Hepatocellular carcinoma is primary malignancy of the liver that commonly arises from underlying liver cirrhosis. Nexavar (Bayer HealthCare / Amgen / Onyx), an angiogenesis inhibitor, was the only drug approved for advanced patients until the 2017 / 2018 approvals of Stivarga (Bayer HealthCare), Opdivo (Bristol Myers Squibb / Ono Pharmaceutical), Keytruda (Merck & Co.), Lenvima (Eisai / Merck & Co.), Cabometyx (Exelixis), Cyramza (Eli Lilly), and the 2020 approvals of Tecentriq plus Avastin (Roche / Genentech) and Opdivo and Yervoy (Bristol Myers Squibb / Ono Pharmaceutical). The late-phase drug development pipeline, predominantly focused on the advanced-stage hepatocellular carcinoma segment, encompasses a diverse range of mechanisms of action. The hepatocellular carcinoma market is mostly driven by approvals of premium-priced immune checkpoint inhibitors and the expected uptake of combination regimens. Because the hepatocellular carcinoma market is largely untapped, the developer of an efficacious therapy could reap high commercial rewards.

Questions Answered

  • What is the current treatment landscape for hepatocellular carcinoma, and what clinical needs remain unfulfilled?
  • Which drug classes are in the late-phase development pipeline, and which agents are the most promising?
  • How is the drug-treatable hepatocellular carcinoma population defined, and how will drug-treatment rates change over time?
  • Which emerging therapies do we forecast to enter each of the hepatocellular carcinoma market segments?
  • What uptake and sales are these therapies anticipated to secure?

Product Description

Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

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

Primary research: 19 country-specific interviews with thought leaders (medical oncologists).

Key companies: Bayer HealthCare / Amgen / Onyx, Bristol Myers Squibb / Ono Pharmaceutical, Merck & Co., Eisai, Exelixis / Ipsen, Eli Lilly, Roche / Genentech.

Key drugs: Nexavar, Stivarga, Cabometyx, Cyramza, Avastin, Tecentriq, Opdivo, Yervoy, Lenvima, Keytruda.

Population segments in market forecast: Early-stage, first-line intermediate-stage, second-line intermediate-stage, first-line advanced-stage, and second-line advanced-stage hepatocellular carcinoma.

Emerging therapies: Phase III/PR: 5 drugs; Phase II: 18 drugs; coverage of select preclinical and Phase I products.

