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DNA Vaccines: Technologies and Global Markets

  • July 2014
  • -
  • BCC Research
  • -
  • 169 pages

This BCC Research study determines the specific applications and global market demand for DNA vaccine products over a five-year period from 2014 to 2019. High growth and market potential segments of the industry have been highlighted. This analysis provides a quantitative market basis for biotechnology, pharmaceutical, adjuvant and gene delivery companies to make strategic choices about DNA vaccine technologies and markets. Rapid technological and structural changes occurring in the vaccine industry are strong driving forces for revitalizing this particular market and providing new growth opportunities.

Use this report to:
- Gain detailed information about the role of DNA vaccines within the overall vaccine industry.
- Analyze the importance of biotechnology and pharmaceutical firms.
- Understand the technology and market dynamics within this industry to develop the informed strategic plans and actions.
- Learn about the DNA vaccine products that are commercial or likely to be commercialized within the next five years.

Highlights
- The global market for DNA vaccines was valued at $243.7 million in 2013 and is expected to increase to $305.3 million in 2014, and further to $2.7 billion by 2019, a compound annual growth rate (CAGR) of 54.8% over the five-year period from 2014 through 2019.
- Research tools as a segment of the market is expected to grow at a five-year CAGR of 11.1% from 2014 to 2019 and is expected to reach $182.3 million by 2014 and nearly $308 million by 2019.
- The clinical vaccines segment of the market is expected to be $123.0 million in 2014. With a CAGR of 81.2%, BCC Research expects this market will reach nearly $2.4 billion by 2019.

INTRODUCTION

STUDY GOALS AND OBJECTIVES
BCC Research’s goal for this study is to determine the specific applications and global market demand for DNA vaccine products over a five-year period from 2014 to 2019. Our particular interest is to analyze and quantify the DNA vaccines market potential by disease type, end-use market and technology. We also identify emerging growth opportunities in DNA vaccine delivery technologies, adjuvants and synthetic genes. Our key objective is to present a comprehensive analysis of the emerging DNA vaccine
industry, with an emphasis on products and technologies that are commercially important in the 2014 to 2019 time period. The role of DNA vaccines within the overall vaccine industry is examined. We highlight high growth and market potential segments of the industry. This analysis provides a quantitative market basis for biotechnology,
pharmaceutical, adjuvant and gene delivery companies to make strategic choices about DNA vaccine technologies and markets. The report will be particularly useful to
companies supplying DNA vaccine components and systems, including synthetic genes, DNA delivery technologies and adjuvants. In addition, the study will benefit a wide range of life-science companies that supply enabling technologies for vaccine discovery and development, such as micro fluidics, nanotechnology, and genomics and proteomics tools.

REASONS FOR DOING THE STUDY
The vaccine industry is rapidly changing from a mostly empirical approach to a rational design approach. Rapid developments in molecular biology, DNA synthesis and
immunobiology enable rational design approaches. These technologies allow highly targeted vaccines aimed at specific epitopes. The result is new vaccines for a wider range of diseases than was previously feasible, including a new class of therapeutic vaccines. These new technologies allow pharmaceutical firms to discover and develop high-value vaccines for novel applications, creating a substantial new market opportunity.

DNA vaccines have many potential advantages, including specific targeting, use of multiple genes to enhance immunity, and reduced risk compared with conventional vaccines. Translating the advantages of DNA vaccines into the clinic has historically been difficult; however, new advances in the fields of vaccine design and DNA delivery
are addressing the previous issues. Achievements in these fields promise to overcome the translational hurdles and create strategic opportunity. This report analyzes these
trends and their effects on the future markets for DNA vaccines. The technological and structural changes occurring in the vaccine industry are strong driving forces for revitalizing this particular market and providing new growth opportunities. It is important that biotechnology and pharmaceutical firms understand the technology and market dynamics within this industry in order to best develop strategic plans and actions. Based on these market and technology dynamics, it is especially timely to examine the
future DNA vaccines markets.

