GLOBAL MARKETS FOR BIOENGINEERED PROTEIN DRUGS

Transcription

1 GLOBAL MARKETS FOR BIOENGINEERED PROTEIN DRUGS BIO009G January 2017 Shalini Shahani Dewan Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) info@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY GOALS AND 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 4 ANALYST'S CREDENTIALS 4 RELATED BCC RESEARCH REPORTS 4 BCC RESEARCH WEBSITE 5 DISCLAIMER 5 CHAPTER 2 EXECUTIVE SUMMARY 7 SUMMARY TABLE GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY REGION, THROUGH 2021 ($ SUMMARY FIGURE GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY REGION, ($ 8 8 CHAPTER 3 OVERVIEW 10 BIOSYNTHESIS OF PROTEINS 10 TRANSCRIPTION 10 TRANSLATION 11 POST-TRANSLATIONAL MODIFICATION 11 BIOENGINEERED PROTEIN DRUGS 11 TABLE 1 BIOENGINEERED PROTEIN DRUGS VS. CHEMICALLY SYNTHESIZED DRUGS 12 HISTORY OF BIOENGINEERED PROTEIN DRUGS 13 TABLE 2 EVOLUTION OF BIOENGINEERED PROTEIN DRUGS 13 ADVANTAGES OF BIOENGINEERED PROTEIN DRUGS 14 MANUFACTURING TECHNOLOGY 15 FRACTIONATION/COHN'S METHOD 15 TABLE 3 PROTEIN DRUGS MADE BY FRACTIONATION 16 MICROBIAL/FERMENTATION PROCESS 16 TABLE 4 THERAPETIC DRUGS PRODUCED BY MICROBIAL FERMENTATION 17 GENETIC ENGINEERING 17 GENETICALLY MODIFIED ORGANISMS 18 PHARMING 18 TABLE 5 PROTEIN DRUGS PRODUCED BY TRANSGENIC ANIMALS, PLANTS AND MICROORGANISMS MAMMALIAN CELL CULTURE 19 TABLE 6 PROTEIN DRUGS MADE BY MAMMALIAN CELL CULTURE 19 ADMINISTRATION TECHNOLOGIES OF BIOENGINEERED PROTEIN DRUGS 20 USE OF DRUG DELIVERY SYSTEMS IN CURRENT MEDICAL APPROACHES 20 TRADITIONAL METHODS OF DRUG DELIVERY 20 Oral 20 Topical 21 Trans mucosal 21 18

3 Inhalation 21 Parenteral 21 TABLE 7 ROUTES OF DRUG DELIVERY 21 Limitations Encountered by Traditional Drug Delivery 22 MOLECULAR CLASSIFICATION 22 MONOCLONAL ANTIBODIES 22 CYTOKINES 23 Interferons 23 Interleukins 24 Colony Stimulating Factors 24 PEPTIDE HORMONES 24 Follicle Stimulating Hormone and Luteinizing Hormone 25 Growth Hormones 25 Erythropoietin 25 Insulin 25 BLOOD PRODUCTS 26 Alpha 1-Protease Inhibitor 26 Anti-Hemophilic Factor 26 Anti-Thrombin 26 C1-Esterase Inhibitor 27 Coagulation Factors 27 Immunoglobulins 27 Protein C 28 Thrombin 28 PEPTIDE ANTIBIOTICS 28 VACCINES 28 THERAPEUTIC ENZYMES 29 CHAPTER 4 REGULATORY ASPECTS 32 MONOCLONAL ANTIBODIES 32 TABLE 8 NEW APPROVALS OF MONOCLONAL ANTIBODIES (FROM 2014-MAY 2016) 32 CYTOKINES 33 TABLE 9 NEW APPROVALS OF CYTOKINES (FROM )* 34 VACCINES 34 TABLE 10 NEW APPROVALS IN VACCINES (FROM 2014 MAY 2016) 34 PEPTIDE HORMONES 35 TABLE 11 NEW APPROVALS IN PEPTIDE HORMONES (FROM )* 35 THERAPUETIC ENZYMES 36 TABLE 12 NEW APPROVALS IN THERAPEUTIC ENZYMES (FROM )* 36 BLOOD PRODUCTS 36 TABLE 13 NEW APPROVALS IN BLOOD PRODUCTS (FROM 2014 MAY 2016) 36 PEPTIDE ANTIBIOTICS 37 TABLE 14 NEW APPROVALS IN PEPTIDE ANTIBIOTICS (FROM )* 37 RECALLS 38 TABLE 15 RECALLS (FROM )* 38 SAFETY ALERTS 39 TABLE 16 SAFETY ALERTS (FROM )* 39

