STUDY OBJECTIVES

The objective of BCC in conducting this study is to provide an overview of the current and future characteristics of the global market for protein drugs/therapeutics. The key objective is to present a comprehensive analysis and future direction of protein drugs as an important tool in the treatment of various diseases.
This report explores present and future strategies within the protein therapeutics market, which includes peptide hormones, therapeutic enzymes, cytokines, monoclonal antibodies, blood factors, vaccines and peptide antibodies. The improvisation of the market, the setbacks and the needs of the market are discussed in this report. The classifications, manufacturing processes and usage of are also portrayed.
A detailed analysis of protein therapeutics industry structure has been conducted. Revenues are broken down by region, by type and by manufacturing method. Sales figures are given for 2011, 2012 and estimated for the five-year period from 2013 through 2018.
The report also covers significant patents and their allotments in each category.

REASONS FOR DOING THIS STUDY

Widespread research in the field of protein therapeutics has discovered specific functionality in being able to provide therapeutic treatments for various diseases.
R&D spending, along with increasing competition, patent expiries and new technologies are providing a new direction. The new advancements, new product launches and a changing lifestyle have caused the market to grow in the foreseeable 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 of technology in light of the new technologies, growing competition, and changing customer needs.

INTENDED AUDIENCE

This study contributes to the areas of market growth in protein therapeutics manufacturers and users. Pharmaceutical biotechnical companies, research institutes, and physicians will find this study to be of interest.

SCOPE OF THE STUDY

The scope of this study encompasses protein therapeutics in pharmaceutical and biotechnology markets. BCC analyzes each market and its applications, regulatory environment, technology, market projections, and market shares. Technological issues include the latest trends and developments. The emerging market for enzyme inhibitors includes countries like India, China, Japan, Korea, Taiwan, Africa, Australia, New Zealand, etc.

METHODOLOGY

Both primary and secondary research methodologies were used in preparing this study. BCC conducted a comprehensive literature search, which included technical newsletters and journals, and many other sources. Data were collected through interviews and correspondence with manufacturers of enzyme inhibitors technical experts. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions, and market trends.

INFORMATION SOURCES

Many companies were surveyed to obtain data for this study. Included were manufacturers and end users of kinase inhibitors in therapeutic categories and various disease sectors industries. Data were gathered from various industry sources. BCC spoke with officials within the industry, consulted newsletters, company literature, product literature, and a host of technical articles, journals, indexes, and abstracts. Exhaustive investigations of databases by key terminology were completed. In addition, data were compiled from current financial, trade, and government sources.

ABOUT THE AUTHOR

A team of professionals in the biotechnology industry carried out this study. The project manager is Shalini S Dewan, who holds a master’s degree in pharmaceutical chemistry and has over 14 years of industry experience. Among the research topics she has covered are studies on compounds of potential pharmaceutical interest from ibuprofen and 2-naphthyl acetic acid. Shalini was awarded a Gold Medal by the Prime Minister of India for her work and has worked with top companies in India and in the U.S.

Some of her other reports with BCC are:
• Reagents of Chromatography; Spectroscopy, an Enduring Market; Advanced Drug Delivery Systems.
• Orthopedic Drugs, Implants and Devices.
• Imaging Reagents; Regulatory Industry.
• Dynamic Sera, Media and Reagents Used in Biotechnology.
• Contract Pharmaceutical Manufacturing, Research and Packaging.
• Chiral Technology: Global Markets.
• Autacoids and Related Drugs.
• Contraceptives.
• Liver Disease Treatments.
• The Global Market, Hormone Replacement Therapies and Other Hormone Therapies.
• Global Markets, Cardiovascular Medicine: Diagnostics, Drugs and Devices.
• Cancer Therapies: Technologies and Global Market;
• Medical Imaging Reagents and Analysis Equipment.

The lead consultant for this project was Dr. Kapil A Setia, who holds a doctoral degree in life sciences. She has a number of research publications to her credit, including her thesis, which was given an award of excellence.

REPORT HIGHLIGHTS

This report will provide:
• An overview of the markets for each major class of protein in the segments therapeutic monoclonal antibodies, cytokines, peptide hormones, vaccines, and blood products
• Analyses of global market trends, with data from 2012, estimates for 2013, and projections of compound annual growth rates (CAGRs) through 2018
• Examinations of current successes, including the size and sales forecast for each class in the next five years
• Discussion of challenges such as delivery methods and side effects
• Consideration of issues regarding add-on products and patent protection
• Comprehensive company profiles of major players.

Table Of Contents

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

STUDY OBJECTIVES 2
REASONS FOR DOING THIS STUDY 2
INTENDED AUDIENCE 2
SCOPE OF THE STUDY 2
METHODOLOGY 3
INFORMATION SOURCES 3
ABOUT THE AUTHOR 3
RELATED BCC RESEARCH REPORTS 4
BCC ONLINE SERVICES 4
DISCLAIMER 4

CHAPTER 2 SUMMARY 6

SUMMARY TABLE GLOBAL REVENUE OF PROTEIN THERAPEUTICS MARKET,
THROUGH 2018 ($ MILLIONS) 6
SUMMARY FIGURE GLOBAL REVENUE OF PROTEIN THERAPEUTICS MARKET,
2011-2018 ($ MILLIONS) 7

