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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 protein drugs 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 that provides therapeutic treatments for various diseases.
R&D spending, along with increasing competition, patent expiries and new technologies are providing a new direction. 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 Research 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 Research 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 and 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 Research 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 Research 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. He has a number of research publications to his credit, including his thesis, which was given an award of excellence.

REPORT HIGHLIGHTS

This report provides:
• An overview of the markets for major classes of protein with a focus on blood factors, vaccines, and peptide antibiotics.
• Analyses of market trends, with data from 2011 and 2012, estimates for 2013, and projections of compound annual growth rates (CAGRs) for the period 2013 to 2018.
• Examinations of current successes, including size and sales forecasts for this segment over the next five years.
• Discussion of the regulatory environment, technological developments and their related strengths and weaknesses, as well as discussion on growing competition and changing customer needs.

Table Of Contents

Global Markets and Manufacturing Technologies for Protein Drugs -- Focus on Blood Factors, Vaccines and Peptide Antibiotics
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 22
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 BLOOD FACTORS, VACCINES AND PEPTIDE ANTIBIOTICS 103

MARKET BY TYPE 103
MARKET OVERVIEW 104
MARKET REVENUE 105
TABLE 36 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, THROUGH 2018 ($ MILLIONS) 106
FIGURE 13 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, 2011-2018 ($ MILLIONS) 106
MARKET SHARE 106
TABLE 37 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, 2012 (%) 107
FIGURE 14 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, 2012 (%) 107
MARKET FOR BLOOD FACTORS 107
Market Overview 108
Market Revenue 108
TABLE 38 GLOBAL MARKET FOR BLOOD FACTORS BY TYPE, THROUGH 2018 ($
MILLIONS) 109
FIGURE 15 GLOBAL MARKET FOR BLOOD FACTORS BY TYPE, THROUGH 2018 ($
MILLIONS) 109
Market Share 110
TABLE 39 MARKET SHARE OF BLOOD FACTORS, BY TYPE, 2012 (%) 110
FIGURE 16 MARKET SHARE OF BLOOD FACTORS, BY TYPE, 2012 (%) 110
MARKET FOR VACCINES 110
Market Overview 111
Market Revenue 112
TABLE 40 GLOBAL MARKET FOR VACCINES BY TYPE, THROUGH 2018 ($ MILLIONS) 112
FIGURE 17 GLOBAL MARKET FOR VACCINES BY TYPE, 2011-2018 ($ MILLIONS) 113
Market Share 113
TABLE 41 MARKET SHARE OF VACCINES BY TYPE, 2012 (%) 113
FIGURE 18 MARKET SHARE OF VACCINES BY TYPE, 2012 (%) 113
MARKET FOR PEPTIDE ANTIBIOTICS 114
Market Overview 114
Market Revenue 115
TABLE 42 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPE, THROUGH 2018 ($
MILLIONS) 115
FIGURE 19 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPE, 2011-2018 ($
MILLIONS) 115
Market Share 116
TABLE 43 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY TYPE, 2012 (%) 116
FIGURE 20 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY TYPE, 2012 (%) 116
MARKET BY REGION 117
BLOOD FACTORS 117
Market Overview 117
Market Revenue 118
TABLE 44 GLOBAL MARKET FOR BLOOD FACTORS BY REGION, THROUGH 2018 ($
MILLIONS) 119
FIGURE 21 GLOBAL MARKET FOR BLOOD FACTORS BY REGION, 2011-2018 ($
MILLIONS) 119
Market Share 119
TABLE 45 MARKET SHARE OF BLOOD FACTORS, BY REGION, 2012 (%) 120
FIGURE 22 MARKET SHARE OF BLOOD FACTORS, BY REGION, 2012 (%) 120
VACCINES 120
