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The Global Cancer Vaccine Market, 2nd Edition: Pipeline Analysis and Future Market Impact

Abstract

In 2010, the therapeutic cancer vaccine market witnessed several key milestones. Dendreon' s Provenge (sipuleucel-T) became the first product to reach the market; gaining long-awaited FDA approval for metastatic hormone-refractory prostate cancer. The Cancer Research Institute (CRI) and the Cancer Immunotherapy Consortium (CIC) also proposed much needed criteria to standardize vaccine clinical trials.

Although the major milestones attained in the clinical development of therapeutic cancer vaccines has brought hope and guidance for investors, the market is in its commercial infancy. According to Arrowhead' s new publication: The Global Cancer Vaccine Market, 2nd Edition: Pipeline Analysis and Future Market Impact, numerous challenges must be overcome to create optimal vaccines on an economical scale. Stakeholders can learn from Provenge' s developmental pathway to maximize success in this potentially lucrative market.

With over 1.3 million people having been diagnosed with colorectal cancer, breast cancer, lung cancer, prostate cancer, pancreatic cancer or melanoma across the seven major markets in 2010, coupled with unsatisfactory survival rates; vaccines could hold the ability to transform the management of cancer.

This in-depth report provides:

  • An identification and analysis of the major challenges within therapeutic cancer vaccine R&D including clinical trial standardization recommendations , designing optimal vaccines and the lessons learnt from Provenge' s development pathway
  • Clinical and commercial analysis of key Phase III oncology vaccine candidates
  • An overview and analysis of the current markets for the treatment of various cancers
  • Insight from key opinion leaders (KOLs) on the future applicability of therapeutic vaccines for the treatment of cancer
  • Sales growth rates to 2020 for key products in development

Report highlights

Traditional cancer clinical trial endpoints are not always applicable in the assessment of cancer vaccines. Lengthy trials allowing full data maturation of measuring immune response is limiting market entry. R&D must establish an effective and consistent way to assess vaccines.

Arrowhead has identified almost 400 clinical trials investigating therapeutic oncology vaccines. Whole-cell vaccines are the most popular design in late-stage development. Arrowhead anticipates a wave of products to reach the market over the coming decade.

The market is set to become highly competitive, especially within the lung cancer and melanoma sectors. By 2020 the market could be worth $8 billion. Top revenue earning candidates include GSK' s MAGE-ASCI-A3, Merck/Oncothyreon' s Stimuvax (BLP25), NovaRX' s Lucanix and Lorus Therapeutics/Zor Pharma' s Virulizin.

Key questions answered by this report

  • How can therapeutic cancer vaccine clinical trials be optimized to aid regulatory approval and commercial success?
  • What lessons can stakeholders learn from Provenge' s developmental and commercial pathway?
  • What is the optimal design of a therapeutic cancer vaccine?
  • What candidates are in the current therapeutic cancer vaccine pipeline?
  • What are the key pipeline therapeutic cancer vaccine candidates in late-stage development?
  • What are the clinical and commercial attributes of key late-stage therapeutic cancer vaccine candidates?
  • Which biopharmaceutical companies are involved in the arena?
  • What revenues will therapeutic cancer vaccine products generate over the next coming decade?
  • Which cancer types will realize the greatest benefits from vaccines?
  • What major challenges face the arena over the coming years; and how can these be overcome?
  • What advice do leading expert immunology/oncology vaccine developers give to stakeholders in the arena?
  • What are the greatest commercial opportunities within the future therapeutic cancer vaccine market?

Reasons to buy this report

  • Identify key therapeutic cancer vaccine candidates in late-phase development based on sales forecasts to 2020 to maximize your products commercial potential
  • Assess opportunities and risks influencing R&D in therapeutic cancer vaccines
  • Gain an impartial perspective of strategies that can be used to enhance new product performance in the therapeutic cancer vaccine market
  • Better understand how cancer vaccines will fit into future therapeutic regimens for cancer

Table of Contents

1 EXECUTIVE SUMMARY

  • 1.1 Scope of Global Cancer Vaccine Market, 2nd Edition: the Potential Revolution of Oncology Management
  • 1.2 Methodology of Global Cancer Vaccine Market, 2nd Edition: the Potential Revolution of Oncology Management
  • 1.3 Epidemiology of Cancer in the Seven Major Markets
  • 1.4 Key Challenges in Therapeutic Cancer Vaccine R&D
  • 1.5 Therapeutic Cancer Vaccines Pipeline Analysis
  • 1.6 Therapeutic Cancer Vaccines Market Analysis

