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Published by: Datamonitor
Published: May. 2, 2003 - 180 Pages
Table of Contents
CHAPTER 1 EXECUTIVE SUMMARY
- Scope 3
- Datamonitor insight into the hepatitis B and C Markets
- Viral genotype plays an important role in determining the efficacy of interferon
- therapy in both hepatitis B (HBV) and hepatitis C (HCV) treatments. Datamonitor
- believes this factor will play a key role in shaping the future dynamics of both
- markets revealing two main strategies. Companies can either follow a standard
- broad-spectrum approach targeting the mass patient population and/or begin
- focusing on niche groups such as ‘non-responders’
- An increase in antiviral product development, especially in HBV, will boost therapy
- rates as treatment regimes move towards the combination format observed in the
- HIV market. Datamonitor believes this trend will address not only issues of
- resistance, but also promote increased efficacy, patient compliance and physician
confidence
- Phase III clinical trials of Roche’s Pegasys have set a precedent for increased trial
- size and length. Development costs are spiraling, both raising entry barriers for
- smaller companies and increasing the necessity to form marketing alliances
- In comparision with HCV, the HBV market is more attractive to smaller companies.
- Costs are lower and competitive rivalry less intense. Datamonitor expects alliance
- formation, portfolio synergies and ‘out-licensing’ to be key techniques used by
- biotechs for revenue maximization
- Key metrics
CHAPTER 2 PATIENT POTENTIAL
- Introduction
- Hepatitis C
- Disease definition
- HCV disease progression
- Acute infection
- Chronic infection
- End-stage liver disease
- Epidemiology
- US
- Japan
- Europe
- Epidemiological conclusion
- HCV segmentation
- HCV genotype
- Ethnic segmentation
- Comorbidities
- HCV diagnosis and treatment
- HCV diagnosis and treatment potential
- Future trends in HCV incidence and prevalence
- Unmet needs
- Treatment response rates
- Side effects
- Diagnosis rate
- Hepatitis B
- Disease definition
- HBV disease progression
- Acute infection
- Chronic infection
- Epidemiology
- US
- Japan
- Europe
- Epidemiological conclusion
- HBV segmentation
- HBV genotype
- Lamivudine resistance
- Comorbidities
- HBV diagnosis and treatment rates
- Future trends in HBV incidence and prevalence
- Vaccine coverage in the seven major markets
- Vaccine coverage in the emerging markets
- Unmet needs
- Treatment response rates
- Drug resistance
- Patient compliance
CHAPTER 3 R&D APPROACH
- Introduction
- Classification of HCV pipeline products
- Interferons and antivirals
- Mechanisms of action
- Current market performance
- Immunomodulatory drugs
- Therapeutic vaccines
- HCV clinical trial design
- Early-stage trials
- Late-stage trials
- Pegasys monotherapy
- Pegasys/ribavirin combination therapy
- Conclusions
- Clinical trial endpoints
- Sustained viral response
- Virologic response
- Normalization of ALT
- Classification of HBV pipeline products
- Interferons
- Antivirals
- Immunomodulatory drugs
- HBV clinical trial design
- Early-stage trials
- Late-stage trials
- Clinical trial endpoints in hepatitis B
- Anti-HBe seroconversion
- Histologic response
- Normalization of ALT
- Virologic response
CHAPTER 4 PIPELINE ANALYSIS
- HCV late-stage pipeline overview
- Key companies involved in the HCV pipeline
- Schering-Plough and Roche
- Smaller players in the HCV market
- R&D company strategy
- Drug delivery
- New indications
- Targeting niche HCV populations
- HBV late-stage pipeline overview
- Key companies involved in the HBV pipeline
- Gilead
- Bristol-Myers Squibb
- Smaller HBV companies
- R&D company strategy
- Key licensing strategies in HBV
- New indications
- Portfolio design in hepatitis B
CHAPTER 5 LATE-STAGE DRUG ANALYSIS & FORECASTS
- The HCV late-stage pipeline
- Definition of current comparator therapy
- PEG-Intron/Rebetol response rates
- Marketing strength
- Other comparative factors
- Zadaxin 88
- Profile
- Zadaxin overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- BILN 2061
- Profile
- BILN 2061 overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Ceplene99
- Profile
- Ceplene overview
- Clinical trial data
- Patient potential
- Marketing factors
- InnoVac-C
- Profile
- Innovac-C overview
- Clinical trial data
