The hepatitis C virus (HCV) therapy market has been marked by tremendous growth, and the treatment landscape has undergone a rapid evolution with the launch of novel direct-acting antivirals (DAAs) and DAA combinations, including simeprevir (Janssen’s Olysio, Medivir’s Sovriad), sofosbuvir (Gilead’s Sovaldi), sofosbuvir/ledipasvir (Gilead’s Harvoni), ombitasvir/paritaprevir/ritonavir plus dasabuvir (AbbVie’s Viekira Pak), daclatasvir (Bristol-Myers Squibb’s Daklinza), Zepatier (Merck’s elbasvir/grazoprevir), and Epclusa (Gilead’s sofosbuvir/velpatasvir). The forthcoming rise in pangenetic regimens (i.e., Epclusa, AbbVie’s glecaprevir/pibrentasvir, and Gilead’s sofosbuvir/velpatasvir/voxilaprevir) with potentially shorter treatment durations will not only expand treatment options for HCV patients, including difficult-to-treat patients (e.g., DAA treatment failures), but will shift the treatment paradigm once again, triggering a departure in genotype-specific prescribing, which has traditionally been the cornerstone of HCV treatment. In this post-DAA era, commercial opportunity in this therapy market will continue to be driven by a large prevalent viremic population and a relaxation in access restrictions that have limited the uptake of highly efficacious but costly DAA-based treatment options in cost-sensitive markets. However, as increasing competition continues to reduce the cost of treatment, the overall value of the therapy market will gradually decline.

Questions Answered:

How large is the treatable HCV population, and how will diagnosis/drug-treatment rates change over time?

What is the current state of treatment for chronic HCV infection? Which are the most important drugs and why? What are interviewed experts’ insights on current treatment options? What clinical needs remain untapped?

What pipeline products are most promising, and what sales/uptake could they secure in HCV markets? What therapies of note are progressing in earlier phases?

What are the drivers and constraints in the HCV therapy market, and how will the market evolve over the forecast period?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 22 country-specific interviews with thought leaders in HCV treatment.

Epidemiology: Seroprevalence of HCV, prevalence of HCV viremia, and incidence of HCV viremia.

Population segments in market forecast: Noncirrhotic genotypes 1, 4, 5, and 6; noncirrhotic genotype 2; noncirrhotic genotype 3; cirrhotic genotypes 1, 4, 5, and 6; cirrhotic genotype 2; cirrhotic genotype 3.

Emerging therapies and current IFN-free therapies: Phase II: 2 drugs; preregistration: 1 drugs; registered: 11 drugs.

