Advances in Vaccine Technology and Delivery

Date: January 22, 2010
Pages: 164
Price:
US$ 1,390.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: AD961F4857CEN
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Advances in Vaccine Technology and Delivery
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.

KThe 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.

KUnbeatable 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.

KVaccines 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.

KProphylactic 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.

KInfluenza: 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.

KCancer 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.

KTHIS 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?

KAbout 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-Synthélabo. In 2002 Dr Barton founded a consulting business Pharmavision to provide independent, tailormade, pharmaceutical thematic research to investment houses and pharmaceutical companies.
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
Advances in Vaccine Technology & Delivery
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
  Table of Contents
Advances in Vaccine Technology & Delivery
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 APPENDI X I

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