Abstract
Overview
Introduction
Influenza is a highly infectious disease which globally infects 10-20% of the population every year causing up to 500,000 deaths. Although all persons are at risk, the elderly and the young are the most vulnerable. For decades, trivalent prophylactic vaccines produced in chicken eggs have been used to reduce the burden of influenza with approximately 300 million doses produced globally.
Scope
- Evaluation of total 2004 global vaccine market value, historical growth since 1999 and major company market share
- Overview of major influenza vaccine products, producers and new product development
- Expert led discussion of drivers and resistors to cell culture flu systems in seasonal/pandemic scenarios
- Forecast value and demand (doses) for influenza vaccines in 2010 with launch predictions
Report Highlights
Despite the Chiron debacle, collective sales of influenza vaccines from Western producers surpassed the $1 billion level in 2004 with 10% growth over the previous year. Expanding recommendations for vaccination continue to fuel global demand.
Datamonitor forecasts that in the seven major markets demand for influenza vaccines will expand to 370 million doses and a market value of $3.7 billion by 2010. Global capacity will expand appropriately to meet this goal but competition will intensify with 11 predicted new product launches.
Cell culture flu could amount to 15% of US doses supplied in 2010 if the FDA can overcome safety concerns with the MDCK line. Although heralded as a much needed solution, cell culture flu still requires substantial capital investment.
Reasons to Purchase
- Review an up to date expert discussion of major dynamics within the global vaccine market
- Gain insight into how the market for influenza vaccines is now an attractive growth option
- Understand commercial drivers and resistors for cell culture flu systems
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Infectious Disease pharmaceutical analysis team
- CHAPTER 1 VACCINE MARKET OVERVIEW
- Towards the $10 billion barrier
- Vaccines - a good business to be in
- Differences between IMS Health and company-reported data
- Vaccines - a good business to be in
- The US market - strong products and stakeholder commitment
- Childhood vaccines - more coverage, better tracking
- Adult vaccines - playing catch-up
- Vaccine funding - moving to the private sector
- Prevnar maintains dominance of pneumococcal vaccines
- A successful year
- Strong clinical impact
- Overcoming vaccine shortages
- International roll-out
- Future challenges to Prevnar
- The US market - the strengthening adolescent segment
- GSK's Boostrix and Sanofi's Adacel
- Boostrix profile
- Adacel profile
- Sanofi's Menactra
- US recommendations for college students - a long time coming
- Menactra - a better meningitis vaccine
- Menactra - an expensive campaign
- Menactra - next steps
- Chiron's meningococcal ACWY vaccine
- HPV vaccines on the way
- Merck and GSK are developing preventative HPV vaccines
- Gardasil versus Cervarix
- Issues associated with STI vaccination
- HPV vaccine market potential
- GSK's Boostrix and Sanofi's Adacel
- 2005 - unprecedented commercial activity
- Aggressive GSK leads a growing global market
- Acquisition of ID Biomedical
- Novartis acquires weakened Chiron
- Further consolidation - Crucell moves on Berna
- Aggressive GSK leads a growing global market
- Towards the $10 billion barrier
- CHAPTER 2 THE INFLUENZA VACCINE MARKET
- Influenza is a global killer
- Influenza is a global burden, affecting mainly the elderly and the very young
- Influenza A and B cause annual epidemics
- Antigenic drift versus antigenic shift
- Seasonal (interpandemic) influenza
- Pandemic influenza
- A rare but recurrent event
- Avian influenza H5N1 - a pandemic strain?
