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Therapeutic Vaccines: The Global Market
Published on March 2010
Report Summary
THIS REPORT:
Examine a period of dynamic growth in the therapeutic vaccines market with the expected rollout of some 20 products by 2010
Provide data on the global market for 2008, estimates for 2009, and forecasts, with compound annual growth rates (CAGRs), through
2014
Focus on companies poised to introduce products during the forecast period and how these introductions will play out in terms of the
competitive environment
Explain how various approaches are being used to develop vaccines that boost the immune response to cancerous cells, and how
they will add a powerful new component to standard cancer treatments.
Table of Content
Chapter- 1: INTRODUCTION
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THIS STUDY 1
INTENDED AUDIENCE 1
SCOPE OF REPORT 2
METHODOLOGY 2
INFORMATION SOURCES 3
AUTHOR'S CREDENTIALS 3
RELATED BCC REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 4
Chapter-2: SUMMARY
SUMMARY 5
SUMMARY TABLE THE WORLDWIDE MARKET FOR THERAPEUTIC VACCINES BY INDICATION, THROUGH 2014 ($
MILLIONS) 6
SUMMARY FIGURE THE WORLDWIDE MARKET FOR THERAPEUTIC VACCINES BY INDICATION, 2010-2014 6
Chapter-3: OVERVIEW
DEFINITION OF A THERAPEUTIC VACCINE 7
IMMUNE SYSTEM OVERVIEW: CAST OF CHARACTERS 7
B-CELLS, T-CELLS AND ANTIGEN-PRESENTING CELLS 7
B-Cells 8
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T-Cells 8
Antigen-Presenting Cells 8
CELLULAR VERSUS HUMORAL IMMUNITY 8
INNOVATIVE APPROACHES TO VACCINE TECHNOLOGY 9
DNA VACCINES 9
CARBOHYDRATE VACCINES 9
THE ROLE OF ADJUVANTS 10
ATTRACTIVE FEATURES OF THERAPEUTIC VACCINES VERSUS OTHER CLASSES OF THERAPIES 11
TABLE 1 FEATURES OF THERAPEUTIC VACCINES VERSUS OTHER DRUG CLASSES 11
THERAPEUTIC VACCINES APPROVED FOR CLINICAL USE OR IN CLINICAL TRIALS 11
TABLE 2 THERAPEUTIC VACCINES IN CLINICAL TRIALS, ORDERED BY PHASE 11
TABLE 2 (CONTINUED) 12
TABLE 2 (CONTINUED) 13
TABLE 2 (CONTINUED) 14
TABLE 2 (CONTINUED) 15
TABLE 3 NUMBER OF THERAPEUTIC VACCINES IN CLINICAL TRIALS, BY PHASE 15
FIGURE 1 VACCINES IN CLINICAL TRIALS BY INDICATION, 2010 (%) 16
TABLE 4 VACCINES IN CLINICAL TRIALS BY TECHNOLOGY 16
TABLE 5 COMPANIES WITH THERAPEUTIC VACCINES IN CLINICAL TRIALS 17
Chapter-4: TECHNOLOGY OVERVIEW
TYPES OF THERAPEUTIC VACCINES 18
TABLE 6 COMPARISON OF AUTOLOGOUS VERSUS ALLOGENEIC VACCINES 18
TABLE 7 NUMBER OF ALLOGENEIC AND AUTOLOGOUS THERAPEUTIC VACCINES IN DEVELOPMENT BY PHASE 19
Chapter-5: PATENT EVALUATION
PATENT LENGTHS AND MARKET EXCLUSIVITY 20
TABLE 8 PATENT EXPIRATION DATES FOR THERAPEUTIC VACCINES IN LATE STAGES OF DEVELOPMENT 21
Chapter-6: PRODUCTS
ADDICTION VACCINES 22
TABLE 9 ADDICTION VACCINES IN DEVELOPMENT BY PHASE 23
TABLE 10 THE WORLDWIDE MARKET FOR ADDICTION VACCINES, THROUGH 2014 ($ MILLIONS) 23
