治療用ワクチンの世界市場

Abstract

Overview

Introduction

Therapeutic vaccines have faced numerous setbacks in recent years. The only three vaccines to reach the market have had insignificant sales, while the pipeline has seen numerous high-profile failures and no new product launches in three years. However, new 'off-the-shelf' generalized vaccines driven by genomic advances promise to remedy the commercial drawbacks of early personalized vaccines

Scope

• In-depth coverage of over 200 marketed and pipeline therapeutic vaccines, including forecasts for sales up to 2010 and analysis of future trends
• Profiles of 16 leading therapeutic vaccines companies, their strategic position, pipelines, partnerships and financial outlook
• Discussion of the many challenges facing therapeutic vaccine developers, and how technology evolution is driving the industry forward
• Analysis of big pharma's level of interest in the sector, their partnerships and pipelines

Report Highlights

Polyvalent, patient-specific vaccines have major commercial disadvantages that have limited their uptake. However, rapid scientific progress means that antigen-specific, generalized vaccines could soon offer comparable efficacy, to complement their strong commercial profile. As a result generalized vaccines are now starting to dominate the pipeline

Therapeutic vaccines development is seeing an increasing trend towards the use of multiple antigens (and adjuvants), to attack cancers or HIV from multiple angles. Combinations of therapies, and novel approaches such as prime-boost regimens are expected to yield exciting results. Partnerships will therefore become much more important

Therapeutic vaccine development is currently heavily weighted towards cancer vaccines, which account for 60.6% of all pipeline projects. However, the early-stage pipeline is starting to show greater interest in other therapeutic areas, from HIV and infectious disease to nicotine addiction, CNS and cardiovascular diseases

Reasons to Purchase

• Understand the scientific and commercial issues that are impeding therapeutic vaccines, and learn how they can become a success in the future
• Assess the entire pipeline of therapeutic vaccines with an interactive Excel model containing details of over 200 therapeutic vaccines in development
• Analyze and benchmark leading companies' strategies and pipelines, as well as big pharma's interest in the sector