- Global preparedness planning
- Despite decades of experience, producing flu vaccines is a difficult
business
- Current flu vaccines are classified into TIV and LAIV
- Unpredictable demand and commodity pricing
- Historical fluctuation in number of flu vaccine manufacturers
- Chiron debacle exposes the fragility of US seasonal vaccine supply
- Current value and volume estimation of the global seasonal influenza vaccine market
- The challenge of new product development
- The pros and cons of LAIV
- Intranasal administration is not enough to command premium pricing
- Restricted age indication prevents usage in high-risk groups
- FluMist requires storage at -15蚓 and cannot be refrozen following thawing
- Strategies designed to increase product uptake
- Influenza is a global killer
- CHAPTER 3 MARKETED AND DEVELOPMENTAL INFLUENZA VACCINES
- Overview of egg-based systems
- Producing an egg-based vaccine takes six months
- Adjuvantation significantly improves vaccine efficacy
- Fluzone
- Key facts
- Vaccine description
- Event screen
- Fluvirin
- Key facts
- Vaccine description
- Clinical trial data
- Event screen
- Fluarix
- Key facts
- Vaccine description
- Clinical trial data
- Event screen
- FluMist
- Key facts
- Vaccine description
- Clinical trial data
- Event screen
- Inflexal
- Key facts
- Vaccine description
- Clinical trial data
- Event screen
- Fluviral
- Key facts
- Vaccine description
- Ongoing clinical trials
- Event screen
- Summary
- Producing an egg-based vaccine takes six months
- Developmental influenza vaccines
- Egg-based systems - a time for replacement?
- Newer egg-based systems
- Solvay's Invivac is based on virosomal technology
- MedImmune's CAIV-T - a replacement for FluMist?
- Cell culture-based systems
- Vero, MDCK or PER.C6 cells?
- Solvay's Influvac TC has long been approved but not marketed
- Baxter's InfluJect (PreFluCel) - an uncertain future
- Chiron's cell culture influenza vaccine
- Sanofi-Crucell's inactivated split virus vaccine
- Nobilon's/BioDiem's LAIV
- Other technologies
- FluInsure - a proteosome-based approach
- FluBl噅 - producing hemagglutinin in insect cells
- PowderMed's plasmid DNA vaccine - is it safe?
- Acambis's "universal" M2 ion channel-based influenza vaccine
- Overview of egg-based systems
- CHAPTER 4 FUTURE OUTLOOK
- Several growth drivers fuel significant expansion of the influenza
vaccine market
- Commitments to increased vaccination
- Strategies aimed at increasing vaccination coverage
- Over 10 new vaccine launches by 2010
- Commitments to increased vaccination
- The global vaccine market 2010
- In the seven major markets, 2010 sales might be as high as $3.7 billion
- Consensus among different forecasts
- Assumptions
- Methodology
- In the seven major markets, 2010 sales might be as high as $3.7 billion
- Commercial drivers and resistors to cell culture flu
- Expensive to establish
- Expensive to license
- Who is most committed?
- The role of vaccination in a pandemic
- H5N1 prototype pandemic vaccines
- Sanofi Pasteur's alum adjuvanted vaccine
- Chiron's MF59 adjuvanted vaccine
- GSK's pandemic vaccine
- Others
- H5N1 prototype pandemic vaccines
- Vaccines versus antivirals
- Roche and the renaissance of Tamiflu
- Several growth drivers fuel significant expansion of the influenza
vaccine market
- APPENDIX A
- Segmenting the vaccine market
- Sales channels and limitations of IMS data
- Bibliography
- Journals
- Datamonitor reports
- Miscellaneous
- Press releases
- Other press releases (not sourced in the text)
- Websites
- List of Tables
- Table 1: Classification of global vaccines businesses
- Table 2: Major company reported vaccines sales, 1999-2005
- Table 3: Coverage estimates for school entry vaccinations, 2004-05 school year
- Table 4: Pediatric/VFC Vaccine Price List, December 2005
- Table 5: Adult vaccine price list, December 2005
- Table 6: Booster responses to the Tetanus, Diphteria and Pertussis antigens following Boostrix in individual aged 10-18 years
- Table 7: Scenarios measuring cost effectiveness of meningitis vaccination
- Table 8: Estimated prophylactic HPV vaccine peak sales
- Table 9: TIV versus LAIV vaccines: key common and differentiating factors
- Table 10: Unfolding of events at Chiron's Liverpool plant
- Table 11: Global influenza vaccine sales for key Western manufacturers, 2003-04
