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Commercial Insight: Hepatitis B and C - Awaiting New DevelopmentsPublished by: Datamonitor Published: Jun. 4, 2004 - 242 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the hepatitis B & C market 4 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; 5 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; 6 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; 8 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; 10 Summary 11 Key metrics 12 CHAPTER 2 MARKET SEGMENTATION & DEFINITION 29 Strategic scope and focus 29 Market definition 30 Hepatitis B 30 Disease definition 30 Epidemiology 34 Hepatitis C 37 Disease definition 37 Therapy classes covered 44 Pegylated interferons (used in conjunction with ribavirin): the gold standard in hepatitis C treatment 45 Lamivudine: the gold standard in hepatitis B 46 Associated pharmaceutical markets and indications 46 Co-morbidities 46 Co-infection with HIV 47 HBV/hepatitis D 49 HBV/HCV co-infection 49 Vaccination 50 CHAPTER 3 GLOBAL MARKET OVERVIEW 52 Global hepatitis market analysis 52 Market overview 52 Interferons 54 Interferons value and volume analysis 54 R&D interferons 55 Intron A (interferon alfa-2b, recombinant) analysis 56 Intron A: 12-month event screen 58 Intron A sales analysis 58 Intron A strategic analysis 61 Intron A Forecasts 64 Rebetron analysis 64 PEG-Intron analysis 65 PEG-Intron: 12-month event screen 67 PEG-Intron sales analysis 67 PEG-Intron strategic analysis 70 Peg-Intron Forecasts 72 Pegasys analysis 73 Pegasys: 12-month event screen 74 Pegasys sales analysis 76 Pegasys strategic analysis 79 Pegasys forecasts 82 Roferon-A analysis 82 Sales analysis 83 Roferon-A strategic analysis 86 Roferon A forecasts 88 Sumiferon analysis 88 Sumiferon: 12-month event screen 89 Sales analysis 90 Sumiferon strategic analysis 92 Infergen analysis 94 Infergen: 12-month event screen 95 Sales analysis 97 Infergen strategic analysis 99 Antivirals analysis 101 Antivirals value and volume analysis 101 R&D drugs in antivirals 102 Rebetol analysis 103 Rebetol: 12-month event screen 104 Sales analysis 106 Rebetol strategic analysis 109 Rebetol sales forecasts 111 Copegus analysis 112 Copegus: 12-month event screen 113 Sales analysis 114 Copegus strategic analysis 117 Copegus forecasts 119 Hepsera analysis 120 Hepsera: 12-month event screen 122 Sales analysis 123 Hepsera strategic analysis 124 Hepsera sales forecasts 126 Zeffix analysis 127 Zeffix: 12-month event screen 129 Sales analysis 130 Zeffix strategic analysis 133 Zeffix sales forecasts 133 Other hepatitis drugs analysis 134 Other hepatitis R&D drugs 134 Zadaxin analysis 134 Zadaxin: 12-month event screen 136 Sales analysis 138 Zadaxin strategic analysis 139 Global market forecasts 141 General events 141 Country-specific events 142 Product/class events 144 CHAPTER 4 STRATEGIC ANALYSIS 149 Portfolio management 149 Market attractiveness 149 Comparative attractiveness of the hepatitis market 149 Positioning of the major hepatitis players 150 Hepatitis C 152 Hepatitis B 153 Chronic viral infection portfolios - a synergistic approach to management? 155 Chronic viral portfolios - who could gain? 155 Advantages of merged portfolios 157 Limitations of merged portfolios 160 Lifecycle management in hepatitis 161 The hepatitis product lifecycle 161 Launch strategy and market penetration 164 Promoting pre-launch brand awareness 164 Expanded access schemes 165 Optimizing peak sales 167 Post-launch promotion - targeting the right physicians 167 Post-launch promotion - targeting patients 169 Driving patient potential - develop more effective diagnostics 172 Driving patient potential - indication expansion and clinical trials 173 Driving patient potential - emerging markets 177 Combination therapy 180 Reformulation 181 Revenue protection strategies 182 Bundling combination therapies 182 Patent expiry - strike a deal 185 Pricing and reimbursement 185 Health economic considerations 185 Pricing strategies 186 Pricing data for key products in the major markets 186 Treatment cost analysis 188 Hepatitis C 188 Hepatitis B 189 APPENDIX A - OPINION LEADER TRANSCRIPTS 192 ITALIAN OPINION LEADER 192 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? 192 What is the current standard 1st choice therapy for treating: 193 Under what circumstances would you prescribe a drug other than the current 1st choice standard therapy? 193 Therapies: interferons 194 What affects your prescription practices regarding PEG-Intron/Pegasys? Which product do you preferentially prescribe? Why? 194 What do you believe will be the impact of Redipen upon physicians when choosing between PEG-Intron and Pegasys? 194 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. 195 Do you see a role for Intron A and Roferon-A now that the pegylated interferons have been launched? 196 Intron A sales are greatly superior to Roferon-A. Why do physicians prescribe Intron A preferentially? 197 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. 197 Do you prescribe less common interferons, such as Alfacon-1? When do you/would you prescribe such a product? 199 What would you say is the approximate percentage split between pegylated/interferon use against HBV/HCV and other indications, e.g. cancer? 199 Therapies: antivirals 200 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? 200 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? 200 Is vaccination reducing the need for HBV therapies? Do you see this as an issue in the future? 201 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? 201 What are you feeling regarding Zeffix (lamivudine) in the treatment of hepatitis? 202 What are you feeling regarding Hepsera (Adefovir dipivoxil) in the treatment of hepatitis? 