Cancer Vaccines Markets
Cancer vaccines have the potential to become a significant force in future cancer treatments. In 2010, Dendreon’s Provenge became the first cancer vaccine approved by the FDA, generating renewed interest and support for this type of cancer immune therapy. Cancer vaccines can be divided into six main categories: antigen/adjuvant vaccines, DNA vaccines, vector-based vaccines, tumor cell vaccines, dendritic cell vaccines and anti-idiotype vaccines. This relatively new commercial market for cancer vaccines is poised to dramatically increase to over $7 billion by 2015.
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The purpose of this TriMark Publications report is to supply comprehensive information on the developing market for cancer vaccines. This study surveys almost all of the companies known to be marketing, manufacturing, or developing cancer vaccines in the world, providing in-depth analysis of the current and emerging technologies in the cancer vaccines market. Each company is extensively examined, with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company’s market position. Moreover, this report provides detailed discussions of cancer vaccines funding trends, intellectual property, market opportunities, research collaborations, partnership activities, regulatory issues and guidelines for establishing new ventures. Detailed tables and charts with sales forecasts and market share data are also included.
TABLE OF CONTENTS
1. Overview 5
1.1 About this Report 5
1.2 Scope of the Report 6
1.3 Objectives 6
1.4 Methodology 6
1.5 Executive Summary 7
1.1 About this Report 5
1.2 Scope of the Report 6
1.3 Objectives 6
1.4 Methodology 6
1.5 Executive Summary 7
2. Overview of Cancer 9
2.1 Cancer Statistics 9
2.2 The Cost of Cancer 13
2.3 Cancers Being Targeted by Vaccine Therapies: Overview of Disease and Market
16
2.1 Cancer Statistics 9
2.2 The Cost of Cancer 13
2.3 Cancers Being Targeted by Vaccine Therapies: Overview of Disease and Market
16
3. Introduction to Cancer Vaccines 24
3.1 Overview of the Types of Cancer Vaccines 24
3.2 Antigen/Adjuvant Vaccines 27
3.3 DNA Vaccines 33
3.4 Vector-based Vaccines 35
3.5 Tumor Cell Vaccines 35
3.6 Dendritic Cell (DC) Vaccines 37
3.7 Anti-Idiotype Vaccines 38
3.1 Overview of the Types of Cancer Vaccines 24
3.2 Antigen/Adjuvant Vaccines 27
3.3 DNA Vaccines 33
3.4 Vector-based Vaccines 35
3.5 Tumor Cell Vaccines 35
3.6 Dendritic Cell (DC) Vaccines 37
3.7 Anti-Idiotype Vaccines 38
4. Prophylactic Vaccines on the Market and in Development 40
4.1 Cervical Cancer (HPV) 40
4.2 Prophylactic Breast Cancer Vaccine in Development 42
4.1 Cervical Cancer (HPV) 40
4.2 Prophylactic Breast Cancer Vaccine in Development 42
5. Therapeutic Vaccines on the Market and in Development 43
5.1 Breakthroughs in the Cancer Vaccine Market: Vaccines on the Market 43
5.2 Vaccines in Development (by Type of Vaccine) 45
5.1 Breakthroughs in the Cancer Vaccine Market: Vaccines on the Market 43
5.2 Vaccines in Development (by Type of Vaccine) 45
6. Challenges and Issues in Cancer Vaccine Development 74
6.1 Eliciting Appropriate Immune Response Against Cancer 74
6.2 Clinical Trial Design 78