CHAPTER 3 OVERVIEW 9

DEFINITIONS 9
HISTORY 9
TABLE 1 EVOLUTION OF THERAPEUTIC PROTEINS 10
PHARMACOLOGICAL CLASSIFICATION OF THERAPEUTIC PROTEINS 11
PROTEIN THERAPEUTICS WITH ENZYMATIC OR REGULATORY ACTIVITY 11
PROTEIN THERAPEUTICS WITH SPECIAL TARGETED ACTIVITY 12
PROTEIN VACCINES 12
MANUFACTURING TECHNOLOGIES 12
NATURAL SOURCING AND EXTRACTION 13
TABLE 2 PROTEIN DRUGS MADE BY HUMAN SOURCE EXTRACTION 13
TABLE 3 PROTEIN DRUGS MADE BY ANIMAL SOURCE EXTRACTION 14
MICROBIAL FERMENTATION 15
TABLE 4 PROTEIN DRUGS MADE BY MICROBIAL FERMENTATION 16
TRANSGENICS 16
TABLE 5 PROTEIN DRUGS MADE BY TRANSGENIC ORGANISMS 17
MAMMALIAN CELL CULTURE 17
TABLE 6 PROTEIN DRUGS MADE BY MAMMALIAN CELL CULTURE 18
OTHER CELL CULTURE SYSTEMS 18
TABLE 7 PROTEIN DRUGS MADE BY INSECT CELL CULTURE 18
MOLECULAR CLASSIFICATION OF THERAPEUTIC PROTEINS 18
CYTOKINES 19
Colony-stimulating Factors 19
Interferons 19
Interleukins 20
ANTIBODIES 20
BLOOD PRODUCTS 21
Alpha-1- Proteinase Inhibitor 21
Antihemophilic Factor 21
Antithrombin 22
C1 Esterase Inhibitor 22
Coagulation Factors 23
Immuno-Globulins 23
Protein C 24
Thrombin 24
PEPTIDE ANTIBIOTICS 25
VACCINES 25
ENZYMES 26
Digestive Enzymes 27
Lysosomal Enzymes 27
Thrombolytic Enzymes 28
Other Enzymes 28
PEPTIDE HORMONES 28
Follicle-stimulating Hormone and Luteinizing Hormone 29
Adrenocorticotropic Hormone 29
Growth Hormones 29
Erythropoietin 29
Insulin 30

CHAPTER 4 REGULATORY ASPECTS 32

MONOCLONAL ANTIBODIES 32
TABLE 8 NEW APPROVALS OF MONOCLONAL ANTIBODIES (2009-JUNE 2013) 32
THERAPEUTIC ENZYMES 34
TABLE 9 NEW APPROVALS OF THERAPEUTIC ENZYMES (2009-JUNE 2013) 34
CYTOKINES 35
TABLE 10 NEW APPROVALS OF CYTOKINES (2009-JUNE 2013) 36
VACCINES 36
TABLE 11 NEW APPROVALS OF VACCINES (2009-JUNE 2013) 36
BLOOD FACTORS 39
TABLE 12 NEW APPROVALS OF BLOOD FACTORS (2009-JUNE 2013) 39
PEPTIDE HORMONES 42
TABLE 13 NEW APPROVALS OF PEPTIDE HORMONES (2009- JUNE 2013) 42
NEW DRUG APPLICATIONS/BIOLOGICAL LICENSE APPLICATIONS 42
TABLE 14 NEW DRUG APPLICATIONS/BIOLOGICAL LICENSE APPLICATIONS
(2009-JUNE 2013) 43
RECALLS 44
TABLE 15 RECALLS (2009-JUNE 2013) 45
SAFETY ALERTS 48
TABLE 16 SAFETY ALERTS (2009-JUNE 2013) 49

CHAPTER 5 NEW DEVELOPMENTS 52

BLOOD PRODUCTS 52
TABLE 17 NEW DEVELOPMENTS/CLINICAL TRIALS IN BLOOD PRODUCTS 53
VACCINES 55
TABLE 18 NEW DEVELOPMENTS/CLINICAL TRIALS IN VACCINES 55
PEPTIDE HORMONES 58
TABLE 19 NEW DEVELOPMENTS/CLINICAL TRIALS IN PEPTIDE HORMONES 58
PEPTIDE ANTIBIOTICS 60
TABLE 20 NEW DEVELOPMENTS/CLINICAL TRIALS IN PEPTIDE ANTIBIOTICS 61
CYTOKINES 62
TABLE 21 NEW DEVELOPMENTS/CLINICAL TRIALS IN CYTOKINES 63
MONOCLONAL ANTIBODIES 64
TABLE 22 NEW DEVELOPMENTS/CLINICAL TRIALS IN MONOCLONAL ANTIBODIES 65
THERAPEUTIC ENZYMES 70
TABLE 23 NEW DEVELOPMENTS/CLINICAL TRIALS IN ENZYMES 71

