Chapter- 1: INTRODUCTION
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
INTENDED AUDIENCE 2
SCOPE OF REPORT 2
METHODOLOGY 3
INFORMATION SOURCES 3
RELATED BCC REPORTS 3
ANALYST CREDENTIALS 4
BCC ONLINE SERVICES 4
DISCLAIMER 4
Chapter-2: SUMMARY
SUMMARY 5
SUMMARY TABLE GLOBAL VALUE OF DNA VACCINE MARKET BY APPLICATION, THROUGH 2014 ($ MILLIONS) 6
SUMMARY FIGURE GLOBAL VALUE OF DNA VACCINE MARKET BY APPLICATION, THROUGH 2014 ($ MILLIONS) 6
SUMMARY (CONTINUED) 7
Chapter-3: OVERVIEW
INTRODUCTION 8
TABLE 1 CLINICAL STATUS OF DNA VACCINES, AS OF JULY 2009 (NUMBER) 8
DNA VACCINE TECHNOLOGIES COVERED IN THIS REPORT 9
TABLE 2 SCOPE OF THIS REPORT 9
GLOBAL MARKET FOR DNA VACCINES 9
TABLE 3 GLOBAL VALUE OF DNA VACCINE MARKET BY APPLICATION, THROUGH 2014 ($ MILLIONS) 10
TABLE 4 GLOBAL VALUE OF HUMAN DNA VACCINE MARKET BY INDICATION, THROUGH 2014 ($ MILLIONS) 10
FORCES DRIVING DNA VACCINE MARKET GROWTH 11
TABLE 5 DNA VACCINE INDUSTRY GROWTH DRIVING FORCES 11
LIFE CYCLE STATUS OF DNA VACCINE TECHNOLOGIES 12
TABLE 6 LIFE CYCLE STAGE OF VACCINE TYPES 12
COMMERCIAL STATUS OF DNA VACCINE TECHNOLOGIES 12
TABLE 7 COMMERCIAL STATUS OF DNA VACCINES 13
DNA VACCINE INDUSTRY 13
TABLE 8 DNA VACCINE INDUSTRY STRUCTURE 14
Chapter-4: DNA VACCINE TECHNOLOGIES
HISTORY 15
TABLE 9 DNA VACCINE HISTORY 15
THE HUMAN IMMUNE SYSTEM 16
TABLE 10 COMPONENTS OF THE IMMUNE SYSTEM 17
THE HUMAN IMMUNE SYSTEM (CONTINUED) 18
VACCINES 19
VACCINE EVOLUTION 19
FIGURE 1 EVOLUTION OF VACCINE TECHNOLOGIES 19
VACCINE TYPES 20
TABLE 11 VACCINE TYPES 20
Technology Life-Cycle Stage of Vaccine Types 21
TABLE 12 TECHNOLOGY LIFE-CYCLE STAGE OF VACCINE TYPES 21
DNA VACCINES 22
INTRODUCTION 22
FIGURE 2 MECHANISM OF ACTION OF A DNA VACCINE 23
CHANGING VACCINE PARADIGM 23
TABLE 13 CHANGING VACCINE PARADIGM 24
TABLE 14 ADVANTAGES AND DISADVANTAGES OF DNA VACCINES 25
Changing Vaccine Paradigm (Continued) 26
FIGURE 3 SAFETY AND EFFICACY PROFILE OF DNA VERSUS VIRAL-VECTOR VACCINES 27
FUNCTION AND SCOPE OF DNA VACCINES 28
FIGURE 4 DNA VACCINE FUNCTION AND MARKET SCOPE 28
TABLE 15 EMERGING COMPETITIVE LANDSCAPE FOR DNA VACCINES 29
CANCER DNA VACCINES 30
TABLE 16 CANCER VACCINE TYPES 30
DNA VACCINE TECHNOLOGY VALUE CHAIN 31
FIGURE 5 DNA VACCINE TECHNOLOGY VALUE CHAIN 32
TABLE 17 TECHNOLOGY DRIVERS FOR DNA VACCINE VALUE CHAIN 33
ANTIGEN DISCOVERY 34
PLASMID DESIGN 34
TABLE 18 PLASMID DESIGN OBJECTIVES 34
TABLE 19 WAYS TO OPTIMIZE MAMMALIAN GENE EXPRESSION IN PLASMID DNA 35
Plasmid Design (Continued) 36
PLASMID MANUFACTURE 37
FIGURE 6 CONVENTIONAL AND PLASMID DNA VACCINE PRODUCTION PROCESS 38
