Global Markets and Manufacturing Technologies for Protein Drugs

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ReportLinker Find Industry reports, Company profiles and Market Statistics >> Get this Report Now by email! Global Markets and Manufacturing Technologies for Protein Drugs Published on October 2013 Report Summary 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 Global Markets and Manufacturing Technologies for Protein Drugs (From Issuu) Page 1/21

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STUDY OBJECTIVESThe 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 2...

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Global Markets and Manufacturing Technologies for Protein Drugs

Published on October 2013

Report Summary

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

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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.

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Table of Content

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

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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

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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

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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,

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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

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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

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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

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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

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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

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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

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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

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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 & JOHNSON 234

KAMADA LTD. 235

KEDRION BIOPHARMACEUTICALS, SPA 235

LUNDBECK LLC 236

MEDIMMUNE LLC 236

MERCK & CO, INC 236

MERCK KGAA 237

MYLAN INC. 238

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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

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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

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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

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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

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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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