CHAPTER 6 GLOBAL MARKETS 73

MARKETS BY TYPE 74
MARKET OVERVIEW 75
MARKET REVENUE 79
TABLE 24 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPE, THROUGH 2018
($ MILLIONS) 79
FIGURE 1 GLOBAL MARKET FOR PROTEIN THERAPEUTICS, BY TYPE, THROUGH 2018
($ MILLIONS) 79
MARKET SHARE 80
TABLE 25 MARKET SHARE OF PROTEIN THERAPEUTICS, BY TYPE, 2012 (%) 80
FIGURE 2 MARKET SHARE OF PROTEIN THERAPEUTICS, BY TYPE, 2012 (%) 80
MARKET BY REGION 81
MARKET OVERVIEW 82
MARKET REVENUE 84
TABLE 26 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY REGION, THROUGH
2018 ($ MILLIONS) 84
FIGURE 3 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY REGION, 2011-2018 ($
MILLIONS) 84
MARKET SHARE 85
TABLE 27 MARKET SHARE OF PROTEIN THERAPEUTICS, BY REGION, 2012 (%) 85
FIGURE 4 MARKET SHARE OF PROTEIN THERAPEUTICS, BY REGION, 2012 (%) 85
MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES 85
Market Overview 86
Market Revenue 86
TABLE 28 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES
BY REGION, THROUGH 2018 ($ MILLIONS) 87
FIGURE 5 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES
BY REGION, 2011-2018 ($ MILLIONS) 87
Market Share 87
TABLE 29 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES
BY REGION, 2012 (%) 88
FIGURE 6 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES BY
REGION, 2012 (%) 88
MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES 88
Market Overview 89
Market Revenue 89
TABLE 30 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, THROUGH 2018 ($ MILLIONS) 90
FIGURE 7 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, 2011-2018 ($ MILLIONS) 90
Market Share 91
TABLE 31 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 91
FIGURE 8 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 91
MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE ANTIBIOTICS 91
Market Overview 92
Market Revenue 93
TABLE 32 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, THROUGH 2018 ($ MILLIONS) 93
FIGURE 9 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2011-2018 ($ MILLIONS) 93
Market Share 94
TABLE 33 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2012 (%) 94
FIGURE 10 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2012 (%) 94
MARKET BY MANUFACTURING PROCESS 95
MARKET OVERVIEW 97
MARKET REVENUE 99
TABLE 34 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 99
FIGURE 11 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 100
MARKET SHARE 100
TABLE 35 MARKET SHARE OF PROTEIN THERAPEUTICS BY TYPE OF
MANUFACTURING PROCESS, 2012 (%) 100
FIGURE 12 MARKET SHARE OF PROTEIN THERAPEUTICS BY TYPE OF
MANUFACTURING PROCESS, 2012 (%) 101

CHAPTER 7 PEPTIDE HORMONES AND THERAPEUTIC ENZYMES 103

MARKET BY TYPE 103
MARKET OVERVIEW 103
MARKET REVENUE 104
TABLE 36 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
THROUGH 2018 ($ MILLIONS) 104
FIGURE 13 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC
ENZYMES, 2011-2018 ($ MILLIONS) 104
MARKET SHARE 105
TABLE 37 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
2012 (%) 105
FIGURE 14 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
2012 (%) 105
MARKET FOR PEPTIDE HORMONES 106
Market Overview 106
Market Revenue 107
TABLE 38 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPE, THROUGH 2018 ($
MILLIONS) 108
FIGURE 15 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPE, 2011-2018 ($
MILLIONS) 108
Market Share 109
TABLE 39 MARKET SHARE OF PEPTIDE HORMONES BY TYPE, 2012 (%) 109
FIGURE 16 MARKET SHARE OF PEPTIDE HORMONES BY TYPE, 2012 (%) 109
MARKET FOR THERAPEUTIC ENZYMES 109
Market Overview 110
Market Revenue 110
TABLE 40 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH 2018
($ MILLIONS) 111
FIGURE 17 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH
2018 ($ MILLIONS) 111
Market Share 112
TABLE 41 MARKET SHARE OF THERAPEUTIC ENZYMES BY TYPE, 2012 (%) 112
FIGURE 18 MARKET SHARE OF THERAPEUTIC ENZYMES BY TYPE, 2012 (%) 112
MARKET BY REGION 112
PEPTIDE HORMONES 113
Market Overview 113
Market Revenue 114
TABLE 42 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2018
($ MILLIONS) 114
FIGURE 19 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2018
($ MILLIONS) 114
Market Share 115
TABLE 43 MARKET SHARE OF PEPTIDE HORMONES BY REGION, 2012 (%) 115
FIGURE 20 MARKET SHARE OF PEPTIDE HORMONES BY REGION, 2012 (%) 115
THERAPEUTIC ENZYMES 115
Market Overview 116
Market Revenue 116
TABLE 44 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH
2018 ($ MILLIONS) 117
FIGURE 21 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, 2011-2018
($ MILLIONS) 117
Market Share 118
TABLE 45 MARKET SHARE OF THERAPEUTIC ENZYMES BY REGION, 2012 (%) 118
FIGURE 22 MARKET SHARE OF THERAPEUTIC ENZYMES BY REGION, 2012 (%) 118
MARKET BY MANUFACTURING PROCESS 118
PEPTIDE HORMONES 119
Market Overview 119
Market Revenue 120
TABLE 46 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 121
FIGURE 23 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 121
Market Shares 121
TABLE 47 MARKET SHARE OF PEPTIDE HORMONES BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 122
FIGURE 24 MARKET SHARE OF PEPTIDE HORMONES BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 122
THERAPEUTIC ENZYMES 122
Market Overview 123
Market Revenue 123
TABLE 48 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 124
FIGURE 25 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 124
Market Share 124
TABLE 49 MARKET SHARE OF ENZYMES BY TYPE OF MANUFACTURING PROCESSES,
2012 (%) 125
FIGURE 26 MARKET SHARE OF ENZYMES BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 125
INDUSTRY STRUCTURE 125
PEPTIDE HORMONES 125
Market Leaders 125
TABLE 50 PEPTIDE HORMONES 126
Market Share 128
TABLE 51 MARKET SHARE OF PEPTIDE HORMONES MANUFACTURING COMPANIES,
2012 (%) 129
FIGURE 27 MARKET SHARE OF PEPTIDE HORMONES MANUFACTURING COMPANIES,
2012 (%) 129
THERAPEUTIC ENZYMES 130
TABLE 52 THERAPEUTIC ENZYMES 130
Market Share 131
TABLE 53 MARKET SHARE OF THERAPEUTIC ENZYME MANUFACTURING
COMPANIES, 2012 (%) 131
FIGURE 28 MARKET SHARE OF THERAPEUTIC ENZYME MANUFACTURING
COMPANIES, 2012 (%) 131