Table of contents

  • Hepatitis C Virus - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • August 2017
      • June 2017
    • Executive Summary
      • Key Findings
        • Hepatitis C Virus Major-Market Share by Country in 2016
        • Hepatitis C Virus Major-Market Share by Country in 2026
        • Major-Market Share for Hepatitis C Virus Regimen Classes in 2016
        • Major-Market Share for Hepatitis C Virus Regimen Classes in 2026
        • Hepatitis C Virus SWOT Analysis
    • Market Outlook
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for Hepatitis C Virus?
        • What Factors Are Constraining the Market for Hepatitis C Virus?
        • Key Market Events for Hepatitis C Virus
        • Major-Market Sales in Hepatitis C Virus by Liver Damage: 2016-2026
        • Major-Market Hepatitis C Virus Drug-Treated Patients by Liver Damage: 2016-2026
      • Drug Class-Specific Trends
        • Expert Insight: Use of Interferon in the Treatment of Hepatitis C Virus Infection
        • Major-Market Sales in Hepatitis C Virus by Region: 2016-2026
        • Major-Market Sales in Hepatitis C Virus by EU5 Country: 2016-2026
        • Major-Market Sales for Hepatitis C Virus Regimens: 2016-2026
        • Major-Market Patient Share of HCV Regimens in Noncirrhotic Genotype 1, 4, 5, and 6 Populations: 2016-2026
        • Major-Market Patient Share of HCV Regimens in the Noncirrhotic Genotype 2 Population: 2016-2026
        • Major-Market Patient Share of HCV Regimens in the Noncirrhotic Genotype 3 Population: 2016-2026
        • Relative Major-Market Patient Share of Pangenotypic HCV Regimens: 2016-2026
    • Forecast
      • Sales of Drugs to Treat Hepatitis C Virus in the Major Pharmaceutical Markets: 2016-2026
    • Etiology and Pathophysiology
      • Epidemiology Overview
        • Introduction
          • Key Findings
        • Epidemiology Populations
          • Disease Definition
          • Methods
          • Sources Used for Total Incident Cases of HCV
          • Number of Total Incident Cases of HCV: 2016-2026
          • Disease Definition
          • Methods
          • Sources Used for Total Prevalent Cases by Viremic Status
          • Number of Total Prevalent Cases of Viremic HCV: 2016-2026
          • Disease Definition
          • Methods
          • Sources Used for Total Prevalent Cases of Cirrhosis by HCV Genotype
          • Number of Total Prevalent Cases of Cirrhotic HCV by Genotype: 2016-2026
          • Number of Total Prevalent Cases of Noncirrhotic HCV by Genotype: 2016-2026
          • Percentage Diagnosed
          • Percentage Drug-Treated
          • Number of Diagnosed and Drug-Treated Cases of Viremic HCV by Genotype and Cirrhotic Status: 2016-2026
          • Number of Diagnosed and Drug-Treated Cases of Viremic HCV by Genotype and Noncirrhotic Status: 2016-2026
      • Current Treatment Overview
        • Key Findings
        • Expert Insight
        • Treatment Goals
          • Key End Points Used in Clinical Trials for Hepatitis C Virus
          • Key Physician Insights on Clinical End Points
        • Key Current Therapies
          • Overview
          • Mechanism of Action of Key Current Drug Classes Used for Hepatitis C Virus
          • Current Treatments Used for Hepatitis C Virus
          • Market Events Impacting the Use of Key Current Therapies in Hepatitis C Virus
          • Advantages and Disadvantages of Sofosbuvir
          • Expert Insight: Use of Sofosbuvir in the Treatment of Hepatitis C Virus Infection
          • Advantages and Disadvantages of Simeprevir
          • Expert Insight: Use of Simeprevir in the Treatment of Hepatitis C Virus Infection
          • Telaprevir and Boceprevir
          • Advantages and Disadvantages of Telaprevir and Boceprevir
          • Advantages and Disadvantages of Sofosbuvir/Ledipasvir
          • Expert Insight: Use of Sofosbuvir/Ledipasvir in the Treatment of Hepatitis C Virus Infection
          • Advantages and Disadvantages of Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir
          • Expert Insight: Use of Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir in the Treatment of Hepatitis C Virus Infection
          • Daclatasvir plus Sofosbuvir
          • Advantages and Disadvantages of Daclatasvir plus Sofosbuvir
          • Expert Insight: Use of Daclatasvir plus Sofosbuvir in the Treatment of Hepatitis C Virus Infection
          • Advantages and Disadvantages of Elbasvir/Grazoprevir
          • Expert Insight: Elbasvir/Grazoprevir
          • Advantages and Disadvantages of Sofosbuvir/Velpatasvir
          • Expert Insight: Epclusa
          • Advantages and Disadvantages of Glecaprevir/Pibrentasvir
          • Expert Insight: Glecaprevir/Pibrentasvir
          • Advantages and Disadvantages of Sofosbuvir/Velpatasvir/Voxilaprevir
          • Expert Insight: Sofosbuvir/Velpatasvir/Voxilaprevir
          • Advantages and Disadvantages of Ribavirin and Pegylated-Interferon-Alpha
        • Medical Practice
          • Overview
          • Treatment Guidelines
          • Hepatitis C Virus Treatment Guidelines, by Market
          • Drug Selection
          • Factors Influencing Drug Selection in Hepatitis C Virus
          • Treatment Decision Tree for Hepatitis C Virus: United States
          • Treatment Decision Tree for Hepatitis C Virus: EU5
          • Treatment Decision Tree for Hepatitis C Virus: Japan
      • Unmet Need Overview
        • Key Findings
          • Expert Insight
        • Attainment of Unmet Needs
          • Current Attainment of Unmet Needs in Hepatitis C Virus
          • Future Attainment of Unmet Needs in Hepatitis C Virus
          • Expert Insight on Hepatitis C Virus Unmet Needs
          • Top Unmet Needs in Hepatitis C Virus: Current and Future Attainment
      • Emerging Therapies Overview
        • Key Findings
        • Expert Insight
        • Pipeline Overview
          • Pipeline Trends in Hepatitis C Virus