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope
  • Datamonitor's opinion on the future of the therapeutic vaccines market
    • The early days of the therapeutic vaccine industry have so far been characterized by clinical and commercial failures. This has led to a vicious circle, where a lack of adequate funding and pharmaceutical experience through partnerships, has led to sub-optimal product development, leading to poor clinical results which have further damaged the industry's reputation
    • The first therapeutic vaccines to reach the market have performed poorly. Polyvalent, patient-specific vaccines have major commercial disadvantages that have limited their uptake. However, rapid scientific progress means that antigen-specific, generalized vaccines could soon offer comparable efficacy, to complement their strong commercial profile. As a result, generalized vaccines are now starting to dominate the pipeline
    • Datamonitor believes that there is an increasing trend in therapeutic vaccines development towards the use of multiple antigens (and adjuvants), to attack cancers or HIV from multiple angles-the generally low levels of side effects make this a viable option. Combinations of therapies, and novel approaches such as prime-boost regimens are expected to yield exciting results
    • Because of the increasing focus on combining technologies and vaccines, partnerships will become much more important. The low level of cooperation between vaccine players needs to be addressed in order to accelerate the development of effective vaccines
    • Therapeutic vaccine development is currently heavily weighted towards cancer vaccines, which account for 60.6% of all pipeline projects. However, the early-stage pipeline is starting to show greater interest in other therapeutic areas, from HIV and infectious disease to nicotine addiction, CNS and cardiovascular diseases.
• CHAPTER 2 STRATEGIC ISSUES IN THE THERAPEUTIC VACCINES INDUSTRY
  • Introduction
  • Factors driving therapeutic vaccine development
    • Unmet clinical needs in cancer and chronic infectious disease
      • Specific examples of unique clinical benefits shown with therapeutic vaccines
    • Low level of side effects
      • Case study - Melacine's side-effect profile was its key advantage
    • Infrequent dosing required because of long-lasting effect
    • Advances in genomics and proteomics enabling improved antigen selection
  • Scientific issues inhibiting successful development, and how these may be overcome
    • Finding the right antigen or antigens is central to therapeutic vaccine development
      • Well-characterized antigens: an obvious starting point
      • Using genomics and proteomics to generate new antigen targets
    • Delivery technologies - numerous variants, no consensus
    • Adjuvants - a key role in maximizing the immune response, but little commercial interest
      • Older adjuvants - first targeting antibody response, and later T cell response
      • Novel adjuvants - a niche area of R&D
    • Finding the right combination of antigens, delivery method and adjuvant
      • The use of multiple antigens or adjuvants is increasingly popular, encouraged by the low level of side effects
      • Partnerships are the key to creating effective combination products
    • High variability of patient response
    • Targeting the right patient populations
      • Late-stage cancer therapy versus early-stage: when is the optimal time for therapeutic vaccine usage?
    • Mutation of antigens makes a universal immune response difficult with antigen-specific vaccines
  • Commercial issues inhibiting successful commercialization, and how these may be overcome
    • Some commercial issues are common to both personalized and generalized vaccines...
      • Long clinical trials
    • ...but personalized vaccines present many unique commercial problems
      • High cost, and low scalability of personalized vaccine manufacturing
      • Potential regulatory difficulties
      • Logistical difficulties with collecting and transporting samples and vaccines
      • Lack of acceptance by physicians and the general public
      • Lack of interest from pharmaceutical companies in personalized therapies
      • Lack of funding: the vicious circle
    • Are generalized therapies the answer?
      • In the near term, personalized and generalized vaccines are expected to have similar overall prospects
      • In the longer term, there are clear signs that generalized vaccines are being favored in early-stage development
  • Products failing clinical trials - high-profile failures and their causes and effects
    • Aphton's Insegia (G17DT) - no survival benefit
    • CancerVax's Canvaxin - no survival benefit
    • Cell Genesys's GVAX lung and myeloma - commercial limitations of personalized vaccines
