Table of Contents
- About the Infectious Diseases Pharmaceutical Analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Key metrics
- CHAPTER 2 EPIDEMIOLOGY
- Incidence
- Risk groups
- Transmission and symptoms
- Diagnosis
- Virus subtypes
- Prevention and treatment
- Vaccination prevents influenza infection
- Antivirals can provide symptom relief and accelerate recovery
- Antigenic shift and drift
- Seasonal influenza epidemics
- Influenza pandemics
- Recent pandemics - fearsome lessons
- Current pandemic status - waiting for the wave
- H5N1 - the next pandemic virus?
- Pandemic scenario - dramatic outlook for public health and economy
- Preparing for disaster - national and international pandemic planning
- CHAPTER 3 MARKET DEFINITION AND OVERVIEW
- Market size and growth estimates
- Current vaccine classes
- Trivalent inactivated vaccines
- Life-attenuated influenza vaccines
- Vaccine manufacturing
- Egg-based manufacturing is lengthy and inflexible
- Cell-based manufacturing would offer big advantages
- MDCK (Madin Darby Canine Kidney Cells)
- Vero cells
- Per.C6 cells
- Although highly promising, cell culture-based manufacturing still
needs further development
- Influenza vaccine supply - a yearly gamble
- The number of vaccine manufacturers is fluctuating
- Manufacturing capacities are expanding, but still not sufficient to
meet global needs
- Manufacturing problems can have a dramatic impact - the Chiron case
- Influenza vaccine demand fluctuates considerably and is hard to predict
- Time shifts between supply and vaccination schedules lead to fading
demand as the flu season progresses
- Changes in recommendations and subjective perception of risk have a
significant impact on demand
- Vaccination coverage rates vary among countries
- Complex distribution pathways can delay timely vaccine supply
- Country analysis
- US - actively encouraging increased vaccination and influenza research
- Pull - enlarging the national market size
- Push - supporting the entry of additional products and suppliers
- EU5 - slowly waking up to the influenza challenge
- A European Influenza Task Force could improve co-ordination between
European countries and the industry
- Flu vaccines are cheaper in Europe than in the US
- Reimbursement policies favor risk groups
- Japan - low awareness and distrust hamper vaccine uptake
- Japan has a low vaccination coverage due to low awareness and
unfavorable reimbursement rates
- Pandemic preparedness is a central concern of the Japanese government
- Unmet needs in influenza vaccines
- Pandemic vaccines could moderate the impact of a flu pandemic
- Extending of manufacturing capacities would guarantee sufficient
vaccine supply
- Adjuvants could lead to better efficacy of vaccines in the elderly and
reduce the amount of antigen needed for immunization
- Faster manufacturing techniques would make vaccine production more
flexible
- Universal vaccines could eliminate the need for yearly updates
- Needle-free administration methods would make vaccination more
convenient
- CHAPTER 4 CURRENT PLAYERS AND THEIR STRATEGIES
- Overview
- Sanofi pasteur - expanding market leadership
- Current position
- Strategic development
- Cell-culture-based manufacturing - high hopes for Per.C6
- Capacity - leading the field
- Adjuvants - falling behind?
- Pandemic vaccines - first-to-market in the US?
- Strategic outlook
- Novartis Vaccines - recovering from Chiron' s failure
- Current position
- Fluvirin
- Agrippal S1
- Fluad
- Begrivac
- Strategic development
- Expanding reach - acquisition of Chiron provided access to influenza
vaccine market
- Cell-culture-based manufacturing - first-to-market with Optaflu?
- Capacity - new facilities in the US and Europe set to increase
production
- Adjuvants - MF59, a new paradigm?