        • Late-Phase Pipeline Analysis
          • Therapies in Late-Phase Development for Hepatitis C Virus
          • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Hepatitis C Virus
        • Key Emerging Therapies
          • Glecaprevir/Pibrentasvir Profile
          • Glecaprevir/Pibrentasvir Clinical Development
          • Clinical Development Milestones for Glecaprevir/Pibrentasvir in the Treatment of Hepatitis C Virus Infection
          • Expert Insight: Use of Glecaprevir/Pibrentasvir in the Treatment of Hepatitis C Virus Infection
          • Expectations for Launch and Sales Opportunity of Glecaprevir/Pibrentasvir in Hepatitis C Virus
          • Sofosbuvir/Velpatasvir/Voxilaprevir Profile
          • Sofosbuvir/Velpatasvir/Voxilaprevir Clinical Development
          • Clinical Development Milestones for Sofosbuvir/Velpatasvir/Voxilaprevir in the Treatment of HCV Infection
          • Expert Insight: Use of Sofosbuvir/Velpatasvir/Voxilaprevir in the Treatment of HCV Infection
          • Expert Insight: Sofosbuvir/Velpatasvir/Voxilaprevir
          • Expectations for Launch and Sales Opportunity of Sofosbuvir/Velpatasvir/Voxilaprevir in HCV
          • Daclatasvir/Asunaprevir/Beclabuvir Profile
          • Daclatasvir/Asunaprevir/Beclabuvir Clinical Development
          • Clinical Development Milestones for Daclatasvir/Asunaprevir/Beclabuvir in the Treatment of HCV Infection
          • Expectations for Launch and Sales Opportunity of Daclatasvir/Asunaprevir/Beclabuvir in Hepatitis C Virus
        • Early-Phase Pipeline Analysis
          • Notable Developments in the Early-Phase Pipeline for Hepatitis C Virus
          • Select Phase II Regimens in Development for Hepatitis C Virus
          • Select Phase I Compounds in Development for Hepatitis C Virus
      • Access and Reimbursement Overview
        • Region-Specific Reimbursement Practices
          • Key Market Access Considerations in HCV: United States
          • Reimbursement Dynamics for HCV in the United States: Current and Future
          • Coverage of Current HCV Therapies in Largest Commercial Plan
          • Anticipated Coverage of Current HCV Therapies in Largest Commercial Plan
          • General Reimbursement Environment: United States
          • Key Market Access Considerations in HCV: France
          • Key Market Access Considerations in HCV: Germany
          • Key Market Access Considerations in HCV: Italy
          • Key Market Access Considerations in HCV: Spain
          • Key Market Access Considerations in HCV: United Kingdom
          • EU5 Reimbursement for HCV Therapies
          • Payer Insights on Future Reimbursement for HCV Therapies
          • General Reimbursement Environment: EU5
          • Key Market Access Considerations in HCV: Japan
          • General Reimbursement Environment: Japan
        • EM Reimbursement Dynamics: Current and Future
          • Current Reimbursement for HCV Therapies in China and South Korea
          • Payer Insight on Future Reimbursement for Hepatitis C Drugs in China and South Korea
          • Patient Access for Chronic HCV Therapies in Brazil and Colombia
          • Payer Insights on Future Coverage for Chronic Hepatitis C Therapies in Brazil and Colombia
        • U.S. Access & Reimbursement Considerations for Emerging Therapies for HCV
          • Access & Reimbursement Considerations for HCV Emerging Therapies in the United States
          • Anticipated Coverage of Glecaprevir/Pibrentasvir in Largest Commercial Plan at Various Pricing Scenarios
        • EU5 Access & Reimbursement Considerations for Emerging Therapies for HCV
          • Access & Reimbursement Considerations for HCV Emerging Therapies in the EU5
          • Payer Insight on HCV Emerging Therapies
          • HCV Drug Development Priorities Important to Physicians: EU5
        • EM Access & Reimbursement Considerations for Emerging Therapies
          • Access & Reimbursement Considerations for Emerging HCV Chronic Infection Therapies in China and South Korea
          • Payer Insight on the Pricing of Emerging DAAs in China and South Korea
          • Market Access Challenges for DAAs in China and South Korea (Factors Affecting Physicians' Selection)
          • Access & Reimbursement Considerations for Emerging Therapies for Chronic HCV in Brazil and Colombia
          • Acceptable Launch Prices for Harvoni
          • Payer Insight: Emerging Therapies for Chronic HCV
      • Methodology
        • Market Forecast Assumptions File
        • Bottom-Up Forecasting Overview
          • Patient Populations
          • Drug-Specific Assumptions
        • Bottom-Up Forecast Assumptions
          • General Sources of Data
          • General Statements About Pricing
          • Sources for Drug Prices
          • 2016 Exchange Rates
          • Dosing, Days of Therapy, and Compliance
          • Generic Erosion
          • Out-Year Forecasting
          • Emerging Therapy Prices
          • Estimated Cost (US$) of 8- or 12-Week Regimens of Key Direct-Acting Antiviral Combinations in the Major Pharmaceutical Markets
        • Primary Market Research
          • Experts Interviewed
      • Appendix
        • Key Abbreviations Related to Hepatitis C Virus
        • HCV Bibliography
        • Supplemental Epidemiology Bibliography

    Author(s): Steven F. Trueman, PhD

    Steve is a member of Decision Resources Group’s Infectious, Niche, and Rare Diseases (INRD) team. Currently, he provides analyses and content production on infections caused by the human immunodeficiency virus (HIV) and the hepatitis C virus (HCV).

    Steve conducted his postdoctoral research on models of neurodegenerative disease in the Department of Biochemistry at Brandeis University. He earned a doctorate in biochemistry from the University of Massachusetts Medical School, Graduate School of Biomedical Sciences, where he studied protein translocation into the endoplasmic reticulum.