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Market Research Report

Advances in Vaccine Technology and Delivery

Published by Espicom Business Intelligence
Published January, 2010 Product code 107548
Content info Pages: 164
Price
US $ 1390 Hard Copy
US $ 1390 PDF by E-mail (Single user license)
US $ 1390 Web Access (Single user license)


Advances in Vaccine Technology and Delivery published by Espicom Business Intelligence in January, 2010. This report consists of Pages: 164 and the price starts from US $ 1390.

Introduction

Abstract

A comprehensive 164-page analysis of this fast-growing sector with market projections and extensive company, product and research evaluation of all major vaccine areas.

Key areas addressed by this new January 2010 report...

  • Market trends and challenges with projections to 2015 for the major vaccine sectors
  • The latest advances in vaccine technologies including DNA vaccines (viral, bacterial, yeast-based and complex DNA) and adjuvants (immune potentiators)
  • Novel delivery systems including needle free, liquid jet injectors, solid dose, intranasal, oral and transdermal delivery options
  • How a better understanding of immunology is driving the sector
  • An assessment of current and future vaccines for viral infections including influenza, hepatitis, HIV and herpes
  • Emerging disease, biodefence and parasitic disease targets including malaria, Ebola, dengue fever and West Nile virus
  • The issues surrounding effective clinical trial design for vaccines Prophylactic vaccines for cervical and gastric cancer
  • Therapeutic cancer vaccine research approaches and vaccines under development for 12 cancer types
  • A review of novel therapeutic vaccines in key areas such as diabetes, Alzheimer' s disease and allergies.

The vibrant field of vaccine research will continue to grow and evolve over the next few years and to generate ever increasing revenues as new vaccines reach the market.

Unbeatable coverage and analysis of this high growth market sector...

The advances made in immunology over the past two decades, in conjunction with the growing acceptance of the importance of preventive medicine, have given the field of vaccine research a new lease of life. Vaccines for difficult infectious disease targets, such as Neisseria meningitidis Group B and malaria, may become a reality over the next five to ten years. However, for other difficult and important targets such as HIV and cancer the wait for a vaccine may be longer and will rely on the use of new technologies, including plasmid DNA, adjuvants and delivery systems that are currently in the early stages of development.

Vaccines are attracting significant research attention

The increasing use of novel technologies is reflected in the fact that almost half of the current pipeline of prophylactic vaccines against infectious diseases are in preclinical or Phase I trials. These vaccine candidates have largely been developed by smaller companies emerging from academia, such as Vical, Novavax, Acambis, Coley Pharmaceuticals, Crucell and Intercell, and represent future licensing and acquisition targets. Most of the pharma companies with the highest stakes in the vaccines market - sanofi-aventis, Pfizer, Merck & Co, GlaxoSmithKline and Novartis - have extensive pipelines of vaccine candidates in development based on acquired technology and will be vigilant for the opportunities offered by up-coming companies with promising new platform technologies.

Prophylactic vaccines: A high growth market

Our forecasts indicate that the prophylactic infectious disease vaccine market (excluding pandemic H1N1 influenza vaccines) will grow from US$21.4 billion in 2009 to US$36.4 billion in 2015, representing a compound average growth rate (CAGR 2009-2015) of 8%. This growth relies on the approval of vaccines for a number of infectious conditions for which no vaccine is currently available, such as Neisseria meningitidis Group B meningococcal disease.

Influenza: long term impact

The current influenza pandemic has also given the vaccine market sector an enormous boost in terms of revenue over the next few years, as well as future investment. Our forecasts indicate that pandemic H1N1 influenza vaccines will generate US$4.8 billion in 2009 with growth in 2010-11 and sales of these vaccines for a subsequent two year period. This pandemic H1N1 influenza vaccine forecast is subject to a number of uncertainties surrounding the ongoing extent of the pandemic and the response of individual governments to it. Increased funding for new vaccines and their manufacturing methods will change the face of the influenza vaccine market as a whole and increase the number of doses available. However, due to the large investments in expanding manufacturing capacity made by the largest pharma companies over the past few years, these changes to the overall market are likely to be realised over the next two decades rather than in the next few years.

Cancer Vaccines - when will they deliver on their promise?

In contrast to the prophylactic vaccine pipeline, the pipeline of therapeutic cancer vaccines has a higher proportion of vaccines in late-stage trials. These late-stage products utilise technologies that have not been proven successful to date and have been in development for many years; a relatively high risk of failure remains. However, the knowledge gained from human trials with cancer vaccines has informed, and will continue to inform, the development of the next generation of candidate vaccines that use new technologies to generate improved immune responses and, therefore, clinical responses in cancer patients. We forecast a total therapeutic vaccine market of US$3.7 billion in 2015. These figures are dependent on the approval of Dendreon' s Provenge in 2010, which could open up the cancer market to a new therapeutic class known as active cellular immunotherapeutics.

