PharmaPoint: Hepatitis C Virus (HCV) Therapeutics-Global Drug Forecast and Market Analysis to 2025

PharmaPoint: Hepatitis C Virus (HCV) Therapeutics-Global Drug Forecast and Market Analysis to 2025


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Executive Summary

PharmaPoint: Hepatitis C Virus (HCV) Therapeutics-Global Drug Forecast and Market Analysis to 2025

Summary

The hepatitis C virus (HCV) is a small, enveloped RNA virus that causes acute and chronic infections of the liver and, if left untreated, can result in fibrosis, permanent liver damage (cirrhosis), HCC, and eventually death. A member of the Flaviviridae viral family and hepacivirus genus, HCV can be classified into six major genotypes, with many additional subtypes within each genotype. While genotype 1 (GT1) causes almost half of HCV infections, all six major genotypes (GT1-6) are prevalent worldwide. The genetic diversity of HCV strains, even within the same host, originates from the low fidelity of the ribonucleic acid (RNA) polymerase, and is thought to account for viral resistance when HCV is treated with a single drug.

During the last few years, the hepatitis C treatment landscape has experienced successive waves of revolutionary change, and is now dominated by high-performance regimens comprising a new generation direct acting antivirals (DAAs). The treatment arsenal has rapidly expanded from only one unsatisfactory option-peginterferon plus ribavirin-to a collection of combination and fixed-dose combination regimens that can cure most patients in as little as 8?12 weeks, many without the use of interferon and/or ribavirin. Currently, these interferon-free and interferon-sparing DAA regimens dominate the treatment landscape as they combine a very high cure rate with improved tolerability and simplified dosing.

Highlights

Key Questions Answered

Based on interviews with key opinion leaders (KOLs), GlobalData has identified key unmet needs in the hepatitis C marketplace.

What will be the effect of recent and upcoming approval of pan-genotypic DAA regimens?

How will patient populations develop with changing treatment rates and high cure rates?

What research and development (R&D) strategies will companies leverage to compete in the future hepatitis C marketplace?

Which patient population(s) are most likely to be targeted by upcoming pan-genotypic DAA treatment algorithms?

Key Findings

GlobalData estimates that drug sales for hepatitis C in 2015 were approximately $21.7 billion across the 9MM. The global hepatitis C market is expected to experience a steady decline during the forecast period resulting in total sales of $17.5 billion by 2025, translating into a negative Compound Annual Growth Rate (CAGR) of 2.1%. The decline in sales will be most prominent in the US and in France, Germany, and the UK, while the southern European countries, Spain and Italy, as well as China, will see constant or even increasing market sizes during the forecast period.

The launch of multiple pan-genotypic DAA regimens will provide improved efficacy profiles for difficult-to-treat patients, including patients infected with genotype 3 (GT3), individuals with renal failure, and patients with decompensated liver cirrhosis.

The main barrier of future growth of the global HCV market will originate from the declining prevalence rates in most countries. Driven by modest treatment rates and excellent cure rates, the patient pools in most countries will steadily decline throughout the forecast; several markets will see significantly reduced total patient pools by 2025.

Scope

Overview of hepatitis C infections, including epidemiology, etiology, pathophysiology, regional genotype distribution, as well current routine treatment recommendations of all 9MM covered.

Topline hepatitis C market revenue from 2015-2025. Recent acquisitions, approvals and governmental recommendations and restrictions are included in the forecast model.

Key topics covered include dynamics in the number of prevalent cases during the forecast, market characterization, unmet needs, and company strategies.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.

Analysis of the current and future market competition in the global hepatitis C marketplace. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

The report will enable you to

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 hepatitis C market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the hepatitis C market in the 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.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.