2 THE EPIDEMIOLOGICAL AND ECONOMIC IMPACT OF CANCER

  • 2.1 Cancer Across the Globe
  • 2.2 Cancer in the US
  • 2.3 Cancer Survival Rates
  • 2.4 The Economic Impact of Cancer

3 INTRODUCTION TO THERAPEUTIC CANCER VACCINES

  • 3.1 The Immune System and Cancer
  • 3.2 What are Vaccines?
  • 3.3 Unmet Needs in Current Cancer Therapy
  • 3.4 The Basics of Cancer Vaccines
  • 3.5 Why Therapeutic Cancer Vaccines?
  • 3.6 Early Efforts of Cancer Vaccines
  • 3.7 Allogeneic Versus Autologous Vaccines
  • 3.8 Types of Cancer Vaccines
    • 3.8.1 Viral Vectors and DNA Vaccines
    • 3.8.2 Antigen/Adjuvant Vaccines
    • 3.8.3 Whole-Cell Cancer Vaccines
    • 3.8.4 Anti-Idiotype Vaccines
    • 3.8.5 Dendritic Cell Vaccines

4 VACCINES AND THE COLORECTAL CANCER THERAPEUTIC MARKET

  • 4.1 Overview of Colorectal Cancer
    • 4.1.1 Prognosis of Colorectal Cancer
  • 4.2 Epidemiology of Colorectal Cancer in the Seven Major Markets
  • 4.3 The Therapeutic Management of Colorectal Cancer
    • 4.3.1 An Overview of Chemotherapy for Colorectal Cancer
    • 4.3.2 Amgen' s Vectibix (panitumumab)
    • 4.3.3 Roche' s Avastin (bevacizumab)
    • 4.3.4 Clinical Analysis of Arrowhead' s Leading Brand Product in the Colorectal Cancer Market: ImClone/Bristol-Myers Squibb/Merck KgaA' s Erbitux (cetuximab)
  • 4.4 Revenue Review of Colorectal Cancer Branded Products
  • 4.5 Unmet Needs in the Colorectal Cancer Market
  • 4.6 Therapeutic Colorectal Cancer Vaccine Pipeline Analysis
    • 4.6.1 Vaccinogen' s Oncovax (oncovax-o)
  • 4.7 Colorectal Cancer Market Commentary
    • 4.7.1 Financial Forecast of Therapeutic Colorectal Cancer Vaccines

5 VACCINES AND THE PROSTATE CANCER THERAPEUTIC MARKET

  • 5.1 Overview of Prostate Cancer
    • 5.1.1 Prognosis of Prostate Cancer
  • 5.2 Epidemiology of Prostate Cancer in the Seven Major Markets
  • 5.3 The Therapeutic Management of Prostate Cancer
    • 5.3.1 An Overview of Chemotherapy for Prostate Cancer
    • 5.3.2 Sanofi-Aventis' Taxotere (docetaxol)
    • 5.3.3 Clinical Analysis of Arrowhead' s Leading Brand Product in the Prostate Cancer Market: Dendreon' s Provenege (spiuleucel-t)
  • 5.4 Revenue Review of Prostate Cancer Branded Products
  • 5.5 Unmet Needs in the Prostate Cancer Market
  • 5.6 Therapeutic Prostate Cancer Vaccine Pipeline Analysis
    • 5.6.1 Bavarian Nordic/NCI' s Prostvac
    • 5.6.2 Northwest Biotherapeutic' s DCVax (dcax- prostate)
  • 5.7 Prostate Cancer Therapeutics Market Commentary
    • 5.7.1 Financial Forecast of Therapeutic Prostate Cancer Vaccines

6 VACCINES AND THE LUNG CANCER THERAPEUTIC MARKET

  • 6.1 Lung Cancer Overview
    • 6.1.1 Prognosis of Lung Cancer
  • 6.2 Epidemiology of Lung Cancer in the Seven Major Markets
  • 6.3 The Therapeutic Management of Lung Cancer
    • 6.3.1 An Overview of Chemotherapy for Lung Cancer
    • 6.3.2 Roche' s Avastin (bevacizumab)
    • 6.3.3 AstraZeneca' s Iressa (gefitinib)
    • 6.3.4 Clinical Analysis of Arrowhead' s Leading Brand in the Lung Cancer Market: Roche' s Tarceva (erlotinib)
  • 6.4 Revenue Review of Lung Cancer Branded Products
  • 6.5 Unmet Needs in the Lung Cancer Market
  • 6.6 Therapeutic Lung Cancer Vaccines Pipeline Analysis
    • 6.6.1 Nova Rx' s Lucanix
    • 6.6.2 Transgene/Novartis' TG4010 (mva-muc-il2)
    • 6.6.3 GlaxoSmithKline' s MAGE-A3-ASCI (GSK1572932A)
    • 6.6.4 Merck/Oncothyreon' s Stimuvax (BLP25)
  • 6.7 LUNG CANCER THERAPEUTICS MARKET COMMENTARY
    • 6.7.1 Financial Forecast of Therapeutic Lung Cancer Vaccines

