The hepatitis B virus (HBV) therapy market is primarily defined by patients chronically infected with HBV who require lifelong treatment with a daily nucleoside analogue. Although the majority of HBV patients are well served with older, generically available agents such as Bristol-Myers Squibb’s Baraclude (entecavir, generics), new agents are needed that can reduce the long-term toxicities and adverse events that are generally associated with nucleoside reverse transcriptase inhibitors. The recent market launch of Gilead’s Vemlidy (tenofovir alafenamide) not only offers an additional treatment option for HBV patients, but it will be the primary growth driver in a market constrained by generic erosion. Furthermore, drug developers are recognizing the commercial opportunity in the HBV market and thus are focusing on developing agents with novel mechanisms of action in an effort to advance the standard of care in this space.

Questions Answered:

  • How large is the diagnosed HBV population in the U.S. and EU5, and how will its size change over time?
  • What is the current treatment landscape for chronic HBV infections, and how will it change in the next ten years?
  • What is the market share of current agents in the U.S./EU5 HBV market?
  • What do interviewed experts believe is the greatest unmet medical need in the treatment of chronic HBV infections?
  • What are interviewed experts’ insights on emerging therapies? How will emerging therapies fit into future medical practice?

Scope

  • Markets covered: United States, France, Germany, Italy, Spain, and the United Kingdom.
  • Primary research: Six country-specific interviews with thought-leading gastroenterologists and hepatologists.
  • Epidemiology: Diagnosed prevalence of HBV and drug-treated patients by country and segmented by HBeAg-seropositive and -negative status.
  • Market forecast: Drug-level sales and patient share of key HBV therapies in 2016 and 2026.
  • Emerging therapies: Phase II: 4 drugs. Coverage of select Phase I/II and I products.

Key companies: Bristol-Myers Squibb, GlaxoSmithKline, Roche, Gilead, Novartis, Spring Bank Pharmaceuticals, Inovio Pharmaceuticals, Ionis Pharmaceuticals, Alnylam Pharmaceuticals, Novira Therapeutics, Myr GmbH.

Key drugs: Entecavir (Baraclude, generics), lamivudine (Epivir-HBV, Zeffix, generics), pegylated interferon-α-2a (Pegasys), tenofovir alafenamide (Vemlidy), tenofovir disoproxil fumarate (Viread), SB-9200, GS-9620, INO-1800, IONIS-HBVRx, ALN-HBV, Myrcludex B, NVR-3778.

