PharmaPoint: Hepatitis C Virus - United States Drug Forecast and Market Analysis



Summary



GlobalData has released its new Country report, “PharmaPoint: Hepatitis C Virus - United States Drug Forecast and Market Analysis”. 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

Table Of Contents

1 Table of Contents
1 Table of Contents 5
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 12
3 Disease Overview 13
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 17
3.1.3 Prognosis 18
3.2 Symptoms 18
4 Disease Management 19
4.1 Diagnosis and Referral Overview 19
4.2 Treatment Overview 20
4.3 US 23
4.3.1 Diagnosis 23
4.3.2 Clinical Practice 25
5 Competitive Assessment 28
5.1 Overview 28
5.2 Strategic Competitor Assessment 28
5.3 Product Profiles - Major Brands 29
5.3.1 Incivek (telaprevir) 29
5.3.2 Victrelis (boceprevir) 35
5.3.3 Pegasys (peginterferon alfa-2a) 40
5.3.4 PegIntron (peginterferon alfa-2b) 44
5.3.5 Copegus, Rebetol, and Generic Ribavirin 48
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 55
6.4 Opportunities 56
6.4.1 Opportunity: Pan-genotypic HCV Regimen 56
6.4.2 Opportunity: Treatment of Underrepresented Patient Populations 56
6.4.3 Opportunity: Involvement of Immune System 57
7 Pipeline Assessment 58
7.1 Overview 58
7.2 Promising Drugs in Clinical Development 58
7.2.1 Sofosbuvir and Sofosbuvir/Ledipasvir 60
7.2.2 Simeprevir 70
7.2.3 ABT-450 plus ABT-267 and ABT-333 77
7.2.4 Faldaprevir and Faldaprevir plus BI 207127 84
7.2.5 Daclatasvir and Daclatasvir plus Asunaprevir 91
7.2.6 Other Drug Classes 99
8 Market Outlook 102
8.1 US 102
8.1.1 Forecast 102
8.1.2 Key Events 107
8.1.3 Drivers and Barriers 107
9 Appendix 112
9.1 Bibliography 112
9.2 Abbreviations 120
9.3 Methodology 122
9.4 Forecasting Methodology 122
9.4.1 Percent Drug-Treated Patients 122
9.4.2 Patient Warehousing 122
9.4.3 Drugs Included in Each Therapeutic Class 123
9.4.4 Launch and Patent Expiry Dates 124
9.4.5 General Pricing Assumptions 125
9.4.6 Individual Drug Assumptions 125
9.4.7 Generic Erosion 127
9.4.8 Selection of Pipeline Agents 127
9.4.9 Pricing of Pipeline Agents 128
9.5 Physicians and Specialists Included in this Study 130
9.6 Survey of Prescribing Physicians 132
9.7 About the Authors 132
9.7.1 Author 132
9.7.2 Global Head of Healthcare 133
9.8 About GlobalData 134
9.9 Contact Us 134
9.10 Disclaimer 134

List of Tables

Table 1: Modes of HCV Transmission 17
Table 2: Symptoms of Acute and Chronic HCV Infection 18
Table 3: HCV Genotypes Present in the 9MM 20
Table 4: General Standard of Care by HCV Genotype 20
Table 5: Treatment Guidelines for HCV by Country 21
Table 6: Most-Prescribed Drugs for HCV by Class in the Global Markets, 2013 22
Table 7: Leading Treatments for HCV, 2012 29
Table 8: Overall Unmet Needs - Current Level of Attainment 51
Table 9: Clinical Unmet Needs - Gap Analysis, 2012 55
Table 10: HCV - Pipeline, 2012 58
Table 11: Comparison of Therapeutic Classes in Development for HCV, 2012 59
Table 12: Sales Forecasts ($m) for HCV in the US, 2012-2022 105
Table 13: Key Events Impacting Sales for HCV in the US, 2012 107
Table 14: US HCV Market - Drivers and Barriers, 2012 107
Table 15: Key Launch Dates 124
Table 16: Key Patent Expiries 124
Table 17: Physicians Surveyed, By Country 132

List of Figures

Figure 1: HCV Genome and Polyprotein Composition 14
Figure 2: HCV Lifecycle Overview 15
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HCV, 2012-2022 59
Figure 4: Sales for HCV Therapeutics in the US by Drug Class, 2012-2022 106

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