7 VACCINES AND THE BREAST CANCER MARKET

  • 7.1 Breast Cancer Overview
    • 7.1.1 Prognosis of Breast Cancer
  • 7.2 Epidemiology of Breast Cancer in the Seven Major Markets
  • 7.3 The Therapeutic Management of Breast Cancer
    • 7.3.1 An Overview of Chemotherapy for Breast Cancer
    • 7.3.2 GlaxoSmithKline' s Tykerb/Tyverb (lapatinib)
    • 7.3.3 Clinical Analysis of Arrowhead' s Leading Brand in the Breast Cancer Market: Roche' s Herceptin (trastuzumab)
  • 7.4 Revenue Review of Breast Cancer Branded Products
  • 7.5 Unmet Needs in the Breast Cancer Market
  • 7.6 Therapeutic Breast Cancer Vaccine Pipeline Analysis
    • 7.6.1 Celldex' s CDX1307
  • 7.7 Breast Cancer Therapeutics Market Commentary
    • 7.7.1 Financial Forecast of Breast Cancer Therapeutic Vaccines

8 VACCINES AND THE PANCREATIC CANCER MARKET

  • 8.1 Pancreatic Cancer Overview
    • 8.1.1 Prognosis of Pancreatic Cancer
  • 8.2 Epidemiology of Pancreatic Cancer in the Seven Major Markets
  • 8.3 The Therapeutic Management of Pancreatic Cancer
    • 8.3.1 An Overview of Chemotherapy for Pancreatic Cancer
    • 8.3.2 Roche' s Tarceva (erlotinib)
    • 8.3.3 Clinical Analysis of Arrowhead' s Leading Brand Product in the Pancreatic Cancer Market: Eli-Lilly' s Gemzar (gemcitabine)
  • 8.4 Revenue Review of Pancreatic Cancer Branded Products
  • 8.5 Unmet Needs in the Pancreatic Cancer Market
  • 8.6 Therapeutic Pancreatic Cancer Vaccine Pipeline Analysis
    • 8.6.1 Kael/GemVax' s GV1001
    • 8.6.2 Lorus Therapeutic/Zor Pharma' s Virulizin
  • 8.7 Pancreatic Cancer Therapeutic Market Commentary
    • 8.7.1 Financial Forecast of Pancreatic Cancer Therapeutic Vaccines

9 VACCINES AND THE MELANOMA MARKET

  • 9.1 Melanoma Overview
    • 9.1.1 Prognosis of Melanoma
  • 9.2 Epidemiology of Melanoma in the Seven Major Markets
  • 9.3 The Therapeutic Management of Melanoma
    • 9.3.1 An Overview of Chemotherapy for Melanoma
    • 9.3.2 Merck/Schering-Plough' s Intron-A (interferon-Alfa 2b)
    • 9.3.3 Clinical Analysis of Arrowhead' s Leading Brand in the Melanoma Market: Novartis' Proleukin (aldesleukin)
  • 9.4 Revenue Review of Melanoma Branded Products
  • 9.5 Unmet Needs in the Melanoma Market
  • 9.6 Therapeutic Melanoma Vaccine Pipeline Analysis
    • 9.6.1 AVAX Tech' s M-Vax (autologous cell vaccine)
    • 9.6.2 Goshen Health System/NCI' s Gp100 Antigen
    • 9.6.3 BioVex' s OncoVEX (oncovex gm-csf)
    • 9.6.4 Antigenic' s Oncophage (vitespen)
  • 9.7 Melanoma Therapeutics Market Commentary
    • 9.7.1 Financial Forecast of Melanoma Therapeutic Vaccines

