Biologic Therapeutic Drugs: Technologies and Global Markets

NEW YORK, Jan. 8, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Biologic Therapeutic Drugs: Technologies and Global Markets

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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 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 6SUMMARY TABLE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT,THROUGH 2017 ($ MILLIONS) 6SUMMARY 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 20BIOPHARMACEUTICAL INDUSTRY STRUCTURE 20THE ORIGINS OF BIOTECHNOLOGY 20INVOLVEMENT 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 43TABLE 17 PATENT AND MARKETING EXCLUSIVITY EXPIRATION FOR TOP SELLINGBIOLOGICS 44TABLE 18 NUMBER OF BIOSIMILARS PREDICTED TO BE LAUNCHED DURING PERIOD2012-2019 44TABLE 19 TOP 10 BIOLOGICS DRUGS IN (2011 REVENUES) WITH GREATEST LEVEL OFBIOSIMILAR COMPETITION ($ MILLIONS) 45RATIONALE FOR BIOSIMILAR DEVELOPMENT 45ERYTHROPOIETIN 45GRANULOCYTE-COLONY STIMULATING FACTOR 46INTERFERONS 46HUMAN GROWTH HORMONE 46OPPORTUNITY AND THREAT FROM BIOSIMILARS 46MARKET TRENDS: GROWTH DRIVERS AND RESISTORS 47BIOSIMILARS: REGULATORY UPDATE 48U.S. FDA 48EUROPEAN 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 57GEOGRAPHIC MARKET ANALYSIS 57TABLE 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 70TABLE 35 DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUGAPPROVAL 70CANCER BIOLOGIC DRUGS 71TABLE 36 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR CANCERTREATMENT, 2012 71GASTROINTESTINAL AND RELATED DISEASES 74TABLE 37 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR GI AND RELATEDDISEASE TREATMENT, 2012 74HEART DISEASE 75TABLE 38 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR HEART ANDRELATED 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 90MONOCLONAL ANTIBODY PATENTS 90TABLE 41 U.S. PATENTS FOR MONOCLONAL ANTIBODIES 90THERAPEUTIC PROTEIN PATENTS 93TABLE 42 PATENTS ISSUED FOR THERAPEUTIC PROTEINS 93VACCINE PATENTS 96TABLE 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 119ABBOTT LABORATORIES 119BIOLOGICAL PRODUCTS 119ADVAXIS INC. 119BIOLOGICAL PRODUCTS 120AGENNIX AG 120AKEBIA THERAPEUTICS INC. 121AMGEN INC. 121BIOLOGICAL PRODUCTS 121APOGENIX GMBH 122BAXTER BIOSCIENCE INC. 122BIOLOGICAL PRODUCTS 123BAYER SCHERING PHARMA AG 123BIOLOGICAL PRODUCTS 123BIOGEN IDEC INC. 124BIOLOGICAL PRODUCTS 124BIOINVENT INTERNATIONAL AB 124BIOLOGICAL PRODUCTS 125BIOVITRUM AB 125CELLDEX THERAPEUTICS INC. 125BIOLOGICAL PRODUCTS 126CHUGAI PHARMACEUTICALS 126BIOLOGICAL PRODUCTS 126CSL BEHRING 126BIOLOGICAL PRODUCTS 127CYTHERIS SA 127DEBIOPHARM GROUP 127DENDREON CORPORATION 128DYAX CORP. 128BIOLOGICAL PRODUCTS 129ELI LILLY & CO. 129BIOLOGICAL PRODUCTS 129ERYTECH PHARMA 130BIOLOGICAL PRODUCTS 130GENENTECH INC. 130BIOLOGICAL PRODUCTS 131GENMAB A/S 131BIOLOGICAL PRODUCTS 131GENZYME CORPORATION 132BIOLOGICAL PRODUCTS 132GLAXOSMITHKLINE PLC 132BIOLOGICAL PRODUCTS 133GLYCOTOPE GMBH 133BIOLOGICAL PRODUCTS 134H. LUNDBECK A/S 134CURRENT PRODUCTS 134HAWAII BIOTECH INC. 135HELIX BIOPHARMA CORPORATION 135HUMAN GENOME SCIENCES INC. 135BIOLOGICAL PRODUCTS 136IMCLONE SYSTEMS INC. 136BIOLOGICAL PRODUCTS 137IMMUNOGEN INC. 137BIOLOGICAL PRODUCTS 137IMMUNOVACCINE TECHNOLOGIES INC. 138BIOLOGICAL PRODUCTS 138IMMUTEP S.A. 138BIOLOGICAL PRODUCTS 139INNATE PHARMA 139BIOLOGICAL PRODUCTS 139INTERCELL AG 140BIOLOGICAL PRODUCTS 140IPSEN 140BIOLOGICAL PRODUCTS 141MEDAREX INC. 141BIOLOGICAL PRODUCTS 141MERCK & CO. INC. USA 142BIOLOGICAL PRODUCTS 142MERCK SERONO S.A. 142BIOLOGICAL PRODUCTS 142NOVARTIS AG 143BIOLOGICAL PRODUCTS 143NOVO NORDISK A/S 143BIOLOGICAL PRODUCTS 144OCTAPHARMA AG 144BIOLOGICAL PRODUCTS 144PFIZER INC. 145BIOLOGICAL PRODUCTS 145PHOSPHAGENICS LIMITED 145PROTEON THERAPEUTICS INC. 146ROCHE LTD. 146BIOLOGICAL PRODUCTS 146SANOFI-AVENTIS 147BIOLOGICAL PRODUCTS 147SEATTLE GENETICS INC. 147BIOLOGICAL PRODUCTS 148SHIRE PLC 148BIOLOGICAL PRODUCTS 149SOLIGENIX INC. 149TEVA PHARMACEUTICAL INDUSTRIES LTD. 149BIOLOGICAL PRODUCTS 150THROMBOGENICS NV 150BIOLOGICAL PRODUCTS 151TOLERX INC. 151TRIPEP AB 151TRUBION PHARMACEUTICALS INC. 152UCB S. A. 152BIOLOGICAL PRODUCTS 153VICAL INC. 153BIOLOGICAL PRODUCTS 154WILEX AG 154XCELLEREX INC. 154ZYMOGENETICS INC. 155BIOLOGICAL 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

To order this report:Biopharmaceutical Industry: Biologic Therapeutic Drugs: Technologies and Global Markets

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