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This BCC Research report explores the present and future strategies within the manufacturing of the protein drugs market, which includes peptide hormones, monoclonal antibodies, cytokines, therapeutic enzymes, blood factors, vaccines and peptide antibiotics. Forecast provided from 2015 through 2020.

Use this report to:

Explore present and future strategies within manufacturing of the protein drugs market.
Analyze the protein drug market and its applications, regulatory environment, technology, market projections and market shares.
Gain information about the history of therapeutic proteins and its manufacturing technologies.
Relevant patent analysis and profiles of companies that lead manufacturing in the protein drug industry

Highlights

The global protein drugs market reached nearly $174.7 billion in 2015 and should reach nearly $248.7 billion by 2020 increasing at a compound annual growth rate (CAGR) of 7.3% through 2020.
The U.S., leader in the protein drugs market, reached nearly $92.0 billion in 2015 and should reach $154.1 billion by 2020 at a CAGR of 10.9% through 2020.
Europe as a segment reached $42.2 billion in 2015 and should reach $48.1 billion by 2020, at a CAGR of 2.6% through 2020.

STUDY OBJECTIVES

Proteins play the most diverse role in the body. Protein drug products have many advantages over small-molecule drugs; their actions are highly specific and they are less likely to interfere with normal biological processes, and are often well tolerated by the body. The protein drug market is highly segmented and promising. Protein drugs can be manufactured through many different ways. They are either created through recombinant deoxyribonucleic acid (rDNA) technology, or can be isolated as naturally occurring substances from animals, microorganisms and insects. BCC Research’s goal in conducting this study is to provide an overview of the current and future characteristics of the global market for manufacturing of protein drugs.

This report explores the present and future strategies within the manufacturing of the protein drugs market, which includes peptide hormones, monoclonal antibodies, cytokines, therapeutic enzymes, blood factors, vaccines and peptide antibiotics. The history of the market, the restraining factors and the needs of the market are discussed in this report. The classification of these products and their manufacturing processes are also detailed in this report.

An analysis of the industry structure of protein drug products has been conducted.

Revenues are broken down by region. Sales figures are estimated for the five-year period from 2015 through 2020. The market by manufacturing process for these protein drugs is discussed separately in the report. The report also covers significant patents and their allotments in each category.

REASONS FOR DOING THIS STUDY

Protein drugs play an important role in the biopharmaceutical industry. The increase in incidences of chronic diseases such as cancer, various hormone and enzymatic disorders, asthma and autoimmune diseases have added to the growth of the protein drug market. Outstanding improvements in technologies such as mass spectrometry, advances in molecular genetics, and progress in production technologies are driving
the market’s growth. Extensive research in the manufacturing process of protein drugs has revealed their usage in developing efficient, user-friendly and affordable products.

Modern industries have now begun to explore the advantages of these technologies for manufacturing protein drugs in their productions and processes.

R&D spending, along with increasing competition, patent expiries and new technologies are giving a new direction to the market. The advancements, new product launches and the changing lifestyle have influenced the market to grow in the future.

This study looks at almost all the systems affected by these factors. Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strength and weaknesses of each type in light of the new technologies, growing competition, and changing customer needs.

SCOPE OF THE STUDY

The scope of this study covers manufacturing of protein drugs technologies. BCC Research analyzed each market and its applications, regulatory environment, technology, market projections and market shares. Technological issues include the latest trends and developments. This report covers the currently used six techniques in manufacturing of protein therapeutics, which includes fractionation from natural
human/animal sources, microbial fermentation, cell culture, chemical synthesis, transgenics and embryonated eggs. The emerging market for enzyme inhibitors includes countries such as India, China, Japan, Korea, Taiwan, Canada, Africa, Australia and New Zealand. The protein drugs that are covered in this report are monoclonal antibodies, cytokines, peptide antibiotics, vaccines, enzymes and blood factors. The market is also analyzed on the basis of the manufacturing process used in making therapeutic protein drugs.