10 KEY ISSUES IN THERAPEUTIC CANCER VACCINE RESEARCH AND DEVELOPMENT (R&D)

  • 10.1 Standardization of Cancer Vaccine Clinical Trials
    • 10.1.1 FDA Proposals of Standardizing Therapeutic Cancer Vaccine Clinical Trials
    • 10.1.2 CRI and CIC Proposals of Standardizing Therapeutic Cancer Vaccine Clinical Trials
    • 10.1.3 Autologous Therapeutic Cancer Vaccine Clinical Trial Designs
  • 10.2 Creating Highly Effective Therapeutic Cancer Vaccines
    • 10.2.1 Vaccine Designs: Antigen Versus Adjuvant s
    • 10.2.2 Optimal Disease Stage
    • 10.2.3 Concomitant Therapies
  • 10.3 Development of Vaccines with Non-invasive Delivery Routes
  • 10.4 Lessons to be Learnt from Dendreon' s Provenge Development

11 THERAPEUTIC CANCER VACCINES PIPELINE WATCH

  • 11.1 Introduction to the Therapeutic Cancer Vaccine Pipeline
    • 11.1.1 Accentia/BioVest' s BioVaxID
    • 11.1.2 TVAX Biomedicals' TVAX (Tvax-Brain-1)
  • 11.2 Development Status Updates of Phase III Candidate Therapeutic Cancer Vaccines

12 THERAPEUTIC CANCER VACCINES MARKET IMPACT

  • 12.1 Therapeutic Cancer Vaccine Potential Promise
  • 12.2 SWOT Analysis of the Therapeutic Cancer Vaccine Market, 2010
  • 12.3 Financial Forecast of the Therapeutic Cancer Vaccine Market

13 BIBLIOGRAPHY

LIST OF TABLES

  • Table 1: Colorectal, Prostate, Lung, Breast, Pancreatic and Melanoma Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Table 2: Current Late-Stage Therapeutic Cancer Vaccine Pipeline, November 2010
  • Table 3: Worldwide Incidence of Cancer by Geographic Region, 2008
  • Table 4: Worldwide Incidence and Deaths Rates by Leading Cancer Type, 2008
  • Table 5: Worldwide Number of Cancer Cases for Both Males and Females Combined, 2008
  • Table 6: Estimated Newly Diagnosed Cases and Death Rates in the US by Cancer Type, 2010
  • Table 7: Five-Year Survival Rates for Select Cancers by Stage at Diagnosis, US 2005
  • Table 8: The Economic Impact of Cancer in the US, 2010
  • Table 9: Colorectal Cancer Diagnosis and Five-Year Survival Rate by Disease Stage
  • Table 10: Crude Incidence Rate of Colorectal Cancer by Gender in the Seven Major Markets, 2010
  • Table 11: Colorectal Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Table 12: Therapeutics Used in Colorectal Cancer
  • Table 13: Worldwide Leading Colorectal Cancer Branded Product Revenues ($ millions) 2007- H1 2010
  • Table 14: Late-Stage and Phase II Therapeutic Colorectal Cancer Vaccines Pipeline, November 2010
  • Table 15: Colorectal Cancer Therapeutic Vaccines Revenue Forecast 2015-2020 ($ millions)
  • Table 16: Prostate Cancer Diagnosis and Five-Year Survival Rate by Disease Stage
  • Table 17: Crude Incidence Rate of Prostate Cancer for Males in the Seven Major Markets, 2010
  • Table 18: Prostate Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Table 19: Therapeutics Used in Prostate Cancer
  • Table 20: Worldwide Leading Prostate Cancer Branded Product Revenues ($ millions) 2007- H1 2010
  • Table 21: Late-Stage and Phase II Therapeutic Prostate Cancer Vaccine Pipeline, November 2010
  • Table 22: Prostate Cancer Therapeutic Vaccines Revenue Forecast 2010-2020 ($ millions)
  • Table 23: Lung Cancer Diagnosis and Five-Year Survival Rate by Disease Stage
  • Table 24: Crude Incidence Rate of Lung Cancer by Gender (per 100,000) in the Seven Major Markets, 2010
  • Table 25: Lung Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Table 26: Therapeutics Used in Lung Cancer
  • Table 27: Worldwide Leading Lung Cancer Branded Product Revenues ($ millions) 2007-2010 H1
  • Table 28: Late-Stage and Phase II Therapeutic Lung Cancer Vaccines Pipeline, November 2010
  • Table 29: Lung Cancer Therapeutic Vaccines Revenue Forecast 2010-2020 ($ millions)
  • Table 30: Breast Cancer Diagnosis and Five-Year Survival Rate by Disease Stage
  • Table 31: Crude Incidence Rate of Breast Cancer for Females in the Seven Major Markets, 2010
  • Table 32: Breast Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Table 33: Therapeutics Used in Breast Cancer
  • Table 34: Worldwide Leading Breast Cancer Branded Product Revenues ($ millions) 2007-2010 H1
  • Table 35: Late-Stage and Phase II Therapeutic Breast Cancer Vaccines Pipeline, November 2010
  • Table 36: Pancreatic Cancer Diagnosis and Five-Year Survival Rate by Disease Stage
  • Table 37: Crude Incidence Rate of Pancreatic Cancer by Gender in the Seven Major Markets, 2010
  • Table 38: Pancreatic Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Table 39: Therapeutics Used in Pancreatic Cancer
  • Table 40: Worldwide Leading Pancreatic Cancer Branded Product Revenues ($ millions) 2007-H1 2010
  • Table 41: Late-Stage and Phase II Therapeutic Pancreatic Cancer Vaccines Pipeline, Novemeber 2010
  • Table 42: Pancreatic Cancer Therapeutic Vaccines Revenue Forecast 2015-2020 ($ millions)
  • Table 43: Melanoma Cancer Diagnosis and Five-Year Survival Rate by Disease Stage
  • Table 44: Crude Incidence Rate of Melanoma by Gender in the Seven Major Markets, 2010
  • Table 45: Melanoma Incidence Forecast in the Seven Major Markets, 2008-2020
  • Table 46: Therapeutics Used in Melanoma
  • Table 47: Worldwide Leading Melanoma Branded Product Revenues ($ millions) 2007-H1 2010
  • Table 48: Late-Stage and Phase II Therapeutic Melanoma Vaccines Pipeline, November 2010
  • Table 49: Melanoma Therapeutic Vaccines Revenue Forecast 2010-2020 ($ millions)
  • Table 50: FDA' s Considerations for Therapeutic Cancer Vaccine Clinical Trials
  • Table 51: Challenges and Recommendations for Assessment of Cancer Immunotherapies
  • Table 52: The Relative Advantages of Different Therapeutic Cancer Vaccine Designs
  • Table 53: Current Late Stage and Phase II Therapeutic Cancer Vaccines Pipeline, November 2010
  • Table 54: Development Status Updates of Selected Phase III Therapeutic Cancer Vaccines
  • Table 55: Therapeutic Cancer Vaccines Revenue Forecast 2010-2020 ($ millions)