4 CHAPTER 5 NEW DEVELOPMENTS 42 MONOCLONAL ANTIBODIES 42 TABLE 17 PIPELINE PRODUCTS OF MONOCLONAL ANTIBODIES 42 VACCINES 47 TABLE 18 PIPELINE PRODUCTS OF VACCINES 48 CYTOKINES 50 TABLE 19 PIPELINE PRODUCTS OF CYTOKINES 50 PEPTIDE HORMONES 50 TABLE 20 PIPELINE PRODUCTS OF PEPTIDE HORMONES 51 PEPTIDE ANTIBIOTICS 51 TABLE 21 PIEPLINES PRODUCTS OF PEPTIDE ANTIBIOTICS 52 THERAPUETIC ENZYMES 52 TABLE 22 PIPELINE PRODUCTS OF THERAPUETIC ENZYMES 53 BLOOD PRODUCTS 53 TABLE 23 PIPELINE PRODUCTS OF BLOOD PRODUCTS 53 MERGERS AND ACQUISITIONS 54 TABLE 24 MERGERS AND ACQUISITIONS OF TOP PHARMACEUTICAL COMPANIES 54 CHAPTER 6 MARKET ANALYSIS BY TYPE 58 MARKET BY TYPE 58 MARKET OVERVIEW 59 MARKET REVENUE 59 TABLE 25 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE, THROUGH 2021 ($ FIGURE 1 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE, ($ MARKET SHARE 61 TABLE 26 GLOBAL MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE, FIGURE 2 GLOBAL MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE, PEPTIDE HORMONES 62 Market Overview 63 Market Revenue 64 TABLE 27 GLOBAL MARKET FOR PEPTIDE HORMONES, BY REGION, THROUGH 2021 ($ FIGURE 3 GLOBAL MARKET FOR PEPTIDE HORMONES, BY REGION, ($ VACCINES 65 Market Overview 66 Market Revenue 66 TABLE 28 GLOBAL MARKET FOR VACCINES, BY REGION, THROUGH 2021 ($ FIGURE 4 GLOBAL MARKET FOR VACCINES, BY REGION, ($ 67 THERAPEUTIC ENZYMES 68 Market Overview 68 Market Revenue

5 TABLE 29 GLOBAL MARKET FOR THERAPEUTIC ENZYMES, BY REGION, THROUGH 2021 ($ FIGURE 5 GLOBAL MARKET FOR THERAPEUTIC ENZYMES, BY REGION, ($ MONOCLONAL ANTIBODIES 70 Market Overview 70 Market Revenue 71 TABLE 30 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES, BY REGION, THROUGH 2021 ($ FIGURE 6 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES, BY REGION, ($ CYTOKINES 72 Market Overview 73 Market Revenue 73 TABLE 31 GLOBAL MARKET FOR CYTOKINES, BY REGION, THROUGH 2021 ($ FIGURE 7 GLOBAL MARKET FOR CYTOKINES, BY REGION, ($ 74 BLOOD PRODUCTS AND PEPTIDE ANTIBIOTICS 74 Market Overview 75 Market Revenue 76 TABLE 32 GLOBAL MARKET FOR BLOOD FACTORS AND PEPTIDE ANTIBIOTICS, BY REGION, THROUGH 2021 ($ FIGURE 8 GLOBAL MARKET FOR BLOOD FACTORS AND PEPTIDE ANTIBIOTICS, BY REGION, ($ CHAPTER 7 INDUSTRY STRUCTURE 79 PEPTIDE HORMONES 79 MARKET LEADERS 79 TABLE 33 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE HORMONES, MARKET SHARE 81 TABLE 34 GLOBAL MARKET SHARE OF MANUFACTURERS AND SUPPLIERS FOR BIOENGINEERED PEPTIDE HORMONES, FIGURE 9 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR BIOENGINEERED PEPTIDE HORMONES, VACCINES 82 MARKET LEADERS 82 TABLE 35 LEADING MANUFACTURERS/SUPPLIERS OF VACCINES, MARKET SHARE 85 TABLE 36 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, FIGURE 10 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, THERAPEUTIC ENZYMES 86 MARKET LEADERS 86 TABLE 37 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC ENZYMES, 2015 MARKET SHARE 87 TABLE 38 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC ENZYMES,