Read More



Contact Us:
Ken Research
Ankur Gupta, Head Marketing & Communications

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1 Table of Contents

1 Table of Contents 11

1.1 List of Tables 18

1.2 List of Figures 25

2 Introduction 28

2.1 Catalyst 28

2.2 Related Reports 29

2.3 Upcoming Related Reports 29

3 Disease Overview 30

3.1 Etiology and Pathophysiology 31

3.1.1 Etiology 31

3.1.2 Pathophysiology 34

3.2 Symptoms 35

3.3 Prognosis and Quality of Life 36

4 Epidemiology 38

4.1 Disease Background 38

4.2 Risk Factors and Comorbidities 39

4.3 Global Trends 41

4.3.1 Diagnosed Incidence and Total Prevalence 42

4.3.2 Genotype 48

4.4 Forecast Methodology 48

4.4.1 Sources Used Tables 50

4.4.2 Forecast Assumptions and Methods 60

4.4.3 Sources Not Used 81

4.5 Epidemiological Forecast of HCV (2015-2025) 82

4.5.1 Total Prevalent Cases 82

4.5.2 Diagnosed Prevalent Cases 98

4.6 Discussion 113

4.6.1 Epidemiological Forecast Insight 113

4.6.2 Limitations of the Analysis 114

4.6.3 Strengths of the Analysis 115

5 Disease Management 117

5.1 Diagnosis Overview 117

5.1.1 Initial Diagnosis and Referral 117

5.1.2 Patient Assessment 118

5.1.3 Viral Assessment 119

5.2 Treatment Guildines 120

5.3 US 124

5.3.1 Diagnosis 125

5.3.2 Treatment Guidelines 126

5.3.3 Clinical Practice and Coverage 129

5.4 5EU 133

5.4.1 Diagnosis Overview 134

5.4.2 Treatment Guidelines Overview 134

5.5 France 137

5.5.1 Diagnosis 137

5.5.2 Clinical Practice 138

5.6 Germany 139

5.6.1 Diagnosis 139

5.6.2 Clinical Practice 139

5.7 Italy 140

5.7.1 Diagnosis 140

5.7.2 Clinical Practice 140

5.8 Spain 141

5.8.1 Diagnosis 141

5.8.2 Clinical Practice 142

5.9 UK 142

5.9.1 Diagnosis 142

5.9.2 Clinical Practice 143

5.10 Japan 145

5.10.1 Diagnosis 145

5.10.2 Clinical Practice 146

5.11 Brazil 148

5.11.1 Diagnosis 149

5.11.2 Clinical Practice 149

5.12 China 150

5.12.1 Diagnosis 151

5.12.2 Clinical Practice 152

6 Competitive Assessment 155

6.1 Overview 155

6.2 Strategic Competitor Assessment 158

6.3 Major Brands-Fixed-Dose Combination Direct-Acting Antivirals 161

6.3.1 Harvoni (Ledipasvir/Sofosbuvir) 161

6.3.2 Viekira Pak (Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir) and Technivie (Ombitasvir/Paritaprevir/Ritonavir) 173