202 Miscellaneous 202 What are you feeling regarding Zadaxin (thymosin alpha 1) in the treatment of hepatitis? 202 What are the key unmet needs in the treatment of HBV/HCV? 202 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). 203 Are there any other important HBV/HCV products that you feel have not been adequately discussed during this interview? 204 Are you aware of any patient-physician hepatitis networks organized/sponsored by a pharmaceutical company? 204 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? 204 Are there any other comments you would like to make? 205 UK OPINION LEADER 205 Presentation and prescription 205 How do HBV and HCV patients typically present themselves to the medical profession? 205 Which physicians are responsible for prescribing hepatitis B or C therapy? 206 What informs your decision when choosing between hepatitis drugs? 207 What is the current standard 1st choice therapy for treating: 207 Under what circumstances would you prescribe a drug other than the current 1st choice standard therapy? 208 Therapies: interferons 209 What affects your prescription practices regarding PEG-Intron/Pegasys? Which product do you preferentially prescribe? Why? 209 Are you aware of Redipen? 209 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. 210 Do you see a role for Intron A and Roferon-A now that the pegylated interferons have been launched? 211 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. 211 Do you prescribe less common interferons, such as Alfacon-1? 212 What would you say is the approximate percentage split between pegylated/interferon use against HBV/HCV and other indications, e.g. cancer? 212 Therapies: antivirals 212 What are your opinions regarding antivirals with dual activity against both HBV/HCV and HIV? 212 If a patient is co-infected with hepatitis B does that change prescription habits? 213 Is vaccination reducing the need for HBV therapies? Do you see this as an issue in the future? 213 Do you mix brands when prescribing interferon/ribavirin combination therapies, e.g. use PEG-Intron with Copegus? 213 Have you ever prescribed generic ribavirin? 214 What are you feelings regarding Zeffix (lamivudine) in the treatment of hepatitis? 214 Miscellaneous 214 What are you feeling regarding Zadaxin (thymosin alpha 1) in the treatment of hepatitis? 214 What are the key unmet needs in the treatment of HBV/HCV? Please prioritize them. 214 What is the average duration of HBV/HCV therapy? 215 What do you believe would be the best way to improve hepatitis diagnosis rates, and therefore the number of patients receiving therapy? 216 Are there any other important HBV/HCV products that you feel have not been adequately discussed during this interview? 216 Are you aware of any patient-physician hepatitis networks organized/sponsored by a pharmaceutical company? 217 Would such an affiliation between a drugs company and a support group influence prescription habits? 217 How common is off-label use of interferon or antivirals? 218 Are there any other comments you would like to make? 218 US OPINION LEADER 219 Presentation and prescription 219 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? 219 Which physicians are responsible for deciding which treatment regimen will be used? 220 Who informs physicians when choosing between hepatitis drugs? How do prescribing physicians become aware of new products? 220 What is the current standard 1st choice therapy for treating: 221 Under what circumstances would you prescribe a drug other than the current 1st choice standard therapy? 223 Therapies: interferons 225 What affects physicians’ prescription practices regarding PEG-Intron/Pegasys? Which product do they preferentially prescribe? Why? 225 What do you know about Schering-Plough's Redipen? 225 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. 226 Intron A sales are greatly superior to Roferon-A. Do you know why that is? 226 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. 227 Are you aware that physicians in your country prescribe Alfacon-1? 228 Where and by whom is interferon therapy administered? 228 Therapies: antivirals 228 What are your opinions regarding antivirals with dual activity against both HBV/HCV and HIV? 228 What are your opinions regarding antivirals with dual activity against both HBV and HDV? 229 Is vaccination reducing the need for HBV therapies? Do you see this as an issue in the future? 230 What are you feeling regarding Zeffix (lamivudine) in the treatment of hepatitis? 230 What are you feeling regarding Hepsera (Adefovir dipivoxil) in the treatment of hepatitis? 230 Miscellaneous 231 What are you feeling regarding Zadaxin (thymosin alpha 1) in the treatment of hepatitis? 231 What are the key unmet needs in the treatment of HBV/HCV? Please prioritize them. 231 What is the average duration of HBV/HCV therapy? 232 What do you see the future of hepatitis B and C therapy to be? 232 Are there any other important HBV/HCV products that you feel have not been adequately discussed during this interview? 233 Are you aware of any patient-physician hepatitis networks organized/sponsored by a pharmaceutical company? 233 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? 233 How common is off-label use of interferon or antivirals? 233 Are there any other comments you would like to make? 234 APPENDIX B 235 Bibliography 235 Epidemiology 235 Clinical trial data 236 Other 237 Report methodology 237 Global Sales 237 Standard units 237 Japanese market data 238 Regional launch dates for new products 238 About Datamonitor 239 About Datamonitor Healthcare 239 Datamonitor Healthcare’s research and analysis methodologies 240 Disclaimer 241 AbstractIntroductionThe 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 Get Full Details About This Report >> |
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