Table of contents

  • Hepatocellular Carcinoma - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q1 2021
        • February 2021
        • January 2021
      • Q4 2020
        • November 2020
      • Q3 2020
        • September 2020
      • Q2 2020
        • May 2020
      • Q4 2019
        • December 2019
    • Key Findings
      • Market Outlook
        • Key Findings
          • Market Share of Drug Classes for Hepatocellular Carcinoma: 2019
          • Market Share of Drug Classes for Hepatocellular Carcinoma: 2029
          • Drug-Treatable Population Share and Major-Market Sales Share in Hepatocellular Carcinoma: 2019
          • Drug-Treatable Population Share and Major-Market Sales Share in Hepatocellular Carcinoma: 2029
          • Current Therapies with Sales Potential in Hepatocellular Carcinoma: Population Positioning
          • Emerging Therapies with Sales Potential in Hepatocellular Carcinoma: Population Positioning
          • Hepatocellular Carcinoma SWOT Analysis
        • COVID-19: Areas of Potential Forecast Impact
          • Expert Insight: COVID-19 Impact
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Hepatocellular Carcinoma?
          • What Factors Are Constraining the Market for Hepatocellular Carcinoma?
          • Major-Market Sales for Hepatocellular Carcinoma by Drug-Treatable Population: 2019-2029
          • Major-Market Sales of Immune Checkpoint Inhibitors for Hepatocellular Carcinoma: 2019-2029
          • Major-Market Sales of Angiogenesis Inhibitors for Hepatocellular Carcinoma: 2019-2029
        • Segment-Specific Trends
          • Patient-Share Dynamics of Therapies for Early-Stage Hepatocellular Carcinoma in the United States: 2019-2029
          • Patient-Share Dynamics of Therapies in First-Line Intermediate-Stage Hepatocellular Carcinoma in the United States: 2019-2029
          • Patient-Share Dynamics of Therapies in Second-Line Intermediate-Stage Hepatocellular Carcinoma in the United States: 2019-2029
          • Patient-Share Dynamics of Therapies in First-Line Advanced-Stage Hepatocellular Carcinoma in the United States: 2019-2029
          • Patient-Share Dynamics of Therapies in Second-Line Advanced-Stage Hepatocellular Carcinoma in the United States: 2019-2029
      • Forecast
        • Market Forecast Downloads
        • Market Forecast Assumptions
        • Market Forecast Dashboard
      • Etiology and Pathophysiology
        • Disease Overview
          • Etiology
            • Key Risk Factors Associated with the Development of Hepatocellular Carcinoma
          • Disease Pathophysiology
            • Liver Anatomy and Tumorigenesis
            • Hepatocellular Carcinoma Pathogenesis
          • Staging and Classification
            • AJCC TNM Staging
            • BCLC Staging Criteria
            • Child-Pugh Score
            • LCSGJ TNM Staging
            • Liver Damage Score
            • Evidence-Based Algorithm for Hepatocellular Carcinoma
          • Key Pathways and Drug Targets
            • Drug Targets and Potential Therapies for Hepatocellular Carcinoma
            • Drug Targets for Hepatocellular Carcinoma
            • Biology of Immune Checkpoint Inhibitors and Modulators
        • Epidemiology
          • Key Findings
            • Epidemiology Populations
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Incidence of Hepatocellular Carcinoma
              • Diagnosed Incident Cases of Hepatocellular Carcinoma: 2019-2029
              • Disease Definition
              • Methods
              • Sources Used for Stage Distribution of Hepatocellular Carcinoma
              • Diagnosed Incident Cases of Hepatocellular Carcinoma by Stage Distribution: 2019-2029
              • Definition
              • Methods
              • Sources Used for Recurrent Incidence of Hepatocellular Carcinoma
              • Recurrent Incident Cases of Hepatocellular Carcinoma: 2019-2029
              • Hepatocellular Carcinoma Patient Flow
              • Drug-Treatable Cases: 2019-2029
              • Drug-Treated Cases: 2019-2029
          • Current Treatment
            • Key Findings
              • Treatment Goals
                • Key Endpoints Used in Clinical Trials for Hepatocellular Carcinoma
              • Key Current Therapies
                • Overview
                • Mechanism of Action of Key Current Drug Classes Used for Hepatocellular Carcinoma
                • Current Treatments Used for Hepatocellular Carcinoma
                • Market Events Impacting the Use of Key Current Therapies for Hepatocellular Carcinoma
                • Key Results from Select Clinical Trials Investigating Nexavar for the Treatment of Hepatocellular Carcinoma
                • Ongoing Clinical Development of Nexavar
                • Key Ongoing Clinical Trials of Nexavar in the Treatment of Hepatocellular Carcinoma
                • Expert Insight: Nexavar
                • Key Results from Select Clinical Trials Investigating Stivarga for the Treatment of Hepatocellular Carcinoma
                • Ongoing Clinical Development of Stivarga
                • Key Ongoing Clinical Trials of Stivarga in the Treatment of Hepatocellular Carcinoma
                • Expert Insight: Stivarga
                • Key Results from Select Clinical Trials Investigating Lenvima for the Treatment of Hepatocellular Carcinoma
                • Ongoing Clinical Development of Lenvima
                • Key Ongoing Clinical Trials of Lenvima in the Treatment of Hepatocellular Carcinoma
                • Expert Insight: Lenvima
                • Key Results from Select Clinical Trials Investigating Cabometyx for the Treatment of Hepatocellular Carcinoma
                • Ongoing Clinical Development of Cabometyx
                • Key Ongoing Clinical Trials of Cabometyx in the Treatment of Hepatocellular Carcinoma
                • Expert Insight: Cabometyx
                • Key Results from Select Clinical Trials Investigating Cyramza for the Treatment of Hepatocellular Carcinoma
                • Analysis of the Clinical Development Program for Cyramza
                • Expert Insight: Cyramza
                • Key Results from Select Clinical Trials Investigating Opdivo (plus Yervoy) for the Treatment of Hepatocellular Carcinoma
                • Ongoing Clinical Development of Opdivo (plus Yervoy)
                • Key Ongoing Clinical Trials of Opdivo (plus Yervoy) in the Treatment of Hepatocellular Carcinoma
                • Expert Insight: Opdivo (plus Yervoy)
