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 a direct-acting antiviral (DAA), such as Gilead’s Sovaldi (sofosbuvir) or Janssen’s Olysio (simeprevir), along with pegylated interferon (e.g., Roche’s Pegasys and Merck’s PegIntron) and/or ribavirin (e.g., Roche’s Copegus and Merck’s Rebetol) are used to treat HCV infections. Sovaldi and Olysio have largely replaced first-generation NS3/4A protease inhibitors, such as Vertex’s Incivek (telaprevir) and Merck’s Victrelis (boceprevir) due to their increased tolerability, efficacy, and shorter treatment duration. The entrance of next-generation , all-oral HCV therapies is expected to fundamentally alter the HCV treatment algorithm.

Highlights

Key Questions Answered

• How quickly, and to what extent, will interferon-sparing and all-oral regimens replace Incivek and Victrelis in the treatment algorithm?
• What role, if any, will interferon-based therapies have in the HCV treatment landscape over the next decade?
• Which novel HCV therapies will face adoption challenges in the market? What is the projected uptake of new drugs, such as Merck’s MK-5172/MK-8742, over the forecast period?
• Will the reduced pill burden and increased convenience of fixed-dose, all-oral combination therapies lead to their widespread uptake?
• How will pricing influence the use of next-generation DAAs?
• Which HCV regimen(s) in development are physicians most excited about?

Key Findings

• Patient awareness is anticipated to increase in response to government education and screening initiatives.
• Interferon use is predicted to drastically decrease over the next 10 years.
• The launch of next-generation, all-oral DAA regimens is expected to streamline the HCV treatment algorithm.
• The approval of more-tolerable HCV therapies is likely to result in patients deciding to undergo treatment (i.e., decrease in the warehouse effect).
• Fixed-dose combination therapies are expected to seize market share due to their reduced pill burden and convenience.

Scope

• Overview of hepatitis C virus (HCV), including epidemiology, etiology, general symptoms from infection, and national vaccination recommendations and guidelines.
• Annualized HCV therapeutics market revenue, annual cost of therapy, and treatment usage pattern data from 2012 and forecast for 10 years to 2022.
• Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HCV market.
• Pipeline analysis: comprehensive data split across different phases, and emerging trends, specifically interferon-free therapies and fixed-dose combinations.
• Analysis of the current and future market competition in the global HCV therapeutics market. Insightful review of the key industry and governmental drivers, restraints and challenges.
• Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
• Develop business strategies by understanding the trends shaping and driving the global HCV therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HCV market in future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Track drug sales in the global HCV therapeutics market from 2012-2022.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 Table of Contents 7
1.1 List of Tables15
1.2 List of Figures 21

2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 22
2.3 Upcoming Related Reports 23

3 Disease Overview 24
3.1 Etiology and Pathophysiology 24
3.1.1 Etiology 24
3.1.2 Pathophysiology 28
3.1.3 Prognosis 29
3.2 Symptoms 29

4 Epidemiology 31
4.1 Risk Factors and Comorbidities 31
4.1.1 The risk of contracting HCV is almost 50 times higher among injection drug users 32
4.1.2 There is a 10.9-fold increased risk of developing HCV infection through a blood transfusion 33
4.1.3 No current preventative therapy to reduce perinatal HCV transmission 33
4.1.4 Metabolic syndrome is a common comorbidity in HCV-infected individuals 34
4.1.5 Chronic alcoholism greatly magnifies the risk of HCC 35
4.1.6 HBV and HCV share similar modes of transmission, resulting in co-infection 35
4.1.7 HCV/HIV co-infection complicates treatment options and accelerates liver damage 35
4.2 Global Trends 36
4.2.1 US 37
4.2.2 5EU 38
4.2.3 Japan 41
4.2.4 Brazil 41
4.2.5 China 42
4.3 Forecast Methodology 43
4.3.1 Sources Used 43
4.3.2 Forecast Assumptions and Methods 47
4.3.3 Forecast Assumptions and Methods (HCV Genotypes) 51
4.3.4 Sources Not Used 55
4.4 Epidemiology Forecast for HCV (2012-2022) 55
4.4.1 Total Prevalent Cases of HCV 55
4.4.2 Age-Specific Prevalent Cases of HCV 58
4.4.3 Sex-Specific Prevalent Cases of HCV 61
4.4.4 Age-Standardized Prevalence of HCV 64
4.4.5 HCV Genotype Class Distributions 66
4.5 Discussion 67
4.5.1 Conclusion on Epidemiology Trends 67
4.5.2 Limitations of the Analysis 68
4.5.3 Strengths of the Analysis 69