Market Overview 120
Market Revenue 121
TABLE 46 GLOBAL MARKET FOR VACCINES BY REGION, THROUGH 2018 ($
MILLIONS) 121
FIGURE 23 GLOBAL MARKET FOR VACCINES BY REGION, 2011-2018 ($ MILLIONS) 121
Market Share 122
TABLE 47 MARKET SHARE OF VACCINES BY REGION, 2012 (%) 122
FIGURE 24 MARKET SHARE OF VACCINES BY REGION, 2012 (%) 122
PEPTIDE ANTIBIOTICS 123
Market Overview 123
Market Revenue 124
TABLE 48 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY REGION, THROUGH 2018
($ MILLIONS) 125
FIGURE 25 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY REGION, 2011-2018 ($
MILLIONS) 125
Market Share 126
TABLE 49 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY REGION, 2012 (%) 126
FIGURE 26 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY REGION, 2012 (%) 126
MARKET BY MANUFACTURING PROCESS 126
BLOOD FACTORS 127
Market Overview 127
Market Revenue 127
TABLE 50 GLOBAL MARKET FOR BLOOD FACTORS BY TYPES OF MANUFACTURING
PROCESSES, THROUGH 2018 ($ MILLIONS) 128
FIGURE 27 GLOBAL MARKET FOR BLOOD FACTORS BY TYPES OF MANUFACTURING
PROCESSES, 2011-2018 ($ MILLIONS) 128
Market Share 128
TABLE 51 MARKET SHARE OF BLOOD FACTORS BY TYPE OF MANUFACTURING
PROCESS, 2012 (%) 129
FIGURE 28 MARKET SHARE OF BLOOD FACTORS BY TYPE OF MANUFACTURING
PROCESS, 2012 (%) 129
VACCINES 129
Market Overview 130
Market Revenue 130
TABLE 52 GLOBAL MARKET FOR VACCINES BY TYPES OF MANUFACTURING
PROCESSES, THROUGH 2018 ($ MILLIONS) 130
FIGURE 29 GLOBAL MARKET FOR VACCINES BY TYPES OF MANUFACTURING
PROCESSES, 2011-2018 ($ MILLIONS) 131
Market Share 131
TABLE 53 MARKET SHARE OF VACCINES, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 132
FIGURE 30 MARKET SHARE OF VACCINES, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 132
PEPTIDE ANTIBIOTICS 132
Market Overview 133
Market Revenue 133
TABLE 54 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 134
FIGURE 31 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 134
Market Share 134
TABLE 55 MARKET SHARE OF PEPTIDE ANTIBIOTICS, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 135
FIGURE 32 MARKET SHARE OF PEPTIDE ANTIBIOTICS, BY TYPE OF
MANUFACTURING PROCESSES, 2012 (%) 135
INDUSTRY STRUCTURE 135
BLOOD FACTORS 135
Market Leaders 135
TABLE 56 LEADING MANUFACTURERS OF THERAPEUTIC BLOOD PRODUCTS 136
Market Share 138
TABLE 57 MARKET SHARE OF BLOOD FACTOR MANUFACTURING COMPANIES, 2012
(%) 138
FIGURE 33 MARKET SHARE OF BLOOD FACTOR MANUFACTURING COMPANIES,
2012 (%) 139
VACCINES 139
Market Leaders 139
TABLE 58 LEADING MANUFACTURERS OF VIRAL VACCINES 139
Market Share 142
TABLE 59 MARKET SHARE OF VACCINE MANUFACTURING COMPANIES, 2012 (%) 143
FIGURE 34 MARKET SHARE OF VACCINES MANUFACTURING COMPANIES, 2012 (%) 143
PEPTIDE ANTIBIOTICS 144
Market Leaders 144
TABLE 60 LEADING MANUFACTURERS OF PEPTIDE ANTIBIOTICS 144
Market Share 145
TABLE 61 MARKET SHARE OF PEPTIDE ANTIBIOTIC MANUFACTURING COMPANIES,
2012 (%) 145
FIGURE 35 MARKET SHARE OF PEPTIDE ANTIBIOTIC MANUFACTURING COMPANIES,
2012 (%) 145

CHAPTER 8 PATENT ANALYSIS 147

PATENTS BY YEAR 147
TABLE 62 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 147
FIGURE 36 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 147
PATENTS BY TYPE/CATEGORY 148
TABLE 63 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 148
FIGURE 37 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 148
PATENTS BY COMPANY 149
TABLE 64 NUMBER OF U.S. PATENTS, BY COMPANY, JANUARY 2009- JUNE 2013 149
PATENTS BY COUNTRY 154
TABLE 65 NUMBER OF U.S. PATENTS, BY COUNTRY, JANUARY 2009-JUNE 2013 154
TABLE 66 PATENT SHARES, BY COUNTRY, JANUARY 2009-JUNE 2013 (%) 155
PATENTS BY ASSIGNEE 156
TABLE 67 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 156
FIGURE 38 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 156