6.3 Combination Therapies 82
6.1 Eliciting Appropriate Immune Response Against Cancer 74
6.2 Clinical Trial Design 78
6.3 Combination Therapies 82
7. Regulatory Issues 84
7.1 Pharmaceutical Product Regulation 84
7.2 New Drug Application (NDA) or Biologics License Application (BLA) 86
7.3 Post-Approval Phase 86
7.4 Fast-Track Review 87
7.5 Orphan Drug Designation and Exclusivity 88
7.6 What Regulatory Guidance Is Needed for Companion Biomarkers? 88
7.7 Oncology Biomarker Qualification Initiative 89
7.8 IRB Approval in Clinical Trials 89
7.9 U.S. Patent and Trademark Office (USPTO) 89
7.1 Pharmaceutical Product Regulation 84
7.2 New Drug Application (NDA) or Biologics License Application (BLA) 86
7.3 Post-Approval Phase 86
7.4 Fast-Track Review 87
7.5 Orphan Drug Designation and Exclusivity 88
7.6 What Regulatory Guidance Is Needed for Companion Biomarkers? 88
7.7 Oncology Biomarker Qualification Initiative 89
7.8 IRB Approval in Clinical Trials 89
7.9 U.S. Patent and Trademark Office (USPTO) 89
8. Trends Affecting the Cancer Vaccine Market 90
8.1 Screening and Cancer Detection 90
8.2 Public Perception of Vaccines 90
8.3 Insurance Issues 91
8.4 New Technological and Scientific Developments 91
8.5 Personalized Medicine 91
8.1 Screening and Cancer Detection 90
8.2 Public Perception of Vaccines 90
8.3 Insurance Issues 91
8.4 New Technological and Scientific Developments 91
8.5 Personalized Medicine 91
9. Business Landscape 93
9.1 Technology and Market Trends 93
9.2 M&A Activity 94
9.3 Partnering 94
9.4 Competitive Situation 96
9.5 Intellectual Property Rights 97
9.6 Industry Challenges and Strategic Recommendations for Commercialization 98
9.7 Opportunities and Strategic Recommendations 99
9.8 Requirements for a Successful Cancer Vaccine Products Industry 102
9.1 Technology and Market Trends 93
9.2 M&A Activity 94
9.3 Partnering 94
9.4 Competitive Situation 96
9.5 Intellectual Property Rights 97
9.6 Industry Challenges and Strategic Recommendations for Commercialization 98
9.7 Opportunities and Strategic Recommendations 99
9.8 Requirements for a Successful Cancer Vaccine Products Industry 102
10. Company Profiles 106
10.1 Advaxis 106
10.2 Agenus (formerly Antigenics) 106
10.3 AlphaVax 106
10.4 Antigen Express 107
10.5 Apthera 107
10.6 Argos Therapeutics 107
10.7 AVAX Technologies 107
10.8 Bavarian Nordic 108
10.9 Bellicum Pharmaceuticals 108
10.10 BioSante Pharmaceuticals 108
10.11 Biovest International 108
10.12 Celldex Therapeutics 109
10.13 CG Therapeutics 109
10.14 CureVac 109
10.15 DanDrit Biotech 109
10.16 Dendreon 110
10.17 EMD Serono 110
10.18 Geron 110
10.19 GlaxoSmithKline 110
10.20 GlobeImmune 111
10.21 Immatics Biotechnologies 111
10.22 ImmunoCellular Therapeutics 111
10.23 Immunovaccine 111
10.24 Inovio Pharmaceuticals 111
10.25 KAEL-Gemvax 112
10.26 MannKind 112
10.27 Mologen AG 112
10.28 NewLink Genetics Corporation 112
10.29 Northwest Biotherapeutics 113
10.30 NovaRx 113
10.31 Oxford BioMedica 113
10.32 Prima BioMed 113
10.33 Scancell 113
10.34 Transgene 113
10.35 Trimed Biotech 114
10.36 Vaccinogen 114
10.37 Vical 114
10.1 Advaxis 106
10.2 Agenus (formerly Antigenics) 106
10.3 AlphaVax 106