INTENDED AUDIENCE
We have compiled a study of DNA vaccine technologies that will be commercially important in the major market segments, including cancer, infectious diseases, animal
health, allergies and biodefense. We present DNA vaccine delivery and synthesis technologies, growth driving forces, product formats, market applications, clinical trials, industry structure and alliances, and global sales forecasts for the period from 2014 through 2019. We estimate the future use of DNA vaccines in the important disease markets, and by technology. This report will serve as a useful industry guide for biotechnology, DNA plasmid, gene therapy, DNA delivery, pharmaceutical, vaccine, animal health and biodefense companies, as well as for suppliers of genetic tools, synthetic genes and vaccine adjuvants. It will also be of interest to professionals within the regulatory agencies to understand the scope and pace of DNA vaccine technologies as they move from clinical trials into the market.

SCOPE OF REPORT
The study scope includes DNA vaccine products that are commercial or likely to be commercialized within the next five years. Both human and animal health markets are
studied. DNA vaccine delivery technologies are also included. DNA vaccine candidates in clinical trials are examined by indication, and future market growth from 2014
through 2019 is estimated. The role that DNA vaccines play in the overall vaccines industry is examined, as well as how the vaccine industry structure and dynamics are changing. We examine DNA synthesis, biotechnology and pharmaceuticals firms, strategic industry alliances, and the role of gene delivery and synthesis technologies. The major markets for DNA vaccines, including infectious diseases, cancers, animal health, allergies and biodefense, are analyzed, and the main companies in these fields are
highlighted.

