Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Infectious Diseases pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the disease market
- Contributing experts
- Key metrics
- Datamonitor Pipeline Assessment Summary
- Related reports
- Upcoming related reports
- CHAPTER 2 HEPATITIS B - DISEASE BACKGROUND
- Summary
- Epidemiology
- Virus
- Transmission
- Risk groups
- Symptoms and disease progression
- Acute HBV infection
- Chronic HBV infection
- Diagnosis
- CHAPTER 3 MARKET DEFINITION AND OVERVIEW
- Summary
- Market definition for this report
- Current market situation
- Sales and volume use in HBV are increasing steadily
- Key events - Five new drug approvals since 1999 have increased
treatment diversity
- Country market analysis - US is leading the field, while market growth
is strongest in the EU5
- US: New antivirals experience a good uptake in a diverse market
- Japan: Lamivudine takes over from interferon alfa-2b
- EU5: Strong growth driven by adefovir
- Market drivers and restrictors - Disease awareness as the key factor
- Lack of awareness leads to low diagnosis and treatment rates for HBV
infections
- Segmentation of Hepatitis B
- HBV prevalence is highest in adults aged >25 years of age
- Men represent a higher percentage of HBV patients than women
- Sex between men accounts for an increasing percentage of HBV cases
- Immigrants account for the vast majority of infections
- HIV-HBV co-infected patients constitute a significant target population
- Unmet needs in hepatitis B
- A cure for hepatitis B is the key clinical unmet need
- The increasing level of HBV drug resistance is creating a need for
novel therapeutics
- Combination therapy approaches are needed for second- and third-line
therapy
- Market forecast
- The HBV market is set to grow to $1.2 billion by 2012, but will
stagnate afterwards
- Genericization will start in 2010, but its impact will remain limited
- The US will remain leader in sales, whereas Japan will show high
growth in volume use
- CHAPTER 4 PREVENTION AND TREATMENT
- Summary
- Vaccines
- HBV vaccination is recommended in more and more countries
- Plasma-derived vaccines have been replaced by safer, recombinant
products
- Currently available vaccines provide strong protection
- HBV vaccination is widely regarded as safe
- Coverage in most of the 7MM is high
- Currently marketed Hep B vaccines include single-antigen as well as
combination vaccines
- HBV pharmacotherapy
- Serum levels of ALT and HBV DNA are the key factors for treatment
initiation
- Suppression of HBV replication is the key endpoint in chronic
hepatitis B (CHB) therapy
- Currently marketed drugs are split into interferons and antivirals
- Choice of first-line treatment depends on multiple factors
- Interferons
- Antivirals
- CHAPTER 5 KEY PLAYERS IN THE HEPATITIS B MARKET
- Summary
- Gilead and Bristol-Myers Squibb will dominate the HBV market, whereas
GSK and Schering-Plough will lose share
- GSK - vaccines as future revenue drivers?
- Current position
- Strategic development
- Outlook
- Gilead - New hope in tenofovir
- Current position
- Strategic development
- Outlook
- Bristol-Myers Squibb - the one-product franchise
- Current position
- Strategic development
- Outlook
- Novartis - a new entrant with ambitions
- Current position
- Strategic development
- Outlook
- Roche - flying on the wings of Pegasys
- Current position
- Strategic development
- Outlook
- Schering-Plough - gloomy prospects
- Current position
- Strategic development
- Outlook
- CHAPTER 6 FORECASTING ANALYSIS
- New product launches
- Patent expiries
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Forecasts
- Forecast methodology
- CHAPTER 7 HBV PIPELINE: CLASS OVERVIEW AND R&D APPROACH
- Summary
- Pipeline overview: The immune system is the key target for future HBV
drugs
- Clinical trial design in hepatitis B
- CHAPTER 8 HBV VACCINES: LATE-STAGE PIPELINE ANALYSIS
- Summary