Also included in the report are relevant patent analysis and comprehensive profiles of companies that lead the manufacturing of the protein drug industry. Some of the major players of the market include Eli Lilly & Co., Abbvie Inc., F. Hoffmann-La Roche Ltd., Sanofi S.A., Novo Nordisk AG, Novartis AG, Merck & Co., Merck KGaA and Amgen Inc..




Table Of Contents

Global Markets and Manufacturing Technologies for Protein Drugs

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
2020 ($ MILLIONS) 8
SUMMARY FIGURE GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, 2013-2020
($ MILLIONS) 8
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
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 26
MAMMALIAN CELL CULTURE 27
TABLE 5 PROTEIN DRUGS MADE BY CELL CULTURE 27
CHAPTER 4 REGULATORY ASPECTS 29
MONOCLONAL ANTIBODIES 29
TABLE 6 NEW APPROVALS OF MONOCLONAL ANTIBODIES, 2013-OCTOBER 2015 29
THERAPEUTIC ENZYMES 30
TABLE 7 NEW APPROVALS IN THERAPEUTIC ENZYMES, 2013-OCTOBER 2015 31
CYTOKINES 31
TABLE 8 NEW APPROVALS OF CYTOKINES, 2013-OCTOBER 2015 31
PEPTIDE HORMONES 31
TABLE 9 NEW APPROVALS OF PEPTIDE HORMONES, 2013-OCTOBER 2015 32
VACCINES 32
TABLE 10 NEW APPROVALS OF VACCINES, 2013-OCTOBER 2015 33
BLOOD PRODUCTS 34
TABLE 11 NEW APPROVALS OF BLOOD PRODUCTS, 2013-OCTOBER 2015 34
PEPTIDE ANTIBIOTICS 36
TABLE 12 NEW APPROVALS OF PEPTIDE ANTIBIOTICS, 2013-OCTOBER 2015 36
RECALLS 36
TABLE 13 RECALLS, 2013-OCTOBER 2015 37
SAFETY ALERTS 39
TABLE 14 SAFETY ALERTS, 2013-OCTOBER 2015 39
CHAPTER 5 NEW DEVELOPMENTS 42
MONOCLONAL ANTIBODIES 42
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 ($
MILLIONS) 59
FIGURE 1 GLOBAL REVENUE FOR PROTEIN DRUGS BY TYPE, 2013-2020 ($
MILLIONS) 59
MARKET SHARE 60
TABLE 24 MARKET SHARE OF PROTEIN DRUGS BY TYPE, 2014 (%) 60
FIGURE 2 MARKET SHARE OF PROTEIN DRUGS BY TYPE, 2014 (%) 60
PEPTIDE HORMONES 61
Market Overview 62
Market Revenue 62
TABLE 25 GLOBAL REVENUE FOR PEPTIDE HORMONES BY TYPE, THROUGH 2020 ($
MILLIONS) 63
FIGURE 3 GLOBAL REVENUE FOR PEPTIDE HORMONES BY TYPE, 2013-2020 ($
MILLIONS) 63
VACCINES 64
Market Overview 64
Market Revenue 66
TABLE 26 GLOBAL REVENUE FOR VACCINES BY TYPE, THROUGH 2020 ($ MILLIONS) 66
FIGURE 4 GLOBAL REVENUE FOR VACCINES BY TYPE, 2013-2020 ($ MILLIONS) 67
THERAPEUTIC ENZYMES 67
Market Overview 67
Market Revenue 69
TABLE 27 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH
2020 ($ MILLIONS) 69
FIGURE 5 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY TYPE, 2013-2020 ($
MILLIONS) 69
MONOCLONAL ANTIBODIES 70
Market Overview 71
Market Revenue 72
TABLE 28 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY TYPE, THROUGH
2020 ($ MILLIONS) 73
FIGURE 6 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY TYPE, 2013-2020
($ MILLIONS) 74
CYTOKINES 74
Market Overview 75
Market Revenue 75
TABLE 29 GLOBAL REVENUE FOR CYTOKINES BY TYPE, THROUGH 2020 ($
MILLIONS) 76
FIGURE 7 GLOBAL REVENUE FOR CYTOKINES BY TYPE, 2013-2020 ($ MILLIONS) 77
BLOOD FACTORS 77
Market Overview 78
Market Revenue 79
TABLE 30 GLOBAL REVENUE FOR BLOOD FACTORS BY TYPE, THROUGH 2020 ($
MILLIONS) 79
FIGURE 8 GLOBAL REVENUE FOR BLOOD FACTORS BY TYPE, 2013-2020 ($
MILLIONS) 79
PEPTIDE ANTIBIOTICS 80
Market Overview 80
Market Revenue 81
TABLE 31 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY TYPE, THROUGH 2020
($ MILLIONS) 82
FIGURE 9 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY TYPE, 2013-2020 ($
MILLIONS) 82
MARKET BY REGION 82
MARKET OVERVIEW 83
MARKET REVENUE 84
TABLE 32 GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, THROUGH 2020 ($
MILLIONS) 85
