GLOBAL MARKETS AND MANUFACTURING TECHNOLOGIES FOR PROTEIN DRUGS

Transcription

1 GLOBAL MARKETS AND MANUFACTURING TECHNOLOGIES FOR PROTEIN DRUGS BIO021E May 2016 Shalini Shahani Dewan Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) information@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY OBJECTIVES 2 REASONS FOR DOING THIS STUDY 2 CONTRIBUTIONS OF THE STUDY AND FOR WHOM 3 SCOPE OF THE STUDY 3 METHODOLOGY 3 INFORMATION SOURCES 3 ANALYSTS' CREDENTIALS 4 RELATED BCC RESEARCH REPORTS 4 BCC RESEARCH WEBSITE 4 DISCLAIMER 5 CHAPTER 2 EXECUTIVE SUMMARY 7 SUMMARY TABLE GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, THROUGH SUMMARY FIGURE GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, CHAPTER 3 OVERVIEW 10 HISTORY 10 TABLE 1 EVOLUTION OF THERAPEUTIC PROTEINS 10 PHARMACOLOGICAL CLASSIFICATION OF THERAPEUTIC PROTEINS 11 PROTEIN THERAPEUTICS WITH ENZYMATIC OR REGULATORY ACTIVITY 12 By Replacing the Deficient or Abnormal Protein 12 By Augmenting an Existing Pathway 12 By Providing a Novel Function or Activity 12 PROTEIN THERAPEUTICS WITH SPECIAL TARGETING ACTIVITY 13 Interfering with a Molecule or Organism 13 Delivering Other Compounds or Proteins 13 PROTEIN VACCINES 13 MOLECULAR CLASSIFICATION OF THERAPEUTIC PROTEINS 13 CYTOKINES 14 Interferons 14 Interleukins 14 Colony Stimulating Factors 15 MONOCLONAL ANTIBODIES 15 BLOOD PRODUCTS 16 Alpha 1 Proteinase Inhibitor 16 Anti-Hemophilic Factor 16 Anti-Thrombin 16 C1-Esterase Inhibitor 17 Coagulation Factors 17 Immuno Globulins 17 Protein C 18 Thrombin 18 PEPTIDE ANTIBIOTICS 18

3 VACCINES 18 Live, Attenuated Vaccines 19 Inactivated/Killed Vaccines 19 Toxoid 19 Subunit/Conjugate 19 ENZYMES 20 Digestive Enzymes 20 Metabolic Enzymes/Lysosomal Enzymes 20 Other Enzymes 21 PEPTIDE HORMONES 21 Follicle Stimulating Hormone and Luteinizing Hormone 22 Growth Hormones 22 Erythropoietin 22 Insulin 22 MANUFACTURING TECHNOLOGIES 23 FRACTIONATION/ EXTRACTION FROM NATURAL SOURCES (HUMAN/ANIMAL) 23 TABLE 2 PROTEIN DRUGS MADE BY FRACTIONATION 24 MICROBIAL FERMENTATION AND BIOREACTORS 25 Bioreactors 25 TABLE 3 THERAPETIC DRUGS PRODUCED BY MICROBIAL FERMENTATION 25 TRANSGENICS 26 TABLE 4 PROTEIN DRUGS PRODUCED BY TRANSGENIC ANIMALS, PLANTS AND MICROORGANISMS MAMMALIAN CELL CULTURE 27 TABLE 5 PROTEIN DRUGS MADE BY CELL CULTURE CHAPTER 4 REGULATORY ASPECTS 29 MONOCLONAL ANTIBODIES 29 TABLE 6 NEW APPROVALS OF MONOCLONAL ANTIBODIES, 2013-OCTOBER THERAPEUTIC ENZYMES 30 TABLE 7 NEW APPROVALS IN THERAPEUTIC ENZYMES, 2013-OCTOBER CYTOKINES 31 TABLE 8 NEW APPROVALS OF CYTOKINES, 2013-OCTOBER PEPTIDE HORMONES 31 TABLE 9 NEW APPROVALS OF PEPTIDE HORMONES, 2013-OCTOBER VACCINES 32 TABLE 10 NEW APPROVALS OF VACCINES, 2013-OCTOBER BLOOD PRODUCTS 34 TABLE 11 NEW APPROVALS OF BLOOD PRODUCTS, 2013-OCTOBER PEPTIDE ANTIBIOTICS 36 TABLE 12 NEW APPROVALS OF PEPTIDE ANTIBIOTICS, 2013-OCTOBER RECALLS 36 TABLE 13 RECALLS, 2013-OCTOBER SAFETY ALERTS 39 TABLE 14 SAFETY ALERTS, 2013-OCTOBER CHAPTER 5 NEW DEVELOPMENTS 42 MONOCLONAL ANTIBODIES 42

