Commercial Insight: Hepatitis B and C - Awaiting New Developments

SUMMARY

Introduction

The launch of the pegylated interferons has had a dramatic effect on the market for hepatitis treatments, with the improvements in side-effect profile and efficacy leading to significant drug switching. Companies involved in this sector need to reassess their competitive position and understand the new dynamics of this sector.

Scope

• In-depth profiles of all leading hepatitis B and hepatitis C products, including recent event screens and key clinical trial data
• Analysis of historical sales performance of all leading hepatitis products, including quarterly seven major market sales from 1999 to 2003
• Country specific forecasts for all leading products up to 2014 and in-depth analysis of key events that will impact sales
• Detailed analysis of life-cycle management and revenue protection strategies available to key players

Highlights

The hepatitis market is expected to exhibit rapid growth to 2010, with a CAGR greater than other infectious disease sectors (CAGR 2000-2010 = 9.0%). In the short-term, Datamonitor expects continued uptake of existing products to drive such growth, through geographical expansion and increased targeting of niche populations.

The current lack of clinical differentiation between Pegasys and Peg-Intron highlights the importance of effective life-cycle management strategies. During the next 5 years, securing additional indications and geographical expansion will prove more influential in determining hepatitis C market success than efficacy and safety profiles.

The clear limitations of current hepatitis B (HBV) antivirals have led to increased research assessing the potential of HBV combination therapy. Datamonitor believes that the development of this concept will lead to increased investment in antiviral R&D, alongside greater licensing and partnership activity.

Reasons to Purchase

• Identify and assess the factors that will determine the relative success of Pegasys and Peg-Intron
• Quantify the impact of the launch of generic ribavirin on key hepatitis C product performance
• Discover novel options for maximizing hepatitis product revenues and extending commercial longevity

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY

• Scope of the analysis
• Datamonitor insight into the hepatitis B & C market
• The hepatitis market is expected to exhibit rapid growth to 2010, with a CAGR greater than other infectious disease sectors (CAGR 2000-2010 = 9.0%). In the short term, Datamonitor expects continued uptake of existing products through geographical expansion and increased targetting of niche populations. Growth from 2009 onwards will then be driven by the arrival of novel antivirals for Hepatitis B;
• The current lack of clinical differentiation between Roche's Pegasys and Schering-Plough's PEG-Intron highlights the importance of effective life-cycle management (LCM) strategies. During the next five years, securing wider product labeling and enhancing key promotional messages will prove more influential in determining market success than clinical performance alone. With a lack of new HCV therapies on the horizon, Roche and Schering-Plough would be well advised to continue searching for a new complimentary antiviral;
• The launch and uptake of generic ribavirin in the US will alter competitive dynamics between Schering-Plough and Roche placing greater emphasis on interferon product revenues. While physicians currently appear reluctant to utilize customized mixtures of individual products, Datamonitor believes that increasing cost-constraints and greater pharmacist influence will lead to increased generic substitution in most Western markets;
• Clear limitations of current hepatitis B (HBV) antivirals has led to increased clinical activity assessing the potential of HBV combination therapy. This will in turn lead to greater licensing and partnership activity similar to that recently announced in the HIV market. Both GSK and Gilead are obvious candidates and in light of similar challenges between HBV/HCV and HIV, Datamonitor expects increased portfolio synergies for the management of chronic viral conditions;
• Summary
• Key metrics

TABLE OF CONTENTS

CHAPTER 2 MARKET SEGMENTATION & DEFINITION

• Strategic scope and focus
• Market definition
• Hepatitis B
• Hepatitis C
• Pegylated interferons (used in conjunction with ribavirin): the gold standard in hepatitis C treatment
• Lamivudine: the gold standard in hepatitis B
• Associated pharmaceutical markets and indications
• Co-morbidities
• Vaccination

CHAPTER 3 GLOBAL MARKET OVERVIEW

• Global hepatitis market analysis
• Market overview
• Interferons
• Interferons value and volume analysis
• R&D interferons
• Intron A (interferon alfa-2b, recombinant) analysis
• Rebetron analysis
• PEG-Intron analysis
• Pegasys analysis
• Roferon-A analysis
• Sumiferon analysis
• Infergen analysis
• Antivirals analysis
• Antivirals value and volume analysis
• R&D drugs in antivirals
• Rebetol analysis
• Copegus analysis
• Hepsera analysis
• Zeffix analysis
• Other hepatitis drugs analysis
• Other hepatitis R&D drugs
• Zadaxin analysis
• Global market forecasts