FIGURE 10 GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, 2013-2020 ($
MILLIONS) 85
MARKET SHARE 86
TABLE 33 MARKET SHARE OF PROTEIN DRUGS BY REGION, 2014 (%) 86
FIGURE 11 MARKET SHARE OF PROTEIN DRUGS BY REGION, 2014 (%) 86
PEPTIDE HORMONES 86
Market Overview 87
Market Revenue 88
TABLE 34 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2020
($ MILLIONS) 88
FIGURE 12 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, 2013-2020 ($
MILLIONS) 89
VACCINES 89
Market Overview 89
Market Revenue 90
TABLE 35 GLOBAL REVENUE FOR VACCINES BY REGION, THROUGH 2020 ($
MILLIONS) 91
FIGURE 13 GLOBAL REVENUE FOR VACCINES BY REGION, 2013-2020 ($ MILLIONS) 91
THERAPEUTIC ENZYMES 91
Market Overview 92
Market Revenue 92
TABLE 36 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH
2020 ($ MILLIONS) 93
FIGURE 14 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, 2013-2020
($ MILLIONS) 93
MONOCLONAL ANTIBODIES 93
Market Overview 94
Market Revenue 94
TABLE 37 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY REGION,
THROUGH 2020 ($ MILLIONS) 95
FIGURE 15 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY REGION,
2013-2020 ($ MILLIONS) 95
CYTOKINES 96
Market Overview 96
Market Revenue 96
TABLE 38 GLOBAL REVENUE FOR CYTOKINES BY REGION, THROUGH 2020 ($
MILLIONS) 97
FIGURE 16 GLOBAL REVENUE FOR CYTOKINES BY REGION, 2013-2020 ($ MILLIONS) 98
BLOOD FACTORS 98
Market Overview 98
Market Revenue 99
TABLE 39 GLOBAL REVENUE FOR BLOOD FACTORS BY REGION, THROUGH 2020 ($
MILLIONS) 99
FIGURE 17 GLOBAL REVENUE FOR BLOOD FACTORS BY REGION, 2013-2020 ($
MILLIONS) 99
PEPTIDE ANTIBIOTICS 100
Market Overview 100
Market Revenue 101
TABLE 40 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY REGION, THROUGH
2020 ($ MILLIONS) 101
FIGURE 18 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY REGION, 2013-2020 ($
MILLIONS) 101
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 2020 ($ MILLIONS) 106
FIGURE 19 GLOBAL REVENUE FOR PROTEIN DRUGS BY MANUFACTURING PROCESS,
2013-2020 ($ MILLIONS) 106
MARKET SHARE 107
TABLE 42 MARKET SHARE OF PROTEIN DRUGS BY MANUFACTURING PROCESS,
2014 (%) 107
FIGURE 20 MARKET SHARE OF PROTEIN DRUGS BY MANUFACTURING PROCESS,
2014 (%) 108
PEPTIDE HORMONES 108
Market Overview 109
Market Revenue 109
TABLE 43 GLOBAL REVENUE FOR PEPTIDE HORMONES BY MANUFACTURING
PROCESS, THROUGH 2020 ($ MILLIONS) 110
FIGURE 21 GLOBAL REVENUE FOR PEPTIDE HORMONES BY MANUFACTURING
PROCESS, 2013-2020 ($ MILLIONS) 110
VACCINES 111
Market Overview 111
Market Revenue 112
TABLE 44 GLOBAL REVENUE FOR VACCINES BY MANUFACTURING PROCESS,
THROUGH 2020 ($ MILLIONS) 112
FIGURE 22 GLOBAL REVENUE FOR VACCINES BY MANUFACTURING PROCESS,
2013-2020 ($ MILLIONS) 112
THERAPEUTIC ENZYMES 113
Market Overview 114
Market Revenue 114
TABLE 45 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY MANUFACTURING
PROCESS, THROUGH 2020 ($ MILLIONS) 115
FIGURE 23 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY MANUFACTURING
PROCESS, 2013-2020 ($ MILLIONS) 115
MONOCLONAL ANTIBODIES 115
Market Overview 116
Market Revenue 117
TABLE 46 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY MANUFACTURING
PROCESS, THROUGH 2020 ($ MILLIONS) 117
FIGURE 24 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY
MANUFACTURING PROCESS, 2013-2020 ($ MILLIONS) 117
CYTOKINES 118
Market Overview 118
Market Revenue 119
TABLE 47 GLOBAL REVENUE FOR CYTOKINES BY MANUFACTURING PROCESS,
THROUGH 2020 ($ MILLIONS) 119
FIGURE 25 GLOBAL REVENUE FOR CYTOKINES BY MANUFACTURING PROCESS,
2013-2020 ($ MILLIONS) 120
BLOOD FACTORS 120
Market Overview 120
Market Revenue 121
