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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 peptide hormones and therapeutic enzymes.
• 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 Peptide Hormones and Therapeutic Enzymes
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) 7
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 69
TABLE 23 NEW DEVELOPMENTS/CLINICAL TRIALS IN ENZYMES 70

CHAPTER 6 GLOBAL MARKETS 72

MARKETS BY TYPE 73
MARKET OVERVIEW 74
MARKET REVENUE 78
TABLE 24 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPE, THROUGH 2018
($ MILLIONS) 78
FIGURE 1 GLOBAL MARKET FOR PROTEIN THERAPEUTICS, BY TYPE, THROUGH 2018
($ MILLIONS) 78
MARKET SHARE 79
TABLE 25 MARKET SHARE OF PROTEIN THERAPEUTICS, BY TYPE, 2012 (%) 79
FIGURE 2 MARKET SHARE OF PROTEIN THERAPEUTICS, BY TYPE, 2012 (%) 79
MARKET BY REGION 80
MARKET OVERVIEW 81
MARKET REVENUE 83
TABLE 26 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY REGION, THROUGH
2018 ($ MILLIONS) 83
FIGURE 3 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY REGION, 2011-2018 ($
MILLIONS) 83
MARKET SHARE 84
TABLE 27 MARKET SHARE OF PROTEIN THERAPEUTICS, BY REGION, 2012 (%) 84
FIGURE 4 MARKET SHARE OF PROTEIN THERAPEUTICS, BY REGION, 2012 (%) 84
MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES 84
Market Overview 85
Market Revenue 85
TABLE 28 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES
BY REGION, THROUGH 2018 ($ MILLIONS) 86
FIGURE 5 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES
BY REGION, 2011-2018 ($ MILLIONS) 86
Market Share 86
TABLE 29 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES
BY REGION, 2012 (%) 87
FIGURE 6 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES BY
REGION, 2012 (%) 87
MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES 87
Market Overview 88
Market Revenue 88
TABLE 30 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, THROUGH 2018 ($ MILLIONS) 89
FIGURE 7 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, 2011-2018 ($ MILLIONS) 89
Market Share 90
TABLE 31 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 90
FIGURE 8 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 90
MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE ANTIBIOTICS 90
Market Overview 91
Market Revenue 92
TABLE 32 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, THROUGH 2018 ($ MILLIONS) 92
FIGURE 9 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2011-2018 ($ MILLIONS) 92
Market Share 93
TABLE 33 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2012 (%) 93
FIGURE 10 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2012 (%) 93
MARKET BY MANUFACTURING PROCESS 94
MARKET OVERVIEW 96
MARKET REVENUE 98
TABLE 34 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 98
FIGURE 11 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 99
MARKET SHARE 99
TABLE 35 MARKET SHARE OF PROTEIN THERAPEUTICS BY TYPE OF
MANUFACTURING PROCESS, 2012 (%) 99
FIGURE 12 MARKET SHARE OF PROTEIN THERAPEUTICS BY TYPE OF
MANUFACTURING PROCESS, 2012 (%) 100

