a special focus on how new products and technologies are influencing the current standard of care
- Comprehensive profiles of current market leaders, as well as companies with innovative products poised to advance within the forecast period.

Table Of Contents

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 1
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
SCOPE OF REPORT 1
INTENDED AUDIENCE 2
METHODOLOGY AND INFORMATION SOURCES 3
ANALYST'S CREDENTIALS 3
RELATED REPORTS 3
BCC ON-LINE SERVICES 3
DISCLAIMER 4

CHAPTER 2 EXECUTIVE SUMMARY 6
SUMMARY TABLE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT,
THROUGH 2017 ($ MILLIONS) 6
SUMMARY FIGURE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT,
2009-2017 ($ MILLIONS) 6

CHAPTER 3 OVERVIEW 9
BIOLOGICS NEW PRODUCTS IN DISEASE TREATMENT 9
TABLE 1 SUBCLASSES OF BIOLOGICS DRUGS 10
MONOCLONAL ANTIBODIES 10
FIGURE 1 DIAGRAM OF TYPICAL ANTIBODY STRUCTURE 11
THERAPEUTIC PROTEINS 12
HEMOPOIETIC GROWTH FACTORS (HGFS) 12
Cytokines 13
Blood Factors 13
VACCINES 14
Traditional Vaccines 14
Novel Vaccine Technologies 14
MAJOR BIOLOGICS PRODUCT CLASSES 15
TABLE 2 MONOCLONAL ANTIBODY AND THERAPEUTIC PROTEIN DRUGS SUBCLASSES 15
TABLE 3 GLOBAL BIOLOGICS MARKET REVENUE, THROUGH 2017 ($ MILLIONS) 15
CHALLENGES WITH RNAI 16
ORPHAN DRUG DESIGNATION 17

CHAPTER 4 BIOPHARMACEUTICAL INDUSTRY AND COMPETITIVE ANALYSIS 20
BIOPHARMACEUTICAL INDUSTRY STRUCTURE 20
THE ORIGINS OF BIOTECHNOLOGY 20
INVOLVEMENT OF LARGE PHARMACEUTICAL COMPANIES 21

CHAPTER 5 BIOLOGICS MARKET OVERVIEW 23
TABLE 4 MAJOR BIOPHARMACEUTICAL PLAYERS BY REVENUE, 2011 ($ MILLIONS) 23
TABLE 5 TOP 25 BIOPHARMACEUTICAL PRODUCTS BY REVENUE, 2011 ($ MILLIONS) 24
TABLE 6 TOP 50 REVENUE GENERATING BIOPHARMACEUTICAL PRODUCTS, 2010 ($
MILLIONS) 25
MONOCLONAL ANTIBODIES 26
TABLE 7 GLOBAL MARKET FORECAST FOR MABS, THROUGH 2017 ($ MILLIONS) 27
TABLE 8 LEADING MONOCLONAL ANTIBODY PRODUCTS, 2011 ($ MILLIONS) 27
TABLE 9 VOLUME OF MAMMALIAN CELL CULTURE PRODUCED MABS, 2012 AND 2017 28
CONJUGATED ANTIBODIES 29
ANTIBODY FRAGMENTS 30
LARGE PHARMACEUTICAL COMPANIES AND BIOPHARMA 30
LARGE PHARMACEUTICAL COMPANY CONSORTIUM FORMED 31
THERAPEUTIC PROTEINS 31
TABLE 10 REVENUE FOR THERAPEUTIC PROTEINS SEGMENT OF BIOLOGICS MARKET,
THROUGH 2017 ($ MILLIONS) 32
HEMOPOIETIC GROWTH FACTORS 32
TABLE 11 LEADING HEMOPOIETIC GROWTH FACTOR BIOLOGIC PRODUCTS ($ MILLIONS) 33
Hemopoietic Growth Factor Clinical Trials 34
TABLE 12 CLINICAL TRIALS ON G-CSF RECEPTORS IN 2012 34
CYTOKINES 35
TABLE 13 CLINICAL TRIALS ON CYTOKINES UNDERWAY IN 2012 36
ANTIHEMOPHILIA PRODUCTS 37
TABLE 14 TOP 30 REVENUE-GENERATING THERAPEUTIC PROTEIN PRODUCTS, 2011 ($
MILLIONS) 37
VACCINES 39
VACCINE MARKET REVENUES 39
TABLE 15 VACCINE REVENUES, THROUGH 2017 ($ MILLIONS) 40
TABLE 16 CLINICAL TRIALS ON VACCINES, 2012 40