TABLE 48 GLOBAL REVENUE FOR BLOOD FACTORS BY MANUFACTURING PROCESS,
THROUGH 2020 ($ MILLIONS) 122
FIGURE 26 GLOBAL REVENUE FOR BLOOD FACTORS BY MANUFACTURING
PROCESS, 2013-2020 ($ MILLIONS) 122
PEPTIDE ANTIBIOTICS 122
Market Overview 123
Market Revenue 123
TABLE 49 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY MANUFACTURING
PROCESS, THROUGH 2020 ($ MILLIONS) 124
FIGURE 27 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY MANUFACTURING
PROCESS, 2013-2020 ($ MILLIONS) 124
CHAPTER 8 INDUSTRY STRUCTURE 126
PEPTIDE HORMONES 126
MARKET LEADERS 126
TABLE 50 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE HORMONES, 2014 126
MARKET SHARE 128
TABLE 51 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE
HORMONES, 2014 (%) 128
FIGURE 28 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE
HORMONES, 2014 (%) 128
VACCINES 129
MARKET LEADERS 129
TABLE 52 LEADING MANUFACTURERS/SUPPLIERS OF VACCINES, 2014 129
MARKET SHARE 132
TABLE 53 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, 2014
(%) 132
FIGURE 29 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, 2014
(%) 133
THERAPEUTIC ENZYMES 133
MARKET LEADERS 133
TABLE 54 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC ENZYMES,
2014 133
MARKET SHARE 134
TABLE 55 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC
ENZYMES, 2014 (%) 135
FIGURE 30 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC
ENZYMES, 2014 (%) 135
MONOCLONAL ANTIBODIES 136
MARKET LEADERS 136
TABLE 56 LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODIES,
2014 136
MARKET SHARE 137
TABLE 57 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL
ANTIBODIES, 2014 (%) 137
FIGURE 31 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL
ANTIBODIES, 2014 (%) 138
CYTOKINES 138
MARKET LEADERS 138
TABLE 58 LEADING MANUFACTURERS/SUPPLIERS OF CYTOKINES, 2014 138
MARKET SHARE 139
TABLE 59 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINES, 2014
(%) 139
FIGURE 32 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINES, 2014
(%) 139
BLOOD FACTORS 140
MARKET LEADERS 140
TABLE 60 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC BLOOD
PRODUCTS, 2014 141
MARKET SHARE 143
TABLE 61 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT
BLOOD PRODUCTS, 2014 (%) 143
FIGURE 33 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT
BLOOD PRODUCTS, 2014 (%) 144
PEPTIDE ANTIBIOTICS 144
MARKET LEADERS 144
TABLE 62 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE ANTIBIOTICS, 2014 144
MARKET SHARE 145
TABLE 63 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE
ANTIBIOTICS, 2014 (%) 145
FIGURE 34 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE
ANTIBIOTICS, 2014 (%) 145
CHAPTER 9 PATENT ANALYSIS 148
PATENTS BY YEAR 148
TABLE 64 NUMBER OF PATENTS BY YEAR, 2013-OCTOBER 2015 149
FIGURE 35 NUMBER OF PATENTS BY YEAR, 2013-OCTOBER 2015 149
PATENTS BY TYPE 149
TABLE 65 NUMBER OF PATENTS BY TYPE, 2013-OCTOBER 2015 149
FIGURE 36 NUMBER OF PATENTS BY TYPE, 2013-OCTOBER 2015 150
PATENTS BY COMPANY 150
TABLE 66 NUMBER OF PATENTS BY COMPANY, 2013-OCTOBER 2015 151
PATENTS BY COUNTRY 154
TABLE 67 NUMBER OF PATENTS BY COUNTRY, 2013-OCTOBER 2015 155
TABLE 68 PATENT SHARES BY COUNTRY, 2013-OCTOBER 2015 (%) 156
FIGURE 37 PATENT SHARES BY COUNTRY, 2013-OCTOBER 2015 (%) 156
PATENTS BY ASSIGNEE 157
TABLE 69 NUMBER OF PATENTS BY ASSIGNEE, 2013-OCTOBER 2015 158
FIGURE 38 NUMBER OF PATENTS BY ASSIGNEE, 2013-OCTOBER 2015 158
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
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 and JOHNSON 175
MEDIMMUNE LLC 175
MERCK and 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