TABLE 20 DNA PLASMID QUALITY COMPARSION 38
DELIVERY TECHNOLOGIES 39
TABLE 21 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 44
TABLE 22 IN VIVO VIRAL VECTOR TECHNOLOGIES COMPARED 44
Viruses (Continued) 45
TARGETING TECHNOLOGIES 46
FIGURE 8 STRATEGIES FOR TARGETING DENDRITIC CELLS 47
ADJUVANT TECHNOLOGIES 47
TABLE 23 DNA VACCINE ADJUVANT TECHNOLOGIES 48
DNA VACCINE TECHNOLOGY NEEDS 48
TABLE 24 TECHNOLOGY NEEDS FOR DNA VACCINES 49
DNA Vaccine Technology ... (Continued) 50
Chapter-5: DNA VACCINE APPLICATIONS
RESEARCH TOOLS APPLICATIONS 51
CLINICAL APPLICATIONS 51
OVERVIEW TO DNA VACCINE CLINICAL TRIALS PROCESS 51
TABLE 25 DNA VACCINE DEVELOPMENT FLOWSHEET 52
TABLE 26 DNA VACCINE PRECLINICAL DEVELOPMENT STEPS 53
FIGURE 9 FUTURE VACCINE CLINICAL TRIALS OVERVIEW 54
Overview to DNA ... (Continued) 55
DNA VACCINE CLINICAL TRIALS SUMMARY 56
TABLE 27 DNA VACCINES CLINICAL TRIALS SUMMARY BY DISEASE TYPE, AS OF JULY 2009 56
TABLE 28 DNA VACCINES CLINICAL TRIALS SUMMARY BY DELIVERY TECHNOLOGY, AS OF JULY 2009 57
TABLE 29 DNA VACCINES CLINICAL TRIALS SUMMARY BY VACCINE TYPE, AS OF JULY 2009 58
TABLE 30 DNA VACCINES CLINICAL TRIALS SUMMARY BY VACCINE TYPE AND INDICATION, AS OF JULY 2009 58
CANCER DNA VACCINE CLINICAL TRIALS 59
TABLE 31 CANCER DNA VACCINES CLINICAL TRIALS, AS OF 2009 60
TABLE 31 (CONTINUED) 61
TABLE 31 (CONTINUED) 62
Melanoma 62
Melanoma (Continued) 63
Prostate Cancer 64
Breast Cancer 65
Multiple Cancers 65
INFECTIOUS DISEASE DNA VACCINES 66
TABLE 32 INFECTIOUS DISEASES DNA VACCINES CLINICAL TRIALS, AS OF JULY 2009 66
TABLE 32 (CONTINUED) 67
HSV 67
HPV 68
Influenza 68
Influenza (Continued) 69
Influenza (Continued) 70
SARS 71
Dengue 71
TABLE 33 DENGUE VACCINE LANDSCAPE, AS OF JULY 2009 71
HBV 72
TABLE 34 HBV THERAPEUTIC LANDSCAPE, AS OF JULY 2009 72
HBV (Continued) 73
HCV 74
Japanese Encephalitis 74
TABLE 35 JAPANESE ENCEPHALITIS VACCINE LANDSCAPE, AS OF JULY 2009 74
CMV 75
TABLE 36 CMV VACCINE LANDSCAPE, AS OF JULY 2009 76
HIV 76
TABLE 37 HIV DNA VACCINES CLINICAL TRIALS, AS OF JULY 2009 77
TABLE 37 (CONTINUED) 78
TABLE 37 (CONTINUED) 79
TABLE 37 (CONTINUED) 80
HIV (Continued) 81
BIODEFENSE DNA VACCINES 82
TABLE 38 BIODEFENSE DNA VACCINES CLINICAL TRIALS, AS OF JULY 2009 82
ANIMAL HEALTH DNA VACCINES 82
TABLE 39 ANIMAL HEALTH DNA VACCINES CLINCAL PIPELINE, AS OF JULY 2009 83
TABLE 40 WEST NILE VIRUS HUMAN VACCINES LANDSCAPE, AS OF JULY 2009 84
Chapter-6: DNA VACCINE INDUSTRY
VACCINE INDUSTRY STRUCTURAL SHIFTS 85
TABLE 41 VACCINE INDUSTRY STRUCTURAL SHIFTS 85
INDUSTRY STRUCTURE 86
TABLE 42 VACCINE INDUSTRY STRUCTURE: TRADITIONAL VERSUS EMERGING 87