5 Disease Management 70
5.1 Diagnosis and Referral Overview 70
5.2 Treatment Overview 71
5.3 US 74
5.3.1 Diagnosis 74
5.3.2 Clinical Practice 76
5.4 France 79
5.4.1 Diagnosis 79
5.4.2 Clinical Practice 80
5.5 Germany 81
5.5.1 Diagnosis 81
5.5.2 Clinical Practice 82
5.6 Italy 83
5.6.1 Diagnosis 83
5.6.2 Clinical Practice 83
5.7 Spain 84
5.7.1 Diagnosis 84
5.7.2 Clinical Practice 84
5.8 UK 86
5.8.1 Diagnosis 86
5.8.2 Clinical Practice 87
5.9 Japan 88
5.9.1 Diagnosis 88
5.9.2 Clinical Practice 88
5.10 Brazil 89
5.10.1 Diagnosis 89
5.10.2 Clinical Practice 90
5.11 China 90
5.11.1 Diagnosis 90
5.11.2 Clinical Practice 91

6 Competitive Assessment 92
6.1 Overview 92
6.2 Strategic Competitor Assessment 92
6.3 Product Profiles - Major Brands 94
6.3.1 Sovaldi and Sovaldi/Ledipasvir 94
6.3.2 Olysio 106
6.3.3 Incivek 114
6.3.4 Victrelis 121
6.3.5 Pegasys 127
6.3.6 PegIntron 133
6.3.7 Copegus, Rebetol, and Generic Ribavirin 139
6.3.8 Therapeutic Class: Interferon 144

7 Opportunity and Unmet Need 145
7.1 Overview 145
7.2 Unmet Needs 146
7.2.1 Unmet Need: Enhanced Efficacy in Difficult-to-Treat Patient Populations 146
7.2.2 Unmet Need: Improved Understanding of Drug-Drug Interactions 147
7.2.3 Unmet Need: Increased Disease Awareness and Diagnosis of HCV 148
7.2.4 Unmet Need: Reduced Cost of All-Oral Regimens 149
7.2.5 Unmet Need: Improved Treatment Tolerability 149
7.2.6 Unmet Need: Simplified Treatment Algorithm 150
7.2.7 Unmet Need: Shorter Treatment Duration 151
7.3 Unmet Needs Gap Analysis 152
7.4 Opportunities 153
7.4.1 Opportunity: Develop a Pan-Genotypic, All-Oral HCV Regimen 153
7.4.2 Opportunity: Target Difficult-to-Treat Patient Populations 153
7.4.3 Opportunity: Eliminate Ribavirin from All-Oral Regimens 154
7.4.4 Opportunity: Involvement of the Immune System 155

8 Pipeline Assessment 156
8.1 Overview 156
8.2 Clinical Trial Mapping 157
8.2.1 Clinical Trials by Country 157
8.3 Clinical Trials by Phase and Trial Status 158
8.4 Promising Direct-Acting Antivirals (DAAs) in Clinical Development 160
8.4.1 ABT-450/Ombitasvir + Dasabuvir 162
8.4.2 Faldaprevir 172
8.4.3 Daclatasvir, Daclatasvir + Asunaprevir, and Daclatasvir/Asunaprevir/BMS-791325 181
8.4.4 MK-5172/MK-8742 194
8.4.5 Vaniprevir 202
8.5 Other Drug Classes in Clinical Development 208
8.5.1 Interferon Derivatives 208
8.5.2 Host-Targeting Therapies 210

9 Current and Future Players 212
9.1 Overview 212
9.2 Trends in Corporate Strategy 214
9.3 Company Profiles 216
9.3.1 Merck 216
9.3.2 Roche 218
9.3.3 Vertex 221
9.3.4 Janssen 224
9.3.5 Gilead 226
9.3.6 AbbVie 231
9.3.7 Bristol-Myers Squibb 233
9.3.8 Boehringer Ingelheim 236
9.4 Additional Companies with Promising Drugs 239
9.4.1 Mitsubishi Tanabe Pharmaceutical Corporation 239
9.4.2 Achillion 240
9.4.3 Scynexis 241
9.4.4 Idenix 242
9.4.5 Presidio 243
9.4.6 Novartis 244