10.4 Antigen Express 107
10.5 Apthera 107
10.6 Argos Therapeutics 107
10.7 AVAX Technologies 107
10.8 Bavarian Nordic 108
10.9 Bellicum Pharmaceuticals 108
10.10 BioSante Pharmaceuticals 108
10.11 Biovest International 108
10.12 Celldex Therapeutics 109
10.13 CG Therapeutics 109
10.14 CureVac 109
10.15 DanDrit Biotech 109
10.16 Dendreon 110
10.17 EMD Serono 110
10.18 Geron 110
10.19 GlaxoSmithKline 110
10.20 GlobeImmune 111
10.21 Immatics Biotechnologies 111
10.22 ImmunoCellular Therapeutics 111
10.23 Immunovaccine 111
10.24 Inovio Pharmaceuticals 111
10.25 KAEL-Gemvax 112
10.26 MannKind 112
10.27 Mologen AG 112
10.28 NewLink Genetics Corporation 112
10.29 Northwest Biotherapeutics 113
10.30 NovaRx 113
10.31 Oxford BioMedica 113
10.32 Prima BioMed 113
10.33 Scancell 113
10.34 Transgene 113
10.35 Trimed Biotech 114
10.36 Vaccinogen 114
10.37 Vical 114
LIST OF FIGURES
Figure 2.1: Estimates of National Expenditures for Cancer Care in 2006 by Cancer
Site 14
Figure 2.2: Person-Years of Life Lost (PYLL) in the U.S. Due to Cancer, Male,
2006 15
Figure 2.3: Person-Years of Life Lost (PYLL) in the U.S. Due to Cancer, Female,
2006 16
Figure 3.1: Antigen Presentation 25
Figure 3.2: Antigen/Adjuvant Cancer Vaccine Immunotherapy Process 27
Figure 3.3: DNA Cancer Vaccine Immunotherapy Process 34
Figure 3.4: Viral Vector Cancer Vaccine Immunotherapy Process 35
Figure 3.5: Modified Tumor Cell Cancer Vaccines 37
Figure 3.6: Dendritic Cell Vaccination Process 38
Figure 3.7: Schematic of Anti-idiotype Antibodies for Cancer Vaccines 39
Figure 5.1: New Therapeutic Cancer Vaccines Entering Clinical Study Per Year
During 1990-2006 46
Site 14
Figure 2.2: Person-Years of Life Lost (PYLL) in the U.S. Due to Cancer, Male,
2006 15
Figure 2.3: Person-Years of Life Lost (PYLL) in the U.S. Due to Cancer, Female,
2006 16
Figure 3.1: Antigen Presentation 25
Figure 3.2: Antigen/Adjuvant Cancer Vaccine Immunotherapy Process 27
Figure 3.3: DNA Cancer Vaccine Immunotherapy Process 34
Figure 3.4: Viral Vector Cancer Vaccine Immunotherapy Process 35
Figure 3.5: Modified Tumor Cell Cancer Vaccines 37
Figure 3.6: Dendritic Cell Vaccination Process 38
Figure 3.7: Schematic of Anti-idiotype Antibodies for Cancer Vaccines 39
Figure 5.1: New Therapeutic Cancer Vaccines Entering Clinical Study Per Year
During 1990-2006 46
LIST OF TABLES
Table 2.1: Estimated New Cancer Cases and Deaths in the U.S. by Sex for all
Cancer Sites, 2010 9
Table 2.2: Estimated New Cancer Cases and Deaths for Ten Leading Cancer Sites in
the U.S. in 2010, by Sex 11
Table 2.3: Worldwide Number of New Cancer Cases and Deaths by Leading Cancer
Sites and by Level of Economic Development, 2008 12
Table 2.4: Number of New Cancer Cases and Deaths by World Area, 2008 13
Table 2.5: Estimated Annual Costs of Cancer in the U.S. in Billions, 2008 14
Table 2.6: Cancer Vaccines in the Pipeline, by Cancer Type 17
Table 3.1: Infectious Agents Involved in Cancer 24
Table 3.2: Cancer Vaccine Technologies 26
Table 3.3: Antigens Commonly Found in Cancer Vaccines 29
Table 3.4: Adjuvants Commonly Found in Cancer Vaccines 31
Table 4.1: Cervical Cancer Vaccines on the Market 41
Table 5.1: Therapeutic Vaccines on the Market 44