6.3.3 Zepatier (Elbasvir/Grazoprevir) 187

6.3.4 Epclusa (Sofosbuvir/Velpatasvir) 198

6.4 Major Brands-Single Component Direct-Acting Antivirals 209

6.4.1 Sovaldi (Sofosbuvir) 209

6.4.2 Daklinza (Daclatasvir) 218

6.4.3 Olysio (Simeprevir) 228

6.5 Major Brands-Peginterferon and Ribavirin 238

6.5.1 Pegasys (Peginterferon alfa-2a) and PegIntron (Peginterferon alfa-2b) 238

6.5.2 Copegus, Rebetol, and Generic Ribavirin 247

6.6 Other Branded Direct-Acting Antivirals 251

6.6.1 Incivek (Telaprevir) and Victrelis (Boceprevir) 252

6.6.2 Sunvepra (Asunaprevir) 254

6.6.3 Exviera (Dasabuvir) 254

6.6.4 Vanihep (Vaniprevir) 255

7 Unmet Needs and Opportunity Analysis 256

7.1 Overview 256

7.2 Reducing the Overall Cost Burden of Direct-Acting Antiviral Treatment Algorithms 258

7.2.1 Unmet Need 258

7.2.2 Gap Analysis 260

7.2.3 Opportunity 263

7.3 Increasing Awareness of Hepatitis C Treatment Opportunities 264

7.3.1 Adjusting the Approaches Physicians Take with Hepatitis C 264

7.3.2 Awareness in the General Population 268

7.4 Expanding Treatment Access 270

7.4.1 Unmet Need 270

7.4.2 Gap Analysis 271

7.4.3 Opportunity 271

7.5 Improving Diagnosis Rates in Patients with Chronic Hepatitis C Infection 272

7.5.1 Unmet Need 272

7.5.2 Gap Analysis 274

7.5.3 Opportunity 275

7.6 Reducing Frequency and Severity of Adverse Events in All Patient Groups 276

7.6.1 Unmet Need 276

7.6.2 Gap Analysis 277

7.6.3 Opportunity 277

7.7 Enhanced Cure Rates in Difficult-to-Treat Patients 278

7.7.1 Unmet Need 278

7.7.2 Gap Analysis 279

7.7.3 Opportunity 280

7.8 Clinical Evalulation of Direct-Acting Antiviral Efficacy in Pediatric Patients 281

7.8.1 Unmet Need 281

7.8.2 Gap Analysis 281

7.8.3 Opportunity 282

8 Pipeline Assessment 283

8.1 Overview 283

8.2 Clinical Trial Mapping 285

8.2.1 Clinical Trials by Status and Phase 285

8.3 Promising DAA Regimens in Clinical Development 286

8.3.1 Sofosbuvir/Velpatasvir/Voxilaprevir 289

8.3.2 Glecaprevir/pibrentasvir 298

8.3.3 Asunaprevir/Beclabuvir/Daclatasvir 309

8.3.4 MK-3682A and MK-3682B 317

8.3.5 Odalasvir-Based Regimens 324

8.4 Other Products in Clinical Development 331

8.4.1 Investigational Therapies with Established MOAs 331

8.4.2 Investigational Therapies with Novel MOAs 334

8.4.3 Clinical Development Outside 9MM 336

9 Current and Future Players 338

9.1 Overview 338

9.2 Trends in Corporate Strategy 343

9.3 Company Profiles 349

9.3.1 Gilead Sciences 349

9.3.2 AbbVie 353

9.3.3 Merck 355

9.3.4 Janssen 357

9.3.5 Bristol-Myers Squibb 359

9.3.6 Roche 361

9.4 Additional Companies with Promising Drugs 363

9.4.1 Regulus Therapeutics 363

9.4.2 Presidio Pharmaceuticals 364

9.4.3 Trek Therapeutics 366

10 Market Outlook 367

10.1 Global Markets 367

10.1.1 Forecast 367

10.1.2 Drivers and Barriers-Global Issues 374

10.2 US 375

10.2.1 Forecast 375

10.2.2 Key Events 380

10.2.3 Drivers and Barriers 380

10.3 5EU 381

10.3.1 5EU 381

10.3.2 France 387

10.3.3 Germany 393

10.3.4 Italy 398

10.3.5 Spain 403

10.3.6 UK 408

10.4 Japan 413

10.4.1 Forecast 413

10.4.2 Key Events 417

10.4.3 Drivers and Barriers 417

10.5 Brazil 418

10.5.1 Forecast 418

10.5.2 Key Events 422

10.5.3 Drivers and Barriers 422

10.6 China 423

10.6.1 Forecast 423

10.6.2 Key Events 427

10.6.3 Drivers and Barriers 428

11 Appendix 429

11.1 Bibliography 429

11.2 Abbreviations 472

11.3 Methodology 477

11.4 Forecasting Methodology 477

11.4.1 Patient Populations 477

11.4.2 Drugs Included in Each Therapeutic Class 479

11.4.3 Launch and Patent Expiry Dates 480

11.4.4 General Pricing Assumptions 481

11.4.5 Individual Drug Assumptions 482

11.4.6 Generic Erosion 488

11.4.7 Pricing of Pipeline Agents 488

11.5 Primary Research-KOLs and Payers Interviewed for this Report 489

11.5.1 KOLs 489

11.5.2 Payers 493

11.6 Primary Research-Prescriber Survey 494

11.7 About the Authors 495

11.7.1 Analysts 495

11.7.2 Therapy Area Director 495

11.7.3 Epidemiologists 496

11.7.4 Global Director of Therapy Analysis and Epidemiology 497

11.8 About GlobalData 498

11.9 Disclaimer 498

1.2 List of Figures

Figure 1: HCV Genome and Polyprotein Composition 32

Figure 2: HCV Lifecycle Overview 33

Figure 3: 9MM, Anti-HCV+ Total Prevalent Cases, All Ages, Both Sexes, N, Selected Years 2015-2025 83