CHAPTER 9 CURRENT SITUATION 158

FACTORS AFFECTING THE PROTEIN THERAPEUTICS MARKET 158
INCREASING PREVALENCE OF CHRONIC DISEASES 158
GROWING AGING POPULATION 158
LIFESTYLE CHANGES 159
NEW PRODUCT LAUNCHES 159
ADVANCEMENTS IN MANUFACTURING TECHNOLOGIES 159
PRICE CONTROLS 160
REGULATORY PRESSURES 160
ENTRY OF FOLLOW-ON-BIOLOGICS/BIOSIMILARS 160
MERGERS AND ACQUISITIONS 161
LICENSING AGREEMENTS 161

CHAPTER 10 COMPANY PROFILES 163

ABBOTT LABORATORIES 163
AFFYMAX 163
ALCON 164
ALEXION PHARMACEUTICALS 164
ALLERGAN INC 165
AMGEN 165
BAXTER HEALTHCARE 166
BAYER HEALTHCARE PHARMACEUTICALS 166
BIO PRODUCTS LABORATORY 167
BIOGEN IDEC 167
BIOTEST PHARMACEUTICALS CORPORATION 168
BOEHRINGER INGELHEIM 168
BRISTOL-MYERS SQUIBB 169
BTG INTERNATIONAL LIMITED 169
CANGENE CORPORATION 170
CSL LIMITED 170
DENDREON COPORATION 171
EISAI CO. LTD. 171
ELI LILLY 172
FERRING PHARMACEUTICALS 173
FRESENIUS KABI USA 173
GLAXOSMITHKLINE 174
GRIFOLS BIOLOGICALS INC 174
HOFFMAN-LA-ROCHE 175
HOSPIRA 175
JANSSEN-CILAG 175
JOHNSON and JOHNSON 176
KAMADA LTD. 177
KEDRION BIOPHARMACEUTICALS, SPA 177
LUNDBECK LLC 178
MEDIMMUNE LLC 178
MERCK and CO, INC 178
MERCK KGAA 179
MYLAN INC. 180
NABI BIOPHARMACEUTICALS (NOW BIOTA PHARMACEUTICALS) 180
NOVARTIS 181
NOVO NORDISK INC 182
OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H 182
OMRIX BIOPHARMACEUTICALS LTD 183
PFIZER INC 183
PROTEIN SCIENCES CORPORATION 184
RARE DISEASE THERAPEUTICS INC. 184
REVO BIOLOGICS 185
SANDOZ 185
SANOFI 186
SEATTLE GENETICS INC. 186
SPECTRUM PHARMACEUTICALS INC. 187
TAKEDA PHARMACEUTICALS 187
UCB COMPANY 188
UPSHER SMITH LABORATORIES INC 188
VIROPHARMA INC 189
WATSON LABS 189
WOCKHARDT LIMITED 190
X-GEN PHARMS 190
ZYMOGENETICS, INC 190

CHAPTER 11 APPENDIX: ABBREVIATIONS 193



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 BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, THROUGH 2018 ($ MILLIONS) 106
TABLE 37 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, 2012 (%) 107
TABLE 38 GLOBAL MARKET FOR BLOOD FACTORS BY TYPE, THROUGH 2018 ($
MILLIONS) 109
TABLE 39 MARKET SHARE OF BLOOD FACTORS, BY TYPE, 2012 (%) 110
TABLE 40 GLOBAL MARKET FOR VACCINES BY TYPE, THROUGH 2018 ($ MILLIONS) 112
TABLE 41 MARKET SHARE OF VACCINES BY TYPE, 2012 (%) 113
TABLE 42 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPE, THROUGH 2018 ($
MILLIONS) 115
TABLE 43 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY TYPE, 2012 (%) 116
TABLE 44 GLOBAL MARKET FOR BLOOD FACTORS BY REGION, THROUGH 2018 ($
MILLIONS) 119
TABLE 45 MARKET SHARE OF BLOOD FACTORS, BY REGION, 2012 (%) 120
TABLE 46 GLOBAL MARKET FOR VACCINES BY REGION, THROUGH 2018 ($ MILLIONS) 121
TABLE 47 MARKET SHARE OF VACCINES BY REGION, 2012 (%) 122
TABLE 48 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY REGION, THROUGH 2018
($ MILLIONS) 125
TABLE 49 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY REGION, 2012 (%) 126
TABLE 50 GLOBAL MARKET FOR BLOOD FACTORS BY TYPES OF MANUFACTURING
PROCESSES, THROUGH 2018 ($ MILLIONS) 128
TABLE 51 MARKET SHARE OF BLOOD FACTORS BY TYPE OF MANUFACTURING
PROCESS, 2012 (%) 129
TABLE 52 GLOBAL MARKET FOR VACCINES BY TYPES OF MANUFACTURING
PROCESSES, THROUGH 2018 ($ MILLIONS) 130
TABLE 53 MARKET SHARE OF VACCINES, BY TYPE OF MANUFACTURING PROCESSES,
2012 (%) 132
TABLE 54 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 134
TABLE 55 MARKET SHARE OF PEPTIDE ANTIBIOTICS, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 135
TABLE 56 LEADING MANUFACTURERS OF THERAPEUTIC BLOOD PRODUCTS 136
TABLE 57 MARKET SHARE OF BLOOD FACTOR MANUFACTURING COMPANIES, 2012
(%) 138
TABLE 58 LEADING MANUFACTURERS OF VIRAL VACCINES 139
TABLE 59 MARKET SHARE OF VACCINE MANUFACTURING COMPANIES, 2012 (%) 143
TABLE 60 LEADING MANUFACTURERS OF PEPTIDE ANTIBIOTICS 144
TABLE 61 MARKET SHARE OF PEPTIDE ANTIBIOTIC MANUFACTURING COMPANIES,
2012 (%) 145
TABLE 62 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 147
TABLE 63 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 148
TABLE 64 NUMBER OF U.S. PATENTS, BY COMPANY, JANUARY 2009- JUNE 2013 149
TABLE 65 NUMBER OF U.S. PATENTS, BY COUNTRY, JANUARY 2009-JUNE 2013 154
TABLE 66 PATENT SHARES, BY COUNTRY, JANUARY 2009-JUNE 2013 (%) 155
TABLE 67 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 156