CHAPTER 6 IMPACT OF BIOSIMILAR DRUGS ON BIOLOGICS MARKET 43
TABLE 17 PATENT AND MARKETING EXCLUSIVITY EXPIRATION FOR TOP SELLING
BIOLOGICS 44
TABLE 18 NUMBER OF BIOSIMILARS PREDICTED TO BE LAUNCHED DURING PERIOD
2012-2019 44
TABLE 19 TOP 10 BIOLOGICS DRUGS IN (2011 REVENUES) WITH GREATEST LEVEL OF
BIOSIMILAR COMPETITION ($ MILLIONS) 45
RATIONALE FOR BIOSIMILAR DEVELOPMENT 45
ERYTHROPOIETIN 45
GRANULOCYTE-COLONY STIMULATING FACTOR 46
INTERFERONS 46
HUMAN GROWTH HORMONE 46
OPPORTUNITY AND THREAT FROM BIOSIMILARS 46
MARKET TRENDS: GROWTH DRIVERS AND RESISTORS 47
BIOSIMILARS: REGULATORY UPDATE 48
U.S. FDA 48
EUROPEAN BIOSIMILAR REGULATORY GUIDANCE 48

CHAPTER 7 MAJOR PLAYERS IN BIOLOGIC AND BIOSIMILARS DRUG MARKET 51
MONOCLONAL ANTIBODIES 51
TABLE 20 TOP 10 SELLING MABS IN 2011 51
TABLE 21 MAJOR PLAYERS (BY REVENUE) IN MAB MARKET IN 2011 ($ MILLIONS) 52
THERAPEUTIC PROTEINS 52
TABLE 22 TOP 10 THERAPEUTIC PROTEIN PRODUCTS, 2011 ($ MILLIONS) 53
TABLE 23 MAJOR PLAYERS (BY REVENUE) IN THE THERAPEUTIC PROTEINS MARKET, 2011
($ MILLIONS) 53
VACCINES 54
TABLE 24 TOP 10 VACCINES BY REVENUE, 2011 ($ MILLIONS) 55

CHAPTER 8 GEOGRAPHIC DISTRIBUTION OF BIOLOGICS MARKET 57
GEOGRAPHIC MARKET ANALYSIS 57
TABLE 25 GEOGRAPHIC DISTRIBUTION OF TOTAL BIOLOGICS MARKET, THROUGH 2017 ($
MILLIONS, % OF TOTAL) 58

CHAPTER 9 PIPELINE ANALYSIS 60
TABLE 26 BIOLOGIC DRUGS OBTAINING FDA APPROVAL FROM 2010 TO 2012 60
BIOLOGICS IN COMPANY PIPELINES 2012 61
AMGEN 61
TABLE 27 AMGEN BIOLOGICS PIPELINE, 2012 61
ROCHE 62
TABLE 28 ROCHE/GENENTECH/CHUGAI BIOLOGICS PIPELINE, 2012 62
BAYER 63
TABLE 29 BAYER BIOLOGICS PIPELINE, 2012 63
NOVO NORDISK 64
TABLE 30 NOVO NORDISK BIOLOGICS PIPELINE, 2012 64
MERCK 65
TABLE 31 MERCK BIOLOGICS PIPELINE, 2012 65
PFIZER 65
TABLE 32 PFIZER BIOLOGICS PIPELINE, 2012 66
BIOGEN IDEC 66
TABLE 33 BIOGEN IDEC BIOLOGICS PIPELINE, 2012 67
SANOFI 67
TABLE 34 SANOFI BIOLOGICS PIPELINE, 2012 68

CHAPTER 10 BIOLOGICS CLINICAL TRIALS 70
TABLE 35 DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUG
APPROVAL 70
CANCER BIOLOGIC DRUGS 71
TABLE 36 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR CANCER
TREATMENT, 2012 71
GASTROINTESTINAL AND RELATED DISEASES 74
TABLE 37 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR GI AND RELATED
DISEASE TREATMENT, 2012 74
HEART DISEASE 75
TABLE 38 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR HEART AND
RELATED DISEASE TREATMENT, 2012 76

CHAPTER 11 MERGER AND ACQUISITIONS IN BIOLOGICS AREA 78
TABLE 39 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS
IN BIOLOGICS 78
TABLE 40 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS
IN BIOLOGICS (CONTINUED) 82