- Pandemic vaccines - Europe as stepping stone
- Strategic outlook
- GSK - the lucky third
- Current position
- Fluarix
- FluLaval/Fluviral
- Strategic development
- Expanding reach - acquisition of ID Biomedical opens gate to the US
market
- Cell-culture-based manufacturing - lagging behind the competition
- Capacity - acquisition of Wyeth' s Marietta facility set to speed up
cell-based manufacturing
- Adjuvants -acquisition of Corixa provides access to novel
technologies
- Pandemic vaccines - first and second generation candidates show
promising prospects
- Strategic outlook
- MedImmune - new hope in pediatric treatment
- Current position
- Strategic development
- Expanding reach - positioning and market penetration as main issues
- Cell-culture-based manufacturing - catching up with the giants
- Capacity - fill/finish as critical bottleneck
- Pandemic vaccines - joining forces with NIAID
- Strategic outlook
- CSL - preparing to enter the US market
- Current position
- Strategic development
- Expanding reach - US launch likely in the near future
- Capacity - doubling production for the US market
- Pandemic vaccines - slim chances to match the competition
- Strategic outlook
- Solvay - failing to commercialize on Influvac TC
- Current position
- Influvac
- Invivac/Inflexal V
- Strategic development
- Cell-culture-based manufacturing - Influvac TC loses competitive
advantage due to manufacturing delay
- Capacity - it' s all about cell-based production
- Pandemic vaccines - projects still in early stages
- Strategic outlook
- CHAPTER 5 PATIENT-BASED FORECAST ANALYSIS
- patient-based forecasting model
- Limitations of the patient-based forecasting model
- CHAPTER 6 R&D APPROACH
- Classification of pipeline products
- Seasonal influenza vaccines
- Pandemic influenza vaccines
- Clinical trial design in influenza vaccine studies
- CHAPTER 7 PIPELINE ANALYSIS SEASONAL INFLUENZA
- Pipeline overview for seasonal influenza
- Late-stage pipeline summary
- Comparative assessment
- Definition of current comparator therapy
- Seasonal influenza vaccine gold standard: Fluzone
- Optaflu (Novartis Vaccines)
- Drug overview
- Clinical trial data
- Phase III trial (EU) - comparison of safety, tolerability and
immunogenicity of influenza vaccines in adults and elderly
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- drug assessment summary
- FluBlØk (Protein Sciences/UMN Pharma)
- Drug overview
- Clinical trial data
- Phase II/III - immunogenicity and safety of trivalent recombinant
baculovirus-expressed hemagglutinin influenza vaccine in healthy adults
- Phase IIb - dose-related safety and immunogenicity of a trivalent
baculovirus-expressed influenza-virus hemagglutinin vaccine in elderly
adults
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- drug assessment summary
- Flu Improved (GlaxoSmithKline)
- Drug overview
- Clinical trial data
- Phase II trial (EU) - Study to evaluate the immunogenicity and the
safety of an adjuvanted influenza vaccine candidate
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- drug assessment summary
- Seasonal flu vaccines (Sanofi pasteur)
- Flu Micro-Injection
- Flu Infants
- Flu vaccine - new formulation
- FluInsure (GlaxoSmithKline)
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- drug assessment summary
- Immunostimulant seasonal influenza vaccine (Iomai)
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- drug assessment summary
- Late-stage pipeline vaccines developed outside the seven major markets
- Influsome-Vac (NasVax)
- LAIV (BioDiem, Nobilon)
- Early-stage vaccines for prevention of seasonal influenza
- DNA vaccines
- PowderMed - Pfizer' s entry route into the vaccine business
- Universal vaccines
- Late-stage development compounds recently discontinued
- InfluJect (Baxter) - an uncertain future
- CHAPTER 8 PIPELINE ANALYSIS PANDEMIC INFLUENZA
- Pipeline overview for pandemic influenza
- Late-stage pipeline summary
- Comparative assessment
- Definition of current comparator therapy
- H5N1 vaccines
- Sanofi pasteur
- H5N1 influenza virus vaccine
- GSK
- Novartis Vaccines
- Baxter
- CSL
- H9N2 vaccines
- Novartis Vaccines
- GSK
- Crucell
- H2N2 vaccines
- Early-stage vaccines for prevention of pandemic influenza
- APPENDIX A - BIBLIOGRAPHY
- APPENDIX B
- Limitations of IMS data
- About
- Healthcare' s therapy area capabilities