FIGURE 10 MARKETING OF APPROVED VACCINES IN THE UNITED STATES, 2009 (%) 88
TABLE 43 COMPARISON OF VACCINES AND PHARMACEUTICALS BUSINESSES 89
INDUSTRY STRUCTURE (CONTINUED) 90
DNA VACCINE INDUSTRY COMPETITORS 91
TABLE 44 DNA VACCINE INDUSTRY COMPETITOR POSITION 91
DNA VACCINE COMMERCIAL VALUE CHAIN 92
FIGURE 11 DNA VACCINE COMMERCIAL VALUE CHAIN 93
DNA VACCINE COMPETITOR STRATEGIC POSITIONING 93
TABLE 45 LARGE PHARMA VACCINE COMPANY STRATEGIC FOCUS 94
TABLE 46 INTEGRATED BIOTECHNOLOGY COMPANY STRATEGIC FOCUS 95
TABLE 47 INTEGRATED BIOTECHNOLOGY COMPANY STRATEGIC MARKET FOCUS 96
TABLE 47 (CONTINUED) 97
TABLE 48 SPECIALIZED BIOTECHNOLOGY COMPANY STRATEGIC FOCUS 98
INDUSTRY ACQUISITIONS AND STRATEGIC ALLIANCES 99
TABLE 49 INDUSTRY ACQUISITIONS AND MERGERS, 2006-2009 99
INDUSTRY ACQUISITIONS AND ... (CONTINUED) 100
TABLE 50 DNA VACCINE STRATEGIC ALLIANCES 101
INDUSTRY ACQUISITIONS AND ... (CONTINUED) 102
Chapter-7: DNA VACCINE MARKETS
GROWTH DRIVING FORCES 103
TABLE 51 DNA VACCINE INDUSTRY GROWTH DRIVING FORCES 103
MARKET FORECASTS 104
OVERVIEW 104
TABLE 52 GLOBAL VALUE OF PHARMACEUTICAL MARKET BY TYPE, THROUGH 2014 ($ MILLIONS) 104
Overview (Continued) 105
DNA VACCINE MARKETS BY END USE 106
TABLE 53 GLOBAL VALUE OF DNA VACCINES BY END USE, THROUGH 2014 ($ MILLIONS) 106
DNA VACCINE RESEARCH TOOLS MARKETS 106
TABLE 54 GLOBAL VALUE OF DNA VACCINES RESEARCH TOOLS MARKET BY APPLICATION, THROUGH 2014 ($ MILLIONS) 107
DNA VACCINE CLINICAL MARKETS 107
TABLE 55 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY APPLICATION, THROUGH 2014 ($ MILLIONS) 108
Strategic Positioning 108
FIGURE 12 DNA VACCINE STRATEGIC MARKET GRID 109
Allergies 109
TABLE 56 DNA VACCINE ALLERGY MARKET OPPORTUNITIES 110
Cancer Therapeutics 110
TABLE 57 CAUSE OF DEATH, WORLDWIDE, 2004 AND 2030 (% OF ALL DEATHS) 111
Infectious Diseases 111
DNA CANCER VACCINES MARKET 111
TABLE 58 GLOBAL VALUE OF CANCER CLINICAL DNA VACCINES BY INDICATION, THROUGH 2014 ($ MILLIONS) 112
TABLE 59 DNA VACCINE CANCER MARKET OPPORTUNITIES 112
DNA Cancer Vaccines Market (Continued) 113
Melanoma 114
Solid Tumors (Including Ovarian, Breast and Small-Cell Lung Cancer) 114
Pancreatic Cancer 114
INFECTIOUS DISEASE DNA VACCINE MARKETS 114
TABLE 60 GLOBAL VALUE OF INFECTIOUS DISEASE CLINICAL DNA VACCINES MARKET BY INDICATION, THROUGH 2014 ($ MILLIONS) 115
CMV 115
HBV 116
HPV 116
HCV 117
HIV 118
ANIMAL HEALTH DNA VACCINE MARKETS 119
TABLE 61 GLOBAL VALUE OF ANIMAL HEALTH CLINICAL DNA VACCINES MARKET, BY INDICATION, THROUGH 2014 ($ MILLIONS) 119
Canine Melanoma 120