CHAPTER 12 PATENTS FOR BIOLOGIC DRUGS 90
MONOCLONAL ANTIBODY PATENTS 90
TABLE 41 U.S. PATENTS FOR MONOCLONAL ANTIBODIES 90
THERAPEUTIC PROTEIN PATENTS 93
TABLE 42 PATENTS ISSUED FOR THERAPEUTIC PROTEINS 93
VACCINE PATENTS 96
TABLE 43 PATENTS ISSUED FOR VACCINES (OR VACCINE RELATED PRODUCTS)
ASSOCIATED WITH BIOLOGICALS 96

CHAPTER 13 BIOLOGICS MANUFACTURING 100
BIOPHARMACEUTICAL MANUFACTURING PROCESS 100
THE PREPARATION PROCESS 101
Cell Banking and Seed Culture 101
Production 101
Cell Culture Formats 101
Batch and Continuous Processing 102
Perfusion and Fed-Batch Mode 102
TABLE 44 BIOLOGICS PRODUCTS USING PERFUSION METHOD 103
Perfusion Methods 103
Fed-Batch Methods 103
TABLE 45 BIOLOGICS THERAPEUTIC PRODUCTS USING FED-BATCH METHOD 104
Harvest and Concentration 104
THE FINISHING PROCESS 104
PURIFICATION OF BIOPHARMACEUTICALS 105
AUTOMATED PROCESSING SYSTEMS-SKIDS 106
FORMULATION 107
LYOPHILIZATION 107
CRYOGRANULATION 107
SPRAY DRYING 107
UNDERCOOLING 108
PROCESS INTEGRATION: THE CRITICAL ACTIVITY 108
EXPRESSION SYSTEMS FOR THERAPEUTIC PROTEIN PRODUCTION 108
MICROBIAL THERAPEUTIC PROTEIN PRODUCTION 109
E.COLI ADVANTAGES FOR MICROBIAL PRODUCTION 109
Fast Accumulation 109
Safety Advantage 109
Growth on Inexpensive Carbon Sources 109
Propensity for High-Cell-Density Fermentations 109
Simple Process Scale-Up 110
TABLE 46 MARKETED BIOPHARMACEUTICALS USING E.COLI EXPRESSION SYSTEM 110
MAMMALIAN CELL THERAPEUTIC PROTEIN PRODUCTION 110
TABLE 47 MARKETED BIOPHARMACEUTICALS USING ANIMAL CELL LINE EXPRESSION
SYSTEM 111
EMERGING PRODUCTION SYSTEMS 112
PICHIA AND FILAMENTOUS FUNGI 112
TRANSGENIC PROTEIN PRODUCTION SYSTEMS 113
TRANSGENIC PLANTS 113
TABLE 48 PLANT-BASED TRANSGENIC COMPANIES AND THEIR PIPELINES OF
RECOMBINANT PROTEINS 114
TRANSGENIC ANIMALS 115
TABLE 49 THERAPEUTIC PROTEINS PRODUCED IN TRANSGENIC ANIMALS 115
TABLE 50 MARKETED BIOPHARMACEUTICALS USING MURINE (MOUSE) HYBRIDOMA
EXPRESSION SYSTEM 117