- Overview for prophylactic HBV vaccines
- Pipeline summary
- Definition of current comparator therapy
- Engerix-B
- Key improvement opportunities
- Heplisav
- Vaccine overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Datamonitor vaccine assessment summary
- Other late-stage HBV vaccine candidates
- Sci-B-Vac (SciGen)
- Supervax (Dynavax)
- Overview for therapeutic HBV vaccines
- Pipeline overview
- Hepatitis B Therapeutic Vaccine (Emergent BioSolutions)
- Hi-8 Hepatitis B Vaccine (Oxford BioMedica)
- CHAPTER 9 HBV THERAPEUTICS: LATE-STAGE PIPELINE ANALYSIS AND FORECAST
- Summary
- Overview for HBV therapeutics
- Pipeline summary
- Assessment of clinical and commercial attractiveness
- Comparative forecasts
- Definition of current comparator therapy
- Tenofovir/emtricitabine
- Drug overview
- Clinical trial data
- Trials investigating tenofovir as monotherapy in CHB patients
- Trials investigating tenofovir in combination with emtricitabine in
CHB patients
- Trials investigating tenofovir with and without emtricitabine in
HIV-HBV co-infected patients
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Clevudine
- Drug overview
- Clinical trial data
- The Korean Phase III trials - more data needed on long-term efficacy
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Other HBV therapeutics in late-stage development
- Valtorcitabine (Novartis/Idenix)
- EHT899 (Enzo Biochem Inc)
- Nitazoxanide (Romark Laboratories LC)
- Elvucitabine (Achillion Pharmaceuticals)
- Immunitin/HE2000 (Hollis-Eden Pharmaceuticals)
- Late-stage development compounds recently discontinued
- Pradefovir (Metabasis Therapeutics/Valeant/Schering-Plough)
- CHAPTER 10 COMBINATION THERAPIES
- Summary
- Combination therapy would prove a valuable alternative in resistant
patients and potentially increase the chance of eradicating the virus
- Combinations between two antivirals
- Lamivudine plus adefovir dipivoxil - no benefits in efficacy, but in
decelerating resistance development
- Combinations with telbivudine - potential benefits with tenofovir,
adefovir or valtorcitabine?
- Tenofovir plus emtricitabine - extending Truvada' s success in HIV?
- Others - focus on entecavir plus nucleotides
- Combinations between one interferon and one antiviral
- Combinations with peginterferon alfa-2a - building on the success in
HCV treatment?
- Combinations with interferon alfa-2b - no added value in efficacy
shown for lamivudine and ribavirin
- BIBLIOGRAPHY
- APPENDIX A - MARKET FORECAST DATA
- Seven major markets
- EU5
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- APPENDIX B
- Methodology
- Datamonitor forecast methodology
- Epidemiology forecasts
- Product forecasts
- Definition of a standard unit
- Datamonitor drug assessment summary
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor 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, Analyst, Infectious Diseases
- Disclaimer
- List of Tables
- Table 1: Key parameters of Hepatitis B for the seven major markets,
2006-2016
- Table 2: Forecast key products in Hepatitis B; 7MM, 2006-2016 ($m)
- Table 3: HBV nomenclature - viral and host-derived serum markers
- Table 4: HBV serology - diagnosis results
- Table 5: HBV - prevalence, diagnosis and treatment rates across the
7MM, 2004
- Table 6: Hep B vaccines - key products, 2007
- Table 7: Currently marketed HBV drugs
- Table 8: Factors influencing the choice of first-line therapy for HBV
- Table 9: HBV treatment options - comparison of resistances, mode of
administration, safety profile and duration of treatment
- Table 10: HBV therapy with interferons - factors indicating the
likelihood of response
- Table 11: Intron A: product profile
- Table 12: Events impacting sales forecast for Intron-A, 2006-2016
- Table 13: Pegasys: product profile
- Table 14: Events impacting sales forecast for Pegasys, 2006-2016
- Table 15: Mechanism of currently marketed antivirals, 2007