Figure 4: 9MM, Anti-HCV+ Total Prevalent Cases, by Age, Both Sexes, N, 2015 86

Figure 5: 9MM, Anti-HCV+ Total Prevalent Cases, All Ages, by Sex, N, 2015 88

Figure 6: 9MM, Age-Standardized Anti-HCV+ Total Prevalence, All Ages, by Sex, %, 2015 89

Figure 7: 9MM, HIV and HBV Co-Infections Among Anti-HCV+ Total Prevalent Cases, All Ages, Both Sexes, N, 2015 91

Figure 8: 9MM, HCV RNA+ Total Prevalent Cases, All Ages, Both Sexes, N, Selected Years, 2015-2025 93

Figure 9: 9MM, HCV RNA+ Total Prevalent Cases, by Age, Both Sexes, N, 2015 95

Figure 10: 9MM, HCV RNA+ Total Prevalent Cases, by Sex, N, 2015 97

Figure 11: 9MM, Age-Standardized HCV RNA+ Total Prevalence, All Ages, by Sex, %, 2015 98

Figure 12: 9MM, Anti-HCV+ Diagnosed Prevalent Cases, All Ages, Both Sexes, N, Selected Years 2015-2025 100

Figure 13: 9MM, Age-Specific Anti-HCV+ Diagnosed Prevalent Cases, Both Sexes, N, 2015 102

Figure 14: 9MM, Anti-HCV+ Diagnosed Prevalent Cases, All Ages, by Sex, N, 2015 104

Figure 15: 9MM, Age-Standardized Anti-HCV+ Diagnosed Prevalence, All Ages, by Sex, %, 2015 105

Figure 16: 9MM, Anti-HCV+ Diagnosed Prevalent Cases by Liver Cirrhosis Status, All Ages, Both Sexes, N, 2015 106

Figure 17: 9MM, HCV RNA+ Diagnosed Prevalent Cases, All Ages, Both Sexes, N, Selected Years 2015-2025 108

Figure 18: 9MM, Age-Specific HCV RNA+ Diagnosed Prevalent Cases, Both Sexes, N, 2015 110

Figure 19: 9MM, HCV RNA+ Diagnosed Prevalent Cases, All Ages, by Sex, N, 2015 112

Figure 20: 9MM, Age-Standardized HCV RNA+ Diagnosed Prevalence, All Ages, by Sex, %, 2015 113

Figure 21: Hepatitis C-Clinical Trials by Status and Phase, 2016 286

Figure 22: HCV Infection Therapies-Phase II-III Pipeline, 2016 288

Figure 23: Competitive Assessment of Late-Stage Pipeline Agents for HCV Infection, 2015-2025 289

Figure 24: Clinical and Commercial Positioning of Sofosbuvir/Velpatasvir/Voxilaprevir 296

Figure 25: Clinical and Commercial Positioning of Glecaprevir/Pibrentasvir 307

Figure 26: Clinical and Commercial Positioning of Asunaprevir/Beclabuvir/Daclatasvir 315