    • Progenics' GMK - still in development, but inferiority to interferon alpha severely limits its prospects
    • VaxGen's AIDSVAX - high-profile failure of an HIV vaccine candidate
    • Biomira's Theratope - another vaccine that failed to meet endpoints and improve survival
  • Is big pharma losing interest?
    • Key big pharma players and their partnerships
      • Sanofi Pasteur
      • GlaxoSmithKline
      • Merck & Co
      • Wyeth
      • Merck KGaA
      • Bristol-Myers Squibb
      • Pfizer
      • Roche
  • Technological advances give hope for the future
    • Polyvalent vaccines
      • Whole cell vaccines
      • Heat shock proteins
    • Antigen-specific vaccines
      • Recombinant viral vector
      • Recombinant bacterial vector
      • Subunit vaccine
      • Peptide vaccine
      • Conjugated vaccines
      • Anti-idiotype vaccines
      • DNA vaccines
      • Prime-boost vaccines
    • Other vaccines
      • Dendritic cell vaccine
      • Toxoid vaccine
    • How can therapeutic vaccines move forward
      • Parallels between the evolution of therapeutic vaccines and monoclonal antibodies
• CHAPTER 3 THERAPEUTIC VACCINE MARKET AND PIPELINE ANALYSIS, 2005 - 2010
  • Current market position, 2005
    • Profiles of marketed therapeutic vaccines
      • Avax's M-Vax
      • IntraCel's OncoVax
      • Corixa's Melacine (discontinued)
  • Pipeline overview
    • Patient-specific versus non-patient-specific vaccines
    • Pipeline analysis according to vaccine type
    • Pipeline analysis according to therapy area
      • Cancer indications being targeted: melanoma is the most common, followed by the 'big four' tumor types and hematological tumors
      • Beyond cancer and infectious disease: emerging therapy areas
  • Sales forecasts
    • Pipeline products from leading companies profiled in Chapter 4
      • GVAX Prostate - proven survival benefit in prostate cancer makes this Cell Genesys' great hope
      • Provenge - Dendreon's vaccine is the first to achieve survival benefit in Phase III trials for prostate cancer
      • PANVAC/CEA VF-TRICOM - addressing the challenge of pancreatic cancer
      • Oncophage - appears effective only in a small subgroup of melanoma patients
      • MyVax - Genitope leads the race to market an anti-idiotype vaccine for non-Hodgkin's lymphoma
      • Aphton's IGN101 - possible use in various cancers: NSCLC is first but colorectal could eventually provide its biggest success
      • Biovest's BiovaxID - may have lost the chance to be first lymphoma vaccine to market
      • FavID - Favrille looks likely to face stiff competition in the lymphoma marketplace
    • Additional products not covered in company profiles
      • MDX-1379 - Medarex's combination therapy with MDX-010 could be a breakthrough for cancer vaccines
      • GMK vaccine - Progenics
      • AIDSVAX - VaxGen
• CHAPTER 4 PROFILES OF LEADING COMPANIES
  • Antigenics
    • Summary
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • Heat Shock Protein technology
      • Liposome encapsulation
      • QS-21 adjuvant
    • Therapeutic vaccines pipeline
      • Oncophage (vitespen; formerly HSPPC-96)
      • AG-858 (HSPPC-70)
      • AG-707
    • Financial outlook
      • Other activities beyond therapeutic vaccines
  • Aphton
    • Summary
    • SWOT analysis
    • Key events in 2005
    • Alliance network
    • Technology platforms
      • Anti-gastrin technology
    • Therapeutic vaccines pipeline
      • Insegia (G17DT immunogen)
      • IGN101
      • GnRH Pharmaccine
    • Financial outlook
      • Other activities beyond therapeutic vaccines
  • Biomira
    • Summary
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • Liposome Vaccine platform
    • Therapeutic vaccines pipeline
      • L-BLP25
      • Theratope (development suspended)
      • L-BGLP40
    • Financial outlook
      • Other activities beyond therapeutic vaccines
  • Biovest International
    • Key findings
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • BiovaxID Technology Platform
    • Therapeutic vaccines pipeline
      • BiovaxID
    • Financial outlook
  • CancerVax
    • Summary
    • SWOT analysis
    • Alliance network
    • Technology platforms
    • Therapeutic vaccines pipeline
      • Canvaxin (suspended)
      • SAI-EGF
      • Preclinical programs: SAI-TGF-alpha and SAI-EGFR-ECD
    • Financial outlook
      • Other activities beyond therapeutic vaccines
  • Cell Genesys
    • Key findings
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • GVAX Technology Platform
    • Therapeutic vaccines pipeline
      • GVAX Prostate
      • GVAX Pancreatic
      • GVAX Leukemia
    • Financial outlook
  • Cytos Biotechnology
    • Summary
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • Immunodrugs platform
      • DELphi protein discovery technology