Equine West Nile Virus 120
Leishmaniasis 120
Feline Leukemia Virus 121
Fish Vaccine Adjuvants 121
BIODEFENSE DNA VACCINE MARKETS 122
TABLE 62 GLOBAL VALUE OF BIODEFENSE CLINICAL DNA VACCINES MARKET, BY END USE, THROUGH 2014 ($ MILLIONS) 122
Biodefense DNA Vaccine Markets (Continued) 123
Biodefense DNA Vaccine Markets (Continued) 124
DNA VACCINE MARKETS BY DELIVERY TECHNOLOGY 125
TABLE 63 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY DELIVERY TECHNOLOGY, THROUGH 2014 ($ MILLIONS) 126
DNA VACCINE MARKET BY FORMAT AND FUNCTION 126
TABLE 64 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY VACCINE FORMAT, THROUGH 2014 ($ MILLIONS) 127
TABLE 65 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY FUNCTION, THROUGH 2014 ($ MILLIONS) 127
DNA VACCINES MARKET BY GEOGRAPHY 128
TABLE 66 GLOBAL VALUE OF DNA VACCINES MARKET, BY GEOGRAPHICAL REGION, THROUGH 2014 ($ MILLIONS) 129
Chapter-8: PATENT STATUS
INTRODUCTION 130
FIGURE 13 PATENT SCOPE FOR DNA VACCINES 130
DNA VACCINE PATENTS BY COMPANY AND TECHNOLOGY SUBCLASS 130
FIGURE 14 U.S., EP, AND WO INTEGRATED BIOTECHNOLOGY COMPANY DNA VACCINE-RELATED PATENTS AND PATENT APPLICATIONS, AS OF JULY 2009 131
FIGURE 15 U.S., EP, AND WO INTEGRATED BIOTECHNOLOGY COMPANY DNA VACCINE-RELATED PATENTS BY TECHNOLOGY SUBCLASS AND PATENT APPLICATIONS, AS OF JULY 2009 132
DNA VACCINE PATENTS BY COMPANY ... (CONTINUED) 133
FIGURE 16 U.S., EP, AND WO INTEGRATED BIOTECHNOLOGY COMPANY DNA VACCINE-RELATED PATENTS BY TECHNOLOGY SUBCLASS, AS OF JULY 2009 134
ANTIGENS AND ASSOCIATED PDNA 134
ANTIGENS AND ASSOCIATED PDNA (CONTINUED) 135
TABLE 67 FUNDAMENTAL DNA INFLUENZA VACCINE PATENTS 136
DNA VACCINE PATENTS BY GEOGRAPHY 136
FIGURE 17 GEOGRAPHICAL REGIONS IN WHICH PATENTS HAVE BEEN GRANTED AND PATENT APPLICATIONS FILEDFOR INTEGRATED BIOTECHNOLOGY COMPANIES, AS OF JULY 2009 (%) 137
KEY INDUSTRY PATENTS ON OTHER PARTS OF THE VALUE CHAIN 137
TABLE 68 FUNDAMENTAL PATENTS ON DNA VACCINE DELIVERY, TARGETING, AND ADJUVANTS 138
LITIGATION STATUS 138
TABLE 69 IP LITIGATION STATUS 139
IP POSITION OF SELECTED DNA VACCINE COMPANIES 139
GENEART 139
GENEXINE 140
TABLE 70 GENEXINE PATENT FAMILIES 140
IMMUNOMIC THERAPEUTICS, INC. (ITI) 141
VICAL 142
Chapter-9: COMPANY PROFILES
ADIMMUNE 143
ALDEVRON, LLC 144
ALTEA THERAPEUTICS 144
ALTHEA TECHNOLOGIES, INC. 145
ANGES MG, INC. 145
AVAX TECHNOLOGIES 146
BACILLIGEN, INC. 146
BAVARIAN NORDIC A/S 147
BAYHILL THERAPEUTICS 148
TABLE 71 BAYHILL DNA VACCINE PIPELINE 148
BIGDNA, LTD. 149
BIOJECT MEDICAL TECHNOLOGIES, INC. 150
CHANGCHUN BAIKE PHARMACEUTICAL CO., LTD. 150
