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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
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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
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
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
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
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
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
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