CHAPTER 4 STRATEGIC ANALYSIS

• Portfolio management
• Market attractiveness
• Positioning of the major hepatitis players
• Chronic viral infection portfolios - a synergistic approach to management?
• Lifecycle management in hepatitis
• The hepatitis product lifecycle
• Launch strategy and market penetration
• Optimizing peak sales
• Revenue protection strategies
• Pricing and reimbursement
• Health economic considerations
• Pricing strategies
• Treatment cost analysis

ITALIAN OPINION LEADER

• How do HBV and HCV patients typically present themselves to the medical profession? Are they then referred to a specialist? Who monitors the patient during treatment?
• What is the current standard 1st choice therapy for treating:
• Under what circumstances would you prescribe a drug other than the current 1st choice standard therapy?
• Therapies: interferons
• What affects your prescription practices regarding PEG-Intron/Pegasys? Which product do you preferentially prescribe? Why?
• What do you believe will be the impact of Redipen upon physicians when choosing between PEG-Intron and Pegasys?
• Schering-Plough said it will conduct a large clinical trial comparing its hepatitis C therapy PEG-Intron against Pegasys. Schering-Plough said the trial would involve 2,880 patients and compare the efficacy and safety of the drugs.
• Do you see a role for Intron A and Roferon-A now that the pegylated interferons have been launched?
• Intron A sales are greatly superior to Roferon-A. Why do physicians prescribe Intron A preferentially?
• Assessments of early virologic response (EVR) in patients with chronic hepatitis C following 12 weeks of individualized, weight-based dosing of PEG-Intron/Rebetol can be made. From such a study it is possible to identify patients unlikely to achieve a sustained response to a full course of therapy.
• Do you prescribe less common interferons, such as Alfacon-1? When do you/would you prescribe such a product?
• What would you say is the approximate percentage split between pegylated/interferon use against HBV/HCV and other indications, e.g. cancer?
• Therapies: antivirals
• What are your opinions regarding antivirals with dual activity against both HBV/HCV and HIV? What dual-acting product do you/would prescribe, and why?
• What are your opinions regarding antivirals with dual activity against both HBV and HDV? What do you think is the potential of such a product?
• Is vaccination reducing the need for HBV therapies? Do you see this as an issue in the future?
• Do you mix brands when prescribing interferon/ribavirin combination therapies e.g. use PEG-Intron with Copegus? Do you ever prescribe generic ribavirin for use in such a combination therapy?
• What are you feeling regarding Zeffix (lamivudine) in the treatment of hepatitis?
• What are you feeling regarding Hepsera (Adefovir dipivoxil) in the treatment of hepatitis?
• Miscellaneous
• What are you feeling regarding Zadaxin (thymosin alpha 1) in the treatment of hepatitis?
• What are the key unmet needs in the treatment of HBV/HCV?
• Please list your choice of therapy for I) HBV and II) HCV in order of preference (e.g. 1 Intro-A (best), 2 Alfacon-1 (second best) etc).
• Are there any other important HBV/HCV products that you feel have not been adequately discussed during this interview?
• Are you aware of any patient-physician hepatitis networks organized/sponsored by a pharmaceutical company?
• Would such an affiliation between a drugs company and a support group influence your prescription habits, i.e. view the benefits of being the member of such a network being more important than minor pharmacological drawbacks?
• Are there any other comments you would like to make?