THIS REPORT ANSWERS KEY BUSINESS QUESTIONS...

  • There are 18 companies developing DNA vaccines - who are they?
  • Who are the 16 companies involved in developing therapeutic vaccines for indications other than cancer?
  • sanofi-aventis and GSK are battling for leadership in the vaccines sector, but what are the prospects for Merck, Pfizer, Sanofi Pasteur/MSD and Novartis?
  • What patient safety benefits have adenovirus-based vaccines demonstrated in clinical trials?
  • What are the benefits and challenges for adjuvant vaccine delivery systems and which companies are involved?
  • What are the prospects for a universal broad spectrum influenza vaccine?
  • GSK' s Synlorix, approved by the EMEA in March 2009, will compete with Pfizer' s followon product Prevnar 13 in the pneumococcal sector - what is the rest of the research pipeline looking like and who is involved?
  • A number of development companies with promising products and pipelines have yet to find a commercial partner or have failed because of financial pressure - who are they and is the time right for big pharma to take a closer look at the investment opportunities that exist?
  • Why is vaccine development subject to high failure rates and how many new delivery technologies improve development strategies?

About the Author

Dr. Cheryl Barton is a highly regarded independent consultant with over 16 years research and business analysis experience. During her senior research positions in academia and seven years with Merck, she was responsible for research projects ranging from Alzheimer' s disease to schizophrenia. Dr Barton subsequently joined Dutch investment bank ABN Amro NV as a senior equity analyst where she was lead analyst on major pharmaceutical companies such as Roche and Sanofi-Synthelabo. In 2002 Dr Barton founded a consulting business Pharmavision to provide independent, tailormade, pharmaceutical thematic research to investment houses and pharmaceutical companies.

Table of Contents

EXECUTIVE SUMMARY

  • Advances in Vaccine Technology & Delivery
  • Advances in Vaccines for Infectious Diseases
  • Advanced Therapeutic Vaccines

1. ADVANCES IN VACCINE TECHNOLOGY & DELIVERY

  • Introduction to the vaccine market
    • Current market size and major players
      • Figure 1: Global vaccine market sales 2008
      • Figure 2: Blockbuster vaccine brands 2008
      • Figure 3: Sales figures for the top 6 vaccine companies 2008
    • Market drivers: challenges and opportunities
  • Introduction to novel vaccine technologies
    • Figure 4: Schematic showing simplified mechanisms of humoral and cellular immune responses
  • DNA vaccines
    • Table 1: Advantages and disadvantages of DNA vaccines
  • Viral delivery methods
    • Table 2: Adenovirus-based vaccines in clinical development
    • Table 3: MVA-based vaccines in development
    • Table 4: Alphavirus-vectored vaccines in development
    • Table 5: Other viral vectors under consideration for vaccine delivery
  • Bacterial delivery
  • Yeast-based delivery
    • Table 6: GlobeImmune' s product pipeline
  • Complexed DNA
  • Delivery of uncomplexed DNA
    • Table 7: Companies developing electroporation devices for DNA vaccine delivery
    • Table 8: Pipelines of DNA vaccines delivered using electroporation
    • Figure 5: Electroporation devices from Ichor, CytoPulse and Inovio
  • Adjuvants
    • Figure 6: Key reasons for adjuvant development
    • Table 9: Classification of vaccine adjuvants
  • Immune potentiators
    • Table 10: Members of the three most common families of pattern-recognition receptors
    • Table 11: Toll-like receptor agonists currently in development for vaccines
    • Figure 7: Pathway of events following TLR9 activation by CpG oligonucleotides
    • Table 12: Examples of current vaccine development programmes with CpG ODNs
    • Table 13: Examples of current vaccine development programmes with host-derived immune potentiators
  • Adjuvant delivery systems
    • Table 14: Examples of adjuvant delivery systems and development projects
    • Figure 8: Mechanism of Versamune action
    • Table 15: Advantages and disadvantages of VLP-based vaccines
  • Introduction to novel vaccine delivery platforms
    • Needle-free vaccine delivery
    • Liquid jet injectors
      • Table 16: Examples of liquid jet injectors for needle-free vaccine delivery
      • Table 17: Vaccine research projects using Bioject' s Biojector 2000
    • Solid dose injectors
      • Figure 9: Glide Pharma' s Solid Dose Injector
    • Delivery to the mucosal system and skin
    • Intranasal and inhaled vaccine delivery
      • Figure 10: Nasal anatomy
      • Table 18: Key companies advancing intranasal vaccine delivery
    • Oral vaccine delivery
      • Table 19: Product pipelines of key companies advancing oral vaccine delivery
      • Figure11: Avant Immunotherapeutic' s live bacterial vaccine vector
    • Plant-derived vaccines
    • Delivery through the skin
      • Table 20 Key companies developing vaccines for delivery through the skin
      • Figure 12: Becton Dickinson' s Soluvia microinjection device
      • Figure 13: Intercell' s vaccine patch for traveller' s diarrhoea
      • Figure 14: Use of the PassPort Patch and Applicator from Altea Therapeutics
      • Figure 15: The MicronJet microneedle delivery system from NanoPass
  • ‘Single-shot’ technologies
  • Conclusion
    • Adjuvants
    • DNA vaccines
    • Mucosal vaccines
    • Needle-free vaccines
    • Overall conclusion
  • Bibliography