CHAPTER 8 CYTOKINES AND MONOCLONAL ANTIBODIES 134

MARKET BY TYPE 134
MARKET OVERVIEW 134
MARKET REVENUE 135
TABLE 54 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, THROUGH 2018 ($ MILLIONS) 136
FIGURE 29 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, 2011-2018 ($ MILLIONS) 136
MARKET SHARE 137
TABLE 55 MARKET SHARE OF CYTOKINES AND MONOCLONAL ANTIBODIES, 2012
(%) 137
FIGURE 30 MARKET SHARE OF CYTOKINES AND MONOCLONAL ANTIBODIES, 2012
(%) 137
CYTOKINES MARKET 137
Market Overview 138
Market Revenue 138
TABLE 56 GLOBAL MARKET FOR CYTOKINES BY TYPE, THROUGH 2018 ($ MILLIONS) 139
FIGURE 31 GLOBAL MARKET FOR CYTOKINES BY TYPE, 2011-2018 ($ MILLIONS) 139
Market Share 140
TABLE 57 MARKET SHARE OF CYTOKINES BY TYPE, 2012 (%) 140
FIGURE 32 MARKET SHARE OF CYTOKINES BY TYPE, 2012 (%) 140
MONOCLONAL ANTIBODIES MARKET 140
Market Overview 141
Market Revenue 141
TABLE 58 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY TYPE, THROUGH
2018 ($ MILLIONS) 142
FIGURE 33 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY TYPE, 2011-2018
($ MILLIONS) 142
Market Share 142
TABLE 59 MARKET SHARE OF MONOCLONAL ANTIBODIES BY TYPE, 2012 (%) 143
FIGURE 34 MARKET SHARE OF MONOCLONAL ANTIBODIES BY TYPE, 2012 (%) 143
MARKET BY REGION 143
CYTOKINES 144
Market Overview 144
Market Revenue 145
TABLE 60 GLOBAL MARKET FOR CYTOKINES BY REGION, THROUGH 2018 ($
MILLIONS) 145
FIGURE 35 GLOBAL MARKET FOR CYTOKINES BY REGION, 2011-2018 ($ MILLIONS) 145
Market Share 146
TABLE 61 MARKET SHARE OF CYTOKINES BY REGION, 2012 (%) 146
FIGURE 36 MARKET SHARE OF CYTOKINES BY REGION, 2012 (%) 146
MONOCLONAL ANTIBODIES 146
Market Overview 147
Market Revenue 148
TABLE 62 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY REGION, THROUGH
2018 ($ MILLIONS) 148
FIGURE 37 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY REGION,
2011-2018 ($ MILLIONS) 148
Market Share 149
TABLE 63 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 149
FIGURE 38 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 149
MARKET BY MANUFACTURING PROCESS 149
CYTOKINES 150
Market Overview 150
Market Revenue 150
TABLE 64 GLOBAL MARKET FOR CYTOKINES BY TYPES OF MANUFACTURING
PROCESSES, THROUGH 2018 ($ MILLIONS) 151
FIGURE 39 GLOBAL MARKET FOR CYTOKINES BY TYPES OF MANUFACTURING
PROCESSES, 2011-2018 (%) 151
Market Share 151
TABLE 65 MARKET SHARE OF CYTOKINES, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 152
FIGURE 40 MARKET SHARE OF CYTOKINES, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 152
MONOCLONAL ANTOBODIES 152
Market Overview 152
Market Revenue 153
TABLE 66 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 153
FIGURE 41 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 153
Market Share 154
TABLE 67 MARKET SHARE OF MONOCLONAL ANTOBODIES BY TYPE OF
MANUFACTURING PROCESSES, 2012 (%) 154
FIGURE 42 MARKET SHARE OF MONOCLONAL ANTOBODIES BY TYPE OF
MANUFACTURING PROCESSES, 2012 (%) 154
INDUSTRY STRUCTURE 155
CYTOKINES 155
Market Leaders 155
TABLE 68 GLOBAL MANUFACTURERS OF CYTOKINES 155
Market Share 156
TABLE 69 MARKET SHARE OF CYTOKINES MANUFACTURING COMPANIES, 2012 (%) 156
FIGURE 43 MARKET SHARE OF CYTOKINES MANUFACTURING COMPANIES, 2012 (%) 156
MONOCLONAL ANTIBODIES 157
Market Leader 157
TABLE 70 GLOBAL MANUFACTURERS OF MONOCLONAL ANTIBODIES 157
Market Share 158
TABLE 71 MARKET SHARE OF MONOCLONAL ANTIBODIES MANUFACTURING
COMPANIES, 2012 (%) 159
FIGURE 44 MARKET SHARE OF MONOCLONAL ANTIBODIES MANUFACTURING
COMPANIES, 2012 (%) 159