4 TABLE 15 PIPELINE PRODUCTS OF MONOCLONAL ANTIBODIES 42 VACCINES 47 TABLE 16 PIPELINE PRODUCTS OF VACCINES 48 CYTOKINES 49 TABLE 17 PIPELINE PRODUCTS OF CYTOKINES 50 PEPTIDE HORMONES 50 TABLE 18 PIPELINE PRODUCTS IN PEPTIDE HORMONES 50 PEPTIDE ANTIBIOTICS 51 TABLE 19 PIEPLINES IN PEPTIDE ANTIBIOTICS 51 THERAPEUTIC ENZYMES 52 TABLE 20 PIPELINE PRODUCTS IN THERAPEUTIC ENZYMES 52 BLOOD PRODUCTS 53 TABLE 21 PIPELINE PRODUCTS IN BLOOD PRODUCTS 53 MERGERS AND ACQUISITIONS 53 TABLE 22 MERGERS AND ACQUISITIONS OF TOP PHARMACEUTICAL COMPANIES 54 CHAPTER 6 MARKET ANALYSIS BY TYPE 57 MARKET BY TYPE 57 MARKET OVERVIEW 58 MARKET REVENUE 58 TABLE 23 GLOBAL REVENUE FOR PROTEIN DRUGS BY TYPE, THROUGH 2020 ($ FIGURE 1 GLOBAL REVENUE FOR PROTEIN DRUGS BY TYPE, ($ MARKET SHARE 60 TABLE 24 MARKET SHARE OF PROTEIN DRUGS BY TYPE, FIGURE 2 MARKET SHARE OF PROTEIN DRUGS BY TYPE, PEPTIDE HORMONES 61 Market Overview 62 Market Revenue 62 TABLE 25 GLOBAL REVENUE FOR PEPTIDE HORMONES BY TYPE, THROUGH 2020 ($ FIGURE 3 GLOBAL REVENUE FOR PEPTIDE HORMONES BY TYPE, ($ VACCINES 64 Market Overview 64 Market Revenue 66 TABLE 26 GLOBAL REVENUE FOR VACCINES BY TYPE, THROUGH 66 FIGURE 4 GLOBAL REVENUE FOR VACCINES BY TYPE, THERAPEUTIC ENZYMES 67 Market Overview 67 Market Revenue 69 TABLE 27 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH FIGURE 5 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY TYPE, ($ MONOCLONAL ANTIBODIES 70 Market Overview 71 Market Revenue

5 TABLE 28 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY TYPE, THROUGH FIGURE 6 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY TYPE, CYTOKINES 74 Market Overview 75 Market Revenue 75 TABLE 29 GLOBAL REVENUE FOR CYTOKINES BY TYPE, THROUGH 2020 ($ FIGURE 7 GLOBAL REVENUE FOR CYTOKINES BY TYPE, BLOOD FACTORS 77 Market Overview 78 Market Revenue 79 TABLE 30 GLOBAL REVENUE FOR BLOOD FACTORS BY TYPE, THROUGH 2020 ($ FIGURE 8 GLOBAL REVENUE FOR BLOOD FACTORS BY TYPE, ($ PEPTIDE ANTIBIOTICS 80 Market Overview 80 Market Revenue 81 TABLE 31 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY TYPE, THROUGH 2020 FIGURE 9 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY TYPE, ($ MARKET BY REGION 82 MARKET OVERVIEW 83 MARKET REVENUE 84 TABLE 32 GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, THROUGH 2020 ($ FIGURE 10 GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, ($ MARKET SHARE 86 TABLE 33 MARKET SHARE OF PROTEIN DRUGS BY REGION, FIGURE 11 MARKET SHARE OF PROTEIN DRUGS BY REGION, PEPTIDE HORMONES 86 Market Overview 87 Market Revenue 88 TABLE 34 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2020 FIGURE 12 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, ($ VACCINES 89 Market Overview 89 Market Revenue 90 TABLE 35 GLOBAL REVENUE FOR VACCINES BY REGION, THROUGH 2020 ($ FIGURE 13 GLOBAL REVENUE FOR VACCINES BY REGION, THERAPEUTIC ENZYMES 91 Market Overview 92 Market Revenue