Table Of Contents

DNA Vaccines: Technologies and Global Markets
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
INTENDED AUDIENCE 3
SCOPE OF REPORT 3
TABLE A SCOPE OF REPORT 3
METHODOLOGY 4
INFORMATION SOURCES 4
RELATED BCC RESEARCH REPORTS 4
ANALYST CREDENTIALS 4
BCC RESEARCH WEBSITE 4
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
SUMMARY TABLE GLOBAL VALUE OF DNA VACCINE MARKET BY APPLICATION,
THROUGH 2019 ($ MILLIONS) 7
SUMMARY FIGURE GLOBAL VALUE OF DNA VACCINE MARKET BY APPLICATION,
2013-2019 ($ MILLIONS) 7
CHAPTER 3 OVERVIEW 11
INTRODUCTION 11
DNA VACCINE TECHNOLOGIES COVERED IN THIS REPORT 11
TABLE 1 SCOPE OF THIS REPORT 11
GLOBAL MARKET FOR DNA VACCINES 12
TABLE 2 GLOBAL VALUE OF DNA VACCINE MARKET BY APPLICATION, THROUGH
2019 ($ MILLIONS) 12
TABLE 3 GLOBAL VALUE OF HUMAN DNA VACCINE MARKET BY INDICATION,
THROUGH 2019 ($ MILLIONS) 12
FORCES DRIVING DNA VACCINE MARKET GROWTH 13
TABLE 4 DNA VACCINE INDUSTRY GROWTH DRIVING FORCES 13
LIFE CYCLE STATUS OF DNA VACCINE TECHNOLOGIES 14
TABLE 5 LIFE CYCLE STAGE OF VACCINE TYPES 14
COMMERCIAL STATUS OF DNA VACCINE TECHNOLOGIES 14
TABLE 6 COMMERCIAL STATUS OF DNA VACCINES 14
DNA VACCINE INDUSTRY 15
TABLE 7 DNA VACCINE INDUSTRY STRUCTURE 15
CHAPTER 4 DNA VACCINE TECHNOLOGIES 18
HISTORY 18
TABLE 8 DNA VACCINE HISTORY 19
THE HUMAN IMMUNE SYSTEM 20
TABLE 9 COMPONENTS OF THE IMMUNE SYSTEM 20
VACCINES 22
VACCINE EVOLUTION 22
FIGURE 1 EVOLUTION OF VACCINE TECHNOLOGIES 22
VACCINE TYPES 23
TABLE 10 VACCINE TYPES 23
Technology Life Cycle Stage of Vaccine Types 24
TABLE 11 TECHNOLOGY LIFE CYCLE STAGE OF VACCINE TYPES 24
DNA VACCINES 25
INTRODUCTION 25
FIGURE 2 MECHANISM OF ACTION OF A DNA VACCINE 25
CHANGING VACCINE PARADIGM 26
TABLE 12 CHANGING VACCINE PARADIGM 26
TABLE 13 ADVANTAGES AND DISADVANTAGES OF DNA VACCINES 27
FIGURE 3 SAFETY AND EFFICACY PROFILE OF DNA VERSUS VIRAL-VECTOR
VACCINES 29
FUNCTION AND SCOPE OF DNA VACCINES 29
FIGURE 4 DNA VACCINE FUNCTION AND MARKET SCOPE 29
TABLE 14 EMERGING COMPETITIVE LANDSCAPE FOR DNA VACCINES 31
CANCER DNA VACCINES 31
TABLE 15 CANCER VACCINE TYPES 32
DNA VACCINE TECHNOLOGY VALUE CHAIN 33
FIGURE 5 DNA VACCINE TECHNOLOGY VALUE CHAIN 33
TABLE 16 TECHNOLOGY DRIVERS FOR DNA VACCINE VALUE CHAIN 34
Antigen Discovery 35
Plasmid Design 35
TABLE 17 PLASMID DESIGN OBJECTIVES 35
TABLE 18 WAYS TO OPTIMIZE MAMMALIAN GENE EXPRESSION IN PLASMID DNA 36
Plasmid Manufacture 37
FIGURE 6 CONVENTIONAL AND PLASMID DNA VACCINE PRODUCTION PROCESS 38
TABLE 19 DNA PLASMID QUALITY COMPARISON 38
Delivery Technologies 39
TABLE 20 COMPARISON OF DNA DELIVERY TECHNOLOGIES 39
Uncomplexed pDNA 39
Electroporation 40
FIGURE 7 EP PROCESS SCHEMATIC 41
Liposomes 41
Gold Particles 42
