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Global Markets for Bioengineered Protein Drugs

  • August 2014
  • -
  • BCC Research
  • -
  • 189 pages

This BCC Research report explores the present and future strategies within the bioengineered protein drugs market. It analyzes each market and its applications, regulatory environment, technologies involved, market projections and market shares. Revenues are broken down by region. CAGR projections are estimated for the five-year period from 2014 through 2019. The report also covers significant patents and their allotments in each category.

Use this report to:
- Receive information about the current and future global market for bioengineered protein drugs.
- Receive information on diseases for which protein drugs are particularly amenable including hemophilia, diabetes, cancer, cystic fibrosis, hepatitis, psoriasis, and congenital
diseases.
- Analyze the industry structure of bioengineered protein drugs.
- Learn about the significant patents and their allotments in each category.

Highlights
- The global market for bioengineered protein drugs was valued at $151.9 billion in 2013 and will reach about $157.0 billion in 2014. The market is further expected to grow to about $222.7 billion in 2019, a compound annual growth rate (CAGR) of 7.2% from 2014 through 2019.
- The U.S. is the largest regional segment of the market; anticipated to be at $72 billion in 2014 and $111 billion by 2019, increasing at a CAGR of 9.1% from 2014 through 2019.
- The European region should reach $38.8 billion in 2014 and nearly $55.4 billion by 2019 at a 7.4% CAGR for the period 2014-2019.

INTRODUCTION

STUDY OBJECTIVES
Proteins play a crucial role in living organisms. They play an important part in defining both structure as well as function. In recent years, technology advances has led to the
development of advanced techniques for controlled and effective delivery of peptides and proteins in the body. This has led to their efficient use in treating human injury and effective targeted treatments to prevent a number of life-threatening diseases. Furthermore, these drugs are useful as preventive vaccinations, blood-clotting factors,
etc. The objective of this report is to provide an overview of the current and future global market for bioengineered protein drugs. The objective is to present a comprehensive analysis of the future direction of bioengineered protein drugs in terms of an important tool for the use of protein-based drugs.

This report explores the present and future strategies within the bioengineered protein drugs market. Drug categories included in this report are monoclonal antibodies,
cytokines, peptide hormones, therapeutic enzymes, vaccines, blood factors and peptide antibiotics. The inventiveness of the market, the setbacks and the needs of the
market are discussed in this report. Usage of these types of drugs in various disease sectors is also depicted in this report. Diseases for which protein drugs are particularly
responsive are also discussed in this report, and include diabetes, cancer, blood disorders and skin diseases, growth hormone disorder, enzyme disorder and fertility
disorder and others. A detailed analysis industry structure has been conducted. Revenues are broken down by region. Sales figures are estimated for the five-year period from 2014 through 2019. The report also covers significant patents and their allotments in each category.

REASONS FOR DOING THIS STUDY
The bioengineered protein drug market is one of the fastest growing markets in recent years in the overall pharmaceutical/biotechnology markets. These drugs have gained
much attention from pharmaceutical companies due to their bioreactivity, specificity, safety and overall success rate in treating disease. Extensive research in the field of
these protein drugs has revealed their usefulness in being able to provide therapeutic treatments for various diseases. R&D spending, along with increasing competition,
patent expiries and new technologies, are directing these drugs to a new direction. The progress in technology, as well as new product launches, has influenced market growth. Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strength and weaknesses of each type of bioengineered proteins in light of the new technologies, growing competition and changing customer needs.

INTENDED AUDIENCE
This study covers the areas of market growth in bioengineered protein drugs 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 involves the bioengineered protein therapeutics used in the pharmaceutical and the biopharmaceutical markets. BCC Research analyzes each
market and its applications, regulatory environment, technologies involved, market projections and market shares. The technological issues include all the latest trends,
pipeline products and developments. The emerging markets cover countries such as India, China, Japan, Korea, Taiwan, Africa, Australia, New Zealand, Canada, etc. The bioengineered protein drugs that are covered in this report are monoclonal antibodies, cytokines, peptide antibiotics, vaccines, enzymes, peptide hormones and blood factors. These products are bioengineered and are produced by recombinant DNA technology. The only blood products considered in this report are recombinant blood products which are derived through the recombinant DNA technology process.

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 bioengineered protein drug experts. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions, and market trends.