6 TABLE 36 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH FIGURE 14 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, MONOCLONAL ANTIBODIES 93 Market Overview 94 Market Revenue 94 TABLE 37 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY REGION, THROUGH FIGURE 15 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY REGION, CYTOKINES 96 Market Overview 96 Market Revenue 96 TABLE 38 GLOBAL REVENUE FOR CYTOKINES BY REGION, THROUGH 2020 ($ FIGURE 16 GLOBAL REVENUE FOR CYTOKINES BY REGION, BLOOD FACTORS 98 Market Overview 98 Market Revenue 99 TABLE 39 GLOBAL REVENUE FOR BLOOD FACTORS BY REGION, THROUGH 2020 ($ FIGURE 17 GLOBAL REVENUE FOR BLOOD FACTORS BY REGION, ($ PEPTIDE ANTIBIOTICS 100 Market Overview 100 Market Revenue 101 TABLE 40 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY REGION, THROUGH FIGURE 18 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY REGION, ($ CHAPTER 7 MARKET ANALYSIS BY MANUFACTURING PROCESS 104 MARKET BY MANUFACTURING PROCESS 104 MARKET OVERVIEW 105 MARKET REVENUE 106 TABLE 41 GLOBAL REVENUE FOR PROTEIN DRUGS BY MANUFACTURING PROCESS, THROUGH FIGURE 19 GLOBAL REVENUE FOR PROTEIN DRUGS BY MANUFACTURING PROCESS, MARKET SHARE 107 TABLE 42 MARKET SHARE OF PROTEIN DRUGS BY MANUFACTURING PROCESS, 2014 FIGURE 20 MARKET SHARE OF PROTEIN DRUGS BY MANUFACTURING PROCESS, 2014 PEPTIDE HORMONES 108 Market Overview 109 Market Revenue 109 TABLE 43 GLOBAL REVENUE FOR PEPTIDE HORMONES BY MANUFACTURING PROCESS, THROUGH

7 FIGURE 21 GLOBAL REVENUE FOR PEPTIDE HORMONES BY MANUFACTURING PROCESS, VACCINES 111 Market Overview 111 Market Revenue 112 TABLE 44 GLOBAL REVENUE FOR VACCINES BY MANUFACTURING PROCESS, THROUGH FIGURE 22 GLOBAL REVENUE FOR VACCINES BY MANUFACTURING PROCESS, THERAPEUTIC ENZYMES 113 Market Overview 114 Market Revenue 114 TABLE 45 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY MANUFACTURING PROCESS, THROUGH FIGURE 23 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY MANUFACTURING PROCESS, MONOCLONAL ANTIBODIES 115 Market Overview 116 Market Revenue 117 TABLE 46 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, THROUGH FIGURE 24 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, CYTOKINES 118 Market Overview 118 Market Revenue 119 TABLE 47 GLOBAL REVENUE FOR CYTOKINES BY MANUFACTURING PROCESS, THROUGH FIGURE 25 GLOBAL REVENUE FOR CYTOKINES BY MANUFACTURING PROCESS, BLOOD FACTORS 120 Market Overview 120 Market Revenue 121 TABLE 48 GLOBAL REVENUE FOR BLOOD FACTORS BY MANUFACTURING PROCESS, THROUGH FIGURE 26 GLOBAL REVENUE FOR BLOOD FACTORS BY MANUFACTURING PROCESS, PEPTIDE ANTIBIOTICS 122 Market Overview 123 Market Revenue 123 TABLE 49 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY MANUFACTURING PROCESS, THROUGH FIGURE 27 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY MANUFACTURING PROCESS, CHAPTER 8 INDUSTRY STRUCTURE 126 PEPTIDE HORMONES 126 MARKET LEADERS 126 TABLE 50 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE HORMONES, MARKET SHARE 128