CHAPTER 14 COMPANY PROFILES 119
ABBOTT LABORATORIES 119
BIOLOGICAL PRODUCTS 119
ADVAXIS INC. 119
BIOLOGICAL PRODUCTS 120
AGENNIX AG 120
AKEBIA THERAPEUTICS INC. 121
AMGEN INC. 121
BIOLOGICAL PRODUCTS 121
APOGENIX GMBH 122
BAXTER BIOSCIENCE INC. 122
BIOLOGICAL PRODUCTS 123
BAYER SCHERING PHARMA AG 123
BIOLOGICAL PRODUCTS 123
BIOGEN IDEC INC. 124
BIOLOGICAL PRODUCTS 124
BIOINVENT INTERNATIONAL AB 124
BIOLOGICAL PRODUCTS 125
BIOVITRUM AB 125
CELLDEX THERAPEUTICS INC. 125
BIOLOGICAL PRODUCTS 126
CHUGAI PHARMACEUTICALS 126
BIOLOGICAL PRODUCTS 126
CSL BEHRING 126
BIOLOGICAL PRODUCTS 127
CYTHERIS SA 127
DEBIOPHARM GROUP 127
DENDREON CORPORATION 128
DYAX CORP. 128
BIOLOGICAL PRODUCTS 129
ELI LILLY and CO. 129
BIOLOGICAL PRODUCTS 129
ERYTECH PHARMA 130
BIOLOGICAL PRODUCTS 130
GENENTECH INC. 130
BIOLOGICAL PRODUCTS 131
GENMAB A/S 131
BIOLOGICAL PRODUCTS 131
GENZYME CORPORATION 132
BIOLOGICAL PRODUCTS 132
GLAXOSMITHKLINE PLC 132
BIOLOGICAL PRODUCTS 133
GLYCOTOPE GMBH 133
BIOLOGICAL PRODUCTS 134
H. LUNDBECK A/S 134
CURRENT PRODUCTS 134
HAWAII BIOTECH INC. 135
HELIX BIOPHARMA CORPORATION 135
HUMAN GENOME SCIENCES INC. 135
BIOLOGICAL PRODUCTS 136
IMCLONE SYSTEMS INC. 136
BIOLOGICAL PRODUCTS 137
IMMUNOGEN INC. 137
BIOLOGICAL PRODUCTS 137
IMMUNOVACCINE TECHNOLOGIES INC. 138
BIOLOGICAL PRODUCTS 138
IMMUTEP S.A. 138
BIOLOGICAL PRODUCTS 139
INNATE PHARMA 139
BIOLOGICAL PRODUCTS 139
INTERCELL AG 140
BIOLOGICAL PRODUCTS 140
IPSEN 140
BIOLOGICAL PRODUCTS 141
MEDAREX INC. 141
BIOLOGICAL PRODUCTS 141
MERCK and CO. INC. USA 142
BIOLOGICAL PRODUCTS 142
MERCK SERONO S.A. 142
BIOLOGICAL PRODUCTS 142
NOVARTIS AG 143
BIOLOGICAL PRODUCTS 143
NOVO NORDISK A/S 143
BIOLOGICAL PRODUCTS 144
OCTAPHARMA AG 144
BIOLOGICAL PRODUCTS 144
PFIZER INC. 145
BIOLOGICAL PRODUCTS 145
PHOSPHAGENICS LIMITED 145
PROTEON THERAPEUTICS INC. 146
ROCHE LTD. 146
BIOLOGICAL PRODUCTS 146
SANOFI-AVENTIS 147
BIOLOGICAL PRODUCTS 147
SEATTLE GENETICS INC. 147
BIOLOGICAL PRODUCTS 148
SHIRE PLC 148
BIOLOGICAL PRODUCTS 149
SOLIGENIX INC. 149
TEVA PHARMACEUTICAL INDUSTRIES LTD. 149
BIOLOGICAL PRODUCTS 150
THROMBOGENICS NV 150
BIOLOGICAL PRODUCTS 151
TOLERX INC. 151
TRIPEP AB 151
TRUBION PHARMACEUTICALS INC. 152
UCB S. A. 152
BIOLOGICAL PRODUCTS 153
VICAL INC. 153
BIOLOGICAL PRODUCTS 154
WILEX AG 154
XCELLEREX INC. 154
ZYMOGENETICS INC. 155
BIOLOGICAL PRODUCTS 155