Table Of Contents

Global Markets for Bioengineered Protein Drugs
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 2
STUDY OBJECTIVES 2
REASONS FOR DOING THIS STUDY 2
INTENDED AUDIENCE 3
SCOPE OF THE STUDY 3
METHODOLOGY 3
INFORMATION SOURCES 3
ANALYST'S CREDENTIALS 3
RELATED BCC RESEARCH REPORTS 4
BCC RESEARCH WEBSITE 4
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
SUMMARY TABLE GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY
REGION, THROUGH 2019 ($ MILLIONS) 8
SUMMARY FIGURE GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY
REGION, 2012-2019 ($ MILLIONS) 8
CHAPTER 3 OVERVIEW 10
BIOSYNTHESIS OF PROTEINS 10
TRANSCRIPTION 10
TRANSLATION 11
POST-TRANSCRIPTIONAL MODIFICATIONS 11
SUMMARY FIGURE 11
HISTORY OF BIOENGINEERED PROTEIN DRUGS 11
TABLE 1 EVOLUTION OF BIOENGINEERED PROTEINS DRUGS 11
BIOENGINEERED PROTEIN DRUGS 12
TABLE 2 BIOENGINEERED PROTEIN DRUGS VS. CHEMICALLY SYNTHESIZED DRUGS 13
ADVANTAGES OF BIOENGINEERED PROTEIN DRUGS 14
MANUFACTURING TECHNOLOGY 14
Fractionation or Cohn Process 14
TABLE 3 PROTEIN DRUGS MADE BY FRACTIONATION 15
Microbial Cell Fermentation and Bioreactors 16
TABLE 4 THERAPEUTIC DRUGS PRODUCED BY MICROBIAL FERMENTATION 16
Genetic Engineering 17
Genetically Modified Organisms 17
Pharming 17
TABLE 5 PROTEIN DRUGS PRODUCED BY TRANSGENIC ANIMALS, PLANTS AND
MICRO-ORGANISMS 17
Mammalian Cell Culture 18
TABLE 6 PROTEIN DRUGS MADE BY CELL CULTURE 19
Cell-Free Protein Synthesis Systems 19
ADMINISTRATION TECHNOLOGIES OF BIOENGINEERED PROTEIN DRUGS 19
Traditional Methods of Drug Delivery 20
Oral 20
Topical 20
Transmucosal 20
Inhalation 20
Parenteral 20
TABLE 7 ROUTES OF DRUG DELIVERY 20
Limitations Encountered by Traditional Drug Delivery 21
Current Research and Novel Approaches 21
Targeted Drug Delivery Carriers 21
Micelles 22
Liposomes 22
Microspheres 22
Nanoparticles 22
Microemulsions 22
Hydrogels 23
Thin-film Drug Delivery 23
Prodrug 23
MOLECULAR CLASSIFICATION OF PROTEIN DRUGS 23
Monoclonal Antibodies 23
Cytokines 24
Interferons 25
Interleukins 25
Colony Stimulating Factors 25
Peptide Hormones 26
Follicle Stimulating Hormones and Luteinizing Hormones 26
Growth Hormones 26
Erythropoietin 26
Insulin 27
Vaccines 27
Live Attenuated Vaccines 27
Inactivated/Killed Vaccines 28
Toxoid 28
Subunit/Conjugate 28
Therapeutic Enzymes 28
Digestive Enzymes 29
Metabolic Enzymes 29
Other Enzymes 29
Peptide Antibiotics 30
Blood Products 30
Alpha 1-Protease Inhibitor 30
Antihemophilic Factor 31
Antithrombin 31
C1 Esterase Inhibitor 31
Coagulation Factors 31
Immune Globulins 32
Protein C 32
Thrombin 32
CHAPTER 4 REGULATORY ASPECTS 34
MONOCLONAL ANTIBODIES 34
TABLE 8 NEW APPROVALS OF MONOCLONAL ANTIBODIES, 2009-MAY 2014 34
CYTOKINES 36
TABLE 9 NEW APPROVALS OF CYTOKINES, 2009-MAY 2014 36
VACCINES 37
TABLE 10 NEW APPROVALS IN VACCINES, 2009-MAY 2014 37
PEPTIDE HORMONES 39
TABLE 11 NEW APPROVALS IN PEPTIDE HORMONES, 2009-MAY 2014 40
THERAPEUTIC ENZYMES 40
TABLE 12 NEW APPROVALS IN THERAPEUTIC ENZYMES, 2009-MAY 2014 40
BLOOD PRODUCTS 41
TABLE 13 NEW APPROVALS IN BLOOD PRODUCTS, 2009-MAY 2014 41
RECALLS 42
TABLE 14 RECALLS, FROM 2009 TO MAY 2014 42
NEW DRUG APPLICATIONS/BIOLOGICAL LICENSE APPLICATIONS 45
TABLE 15 NEW DRUG APPLICATIONS/BIOLOGICAL LICENSE APPLICATIONS, FROM
2009 TO MAY 2014 45
SAFETY ALERTS 48
TABLE 16 SAFETY ALERTS, FROM 2009 TO MAY 2014 48