8 TABLE 51 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE HORMONES, 2014 FIGURE 28 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE HORMONES, 2014 VACCINES 129 MARKET LEADERS 129 TABLE 52 LEADING MANUFACTURERS/SUPPLIERS OF VACCINES, MARKET SHARE 132 TABLE 53 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, 2014 FIGURE 29 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, 2014 THERAPEUTIC ENZYMES 133 MARKET LEADERS 133 TABLE 54 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC ENZYMES, 2014 MARKET SHARE 134 TABLE 55 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC ENZYMES, 2014 FIGURE 30 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC ENZYMES, 2014 MONOCLONAL ANTIBODIES 136 MARKET LEADERS 136 TABLE 56 LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODIES, 2014 MARKET SHARE 137 TABLE 57 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL ANTIBODIES, 2014 FIGURE 31 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL ANTIBODIES, 2014 CYTOKINES 138 MARKET LEADERS 138 TABLE 58 LEADING MANUFACTURERS/SUPPLIERS OF CYTOKINES, MARKET SHARE 139 TABLE 59 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINES, 2014 FIGURE 32 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINES, 2014 BLOOD FACTORS 140 MARKET LEADERS 140 TABLE 60 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC BLOOD PRODUCTS, 2014 MARKET SHARE 143 TABLE 61 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT BLOOD PRODUCTS, 2014 FIGURE 33 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT BLOOD PRODUCTS, 2014 PEPTIDE ANTIBIOTICS 144 MARKET LEADERS 144 TABLE 62 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE ANTIBIOTICS,

9 MARKET SHARE 145 TABLE 63 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE ANTIBIOTICS, 2014 FIGURE 34 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE ANTIBIOTICS, CHAPTER 9 PATENT ANALYSIS 148 PATENTS BY YEAR 148 TABLE 64 NUMBER OF PATENTS BY YEAR, 2013-OCTOBER FIGURE 35 NUMBER OF PATENTS BY YEAR, 2013-OCTOBER PATENTS BY TYPE 149 TABLE 65 NUMBER OF PATENTS BY TYPE, 2013-OCTOBER FIGURE 36 NUMBER OF PATENTS BY TYPE, 2013-OCTOBER PATENTS BY COMPANY 150 TABLE 66 NUMBER OF PATENTS BY COMPANY, 2013-OCTOBER PATENTS BY COUNTRY 154 TABLE 67 NUMBER OF PATENTS BY COUNTRY, 2013-OCTOBER TABLE 68 PATENT SHARES BY COUNTRY, 2013-OCTOBER FIGURE 37 PATENT SHARES BY COUNTRY, 2013-OCTOBER PATENTS BY ASSIGNEE 157 TABLE 69 NUMBER OF PATENTS BY ASSIGNEE, 2013-OCTOBER FIGURE 38 NUMBER OF PATENTS BY ASSIGNEE, 2013-OCTOBER CHAPTER 10 CURRENT SITUATION 160 FACTORS AFFECTING THE PROTEIN THERAPEUTIC MARKET 160 DRIVERS OF THE PROTEIN THERAPEUTIC MARKET 160 Prevalence of Chronic Diseases 160 Growing Aging Population 160 Advancements in Manufacturing Technologies 161 New Product Launches 161 Licensing Agreements 161 RESTRAINTS AND CHALLENGES OF THE MARKET 162 Price Controls 162 Regulatory Pressures 162 Entry of Biosimilars 163 Mergers and Acquisitions 163 CHAPTER 11 COMPANY PROFILES 165 ABBVIE INC. 165 ACTAVIS INC. 165 ALEXION PHARMACEUTICALS 166 ALLERGAN PLC 166 AMGEN INC 167 APOTEX INC. 167 BAXALTA INC 167 BAYER PHARMA AG 168 BIOGEN INC. 168 BIOMARIN PHARMACEUTICAL INC 169

10 BIOTEST PHARMACEUTICALS CORP. 169 BRISTOL-MYERS SQUIBB 170 CSL LIMITED 170 ELI LILLY 171 F. HOFFMANN-LA ROCHE AG 172 FRESENIUS KABI USA 172 GLAXOSMITHKLINE 173 GRIFOLS USA LLC 174 HOSPIRA INC 174 JOHNSON & JOHNSON 175 MEDIMMUNE LLC 175 MERCK & CO, INC 176 MERCK KGAA 177 MYLAN INC. 177 NOVARTIS AG 178 NOVO NORDISK AG 178 OCTAPHARMA AG 179 PFIZER INC 179 PROTEIN SCIENCES CORP. 180 REVO BIOLOGICS INC. 181 SANDOZ 181 SANOFI INC 182 SEATTLE GENETICS INC. 182 SPECTRUM PHARMACEUTICALS INC 183 TAKEDA PHARMACEUTICAL U.S.A., INC 183 UCB COMPANY 184 SHIRE PLC (VIROPHARM INC.) 184 VERTEX PHARMACEUTICALS 185 CHAPTER 12 APPENDIX I - ABBREVIATIONS 187