COCAINE ADDICTION VACCINES 24
The Market for Cocaine Addiction Vaccines 24
TA-CD 25
NICOTINE ADDICTION VACCINES 26
The Market for Nicotine Addiction Vaccines 27
NicVAX 28
TABLE 11 NICOTINE ABSTINENCE RATE AT 12 MONTHS IN DIFFERENT STUDIES (%) 29
NIC002 29
TA-NIC 30
AUTOIMMUNE DISEASE VACCINES 31
TABLE 12 AUTOIMMUNE DISEASE VACCINES IN DEVELOPMENT BY PHASE 31
DIABETES (TYPE 1) 31
Diamyd (rhGAD65) 32
Diamyd (rhGAD65) (Continued) 33
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BHT-3021 34
Tovaxin 35
TNFaKinoid 35
CANCER VACCINES 36
CANCER STATISTICS 37
U.S. Cancer Statistics 37
TABLE 13 INCIDENCE, MORTALITY, AND SURVIVAL RATES FOR COMMON CANCERS IN THE U.S., 2009 38
TABLE 14 CANCER PREVALENCE RATES IN THE U.S., 2006 (THOUSANDS) 39
Current Treatment Methods 39
Surgery 39
Radiation Therapy 40
Pharmaceutical Therapy 40
CANCER VACCINES: A NEW MODALITY OF CARE 41
The Primary Therapeutic Role for Cancer Vaccines 42
The Immune System and Cancer 43
Antigens: Their Role in Cancer Vaccines 43
Antigens Used in Cancer Vaccine Development 44
Carcinoembryonic Antigen 44
Ganglioside Molecules 44
Heat Shock Proteins 45
MART-1 45
Prostate-Specific Antigen 45
Sialyl Tn 46
Tyrosinase 46
MAGE 46
NY-ESO-1 46
MUC1 46
Vaccine Development: Strategies 47
Vaccine Development: '(Continued) 48
A Summary of Two Approaches: Low-technology vs. High-technology 49
Vaccine Types 49
Antigen/Adjuvant Vaccines 49
Dendritic Cell Vaccines (DCs) 49
DNA and Viral Vector Vaccines 49
Idiotype Vaccines 50
Oncolytic Virus Vaccines 50
Whole Cell Tumor Vaccines 50
TABLE 15 TYPES OF VACCINES IN DEVELOPMENT FOR CANCER TREATMENT 51
The Long Road to Market 51
The Market for Cancer Vaccines 52
TABLE 16 ESTIMATED INITIAL U.S. MARKET OPPORTUNITY FOR CANCER VACCINES BY INDICATION 52
TABLE 17 WORLDWIDE MARKET FOR HUMAN CANCER VACCINES BY TYPE, THROUGH 2014 ($ MILLIONS) 53
TABLE 18 THE MARKET FOR HUMAN CANCER VACCINES, BY TECHNOLOGY (AUTOLOGOUS VERSUS ALLOGENEIC),
WORLDWIDE, THROUGH 2014 ($ MILLIONS) 53
FIGURE 2 NUMBER OF AUTOLOGOUS VERSUS ALLOGENEIC CANCER VACCINES IN DEVELOPMENT, 2010 (%) 54
TABLE 19 THE WORLDWIDE MARKET FOR HUMAN CANCER VACCINES, BY INDICATION, THROUGH 2014 ($ MILLIONS) 54
CANCER VACCINES IN DEVELOPMENT 55
TABLE 20 CANCER VACCINES IN PHASE II OR LATER TRIALS BY PHASE 55
TABLE 20 (CONTINUED) 56
CANCER VACCINES APPROVED FOR USE ON THE WORLDWIDE MARKET 57
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CV9103 93
AE37 94
NeuVax (E75) 95
ProstVac 95
INFECTIOUS DISEASE VACCINES 96
TABLE 24 INFECTIOUS DISEASE VACCINES IN DEVELOPMENT BY PHASE 96
HIV/AIDS 97
THE HIV INFECTION PROCESS 97
HIV TRANSMISSION 98
CONFUSION REGARDING THE PROPHYLACTIC VERSUS THERAPEUTIC ACTIVITY OF AIDS VACCINES 98
BARRIERS TO DEVELOPING AND TESTING AIDS VACCINES 99
Barriers to Developing '(Continued) 100
WHAT HAS BEEN LEARNED 101
THE MARKET FOR AIDS VACCINES 102