CHAPTER 5 NEW DEVELOPMENTS 52
VACCINES 52
TABLE 17 PIPELINE PRODUCTS IN VACCINES 53
PEPTIDE HORMONES 57
TABLE 18 PIPELINE PRODUCTS IN PEPTIDE HORMONES 57
THERAPUETIC ENZYMES 59
TABLE 19 PIPELINE PRODUCTS IN THERAPEUTIC ENZYMES 59
BLOOD PRODUCTS 59
TABLE 20 PIPELINE PRODUCTS IN BLOOD PRODUCTS 60
PEPTIDE ANTIBIOTICS 61
TABLE 21 PIPELINE PRODUCTS OF PEPTIDE ANTIBIOTICS 61
CYTOKINES 62
TABLE 22 PIPELINE PRODUCTS OF CYTOKINES 63
MONOCLONAL ANTIBODIES 65
TABLE 23 PIPELINE PRODUCTS OF MONOCLONAL ANTIBODIES 66
MERGERS AND ACQUISITIONS 73
TABLE 24 MERGERS AND ACQUISITIONS OF TOP PHARMACEUTICAL COMPANIES,
2009 TO FEBRUARY 2014 73
NEW TECHNOLOGIES 78
INNOVATIONS IN BIOLOGIC DRUGS 78
FUSION PROTEIN 79
NANOMEDICINE 79
ENGINEERED PROTEIN SCAFFOLDS 79
PROGRAMMED BIOMANUFACTURING 80
CHAPTER 6 MARKET ANALYSIS OF BIOENGINEERED PROTEIN DRUGS 82
MARKET BY TYPE 83
GLOBAL BIOENGINEERED PROTEIN DRUGS MARKET 83
TABLE 25 GLOBAL SALES FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE,
THROUGH 2019 ($ MILLIONS) 83
FIGURE 1 GLOBAL SALES FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE,
2012-2019 ($ MILLIONS) 84
PEPTIDE HORMONES 84
Market Overview 85
Market Revenue 86
TABLE 26 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2019
($ MILLIONS) 87
FIGURE 2 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, 2012-2019 ($
MILLIONS) 87
VACCINES 87
Market Overview 88
Market Revenue 89
TABLE 27 GLOBAL MARKET FOR VACCINES BY REGION, THROUGH 2019 ($
MILLIONS) 90
FIGURE 3 GLOBAL MARKET FOR VACCINES BY REGION, 2012-2019 ($ MILLIONS) 90
THERAPEUTIC ENZYMES 90
Market Overview 91
Market Revenue 92
TABLE 28 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH
2019 ($ MILLIONS) 92
FIGURE 4 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, 2012-2019 ($
MILLIONS) 92
MONOCLONAL ANTIBODIES 93
Market Overview 93
Market Revenue 94
TABLE 29 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY REGION, THROUGH
2019 ($ MILLIONS) 95
FIGURE 5 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY REGION,
2012-2019 ($ MILLIONS) 95
CYTOKINES 96
Market Overview 96
Market Revenue 97
TABLE 30 GLOBAL MARKET FOR CYTOKINES BY REGION, THROUGH 2019 ($
MILLIONS) 98
FIGURE 6 GLOBAL MARKET FOR CYTOKINES BY REGION, 2012-2019 ($ MILLIONS) 98
BLOOD PRODUCTS AND PEPTIDE ANTIBIOTICS 99
Market Overview 100
Market Revenue 101
TABLE 31 GLOBAL MARKET FOR BLOOD PRODUCTS AND PEPTIDE ANTIBIOTICS BY
REGION, THROUGH 2019 ($ MILLIONS) 102
FIGURE 7 GLOBAL MARKET FOR BLOOD PRODUCTS AND PEPTIDE ANTIBIOTICS BY
REGION, 2012-2019 ($ MILLIONS) 102
MARKET SHARE 102
TABLE 32 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY TYPE, IN 2013
(%) 103
FIGURE 8 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY TYPE, IN 2013
(%) 103
MARKET BY REGION 103
MARKET OVERVIEW 104
MARKET REVENUE 106
TABLE 33 GLOBAL REVENUE OF BIOENGINEERED PROTEIN DRUGS BY REGION,
THROUGH 2019 ($ MILLIONS) 106
FIGURE 9 GLOBAL REVENUE OF BIOENGINEERED PROTEIN DRUGS BY REGION,
2012-2019 ($ MILLIONS) 107
MARKET SHARE 107
TABLE 34 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY REGION, IN
2013 (%) 107
FIGURE 10 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY REGION, IN
2013 (%) 107
CHAPTER 7 MARKET BY DISEASES OF BIOENGINEERED PROTEIN DRUGS 110
MARKET BY DISEASES 110
GLOBAL BIOENGINEERED PROTEIN DRUGS MARKET BY DISEASES 110
TABLE 35 GLOBAL SALES FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE,