10 Market Outlook 246
10.1 Global Markets 246
10.1.1 Forecast 246
10.1.2 Drivers and Barriers - Global Issues 250
10.2 US 255
10.2.1 Forecast 255
10.2.2 Key Events 261
10.2.3 Drivers and Barriers 262
10.3 France 266
10.3.1 Forecast 266
10.3.2 Key Events 272
10.3.3 Drivers and Barriers 273
10.4 Germany 275
10.4.1 Forecast 275
10.4.2 Key Events 280
10.4.3 Drivers and Barriers 281
10.5 Italy 283
10.5.1 Forecast 283
10.5.2 Key Events 287
10.5.3 Drivers and Barriers 288
10.6 Spain 290
10.6.1 Forecast 290
10.6.2 Key Events 294
10.6.3 Drivers and Barriers 295
10.7 UK 297
10.7.1 Forecast 297
10.7.2 Key Events 302
10.7.3 Drivers and Barriers 303
10.8 Japan 305
10.8.1 Forecast 305
10.8.2 Key Events 311
10.8.3 Drivers and Barriers 312
10.9 Brazil 314
10.9.1 Forecast 314
10.9.2 Key Events 318
10.9.3 Drivers and Barriers 318
10.10 China 321
10.10.1 Forecast 321
10.10.2 Key Events 325
10.10.3 Drivers and Barriers 325

11 Appendix 328
11.1 Bibliography 328
11.2 Abbreviations 358
11.3 Methodology 361
11.4 Forecasting Methodology 361
11.4.1 Percent Drug-Treated Patients 361
11.4.2 Patient Warehousing 362
11.4.3 Drugs Included in Each Therapeutic Class 362
11.4.4 Launch and Patent Expiry Dates 363
11.4.5 General Pricing Assumptions 364
11.4.6 Individual Drug Assumptions 365
11.4.7 Generic Erosion 369
11.4.8 Selection of Pipeline Agents 369
11.4.9 Pricing of Pipeline Agents 370
11.5 Physicians and Specialists Included in This Study 374
11.6 Survey of Prescribing Physicians 376
11.7 About the Authors 377
11.7.1 Analysts 377
11.7.2 Epidemiologist 378
11.7.3 Therapy Area Director 378
11.7.4 Global Head of Healthcare 379
11.8 About GlobalData 380
11.9 Disclaimer 380