Table of contents

  • Hepatitis B Virus - Landscape & Forecast - Disease Landscape & Forecast
    • Executive Summary
      • Key Findings
        • Regional Sales of Key Therapies to Treat Hepatitis B Virus: 2016 and 2026
        • Hepatitis B Virus SWOT Analysis
    • Commercial Outlook
      • Key Findings
        • Expert Insight
      • Drivers and Constraints
        • What Factors Are Driving Sales in Hepatitis B Virus?
        • What Factors Are Constraining Sales in Hepatitis B Virus?
      • Drug-Class-Specific Trends
        • Nucleoside Analogues
        • Immunomodulators
    • Forecast
      • Forecast Sales of Key Therapies in Hepatitis B Virus
    • Etiology and Pathophysiology
      • Key Findings
        • Expert Insight
        • Disease Overview
        • Expert Insight
      • Etiology
        • Expert Insight
        • HBV Transmission and Risk Factors
        • Expert Insight
        • Hepatitis B Virus Natural Outcomes
        • Viral Markers of Hepatitis B Virus Infection
        • Expert Insight
      • Pathophysiology
        • Hepatitis B Virus Replication
        • Hepatitis B Virus Genome
      • Disease Onset and Symptoms
        • Key Pathways and Drug Targets
        • Epidemiology Overview
          • Key Findings
            • Expert Insight
          • Epidemiology Populations
            • Disease Definition
            • Methods
            • Sources Used for Prevalence of Hepatitis B Virus Infection
            • Total Prevalent Cases of Hepatitis B Virus, 2016-2026
            • Sources Used for Diagnosed Prevalence of Hepatitis B Virus
            • Diagnosed Prevalent Cases of Hepatitis B Virus, 2016-2026
            • Sources Used for Drug-Treated Prevalence of Hepatitis B Virus
            • Drug-Treated Prevalent Cases of Hepatitis B Virus, 2016-2026
            • Disease Definition
            • Methods
            • Sources Used for HBeAg Status of Hepatitis B Virus Cases
            • HBeAg Status of HBV Population, 2016-2026
            • Disease Definition
            • Methods
            • Sources Used for Liver Cirrhosis Comorbidity
            • Liver Cirrhosis Cases, 2016-2026
        • Current Treatment Overview
          • Key Findings
            • Expert Insight
          • Diagnosis
            • Screening Criteria and Testing
            • Treatment Providers and Referral Patterns
            • Expert Insight: Diagnosis of Hepatitis B Virus
          • Treatment Goals
            • Key End Points Used in Clinical Trials for Hepatitis B Virus
            • Physician Insights on Clinical End Points
            • Expert Insight: Clinical End Points
          • Key Current Therapies
            • Overview
            • Current Treatments Used for Hepatitis B Virus
            • Market Events Impacting the Use of Key Current Therapies in Hepatitis B Virus
            • Clinical Trial Outcomes for Entecavir
            • Advantages and Disadvantages of Entecavir
            • Expert Insight: Entecavir
            • Clinical Trial Outcomes for Tenofovir Disoproxil Fumarate
            • Clinical Analysis of Tenofovir Disoproxil Fumarate for the Treatment of Hepatitis B Virus
            • Advantages and Disadvantages of Tenofovir Disoproxil Fumarate
            • Expert Insight: Tenofovir Disoproxil Fumarate
            • Clinical Trial Outcomes for Tenofovir Alafenamide
            • Clinical Analysis of Tenofovir Alafenamide for the Treatment of Hepatitis B Virus
            • Advantages and Disadvantages of Tenofovir Alafenamide
            • Expert Insight: Tenofovir Alafenamide
            • Clinical Trial Outcomes for Lamivudine
            • Clinical Analysis of Lamivudine for the Treatment of Hepatitis B Virus
            • Advantages and Disadvantages of Lamivudine
            • Expert Insight: Lamivudine
            • Clinical Trial Outcomes for PEG-IFN-Alpha
            • Advantages and Disadvantages of PEG-IFN-Alpha
            • Expert Insight: PEG-IFN-Alpha
            • Current and Pipeline Vaccines Used for HBV Prophylaxis
            • HBV Vaccination Protocols by Market
            • Expert Insight: HBV Vaccines
            • Current HBV Immunoglobulins Used for Prophylaxis
            • Expert Insight: HBV Immunoglobulins
          • Medical Practice
            • Overview
            • U.S./EU5 Hepatitis B Virus Treatment Guidelines
            • United States/EU5
            • Generalized Treatment Decision Tree for Hepatitis B Virus
        • Unmet Need Overview
          • Key Findings
            • Expert Insight
          • Attainment of Unmet Needs
            • Future Attainment of Unmet Needs in Hepatitis B Virus
            • Top Unmet Needs in Hepatitis B Virus—Current and Future Attainment
        • Emerging Therapies Overview
          • Key Findings
            • Expert Insight
            • Pipeline Trends for Hepatitis B Virus
          • Key Emerging Therapies
            • Notable Developments Among Key Emerging Therapies for Hepatitis B Virus
            • Key Emerging Therapies in Development for Hepatitis B Virus
            • Target Patient Population of Emerging Agents
            • Expectations for Launch and Sales Opportunity of Immunomodulatory Agents in Hepatitis B Virus
            • SB-9200 Profile
            • SB-9200 Clinical Development
            • Key Ongoing Clinical Trials of SB-9200 in the Treatment of Hepatitis B Virus
            • GS-9620 Profile
            • GS-9620 Clinical Development
            • Key Ongoing Clinical Trials of GS-9620 in the Treatment of Hepatitis B Virus
            • Expert Insight: GS-9620
            • Expert Insight on Use of Immunomodulatory Agents in the Treatment of Hepatitis B Virus
            • Expectations for Launch and Sales Opportunity of Genetic Therapies in Hepatitis B Virus
            • IONIS-HBV Profile
            • IONIS-HBV Clinical Development
            • Key Ongoing Clinical Trials of IONIS-HBV in the Treatment of Hepatitis B Virus
            • ALN-HBV Profile
            • ALN-HBV Clinical Development
            • Key Ongoing Clinical Trials of ALN-HBV in the Treatment of Hepatitis B Virus
            • Expert Insight on Use of Genetic Therapies in the Treatment of Hepatitis B Virus
          • Early-Phase Pipeline Analysis
            • Select Early-Phase Compounds in Development for Hepatitis B Virus
            • Expert Insight: Early-Phase Agents
          • Orphan Drug Designation
          • Access & Reimbursement Overview
            • Region-Specific Reimbursement Practices
            • Methodology
              • Bottom-Up Forecasting Overview
                • Bottom-Up Market Forecasting Overview
                • Patient Populations
                • Drug-Specific Assumptions
              • Bottom-Up Forecast Assumptions
                • General Sources of Data
                • Drug-Treatment Rate in Hepatitis B Virus
                • Patient-Share Assumptions in Hepatitis B Virus
                • General Statements About Pricing
                • Sources for Drug Prices
                • 2016 Exchange Rates
                • Price per Treated Day Assumptions, 2016
                • Price per Treated Day Assumptions, 2026
                • Generic Erosion Assumptions
                • Out-Year Forecasting
              • Primary Market Research
                • Experts Interviewed
            • Appendix
              • Key Abbreviations Related to Hepatitis B Virus
              • Hepatitis B Bibliography

          Author(s): Steven F. Trueman, PhD; Johnson Olabisi, MBBS, MSc

          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.

          Johnson joined Decision Resources Group (DRG) in 2015 and with the Epidemiology team develops epidemiological populations forecasts for different infectious and non-communicable diseases with his particular interests in the oncology space.

          Prior to joining DRG, he trained as a community physician where he was involved in primary (patient) care, primary health care and various community research & activities. He has also supervised and coordinated various governmental and non-governmental public health projects. Johnson holds a Masters of Science in Public Health (Health Economics) degree from the London School of Hygiene and Tropical Medicine with a Masters in Epidemiology and Medical Statistics & a Medical degree from the University of Ibadan, Nigeria.

           


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