THROUGH 2019 ($ MILLIONS) 111
FIGURE 11 GLOBAL SALES FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE,
2012-2019 ($ MILLIONS) 111
DIABETES 112
Type 1 Diabetes 112
Type 2 Diabetes 112
Gestational Diabetes 112
Market Overview 113
Market Revenue 114
TABLE 36 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN DIABETES, BY REGION, THROUGH 2019 ($ MILLIONS) 114
FIGURE 12 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY
APPLICATION IN DIABETES, BY REGION, 2012-2019 ($ MILLIONS) 114
Market Share 115
TABLE 37 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY APPLICATION IN
DIABETES, BY REGION, 2013 (%) 115
FIGURE 13 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN DIABETES, BY REGION, 2013 (%) 115
CANCER 116
TABLE 38 VARIOUS CANCER TYPES DEPENDING ON THE TISSUE OF ORIGIN 116
TABLE 39 CATEGORIES OF CANCER 117
Market Overview 118
Market Revenue 119
TABLE 40 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN CANCER, BY REGION, THROUGH 2019 ($ MILLIONS) 120
FIGURE 14 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY
APPLICATION IN CANCER, BY REGION, 2012-2019 ($ MILLIONS) 120
Market Share 120
TABLE 41 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN CANCER, BY REGION, 2013 (%) 121
FIGURE 15 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN CANCER, BY REGION, 2013 (%) 121
BLOOD DISORDERS AND SKIN DISEASES 121
Blood Disorders 121
Bleeding Disorders 122
Anemia 123
Leukemia 124
Multiple Myeloma 124
Skin Diseases 124
Skin and Skin structure Infections (SSSI) 125
Complicated Skin and Skin Structure Infection (cSSSI) 125
Uncomplicated Skin and Skin Structure Infection (uSSSI) 125
Clostridium difficile (C.difficile) 126
Market Overview 126
Market Revenue 127
TABLE 42 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN BLOOD DISORDERS AND SKIN DISEASES, BY REGION, THROUGH 2019 ($
MILLIONS)
128
FIGURE 16 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY
APPLICATION IN BLOOD DISORDERS AND SKIN DISEASES, BY REGION, 2012-2019
($ MILLIONS)
128
Market Share 128
TABLE 43 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN BLOOD DISORDERS AND SKIN DISEASES, BY REGION, 2013 (%) 129
FIGURE 17 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN BLOOD DISORDERS AND SKIN DISEASES, BY REGION, 2013 (%) 129
GROWTH HORMONE DISORDER, ENZYME DISORDER AND FERTILITY
DISORDER 129
Market Overview 130
Market Revenue 131
TABLE 44 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION,
THROUGH 2019 ($ MILLIONS)
132
FIGURE 18 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY
APPLICATION IN GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY
REGION, 2012-2019 ($ MILLIONS)
132
Market Share 132
TABLE 45 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION, 2013 (%) 133
FIGURE 19 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION, 2013 (%) 133
OTHERS 133
Rheumatoid Arthritis 134
Multiple Sclerosis 134
Crohn's Disease 134
Hepatitis 134
Influenza 135
Pneumonia 135
Cystic Fibrosis 136
Meningitis 136
Asthma 136
Market Overview 137
Market Revenue 137
TABLE 46 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN OTHER DISEASES, BY REGION, THROUGH 2019 ($ MILLIONS) 138
FIGURE 20 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY
APPLICATION IN OTHER DISEASES, BY REGION, 2012-2019 ($ MILLIONS) 138
Market Share 139
