PharmaPoint: Hepatitis C Virus – Japan Drug Forecast and Market Analysis to 2022

Publisher Name :
Date: 31-May-2013
No. of pages: 130

Summary

GlobalData has released its new Country report, “PharmaPoint: Hepatitis C Virus – Japan Drug Forecast and Market Analysis to 2022″. Hepatitis C is a liver infection caused by the hepatitis C virus (HCV) that results in acute or chronic presentation. The disease is often asymptomatic, but infected patients may experience fatigue, joint pain, itchy skin or jaundice. There is no effective vaccine against HCV, so the market is driven by therapeutics. Currently, drug combinations containing pegylated interferon (e.g., Roche’s Pegasys and Merck’s PegIntron) and ribavirin (e.g., Roche’s Copegus and Merck’s Rebetol) are used to treat HCV infection. Patients infected with HCV genotype 1 can also have a protease inhibitor added to their combination therapy, such as Merck’s Victrelis (boceprevir) or Vertex’s Incivek (telaprevir). The entrance of next-generation HCV therapies is expected to fundamentally change the HCV treatment algorithm. GlobalData expects a dramatic shift favoring the uptake of interferon-free regimens due to their more tolerable side-effect profiles and decreased duration of therapy compared with the current standard of care.

The projected drivers of market growth in Japan include the launch of next-generation HCV regimens, increasing awareness of HCV, and a shift toward preventative care of HCV.

Merck’s PegIntron (peginterferon alfa-2b) is the current market leader in Japan. The current standard of HCV therapy in Japan is a combination of interferon and ribavirin. The less-frequent dosing of peginterferon compared with standard interferon (i.e., once a week compared with three times a week) enabled peginterferon to quickly capture market share. In addition to standard interferon, PegIntron directly competes for market share with Roche’s Pegasys (peginterferon alfa-2a). GlobalData’s primary research revealed that peginterferon market position is further bolstered by the frequent use of interferon monotherapy in Japan.

Scope

  • Overview of the HCV including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on the key drugs in Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in Japan from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting Japan HCV market.

Reasons to buy

  • Understand and capitalize by identifying products that are most likely to ensure a robust return
  • Stay ahead of the competition by understanding the changing competitive landscape for HCV
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed business decisions from insightful and in-depth analysis of drug performance
  • Obtain sales forecast for drugs from 2012-2022 in Japan

PharmaPoint: Hepatitis C Virus – Japan Drug Forecast and Market Analysis to 2022

Table Of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 9

2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 10
2.3 Upcoming Related Reports 11

3 Disease Overview 12
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 16
3.1.3 Prognosis 17
3.2 Symptoms 17

4 Disease Management 18
4.1 Diagnosis and Referral Overview 18
4.2 Treatment Overview 19
4.3 Japan 21
4.3.1 Diagnosis 21
4.3.2 Clinical Practice 22

5 Competitive Assessment 23
5.1 Overview 23
5.2 Strategic Competitor Assessment 23
5.3 Product Profiles - Major Brands 25
5.3.1 Incivek (telaprevir) 25
5.3.2 Pegasys (peginterferon alfa-2a) 30
5.3.3 PegIntron (peginterferon alfa-2b) 34
5.3.4 Copegus, Rebetol, and Generic Ribavirin 38
5.3.5 Therapeutic Class: Interferon 40

6 Opportunity and Unmet Need 41
6.1 Overview 41
6.2 Unmet Needs 42
6.2.1 Unmet Need: Treatment Tolerability 42
6.2.2 Unmet Need: Efficacy 42
6.2.3 Unmet Need: Disease Awareness 43
6.2.4 Unmet Need: Treatment Cost 44
6.2.5 Unmet Need: Shorter Treatment Duration 44
6.2.6 Unmet Need: Simplified Treatment Regimens 45
6.3 Unmet Needs Gap Analysis 45
6.4 Opportunities 46
6.4.1 Opportunity: Pan-genotypic HCV Regimen 46
6.4.2 Opportunity: Treatment of Underrepresented Patient Populations 46
6.4.3 Opportunity: Involvement of Immune System 47

7 Pipeline Assessment 48
7.1 Overview 48
7.2 Promising Drugs in Clinical Development 49
7.2.1 Sofosbuvir and Sofosbuvir/Ledipasvir 51
7.2.2 Simeprevir 60
7.2.3 ABT-450 plus ABT-267 and ABT-333 67
7.2.4 Faldaprevir and Faldaprevir plus BI 207127 74
7.2.5 Daclatasvir and Daclatasvir plus Asunaprevir 82
7.2.6 Vaniprevir 89
7.2.7 Other Drug Classes 94