UK OPINION LEADER

• Presentation and prescription
• How do HBV and HCV patients typically present themselves to the medical profession?
• Which physicians are responsible for prescribing hepatitis B or C therapy?
• What informs your decision when choosing between hepatitis drugs?
• What is the current standard 1st choice therapy for treating:
• Under what circumstances would you prescribe a drug other than the current 1st choice standard therapy?
• Therapies: interferons
• What affects your prescription practices regarding PEG-Intron/Pegasys? Which product do you preferentially prescribe? Why?
• Are you aware of Redipen?
• Schering-Plough said it will conduct a large clinical trial comparing its hepatitis C therapy PEG-Intron against Pegasys. Schering-Plough said the trial would involve 2,880 patients and compare the efficacy and safety of the drugs.
• Do you see a role for Intron A and Roferon-A now that the pegylated interferons have been launched?
• Assessments of early virologic response (EVR) in patients with chronic hepatitis C following 12 weeks of individualized, weight-based dosing of PEG-Intron/Rebetol can be made. From such a study it is possible to identify patients unlikely to achieve a sustained response to a full course of therapy.
• Do you prescribe less common interferons, such as Alfacon-1?
• What would you say is the approximate percentage split between pegylated/interferon use against HBV/HCV and other indications, e.g. cancer?
• Therapies: antivirals
• What are your opinions regarding antivirals with dual activity against both HBV/HCV and HIV?
• If a patient is co-infected with hepatitis B does that change prescription habits?
• Is vaccination reducing the need for HBV therapies? Do you see this as an issue in the future?
• Do you mix brands when prescribing interferon/ribavirin combination therapies, e.g. use PEG-Intron with Copegus?
• Have you ever prescribed generic ribavirin?
• What are you feelings regarding Zeffix (lamivudine) in the treatment of hepatitis?
• Miscellaneous
• What are you feeling regarding Zadaxin (thymosin alpha 1) in the treatment of hepatitis?
• What are the key unmet needs in the treatment of HBV/HCV? Please prioritize them.
• What is the average duration of HBV/HCV therapy?
• What do you believe would be the best way to improve hepatitis diagnosis rates, and therefore the number of patients receiving therapy?
• Are there any other important HBV/HCV products that you feel have not been adequately discussed during this interview?
• Are you aware of any patient-physician hepatitis networks organized/sponsored by a pharmaceutical company?
• Would such an affiliation between a drugs company and a support group influence prescription habits?
• How common is off-label use of interferon or antivirals?
• Are there any other comments you would like to make?
• Presentation and prescription
• How do HBV and HCV patients typically present themselves to the medical profession? Are they then referred to a specialist? Who monitors the patient during treatment?
• Which physicians are responsible for deciding which treatment regimen will be used?
• Who informs physicians when choosing between hepatitis drugs? How do prescribing physicians become aware of new products?
• What is the current standard 1st choice therapy for treating:
• Under what circumstances would you prescribe a drug other than the current 1st choice standard therapy?
• Therapies: interferons
• What affects physicians' prescription practices regarding PEG-Intron/Pegasys? Which product do they preferentially prescribe? Why?
• What do you know about Schering-Plough's Redipen?
• Schering-Plough said it will conduct a large clinical trial comparing its hepatitis C therapy PEG-Intron against Pegasys. Schering-Plough said the trial would involve 2,880 patients and compare the efficacy and safety of the drugs.
• Intron A sales are greatly superior to Roferon-A. Do you know why that is?
• Assessments of early virologic response (EVR) in patients with chronic hepatitis C following 12 weeks of individualized, weight-based dosing of PEG-Intron/Rebetol can be made. From such a study it is possible to identify patients unlikely to achieve a sustained response to a full course of therapy.
• Are you aware that physicians in your country prescribe Alfacon-1?
• Where and by whom is interferon therapy administered?
• Therapies: antivirals