TABLE 47 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN OTHER DISEASES, BY REGION, 2013 (%) 139
FIGURE 21 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN OTHER DISEASES, BY REGION, 2013 (%) 139
CHAPTER 8 INDUSTRY STRUCTURE OF BIOENGINEERED PROTEIN DRUGS 142
INDUSTRY STRUCTURE OF BIOENGINEERED PROTEIN DRUGS, 2013 142
MONOCLONAL ANTIBODIES 142
TABLE 48 LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODIES,
2013 142
Market Share 143
TABLE 49 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF MONOCLONAL
ANTIBODIES, 2013 (%) 143
FIGURE 22 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF MONOCLONAL
ANTIBODIES, 2013 (%) 144
PEPTIDE HORMONES 144
TABLE 50 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE HORMONES, 2013 144
Market Share 146
TABLE 51 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PEPTIDE
HORMONES, 2013 (%) 146
FIGURE 23 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PEPTIDE
HORMONES, 2013 (%) 146
CYTOKINES 147
TABLE 52 LEADING MANUFACTURERS/SUPPLIERS OF CYTOKINES, 2013 147
Market Share 148
TABLE 53 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF CYTOKINE, 2013 (%) 148
FIGURE 24 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF CYTOKINE, 2013
(%) 148
THERAPEUTIC ENZYMES 149
TABLE 54 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC ENZYMES,
2013 149
Market Share 149
TABLE 55 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC
ENZYMES, 2013 (%) 150
FIGURE 25 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC
ENZYMES, 2013 (%) 150
VACCINES 150
TABLE 56 LEADING MANUFACTURERS/SUPPLIERS OF VACCINES, 2013 151
Market Share 153
TABLE 57 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF VACCINES, 2013 (%) 154
FIGURE 26 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF VACCINES, 2013
(%) 154
BLOOD PRODUCTS 154
TABLE 58 LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT BLOOD
PRODUCTS, 2013 155
Market Share 155
TABLE 59 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF RECOMBINANT
BLOOD PRODUCTS, 2013 (%) 155
FIGURE 27 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF RECOMBINANT
BLOOD PRODUCTS, 2013 (%) 156
PEPTIDE ANTIBIOTICS 156
TABLE 60 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE ANTIBIOTICS, 2013 156
Market Share 157
TABLE 61 MARKET SHARE OF MANUFACTURERS/ SUPPLIERS OF PEPTIDE
ANTIBIOTICS, 2013 (%) 157
FIGURE 28 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PEPTIDE
ANTIBIOTICS, 2013 (%) 157
CHAPTER 9 PATENT ANALYSIS 160
PATENTS BY YEAR 160
TABLE 62 NUMBER OF PATENTS, BY YEAR, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 160
FIGURE 29 UMBER OF PATENTS, BY YEAR, JANUARY 2009-FEBRUARY 2014 (%) 161
PATENTS BY TYPE/ CATEGORY 161
TABLE 63 NUMBER OF PATENTS, BY CATEGORY, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 161
FIGURE 30 NUMBER OF PATENTS, BY CATEGORY, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 161
PATENTS BY COMPANY 162
TABLE 64 NUMBER OF PATENTS, BY COMPANY, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 162
PATENTS BY COUNTRY 169
TABLE 65 NUMBER OF PATENTS, BY COUNTRY, JANUARY 2009 -FEBRUARY 2014
(NUMBER OF PATENTS) 169
TABLE 66 PATENT SHARES, BY COUNTRY, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS/%) 170
PATENTS BY ASSIGNEE 171
TABLE 67 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 171
FIGURE 31 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 171