List of Tables

Table 1: Modes of HCV Transmission 28
Table 2: Symptoms of Acute and Chronic HCV Infection 30
Table 3: Risk Factors, Comorbidities, and Complications Associated with HCV Infection 32
Table 4: 9MM, Sources of HCV Prevalence Data Used for the Forecast 44
Table 5: 9MM, Sources of HCV Genotype Data 44
Table 6: Hepatitis C Virus Genotype Description 51
Table 7: 9MM, Prevalent Cases of HCV, Age ?15 Years, Men and Women, N (Millions), 2012-2022 56
Table 8: 9MM, Prevalent Cases of HCV, By Age, N (Millions), (Row %), 2012 59
Table 9: 9MM, Prevalent Cases of HCV, by Sex, Ages ?15 Years, N (Row %), 2012 62
Table 10: 9MM, Prevalent Cases of HCV, by Genotype, Ages ?15 Years, N (Row %), 2012 66
Table 11: HCV Genotypes Present in the 9MM 71
Table 12: General Standard of Care by HCV Genotype 72
Table 13: Treatment Guidelines for HCV by Country 73
Table 14: Most-Prescribed Drugs for HCV by Class in the Global Markets, 2012 74
Table 15: Leading Treatments for HCV, 2014 94
Table 16: Gilead's Sovaldi Ongoing Clinical Trials of Interest 96
Table 17: Product Profile - Sovaldi 98
Table 18: Sovaldi's Most Common Adverse Effects 101
Table 19: Sovaldi SWOT Analysis, 2014 103
Table 20: Global Sales Forecasts ($m) for Sovaldi and Sovaldi/Ledipasvir, 2012-2022 105
Table 21: Janssen's Olysio Clinical Trials of Interest 107
Table 22: Product Profile - Olysio 109
Table 23: Olysio's Efficacy - PILLAR Clinical Trial Results 110
Table 24: Olysio's Safety - Adverse Events Observed in the PILLAR Clinical Trial 111
Table 25: Olysio SWOT Analysis, 2014 113
Table 26: Global Sales Forecasts ($m) for Olysio, 2012-2022 114
Table 27: Product Profile - Incivek 116
Table 28: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial) 117
Table 29: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial) 117
Table 30: Common Incivek Adverse Reactions 118
Table 31: Incivek SWOT Analysis, 2014 120
Table 32: Global Sales Forecasts ($m) for Incivek, 2012-2022 121
Table 33: Product Profile - Victrelis 122
Table 34: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial) 123
Table 35: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial) 124
Table 36: Victrelis SWOT Analysis, 2014 126
Table 37: Global Sales Forecasts ($m) for Victrelis, 2012-2022 127
Table 38: Product Profile - Pegasys 129
Table 39: Antiviral Efficacy of Peginterferon Alfa-2a Compared with Interferon Alfa-2b 130
Table 40: Pegasys SWOT Analysis, 2014 132
Table 41: Global Sales Forecasts ($m) for Pegasys, 2012-2022 133
Table 42: Product Profile - PegIntron 135
Table 43: Antiviral Efficacy of PegIntron Compared With Interferon Alfa-2b 136
Table 44: PegIntron SWOT Analysis, 2014 138
Table 45: Global Sales Forecasts ($m) for PegIntron, 2012-2022 139
Table 46: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 140
Table 47: Ribavirin SWOT Analysis, 2014 142
Table 48: Global Sales Forecasts ($m) for Copegus and Ribavirin, 2012-2022 143
Table 49: Summary of the Minor Therapeutic Classes, 2014 144
Table 50: Overall Unmet Needs - Current Level of Attainment 146
Table 51: Clinical Unmet Needs - Gap Analysis, 2012 152
Table 52: HCV - Clinical Trials by Phase and Status, 2014 159
Table 53: HCV - Late-Stage DAA Pipeline, 2014 160
Table 54: Comparison of Therapeutic Classes in Development for HCV, 2014 162
Table 55: AbbVie's Combination Therapy Clinical Trials of Interest 164
Table 56: Product Profile - AbbVie Combination Therapy 165
Table 57: AbbVie Combination Therapy - AVIATOR Clinical Trial Results 166
Table 58: AbbVie Combination Therapy - Key Phase III Clinical Trial Results 167
Table 59: AbbVie's Combination Therapy SWOT Analysis, 2014 171
Table 60: Global Sales Forecasts* ($m) for AbbVie Combination Therapy, 2012-2022 172
Table 61: BI's Faldaprevir Clinical Trials of Interest 174
Table 62: Product Profile - Faldaprevir 175
Table 63: Faldaprevir SWOT Analysis, 2014 180
Table 64: Global Sales Forecasts ($m) for Faldaprevir, 2012-2022 181
Table 65: BMS' Combination Therapy Clinical Trials of Interest 183
Table 66: Product Profile - BMS' Combination Therapy 185
Table 67: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 186
Table 68: Daclatasvir and Asunaprevir Quad Therapy Efficacy 186
Table 69: Daclatasvir Triple Therapy Adverse Events 187
Table 70: BMS Combination Therapy SWOT Analysis, 2014 191
Table 71: Global Sales Forecasts ($m) for BMS' Combination Therapy and Peginterferon Lambda, 2012-2022 193
Table 72: Merck's Combination Therapy Clinical Trials of Interest 196
Table 73: Product Profile - MK-5172/MK-8742 197
Table 74: MK-5172/MK-8742 SWOT Analysis, 2014 201
Table 75: Global Sales Forecasts ($m) for MK-5172/MK-8742, 2012-2022 202
Table 76: Merck's Vaniprevir Clinical Trials of Interest 203
Table 77: Product Profile - Vaniprevir 203
Table 78: Vaniprevir SWOT Analysis, 2014 207
Table 79: Global Sales Forecasts ($m) for Vaniprevir, 2012-2022 208
Table 80: Comparison of Peginterferon Lambda with Peginterferon Alfa (EMERGE Trial) 209
Table 81: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 210
Table 82: Key Companies in the HCV Market, 2014 213
Table 83: Merck's HCV Portfolio Assessment, 2014 217
Table 84: Merck SWOT Analysis, 2014 218
Table 85: Roche's HCV Portfolio Assessment, 2014 220
Table 86: Roche SWOT Analysis, 2014 221
Table 87: Vertex's HCV Portfolio Assessment, 2014 223
Table 88: Vertex SWOT Analysis, 2014 223
Table 89: Janssen's HCV Portfolio Assessment, 2014 225
Table 90: Janssen SWOT Analysis, 2014 226
Table 91: Gilead's HCV Portfolio Assessment, 2014 229
Table 92: Gilead SWOT Analysis, 2014 230
Table 93: AbbVie's HCV Portfolio Assessment, 2014 232
Table 94: AbbVie SWOT Analysis, 2014 233
Table 95: BMS' HCV Portfolio Assessment, 2014 235
Table 96: BMS' SWOT Analysis, 2014 236
Table 97: BI's HCV Portfolio Assessment, 2014 238
Table 98: BI SWOT Analysis, 2014 238
Table 99: Mitsubishi Tanabe Pharma's HCV Portfolio Assessment, 2014 240
Table 100: Achillion's HCV Portfolio Assessment, 2014 241
Table 101: Scynexis' HCV Portfolio Assessment, 2014 242
Table 102: Idenix's HCV Portfolio Assessment, 2014 243
Table 103: Presidio's HCV Portfolio Assessment, 2014 244
Table 104: Novartis' HCV Portfolio Assessment, 2014 245
Table 105: Global Sales Forecasts ($m) for HCV, 2012-2022 248
Table 106: HCV Market - Drivers and Barriers, 2012-2022 250
Table 107: Sales Forecasts ($m) for HCV in the US, 2012-2022 259
Table 108: Key Events Impacting Sales for HCV in the US, 2012-2022 261
Table 109: US HCV Market - Drivers and Barriers, 2012-2022 262
Table 110: Sales Forecasts ($m) for HCV in France, 2012-2022 270
Table 111: Key Events Impacting Sales for HCV in France, 2012-2022 272
Table 112: French HCV Market - Drivers and Barriers, 2012-2022 273
Table 113: Sales Forecasts ($m) for HCV in Germany, 2012-2022 278
Table 114: Key Events Impacting Sales for HCV in Germany, 2012-2022 280
Table 115: German HCV Market - Drivers and Barriers, 2012-2022 281
Table 116: Sales Forecasts ($m) for HCV in Italy, 2012-2022 285
Table 117: Key Events Impacting Sales for HCV in Italy, 2012-2022 287
Table 118: Italian HCV Market - Drivers and Barriers, 2012-2022 288
Table 119: Sales Forecasts ($m) for HCV in Spain, 2012-2022 292
Table 120: Key Events Impacting Sales for HCV in Spain, 2012-2022 294
Table 121: Spanish HCV Market - Drivers and Barriers, 2012-2022 295
Table 122: Sales Forecasts ($m) for HCV in the UK, 2012-2022 300
Table 123: Key Events Impacting Sales for HCV in the UK, 2012-2022 302
Table 124: UK HCV Market - Drivers and Barriers, 2012-2022 303
Table 125: Sales Forecasts ($m) for HCV in Japan, 2012-2022 309
Table 126: Key Events Impacting Sales for HCV in Japan, 2012-2022 311
Table 127: Japanese HCV Market - Drivers and Barriers, 2012-2022 312
Table 128: Sales Forecasts ($m) for HCV in Brazil, 2012-2022 316
Table 129: Key Events Impacting Sales for HCV in Brazil, 2012-2022 318
Table 130: Brazilian HCV Market - Drivers and Barriers, 2012-2022 318
Table 131: Sales Forecasts ($m) for HCV in China, 2012-2022 323
Table 132: Key Events Impacting Sales for HCV in China, 2012-2022 325
Table 133: Chinese HCV Market - Drivers and Barriers, 2012-2022 325
Table 134: Key Launch Dates 363
Table 135: Key Patent Expiries 364
Table 136: Physicians Surveyed, By Country 376