CHAPTER 9 BLOOD FACTORS, VACCINES AND PEPTIDE ANTIBIOTICS 161

MARKET BY TYPE 161
MARKET OVERVIEW 162
MARKET REVENUE 163
TABLE 72 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, THROUGH 2018 ($ MILLIONS) 164
FIGURE 45 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, 2011-2018 ($ MILLIONS) 164
MARKET SHARE 164
TABLE 73 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, 2012 (%) 165
FIGURE 46 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, 2012 (%) 165
MARKET FOR BLOOD FACTORS 165
Market Overview 166
Market Revenue 166
TABLE 74 GLOBAL MARKET FOR BLOOD FACTORS BY TYPE, THROUGH 2018 ($
MILLIONS) 167
FIGURE 47 GLOBAL MARKET FOR BLOOD FACTORS BY TYPE, THROUGH 2018 ($
MILLIONS) 167
Market Share 168
TABLE 75 MARKET SHARE OF BLOOD FACTORS, BY TYPE, 2012 (%) 168
FIGURE 48 MARKET SHARE OF BLOOD FACTORS, BY TYPE, 2012 (%) 168
MARKET FOR VACCINES 168
Market Overview 169
Market Revenue 170
TABLE 76 GLOBAL MARKET FOR VACCINES BY TYPE, THROUGH 2018 ($ MILLIONS) 170
FIGURE 49 GLOBAL MARKET FOR VACCINES BY TYPE, 2011-2018 ($ MILLIONS) 171
Market Share 171
TABLE 77 MARKET SHARE OF VACCINES BY TYPE, 2012 (%) 171
FIGURE 50 MARKET SHARE OF VACCINES BY TYPE, 2012 (%) 171
MARKET FOR PEPTIDE ANTIBIOTICS 172
Market Overview 172
Market Revenue 173
TABLE 78 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPE, THROUGH 2018 ($
MILLIONS) 173
FIGURE 51 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPE, 2011-2018 ($
MILLIONS) 173
Market Share 174
TABLE 79 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY TYPE, 2012 (%) 174
FIGURE 52 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY TYPE, 2012 (%) 174
MARKET BY REGION 175
BLOOD FACTORS 175
Market Overview 175
Market Revenue 176
TABLE 80 GLOBAL MARKET FOR BLOOD FACTORS BY REGION, THROUGH 2018 ($
MILLIONS) 177
FIGURE 53 GLOBAL MARKET FOR BLOOD FACTORS BY REGION, 2011-2018 ($
MILLIONS) 177
Market Share 177
TABLE 81 MARKET SHARE OF BLOOD FACTORS, BY REGION, 2012 (%) 178
FIGURE 54 MARKET SHARE OF BLOOD FACTORS, BY REGION, 2012 (%) 178
VACCINES 178
Market Overview 178
Market Revenue 179
TABLE 82 GLOBAL MARKET FOR VACCINES BY REGION, THROUGH 2018 ($
MILLIONS) 179
FIGURE 55 GLOBAL MARKET FOR VACCINES BY REGION, 2011-2018 ($ MILLIONS) 179
Market Share 180
TABLE 83 MARKET SHARE OF VACCINES BY REGION, 2012 (%) 180
FIGURE 56 MARKET SHARE OF VACCINES BY REGION, 2012 (%) 180
PEPTIDE ANTIBIOTICS 181
Market Overview 181
Market Revenue 182
TABLE 84 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY REGION, THROUGH 2018
($ MILLIONS) 183
FIGURE 57 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY REGION, 2011-2018 ($
MILLIONS) 183
Market Share 184
TABLE 85 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY REGION, 2012 (%) 184
FIGURE 58 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY REGION, 2012 (%) 184
MARKET BY MANUFACTURING PROCESS 184
BLOOD FACTORS 185
Market Overview 185
Market Revenue 185
TABLE 86 GLOBAL MARKET FOR BLOOD FACTORS BY TYPES OF MANUFACTURING
PROCESSES, THROUGH 2018 ($ MILLIONS) 186
FIGURE 59 GLOBAL MARKET FOR BLOOD FACTORS BY TYPES OF MANUFACTURING
PROCESSES, 2011-2018 ($ MILLIONS) 186
Market Share 186
TABLE 87 MARKET SHARE OF BLOOD FACTORS BY TYPE OF MANUFACTURING
PROCESS, 2012 (%) 187
FIGURE 60 MARKET SHARE OF BLOOD FACTORS BY TYPE OF MANUFACTURING
PROCESS, 2012 (%) 187
VACCINES 187
Market Overview 188
Market Revenue 188
TABLE 88 GLOBAL MARKET FOR VACCINES BY TYPES OF MANUFACTURING
PROCESSES, THROUGH 2018 ($ MILLIONS) 188
FIGURE 61 GLOBAL MARKET FOR VACCINES BY TYPES OF MANUFACTURING
PROCESSES, 2011-2018 ($ MILLIONS) 189
Market Share 189
TABLE 89 MARKET SHARE OF VACCINES, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 190
FIGURE 62 MARKET SHARE OF VACCINES, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 190
PEPTIDE ANTIBIOTICS 190
Market Overview 191
Market Revenue 191
TABLE 90 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 192
FIGURE 63 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 192
Market Share 192
TABLE 91 MARKET SHARE OF PEPTIDE ANTIBIOTICS, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 193
FIGURE 64 MARKET SHARE OF PEPTIDE ANTIBIOTICS, BY TYPE OF
MANUFACTURING PROCESSES, 2012 (%) 193
INDUSTRY STRUCTURE 193
BLOOD FACTORS 193
Market Leaders 193
TABLE 92 LEADING MANUFACTURERS OF THERAPEUTIC BLOOD PRODUCTS 194
Market Share 196
TABLE 93 MARKET SHARE OF BLOOD FACTOR MANUFACTURING COMPANIES, 2012
(%) 196
FIGURE 65 MARKET SHARE OF BLOOD FACTOR MANUFACTURING COMPANIES,
2012 (%) 197
VACCINES 197
Market Leaders 197
TABLE 94 LEADING MANUFACTURERS OF VIRAL VACCINES 197
Market Share 200
TABLE 95 MARKET SHARE OF VACCINE MANUFACTURING COMPANIES, 2012 (%) 201
FIGURE 66 MARKET SHARE OF VACCINES MANUFACTURING COMPANIES, 2012 (%) 201
PEPTIDE ANTIBIOTICS 202
Market Leaders 202
TABLE 96 LEADING MANUFACTURERS OF PEPTIDE ANTIBIOTICS 202
Market Share 203
TABLE 97 MARKET SHARE OF PEPTIDE ANTIBIOTIC MANUFACTURING COMPANIES,
2012 (%) 203
FIGURE 67 MARKET SHARE OF PEPTIDE ANTIBIOTIC MANUFACTURING COMPANIES,
2012 (%) 203