CHAPTER 7 PEPTIDE HORMONES AND THERAPEUTIC ENZYMES 102

MARKET BY TYPE 102
MARKET OVERVIEW 102
MARKET REVENUE 103
TABLE 36 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
THROUGH 2018 ($ MILLIONS) 103
FIGURE 13 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC
ENZYMES, 2011-2018 ($ MILLIONS) 103
MARKET SHARE 104
TABLE 37 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
2012 (%) 104
FIGURE 14 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
2012 (%) 104
MARKET FOR PEPTIDE HORMONES 105
Market Overview 105
Market Revenue 106
TABLE 38 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPE, THROUGH 2018 ($
MILLIONS) 107
FIGURE 15 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPE, 2011-2018 ($
MILLIONS) 107
Market Share 108
TABLE 39 MARKET SHARE OF PEPTIDE HORMONES BY TYPE, 2012 (%) 108
FIGURE 16 MARKET SHARE OF PEPTIDE HORMONES BY TYPE, 2012 (%) 108
MARKET FOR THERAPEUTIC ENZYMES 108
Market Overview 109
Market Revenue 109
TABLE 40 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH 2018
($ MILLIONS) 110
FIGURE 17 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH
2018 ($ MILLIONS) 110
Market Share 111
TABLE 41 MARKET SHARE OF THERAPEUTIC ENZYMES BY TYPE, 2012 (%) 111
FIGURE 18 MARKET SHARE OF THERAPEUTIC ENZYMES BY TYPE, 2012 (%) 111
MARKET BY REGION 111
PEPTIDE HORMONES 112
Market Overview 112
Market Revenue 113
TABLE 42 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2018
($ MILLIONS) 113
FIGURE 19 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2018
($ MILLIONS) 113
Market Share 114
TABLE 43 MARKET SHARE OF PEPTIDE HORMONES BY REGION, 2012 (%) 114
FIGURE 20 MARKET SHARE OF PEPTIDE HORMONES BY REGION, 2012 (%) 114
THERAPEUTIC ENZYMES 114
Market Overview 115
Market Revenue 115
TABLE 44 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH
2018 ($ MILLIONS) 116
FIGURE 21 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, 2011-2018
($ MILLIONS) 116
Market Share 117
TABLE 45 MARKET SHARE OF THERAPEUTIC ENZYMES BY REGION, 2012 (%) 117
FIGURE 22 MARKET SHARE OF THERAPEUTIC ENZYMES BY REGION, 2012 (%) 117
MARKET BY MANUFACTURING PROCESS 117
PEPTIDE HORMONES 118
Market Overview 118
Market Revenue 119
TABLE 46 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 120
FIGURE 23 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 120
Market Shares 120
TABLE 47 MARKET SHARE OF PEPTIDE HORMONES BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 121
FIGURE 24 MARKET SHARE OF PEPTIDE HORMONES BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 121
THERAPEUTIC ENZYMES 121
Market Overview 122
Market Revenue 122
TABLE 48 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 123
FIGURE 25 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 123
Market Share 123
TABLE 49 MARKET SHARE OF ENZYMES BY TYPE OF MANUFACTURING PROCESSES,
2012 (%) 124
FIGURE 26 MARKET SHARE OF ENZYMES BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 124
INDUSTRY STRUCTURE 124
PEPTIDE HORMONES 124
Market Leaders 124
TABLE 50 PEPTIDE HORMONES 125
Market Share 127
TABLE 51 MARKET SHARE OF PEPTIDE HORMONES MANUFACTURING COMPANIES,
2012 (%) 128
FIGURE 27 MARKET SHARE OF PEPTIDE HORMONES MANUFACTURING COMPANIES,
2012 (%) 128
THERAPEUTIC ENZYMES 129
TABLE 52 THERAPEUTIC ENZYMES 129
Market Share 130
TABLE 53 MARKET SHARE OF THERAPEUTIC ENZYME MANUFACTURING
COMPANIES, 2012 (%) 130
FIGURE 28 MARKET SHARE OF THERAPEUTIC ENZYME MANUFACTURING
COMPANIES, 2012 (%) 130

CHAPTER 8 PATENT ANALYSIS 133

PATENTS BY YEAR 133
TABLE 54 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 133
FIGURE 29 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 133
PATENTS BY TYPE/CATEGORY 134
TABLE 55 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 134
FIGURE 30 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 134
PATENTS BY COMPANY 135
TABLE 56 NUMBER OF U.S. PATENTS, BY COMPANY, JANUARY 2009- JUNE 2013 135
PATENTS BY COUNTRY 140
TABLE 57 NUMBER OF U.S. PATENTS, BY COUNTRY, JANUARY 2009-JUNE 2013 140
TABLE 58 PATENT SHARES, BY COUNTRY, JANUARY 2009-JUNE 2013 (%) 141
PATENTS BY ASSIGNEE 142
TABLE 59 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 142
FIGURE 31 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 142

CHAPTER 9 CURRENT SITUATION 144

FACTORS AFFECTING THE PROTEIN THERAPEUTICS MARKET 144
INCREASING PREVALENCE OF CHRONIC DISEASES 144
GROWING AGING POPULATION 144
LIFESTYLE CHANGES 145
NEW PRODUCT LAUNCHES 145
ADVANCEMENTS IN MANUFACTURING TECHNOLOGIES 145
PRICE CONTROLS 146
REGULATORY PRESSURES 146
ENTRY OF FOLLOW-ON-BIOLOGICS/BIOSIMILARS 146
MERGERS AND ACQUISITIONS 147
LICENSING AGREEMENTS 147