11 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, THROUGH TABLE 1 EVOLUTION OF THERAPEUTIC PROTEINS 10 TABLE 2 PROTEIN DRUGS MADE BY FRACTIONATION 24 TABLE 3 THERAPETIC DRUGS PRODUCED BY MICROBIAL FERMENTATION 25 TABLE 4 PROTEIN DRUGS PRODUCED BY TRANSGENIC ANIMALS, PLANTS AND MICROORGANISMS TABLE 5 PROTEIN DRUGS MADE BY CELL CULTURE 27 TABLE 6 NEW APPROVALS OF MONOCLONAL ANTIBODIES, 2013-OCTOBER TABLE 7 NEW APPROVALS IN THERAPEUTIC ENZYMES, 2013-OCTOBER TABLE 8 NEW APPROVALS OF CYTOKINES, 2013-OCTOBER TABLE 9 NEW APPROVALS OF PEPTIDE HORMONES, 2013-OCTOBER TABLE 10 NEW APPROVALS OF VACCINES, 2013-OCTOBER TABLE 11 NEW APPROVALS OF BLOOD PRODUCTS, 2013-OCTOBER TABLE 12 NEW APPROVALS OF PEPTIDE ANTIBIOTICS, 2013-OCTOBER TABLE 13 RECALLS, 2013-OCTOBER TABLE 14 SAFETY ALERTS, 2013-OCTOBER TABLE 15 PIPELINE PRODUCTS OF MONOCLONAL ANTIBODIES 42 TABLE 16 PIPELINE PRODUCTS OF VACCINES 48 TABLE 17 PIPELINE PRODUCTS OF CYTOKINES 50 TABLE 18 PIPELINE PRODUCTS IN PEPTIDE HORMONES 50 TABLE 19 PIEPLINES IN PEPTIDE ANTIBIOTICS 51 TABLE 20 PIPELINE PRODUCTS IN THERAPEUTIC ENZYMES 52 TABLE 21 PIPELINE PRODUCTS IN BLOOD PRODUCTS 53 TABLE 22 MERGERS AND ACQUISITIONS OF TOP PHARMACEUTICAL COMPANIES 54 TABLE 23 GLOBAL REVENUE FOR PROTEIN DRUGS BY TYPE, THROUGH 2020 ($ TABLE 24 MARKET SHARE OF PROTEIN DRUGS BY TYPE, TABLE 25 GLOBAL REVENUE FOR PEPTIDE HORMONES BY TYPE, THROUGH 2020 ($ TABLE 26 GLOBAL REVENUE FOR VACCINES BY TYPE, THROUGH 66 TABLE 27 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH 2020 TABLE 28 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY TYPE, THROUGH TABLE 29 GLOBAL REVENUE FOR CYTOKINES BY TYPE, THROUGH 76 TABLE 30 GLOBAL REVENUE FOR BLOOD FACTORS BY TYPE, THROUGH 2020 ($ TABLE 31 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY TYPE, THROUGH 2020 ($ TABLE 32 GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, THROUGH 2020 ($ TABLE 33 MARKET SHARE OF PROTEIN DRUGS BY REGION, TABLE 34 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2020 ($ TABLE 35 GLOBAL REVENUE FOR VACCINES BY REGION, THROUGH 2020 ($ TABLE 36 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH

12 TABLE HEADING TABLE 37 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY REGION, THROUGH TABLE 38 GLOBAL REVENUE FOR CYTOKINES BY REGION, THROUGH 2020 ($ TABLE 39 GLOBAL REVENUE FOR BLOOD FACTORS BY REGION, THROUGH 2020 ($ TABLE 40 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY REGION, THROUGH 2020 TABLE 41 GLOBAL REVENUE FOR PROTEIN DRUGS BY MANUFACTURING PROCESS, THROUGH TABLE 42 MARKET SHARE OF PROTEIN DRUGS BY MANUFACTURING PROCESS, 2014 TABLE 43 GLOBAL REVENUE FOR PEPTIDE HORMONES BY MANUFACTURING PROCESS, THROUGH TABLE 44 GLOBAL REVENUE FOR VACCINES BY MANUFACTURING PROCESS, THROUGH TABLE 45 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY MANUFACTURING PROCESS, THROUGH TABLE 46 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, THROUGH TABLE 47 GLOBAL REVENUE FOR CYTOKINES BY MANUFACTURING PROCESS, THROUGH TABLE 48 GLOBAL REVENUE FOR BLOOD FACTORS BY MANUFACTURING PROCESS, THROUGH TABLE 49 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY MANUFACTURING PROCESS, THROUGH TABLE 50 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE HORMONES, TABLE 51 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE HORMONES, 2014 TABLE 52 LEADING MANUFACTURERS/SUPPLIERS OF VACCINES, TABLE 53 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, TABLE 54 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC ENZYMES, TABLE 55 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC ENZYMES, 2014 TABLE 56 LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODIES, 2014 TABLE 57 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL ANTIBODIES, 2014 TABLE 58 LEADING MANUFACTURERS/SUPPLIERS OF CYTOKINES, TABLE 59 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINES, 2014 TABLE 60 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC BLOOD PRODUCTS, 2014 TABLE 61 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT BLOOD PRODUCTS, 2014 TABLE 62 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE ANTIBIOTICS, TABLE 63 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE ANTIBIOTICS, 2014 TABLE 64 NUMBER OF PATENTS BY YEAR, 2013-OCTOBER TABLE 65 NUMBER OF PATENTS BY TYPE, 2013-OCTOBER TABLE 66 NUMBER OF PATENTS BY COMPANY, 2013-OCTOBER

13 TABLE HEADING TABLE 67 NUMBER OF PATENTS BY COUNTRY, 2013-OCTOBER TABLE 68 PATENT SHARES BY COUNTRY, 2013-OCTOBER TABLE 69 NUMBER OF PATENTS BY ASSIGNEE, 2013-OCTOBER

14 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, FIGURE 1 GLOBAL REVENUE FOR PROTEIN DRUGS BY TYPE, FIGURE 2 MARKET SHARE OF PROTEIN DRUGS BY TYPE, FIGURE 3 GLOBAL REVENUE FOR PEPTIDE HORMONES BY TYPE, ($ FIGURE 4 GLOBAL REVENUE FOR VACCINES BY TYPE, FIGURE 5 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY TYPE, ($ FIGURE 6 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY TYPE, ($ FIGURE 7 GLOBAL REVENUE FOR CYTOKINES BY TYPE, FIGURE 8 GLOBAL REVENUE FOR BLOOD FACTORS BY TYPE, FIGURE 9 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY TYPE, ($ FIGURE 10 GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, ($ FIGURE 11 MARKET SHARE OF PROTEIN DRUGS BY REGION, FIGURE 12 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, ($ FIGURE 13 GLOBAL REVENUE FOR VACCINES BY REGION, FIGURE 14 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, ($ FIGURE 15 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY REGION, FIGURE 16 GLOBAL REVENUE FOR CYTOKINES BY REGION, FIGURE 17 GLOBAL REVENUE FOR BLOOD FACTORS BY REGION, ($ FIGURE 18 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY REGION, ($ FIGURE 19 GLOBAL REVENUE FOR PROTEIN DRUGS BY MANUFACTURING PROCESS, FIGURE 20 MARKET SHARE OF PROTEIN DRUGS BY MANUFACTURING PROCESS, 2014 FIGURE 21 GLOBAL REVENUE FOR PEPTIDE HORMONES BY MANUFACTURING PROCESS, FIGURE 22 GLOBAL REVENUE FOR VACCINES BY MANUFACTURING PROCESS, FIGURE 23 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY MANUFACTURING PROCESS, FIGURE 24 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, FIGURE 25 GLOBAL REVENUE FOR CYTOKINES BY MANUFACTURING PROCESS, FIGURE 26 GLOBAL REVENUE FOR BLOOD FACTORS BY MANUFACTURING PROCESS, FIGURE 27 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY MANUFACTURING PROCESS, FIGURE 28 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE HORMONES,

15 FIGURE TITLE FIGURE 29 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, 2014 FIGURE 30 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC ENZYMES, 2014 FIGURE 31 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL ANTIBODIES, 2014 FIGURE 32 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINES, 2014 FIGURE 33 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT BLOOD PRODUCTS, 2014 FIGURE 34 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE ANTIBIOTICS, 2014 FIGURE 35 NUMBER OF PATENTS BY YEAR, 2013-OCTOBER FIGURE 36 NUMBER OF PATENTS BY TYPE, 2013-OCTOBER FIGURE 37 PATENT SHARES BY COUNTRY, 2013-OCTOBER FIGURE 38 NUMBER OF PATENTS BY ASSIGNEE, 2013-OCTOBER