Nanoparticles 42
Bacterial Ghosts 43
Bacteriophages 43
Viruses 43
TABLE 21 IN VIVO VIRAL VECTOR TECHNOLOGIES COMPARED 44
Targeting Technologies 45
FIGURE 8 STRATEGIES FOR TARGETING DENDRITIC CELLS 46
Adjuvant Technologies 46
TABLE 22 DNA VACCINE ADJUVANT TECHNOLOGIES 46
DNA VACCINE TECHNOLOGY NEEDS 47
TABLE 23 TECHNOLOGY NEEDS FOR DNA VACCINES 48
CHAPTER 5 DNA VACCINE APPLICATIONS 51
RESEARCH TOOL APPLICATIONS 51
CLINICAL APPLICATIONS 51
OVERVIEW TO DNA VACCINE CLINICAL TRIALS PROCESS 51
TABLE 24 DNA VACCINE DEVELOPMENT FLOW SHEET 52
TABLE 25 DNA VACCINE PRECLINICAL DEVELOPMENT STEPS 53
FIGURE 9 FUTURE VACCINE CLINICAL TRIALS OVERVIEW 53
DNA VACCINE CLINICAL TRIALS SUMMARY 55
TABLE 26 DNA VACCINES CLINICAL TRIALS SUMMARY BY STARTING YEAR, AS OF
APRIL 2014 55
TABLE 27 DNA VACCINE CLINICAL PHASE I TRIALS SUMMARY, AS OF APRIL 2014 56
TABLE 28 DNA VACCINE CLINICAL PHASE I/II TRIALS SUMMARY, AS OF APRIL 2014 59
TABLE 29 DNA VACCINE CLINICAL PHASE II TRIALS SUMMARY, AS OF APRIL 2014 60
TABLE 30 DNA VACCINE CLINICAL PHASE II/III TRIALS SUMMARY, AS OF APRIL 2014 61
TABLE 31 DNA VACCINE CLINICAL PHASE III TRIALS SUMMARY, AS OF APRIL 2014 62
TABLE 32 DNA VACCINE CLINICAL PHASE IV TRIALS SUMMARY, AS OF APRIL 2014 64
CANCER DNA VACCINE CLINICAL TRIALS 65
TABLE 33 DNA VACCINE CANCER CLINICAL TRIALS SUMMARY, AS OF APRIL 2014 65
Melanoma 67
INFECTIOUS DISEASE DNA VACCINES 68
TABLE 34 INFECTIOUS DISEASES DNA VACCINES CLINICAL TRIALS, AS OF APRIL
2014 68
HSV 73
HPV 73
Influenza 74
HBV 75
Japanese Encephalitis 76
CMV 76
HIV 77
ALLERGY AND AUTOIMMUNE DISEASE 78
TABLE 35 INFECTIOUS DISEASES DNA VACCINES CLINICAL TRIALS, AS OF APRIL
2014 78
BIODEFENSE DNA VACCINES 78
ANIMAL HEALTH DNA VACCINES 79
CHAPTER 6 DNA VACCINE INDUSTRY 82
VACCINE INDUSTRY STRUCTURAL SHIFTS 82
TABLE 36 VACCINE INDUSTRY STRUCTURAL SHIFTS 82
INDUSTRY STRUCTURE 83
TABLE 37 VACCINE INDUSTRY STRUCTURE: TRADITIONAL VERSUS EMERGING 83
FIGURE 10 MARKETING OF APPROVED VACCINES IN THE UNITED STATES, 2014 (%) 84
TABLE 38 COMPARISON OF VACCINES AND PHARMACEUTICALS BUSINESSES 85
DNA VACCINE INDUSTRY COMPETITORS 87
TABLE 39 DNA VACCINE INDUSTRY COMPETITOR POSITION 87
DNA VACCINE COMMERCIAL VALUE CHAIN 88
FIGURE 11 DNA VACCINE COMMERCIAL VALUE CHAIN 89
DNA VACCINE COMPETITOR STRATEGIC POSITIONING 89
TABLE 40 LARGE PHARMA VACCINE COMPANY STRATEGIC FOCUS 89
TABLE 41 INTEGRATED BIOTECHNOLOGY COMPANY STRATEGIC FOCUS 90
TABLE 42 INTEGRATED BIOTECHNOLOGY COMPANY STRATEGIC MARKET FOCUS 91
TABLE 43 SPECIALIZED BIOTECHNOLOGY COMPANY STRATEGIC FOCUS 93
RESEARCH and DEVELOPMENT FOCUS 94
TABLE 44 ASTELLAS PHARMA INC. OPEN CLINICAL TRIALS, AS OF APRIL 2014 94
TABLE 45 BAVARIAN NORDIC OPEN CLINICAL TRIALS, AS OF APRIL 2014 94