LIST OF TABLES

SUMMARY TABLE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, THROUGH
2017 ($ MILLIONS) 6
TABLE 1 SUBCLASSES OF BIOLOGICS DRUGS 10
TABLE 2 MONOCLONAL ANTIBODY AND THERAPEUTIC PROTEIN DRUGS SUBCLASSES 15
TABLE 3 GLOBAL BIOLOGICS MARKET REVENUE, THROUGH 2017 ($ MILLIONS) 15
TABLE 4 MAJOR BIOPHARMACEUTICAL PLAYERS BY REVENUE, 2011 ($ MILLIONS) 23
TABLE 5 TOP 25 BIOPHARMACEUTICAL PRODUCTS BY REVENUE, 2011 ($ MILLIONS) 24
TABLE 6 TOP 50 REVENUE GENERATING BIOPHARMACEUTICAL PRODUCTS, 2010 ($
MILLIONS) 25
TABLE 7 GLOBAL MARKET FORECAST FOR MABS, THROUGH 2017 ($ MILLIONS) 27
TABLE 8 LEADING MONOCLONAL ANTIBODY PRODUCTS, 2011 ($ MILLIONS) 27
TABLE 9 VOLUME OF MAMMALIAN CELL CULTURE PRODUCED MABS, 2012 AND 2017 28
TABLE 10 REVENUE FOR THERAPEUTIC PROTEINS SEGMENT OF BIOLOGICS MARKET,
THROUGH 2017 ($ MILLIONS) 32
TABLE 11 LEADING HEMOPOIETIC GROWTH FACTOR BIOLOGIC PRODUCTS ($ MILLIONS) 33
TABLE 12 CLINICAL TRIALS ON G-CSF RECEPTORS IN 2012 34
TABLE 13 CLINICAL TRIALS ON CYTOKINES UNDERWAY IN 2012 36
TABLE 14 TOP 30 REVENUE-GENERATING THERAPEUTIC PROTEIN PRODUCTS, 2011 ($
MILLIONS) 37
TABLE 15 VACCINE REVENUES, THROUGH 2017 ($ MILLIONS) 40
TABLE 16 CLINICAL TRIALS ON VACCINES, 2012 40
TABLE 17 PATENT AND MARKETING EXCLUSIVITY EXPIRATION FOR TOP SELLING
BIOLOGICS 44
TABLE 18 NUMBER OF BIOSIMILARS PREDICTED TO BE LAUNCHED DURING PERIOD
2012-2019 44
TABLE 19 TOP 10 BIOLOGICS DRUGS IN (2011 REVENUES) WITH GREATEST LEVEL OF
BIOSIMILAR COMPETITION ($ MILLIONS) 45
TABLE 20 TOP 10 SELLING MABS IN 2011 51
TABLE 21 MAJOR PLAYERS (BY REVENUE) IN MAB MARKET IN 2011 ($ MILLIONS) 52
TABLE 22 TOP 10 THERAPEUTIC PROTEIN PRODUCTS, 2011 ($ MILLIONS) 53
TABLE 23 MAJOR PLAYERS (BY REVENUE) IN THE THERAPEUTIC PROTEINS MARKET, 2011 ($
MILLIONS) 53
TABLE 24 TOP 10 VACCINES BY REVENUE, 2011 ($ MILLIONS) 55
TABLE 25 GEOGRAPHIC DISTRIBUTION OF TOTAL BIOLOGICS MARKET, THROUGH 2017 ($
MILLIONS, % OF TOTAL) 58
TABLE 26 BIOLOGIC DRUGS OBTAINING FDA APPROVAL FROM 2010 TO 2012 60
TABLE 27 AMGEN BIOLOGICS PIPELINE, 2012 61
TABLE 28 ROCHE/GENENTECH/CHUGAI BIOLOGICS PIPELINE, 2012 62
TABLE 29 BAYER BIOLOGICS PIPELINE, 2012 63
TABLE 30 NOVO NORDISK BIOLOGICS PIPELINE, 2012 64
TABLE 31 MERCK BIOLOGICS PIPELINE, 2012 65
TABLE 32 PFIZER BIOLOGICS PIPELINE, 2012 66
TABLE 33 BIOGEN IDEC BIOLOGICS PIPELINE, 2012 67
TABLE 34 SANOFI BIOLOGICS PIPELINE, 2012 68
TABLE 35 DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUG
APPROVAL 70
TABLE 36 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR CANCER
TREATMENT, 2012 71
TABLE 37 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR GI AND RELATED
DISEASE TREATMENT, 2012 74
TABLE 38 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR HEART AND
RELATED DISEASE TREATMENT, 2012 76
TABLE 39 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS
IN BIOLOGICS 78
TABLE 40 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS
IN BIOLOGICS (CONTINUED) 82
TABLE 41 U.S. PATENTS FOR MONOCLONAL ANTIBODIES 90
TABLE 42 PATENTS ISSUED FOR THERAPEUTIC PROTEINS 93
TABLE 43 PATENTS ISSUED FOR VACCINES (OR VACCINE RELATED PRODUCTS) ASSOCIATED
WITH BIOLOGICALS 96
TABLE 44 BIOLOGICS PRODUCTS USING PERFUSION METHOD 103
TABLE 45 BIOLOGICS THERAPEUTIC PRODUCTS USING FED-BATCH METHOD 104
TABLE 46 MARKETED BIOPHARMACEUTICALS USING E.COLI EXPRESSION SYSTEM 110
TABLE 47 MARKETED BIOPHARMACEUTICALS USING ANIMAL CELL LINE EXPRESSION
SYSTEM 111
TABLE 48 PLANT-BASED TRANSGENIC COMPANIES AND THEIR PIPELINES OF
RECOMBINANT PROTEINS 114
TABLE 49 THERAPEUTIC PROTEINS PRODUCED IN TRANSGENIC ANIMALS 115
TABLE 50 MARKETED BIOPHARMACEUTICALS USING MURINE (MOUSE) HYBRIDOMA
EXPRESSION SYSTEM 117
BIO079B - Biologic Therapeutic Drugs: Technologies and Global Markets



LIST OF FIGURES

SUMMARY FIGURE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT,
2009-2017 ($ MILLIONS) 6
FIGURE 1 DIAGRAM OF TYPICAL ANTIBODY STRUCTURE 11

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