8 Market Outlook 98
8.1 Japan 98
8.1.1 Forecast 98
8.1.2 Key Events 104
8.1.3 Drivers and Barriers 104

9 Appendix 107
9.1 Bibliography 107
9.2 Abbreviations 115
9.3 Methodology 117
9.4 Forecasting Methodology 117
9.4.1 Percent Drug-Treated Patients 117
9.4.2 Patient Warehousing 118
9.4.3 Drugs Included in Each Therapeutic Class 118
9.4.4 Launch and Patent Expiry Dates 119
9.4.5 General Pricing Assumptions 120
9.4.6 Individual Drug Assumptions 120
9.4.7 Generic Erosion 122
9.4.8 Selection of Pipeline Agents 122
9.4.9 Pricing of Pipeline Agents 123
9.5 Physicians and Specialists Included in this Study 126
9.6 Survey of Prescribing Physicians 128
9.7 About the Authors 129
9.7.1 Author 129
9.7.2 Global Head of Healthcare 129
9.8 About GlobalData 130
9.9 Contact Us 130
9.10 Disclaimer 130

List Of Tables

Table 1: Modes of HCV Transmission 16
Table 2: Symptoms of Acute and Chronic HCV Infection 17
Table 3: HCV Genotypes Present in the 9MM 19
Table 4: General Standard of Care by HCV Genotype 19
Table 5: Treatment Guidelines for HCV by Country 20
Table 6: Most-Prescribed Drugs for HCV by Class in the Global Markets, 2013 21
Table 7: Leading Treatments for HCV, 2012 24
Table 8: Product Profile - Incivek 26
Table 9: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial) 26
Table 10: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial) 27
Table 11: Common Incivek Adverse Drug Reactions 28
Table 12: Incivek SWOT Analysis, 2012 29
Table 13: Product Profile - Pegasys 31
Table 14: Antiviral Efficacy of Peginterferon alfa-2a Compared with Interferon alfa-2b 32
Table 15: Pegasys SWOT Analysis, 2012 34
Table 16: Product Profile - PegIntron 35
Table 17: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b 36
Table 18: PegIntron SWOT Analysis, 2012 37
Table 19: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 39
Table 20: Ribavirin SWOT Analysis, 2012 40
Table 21: Summary of Minor Therapeutic Classes, 2012 40
Table 22: Overall Unmet Needs - Current Level of Attainment 41
Table 23: Clinical Unmet Needs - Gap Analysis, 2012 45
Table 24: HCV - Pipeline, 2012 49
Table 25: Comparison of Therapeutic Classes in Development for HCV, 2012 50
Table 26: Gilead's Sofosbuvir Ongoing Clinical Trials of Interest 52
Table 27: Product Profile - Sofosbuvir 53
Table 28: Sofosbuvir's Most Common Adverse Effects 56
Table 29: Sofosbuvir SWOT Analysis, 2012 60
Table 30: Janssen's Simeprevir Ongoing Clinical Trials of Interest 61
Table 31: Product Profile - Simeprevir 62
Table 32: PILLAR Clinical Trial Results 62
Table 33: Adverse Events Observed in PILLAR Clinical Trial 63
Table 34: Simeprevir SWOT Analysis, 2012 67
Table 35: AbbVie's Combination Therapy Ongoing Clinical Trials of Interest 68
Table 36: Product Profile - AbbVie Combination Therapy 69
Table 37: AVIATOR Clinical Trial Results 69
Table 38: AbbVie Combination Therapy SWOT Analysis, 2012 73
Table 39: Boehringer Ingelheim's Faldaprevir Ongoing Clinical Trials of Interest 75
Table 40: Product Profile - Faldaprevir 76
Table 41: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 77
Table 42: Faldaprevir SWOT Analysis, 2012 81
Table 43: Bristol-Myers Squibb's Daclatasvir Ongoing Clinical Trials of Interest 83
Table 44: Product Profile - Daclatasvir 84
Table 45: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 84
Table 46: Daclatasvir and Asunaprevir Quad Therapy Efficacy 85
Table 47: Daclatasvir Triple Therapy Adverse Events 86
Table 48: Daclatasvir SWOT Analysis, 2012 89
Table 49: Merck's Vaniprevir Ongoing Clinical Trials of Interest 90
Table 50: Product Profile - Vaniprevir 90
Table 51: Vaniprevir SWOT Analysis, 2012 94
Table 52: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 95
Table 53: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 96
Table 54: Sales Forecasts ($m) for HCV in Japan, 2012-2022 101
Table 55: Key Events Impacting Sales for HCV in Japan, 2012 104
Table 56: Japanese HCV Market - Drivers and Barriers, 2012 104
Table 57: Key Launch Dates 119
Table 58: Key Patent Expiries 119
Table 59: Physicians Surveyed, By Country 128

List Of Figures

Figure 1: HCV Genome and Polyprotein Composition 13
Figure 2: HCV Lifecycle Overview 14
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HCV, 2012-2022 49
Figure 4: Sales for HCV Therapeutics in Japan by Drug Class, 2012-2022 103

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