CHAPTER 10 THE CURRENT SITUATION 174
FACTORS AFFECTING BIOENGINEERED PROTEIN DRUGS 174
INCREASING PREVALENCE OF CHRONIC DISEASES 174
GROWING AGING POPULATION 174
LIFESTYLE CHANGES 175
NEW PRODUCT LAUNCHES 175
ADVANCEMENTS IN MANUFACTURING TECHNOLOGIES 175
PRICE CONTROLS 176
REGULATORY PRESSURES 176
ENTRY OF FOLLOW-ON-BIOLOGICS/BIOSIMILARS 176
LICENSING AGREEMENTS 177
MERGERS AND ACQUISITIONS 178
CHAPTER 11 COMPANY PROFILES 180
ABBOTT LABORATORIES 180
ACTAVIS INC. (FORMERLY WATSON LABS) 180
ALEXION PHARMACEUTICALS 181
ALLERGAN INC. 181
AMGEN 182
BAXTER HEALTHCARE 182
BAYER HEALTHCARE PHARMACEUTICALS 183
BIOGEN IDEC INC. 183
BIOMARIN PHARMACEUTICAL INC. 184
BRISTOL-MYERS SQUIBB CO. 184
CSL LIMITED 185
ELI LILLY AND CO. 185
FRESENIUS KABI USA 186
GLAXOSMITHKLINE 187
HOFFMAN-LA-ROCHE 187
HOSPIRA 188
JOHNSON and JOHNSON 188
LUNDBECK LLC 189
MEDIMMUNE LLC 189
MERCK and CO. INC. 190
MERCK KGAA 191
MYLAN INC. 191
NOVARTIS 192
NOVO NORDISK INC. 192
PFIZER INC. 193
SANDOZ 194
SANOFI 194
SEATTLE GENETICS INC. 195
TAKEDA PHARMACEUTICAL U.S.A. INC. 196
UCB COMPANY 196
VIROPHARMA INC. 196
VERTEX PHARMACEUTICALS 197
WOCKHARDT LTD. 197
X-GEN PHARMACEUTICALS INC. 198
ZYMOGENETICS INC. 198
CHAPTER 12 APPENDIX—ABBREVIATIONS 200
LIST OF TABLES
SUMMARY TABLE GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY
REGION, THROUGH 2019 ($ MILLIONS) 8
TABLE 1 EVOLUTION OF BIOENGINEERED PROTEINS DRUGS 11
TABLE 2 BIOENGINEERED PROTEIN DRUGS VS. CHEMICALLY SYNTHESIZED DRUGS 13
TABLE 3 PROTEIN DRUGS MADE BY FRACTIONATION 15
TABLE 4 THERAPEUTIC DRUGS PRODUCED BY MICROBIAL FERMENTATION 16
TABLE 5 PROTEIN DRUGS PRODUCED BY TRANSGENIC ANIMALS, PLANTS AND
MICRO-ORGANISMS 17
TABLE 6 PROTEIN DRUGS MADE BY CELL CULTURE 19
TABLE 7 ROUTES OF DRUG DELIVERY 20
TABLE 8 NEW APPROVALS OF MONOCLONAL ANTIBODIES, 2009-MAY 2014 34
TABLE 9 NEW APPROVALS OF CYTOKINES, 2009-MAY 2014 36
TABLE 10 NEW APPROVALS IN VACCINES, 2009-MAY 2014 37
TABLE 11 NEW APPROVALS IN PEPTIDE HORMONES, 2009-MAY 2014 40
TABLE 12 NEW APPROVALS IN THERAPEUTIC ENZYMES, 2009-MAY 2014 40
TABLE 13 NEW APPROVALS IN BLOOD PRODUCTS, 2009-MAY 2014 41
TABLE 14 RECALLS, FROM 2009 TO MAY 2014 42
TABLE 15 NEW DRUG APPLICATIONS/BIOLOGICAL LICENSE APPLICATIONS, FROM
2009 TO MAY 2014 45
TABLE 16 SAFETY ALERTS, FROM 2009 TO MAY 2014 48
TABLE 17 PIPELINE PRODUCTS IN VACCINES 53
TABLE 18 PIPELINE PRODUCTS IN PEPTIDE HORMONES 57
TABLE 19 PIPELINE PRODUCTS IN THERAPEUTIC ENZYMES 59
TABLE 20 PIPELINE PRODUCTS IN BLOOD PRODUCTS 60
TABLE 21 PIPELINE PRODUCTS OF PEPTIDE ANTIBIOTICS 61
TABLE 22 PIPELINE PRODUCTS OF CYTOKINES 63
TABLE 23 PIPELINE PRODUCTS OF MONOCLONAL ANTIBODIES 66
TABLE 24 MERGERS AND ACQUISITIONS OF TOP PHARMACEUTICAL COMPANIES,
2009 TO FEBRUARY 2014 73
TABLE 25 GLOBAL SALES FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE,
THROUGH 2019 ($ MILLIONS) 83
TABLE 26 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2019 ($
MILLIONS) 87
TABLE 27 GLOBAL MARKET FOR VACCINES BY REGION, THROUGH 2019 ($ MILLIONS) 90
TABLE 28 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH
2019 ($ MILLIONS) 92
TABLE 29 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY REGION, THROUGH
2019 ($ MILLIONS) 95
TABLE 30 GLOBAL MARKET FOR CYTOKINES BY REGION, THROUGH 2019 ($
MILLIONS) 98
TABLE 31 GLOBAL MARKET FOR BLOOD PRODUCTS AND PEPTIDE ANTIBIOTICS BY