TABLE 46 BEIJING CENTER FOR DISEASE CONTROL AND PREVENTION; MUNICIPAL
SCIENCE and TECHNOLOGY COMMISSION OPEN CLINICAL TRIALS, AS OF APRIL 2014 95
TABLE 47 CITY OF HOPE MEDICAL CENTER, NATIONAL CANCER INSTITUTE (NCI)
OPEN CLINICAL TRIALS, AS OF APRIL 2014 95
TABLE 48 DYNAVAX TECHNOLOGIES CORPORATION OPEN CLINICAL TRIALS, AS OF
APRIL 2014 95
TABLE 49 GLAXOSMITHKLINE OPEN CLINICAL TRIALS, AS OF APRIL 2014 96
TABLE 50 IMPERIAL COLLEGE LONDON OPEN CLINICAL TRIALS, AS OF APRIL 2014 96
TABLE 51 MERCK SHARP and DOHME OPEN CLINICAL TRIALS, AS OF APRIL 2014 97
TABLE 52 NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)
OPEN CLINICAL TRIALS, AS OF APRIL 2014 97
TABLE 53 NATIONAL TAIWAN UNIVERSITY HOSPITAL OPEN CLINICAL TRIALS, AS OF
APRIL 2014 98
TABLE 54 SANOFI OPEN CLINICAL TRIALS, AS OF APRIL 2014 98
TABLE 55 SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER OPEN CLINICAL
TRIALS, AS OF APRIL 2014 98
TABLE 56 U.S. ARMY MEDICAL RESEARCH OPEN CLINICAL TRIALS, AS OF APRIL
2014 99
TABLE 57 UNIVERSITY OF COLORADO OPEN CLINICAL TRIALS, AS OF APRIL 2014 99
TABLE 58 UNIVERSITY OF OXFORD OPEN CLINICAL TRIALS, AS OF APRIL 2014 100
TABLE 59 UNIVERSITY OF WISCONSIN OPEN CLINICAL TRIALS, AS OF APRIL 2014 100
INDUSTRY ACQUISITIONS AND STRATEGIC ALLIANCES 100
TABLE 60 INDUSTRY ACQUISITIONS AND MERGERS, 2006-2014 100
TABLE 61 DNA VACCINE STRATEGIC ALLIANCES 102
CHAPTER 7 DNA VACCINE MARKETS 105
GROWTH DRIVING FORCES 105
TABLE 62 DNA VACCINE INDUSTRY GROWTH DRIVING FORCES 105
MARKET FORECASTS 106
OVERVIEW 106
TABLE 63 GLOBAL VALUE OF PHARMACEUTICAL MARKET BY TYPE, THROUGH 2019
($ MILLIONS) 106
DNA VACCINE MARKETS BY END USE 107
TABLE 64 GLOBAL VALUE OF DNA VACCINES BY END USE, THROUGH 2019 ($
MILLIONS) 107
DNA VACCINE RESEARCH TOOLS MARKETS 108
TABLE 65 GLOBAL VALUE OF DNA VACCINES RESEARCH TOOLS MARKET BY
APPLICATION, THROUGH 2019 ($ MILLIONS) 108
DNA VACCINE CLINICAL MARKETS 108
TABLE 66 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY APPLICATION,
THROUGH 2019 ($ MILLIONS) 109
Strategic Positioning 109
FIGURE 12 DNA VACCINE STRATEGIC MARKET GRID 109
Allergies 110
TABLE 67 DNA VACCINE ALLERGY MARKET OPPORTUNITIES 110
Cancer Therapeutics 110
TABLE 68 CAUSE OF DEATH, WORLDWIDE, 2004 AND 2030 (% OF ALL DEATHS) 111
Infectious Diseases 111
DNA CANCER VACCINES MARKET 111
TABLE 69 GLOBAL VALUE OF CANCER CLINICAL DNA VACCINES BY INDICATION,
THROUGH 2019 ($ MILLIONS) 112
TABLE 70 DNA VACCINE CANCER MARKET OPPORTUNITIES 112
Melanoma 114
Solid Tumors (Including Ovarian, Breast and Small-Cell Lung Cancer) 114
Pancreatic Cancer 114
INFECTIOUS DISEASE DNA VACCINE MARKETS 114
TABLE 71 GLOBAL VALUE OF INFECTIOUS DISEASE CLINICAL DNA VACCINES