      • pCytTS mammalian expression system
    • Therapeutic vaccines pipeline
      • CYT002-NicQb
      • CYT005-AllQbG10
      • CYT004-MelQbG10
      • CYT007-TNFQb
      • CYT006-AngQb
      • CYT009-GhrQb
      • CAD-106
      • Preclinical products
    • Financial outlook
      • Other activities beyond therapeutic vaccines
  • Dendreon
    • Summary
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • Antigen Delivery Cassette technology
    • Therapeutic vaccines pipeline
      • Provenge (sipuleucel-T)
      • APC8024 (lapuleucel-T)
    • Financial outlook
      • Other activities beyond therapeutic vaccines
  • Favrille
    • Key findings
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • FavID Platform
    • Therapeutic vaccines pipeline
      • FavID
    • Financial outlook
  • Genitope
    • Summary
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • Hi-GET technology
    • Therapeutic vaccines pipeline
      • MyVax Personalized Immunotherapy (GTOP-99)
    • Financial outlook
      • Other activities beyond therapeutic vaccines
  • IDM Pharma
    • Key findings
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • Dendritophage Vaccine Platform
      • DNA Vaccine Platform
      • Free Peptide Vaccine Platform
    • Therapeutic vaccines pipeline
      • EP-2101
      • Uvidem
      • Collidem
      • EP HIV-1090
    • Financial outlook
  • Oxxon Therapeutics
    • Key findings
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • PrimeBoost Technology Platform
    • Therapeutic vaccines pipeline
      • HBV 1, HBV 2
      • Mel 1, Mel 2
      • HIV 1
    • Financial outlook
  • Pharmexa
    • Summary
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • AutoVac platform
    • Therapeutic vaccines pipeline
      • GV1001
      • HER-2 Protein Autovac
      • HER-2 DNA Autovac
      • RANKL vaccine
      • TNF-alpha vaccine
      • AutoVac Alzheimer's vaccine
    • Financial outlook
  • Stressgen Biotechnologies
    • Summary
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • CoVal Fusion Protein technology
    • Therapeutic vaccines pipeline
      • HspE7
    • Financial outlook
      • Other activities beyond therapeutic vaccines
  • Therion Biologics
    • Key findings
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • Recombinant Viral Vector Platform
    • Therapeutic vaccines pipeline
      • PANVAC-VF
      • PROSTVAC-VF
    • Financial outlook
  • Transgene
    • Key findings
    • SWOT analysis
    • Alliance network
    • Technology platforms
      • Recombinant Viral Vector Platform
    • Therapeutic vaccines pipeline
      • MVA-MUC1-IL2
      • MVA-HPV-IL2
      • MVA-HCV
      • Ad-TFN(
    • Financial outlook
• CHAPTER 5 APPENDIX
  • Supplementary data
  • How to contact experts in your industry
  • List of Tables
    • Table 1: Cancer antigens most frequently targeted by pipeline cancer vaccines
    • Table 2: Selected antigen licensing deals
    • Table 3: Commercial factors influencing the successful development and commercialization of therapeutic vaccines
    • Table 4: Three major classes of therapeutic vaccine and the technology types included under each class
    • Table 5: Marketed therapeutic vaccine products
    • Table 6: Distribution of therapeutic vaccine pipeline projects by stage of development
    • Table 7: The percentage of pipeline products that are patient-specific decreases sharply in earlier-stage development
    • Table 8: Forecast sales of therapeutic vaccine product candidates in Phase III trials, 2005
    • Table 9: Antigenics: Key information
    • Table 10: Antigenics' Heat Shock Protein technology
    • Table 11: Antigenics' therapeutic vaccines pipeline, 2005
    • Table 12: Aphton: Key information
    • Table 13: Aphton's Anti-gastrin technology
    • Table 14: Aphton's therapeutic vaccines pipeline, 2005
    • Table 15: Biomira: Key information
    • Table 16: Biomira's Liposome Vaccine platform
    • Table 17: Biomira's therapeutic vaccines pipeline, 2005
    • Table 18: Biovest International: Key information
    • Table 19: BiovaxID Technology Platform
    • Table 20: Biovest's therapeutic vaccines pipeline, 2005
    • Table 21: CancerVax: Key information
    • Table 22: CancerVax's therapeutic vaccines pipeline, 2005
    • Table 23: Cell Genesys: Key information
    • Table 24: GVAX Technology Platform
    • Table 25: Cell Genesys' therapeutic vaccines pipeline, 2005
    • Table 26: Cytos Biotechnology: Key information
    • Table 27: Cytos Biotechnology's Immunodrugs platform
    • Table 28: Cytos Biotechnology's therapeutic vaccines clinical pipeline, 2005
    • Table 29: Dendreon: Key information
    • Table 30: Dendreon's Antigen Delivery Cassette technology
    • Table 31: Dendreon's therapeutic vaccines pipeline, 2005
    • Table 32: Favrille: Key information
    • Table 33: FavID Technology Platform