CHAPTER 10 COMPANY PROFILES 149

ABBOTT LABORATORIES 149
AFFYMAX 149
ALCON 150
ALEXION PHARMACEUTICALS 150
ALLERGAN INC 151
AMGEN 151
BAXTER HEALTHCARE 152
BAYER HEALTHCARE PHARMACEUTICALS 152
BIO PRODUCTS LABORATORY 153
BIOGEN IDEC 153
BIOTEST PHARMACEUTICALS CORPORATION 154
BOEHRINGER INGELHEIM 154
BRISTOL-MYERS SQUIBB 155
BTG INTERNATIONAL LIMITED 155
CANGENE CORPORATION 156
CSL LIMITED 156
DENDREON COPORATION 157
EISAI CO. LTD. 157
ELI LILLY 158
FERRING PHARMACEUTICALS 159
FRESENIUS KABI USA 159
GLAXOSMITHKLINE 160
GRIFOLS BIOLOGICALS INC 160
HOFFMAN-LA-ROCHE 161
HOSPIRA 161
JANSSEN-CILAG 161
JOHNSON and JOHNSON 162
KAMADA LTD. 163
KEDRION BIOPHARMACEUTICALS, SPA 163
LUNDBECK LLC 164
MEDIMMUNE LLC 164
MERCK and CO, INC 164
MERCK KGAA 165
MYLAN INC. 166
NABI BIOPHARMACEUTICALS (NOW BIOTA PHARMACEUTICALS) 166
NOVARTIS 167
NOVO NORDISK INC 168
OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H 168
OMRIX BIOPHARMACEUTICALS LTD 169
PFIZER INC 169
PROTEIN SCIENCES CORPORATION 170
RARE DISEASE THERAPEUTICS INC. 170
REVO BIOLOGICS 171
SANDOZ 171
SANOFI 172
SEATTLE GENETICS INC. 172
SPECTRUM PHARMACEUTICALS INC. 173
TAKEDA PHARMACEUTICALS 173
UCB COMPANY 174
UPSHER SMITH LABORATORIES INC 174
VIROPHARMA INC 175
WATSON LABS 175
WOCKHARDT LIMITED 176
X-GEN PHARMS 176
ZYMOGENETICS, INC 176

CHAPTER 11 APPENDIX: ABBREVIATIONS 179



LIST OF TABLES

SUMMARY TABLE GLOBAL REVENUE OF PROTEIN THERAPEUTICS MARKET, THROUGH
2018 ($ MILLIONS) 7
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 70
TABLE 24 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPE, THROUGH 2018
($ MILLIONS) 78
TABLE 25 MARKET SHARE OF PROTEIN THERAPEUTICS, BY TYPE, 2012 (%) 79
TABLE 26 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY REGION, THROUGH
2018 ($ MILLIONS) 83
TABLE 27 MARKET SHARE OF PROTEIN THERAPEUTICS, BY REGION, 2012 (%) 84
TABLE 28 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES
BY REGION, THROUGH 2018 ($ MILLIONS) 86
TABLE 29 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES BY
REGION, 2012 (%) 87
TABLE 30 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, THROUGH 2018 ($ MILLIONS) 89
TABLE 31 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 90
TABLE 32 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, THROUGH 2018 ($ MILLIONS) 92
TABLE 33 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2012 (%) 93
TABLE 34 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 98
TABLE 35 MARKET SHARE OF PROTEIN THERAPEUTICS BY TYPE OF MANUFACTURING
PROCESS, 2012 (%) 99
TABLE 36 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
THROUGH 2018 ($ MILLIONS) 103
TABLE 37 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
2012 (%) 104
TABLE 38 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPE, THROUGH 2018 ($
MILLIONS) 107
TABLE 39 MARKET SHARE OF PEPTIDE HORMONES BY TYPE, 2012 (%) 108
TABLE 40 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH 2018
($ MILLIONS) 110
TABLE 41 MARKET SHARE OF THERAPEUTIC ENZYMES BY TYPE, 2012 (%) 111
TABLE 42 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2018 ($
MILLIONS) 113
TABLE 43 MARKET SHARE OF PEPTIDE HORMONES BY REGION, 2012 (%) 114
TABLE 44 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH
2018 ($ MILLIONS) 116
TABLE 45 MARKET SHARE OF THERAPEUTIC ENZYMES BY REGION, 2012 (%) 117
TABLE 46 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 120
TABLE 47 MARKET SHARE OF PEPTIDE HORMONES BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 121
TABLE 48 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPES OF
MANUFACTURING PROCESSES, THROUGH 2018 ($ MILLIONS) 123
TABLE 49 MARKET SHARE OF ENZYMES BY TYPE OF MANUFACTURING PROCESSES,
2012 (%) 124
TABLE 50 PEPTIDE HORMONES 125
TABLE 51 MARKET SHARE OF PEPTIDE HORMONES MANUFACTURING COMPANIES,
2012 (%) 128
TABLE 52 THERAPEUTIC ENZYMES 129
TABLE 53 MARKET SHARE OF THERAPEUTIC ENZYME MANUFACTURING COMPANIES,
2012 (%) 130
TABLE 54 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 133
TABLE 55 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 134
TABLE 56 NUMBER OF U.S. PATENTS, BY COMPANY, JANUARY 2009- JUNE 2013 135
TABLE 57 NUMBER OF U.S. PATENTS, BY COUNTRY, JANUARY 2009-JUNE 2013 140
TABLE 58 PATENT SHARES, BY COUNTRY, JANUARY 2009-JUNE 2013 (%) 141
TABLE 59 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 142