Figure 27: Clinical and Commercial Positioning of MK-3682A and MK-3682B 322

Figure 28: Clinical and Commercial Positioning of Odalasvir-Based Regimens 328

Figure 29: Company Market Share in HCV, 2015 and 2025 342

Figure 30: Company Portfolio Gap Analysis in HCV, 2015-2025 343

Figure 31: Annual Global (9MM) Sales of DAAs, by Region, in 2015 and 2025 372

Figure 32: Annual Global (9MM) Sales of DAAs, by Brand, in 2015 and 2025 373

Figure 33: Annual Sales of DAAs in the US in 2015 and 2025 379

Figure 34: Annual Sales of DAAs in the 5EU in 2015 and 2025 385

Figure 35: Annual Sales of DAAs in France in 2015 and 2025 391

Figure 36: Annual Sales of DAAs in Germany in 2015 and 2025 396

Figure 37: Annual Sales of DAAs in Italy in 2015 and 2025 401

Figure 38: Annual Sales of DAAs in Spain in 2015 and 2025 406

Figure 39: Annual Sales of DAAs in the UK in 2015 and 2025 411

Figure 40: Annual Sales of DAAs in Japan in 2015 and 2025 416

Figure 41: Annual Sales of DAAs in Brazil in 2015 and 2025 421

Figure 42: Annual Sales of DAAs in China in 2025 426

1.1 List of Tables

Table 1: Modes of HCV Transmission 35

Table 2: Symptoms of Acute and Chronic HCV Infection 36

Table 3: Risk Factors and Comorbidities Associated with HCV Infection 40

Table 4: 9MM, Anti-HCV+ Total Prevalence from 1988-2015 42

Table 5: Hepatitis C Virus Genotype Description 48

Table 6: 9MM, Sources Used to Forecast Anti-HCV+ Total Prevalent Cases 50

Table 7: 9MM, Sources Used to Forecast HCV RNA+ Total Prevalent Cases 51

Table 8: 9MM, Sources Used to Forecast Anti-HCV+ Total Prevalent Cases by HCV Genotypes 52

Table 9: 9MM, Sources Used to Forecast HCV/HIV Co-Infection Cases Among Anti-HCV+ Total Prevalent Cases 54

Table 10: 9MM, Sources Used to Forecast HCV/HBV Co-Infection Cases Among Anti-HCV+ Total Prevalent Cases 55

Table 11: 9MM, Sources Used to Forecast Anti-HCV+ Diagnosed Prevalent Cases 56

Table 12: 9MM, Sources Used to Forecast HCV RNA+ Diagnosed Prevalent Cases 58

Table 13: 9MM, Sources Used for Anti-HCV+ Diagnosed Prevalent Cases by Liver Cirrhosis Status 60

Table 14: 9MM, Sources Not Used in Epidemiological Forecast for Anti-HCV+ Total Prevalent Cases 81

Table 15: 9MM, Anti-HCV+ Total Prevalent Cases, All Ages, Both Sexes, N, Selected Years 2015-2025 83

Table 16. 9MM, Anti-HCV+ Total Prevalent Cases, by Age, Both Sexes, N (Row %), 2015 85

Table 17: 9MM, Anti-HCV+ Total Prevalent Cases, by Sex, All Ages, N (Row %), 2015 87

Table 18: 9MM, Anti-HCV+ Total Prevalent Cases, by HCV Genotype, All Ages, N (Row %), Both Sexes, 2015 90

Table 19: 9MM, HCV RNA+ Total Prevalent Cases, All Ages, Both Sexes, N, Selected Years 2015-2025 92

Table 20. 9MM, HCV RNA+ Total Prevalent Cases, by Age, Both Sexes, N (Row %), 2015 94

Table 21: 9MM, HCV RNA+ Total Prevalent Cases, by Sex, All Ages, N (Row %), 2015 96

Table 22: 9MM, Anti-HCV+ Diagnosed Prevalent Cases, All Ages, Both Sexes, N, Selected Years 2015-2025 99

Table 23: 9MM, Age-Specific Anti-HCV+ Diagnosed Prevalent Cases, Both Sexes, N (Row %), 2015 101

Table 24: 9MM, Anti-HCV+ Diagnosed Prevalent Cases, by Sex, All Ages, N (Row %), 2015 103

Table 25: 9MM, HCV RNA+ Diagnosed Prevalent Cases, All Ages, Both Sexes, N, Selected Years 2015-2025 107

Table 26: 9MM, Age-Specific HCV RNA+ Diagnosed Prevalent Cases, Both Sexes, N (Row %), 2015 109