List of Figures

Figure 1: HCV Genome and Polyprotein Composition 25
Figure 2: HCV Lifecycle Overview 26
Figure 3: 9MM, Prevalent Cases of HCV, Ages ?15 Years, Men and Women, N (Millions), 2012-2022 57
Figure 4: 9MM, Prevalent Cases of HCV, by Age, N (Millions), 2012 60
Figure 5: 9MM, Prevalent Cases of HCV, by Sex, N (Millions), 2012 63
Figure 6: 9MM, Age-Standardized Prevalence of HCV, Ages ?15 Years, by Sex, %, 2012 65
Figure 7: HCV Therapeutics - Clinical Trials by Country, 2014 158
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in HCV, 2012-2022 161
Figure 9: Company Portfolio Gap Analysis in HCV, 2012-2022 214
Figure 10: Global Sales for HCV Therapeutics by Country, 2012-2022 249
Figure 11: Sales for HCV Therapeutics in the US by Drug Class, 2012-2022 260
Figure 12: Sales for HCV Therapeutics in France by Drug Class, 2012-2022 271
Figure 13: Sales for HCV Therapeutics in Germany by Drug Class, 2012-2022 279
Figure 14: Sales for HCV Therapeutics in Italy by Drug Class, 2012-2022 286
Figure 15: Sales for HCV Therapeutics in Spain by Drug Class, 2012-2022 293
Figure 16: Sales for HCV Therapeutics in the UK by Drug Class, 2012-2022 301
Figure 17: Sales for HCV Therapeutics in Japan by Drug Class, 2012-2022 310
Figure 18: Sales for HCV Therapeutics in Brazil by Drug Class, 2012-2022 317
Figure 19: Sales for HCV Therapeutics in China by Drug Class, 2012-2022 324