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

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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...
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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.

Additional Information

Additional Information

Publisher name GlobalData.
Format PDF
Page count 499
Publication date 6 Dec 2016
Table of contents 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

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