- Table 16: Zeffix: product profile
- Table 17: Events impacting sales forecast for Zeffix; 2006-2016
- Table 18: Hepsera: product profile
- Table 19: Events impacting sales forecast for Hepsera; 2006-2016
- Table 20: Baraclude: product profile
- Table 21: Events impacting sales forecast for Baraclude 2006-2016
- Table 22: Tyzeka: product profile
- Table 23: Events impacting sales forecast for Tyzeka, 2006-2016
- Table 24: Key players in the hepatitis B market, 2007
- Table 25: Datamonitor' s launch dates for HBV therapeutics in the 7MM,
2007-2016
- Table 26: Patent expiry dates for HBV therapeutics in the 7MM,
2007-2016
- Table 27: Number of key hepatitis B pipeline candidates by class and
phase of development, September 2007
- Table 28: HBV prophylactic vaccines pipeline - overview, September 2007
- Table 29: Engerix-B - vaccine profile
- Table 30: Heplisav - vaccine profile
- Table 31: Heplisav - key Phase III clinical trials, 2007
- Table 32: Heplisav - key Phase II clinical trials, 2007
- Table 33: HBV therapeutic vaccines pipeline - overview, September 2007
- Table 34: HBV therapy - clinical pipeline overview, 2007
- Table 35: HBV therapy - preclinical pipeline overview, 2007
- Table 36: Entecavir - comparative profile
- Table 37: Tenofovir - product profile
- Table 38: Tenofovir - clinical trials for monotherapy, 2007
- Table 39: Tenofovir - trials for HBV therapy with tenofovir plus
emtricitabine (Truvada)
- Table 40: Tenofovir - Trials for HIV/HBV co-infection
- Table 41: Impacting factors on the revenues of tenofovir, 2006-2016
- Table 42: Clevudine - drug profile
- Table 43: Clevudine - terminated clinical trials in Korea
- Table 44: Clevudine - ongoing clinical trials
- Table 45: Impacting factors on the revenues of clevudine, 2006-2016
- Table 46: Recently discontinued HBV therapeutics, 2007
- Table 47: Combination therapies - clinical trials for lamivudine +
adefovir dipivoxil
- Table 48: Combination therapies - clinical trials for combinations
involving telbivudine
- Table 49: Combination therapies - other clinical trials
- Table 50: Combination therapies - clinical trials based on
peginterferon alfa-2a
- Table 51: Combination therapies - clinical trials based on interferon
alfa-2b
- Table 52: Seven major market Hepatitis B drug sales ($000s) forecasts,
2006-2016
- Table 53: EU5 Hepatitis B drug sales ($000s) forecasts, 2006-2016
- Table 54: US Hepatitis B drug sales ($000s) forecasts, 2006-2016
- Table 55: Japan Hepatitis B drug sales ($000s) forecasts, 2006-2016
- Table 56: France Hepatitis B drug sales ($000s) forecasts, 2006-2016
- Table 57: Germany Hepatitis B drug sales ($000s) forecasts, 2006-2016
- Table 58: Italy Hepatitis B drug sales ($000s) forecasts, 2006-2016
- Table 59: Spain Hepatitis B drug sales ($000s) forecasts, 2006-2016
- Table 60: UK Hepatitis B drug sales ($000s) forecasts, 2006-2016
- Table 61: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Datamonitor drug assessment summary of pipeline drugs in
development for chronic hepatitis B, 2007
- Figure 2: Global HBV prevalence, 2005
- Figure 3: HBV - prevalence and mortality, 2004
- Figure 4: HBV - impact of vaccination on case numbers, US, 1978-2006
- Figure 5: HBV - key structural elements
- Figure 6: HBV - lifecycle
- Figure 7: HBV - routes of transmission
- Figure 8: HBV - major routes of transmission across the seven major
markets, 2004
- Figure 9: Hepatitis B - course of disease
- Figure 10: HBV - risk of chronic HBV carriage by age of infection
- Figure 11: HBV disease progression - factors triggering development of
cirrhosis
- Figure 12: HBV serology - development of ALT and HBV DNA levels over
the course of HBV infection
- Figure 13: HBV therapeutics market sales value across the 7MM by class
and molecule, 2003-06
- Figure 14: HBV therapeutics market volume across the 7MM by class and
molecule, 2003-06
- Figure 15: Key events impacting the HBV therapeutics market, 1999-2006