LIST OF FIGURES

  • Figure 1: Colorectal, Prostate, Lung, Breast, Pancreatic and Melanoma Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Figure 2: Cancer Incidence Forecast in the Seven Major Markets, 2010 and 2020
  • Figure 3: Key Challenges in Therapeutic Cancer Vaccine R&D
  • Figure 4: The Late-Stage Therapeutic Cancer Vaccine Pipeline by the Number of Candidates of Different Vaccine Type Design, November 2010
  • Figure 5: Comparison of the Value of the Therapeutic Cancer Vaccine Market, 2010 and 2020
  • Figure 6: Cancer Incidence Worldwide by Geographic Region, 2008
  • Figure 7: Worldwide Number of Cancer Cases for Males and Females Combined, 2008
  • Figure 8: Schematic Diagram of the Production of DNA/Viral Vector Vaccines
  • Figure 9: Schematic Diagram of Antigen/Adjuvant Vaccines Mode of Action
  • Figure 10: Schematic Diagram of Whole-Cell Tumor Vaccine Production
  • Figure 11: Schematic Diagram of Anti-Idiotype Vaccine Production
  • Figure 12: Schematic Diagram of Dendritic Cell Cancer Vaccine Production
  • Figure 13: The Anatomy of the Human Digestive System
  • Figure 14: Colorectal Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Figure 15: OncoVax' s Treatment Schedule
  • Figure 16: The Anatomy of the Male Reproductive System
  • Figure 17: Prostate Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Figure 18: The Anatomy of the Human Respiratory System
  • Figure 19: Lung Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Figure 20: The Anatomy of the Human Breast
  • Figure 21: Breast Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Figure 22: The Anatomy of the Human Pancreas
  • Figure 23: Pancreatic Cancer Incidence Forecast in the Seven Major Markets, 2008-2020
  • Figure 24: The Anatomy of Human Skin
  • Figure 25: Melanoma Incidence Forecast in the Seven Major Markets, 2008-2020
  • Figure 26: The Current Therapeutic Cancer Vaccine Pipeline by the Number of Candidates by Vaccine Type, November 2010
  • Figure 27: SWOT Analysis of the Therapeutic Cancer Vaccine Market, 2010
  • Figure 28: Therapeutic Cancer Vaccines Revenue Forecast 2010-2020 ($ millions)
  • Figure 29: Total Therapeutic Cancer Vaccine Market Revenue Forecast 2010-2020 ($ millions)
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