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Oncology Reports

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


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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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