COBRA BIOMANUFACTURING, PLC 151
CRUCELL 152
CYTOGENIX, INC. 152
TABLE 72 CYTOGENIX DNA VACCINE PRECLINICAL PIPELINE 153
CYTO PULSE SCIENCES, INC. 154
TABLE 73 CYTO PULSE PIPELINE 154
PROSTATE CANCER STUDY 154
COLORECTAL CANCER STUDY 155
TOLERANCE STUDIES 155
HIV STUDY 155
CYTRX CORP. 155
DENDREON CORP. 156
DYNAVAX TECHNOLOGIES 156
THE EUROVACC FOUNDATION 157
FIT BIOTECH OYJ, PLC 158
GENEART AG 159
TABLE 74 GENEART STRATEGIC ALLIANCES 160
GENEART AG (CONTINUED) 161
GENETIC IMMUNITY 162
TABLE 75 GENETIC IMMUNITY DNA VACCINE PIPELINE 162
GENEXINE 163
TABLE 76 GENEXINE DNA VACCINE PIPELINE 164
TABLE 77 GENEXINE PATENT FAMILIES 165
TABLE 77 (CONTINUED) 166
IL-12 MUTANT 166
EFFICIENT DNA AND RAD VECTORS 166
SAFE ADENOVIRAL VECTOR 166
GENOMIDEA, INC. 167
GENOVAC GMBH 167
GENOVAC GMBH (CONTINUED) 168
GENVEC, INC. 169
GEOVAX LABS 169
GLAXOSMITHKLINE 170
GLAXOSMITHKLINE (CONTINUED) 171
GREENPAK BIOTECH, LTD. 172
HENDERSON MORLEY, PLC 172
ICHOR MEDICAL SYSTEMS, INC. 173
TABLE 78 ICHOR DNA VACCINE PIPELINE 174
IMMUNOGENETIX THERAPEUTICS, INC. 175
IMMUNOMIC THERAPEUTICS, INC. 176
TABLE 79 IMMUNOMIC DNA VACCINE PIPELINE 176
JRC-LAMP-VAX 177
SRW-LAMP-VAX 178
TABLE 80 ITI STRATEGIC ALLIANCES 178
IMMUNOVACCINE TECHNOLOGIES, INC. 179
IN CELL ART 180
INDIAN IMMUNOLOGICALS 181
INTERCELL AG 182
INVIVOGEN 182
JUVARIS BIOTHERAPEUTICS, INC. 183
TABLE 81 JUVARIS DNA VACCINE PIPELINE 184
LENTIGEN CORP. 184
LIPOXEN, PLC 184
MANNKIND CORP. 185
MANNKIND CORP. (CONTINUED) 186
MEDICAL MARKETING INTERNATIONAL GROUP, PLC 187
TABLE 82 GENVAX PIPELINE 188
MERCK 189
TABLE 83 MERCK DNA VACCINE PIPELINE 189
MERIAL 190
MOGAM BIOTECHNOLOGY RESEARCH INSTITUTE 191
MOLOGEN AG 191
MULTIMERIC BIOTHERAPEUTICS, INC. 192
NATURE TECHNOLOGY CORP. 193
NIH VACCINE RESEARCH CENTER 193
NOVARTIS 193
OXFORD BIOMEDICA, PLC 194
PFIZER 195
PHYTOVATION BV 195
PLASMIDFACTORY GMBH & CO. 196
PROFECTUS BIOSCIENCES, INC. 197
QED BIOSCIENCE, INC. 198
SANOFI-AVENTIS 198
STATENS SERUM INSTITUT 199
SUPRATEK PHARMA 199
TRIPEP 200
TABLE 84 TRIPEP THERAPEUTIC DNA VACCINE PIPELINE 200
VAXGEN, INC. 201
VAXXION THERAPEUTICS, INC. 202
VAXONCO, INC. 202
VECTURA GROUP, PLC 203
VGX PHARMACEUTICALS, INC. 203
VGX PHARMACEUTICALS, INC. (CONTINUED) 204
TABLE 85 INOVIO AND VGX DNA VACCINE CLINICAL TRIALS, AS OF JULY 2009 205
VGX PHARMACEUTICALS, INC. (CONTINUED) 206
VGXI, INC. 207
VICAL, INC. 207
TABLE 86 VICAL STRATEGIC ALLIANCES 208
TABLE 87 VICAL DNA VACCINE PIPELINE 209
TABLE 87 (CONTINUED) 210
FIGURE 18 VICAL LINEAR DNA VACCINE STRATEGIC POSITIONING 211
VIROMED CO., LTD. 212
VIROMED CO., LTD. (CONTINUED) 213