• What are your opinions regarding antivirals with dual activity against both HBV/HCV and HIV?
• What are your opinions regarding antivirals with dual activity against both HBV and HDV?
• Is vaccination reducing the need for HBV therapies? Do you see this as an issue in the future?
• What are you feeling regarding Zeffix (lamivudine) in the treatment of hepatitis?
• What are you feeling regarding Hepsera (Adefovir dipivoxil) in the treatment of hepatitis?
• Miscellaneous
• What are you feeling regarding Zadaxin (thymosin alpha 1) in the treatment of hepatitis?
• What are the key unmet needs in the treatment of HBV/HCV? Please prioritize them.
• What is the average duration of HBV/HCV therapy?
• What do you see the future of hepatitis B and C therapy to be?
• Are there any other important HBV/HCV products that you feel have not been adequately discussed during this interview?
• Are you aware of any patient-physician hepatitis networks organized/sponsored by a pharmaceutical company?
• Would such an affiliation between a drugs company and a support group influence prescription habits, i.e. view the benefits of being the member of such a network being more important than minor pharmacological drawbacks?
• How common is off-label use of interferon or antivirals?
• Are there any other comments you would like to make?
• Bibliography
• Epidemiology
• Clinical trial data
• Other
• Report methodology
• Global Sales
• Standard units
• Japanese market data
• Regional launch dates for new products
• About Datamonitor
• About Datamonitor Healthcare
• Datamonitor Healthcare's research and analysis methodologies
• Disclaimer
• List of Tables
• Table 1: Geographic distribution of HBV genotypes
• Table 2: Defining the gold standard: key clinical trial results for pegylated interferon/ribavirin
• Table 3: Defining the gold standard: key clinical trial results for lamivudine
• Table 4: Prevalence of HBV/HIV co-infection across the seven major markets 2002
• Table 5: HIV/HCV co-infection across the seven major markets, 2001-02
• Table 6: R&D Interferons, Q2 2004
• Table 7: Intron A: key facts
• Table 8: Key Intron A events, 2003-04
• Table 9: Global Intron A Forecasts to 2014, ($000s)
• Table 10: Rebetron: key facts
• Table 11: PEG-Intron: key facts
• Table 12: Key PEG-Intron events, 2003-04
• Table 13: Peg-Intron Global forecasts 2004-2014 ($000s)
• Table 14: Pegasys: key facts
• Table 15: Key Pegasys events, 2003-04
• Table 16: Global sales forecasts for Pegasys, 2004-2014 ($000s)
• Table 17: Roferon-A : key facts
• Table 18: Global sales forecasts for Roferon A, 2004-2014 ($000s)
• Table 19: Sumiferon: key facts
• Table 20: Key Sumiferon events, 2003-04
• Table 21: Infergen: key facts
• Table 22: Infergen events, 2003-04
• Table 23: R&D antivirals, Q2 2004
• Table 24: Rebetol : key facts
• Table 25: Key Rebetol events 2003-04
• Table 26: Global forecasts for Rebetol, 2004-2014 ($000s)
• Table 27: Copegus: key facts
• Table 28: Key Copegus events, 2003-04
• Table 29: TypeTableTitleHere
• Table 30: Hepsera: key facts
• Table 31: Hepsera events, 2003-04
• Table 32: Global Hepsera forecasts, 2004-2014 (000s)
• Table 33: Zeffix: key facts
• Table 34: Key Zeffix events, 2003-04
• Table 35: Global Zeffix forecasts, 2004-2014 (000s)
• Table 36: Other R&D hepatitis drugs, Q2 2004
• Table 37: Zadaxin: key facts
• Table 38: Key Zadaxin events, 2003-04
• Table 39: Total, infectious disease and hepatitis B and C performance of the hepatitis B and C market leaders, 2003
• Table 40: Growth in total, infectious diseases and hepatitis B and C revenues for the hepatitis B and C market leaders, 2002-03
• Table 41: US pricing for key hepatitis products, 2003
• Table 42: Comparative costs of key HCV therapies in the US, 2003
• Table 43: Comparative prices of HBV therapies in the US, 2003
• Table 44: Comparative prices of lamivudine therapy in the US, 2003
• List of Figures
• Figure 1: Key drivers of the hepatitis B & C market to 2014
• Figure 2: HBV prevalence in the seven major markets, 2002
• Figure 3: Quarterly sales of hepatitis products by class, 1999-2003
• Figure 4: Global hepatitis B & C forecast by region, 2000-2014
• Figure 5: Forecast global sales of pegylated interferons by product, 2000-2014
• Figure 6: Key high-risk groups for HBV infection
• Figure 7: Acute hepatitis B virus infection with recovery-typical serological course
• Figure 8: Progression to chronic hepatitis B virus infection-typical serological course