MARKET BY INDICATION, THROUGH 2019 ($ MILLIONS) 115
CMV 115
HBV 116
HPV 116
HCV 117
HIV 117
ANIMAL HEALTH DNA VACCINE MARKETS 118
TABLE 72 GLOBAL VALUE OF ANIMAL HEALTH CLINICAL DNA VACCINES MARKET,
BY INDICATION, THROUGH 2019 ($ MILLIONS) 118
Canine Melanoma 119
Equine West Nile Virus 119
Leishmaniasis 119
Feline Leukemia Virus 120
Fish Vaccine Adjuvants 120
BIODEFENSE DNA VACCINE MARKETS 120
TABLE 73 GLOBAL VALUE OF BIODEFENSE CLINICAL DNA VACCINES MARKET, BY
END USE, THROUGH 2019 ($ MILLIONS) 121
DNA VACCINE MARKETS BY DELIVERY TECHNOLOGY 123
TABLE 74 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY DELIVERY
TECHNOLOGY, THROUGH 2019 ($ MILLIONS) 124
DNA VACCINE MARKET BY FORMAT AND FUNCTION 124
TABLE 75 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY VACCINE
FORMAT, THROUGH 2019 ($ MILLIONS) 125
TABLE 76 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY FUNCTION,
THROUGH 2019 ($ MILLIONS) 125
DNA VACCINES MARKET BY GEOGRAPHICAL REGION 125
TABLE 77 GLOBAL VALUE OF DNA VACCINES MARKET, BY GEOGRAPHICAL REGION,
THROUGH 2019 ($ MILLIONS) 126
CHAPTER 8 COMPANY PROFILES 128
ADIMMUNE 128
ADVANCED BIOSCIENCE LABORATORIES INC. 128
ALDEVRON LLC 129
ALTEA THERAPEUTICS 129
ALTHEA TECHNOLOGIES INC. 130
ANGES MG INC. 130
AVAX TECHNOLOGIES 131
BAVARIAN NORDIC A/S 131
BIGDNA, LTD. 132
BIOJECT MEDICAL TECHNOLOGIES INC. 133
BTX HARVARD APPARATUS 134
CHANGCHUN BAIKE PHARMACEUTICAL CO. LTD. 134
CHRONTECH PHARMA 134
COBRA BIOMANUFACTURING PLC 135
CRUCELL 136
CYTRX CORP. 137
DENDREON CORP. 137
DYNAVAX TECHNOLOGIES 138
EUROVACC FOUNDATION, THE 138
FIT BIOTECH OYJ PLC 139
GENEART AG 140
GENETIC IMMUNITY 141
GENEXINE 142
GENOMIDEA INC. 143
GENOVAC GMBH 144
GENVEC INC. 145
GEOVAX LABS 145
GLAXOSMITHKLINE 146
GREENPAK BIOTECH LTD. 148
HENDERSON MORLEY PLC 148
ICHOR MEDICAL SYSTEMS INC. 149
IGXBIO INC. 150
IMMUNOMIC THERAPEUTICS INC. 150
IMMUNOVACCINE INC. 151
IN CELL ART 152
INDIAN IMMUNOLOGICALS 153
INOVIO 154
INVIVOGEN 156
JUVARIS BIOTHERAPEUTICS INC. 156
LENTIGEN CORP. 157
MANNKIND CORP. 157
MERCK 158
TABLE 78 MERCK VACCINE PRODUCTS 159
MERIAL LTD. 159
MOGAM BIOTECHNOLOGY RESEARCH INSTITUTE 160
MOLOGEN AG 160
MULTIMERIC BIOTHERAPEUTICS INC. 161
NATURE TECHNOLOGY CORP. 162
NIH VACCINE RESEARCH CENTER 162
NOVARTIS 163
OXFORD BIOMEDICA PLC 164
PFIZER 164
PLASMIDFACTORY GMBH and CO. 165
PROFECTUS BIOSCIENCES INC. 166
QED BIOSCIENCE INC. 167
SANOFI-AVENTIS 168
STATENS SERUM INSTITUT 169
SUPRATEK PHARMA 170
TOLERION INC. 170
VALNEVA SE 171
VAXGEN INC. 171
VAXIION THERAPEUTICS INC. 172
VAXONCO INC. 173
VGX PHARMACEUTICALS LLC 173
VGXI INC. 174
VICAL INC. 174
VIROMED CO. LTD. 175
XENETIC BIOSCIENCE INC. 176
TABLE 79 COMPANIES WITH ACTIVE DNA VACCINE CLINICAL TRIALS 176