Table 27: 9MM, HCV RNA+ Diagnosed Prevalent Cases, by Sex, All Ages, N (Row %), 2015 111

Table 28: HCV Genotypes Prevalent in the 9MM 120

Table 29: General Standard of Care by HCV Genotype in 2015 122

Table 30: Treatment Guidelines for Hepatitis C 123

Table 31: Country Profile-US 124

Table 32: Recommended Treatment Options for Treatment-Na�ve Patients in the US, 2016 128

Table 33: Country Profile-5EU 133

Table 34: Recommended Treatment Options for Treatment-na�ve Patients in the 5EU, 2016 136

Table 35: Country Profile-Japan 145

Table 36: Country Profile-Brazil 148

Table 37: Country Profile-China 150

Table 38: Leading Treatments for Hepatitis C, 2016 160

Table 39: Harvoni-Clinical Trials Supporting Regulatory Approval 162

Table 40: Product Profile-Harvoni 164

Table 41: Key Clinical Trials of Gilead's Harvoni 165

Table 42: Safety of Harvoni-Most Common AEs 169

Table 43: Harvoni SWOT Analysis, 2016 171

Table 44: Global Sales Forecasts ($m) for Harvoni, 2015-2025 173

Table 45: Viekira Pak and Technivie-Key Clinical Trials Supporting Regulatory Approval 175

Table 46: Product Profile-Viekira Pak and Technivie 177

Table 47: Efficacy of Viekira Pak and Technivie-SVR12, Key Phase III and Phase II Studies 179

Table 48: Safety of Viekira Pak and Technivie-Most Common AEs 183

Table 49: Viekira Pak and Technivie SWOT Analysis, 2016 185

Table 50: Global Sales Forecast ($m) for Viekira Pak, 2015-2025 186

Table 51: Zepatier-Key Clinical Trials Supporting Regulatory Approval 188

Table 52: Product Profile-Zepatier 191

Table 53: Efficacy of Zepatier-SVR12, Key Phase III and Phase II Clinical Trials 192

Table 54: Treatment-Emergent Amino Acid Substitutions Among Virologic Failures of Zepatier 194

Table 55: Safety of Zepatier-Most Common AEs 195

Table 56: Zepatier SWOT Analysis, 2016 197

Table 57: Global Sales Forecasts ($m) for Zepatier, 2015-2025 198

Table 58: Key Clinical Trials of Gilead's Epclusa 200

Table 59: Product Profile-Epclusa 203

Table 60: Efficacy of Epclusa-SVR12, Key Phase III Trials 204

Table 61: Safety of Epclusa-Most Common AEs 206

Table 62: Epclusa SWOT Analysis, 2016 207

Table 63: Global Sales Forecasts ($m) for Epclusa, 2015-2025 208

Table 64: Sovaldi-Clinical Trials Supporting Regulatory Approval 210

Table 65: Product Profile-Sovaldi 212

Table 66: Efficacy of Sovaldi-SVR12, Key Phase III Trials 213

Table 67: Safety of Sovaldi-Most Common AEs 216

Table 68: Sovaldi SWOT Analysis, 2016 217

Table 69: Global Sales Forecast ($m) for Sovaldi, 2015-2025 218

Table 70: Daklinza-Key Clinical Trials Supporting Regulatory Approval 221

Table 71: Product Profile-Daklinza 223

Table 72: Efficacy of Daklinza-SVR12, Key Phase IIb and III Trials 224

Table 73: Safety of Daklinza-Most Common AEs 226

Table 74: Daklinza SWOT Analysis, 2016 227

Table 75: Global Sales Forecast ($m) for Daklinza, 2015-2025 228

Table 76: Olysio-Key Clinical Trials Supporting Regulatory Approval 230

Table 77: Product Profile-Olysio 232

Table 78: Efficacy of Olysio-SVR12, Key Phase III and Phase II Trials 233

Table 79: Safety of Olysio-Most Common AEs in Clinical Trials 236

Table 80: Olysio SWOT Analysis, 2016 237

Table 81: Global Sales Forecasts ($m) for Olysio, 2015-2025 238

Table 82: Product Profile-Pegasys 241

Table 83: Product Profile-PegIntron 242

Table 84: Efficacy of Pegasys with or without Ribavirin Compared with Interferon Alfa-2b 243