    • Table 34: Favrille's therapeutic vaccines pipeline, 2005
    • Table 35: Genitope: Key information
    • Table 36: Genitope's Hi-GET technology
    • Table 37: Genitope's therapeutic vaccines pipeline, 2005
    • Table 38: IDM Pharma: Key information
    • Table 39: Dendritophage Vaccine Platform
    • Table 40: DNA Vaccine Platform
    • Table 41: Free Peptide Vaccine Platform
    • Table 42: IDM Pharma's therapeutic vaccines pipeline, 2005
    • Table 43: Oxxon Therapeutics: Key information
    • Table 44: PrimeBoost Technology Platform
    • Table 45: Oxxon Therapeutics' therapeutic vaccines pipeline, 2005
    • Table 46: Pharmexa: Key information
    • Table 47: Pharmexa's AutoVac platform
    • Table 48: Pharmexa's therapeutic vaccines pipeline, 2005
    • Table 49: Stressgen Biotechnologies: Key information
    • Table 50: Stressgen's CoVal Fusion Protein technology
    • Table 51: Stressgen's therapeutic vaccines pipeline, 2005
    • Table 52: Therion Biologics: Key information
    • Table 53: Recombinant Viral Vector Platform
    • Table 54: Therion Biologics' therapeutic vaccines pipeline, 2005
    • Table 55: Transgene: Key information
    • Table 56: Recombinant Viral Vector Platform
    • Table 57: Transgene's therapeutic vaccines pipeline, 2005
    • Table 58: Numbers of products in development within each technology type
    • Table 59: Numbers of pipeline products in each stage of development, split by therapy area
  • List of Figures
    • Figure 1: Lack of funding causes a vicious circle in therapeutic vaccine development
    • Figure 2: Generalized vaccines dominate the early-stage pipeline
    • Figure 3: The overwhelming majority (67.8%) of active pipeline therapeutic vaccines are antigen-specific
    • Figure 4: Therapeutic vaccines technology evolution
    • Figure 5: Cancer vaccines dominate the therapeutic vaccines pipeline, followed by infectious disease and HIV vaccines
    • Figure 6: The clinical-stage therapeutic vaccines pipeline is heavily focused on cancer products, but preclinical products are much more widely distributed among other therapeutic areas
    • Figure 7: Technological evolution of immunotherapeutic medicines
    • Figure 8: The overwhelming majority (67.8%) of active pipeline therapeutic vaccines are antigen-specific
    • Figure 9: Lack of funding causes a vicious circle in therapeutic vaccine development
    • Figure 10: Generalized vaccines are forecast slightly stronger sales growth than personalized vaccines up to 2010
    • Figure 11: Analysis of the therapeutic vaccines pipeline suggests that generalized therapies are becoming more popular
    • Figure 12: Therapeutic vaccines technology evolution
    • Figure 13: The therapeutic vaccine pipeline shows strong progression up to Phase II but a very low success rate from Phase II onwards
    • Figure 14: Generalized vaccines dominate the early-stage pipeline
    • Figure 15: The overwhelming majority (67.8%) of active pipeline therapeutic vaccines are antigen-specific
    • Figure 16: Analysis of products in development shows that conjugated, dendritic cell and viral vector vaccines are most popular
    • Figure 17: Cancer vaccines dominate the therapeutic vaccines pipeline, followed by infectious disease and HIV vaccines
    • Figure 18: Cancer is the overwhelmingly dominant therapy area by numbers of therapeutic vaccines in development
    • Figure 19: The clinical-stage therapeutic vaccines pipeline is heavily focused on cancer products, but preclinical products are much more widely distributed among other therapeutic areas
    • Figure 20: Late-stage cancer vaccines are largely focused on melanoma, colorectal, prostate, lung and hematological cancers
    • Figure 21: Assessment of Antigenics' strategic position
    • Figure 22: Antigenics' alliance network
    • Figure 23: Assessment of Aphton's strategic position
    • Figure 24: Assessment of Biomira's strategic position
    • Figure 25: Assessment of Biovest International's strategic position
    • Figure 26: Assessment of CancerVax's strategic position
    • Figure 27: Assessment of Cell Genesys' strategic position
    • Figure 28: Assessment of Cytos Biotechnology's strategic position
    • Figure 29: Assessment of Dendreon's strategic position
    • Figure 30: Assessment of Favrille's strategic position
    • Figure 31: Assessment of Genitope's strategic position
    • Figure 32: Assessment of IDM Pharma's strategic position
    • Figure 33: Assessment of Oxxon Therapeutics' strategic position
    • Figure 34: Assessment of Pharmexa's strategic position
    • Figure 35: Pharmexa's alliance network
    • Figure 36: Assessment of Stressgen's strategic position
    • Figure 37: Assessment of Therion Biologics' strategic position
    • Figure 38: Assessment of Transgene's strategic position