LIST OF TABLES

TABLE A SCOPE OF REPORT 3
SUMMARY TABLE GLOBAL VALUE OF DNA VACCINE MARKET BY APPLICATION,
THROUGH 2019 ($ MILLIONS) 7
TABLE 1 SCOPE OF THIS REPORT 11
TABLE 2 GLOBAL VALUE OF DNA VACCINE MARKET BY APPLICATION, THROUGH
2019 ($ MILLIONS) 12
TABLE 3 GLOBAL VALUE OF HUMAN DNA VACCINE MARKET BY INDICATION,
THROUGH 2019 ($ MILLIONS) 12
TABLE 4 DNA VACCINE INDUSTRY GROWTH DRIVING FORCES 13
TABLE 5 LIFE CYCLE STAGE OF VACCINE TYPES 14
TABLE 6 COMMERCIAL STATUS OF DNA VACCINES 14
TABLE 7 DNA VACCINE INDUSTRY STRUCTURE 15
TABLE 8 DNA VACCINE HISTORY 19
TABLE 9 COMPONENTS OF THE IMMUNE SYSTEM 20
TABLE 10 VACCINE TYPES 23
TABLE 11 TECHNOLOGY LIFE CYCLE STAGE OF VACCINE TYPES 24
TABLE 12 CHANGING VACCINE PARADIGM 26
TABLE 13 ADVANTAGES AND DISADVANTAGES OF DNA VACCINES 27
TABLE 14 EMERGING COMPETITIVE LANDSCAPE FOR DNA VACCINES 31
TABLE 15 CANCER VACCINE TYPES 32
TABLE 16 TECHNOLOGY DRIVERS FOR DNA VACCINE VALUE CHAIN 34
TABLE 17 PLASMID DESIGN OBJECTIVES 35
TABLE 18 WAYS TO OPTIMIZE MAMMALIAN GENE EXPRESSION IN PLASMID DNA 36
TABLE 19 DNA PLASMID QUALITY COMPARISON 38
TABLE 20 COMPARISON OF DNA DELIVERY TECHNOLOGIES 39
TABLE 21 IN VIVO VIRAL VECTOR TECHNOLOGIES COMPARED 44
TABLE 22 DNA VACCINE ADJUVANT TECHNOLOGIES 46
TABLE 23 TECHNOLOGY NEEDS FOR DNA VACCINES 48
TABLE 24 DNA VACCINE DEVELOPMENT FLOW SHEET 52
TABLE 25 DNA VACCINE PRECLINICAL DEVELOPMENT STEPS 53
TABLE 26 DNA VACCINES CLINICAL TRIALS SUMMARY BY STARTING YEAR, AS OF
APRIL 2014 55
TABLE 27 DNA VACCINE CLINICAL PHASE I TRIALS SUMMARY, AS OF APRIL 2014 56
TABLE 28 DNA VACCINE CLINICAL PHASE I/II TRIALS SUMMARY, AS OF APRIL 2014 59
TABLE 29 DNA VACCINE CLINICAL PHASE II TRIALS SUMMARY, AS OF APRIL 2014 60
TABLE 30 DNA VACCINE CLINICAL PHASE II/III TRIALS SUMMARY, AS OF APRIL 2014 61
TABLE 31 DNA VACCINE CLINICAL PHASE III TRIALS SUMMARY, AS OF APRIL 2014 62
TABLE 32 DNA VACCINE CLINICAL PHASE IV TRIALS SUMMARY, AS OF APRIL 2014 64
TABLE 33 DNA VACCINE CANCER CLINICAL TRIALS SUMMARY, AS OF APRIL 2014 65
TABLE 34 INFECTIOUS DISEASES DNA VACCINES CLINICAL TRIALS, AS OF APRIL
2014 68
TABLE 35 INFECTIOUS DISEASES DNA VACCINES CLINICAL TRIALS, AS OF APRIL
2014 78
TABLE 36 VACCINE INDUSTRY STRUCTURAL SHIFTS 82
TABLE 37 VACCINE INDUSTRY STRUCTURE: TRADITIONAL VERSUS EMERGING 83
TABLE 38 COMPARISON OF VACCINES AND PHARMACEUTICALS BUSINESSES 85
TABLE 39 DNA VACCINE INDUSTRY COMPETITOR POSITION 87
TABLE 40 LARGE PHARMA VACCINE COMPANY STRATEGIC FOCUS 89
TABLE 41 INTEGRATED BIOTECHNOLOGY COMPANY STRATEGIC FOCUS 90
TABLE 42 INTEGRATED BIOTECHNOLOGY COMPANY STRATEGIC MARKET FOCUS 91
TABLE 43 SPECIALIZED BIOTECHNOLOGY COMPANY STRATEGIC FOCUS 93
TABLE 44 ASTELLAS PHARMA INC. OPEN CLINICAL TRIALS, AS OF APRIL 2014 94
TABLE 45 BAVARIAN NORDIC OPEN CLINICAL TRIALS, AS OF APRIL 2014 94
TABLE 46 BEIJING CENTER FOR DISEASE CONTROL AND PREVENTION; MUNICIPAL