6 FIGURE 11 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC ENZYMES, MONOCLONAL ANTIBODIES 89 MARKET LEADERS 89 TABLE 39 LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODIES, 2015 MARKET SHARE 90 TABLE 40 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL ANTIBODIES, FIGURE 12 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL ANTIBODIES, CYTOKINES 91 MARKET LEADERS 91 TABLE 41 LEADING MANUFACTURERS/SUPPLIERS OF CYTOKINES, MARKET SHARE 92 TABLE 42 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINE, FIGURE 13 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINE, BLOOD FACTORS 93 MARKET LEADERS 93 TABLE 43 LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT BLOOD PRODUCTS, 2015 MARKET SHARE 94 TABLE 44 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT BLOOD PRODUCTS, FIGURE 14 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT BLOOD PRODUCTS, PEPTIDE ANTIBIOTICS 95 MARKET LEADERS 95 TABLE 45 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE ANTIBIOTICS, MARKET SHARE 96 TABLE 46 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE ANTIBIOTICS, FIGURE 15 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE ANTIBIOTICS, CHAPTER 8 MARKET BY DISEASE 99 MARKET BY DISEASE 99 MARKET OVERVIEW 99 MARKET REVENUE 100 TABLE 47 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE, THROUGH 2021 ($ FIGURE 16 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE, ($ MARKET SHARE 101 TABLE 48 GLOBAL MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE, 2015 FIGURE 17 GLOBAL MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE,

7 DIABETES 102 Type 1 Diabetes 103 Type 2 Diabetes 103 Gestational Diabetes 103 Market Overview 104 Market Revenue 104 TABLE 49 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR DIABETES, BY REGION, THROUGH 2021 ($ FIGURE 18 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR DIABETES, BY REGION, ($ CANCER 106 TABLE 50 VARIOUS CANCER TYPES DEPENDING ON THE TISSUE OF ORIGIN 107 TABLE 51 CATEGORIES OF CANCER 107 Market Overview 108 Market Revenue 109 TABLE 52 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR CANCER, BY REGION, THROUGH 2021 ($ FIGURE 19 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR CANCER, BY REGION, ($ BLOOD DISORDERS AND SKIN DISEASES 110 Blood Disorders 110 Bleeding Disorders 111 Anemia 111 Leukemia 112 Multiple Myeloma 112 Skin Diseases 113 Skin and Skin structure Infections (SSSI) Complicated Skin and Skin structure Infection (csssi) 113 Uncomplicated Skin and Skin structure Infection (usssi) 113 Clostridium difficile (C. difficile) 114 Market Overview 114 Market Revenue 115 TABLE 53 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR BLOOD DISORDERS AND SKIN DISEASES, BY REGION, THROUGH 2021 ($ FIGURE 20 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR BLOOD DISORDERS AND SKIN DISEASES, BY REGION, ($ GROWTH HORMONE DISORDER, ENZYME DISORDER AND FERTILITY DISORDER Market Overview 117 Market Revenue 118 TABLE 54 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION, THROUGH 2021 ($ FIGURE 21 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION, ($ OTHERS 119 Multiple Sclerosis 119 Hepatitis 119 Crohn's Disease

8 Influenza 120 Pneumonia 121 Cystic Fibrosis 121 Asthma 121 Meningitis 121 Rheumatoid Arthritis 121 Market Overview 122 Market Revenue 123 TABLE 55 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR OTHER DISEASES, BY REGION, THROUGH 2021 ($ FIGURE 22 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR OTHER DISEASES, BY REGION, ($ CHAPTER 9 PATENT ANALYSIS 126 PATENTS BY YEAR 126 TABLE 56 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY YEAR, 2014-JUNE 2016 FIGURE 23 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY YEAR, 2014-JUNE 2016 PATENTS BY TYPE 127 TABLE 57 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY TYPE, 2014-JUNE 2016 FIGURE 24 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY TYPE, 2014-JUNE 2016 PATENTS BY COMPANY 128 TABLE 58 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY COMPANY, 2014-JUNE 2016 PATENTS BY COUNTRY 132 TABLE 59 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY COUNTRY,* 2014-JUNE 2016 TABLE 60 PATENT SHARES FOR MANUFACTURING OF PROTEIN DRUGS, BY COUNTRY, 2014-JUNE 2016 (NO./%) PATENTS BY ASSIGNEE 134 TABLE 61 NUMBER OF PATENTS, BY ASSIGNEE, 2014-JUNE FIGURE 25 NUMBER OF PATENTS, BY ASSIGNEE, 2014-JUNE CHAPTER 10 CURRENT SITUATION 137 FACTORS AFFECTING BIOENGINEERED PROTEIN DRUGS 137 INCREASING PREVALENCE OF CHRONIC DISEASES 137 GROWING AGING POPULATION 137 LIFESTYLE CHANGES 138 AWARENESS AND EDUCATION 138 ADVANCEMENTS IN MANUFACTURING TECHNOLOGIES 138 PRICE CONTROLS 138 REGULATORY PRESSURES 139 LICENSING AGREEMENTS 139 MERGERS AND ACQUISITIONS 140 ENTRY OF FOLLOW-ON-BIOLOGICS/BIOSIMILARS 140