Table 5.2: Pipeline of Therapeutic Cancer Vaccines, by Type of Vaccine 46
Table 5.3: Antigen/Adjuvant Vaccines in Development 48
Table 5.4: DNA and RNA Vaccines in Development 55
Table 5.5: Vector-based Vaccines in Development 58
Table 5.6: Autologous Tumor Cell Vaccines in Development 62
Table 5.7: Allogeneic Tumor Cell Vaccines in Development 64
Table 5.8: Dendritic Cell Vaccines in Development 66
Table 5.9: Anti-Idiotype Vaccines in Development 69
Table 5.10: Competitors with Phase III Cancer Vaccine Candidates in Their
Pipelines 71
Table 6.1: Mechanisms of Immune Evasion by Cancers 77
Table 6.2: Key Recommendations for Cancer Vaccine Clinical Trial Design 78
Table 6.3: Challenges and Strategic Recommendations for Clinical Trial Design 79
Table 6.4 Combination Strategies to Enhance a Vaccine’s Anti-Tumor T-Cell
Response 82
Table 7.1: Focus Areas for the FDA Critical Path Initiative 89
Table 9.1: Industry Challenges and Strategic Recommendations for
Commercialization 98
Table 9.2: Required Elements of a Manufacturing Facility 103
Table 9.3: CMO Qualification Audit-Points to Investigate 104
Table 9.4: Strategies for Marketing Cancer Vaccines 105
Cancer Sites, 2010 9
Table 2.2: Estimated New Cancer Cases and Deaths for Ten Leading Cancer Sites in
the U.S. in 2010, by Sex 11
Table 2.3: Worldwide Number of New Cancer Cases and Deaths by Leading Cancer
Sites and by Level of Economic Development, 2008 12
Table 2.4: Number of New Cancer Cases and Deaths by World Area, 2008 13
Table 2.5: Estimated Annual Costs of Cancer in the U.S. in Billions, 2008 14
Table 2.6: Cancer Vaccines in the Pipeline, by Cancer Type 17
Table 3.1: Infectious Agents Involved in Cancer 24
Table 3.2: Cancer Vaccine Technologies 26
Table 3.3: Antigens Commonly Found in Cancer Vaccines 29
Table 3.4: Adjuvants Commonly Found in Cancer Vaccines 31
Table 4.1: Cervical Cancer Vaccines on the Market 41
Table 5.1: Therapeutic Vaccines on the Market 44
Table 5.2: Pipeline of Therapeutic Cancer Vaccines, by Type of Vaccine 46
Table 5.3: Antigen/Adjuvant Vaccines in Development 48
Table 5.4: DNA and RNA Vaccines in Development 55
Table 5.5: Vector-based Vaccines in Development 58
Table 5.6: Autologous Tumor Cell Vaccines in Development 62
Table 5.7: Allogeneic Tumor Cell Vaccines in Development 64
Table 5.8: Dendritic Cell Vaccines in Development 66
Table 5.9: Anti-Idiotype Vaccines in Development 69
Table 5.10: Competitors with Phase III Cancer Vaccine Candidates in Their
Pipelines 71
Table 6.1: Mechanisms of Immune Evasion by Cancers 77
Table 6.2: Key Recommendations for Cancer Vaccine Clinical Trial Design 78
Table 6.3: Challenges and Strategic Recommendations for Clinical Trial Design 79
Table 6.4 Combination Strategies to Enhance a Vaccine’s Anti-Tumor T-Cell
Response 82
Table 7.1: Focus Areas for the FDA Critical Path Initiative 89
Table 9.1: Industry Challenges and Strategic Recommendations for
Commercialization 98
Table 9.2: Required Elements of a Manufacturing Facility 103
Table 9.3: CMO Qualification Audit-Points to Investigate 104
Table 9.4: Strategies for Marketing Cancer Vaccines 105
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