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 BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, 2011-2018 ($ MILLIONS) 106
FIGURE 14 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS, 2012 (%) 107
FIGURE 15 GLOBAL MARKET FOR BLOOD FACTORS BY TYPE, THROUGH 2018 ($
MILLIONS) 109
FIGURE 16 MARKET SHARE OF BLOOD FACTORS, BY TYPE, 2012 (%) 110
FIGURE 17 GLOBAL MARKET FOR VACCINES BY TYPE, 2011-2018 ($ MILLIONS) 113
FIGURE 18 MARKET SHARE OF VACCINES BY TYPE, 2012 (%) 113
FIGURE 19 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPE, 2011-2018 ($
MILLIONS) 115
FIGURE 20 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY TYPE, 2012 (%) 116
FIGURE 21 GLOBAL MARKET FOR BLOOD FACTORS BY REGION, 2011-2018 ($
MILLIONS) 119
FIGURE 22 MARKET SHARE OF BLOOD FACTORS, BY REGION, 2012 (%) 120
FIGURE 23 GLOBAL MARKET FOR VACCINES BY REGION, 2011-2018 ($ MILLIONS) 121
FIGURE 24 MARKET SHARE OF VACCINES BY REGION, 2012 (%) 122
FIGURE 25 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY REGION, 2011-2018 ($
MILLIONS) 125
FIGURE 26 MARKET SHARE OF PEPTIDE ANTIBIOTICS BY REGION, 2012 (%) 126
FIGURE 27 GLOBAL MARKET FOR BLOOD FACTORS BY TYPES OF MANUFACTURING
PROCESSES, 2011-2018 ($ MILLIONS) 128
FIGURE 28 MARKET SHARE OF BLOOD FACTORS BY TYPE OF MANUFACTURING
PROCESS, 2012 (%) 129
FIGURE 29 GLOBAL MARKET FOR VACCINES BY TYPES OF MANUFACTURING
PROCESSES, 2011-2018 ($ MILLIONS) 131
FIGURE 30 MARKET SHARE OF VACCINES, BY TYPE OF MANUFACTURING PROCESSES,
2012 (%) 132
FIGURE 31 GLOBAL MARKET FOR PEPTIDE ANTIBIOTICS BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 134
FIGURE 32 MARKET SHARE OF PEPTIDE ANTIBIOTICS, BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 135
FIGURE 33 MARKET SHARE OF BLOOD FACTOR MANUFACTURING COMPANIES, 2012
(%) 139
FIGURE 34 MARKET SHARE OF VACCINES MANUFACTURING COMPANIES, 2012 (%) 143
FIGURE 35 MARKET SHARE OF PEPTIDE ANTIBIOTIC MANUFACTURING COMPANIES,
2012 (%) 145
FIGURE 36 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 147
FIGURE 37 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 148
FIGURE 38 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 156

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