- About the Infectious Diseases analysis team
- Key therapy team members
- Holger Rovini, Head of Respiratory and Infectious Diseases
- Hedwig Kresse, Associate Analyst, Infectious Diseases
- Disclaimer
- List of Tables
- Table 1: Key influenza parameters for the seven major markets
- Table 2: Companies developing cell-based manufacturing and US funding
for cell culture development
- Table 3: Current and future production capacity of key influenza
vaccine manufacturers
- Table 4: Influenza vaccination rates in the US, 2004
- Table 5: Influenza vaccine catalog prices by manufacturer, US. 2005-06
- Table 6: Influenza pandemic contracts announced to date
- Table 7: Key needle-free influenza vaccine administration methods in
development, 2007
- Table 8: Acquisitions in the influenza vaccine space, 2005-06
- Table 9: Fluzone dosages
- Table 10: Fluvax dosages by age group
- Table 11: Late-stage pipeline seasonal influenza, February 2007
- Table 12: drug assessment parameters
- Table 13: Fluzone (Sanofi pasteur) - product profile
- Table 14: Fluzone formulations, 2006-07
- Table 15: Fluzone - efficacy in children aged 6-24 months
- Table 16: Optaflu (Novartis) - product profile
- Table 17: Optaflu - clinical trial summary
- Table 18: FluBlØk (Protein Sciences) - product profile
- Table 19: FluBlØk - clinical trial summary
- Table 20: Flu Improved (GSK) - product profile
- Table 21: Flu Improved - clinical trial summary
- Table 22: FluInsure (GSK) - product profile
- Table 23: FluInsure - clinical trial summary
- Table 24: Immunostimulant seasonal influenza vaccine (Iomai) - product
profile
- Table 25: Early-stage seasonal and universal influenza vaccines,
February 2007
- Table 26: Key DNA flu vaccines in development
- Table 27: Recently discontinued late-stage influenza vaccines
- Table 28: Pandemic influenza - late-stage pipeline overview
- Table 29: H5N1 influenza virus vaccine (Sanofi pasteur) - product
profile
- Table 30: Daronrix (GSK) - product profile
- Table 31: H5N1-007 (GSK) - product profile
- Table 32: Focetria (Novartis) - product profile
- Table 33: H5N1 pandemic vaccine (Baxter) - product profile
- Table 34: H5N1 pandemic vaccine (CSL) - product profile
- Table 35: H9N2 pandemic vaccine (Novartis) - product profile
- Table 36: H9N2 pandemic vaccine (GSK) - product profile
- Table 37: H9N2 pandemic vaccine (Crucell) - product profile
- Table 38: H2N2 pandemic vaccine (GSK) - product profile
- Table 39: Early stage pipeline pandemic influenza vaccines, February
2007
- List of Figures
- Figure 1: Drivers and restrictors in the influenza vaccine market
- Figure 2: Influenza vaccine market size forecast (7MM), 2006-16
- Figure 3: pipeline assessment summary - seasonal influenza vaccines
- Figure 4: pipeline assessment summary - pandemic influenza vaccines
- Figure 5: Global annual influenza disease burden
- Figure 6: Population at high risk of influenza infection or
influenza-associated complications
- Figure 7: Influenza A virus: structure and electron micrograph
- Figure 8: Antigenic drift versus antigenic shift
- Figure 9: Recommended vaccination schedule and months of peak
influenza activity, US 1976-2006
- Figure 10: Development of a pandemic influenza virus
- Figure 11: Overview over influenza pandemics in the 20th century
- Figure 12: WHO and CDC classification systems for pandemic threat
- Figure 13: Emergence of new Influenza A subtypes, 1977-2006
- Figure 14: Cumulative number of confirmed human cases of avian
Influenza A/(H5N1)
- Figure 15: Spread of H5N1 in poultry, wild birds and humans, 1996-2006
- Figure 16: Current spread of H5N1 in poultry and wild birds, January
2007
- Figure 17: Geographical spread of influenza vaccine sales, 2006
- Figure 18: Growth drivers of the flu vaccine market
- Figure 19: TIV and LAIV - key common and differentiating factors
- Figure 20: Steps of the influenza vaccine manufacturing process and
involved stakeholders
- Figure 21: Egg-based vaccine manufacturing
- Figure 22: Comparative analysis of MDCK, Vero and Per.C6 cells
- Figure 23: Vaccine providers for the US market, 2000-06
- Figure 24: Vaccine manufacturers in the seven major markets, 2006
- Figure 25: Global influenza vaccine manufacturing capacity, 1994-2006
- Figure 26: Influenza vaccine manufacturing facilities, 2006
- Figure 27: High-risk individuals recommended for flu vaccination, US.