Table 85: Efficacy of PegIntron Compared With Interferon Alfa-2b 244

Table 86: Pegasys and PegIntron SWOT Analysis, 2016 245

Table 87: Global Sales Forecast ($m) for Pegasys, 2015-2025 246

Table 88: Global Sales Forecast ($m) for PegIntron, 2015-2025 247

Table 89: Ribavirin SWOT Analysis, 2016 249

Table 90: Global Sales Forecast ($m) for Copegus, 2015-2025 250

Table 91: Global Sales Forecast ($m) for Rebetol, 2015-2025 251

Table 92: Summary of Other Branded DAAs, 2016 251

Table 93: Unmet Needs and Opportunities in Chronic Hepatitis C 258

Table 94: Hepatitis C Virus Infection-Late-Stage Pipeline, 2016 287

Table 95: Key Clinical Trials of Gilead's Sofosbuvir/Velpatasvir/Voxilaprevir Combination 291

Table 96: Product Profile-Sofosbuvir/Velpatasvir/Voxilaprevir 293

Table 97: Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Phase II Clinical Trials 294

Table 98: Sofosbuvir/Velpatasvir/Voxilaprevir SWOT Analysis, 2016 297

Table 99: Global Sales Forecast ($m) for Sofosbuvir/Velpatasvir/Voxilaprevir, 2015-2025 298

Table 100: Phase III Clinical Trials of AbbVie's Glecaprevir/Pibrentasvir Combination 300

Table 101: Product Profile-Glecaprevir/Pibrentasvir 302

Table 102: Efficacy of Glecaprevir/Pibrentasvir in Phase II Trials 303

Table 103: Most Common AEs of Glecaprevir/Pibrentasvir in Phase II Trials 306

Table 104: Glecaprevir/Pibrentasvir SWOT Analysis, 2016 308

Table 105: Global Sales Forecast ($m) for Glecaprevir/Pibrentasvir, 2015-2025 309

Table 106: Phase III Clinical Trials of BMS's Asunaprevir/Beclabuvir/Daclatasvir 310

Table 107: Product Profile-Asunaprevir/Beclabuvir/Daclatasvir 311

Table 108: Efficacy of Asunaprevir/Beclabuvir/Daclatasvir in Phase III Clinical Trials 312

Table 109: Efficacy of Asunaprevir/Beclabuvir/Daclatasvir in Japanese Patients 313

Table 110: Asunaprevir/Beclabuvir/Daclatasvir SWOT Analysis, 2016 316

Table 111: Global Sales Forecast ($m) for Asunaprevir/Beclabuvir/Daclatasvir, 2015-2025 317

Table 112: On-Going Phase II Clinical Trials of MK-3682A and MK-3682B 318

Table 113: Product Profile-MK-3682A and MK-3682B 319

Table 114: Efficacy of MK-3682A and MK-3682B in Phase II Trials 320

Table 115: MK-3682A and MK-3682B SWOT Analysis, 2016 323

Table 116: Global Sales Forecasts ($m) for MK-3682A and MK-3682B, 2015-2025 324

Table 117: Phase II Clinical Trials involving Achillion and Janssen's Odalasvir 325

Table 118: Product Profile-AL-335/odalasvir/simeprevir 326

Table 119: AL-335/Odalasvir/Simeprevir SWOT Analysis, 2016 329

Table 120: Global Sales Forecast ($m) for AL-335/Odalasvir/Simeprevir, 2015-2025 330