9 CHAPTER 11 COMPANY PROFILES 142 ABBVIE INC. 142 ACTAVIS INC. 142 ALEXION PHARMACEUTICALS 142 ALLERGAN PLC. 143 AMGEN INC 143 APOTEX INC. 144 BAXALTA INC 144 BAYER HEALTHCARE PHARMACEUTICALS 145 BIOMARIN PHARMACEUTICAL INC. 145 BIOGEN IDEC 145 BIOTEST PHARMACEUTICALS CORPORATION 146 BRISTOL-MYERS SQUIBB 146 CSL LIMITED 147 ELI LILLY 147 FRESENIUS KABI USA 148 GLAXOSMITHKLINE 148 GRIFOLS USA LLC. 148 HOFFMAN-LA ROCHE 149 HOSPIRA INC. 149 JOHNSON & JOHNSON 149 MEDIMMUNE LLC 150 MERCK & CO, INC 150 MYLAN INC. 151 NOVARTIS AG 151 NOVO NORDISK AG 152 OCTAPHARMA AG 152 PFIZER INC 153 SANOFI INC 153 SEATTLE GENETICS INC. 154 SPECTRUM PHARMACEUTICALS INC. 154 TAKEDA PHARMACEUTICAL U.S.A., INC 154 UCB COMPANY 155 CHAPTER 12 APPENDIX I-ABBREVIATIONS 157

10 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY REGION, THROUGH 2021 ($ TABLE 1 BIOENGINEERED PROTEIN DRUGS VS. CHEMICALLY SYNTHESIZED DRUGS 12 TABLE 2 EVOLUTION OF BIOENGINEERED PROTEIN DRUGS 13 TABLE 3 PROTEIN DRUGS MADE BY FRACTIONATION 16 TABLE 4 THERAPETIC DRUGS PRODUCED BY MICROBIAL FERMENTATION 17 TABLE 5 PROTEIN DRUGS PRODUCED BY TRANSGENIC ANIMALS, PLANTS AND MICROORGANISMS TABLE 6 PROTEIN DRUGS MADE BY MAMMALIAN CELL CULTURE 19 TABLE 7 ROUTES OF DRUG DELIVERY 21 TABLE 8 NEW APPROVALS OF MONOCLONAL ANTIBODIES (FROM 2014-MAY 2016) 32 TABLE 9 NEW APPROVALS OF CYTOKINES (FROM )* 34 TABLE 10 NEW APPROVALS IN VACCINES (FROM 2014 MAY 2016) 34 TABLE 11 NEW APPROVALS IN PEPTIDE HORMONES (FROM )* 35 TABLE 12 NEW APPROVALS IN THERAPEUTIC ENZYMES (FROM )* 36 TABLE 13 NEW APPROVALS IN BLOOD PRODUCTS (FROM 2014 MAY 2016) 36 TABLE 14 NEW APPROVALS IN PEPTIDE ANTIBIOTICS (FROM )* 37 TABLE 15 RECALLS (FROM )* 38 TABLE 16 SAFETY ALERTS (FROM )* 39 TABLE 17 PIPELINE PRODUCTS OF MONOCLONAL ANTIBODIES 42 TABLE 18 PIPELINE PRODUCTS OF VACCINES 48 TABLE 19 PIPELINE PRODUCTS OF CYTOKINES 50 TABLE 20 PIPELINE PRODUCTS OF PEPTIDE HORMONES 51 TABLE 21 PIEPLINES PRODUCTS OF PEPTIDE ANTIBIOTICS 52 TABLE 22 PIPELINE PRODUCTS OF THERAPUETIC ENZYMES 53 TABLE 23 PIPELINE PRODUCTS OF BLOOD PRODUCTS 53 TABLE 24 MERGERS AND ACQUISITIONS OF TOP PHARMACEUTICAL COMPANIES 54 TABLE 25 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE, THROUGH 2021 ($ TABLE 26 GLOBAL MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE, TABLE 27 GLOBAL MARKET FOR PEPTIDE HORMONES, BY REGION, THROUGH 2021 ($ TABLE 28 GLOBAL MARKET FOR VACCINES, BY REGION, THROUGH 2021 ($ TABLE 29 GLOBAL MARKET FOR THERAPEUTIC ENZYMES, BY REGION, THROUGH 2021 ($ TABLE 30 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES, BY REGION, THROUGH 2021 ($ TABLE 31 GLOBAL MARKET FOR CYTOKINES, BY REGION, THROUGH 2021 ($ TABLE 32 GLOBAL MARKET FOR BLOOD FACTORS AND PEPTIDE ANTIBIOTICS, BY REGION, THROUGH 2021 ($ TABLE 33 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE HORMONES, TABLE 34 GLOBAL MARKET SHARE OF MANUFACTURERS AND SUPPLIERS FOR BIOENGINEERED PEPTIDE HORMONES, TABLE 35 LEADING MANUFACTURERS/SUPPLIERS OF VACCINES, TABLE 36 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES,