- Patient potential
- Marketing factors
- ISIS 14803
- Profile
- Isis 14803 overview
- Phase I/II clinical trial data
- Phase II clinical trial data
- Merimepodib
- Profile
- Merimepodib overview
- Clinical trial data
- Omega interferon
- Profile
- Omega interferon overview
- Clinical trial data
- The HBV late-stage pipeline
- Definition of current comparator therapy
- Epivir-HBV response rates and resistance
- Marketing strength
- Drug delivery and side effects
- Emtricitabine
- Profile
- Emtricitabine overview
- Phase II clinical trials
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2011
- Launch of telbivudine and elvucitabine
- Launch of clevudine
- Expansion into the emerging markets
- Growing patient potential
- Entecavir
- Profile
- Entecavir overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2011
- Launch of telbivudine, elvucitabine and clevudine
- Expansion into the emerging markets
- Telbivudine
- Profile
- Telbivudine overview
- Phase III telbivudine trial
- Phase IIb clinical trial data
- Patient potential
- Market potential
- Satisfaction of unmet needs
- Forecasts to 2011
- Use in combination therapy
- Zadaxin 131
- Profile
- Zadaxin overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2011
- Launch into the major HBV markets
- Launch into the HCV major markets
- Growth of the HBV antiviral market
- Continued success in the emerging markets
- Other drugs in class
- Clevudine
- Clevudine overview
- Phase I/II clinical trials
- Elvucitabine
- Elvucitabine overview
- Clinical trial data
- Further Phase II trials
- HE2000
- Pegasys
- Clinical trial data
- Comparison of key HBV compounds
- Response rates
- Resistance development
- Side effects
- Drug delivery
- Marketing strength
- Comparative forecasts
CHAPTER 6 APPENDIX A
- Contributing experts
- List of tables
- List of figures
- Bibliography
- Conferences
- Websites
- Company Websites
- Further Reading
CHAPTER 7 APPENDIX B: ABOUT DATAMONITOR
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare’s research and analysis methodologies
- Datamonitor Healthcare’s therapy area capabilities
- Datamonitor Healthcare’s Consulting expertise
- Datamonitor’s Therapeutic Consulting expertise
- Key therapy team members
- Simon Hemsworth, Director of Therapy Area Analysis
- John Savopoulos , Director of Infectious Diseases
- David Abramson, Therapeutic Lead Consultant
- Disclaimer
AbstractIntroduction:
The Hepatitis markets have high patient potential, despite declining transmission rates. In addition, the current treatments available are not efficacious in the majority of patients and, as such, both markets contain high levels of clinical unmet need. However, commercial interest in these markets has been increasing, with a relatively large number of compounds poised for HBV market entry over the next 5-7 years and the success of Schering-Plough’s PEG-Intron following its launch in 2001.
Scope:
* Review of patient potential across the seven major markets, including patient segmentation by genotype and disease progression
* Overview of current clinical trial design
* In depth analysis of the HCV late-stage pipeline using current gold standard therapy to compare product efficacies
* HBV late-stage pipeline analysis, including forecasts of key Phase III products up to 2011
Report Highlights:
An increase in late-stage HBV antiviral product development will boost therapy rates and drive treatment regimens towards combination strategies as seen in the HIV market. This will not only reduce resistance but also potentially increase treatment efficacy, thereby boosting patient compliance and physician confidence
The viral genotype plays an important role in determining the efficacy of interferon therapy in both HBV and HCV infections. However, while the impact of HCV genotypes have been well characterized the HBV genotype remains comparatively under-studied. Ultimately, viral genotype will play a key role in shaping the future dynamics of both markets.
Reasons to Purchase:
* Pinpoint market niches in order to facilitate successful penetration strategies
* Target research and development resources more effectively through an understanding of unmet needs and recent clinical trials
* Gain an understanding of the clinical and commercial unmet needs within these indications
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