                • Key Results from Select Clinical Trials Investigating Keytruda for the Treatment of Hepatocellular Carcinoma
                • Ongoing Clinical Development of Keytruda
                • Key Ongoing Clinical Trials of Keytruda in the Treatment of Hepatocellular Carcinoma
                • Expert Insight: Keytruda
                • Key Results from Select Clinical Trials Investigating Tecentriq for the Treatment of Hepatocellular Carcinoma
                • Analysis of the Clinical Development Program for Tecentriq
                • Key Ongoing Clinical Trials of Tecentriq in the Treatment of Hepatocellular Carcinoma
                • Expert Insight: Tecentriq
              • Medical Practice
                • ​Early-Stage Hepatocellular Carcinoma
                • Intermediate-Stage Hepatocellular Carcinoma
                • Advanced-Stage Hepatocellular Carcinoma
                • Country-Specific Hepatocellular Carcinoma Treatment Guidelines
                • Patient Characteristics Influencing Drug Selection in Hepatocellular Carcinoma
                • Treatment Decision Tree for Hepatocellular Carcinoma: United States
                • Treatment Decision Tree for Hepatocellular Carcinoma: Europe
                • Treatment Decision Tree for Hepatocellular Carcinoma: Japan
            • Unmet Need Overview
              • Current and Future Attainment of Unmet Needs in Hepatocellular Carcinoma
              • Top Unmet Needs in Hepatocellular Carcinoma: Current and Future Attainment
              • Expert Insight: Unmet Need in Hepatocellular Carcinoma
            • Emerging Therapies
              • Key Findings
                • Pipeline Trends in Hepatocellular Carcinoma
              • Key Emerging Therapies
                • Key Therapies in Development for Hepatocellular Carcinoma
                • Estimated Market Authorization Dates of Key Emerging Therapies for the Treatment of Hepatocellular Carcinoma
                • Key Results from Select Clinical Trials Investigating Imfinzi for the Treatment of Hepatocellular Carcinoma
                • Analysis of the Clinical Development Program for Imfinzi
                • Key Ongoing Clinical Trials of Imfinzi in the Treatment of Hepatocellular Carcinoma
                • Expert Insight: Imfinzi
                • Expectations for Market Authorization and Sales Opportunity of Imfinzi in Hepatocellular Carcinoma
                • Analysis of the Clinical Development Program for Tremelimumab
                • Expectations for Market Authorization and Sales Opportunity of Tremelimumab in Hepatocellular Carcinoma
                • Key Results from Select Clinical Trials Investigating Tislelizumab for the Treatment of Hepatocellular Carcinoma
                • Analysis of the Clinical Development Program for Tislelizumab
                • Key Ongoing Clinical Trials of Tislelizumab in the Treatment of Hepatocellular Carcinoma
                • Expert Insight: Tislelizumab
                • Expectations for Market Authorization and Sales Opportunity of Tislelizumab in Hepatocellular Carcinoma
                • Key Results from Select Clinical Trials Investigating Peretinoin for the Treatment of Hepatocellular Carcinoma
                • Peretinoin Clinical Development
                • Key Ongoing Clinical Trials of Peretinoin in the Treatment of Hepatocellular Carcinoma
                • Expectations for Market Authorization and Sales Opportunity of Peretinoin in Hepatocellular Carcinoma
                • Key Results from Select Clinical Trials Investigating ThermoDox for the Treatment of Hepatocellular Carcinoma
                • Analysis of the Clinical Development Program for ThermoDox
                • Key Ongoing Clinical Trials of ThermoDox in the Treatment of Hepatocellular Carcinoma
                • Expert Insight: ThermoDox
                • Expectations for Market Authorization and Sales Opportunity of ThermoDox in Hepatocellular Carcinoma
              • Early-Phase Pipeline Analysis
                • Select Compounds in Early-Phase Development for Hepatocellular Carcinoma
              • Key Discontinuations and Failures in Hepatocellular Carcinoma
              • Access & Reimbursement Overview
                • Region-Specific Reimbursement Practices
                  • Key Market Access Considerations in Hepatocellular Carcinoma: United States
                  • General Reimbursement Environment: United States
                  • Key Market Access Considerations in Hepatocellular Carcinoma: EU5
                  • General Reimbursement Environment: EU5
                  • Key Market Access Considerations in Hepatocellular Carcinoma: Japan
                  • General Reimbursement Environment: Japan
              • Appendix
                • Key Abbreviations Related to Hepatocellular Carcinoma
                • Brands, Marketers, and Generic Availability of Key Therapies for Hepatocellular Carcinoma by Market
                • Hepatocellular Carcinoma Bibliography

            Author(s): Ananya Sadhu, Ph.D.; Oliver Blandy, M.Sc.

            Ananya Sadhu, Ph.D., is an analyst on the Oncology team at DRG, part of Clarivate. She is primarily responsible for pancreatic cancer content and client support. She has authored several syndicated reports and forecasts for the pancreatic cancer therapy market. Prior to joining DRG, she was a postdoctoral fellow at the National Centre of Biological Sciences in Bangalore, where she studied the role of chromatin architecture in regulating gene expression in breast cancer. She also worked as a scientific officer at Arvind Remedies, where she coordinated various stages of nonclinical / clinical research activities for drug development of a patented polyherbal formulation. She holds a Ph.D. in molecular biology from the National Institute of Immunology in New Delhi.

            Oliver Blandy, M.Sc., is a senior epidemiologist at DRG, part of Clarivate. Before joining DRG, Oliver worked as a research assistant for Imperial College London, where he was the lead for several studies within an NIRH-funded research group investigating healthcare-associated infections and antimicrobial resistance. He holds an M.Sc. from the University of Bristol, where he specialized in nutrition, physical activity, and public health. He also holds a B.Sc. in chemistry and a postgraduate certificate in education, both from the University of Bristol.


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