REGION, THROUGH 2019 ($ MILLIONS) 102
TABLE 32 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY TYPE, IN 2013 (%) 103
TABLE 33 GLOBAL REVENUE OF BIOENGINEERED PROTEIN DRUGS BY REGION,
THROUGH 2019 ($ MILLIONS) 106
TABLE 34 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY REGION, IN 2013
(%) 107
TABLE 35 GLOBAL SALES FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE,
THROUGH 2019 ($ MILLIONS) 111
TABLE 36 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN DIABETES, BY REGION, THROUGH 2019 ($ MILLIONS) 114
TABLE 37 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY APPLICATION IN
DIABETES, BY REGION, 2013 (%) 115
TABLE 38 VARIOUS CANCER TYPES DEPENDING ON THE TISSUE OF ORIGIN 116
TABLE 39 CATEGORIES OF CANCER 117
TABLE 40 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN CANCER, BY REGION, THROUGH 2019 ($ MILLIONS) 120
TABLE 41 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION IN
CANCER, BY REGION, 2013 (%) 121
TABLE 42 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN BLOOD DISORDERS AND SKIN DISEASES, BY REGION, THROUGH 2019 ($
MILLIONS)
128
TABLE 43 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION IN
BLOOD DISORDERS AND SKIN DISEASES, BY REGION, 2013 (%) 129
TABLE 44 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION, THROUGH
2019 ($ MILLIONS)
132
TABLE 45 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION IN
GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION, 2013 (%) 133
TABLE 46 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN OTHER DISEASES, BY REGION, THROUGH 2019 ($ MILLIONS) 138
TABLE 47 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION IN
OTHER DISEASES, BY REGION, 2013 (%) 139
TABLE 48 LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODIES,
2013 142
TABLE 49 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF MONOCLONAL
ANTIBODIES, 2013 (%) 143
TABLE 50 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE HORMONES, 2013 144
TABLE 51 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PEPTIDE HORMONES,
2013 (%) 146
TABLE 52 LEADING MANUFACTURERS/SUPPLIERS OF CYTOKINES, 2013 147
TABLE 53 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF CYTOKINE, 2013 (%) 148
TABLE 54 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC ENZYMES, 2013 149
TABLE 55 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC
ENZYMES, 2013 (%) 150
TABLE 56 LEADING MANUFACTURERS/SUPPLIERS OF VACCINES, 2013 151
TABLE 57 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF VACCINES, 2013 (%) 154
TABLE 58 LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT BLOOD
PRODUCTS, 2013 155
TABLE 59 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF RECOMBINANT
BLOOD PRODUCTS, 2013 (%) 155
TABLE 60 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE ANTIBIOTICS, 2013 156
TABLE 61 MARKET SHARE OF MANUFACTURERS/ SUPPLIERS OF PEPTIDE
ANTIBIOTICS, 2013 (%) 157
TABLE 62 NUMBER OF PATENTS, BY YEAR, JANUARY 2009-FEBRUARY 2014 (NUMBER
OF PATENTS) 160
TABLE 63 NUMBER OF PATENTS, BY CATEGORY, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 161
TABLE 64 NUMBER OF PATENTS, BY COMPANY, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 162
TABLE 65 NUMBER OF PATENTS, BY COUNTRY, JANUARY 2009 -FEBRUARY 2014
(NUMBER OF PATENTS) 169
TABLE 66 PATENT SHARES, BY COUNTRY, JANUARY 2009-FEBRUARY 2014 (NUMBER
OF PATENTS/%) 170