CHAPTER 10 PATENT ANALYSIS 205

PATENTS BY YEAR 205
TABLE 98 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 205
FIGURE 68 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 205
PATENTS BY TYPE/CATEGORY 206
TABLE 99 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 206
FIGURE 69 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 206
PATENTS BY COMPANY 207
TABLE 100 NUMBER OF U.S. PATENTS, BY COMPANY, JANUARY 2009- JUNE 2013 207
PATENTS BY COUNTRY 212
TABLE 101 NUMBER OF U.S. PATENTS, BY COUNTRY, JANUARY 2009-JUNE 2013 212
TABLE 102 PATENT SHARES, BY COUNTRY, JANUARY 2009-JUNE 2013 (%) 213
PATENTS BY ASSIGNEE 214
TABLE 103 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 214
FIGURE 70 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 214

CHAPTER 11 CURRENT SITUATION 216

FACTORS AFFECTING THE PROTEIN THERAPEUTICS MARKET 216
INCREASING PREVALENCE OF CHRONIC DISEASES 216
GROWING AGING POPULATION 216
LIFESTYLE CHANGES 217
NEW PRODUCT LAUNCHES 217
ADVANCEMENTS IN MANUFACTURING TECHNOLOGIES 217
PRICE CONTROLS 218
REGULATORY PRESSURES 218
ENTRY OF FOLLOW-ON-BIOLOGICS/BIOSIMILARS 218
MERGERS AND ACQUISITIONS 219
LICENSING AGREEMENTS 219

CHAPTER 12 COMPANY PROFILES 221

ABBOTT LABORATORIES 221
AFFYMAX 221
ALCON 222
ALEXION PHARMACEUTICALS 222
ALLERGAN INC 223
AMGEN 223
BAXTER HEALTHCARE 224
BAYER HEALTHCARE PHARMACEUTICALS 224
BIO PRODUCTS LABORATORY 225
BIOGEN IDEC 225
BIOTEST PHARMACEUTICALS CORPORATION 226
BOEHRINGER INGELHEIM 226
BRISTOL-MYERS SQUIBB 227
BTG INTERNATIONAL LIMITED 227
CANGENE CORPORATION 228
CSL LIMITED 228
DENDREON COPORATION 229
EISAI CO. LTD. 229
ELI LILLY 230
FERRING PHARMACEUTICALS 231
FRESENIUS KABI USA 231
GLAXOSMITHKLINE 232
GRIFOLS BIOLOGICALS INC 232
HOFFMAN-LA-ROCHE 233
HOSPIRA 233
JANSSEN-CILAG 233
JOHNSON and JOHNSON 234
KAMADA LTD. 235
KEDRION BIOPHARMACEUTICALS, SPA 235
LUNDBECK LLC 236
MEDIMMUNE LLC 236
MERCK and CO, INC 236
MERCK KGAA 237
MYLAN INC. 238
NABI BIOPHARMACEUTICALS (NOW BIOTA PHARMACEUTICALS) 238
NOVARTIS 239
NOVO NORDISK INC 240
OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H 240
OMRIX BIOPHARMACEUTICALS LTD 241
PFIZER INC 241
PROTEIN SCIENCES CORPORATION 242
RARE DISEASE THERAPEUTICS INC. 242
REVO BIOLOGICS 243
SANDOZ 243
SANOFI 244
SEATTLE GENETICS INC. 244
SPECTRUM PHARMACEUTICALS INC. 245
TAKEDA PHARMACEUTICALS 245
UCB COMPANY 246
UPSHER SMITH LABORATORIES INC 246
VIROPHARMA INC 247
WATSON LABS 247
WOCKHARDT LIMITED 248
X-GEN PHARMS 248
ZYMOGENETICS, INC 248