LIST OF TABLES

SUMMARY TABLE GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, THROUGH
2020 ($ MILLIONS) 8
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 26
TABLE 5 PROTEIN DRUGS MADE BY CELL CULTURE 27
TABLE 6 NEW APPROVALS OF MONOCLONAL ANTIBODIES, 2013-OCTOBER 2015 29
TABLE 7 NEW APPROVALS IN THERAPEUTIC ENZYMES, 2013-OCTOBER 2015 31
TABLE 8 NEW APPROVALS OF CYTOKINES, 2013-OCTOBER 2015 31
TABLE 9 NEW APPROVALS OF PEPTIDE HORMONES, 2013-OCTOBER 2015 32
TABLE 10 NEW APPROVALS OF VACCINES, 2013-OCTOBER 2015 33
TABLE 11 NEW APPROVALS OF BLOOD PRODUCTS, 2013-OCTOBER 2015 34
TABLE 12 NEW APPROVALS OF PEPTIDE ANTIBIOTICS, 2013-OCTOBER 2015 36
TABLE 13 RECALLS, 2013-OCTOBER 2015 37
TABLE 14 SAFETY ALERTS, 2013-OCTOBER 2015 39
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 ($
MILLIONS) 59
TABLE 24 MARKET SHARE OF PROTEIN DRUGS BY TYPE, 2014 (%) 60
TABLE 25 GLOBAL REVENUE FOR PEPTIDE HORMONES BY TYPE, THROUGH 2020 ($
MILLIONS) 63
TABLE 26 GLOBAL REVENUE FOR VACCINES BY TYPE, THROUGH 2020 ($ MILLIONS) 66
TABLE 27 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH 2020
($ MILLIONS) 69
TABLE 28 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY TYPE, THROUGH
2020 ($ MILLIONS) 73
TABLE 29 GLOBAL REVENUE FOR CYTOKINES BY TYPE, THROUGH 2020 ($ MILLIONS) 76
TABLE 30 GLOBAL REVENUE FOR BLOOD FACTORS BY TYPE, THROUGH 2020 ($
MILLIONS) 79
TABLE 31 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY TYPE, THROUGH 2020 ($
MILLIONS) 82
TABLE 32 GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, THROUGH 2020 ($
MILLIONS) 85
TABLE 33 MARKET SHARE OF PROTEIN DRUGS BY REGION, 2014 (%) 86
TABLE 34 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2020 ($
MILLIONS) 88
TABLE 35 GLOBAL REVENUE FOR VACCINES BY REGION, THROUGH 2020 ($
MILLIONS) 91
TABLE 36 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH
2020 ($ MILLIONS) 93
TABLE 37 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY REGION, THROUGH
2020 ($ MILLIONS) 95
TABLE 38 GLOBAL REVENUE FOR CYTOKINES BY REGION, THROUGH 2020 ($
MILLIONS) 97
TABLE 39 GLOBAL REVENUE FOR BLOOD FACTORS BY REGION, THROUGH 2020 ($
MILLIONS) 99
TABLE 40 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY REGION, THROUGH 2020
($ MILLIONS) 101
TABLE 41 GLOBAL REVENUE FOR PROTEIN DRUGS BY MANUFACTURING PROCESS,
THROUGH 2020 ($ MILLIONS) 106