• Figure 9: HBV disease progression
• Figure 10: HBV prevalence in the seven major markets, 2002
• Figure 11: Physician perception of HBV diagnosis and treatment rates in the seven major markets, 2002
• Figure 12: HCV disease progression
• Figure 13: HCV population size in the seven major markets, 2002
• Figure 14: Physician perception of HCV diagnosis and treatment rates in the US, Japan and Europe, 2001
• Figure 15: HCV genotype prevalence across the seven major markets
• Figure 16: Countries routinely vaccinating against HBV as part of their national infant immunization schedule in 2003
• Figure 17: Quarterly global hepatitis market performance by volume (SUs) and value ($m), 1999-2003
• Figure 18: Comparative class contribution to hepatitis market growth by quarter (SUs), 1998-2003
• Figure 19: Comparative class contribution to hepatitis market growth by quarter ($m), 1998-2003
• Figure 20: Interferons value/volume quarterly growth, seven major markets 1999-2003
• Figure 21: Global* Intron A sales by quarter, during the period 1999-2003
• Figure 22: Country-specific breakdown of Intron A sales by year, 1999-2003
• Figure 23: Intron A global market share by country, 2003
• Figure 24: SWOT analysis for Intron A
• Figure 25: Global PEG-Intron sales by quarter, 1999-2003
• Figure 26: Country-specific breakdown of PEG-Intron sales by year, 1999-2003
• Figure 27: PEG-Intron global market share by country, 2003
• Figure 28: PEG-Intron SWOT analysis
• Figure 29: Global Pegasys sales by quarter, 1999-2003
• Figure 30: Pegasys global market share by country, 2003
• Figure 31: Comparison of PEG-Intron/Pegasys global sales by quarter, 1999-2003
• Figure 32: SWOT analysis for Pegasys
• Figure 33: Global Roferon-A sales by quarter, 1999-2003
• Figure 34: Country-specific breakdown of Roferon-A sales by year, 1999-2003
• Figure 35: Roferon-A global market share by country, 2003
• Figure 36: SWOT analysis for Roferon-A
• Figure 37: Global Sumiferon sales by quarter, 1999-2003
• Figure 38: Comparison of Japanese Sumiferon sales to the rest of the world, 1999-2003
• Figure 39: Comparison of Sumiferon and Intron A sales in Japan by quarter, 1999-2003
• Figure 40: SWOT analysis for Sumiferon
• Figure 41: Global Infergen sales by quarter, 1999-2003
• Figure 42: Country-specific breakdown of Infergen sales by year, 1999-2003
• Figure 43: Infergen global market share by country, 2003
• Figure 44: SWOT analysis for Infergen
• Figure 45: Antivirals value/volume quarterly growth, seven major markets, 1999-2003
• Figure 46: Global Rebetol sales by quarter, 1999-2003
• Figure 47: Country-specific breakdown of Rebetol sales by year, 1999-2003
• Figure 48: Rebetol global market share by country, 2003
• Figure 49: SWOT analysis for Rebetol
• Figure 50: Global Copegus sales by quarter, 1999-2003
• Figure 51: Copegus global market share by country, 2003
• Figure 52: Comparison of global Copegus and Rebetol sales by quarter, 1999-2003
• Figure 53: SWOT analysis for Copegus
• Figure 54: Quarterly Hepsera sales by country, 2002-03
• Figure 55: Hepsera global market share by country, 2003
• Figure 56: SWOT analysis for Hepsera
• Figure 57: Global Zeffix sales by quarter, 1999-2003
• Figure 58: Country-specific breakdown of Zeffix sales by year, 1999-2003
• Figure 59: Zeffix global market share by country, in 2003
• Figure 60: SWOT analysis for Zeffix
• Figure 61: Global Zadaxin sales by quarter, 1999-2003
• Figure 62: Zadaxin global market share by country, 2003
• Figure 63: Zadaxin SWOT analysis
• Figure 64: Competitive attractiveness of the hepatitis market, 2002-11
• Figure 65: Positioning of the hepatitis B and C market leader portfolios, 2002-03
• Figure 66: Companies building chronic antiviral portfolios, 2004
• Figure 67: Synergies and antergies of combined antiviral portfolios
• Figure 68: Key hepatitis B and C product global* sales by quarter, 1999- 2003
• Figure 69: Comparison of Zeffix and Hepsera US sales by quarter, 1999-2003
• Figure 70: Roche's Pegasys website
• Figure 71: The product adoption cycle
• Figure 72: Roche's lifecycle management strategy for Pegasys, 2004
• Figure 73: Pediatric approvals for leading hepatitis products, 2004
• Figure 74: Quarterly lamivudine sales in India by company, 1999-2003
• Figure 75: GSK's quarterly lamivudine sales in China, 1999-2003
• Figure 76: Combination HBV therapy will drive market diversity