CHAPTER 13 APPENDIX: ABBREVIATIONS 251



LIST OF TABLES

SUMMARY TABLE GLOBAL REVENUE OF PROTEIN THERAPEUTICS MARKET, THROUGH
2018 ($ MILLIONS) 6
TABLE 1 EVOLUTION OF THERAPEUTIC PROTEINS 10
TABLE 2 PROTEIN DRUGS MADE BY HUMAN SOURCE EXTRACTION 13
TABLE 3 PROTEIN DRUGS MADE BY ANIMAL SOURCE EXTRACTION 14
TABLE 4 PROTEIN DRUGS MADE BY MICROBIAL FERMENTATION 16
TABLE 5 PROTEIN DRUGS MADE BY TRANSGENIC ORGANISMS 17
TABLE 6 PROTEIN DRUGS MADE BY MAMMALIAN CELL CULTURE 18
TABLE 7 PROTEIN DRUGS MADE BY INSECT CELL CULTURE 18
TABLE 8 NEW APPROVALS OF MONOCLONAL ANTIBODIES (2009-JUNE 2013) 32
TABLE 9 NEW APPROVALS OF THERAPEUTIC ENZYMES (2009-JUNE 2013) 34
TABLE 10 NEW APPROVALS OF CYTOKINES (2009-JUNE 2013) 36
TABLE 11 NEW APPROVALS OF VACCINES (2009-JUNE 2013) 36
TABLE 12 NEW APPROVALS OF BLOOD FACTORS (2009-JUNE 2013) 39
TABLE 13 NEW APPROVALS OF PEPTIDE HORMONES (2009- JUNE 2013) 42
TABLE 14 NEW DRUG APPLICATIONS/BIOLOGICAL LICENSE APPLICATIONS
(2009-JUNE 2013) 43
TABLE 15 RECALLS (2009-JUNE 2013) 45
TABLE 16 SAFETY ALERTS (2009-JUNE 2013) 49
TABLE 17 NEW DEVELOPMENTS/CLINICAL TRIALS IN BLOOD PRODUCTS 53
TABLE 18 NEW DEVELOPMENTS/CLINICAL TRIALS IN VACCINES 55
TABLE 19 NEW DEVELOPMENTS/CLINICAL TRIALS IN PEPTIDE HORMONES 58
TABLE 20 NEW DEVELOPMENTS/CLINICAL TRIALS IN PEPTIDE ANTIBIOTICS 61
TABLE 21 NEW DEVELOPMENTS/CLINICAL TRIALS IN CYTOKINES 63
TABLE 22 NEW DEVELOPMENTS/CLINICAL TRIALS IN MONOCLONAL ANTIBODIES 65
TABLE 23 NEW DEVELOPMENTS/CLINICAL TRIALS IN ENZYMES 71
TABLE 24 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPE, THROUGH 2018
($ MILLIONS) 79
TABLE 25 MARKET SHARE OF PROTEIN THERAPEUTICS, BY TYPE, 2012 (%) 80
TABLE 26 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY REGION, THROUGH
2018 ($ MILLIONS) 84
TABLE 27 MARKET SHARE OF PROTEIN THERAPEUTICS, BY REGION, 2012 (%) 85
TABLE 28 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES
BY REGION, THROUGH 2018 ($ MILLIONS) 87
TABLE 29 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES BY
REGION, 2012 (%) 88
TABLE 30 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, THROUGH 2018 ($ MILLIONS) 90
TABLE 31 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 91
TABLE 32 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, THROUGH 2018 ($ MILLIONS) 93
TABLE 33 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2012 (%) 94
TABLE 34 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 99
TABLE 35 MARKET SHARE OF PROTEIN THERAPEUTICS BY TYPE OF MANUFACTURING
PROCESS, 2012 (%) 100
TABLE 36 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
THROUGH 2018 ($ MILLIONS) 104
TABLE 37 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
2012 (%) 105
TABLE 38 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPE, THROUGH 2018 ($
MILLIONS) 108
TABLE 39 MARKET SHARE OF PEPTIDE HORMONES BY TYPE, 2012 (%) 109
TABLE 40 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH 2018
($ MILLIONS) 111
TABLE 41 MARKET SHARE OF THERAPEUTIC ENZYMES BY TYPE, 2012 (%) 112
TABLE 42 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2018 ($
MILLIONS) 114
TABLE 43 MARKET SHARE OF PEPTIDE HORMONES BY REGION, 2012 (%) 115
TABLE 44 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH
2018 ($ MILLIONS) 117
TABLE 45 MARKET SHARE OF THERAPEUTIC ENZYMES BY REGION, 2012 (%) 118
TABLE 46 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 121
TABLE 47 MARKET SHARE OF PEPTIDE HORMONES BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 122
TABLE 48 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 124
TABLE 49 MARKET SHARE OF ENZYMES BY TYPE OF MANUFACTURING PROCESSES,
2012 (%) 125
TABLE 50 PEPTIDE HORMONES 126
TABLE 51 MARKET SHARE OF PEPTIDE HORMONES MANUFACTURING COMPANIES,
2012 (%) 129
TABLE 52 THERAPEUTIC ENZYMES 130
TABLE 53 MARKET SHARE OF THERAPEUTIC ENZYME MANUFACTURING COMPANIES,
2012 (%) 131
TABLE 54 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, THROUGH 2018 ($ MILLIONS) 136
TABLE 55 MARKET SHARE OF CYTOKINES AND MONOCLONAL ANTIBODIES, 2012 (%) 137
TABLE 56 GLOBAL MARKET FOR CYTOKINES BY TYPE, THROUGH 2018 ($ MILLIONS) 139
TABLE 57 MARKET SHARE OF CYTOKINES BY TYPE, 2012 (%) 140
TABLE 58 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY TYPE, THROUGH
2018 ($ MILLIONS) 142
TABLE 59 MARKET SHARE OF MONOCLONAL ANTIBODIES BY TYPE, 2012 (%) 143
TABLE 60 GLOBAL MARKET FOR CYTOKINES BY REGION, THROUGH 2018 ($
MILLIONS) 145
TABLE 61 MARKET SHARE OF CYTOKINES BY REGION, 2012 (%) 146
TABLE 62 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY REGION, THROUGH
2018 ($ MILLIONS) 148
TABLE 63 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 149
TABLE 64 GLOBAL MARKET FOR CYTOKINES BY TYPES OF MANUFACTURING
PROCESSES, THROUGH 2018 ($ MILLIONS) 151
TABLE 65 MARKET SHARE OF CYTOKINES, BY TYPE OF MANUFACTURING PROCESSES,
2012 (%) 152
TABLE 66 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 153
TABLE 67 MARKET SHARE OF MONOCLONAL ANTOBODIES BY TYPE OF
MANUFACTURING PROCESSES, 2012 (%) 154
TABLE 68 GLOBAL MANUFACTURERS OF CYTOKINES 155
TABLE 69 MARKET SHARE OF CYTOKINES MANUFACTURING COMPANIES, 2012 (%) 156
TABLE 70 GLOBAL MANUFACTURERS OF MONOCLONAL ANTIBODIES 157
TABLE 71 MARKET SHARE OF MONOCLONAL ANTIBODIES MANUFACTURING
COMPANIES, 2012 (%) 159
TABLE 72 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, THROUGH 2018 ($ MILLIONS) 164
TABLE 73 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, 2012 (%) 165
TABLE 74 GLOBAL MARKET FOR BLOOD FACTORS BY TYPE, THROUGH 2018 ($
MILLIONS) 167
TABLE 75 MARKET SHARE OF BLOOD FACTORS, BY TYPE, 2012 (%) 168
TABLE 76 GLOBAL MARKET FOR VACCINES BY TYPE, THROUGH 2018 ($ MILLIONS) 170
TABLE 77 MARKET SHARE OF VACCINES BY TYPE, 2012 (%) 171
TABLE 78 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPE, THROUGH 2018 ($
MILLIONS) 173
TABLE 79 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY TYPE, 2012 (%) 174
TABLE 80 GLOBAL MARKET FOR BLOOD FACTORS BY REGION, THROUGH 2018 ($
MILLIONS) 177
TABLE 81 MARKET SHARE OF BLOOD FACTORS, BY REGION, 2012 (%) 178
TABLE 82 GLOBAL MARKET FOR VACCINES BY REGION, THROUGH 2018 ($ MILLIONS) 179
TABLE 83 MARKET SHARE OF VACCINES BY REGION, 2012 (%) 180
TABLE 84 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY REGION, THROUGH 2018
($ MILLIONS) 183
TABLE 85 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY REGION, 2012 (%) 184
TABLE 86 GLOBAL MARKET FOR BLOOD FACTORS BY TYPES OF MANUFACTURING
PROCESSES, THROUGH 2018 ($ MILLIONS) 186
TABLE 87 MARKET SHARE OF BLOOD FACTORS BY TYPE OF MANUFACTURING
PROCESS, 2012 (%) 187
TABLE 88 GLOBAL MARKET FOR VACCINES BY TYPES OF MANUFACTURING
PROCESSES, THROUGH 2018 ($ MILLIONS) 188
TABLE 89 MARKET SHARE OF VACCINES, BY TYPE OF MANUFACTURING PROCESSES,
2012 (%) 190
TABLE 90 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 192
TABLE 91 MARKET SHARE OF PEPTIDE ANTIBIOTICS, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 193
TABLE 92 LEADING MANUFACTURERS OF THERAPEUTIC BLOOD PRODUCTS 194
TABLE 93 MARKET SHARE OF BLOOD FACTOR MANUFACTURING COMPANIES, 2012
(%) 196
TABLE 94 LEADING MANUFACTURERS OF VIRAL VACCINES 197
TABLE 95 MARKET SHARE OF VACCINE MANUFACTURING COMPANIES, 2012 (%) 201
TABLE 96 LEADING MANUFACTURERS OF PEPTIDE ANTIBIOTICS 202
TABLE 97 MARKET SHARE OF PEPTIDE ANTIBIOTIC MANUFACTURING COMPANIES,
2012 (%) 203
TABLE 98 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 205
TABLE 99 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 206
TABLE 100 NUMBER OF U.S. PATENTS, BY COMPANY, JANUARY 2009- JUNE 2013 207
TABLE 101 NUMBER OF U.S. PATENTS, BY COUNTRY, JANUARY 2009-JUNE 2013 212
TABLE 102 PATENT SHARES, BY COUNTRY, JANUARY 2009-JUNE 2013 (%) 213
TABLE 103 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 214