SCIENCE and TECHNOLOGY COMMISSION OPEN CLINICAL TRIALS, AS OF APRIL 2014 95
TABLE 47 CITY OF HOPE MEDICAL CENTER, NATIONAL CANCER INSTITUTE (NCI)
OPEN CLINICAL TRIALS, AS OF APRIL 2014 95
TABLE 48 DYNAVAX TECHNOLOGIES CORPORATION OPEN CLINICAL TRIALS, AS OF
APRIL 2014 95
TABLE 49 GLAXOSMITHKLINE OPEN CLINICAL TRIALS, AS OF APRIL 2014 96
TABLE 50 IMPERIAL COLLEGE LONDON OPEN CLINICAL TRIALS, AS OF APRIL 2014 96
TABLE 51 MERCK SHARP and DOHME OPEN CLINICAL TRIALS, AS OF APRIL 2014 97
TABLE 52 NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)
OPEN CLINICAL TRIALS, AS OF APRIL 2014 97
TABLE 53 NATIONAL TAIWAN UNIVERSITY HOSPITAL OPEN CLINICAL TRIALS, AS OF
APRIL 2014 98
TABLE 54 SANOFI OPEN CLINICAL TRIALS, AS OF APRIL 2014 98
TABLE 55 SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER OPEN CLINICAL TRIALS,
AS OF APRIL 2014 98
TABLE 56 U.S. ARMY MEDICAL RESEARCH OPEN CLINICAL TRIALS, AS OF APRIL 2014 99
TABLE 57 UNIVERSITY OF COLORADO OPEN CLINICAL TRIALS, AS OF APRIL 2014 99
TABLE 58 UNIVERSITY OF OXFORD OPEN CLINICAL TRIALS, AS OF APRIL 2014 100
TABLE 59 UNIVERSITY OF WISCONSIN OPEN CLINICAL TRIALS, AS OF APRIL 2014 100
TABLE 60 INDUSTRY ACQUISITIONS AND MERGERS, 2006-2014 100
TABLE 61 DNA VACCINE STRATEGIC ALLIANCES 102
TABLE 62 DNA VACCINE INDUSTRY GROWTH DRIVING FORCES 105
TABLE 63 GLOBAL VALUE OF PHARMACEUTICAL MARKET BY TYPE, THROUGH 2019
($ MILLIONS) 106
TABLE 64 GLOBAL VALUE OF DNA VACCINES BY END USE, THROUGH 2019 ($
MILLIONS) 107
TABLE 65 GLOBAL VALUE OF DNA VACCINES RESEARCH TOOLS MARKET BY
APPLICATION, THROUGH 2019 ($ MILLIONS) 108
TABLE 66 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY APPLICATION,
THROUGH 2019 ($ MILLIONS) 109
TABLE 67 DNA VACCINE ALLERGY MARKET OPPORTUNITIES 110
TABLE 68 CAUSE OF DEATH, WORLDWIDE, 2004 AND 2030 (% OF ALL DEATHS) 111
TABLE 69 GLOBAL VALUE OF CANCER CLINICAL DNA VACCINES BY INDICATION,
THROUGH 2019 ($ MILLIONS) 112
TABLE 70 DNA VACCINE CANCER MARKET OPPORTUNITIES 112
TABLE 71 GLOBAL VALUE OF INFECTIOUS DISEASE CLINICAL DNA VACCINES
MARKET BY INDICATION, THROUGH 2019 ($ MILLIONS) 115
TABLE 72 GLOBAL VALUE OF ANIMAL HEALTH CLINICAL DNA VACCINES MARKET, BY
INDICATION, THROUGH 2019 ($ MILLIONS) 118
TABLE 73 GLOBAL VALUE OF BIODEFENSE CLINICAL DNA VACCINES MARKET, BY
END USE, THROUGH 2019 ($ MILLIONS) 121
TABLE 74 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY DELIVERY
TECHNOLOGY, THROUGH 2019 ($ MILLIONS) 124
TABLE 75 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY VACCINE
FORMAT, THROUGH 2019 ($ MILLIONS) 125
TABLE 76 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY FUNCTION,
THROUGH 2019 ($ MILLIONS) 125
TABLE 77 GLOBAL VALUE OF DNA VACCINES MARKET, BY GEOGRAPHICAL REGION,
THROUGH 2019 ($ MILLIONS) 126
TABLE 78 MERCK VACCINE PRODUCTS 159
TABLE 79 COMPANIES WITH ACTIVE DNA VACCINE CLINICAL TRIALS 176

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