PharmaPoint: Hepatitis C Virus – France 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 France 22
4.3.1 Diagnosis 22
4.3.2 Clinical Practice 23
5 Competitive Assessment 24
5.1 Overview 24
5.2 Strategic Competitor Assessment 24
5.3 Product Profiles – Major Brands 26
5.3.1 Incivek (telaprevir) 26
5.3.2 Victrelis (boceprevir) 31
5.3.3 Pegasys (peginterferon alfa-2a) 35
5.3.4 PegIntron (peginterferon alfa-2b) 40
5.3.5 Copegus, Rebetol, and Generic Ribavirin 44
5.3.6 Therapeutic Class: Interferon 46
6 Opportunity and Unmet Need 47
6.1 Overview 47
6.2 Unmet Needs 48
6.2.1 Unmet Need: Treatment Tolerability 48
6.2.2 Unmet Need: Efficacy 48
6.2.3 Unmet Need: Disease Awareness 49
6.2.4 Unmet Need: Treatment Cost 50
6.2.5 Unmet Need: Shorter Treatment Duration 50
6.2.6 Unmet Need: Simplified Treatment Regimens 51
6.3 Unmet Needs Gap Analysis 52
6.4 Opportunities 53
6.4.1 Opportunity: Pan-genotypic HCV Regimen 53
6.4.2 Opportunity: Treatment of Underrepresented Patient Populations 53
6.4.3 Opportunity: Involvement of Immune System 54
7 Pipeline Assessment 55
7.1 Overview 55
7.2 Promising Drugs in Clinical Development 56
7.2.1 Sofosbuvir and Sofosbuvir/Ledipasvir 58
7.2.2 Simeprevir 68
7.2.3 ABT-450 plus ABT-267 and ABT-333 76
7.2.4 Faldaprevir and Faldaprevir plus BI 207127 83
7.2.5 Daclatasvir and Daclatasvir plus Asunaprevir 91
7.2.6 Other Drug Classes 99
8 Market Outlook 102
8.1 France 102
8.1.1 Forecast 102
8.1.2 Key Events 107
8.1.3 Drivers and Barriers 107
9 Appendix 110
9.1 Bibliography 110
9.2 Abbreviations 118
9.3 Methodology 120
9.4 Forecasting Methodology 120
9.4.1 Percent Drug-Treated Patients 120
9.4.2 Patient Warehousing 121
9.4.3 Drugs Included in Each Therapeutic Class 121
9.4.4 Launch and Patent Expiry Dates 122
9.4.5 General Pricing Assumptions 123
9.4.6 Individual Drug Assumptions 123
9.4.7 Generic Erosion 125
9.4.8 Selection of Pipeline Agents 125
9.4.9 Pricing of Pipeline Agents 126
9.5 Physicians and Specialists Included in this Study 129
9.6 Survey of Prescribing Physicians 131
9.7 About the Authors 132
9.7.1 Author 132
9.7.2 Global Head of Healthcare 132
9.8 About GlobalData 133
9.9 Contact Us 133
9.10 Disclaimer 133
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 25
Table 8: Product Profile – Incivek 27
Table 9: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial) 27
Table 10: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial) 28
Table 11: Common Incivek Adverse Drug Reactions 29
Table 12: Incivek SWOT Analysis, 2012 30
Table 13: Product Profile – Victrelis 31
Table 14: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial) 32
Table 15: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial) 33
Table 16: Victrelis SWOT Analysis, 2012 34
Table 17: Product Profile – Pegasys 36
Table 18: Antiviral Efficacy of Peginterferon alfa-2a Compared with Interferon alfa-2b 37
Table 19: Pegasys SWOT Analysis, 2012 39
Table 20: Product Profile – PegIntron 41
Table 21: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b 41
Table 22: PegIntron SWOT Analysis, 2012 43
Table 23: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 45
Table 24: Ribavirin SWOT Analysis, 2012 46
Table 25: Summary of Minor Therapeutic Classes, 2012 46
Table 26: Overall Unmet Needs – Current Level of Attainment 47
Table 27: Clinical Unmet Needs – Gap Analysis, 2012 52
Table 28: HCV – Pipeline, 2012 56
Table 29: Comparison of Therapeutic Classes in Development for HCV, 2012 57
Table 30: Gilead’s Sofosbuvir Ongoing Clinical Trials of Interest 59
Table 31: Product Profile – Sofosbuvir 60
Table 32: Sofosbuvir’s Most Common Adverse Effects 63
Table 33: Sofosbuvir SWOT Analysis, 2012 67
Table 34: Janssen’s Simeprevir Ongoing Clinical Trials of Interest 69
Table 35: Product Profile – Simeprevir 70
Table 36: PILLAR Clinical Trial Results 70
Table 37: Adverse Events Observed in PILLAR Clinical Trial 71
Table 38: Simeprevir SWOT Analysis, 2012 75
Table 39: AbbVie’s Combination Therapy Ongoing Clinical Trials of Interest 77
Table 40: Product Profile – AbbVie Combination Therapy 78
Table 41: AVIATOR Clinical Trial Results 78
Table 42: AbbVie Combination Therapy SWOT Analysis, 2012 82
Table 43: Boehringer Ingelheim’s Faldaprevir Ongoing Clinical Trials of Interest 84
Table 44: Product Profile – Faldaprevir 85
Table 45: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 85
Table 46: Faldaprevir SWOT Analysis, 2012 90
Table 47: Bristol-Myers Squibb’s Daclatasvir Ongoing Clinical Trials of Interest 92
Table 48: Product Profile – Daclatasvir 93
Table 49: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 93
Table 50: Daclatasvir and Asunaprevir Quad Therapy Efficacy 94
Table 51: Daclatasvir Triple Therapy Adverse Events 95
Table 52: Daclatasvir SWOT Analysis, 2012 98
Table 53: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 99
Table 54: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 100
Table 55: Sales Forecasts ($m) for HCV in France, 2012–2022 105
Table 56: Key Events Impacting Sales for HCV in France, 2012 107
Table 57: French HCV Market – Drivers and Barriers, 2012 107
Table 58: Key Launch Dates 122
Table 59: Key Patent Expiries 122
Table 60: Physicians Surveyed, By Country 131
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 56
Figure 4: Sales for HCV Therapeutics in France by Drug Class, 2012–2022 106
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