2. ADVANCES IN VACCINES FOR INFECTIOUS DISEASES

  • Viral Infectious diseases
    • Figure 16: Viral infectious disease targets for vaccine research
  • Influenza
    • Figure 17: Areas of innovation for influenza vaccines
    • Table 21: Advantages of alternative methods of influenza vaccine manufacture
    • Table 22: Examples of H1N1 pandemic vaccine orders submitted to October 2009
    • Table 23: Leading manufacturer' s key areas of innovation
    • Table 24: Marketed influenza vaccines
    • Table 25: Influenza vaccines under development (Phase III/Pre-registration)
    • Table 26: Influenza vaccines under development (Phase II)
    • Table 27: Influenza vaccines under development (Phase I)
    • Table 28: Influenza vaccines under development (Preclinical)
  • Respiratory syncytial virus (RSV)
    • Table 29: Respiratory syncytial virus vaccines in development
  • Hepatitis B virus (HBV)
    • Table 30: Hepatitis B virus vaccines in development
  • Hepatitis C Virus (HCV)
    • Table 31: Hepatitis C virus vaccines in development
  • Cytomegalovirus (CMV)
    • Table 32: Cytomegalovirus vaccines in development
  • Human immunodeficiency virus (HIV)
    • Table 33: Examples of HIV vaccines in development
  • Herpes simplex virus type 2 (HSV-2)
    • Table 34: HSV-2 vaccines in development
  • Varicella zoster
  • Rotavirus
  • Norovirus
  • Bacterial Infectious Diseases
    • Figure 18: Bacterial infectious disease targets for vaccine research
  • Haemophilus influenzae type B (Hib)
  • Streptococcus pneumoniae
    • Table 35: Pneumococcal vaccines in development
  • Neisseria meningitidis
    • Table 36: Meningococcal vaccines in development
  • Tuberculosis
    • Table 37: Tuberculosis vaccines in development
  • Staphylococcus aureus
    • Table 38: Staphylococcus aureus vaccines in development
  • Clostridium difficile
    • Table 39: Clostridium difficile vaccines in development
  • Cholera
    • Table 40: Cholera vaccines in development
  • Typhoid Fever
  • E coli
    • Table 41: ETEC vaccines in development
  • Figure 19: Intercell' s vaccine patch for traveller' s diarrhoea
    • Campylobacter
  • Table 42: Campylobacter vaccines in development
    • Shigella
  • Helicobacter pylori
  • Group A and B streptococcus
    • Table 43: Group A and B streptococcus vaccines in development
  • Chlamydia
  • Emerging disease targets, bio-defence & parasitic disease targets
    • Figure 20: Emerging diseases, bio-defence and parasitic disease targets
  • Malaria
    • Table 44: Malaria vaccines in development
  • Leishmaniasis
  • Yellow Fever
  • Japanese Encephalitis
    • Table 45: Japanese encephalitis vaccines in development
  • Dengue Fever
    • Table 46: Dengue fever vaccines in development
  • West Nile virus
    • Table 47: West Nile virus vaccines in development
  • Chikungunya
  • Ebola and Marburg viruses
    • Table 48: Ebola and Marburg virus vaccines in development
  • Severe Acute Respiratory Syndrome (SARS)
  • Anthrax
    • Table 49: Anthrax vaccines in development
  • Smallpox
    • Table 50: Smallpox vaccines in development
  • Bibliography