Table 121: Other Products in Clinical Development for HCV Infection, 2016 331

Table 122: Clinical Development outside 9MM, 2016 336

Table 123: Key Companies in the HCV Marketplace in the 9MM, 2016 341

Table 124: Gilead's HCV Portfolio Assessment, 2016 353

Table 125: AbbVie's HCV Portfolio Assessment, 2016 355

Table 126: Merck's HCV Portfolio Assessment, 2016 357

Table 127: Janssen's HCV Portfolio Assessment, 2016 359

Table 128: BMS' HCV Portfolio Assessment, 2016 361

Table 129: Roche's HCV Portfolio Assessment, 2016 363

Table 130: Regulus' HCV Portfolio Assessment, 2016 364

Table 131: Presidio's HCV Portfolio Assessment, 2016 365

Table 132:Trek Therapeutics' HCV Portfolio Assessment, 2016 366

Table 133: Global (9MM) Sales Forecast ($m) for Hepatitis C, 2015-2025 370

Table 134: 9MM Chronic Hepatitis C Market-Drivers and Barriers, 2015-2025 374

Table 135: US Sales Forecast ($m) for Hepatitis C, 2015-2025 377

Table 136: Key Events Impacting Sales for Chronic Hepatitis C in the US, 2015-2025 380

Table 137: Chronic Hepatitis C Market-Drivers and Barriers in the US, 2015-2025 380

Table 138: 5EU Sales Forecast ($m) for Hepatitis C, 2015-2025 383

Table 139: Key Events Impacting Sales for Chronic Hepatitis C in the 5EU, 2015-2025 386

Table 140: Chronic Hepatitis C Market-Drivers and Barriers in the 5EU, 2015-2025 386

Table 141: France Sales Forecast ($m) for Hepatitis C, 2015-2025 389

Table 142: Key Events Impacting Sales for Chronic Hepatitis C in France, 2015-2025 392

Table 143: Chronic Hepatitis C Market-Drivers and Barriers in France, 2015-2025 392

Table 144: Germany Sales Forecasts ($m) for Hepatitis C, 2015-2025 394

Table 145: Key Events Impacting Sales for Chronic Hepatitis C in Germany, 2015-2025 397

Table 146: Chronic Hepatitis C Market-Drivers and Barriers in Germany, 2015-2025 397

Table 147: Italy Sales Forecast ($m) for Hepatitis C, 2015-2025 399

Table 148: Key Events Impacting Sales for Chronic Hepatitis C in Italy, 2015-2025 402

Table 149: Chronic Hepatitis C Market-Drivers and Barriers in Italy, 2015-2025 402

Table 150: Spain Sales Forecast ($m) for Hepatitis C, 2015-2025 404

Table 151: Key Events Impacting Sales for Chronic Hepatitis C in Spain, 2015-2025 407

Table 152: Chronic Hepatitis C Market-Drivers and Barriers in Spain, 2015-2025 407

Table 153: UK Sales Forecasts ($m) for Hepatitis C, 2015-2025 409

Table 154: Key Events Impacting Sales for Chronic Hepatitis C in the UK, 2015-2025 412

Table 155: Chronic Hepatitis C Market-Drivers and Barriers in the UK, 2015-2025 412

Table 156: Japan Sales Forecast ($m) for Hepatitis C, 2015-2025 414

Table 157: Key Events Impacting Sales for Chronic Hepatitis C in Japan, 2015-2025 417

Table 158: Chronic Hepatitis C Market-Drivers and Barriers in Japan, 2015-2025 417

Table 159: Brazil Sales Forecast ($m) for Hepatitis C, 2015-2025 419

Table 160: Key Events Impacting Sales for Chronic Hepatitis C in Brazil, 2015-2025 422

Table 161: Chronic Hepatitis C Market-Drivers and Barriers in Brazil, 2015-2025 422

Table 162: China Sales Forecast ($m) for Hepatitis C, 2015-2025 424

Table 163: Key Events Impacting Sales for Chronic Hepatitis C in China, 2015-2025 427

Table 164: Chronic Hepatitis C Market-Drivers and Barriers in China, 2015-2025 428

Table 165 Key Historical and Projected Launch Dates for Chronic Hepatitis C 480

Table 166 Key Historical and Projected Patent Expiry Dates for Chronic Hepatitis C 481

Table 167: High Prescribers Surveyed 494

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