11 TABLE HEADING TABLE 37 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC ENZYMES, TABLE 38 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC ENZYMES, TABLE 39 LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODIES, 2015 TABLE 40 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL ANTIBODIES, TABLE 41 LEADING MANUFACTURERS/SUPPLIERS OF CYTOKINES, TABLE 42 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINE, TABLE 43 LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT BLOOD PRODUCTS, 2015 TABLE 44 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT BLOOD PRODUCTS, TABLE 45 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE ANTIBIOTICS, TABLE 46 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE ANTIBIOTICS, TABLE 47 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE, THROUGH 2021 ($ TABLE 48 GLOBAL MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE, 2015 TABLE 49 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR DIABETES, BY REGION, THROUGH 2021 ($ TABLE 50 VARIOUS CANCER TYPES DEPENDING ON THE TISSUE OF ORIGIN 107 TABLE 51 CATEGORIES OF CANCER 107 TABLE 52 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR CANCER, BY REGION, THROUGH 2021 ($ TABLE 53 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR BLOOD DISORDERS AND SKIN DISEASES, BY REGION, THROUGH 2021 ($ TABLE 54 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION, THROUGH 2021 ($ TABLE 55 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR OTHER DISEASES, BY REGION, THROUGH 2021 ($ TABLE 56 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY YEAR, 2014-JUNE 2016 TABLE 57 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY TYPE, 2014-JUNE 2016 TABLE 58 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY COMPANY, 2014-JUNE 2016 TABLE 59 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY COUNTRY,* 2014-JUNE 2016 TABLE 60 PATENT SHARES FOR MANUFACTURING OF PROTEIN DRUGS, BY COUNTRY, 2014-JUNE 2016 (NO./%) TABLE 61 NUMBER OF PATENTS, BY ASSIGNEE, 2014-JUNE

12 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY REGION, ($ FIGURE 1 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE, ($ FIGURE 2 GLOBAL MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE, FIGURE 3 GLOBAL MARKET FOR PEPTIDE HORMONES, BY REGION, ($ FIGURE 4 GLOBAL MARKET FOR VACCINES, BY REGION, ($ 67 FIGURE 5 GLOBAL MARKET FOR THERAPEUTIC ENZYMES, BY REGION, ($ FIGURE 6 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES, BY REGION, ($ FIGURE 7 GLOBAL MARKET FOR CYTOKINES, BY REGION, ($ 74 FIGURE 8 GLOBAL MARKET FOR BLOOD FACTORS AND PEPTIDE ANTIBIOTICS, BY REGION, ($ FIGURE 9 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR BIOENGINEERED PEPTIDE HORMONES, FIGURE 10 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, FIGURE 11 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC ENZYMES, FIGURE 12 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL ANTIBODIES, FIGURE 13 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINE, FIGURE 14 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT BLOOD PRODUCTS, FIGURE 15 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE ANTIBIOTICS, FIGURE 16 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE, ($ FIGURE 17 GLOBAL MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE, FIGURE 18 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR DIABETES, BY REGION, ($ FIGURE 19 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR CANCER, BY REGION, ($ FIGURE 20 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR BLOOD DISORDERS AND SKIN DISEASES, BY REGION, ($ FIGURE 21 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION, ($ FIGURE 22 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS FOR OTHER DISEASES, BY REGION, ($ FIGURE 23 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY YEAR, 2014-JUNE 2016 FIGURE 24 NUMBER OF PATENTS GRANTED IN MANUFACTURING OF PROTEIN DRUGS, BY TYPE, 2014-JUNE 2016 FIGURE 25 NUMBER OF PATENTS, BY ASSIGNEE, 2014-JUNE