3. ADVANCED THERAPEUTIC VACCINES

  • Introduction
    • Figure 21: Disease areas covered by therapeutic vaccine development
  • Advanced vaccines: Oncology
    • Table 51: Estimated new cases & mortality of various cancers in the US (2009)
  • Prophylactic vaccines
  • Cervical Cancer
  • Gastric Cancer
  • Therapeutic cancer vaccines
    • Figure 22: Vaccines in development by underlying technology
  • Cell-based cancer vaccines
    • Table 52: Advantages and disadvantages of cell-based cancer vaccines
  • Vaccines containing or expressing tumour antigens
    • Table 53: Advantages and disadvantages of tumour antigen-based vaccines
  • Idiotype vaccines
  • Summary of therapeutic vaccine development status
    • Figure 23: Vaccines in development by project stage
    • Figure 24: Therapeutic cancer vaccines in development by target indication
  • Brain Cancer
    • Table 54: Brain cancer vaccines in development
  • Haematological cancers
    • Table55: Haematological cancer vaccines in development
  • Breast Cancer
    • Table 56: Breast cancer vaccines in development
  • Lung Cancer
    • Table 57: Lung cancer vaccines in development
  • Melanoma
    • Table 58: Melanoma cancer vaccines in development
  • Gynaecological cancers
    • Table 59: Vaccines in development for gynaecological cancers
  • Gastrointestinal cancer
    • Pancreatic Cancer
      • Table 60: Pancreatic cancer vaccines in development
  • Colorectal Cancer
    • Table 61: Colorectal cancer vaccines in development
  • Liver Cancer
  • Genito-urinary cancer
    • Prostate Cancer
      • Table 62: Prostate cancer vaccines in development
    • Renal Cell Carcinoma
      • Table 63: Renal cell carcinoma cancer vaccines in development
    • Bladder cancer
  • Novel Therapeutic vaccines
    • Smoking cessation
      • Table 64: Smoking cessation vaccines in development
    • Inflammatory conditions: allergies and seasonal rhinitis
      • Table65: Allergy vaccines in development
    • Alzheimer' s disease
      • Table 66: Alzheimer' s disease vaccines in development
    • Diabetes
      • Table 67: Diabetes vaccines in development
  • Cardiovascular disease
  • Bibliography

4. MARKET TRENDS AND PROJECTIONS

  • Prophylactic vaccines for infectious diseases
    • The infectious disease vaccine pipeline
      • Figure 25: Prophylactic vaccines in development by project stage
      • Figure26: Number of prophylactic vaccines in development by target infectious agent
      • Figure 27: Stage of development for vaccines targeting the most popular infectious agents
      • Table 68: Late stage vaccine pipeline for other infectious targets (excluding influenza)
      • Table 69: Late stage influenza vaccine pipeline
      • Table 70: Forecast of prophylactic infectious disease vaccine market 2009-2015 (excluding pandemic H1N1 influenza)
      • Table 71: Forecast of pandemic H1N1 influenza vaccine market 2009-2013
  • Market trends, challenges and opportunities
    • Figure 28: Vaccine market drivers
    • Table 72: Deals between big pharma and vaccine companies in emerging vaccine markets
  • ADVANCED THERAPEUTIC VACCINES
    • Market trends, challenges and opportunities
      • Figure 29: Failed or stalled vaccine projects by vaccine type
      • Figure 30: Failed or stalled vaccine projects by cancer target
      • Figure 31: Possible reasons for the failure of therapeutic cancer vaccines
      • Table 73: Deals between vaccine developers and big pharma companies for therapeutic cancer vaccines (1997-2009)
      • Figure 32: Vaccines in development by project stage
      • Figure 33: Therapeutic cancer vaccines in development by target indication
      • Figure 34: Vaccines in late stage clinical development by cancer target
      • Figure 35: Vaccines in late stage clinical development by vaccine type
      • Table74: Likelihood of success for cancer vaccines currently in Phase III
    • Therapeutic vaccines for diseases other than cancer
      • Figure 36: Development pipeline of therapeutic vaccine for diseases other than cancer
      • Table 75: Deals between vaccine developers and big pharma companies for therapeutic vaccines in other indications
      • Table 76: Likelihood of success for therapeutic vaccines for diseases other than cancer currently in Phase III
    • Market projections: Oncology and other therapy areas
      • Table 77: Forecast of therapeutic vaccine market 2010-2015
      • Table 78: Forecast of therapeutic vaccine market 2012-2015 (US$ billion)
  • Conclusions

5. APPENDIX I

  • Table 79: Mergers, agreements and acquisitions with vaccine delivery companies
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