LIST OF FIGURES

SUMMARY FIGURE GLOBAL REVENUE OF PROTEIN THERAPEUTICS MARKET,
2011-2018 ($ MILLIONS) 7
FIGURE 1 GLOBAL MARKET FOR PROTEIN THERAPEUTICS, BY TYPE, THROUGH 2018
($ MILLIONS) 79
FIGURE 2 MARKET SHARE OF PROTEIN THERAPEUTICS, BY TYPE, 2012 (%) 80
FIGURE 3 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY REGION, 2011-2018 ($
MILLIONS) 84
FIGURE 4 MARKET SHARE OF PROTEIN THERAPEUTICS, BY REGION, 2012 (%) 85
FIGURE 5 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES
BY REGION, 2011-2018 ($ MILLIONS) 87
FIGURE 6 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES BY
REGION, 2012 (%) 88
FIGURE 7 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, 2011-2018 ($ MILLIONS) 90
FIGURE 8 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 91
FIGURE 9 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2011-2018 ($ MILLIONS) 93
FIGURE 10 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2012 (%) 94
FIGURE 11 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 100
FIGURE 12 MARKET SHARE OF PROTEIN THERAPEUTICS BY TYPE OF
MANUFACTURING PROCESS, 2012 (%) 101
FIGURE 13 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
2011-2018 ($ MILLIONS) 104
FIGURE 14 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
2012 (%) 105
FIGURE 15 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPE, 2011-2018 ($
MILLIONS) 108
FIGURE 16 MARKET SHARE OF PEPTIDE HORMONES BY TYPE, 2012 (%) 109
FIGURE 17 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH 2018
($ MILLIONS) 111
FIGURE 18 MARKET SHARE OF THERAPEUTIC ENZYMES BY TYPE, 2012 (%) 112
FIGURE 19 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2018
($ MILLIONS) 114
FIGURE 20 MARKET SHARE OF PEPTIDE HORMONES BY REGION, 2012 (%) 115

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