HIV THERAPEUTIC VACCINES IN DEVELOPMENT 102
Results of Early Trials of HIV/AIDS Vaccines 103
AIDSVAX, the Most Advanced HIV Vaccine Candidate but with Mixed Results 104
The Failure of Merck's V520 Prophylactic and Therapeutic Vaccine 105
The Remune (AG1661, HIV-1 Immunogen) Saga 105
The Remune ' (Continued) 106
ALVAC-HIV (vCP1521), AIDSVAX Combination 107
HIV Vaccine 732461 108
Prophylactic and/or Therapeutic HIV Vaccine 108
Vacc-4x 108
DermaVir (LC002) 109
AGS-004 109
OTHER INFECTIOUS DISEASE VACCINES (OUTSIDE HIV) 110
HEPATITIS C 110
GI-5005 111
TG4040 (MVA-HCV) 111
IC41 112
NEUROLOGICAL DISEASE VACCINES 112
TABLE 25 NEUROLOGICAL DISEASE VACCINES IN DEVELOPMENT 112
THE MARKET FOR NEUROLOGICAL DISEASE VACCINES 113
Alzheimer's Disease Vaccine (AN-1792) (Discontinued) 113
ACC-001 114
CAD106 114
PARKINSON'S DISEASE VACCINE 115
OTHER DISEASE VACCINES 115
TABLE 26 OTHER DISEASE VACCINES IN DEVELOPMENT 115
CYT006-AngQb 115
Angiotensin Therapeutic Vaccine 116
Angiotensin ' (Continued) 117
Chapter-7: MAJOR COMPANIES AND MARKET SHARE
MARKET SHARE 118
TABLE 27 FORECASTED SALES AND MARKET SHARE OF COMPANIES INVOLVED IN THERAPEUTIC VACCINES, 2014 ($
MILLIONS/%) 118
COMPANY PROFILES 119
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AFFIRIS 119
ANTIGENICS 120
ARGOS THERAPEUTICS 121
BAVARIAN NORDIC 121
BIOVEST INTERNATIONAL 122
CELLDEX THERAPEUTICS 123
CEL-SCI 123
CELTIC PHARMA 124
CUREVAC 124
CYTOS BIOTECHNOLOGY 125
DENDREON 126
DIAMYD MEDICAL 127
ELAN 127
GENEXINE 128
GERON 128
GLAXOSMITHKLINE 129
GLAXOSMITHKLINE ' U.S. 129
GLOBEIMMUNE 130
KAEL 131
MERCK KGAA (MERCK SERONO) 131
NABI BIOPHARMACEUTICALS 132
NEWLINK GENETICS 132
NOVARTIS 133
NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH 133
NOVARX 133
ONCOTHYREON 134
OXFORD BIOMEDICA 134
PFIZER 135
TRANSGENE 136
VACCINOGEN 137
VACCINOGEN ' U.S. 137
VICAL 137
Vical (Continued) 138
Chapter-8: INTERNATIONAL ASPECTS AND REGULATORY ISSUES
MARKET BY REGION 139
TABLE 28 GLOBAL FORECAST FOR THERAPEUTIC VACCINES MARKET BY REGION, THROUGH 2014 ($ MILLIONS) 139
MARKET BY REGION (CONTINUED) 140
UNITED STATES 141
The FDA Modernization Act of 1997 141
Fast-track Status 141
Special Protocol Assessments 142
New Surveillance and Safety Requirements 142
Approvable Letters No More 143
Medicare 143
Other Healthcare Changes 144
EUROPEAN UNION 144
New Drug Approvals and Innovation 144
New Drug ' (Continued) 145
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Drug Reimbursement and Reference Pricing 146
Relocation of R&D 147
Regulatory Climate 147
JAPAN 148
New Drug Approvals 148
Regulatory Climate 148
Relationship between Academia and Industry 149
Chapter-9: FUTURE DIRECTIONS
THERAPEUTIC VACCINES AS FIRST-LINE THERAPIES 150
THE ROLE OF BIOMARKERS 151
VACCINES AND CLINICAL TRIAL DESIGN 151
COMBINATION THERAPIES 152
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