TABLE 42 MARKET SHARE OF PROTEIN DRUGS BY MANUFACTURING PROCESS, 2014
(%) 107
TABLE 43 GLOBAL REVENUE FOR PEPTIDE HORMONES BY MANUFACTURING
PROCESS, THROUGH 2020 ($ MILLIONS) 110
TABLE 44 GLOBAL REVENUE FOR VACCINES BY MANUFACTURING PROCESS,
THROUGH 2020 ($ MILLIONS) 112
TABLE 45 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY MANUFACTURING
PROCESS, THROUGH 2020 ($ MILLIONS) 115
TABLE 46 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY MANUFACTURING
PROCESS, THROUGH 2020 ($ MILLIONS) 117
TABLE 47 GLOBAL REVENUE FOR CYTOKINES BY MANUFACTURING PROCESS,
THROUGH 2020 ($ MILLIONS) 119
TABLE 48 GLOBAL REVENUE FOR BLOOD FACTORS BY MANUFACTURING PROCESS,
THROUGH 2020 ($ MILLIONS) 122
TABLE 49 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY MANUFACTURING
PROCESS, THROUGH 2020 ($ MILLIONS) 124
TABLE 50 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE HORMONES, 2014 126
TABLE 51 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE
HORMONES, 2014 (%) 128
TABLE 52 LEADING MANUFACTURERS/SUPPLIERS OF VACCINES, 2014 129
TABLE 53 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, 2014 (%) 132
TABLE 54 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC ENZYMES, 2014 133
TABLE 55 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC
ENZYMES, 2014 (%) 135
TABLE 56 LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODIES,
2014 136
TABLE 57 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL
ANTIBODIES, 2014 (%) 137
TABLE 58 LEADING MANUFACTURERS/SUPPLIERS OF CYTOKINES, 2014 138
TABLE 59 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINES, 2014
(%) 139
TABLE 60 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC BLOOD
PRODUCTS, 2014 141
TABLE 61 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT
BLOOD PRODUCTS, 2014 (%) 143
TABLE 62 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE ANTIBIOTICS, 2014 144
TABLE 63 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE
ANTIBIOTICS, 2014 (%) 145
TABLE 64 NUMBER OF PATENTS BY YEAR, 2013-OCTOBER 2015 149
TABLE 65 NUMBER OF PATENTS BY TYPE, 2013-OCTOBER 2015 149
TABLE 66 NUMBER OF PATENTS BY COMPANY, 2013-OCTOBER 2015 151
TABLE 67 NUMBER OF PATENTS BY COUNTRY, 2013-OCTOBER 2015 155
TABLE 68 PATENT SHARES BY COUNTRY, 2013-OCTOBER 2015 (%) 156
TABLE 69 NUMBER OF PATENTS BY ASSIGNEE, 2013-OCTOBER 2015 158

