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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