- Figure 16: Performance of the US, EU5 and Japan HBV therapeutics
markets, 2006
- Figure 17: US HBV market - overview of sales and volume use, 2003-06
- Figure 18: Japanese HBV market - overview of sales and volume use;
2003-06
- Figure 19: EU5 HBV market - overview of sales and volume use, 2003-06
- Figure 20: HBV market - drivers and restrictors, 2007
- Figure 21: Key target groups for HBV therapy
- Figure 22: Incidence of acute hepatitis B by age group, US, 1990-2005
- Figure 23: Incidence of acute HBV infection by sex, US, 2005
- Figure 24: Trends in selected epidemiologic characteristics in
patients with acute HBV infection, US 1999-2005
- Figure 25: Unmet needs in hepatitis B
- Figure 26: HBV market - sales and volume use forecast across the, 7MM
by molecule, 2006-2016
- Figure 27: Impact of genericization on sales and volume use of HBV
drugs, 7MM, 2006-2016
- Figure 28: HBV therapeutics - sales and volume use forecast by
country, 7MM, 2006-2016
- Figure 29: Hepatitis B vaccination - geographical spread of
vaccination introduction and coverage, 2005
- Figure 30: Hepatitis B vaccination - recommendations across the 7MM,
2007
- Figure 31: HBV vaccination - coverage rates, 2007
- Figure 32: Chronic HBV - treatment algorithms
- Figure 33: HBV treatment options - comparison of efficacy in HBeAg+
and HBeAg- patients, 2007
- Figure 34: HBV - cost of treatment in the US, 2006
- Figure 35: Interferon therapy - SWOT analysis, 2007
- Figure 36: Intron-A (interferon alfa 2b) sales in the 7MM for HBV,
2003-06
- Figure 37: Intron-A: sales forecast for HBV, 7MM, 2006-2016
- Figure 38: Pegasys (peginterferon alfa 2a) - 7MM HBV sales 2003-06
- Figure 39: Pegasys - sales forecast in HBV, 7MM, 2006-2016
- Figure 40: Antiviral therapy - SWOT analysis, 2007
- Figure 41: Zeffix (lamivudine) - 7MM sales 2003-06
- Figure 42: Zeffix - sales forecast in HBV, 7MM, 2006-2016
- Figure 43: Hepsera (adefovir dipivoxil) - 7MM sales in HBV, 2003-06
- Figure 44: Hepsera - sales forecast in HBV, 7MM, 2006-2016
- Figure 45: Baraclude (entecavir) - 7MM sales in HBV, 2003-06
- Figure 46: Baraclude - sales forecast, 7MM, 2006-2016
- Figure 47: Tyzeka (telbivudine) - 7MM sales, 2003-06
- Figure 48: Tyzeka - sales forecast, 7MM, 2006-2016
- Figure 49: HBV drugmakers - portfolio focus
- Figure 50: Sales forecast for the HBV drugs market by company - 7MM,
2006-2016
- Figure 51: HBV drugs market by company market share, 2006, 2011 and
2016
- Figure 52: GSK - HBV antiviral revenues by country, 7MM, 2003-07
- Figure 53: GSK - HBV vaccines portfolio, 2007
- Figure 54: GSK - timeline of HBV product approvals, 1993-2007
- Figure 55: Gilead - strategic development of HBV portfolio, 2007
- Figure 56: Bristol-Myers Squibb - strategic development of Baraclude
(entecavir)
- Figure 57: Novartis - strategic development of HBV portfolio, 2007
- Figure 58: HBV pipeline - key focal points of development, 2007
- Figure 59: Engerix-B - efficacy in different age groups
- Figure 60: Heplisav - results of Phase III trial, (Asia, 2005-07)
- Figure 61: Heplisav - results of Phase II/III trial (Singapore, 2005)
- Figure 62: Heplisav - strategic assessment
- Figure 63: Datamonitor drug assessment summary of HBV therapeutics
late-stage pipeline, 2007
- Figure 64: Sales forecasts for HBV therapeutics pipeline, 7MM,
2006-2016
- Figure 65: Tenofovir (HBV) - sales forecast in 7MM by country,
2006-2016
- Figure 66: Datamonitor' s competitive positioning analysis of
tenofovir, 2007
- Figure 67: Clevudine - HBV DNA reduction in Phase III trial in HBeAg+
patients
- Figure 68: Clevudine - HBV DNA reduction in Phase III trial in HBeAg-
patients
- Figure 69: Clevudine - sales forecast in HBV for the 7MM by country,
2006-2016
- Figure 70: Clevudine - impact of genericization, 7MM, 2006-2016
- Figure 71: Datamonitor' s competitive positioning analysis of
clevudine, 2007
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