TABLE 67 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 171
LIST OF FIGURES
SUMMARY FIGURE GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY
REGION, 2012-2019 ($ MILLIONS) 8
SUMMARY FIGURE 11
FIGURE 1 GLOBAL SALES FOR BIOENGINEERED PROTEIN DRUGS, BY TYPE,
2012-2019 ($ MILLIONS) 84
FIGURE 2 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, 2012-2019 ($
MILLIONS) 87
FIGURE 3 GLOBAL MARKET FOR VACCINES BY REGION, 2012-2019 ($ MILLIONS) 90
FIGURE 4 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, 2012-2019 ($
MILLIONS) 92
FIGURE 5 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES BY REGION, 2012-2019
($ MILLIONS) 95
FIGURE 6 GLOBAL MARKET FOR CYTOKINES BY REGION, 2012-2019 ($ MILLIONS) 98
FIGURE 7 GLOBAL MARKET FOR BLOOD PRODUCTS AND PEPTIDE ANTIBIOTICS BY
REGION, 2012-2019 ($ MILLIONS) 102
FIGURE 8 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY TYPE, IN 2013 (%) 103
FIGURE 9 GLOBAL REVENUE OF BIOENGINEERED PROTEIN DRUGS BY REGION,
2012-2019 ($ MILLIONS) 107
FIGURE 10 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY REGION, IN
2013 (%) 107
FIGURE 11 GLOBAL SALES FOR BIOENGINEERED PROTEIN DRUGS, BY DISEASE,
2012-2019 ($ MILLIONS) 111
FIGURE 12 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN DIABETES, BY REGION, 2012-2019 ($ MILLIONS) 114
FIGURE 13 MARKET SHARE OF BIOENGINEERED PROTEIN DRUGS BY APPLICATION IN
DIABETES, BY REGION, 2013 (%) 115
FIGURE 14 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN CANCER, BY REGION, 2012-2019 ($ MILLIONS) 120
FIGURE 15 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN CANCER, BY REGION, 2013 (%) 121
FIGURE 16 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN BLOOD DISORDERS AND SKIN DISEASES, BY REGION, 2012-2019 ($ MILLIONS) 128
FIGURE 17 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN BLOOD DISORDERS AND SKIN DISEASES, BY REGION, 2013 (%) 129
FIGURE 18 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION,
2012-2019 ($ MILLIONS)
132
FIGURE 19 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN GROWTH HORMONE, ENZYME AND FERTILITY DISORDERS, BY REGION, 2013 (%) 133
FIGURE 20 GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN OTHER DISEASES, BY REGION, 2012-2019 ($ MILLIONS) 138
FIGURE 21 MARKET SHARE FOR BIOENGINEERED PROTEIN DRUGS BY APPLICATION
IN OTHER DISEASES, BY REGION, 2013 (%) 139
FIGURE 22 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF MONOCLONAL
ANTIBODIES, 2013 (%) 144
FIGURE 23 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PEPTIDE
HORMONES, 2013 (%) 146
FIGURE 24 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF CYTOKINE, 2013 (%) 148
FIGURE 25 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC
ENZYMES, 2013 (%) 150
FIGURE 26 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF VACCINES, 2013 (%) 154
FIGURE 27 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF RECOMBINANT
BLOOD PRODUCTS, 2013 (%) 156
FIGURE 28 MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PEPTIDE
ANTIBIOTICS, 2013 (%) 157
FIGURE 29 UMBER OF PATENTS, BY YEAR, JANUARY 2009-FEBRUARY 2014 (%) 161
FIGURE 30 NUMBER OF PATENTS, BY CATEGORY, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 161
FIGURE 31 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2009-FEBRUARY 2014
(NUMBER OF PATENTS) 171

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