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

Publisher Name :
Date: 31-May-2013
No. of pages: 140

Summary

GlobalData has released its new Country report, “PharmaPoint: Hepatitis C Virus – United States 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 include increased patient awareness of HCV, broader HCV screening recommendations, the shift in American medicine toward preventative care, and the launch of next-generation HCV therapies.

Vertex’s Incivek is the current market leader. It was among the first DAA HCV therapies launched in the US. Incivek’s improved efficacy over the previous standard of care (i.e., peginterferon and ribavirin combination therapy) in the treatment of the most prevalent HCV genotype in the US, HCV GT1, enabled the drug to quickly capture the market. The adverse events associated with Incivek therapy, such as life-threatening skin reactions, and the slow-progressing nature of HCV, has resulted in many patients deciding to forego treatment in order to wait for the launch of a more-tolerable HCV regimen.

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 the US including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in the US from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting the US 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 the US

PharmaPoint: Hepatitis C Virus – United States 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 13
3.1.1 Etiology 13
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 US 22
4.3.1 Diagnosis 22
4.3.2 Clinical Practice 24

5 Competitive Assessment 27
5.1 Overview 27
5.2 Strategic Competitor Assessment 27
5.3 Product Profiles - Major Brands 29
5.3.1 Incivek (telaprevir) 29
5.3.2 Victrelis (boceprevir) 34
5.3.3 Pegasys (peginterferon alfa-2a) 38
5.3.4 PegIntron (peginterferon alfa-2b) 43
5.3.5 Copegus, Rebetol, and Generic Ribavirin 47
5.3.6 Therapeutic Class: Interferon 50

6 Opportunity and Unmet Need 51
6.1 Overview 51
6.2 Unmet Needs 52
6.2.1 Unmet Need: Treatment Tolerability 52
6.2.2 Unmet Need: Efficacy 52
6.2.3 Unmet Need: Disease Awareness 53
6.2.4 Unmet Need: Treatment Cost 54
6.2.5 Unmet Need: Shorter Treatment Duration 54
6.2.6 Unmet Need: Simplified Treatment Regimens 55
6.3 Unmet Needs Gap Analysis 56
6.4 Opportunities 57
6.4.1 Opportunity: Pan-genotypic HCV Regimen 57
6.4.2 Opportunity: Treatment of Underrepresented Patient Populations 57
6.4.3 Opportunity: Involvement of Immune System 58

7 Pipeline Assessment 59
7.1 Overview 59
7.2 Promising Drugs in Clinical Development 60
7.2.1 Sofosbuvir and Sofosbuvir/Ledipasvir 62
7.2.2 Simeprevir 72
7.2.3 ABT-450 plus ABT-267 and ABT-333 80
7.2.4 Faldaprevir and Faldaprevir plus BI 207127 87
7.2.5 Daclatasvir and Daclatasvir plus Asunaprevir 95
7.2.6 Other Drug Classes 103

8 Market Outlook 106
8.1 US 106
8.1.1 Forecast 106
8.1.2 Key Events 111
8.1.3 Drivers and Barriers 111

9 Appendix 116
9.1 Bibliography 116
9.2 Abbreviations 125
9.3 Methodology 127
9.4 Forecasting Methodology 127
9.4.1 Percent Drug-Treated Patients 127
9.4.2 Patient Warehousing 128
9.4.3 Drugs Included in Each Therapeutic Class 128
9.4.4 Launch and Patent Expiry Dates 129
9.4.5 General Pricing Assumptions 130
9.4.6 Individual Drug Assumptions 130
9.4.7 Generic Erosion 132
9.4.8 Selection of Pipeline Agents 132
9.4.9 Pricing of Pipeline Agents 133
9.5 Physicians and Specialists Included in this Study 136
9.6 Survey of Prescribing Physicians 138
9.7 About the Authors 139
9.7.1 Author 139
9.7.2 Global Head of Healthcare 139
9.8 About GlobalData 140
9.9 Contact Us 140
9.10 Disclaimer 140

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 21
Table 6: Most-Prescribed Drugs for HCV by Class in the Global Markets, 2013 21
Table 7: Leading Treatments for HCV, 2012 28
Table 8: Product Profile - Incivek 30
Table 9: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial) 30
Table 10: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial) 31
Table 11: Common Incivek Adverse Drug Reactions 32
Table 12: Incivek SWOT Analysis, 2012 33
Table 13: Product Profile - Victrelis 34
Table 14: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial) 35
Table 15: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial) 36
Table 16: Victrelis SWOT Analysis, 2012 37
Table 17: Product Profile - Pegasys 39
Table 18: Antiviral Efficacy of Peginterferon alfa-2a Compared with Interferon alfa-2b 40
Table 19: Pegasys SWOT Analysis, 2012 42
Table 20: Product Profile - PegIntron 44
Table 21: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b 44
Table 22: PegIntron SWOT Analysis, 2012 46
Table 23: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 48
Table 24: Ribavirin SWOT Analysis, 2012 49
Table 25: Summary of Minor Therapeutic Classes, 2012 50
Table 26: Overall Unmet Needs - Current Level of Attainment 51
Table 27: Clinical Unmet Needs - Gap Analysis, 2012 56
Table 28: HCV - Pipeline, 2012 60
Table 29: Comparison of Therapeutic Classes in Development for HCV, 2012 61
Table 30: Gilead's Sofosbuvir Ongoing Clinical Trials of Interest 63
Table 31: Product Profile - Sofosbuvir 64
Table 32: Sofosbuvir's Most Common Adverse Effects 67
Table 33: Sofosbuvir SWOT Analysis, 2012 71
Table 34: Janssen's Simeprevir Ongoing Clinical Trials of Interest 73
Table 35: Product Profile - Simeprevir 74
Table 36: PILLAR Clinical Trial Results 74
Table 37: Adverse Events Observed in PILLAR Clinical Trial 75
Table 38: Simeprevir SWOT Analysis, 2012 79
Table 39: AbbVie's Combination Therapy Ongoing Clinical Trials of Interest 81
Table 40: Product Profile - AbbVie Combination Therapy 82
Table 41: AVIATOR Clinical Trial Results 82
Table 42: AbbVie Combination Therapy SWOT Analysis, 2012 86
Table 43: Boehringer Ingelheim's Faldaprevir Ongoing Clinical Trials of Interest 88
Table 44: Product Profile - Faldaprevir 89
Table 45: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 89
Table 46: Faldaprevir SWOT Analysis, 2012 94
Table 47: Bristol-Myers Squibb's Daclatasvir Ongoing Clinical Trials of Interest 96
Table 48: Product Profile - Daclatasvir 97
Table 49: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 97
Table 50: Daclatasvir and Asunaprevir Quad Therapy Efficacy 98
Table 51: Daclatasvir Triple Therapy Adverse Events 99
Table 52: Daclatasvir SWOT Analysis, 2012 102
Table 53: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 103
Table 54: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 104
Table 55: Sales Forecasts ($m) for HCV in the US, 2012-2022 109
Table 56: Key Events Impacting Sales for HCV in the US, 2012 111
Table 57: US HCV Market - Drivers and Barriers, 2012 111
Table 58: Key Launch Dates 129
Table 59: Key Patent Expiries 129
Table 60: Physicians Surveyed, By Country 138

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 60
Figure 4: Sales for HCV Therapeutics in the US by Drug Class, 2012-2022 110

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