- Table 12: FluMist, a LAIV vaccine, is up to 77.5% more expensive than Fluzone, a TIV vaccine
- Table 13: Fluzone: key facts
- Table 14: Fluzone dosing by age group
- Table 15: Key Fluzone events, 2004-05
- Table 16: Fluvirin: key facts
- Table 17: Key Fluvirin events, 2004-05
- Table 18: Fluarix: key facts
- Table 19: Key Fluarix events, 2004-05
- Table 20: FluMist: key facts
- Table 21: Key FluMist events, 2004-05
- Table 22: Inflexal V: key facts
- Table 23: Inflexal clinical trial results
- Table 24: Key Inflexal V events, 2004-05
- Table 25: Fluviral: key facts
- Table 26: Key Fluviral events, 2004-05
- Table 27: Influenza vaccines comparator table
- Table 28: Key developmental influenza vaccines
- Table 29: Protection rates of Invivac versus Influvac
- Table 30: Comparative analysis of Vero, MDCK and PER.C6 cell lines
- Table 31: Estimated US 2003/04 and 2004/05 season influenza vaccine coverage, and 2010 healthy people goal
- Table 32: Census data, 2003 and 2010, seven major markets
- Table 33: Estimated populations for targeted influenza vaccination, 2003/04 influenza season
- Table 34: Actual and estimated influenza vaccination coverage rates, 2003-04 and 2010
- Table 35: Seasonal influenza vaccine market: 2003-04 estimation and 2010 forecast
- Table 36: Key GSK influenza vaccine-related events, 2004-05
- Table 37: Developmental H5N1 pandemic vaccines
- Table 38: Marketed influenza antivirals
- List of Figures
- Figure 1: Evaluating global vaccine market value and contribution, 2004
- Figure 2: Contribution of vaccine companies outside the top 10, 2004
- Figure 3: Market segmentation by region, 2004
- Figure 4: US Recommended and Childhood and Adolescent Immunization Schedule, 2005
- Figure 5: Extent of individuals receiving influenza vaccination by state, 2004
- Figure 6: Recommended Adult Immunization Schedule, 2005-06
- Figure 7: Global market segmentation by vaccine type, 2004
- Figure 8: Number of reported pertussis cases per year, 1922-2000
- Figure 9: Meningitis outbreaks by serogroups and community settings, 1994-2002
- Figure 10: Overview of Gardasil Phase III study presented at the Infectious Diseases Society of America (IDSA) annual meeting 2005
- Figure 11: Comparison of Merck's and GSK's candidate HPV preventative vaccines
- Figure 12: Potential positioning of developmental prophylactic HPV vaccines
- Figure 13: Global market share of major vaccines companies, 2004
- Figure 14: The acquisition of ID Biomedical increases GSK's manufacturing capacity and exposure to the US market
- Figure 15: Overview of GSK's flu vaccine strategy
- Figure 16: Global influenza disease burden
- Figure 17: Population at high risk of influenza infection or influenza-associated complications
- Figure 18: Influenza virus: structure and electron micrograph
- Figure 19: Antigenic drift versus antigenic shift
- Figure 20: Months of peak influenza activity per season and recommended vaccinations season
- Figure 21: Incidence and mortality caused by H5N1 between December 2003 and December 2005
- Figure 22: The six phases of pandemic preparedness
- Figure 23: US Influenza vaccine demand fluctuates between seasons
- Figure 24: Breakdown of high-risk individuals in whom flu vaccination was recommended in the 2004-05 influenza season
- Figure 25: Expected and delivered influenza vaccine for the US 2004/05 season
- Figure 26: Projected supplies for the 2005-06 influenza season
- Figure 27: Approved age groups for influenza vaccines expected to supply the 2005-06 US market
- Figure 28: Strategies to increase FluMist penetration in the short and the long term
- Figure 29: Strategies for the increase of influenza vaccination coverage
- Figure 30: Estimated US launches of developmental influenza vaccines
- Figure 31: The influenza vaccine market is expected to expand to over $3.7 billion by 2010 in the seven major markets
- Figure 32: Forecasting methodology
- Figure 33: Commercial and regulatory resistors against cell culture flu
- Figure 34: Tamiflu versus Relenza sales, seven major markets, 2000-04
- Figure 35: Global Tamiflu sales, 2000-H1 2005
- Figure 36: Global pandemic versus non-pandemic Tamiflu sales, Q1-Q3 2005
- Figure 37: Simplified schematic demonstrating vaccine supply channels to patients
- Segmenting the vaccine market