LIST OF FIGURES

SUMMARY FIGURE GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, 2013-2020
($ MILLIONS) 8
FIGURE 1 GLOBAL REVENUE FOR PROTEIN DRUGS BY TYPE, 2013-2020 ($ MILLIONS) 59
FIGURE 2 MARKET SHARE OF PROTEIN DRUGS BY TYPE, 2014 (%) 60
FIGURE 3 GLOBAL REVENUE FOR PEPTIDE HORMONES BY TYPE, 2013-2020 ($
MILLIONS) 63
FIGURE 4 GLOBAL REVENUE FOR VACCINES BY TYPE, 2013-2020 ($ MILLIONS) 67
FIGURE 5 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY TYPE, 2013-2020 ($
MILLIONS) 69
FIGURE 6 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY TYPE, 2013-2020 ($
MILLIONS) 74
FIGURE 7 GLOBAL REVENUE FOR CYTOKINES BY TYPE, 2013-2020 ($ MILLIONS) 77
FIGURE 8 GLOBAL REVENUE FOR BLOOD FACTORS BY TYPE, 2013-2020 ($ MILLIONS) 79
FIGURE 9 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY TYPE, 2013-2020 ($
MILLIONS) 82
FIGURE 10 GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, 2013-2020 ($
MILLIONS) 85
FIGURE 11 MARKET SHARE OF PROTEIN DRUGS BY REGION, 2014 (%) 86
FIGURE 12 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, 2013-2020 ($
MILLIONS) 89
FIGURE 13 GLOBAL REVENUE FOR VACCINES BY REGION, 2013-2020 ($ MILLIONS) 91
FIGURE 14 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, 2013-2020 ($
MILLIONS) 93
FIGURE 15 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY REGION,
2013-2020 ($ MILLIONS) 95
FIGURE 16 GLOBAL REVENUE FOR CYTOKINES BY REGION, 2013-2020 ($ MILLIONS) 98
FIGURE 17 GLOBAL REVENUE FOR BLOOD FACTORS BY REGION, 2013-2020 ($
MILLIONS) 99
FIGURE 18 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY REGION, 2013-2020 ($
MILLIONS) 101
FIGURE 19 GLOBAL REVENUE FOR PROTEIN DRUGS BY MANUFACTURING PROCESS,
2013-2020 ($ MILLIONS) 106
FIGURE 20 MARKET SHARE OF PROTEIN DRUGS BY MANUFACTURING PROCESS,
2014 (%) 108
FIGURE 21 GLOBAL REVENUE FOR PEPTIDE HORMONES BY MANUFACTURING
PROCESS, 2013-2020 ($ MILLIONS) 110
FIGURE 22 GLOBAL REVENUE FOR VACCINES BY MANUFACTURING PROCESS,
2013-2020 ($ MILLIONS) 112
FIGURE 23 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY MANUFACTURING
PROCESS, 2013-2020 ($ MILLIONS) 115
FIGURE 24 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY MANUFACTURING
PROCESS, 2013-2020 ($ MILLIONS) 117
FIGURE 25 GLOBAL REVENUE FOR CYTOKINES BY MANUFACTURING PROCESS,
2013-2020 ($ MILLIONS) 120
FIGURE 26 GLOBAL REVENUE FOR BLOOD FACTORS BY MANUFACTURING PROCESS,
2013-2020 ($ MILLIONS) 122
FIGURE 27 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY MANUFACTURING
PROCESS, 2013-2020 ($ MILLIONS) 124
FIGURE 28 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE
HORMONES, 2014 (%) 128
FIGURE 29 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, 2014
(%) 133
FIGURE 30 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC
ENZYMES, 2014 (%) 135
FIGURE 31 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL
ANTIBODIES, 2014 (%) 138
FIGURE 32 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINES, 2014
(%) 139
FIGURE 33 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT
BLOOD PRODUCTS, 2014 (%) 144
FIGURE 34 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE
ANTIBIOTICS, 2014 (%) 145
FIGURE 35 NUMBER OF PATENTS BY YEAR, 2013-OCTOBER 2015 149
FIGURE 36 NUMBER OF PATENTS BY TYPE, 2013-OCTOBER 2015 150
FIGURE 37 PATENT SHARES BY COUNTRY, 2013-OCTOBER 2015 (%) 156
FIGURE 38 NUMBER OF PATENTS BY ASSIGNEE, 2013-OCTOBER 2015 158

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