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) 78
FIGURE 2 MARKET SHARE OF PROTEIN THERAPEUTICS, BY TYPE, 2012 (%) 79
FIGURE 3 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY REGION, 2011-2018 ($
MILLIONS) 83
FIGURE 4 MARKET SHARE OF PROTEIN THERAPEUTICS, BY REGION, 2012 (%) 84
FIGURE 5 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES
BY REGION, 2011-2018 ($ MILLIONS) 86
FIGURE 6 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES BY
REGION, 2012 (%) 87
FIGURE 7 GLOBAL MARKET FOR CYTOKINES AND MONOCLONAL ANTIBODIES BY
REGION, 2011-2018 ($ MILLIONS) 89
FIGURE 8 MARKET SHARE OF MONOCLONAL ANTIBODIES BY REGION, 2012 (%) 90
FIGURE 9 GLOBAL MARKET FOR BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2011-2018 ($ MILLIONS) 92
FIGURE 10 MARKET SHARE OF BLOOD FACTORS, VACCINES AND PEPTIDE
ANTIBIOTICS BY REGION, 2012 (%) 93
FIGURE 11 GLOBAL MARKET FOR PROTEIN THERAPEUTICS BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 99
FIGURE 12 MARKET SHARE OF PROTEIN THERAPEUTICS BY TYPE OF
MANUFACTURING PROCESS, 2012 (%) 100
FIGURE 13 GLOBAL MARKET FOR PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
2011-2018 ($ MILLIONS) 103
FIGURE 14 MARKET SHARE OF PEPTIDE HORMONES AND THERAPEUTIC ENZYMES,
2012 (%) 104
FIGURE 15 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPE, 2011-2018 ($
MILLIONS) 107
FIGURE 16 MARKET SHARE OF PEPTIDE HORMONES BY TYPE, 2012 (%) 108
FIGURE 17 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH 2018
($ MILLIONS) 110
FIGURE 18 MARKET SHARE OF THERAPEUTIC ENZYMES BY TYPE, 2012 (%) 111
FIGURE 19 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2018
($ MILLIONS) 113
FIGURE 20 MARKET SHARE OF PEPTIDE HORMONES BY REGION, 2012 (%) 114
FIGURE 21 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, 2011-2018 ($
MILLIONS) 116
FIGURE 22 MARKET SHARE OF THERAPEUTIC ENZYMES BY REGION, 2012 (%) 117
FIGURE 23 GLOBAL MARKET FOR PEPTIDE HORMONES BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 120
FIGURE 24 MARKET SHARE OF PEPTIDE HORMONES BY TYPE OF MANUFACTURING
PROCESSES, 2012 (%) 121
FIGURE 25 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY TYPES OF
MANUFACTURING PROCESSES, 2011-2018 ($ MILLIONS) 123
FIGURE 26 MARKET SHARE OF ENZYMES BY TYPE OF MANUFACTURING PROCESSES,
2012 (%) 124
FIGURE 27 MARKET SHARE OF PEPTIDE HORMONES MANUFACTURING COMPANIES,
2012 (%) 128
FIGURE 28 MARKET SHARE OF THERAPEUTIC ENZYME MANUFACTURING COMPANIES,
2012 (%) 130
FIGURE 29 NUMBER OF SIGNIFICANT PATENTS, BY YEAR, JANUARY 2009-JUNE 2013 133
FIGURE 30 PATENTS BY CATEGORY, JANUARY 2009-JUNE 2013 134
FIGURE 31 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-JUNE 2013 142

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