2004-05
- Figure 28: Chiron - share price in response to events, Aug 2004- May
2005
- Figure 29: Expected, delivered and demanded influenza vaccine supply
for the US, 2004-05 season
- Figure 30: Influenza vaccine supply versus demand in the US, 1980-2006
- Figure 31: Flu vaccine supply and demand in relation to population
recommended for vaccination, US 2003-06
- Figure 32: Supply versus demand in a typical flu season
- Figure 33: Global influenza vaccination coverage, 2002-03 season
- Figure 34: Drivers and restrictors for influenza vaccination
- Figure 35: US influenza vaccine distribution network
- Figure 36: Use of different providers for influenza vaccination, US,
2005-06
- Figure 37: US government strategies to foster growth of the national
flu vaccine market
- Figure 38: US average prices per dose in multi-dose vials, TIVs,
2002-06
- Figure 39: Unmet needs in influenza vaccines
- Figure 40: Leading players in the influenza vaccine market, US and
EU5, 2005
- Figure 41: Sanofi pasteur - influenza vaccine strategy
- Figure 42: Novartis Vaccines - influenza vaccine strategy
- Figure 43: GSK - influenza vaccine strategy
- Figure 44: MedImmune - influenza vaccine strategy
- Figure 45: CSL - influenza vaccine strategy
- Figure 46: Solvay - influenza vaccine strategy
- Figure 47: Influenza vaccine clinical trial process
- Figure 48: assessment of seasonal influenza pipeline vaccines
- Figure 49: Fluzone - strengths and weaknesses
- Figure 50: Comparison of seroprotection rates between Optaflu and
Agrippal in EU Phase III trial, 2006
- Figure 51: Optaflu - competitive positioning analysis for seasonal
influenza, 2007
- Figure 52: FluBlØk: - efficacy results of Phase IIb trial
- Figure 53: FluBlØk - competitive positioning analysis for seasonal
influenza, 2007
- Figure 54: Flu Improved - competitive positioning analysis for
seasonal influenza, 2007
- Figure 55: FluInsure - competitive positioning analysis for seasonal
influenza, 2007
- Figure 56: Iomai' s immunostimulant seasonal influenza vaccine -
competitive positioning analysis for seasonal influenza, 2007
- Figure 57: Pandemic versus pre-pandemic vaccination strategy
- Figure 58: drug assessment summary - pandemic influenza pipeline
vaccines
- Figure 59: competitive positioning analysis of H5N1 influenza virus
vaccine (Sanofi pasteur) for pandemic influenza, 2007
- Figure 60: competitive positioning analysis of Daronrix (GSK) for
pandemic influenza, 2007
- Figure 61: competitive positioning analysis of H5N1-007 (GSK) for
pandemic influenza, 2007
- Figure 62: competitive positioning analysis of Focetria (Novartis)
for pandemic influenza, 2007
- Figure 63: competitive positioning analysis of H5N1 pandemic vaccine
(Baxter) for pandemic influenza, 2007
- Figure 64: competitive positioning analysis of H5N1 pandemic vaccine
(CSL) for pandemic influenza, 2007
- Figure 65: competitive positioning analysis of H9N2 pandemic vaccine
(Novartis) for pandemic influenza, 2007
- Figure 66: competitive positioning analysis of H9N2 pandemic vaccine
(GSK) for pandemic influenza, 2007
- Figure 67: competitive positioning analysis of H9N2 pandemic vaccine
(Crucell) for pandemic influenza, 2007
- Figure 68: competitive positioning analysis of H2N2 pandemic vaccine
(GSK) for pandemic influenza, 2007
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