The pharmaceutical market for nonalcoholic steatohepatitis (NASH), a severe form of nonalcoholic fatty liver disease (NAFLD), has the potential to become lucrative owing to the current lack of approved agents and the disease’s large and growing prevalence. The body of evidence for the significant burden the disease places on healthcare systems is accumulating, particularly with respect to the increased risk of cardiovascular disease, liver failure, and NASH’s potential to quickly become the leading reason for liver transplantation. The lack of treatment options, and limited awareness of the disease and its complications have kept diagnosis and treatment rates low. Despite guidelines recommending certain off-label medications, prescribing is usually limited to specialists caring for patients with more-advanced disease. However, with more education about the disease, development of novel diagnostic tools , and approved medical therapies becoming available, diagnosis and treatment rates will increase and drive growth of the market overall. Over the 2019-2029 study period, the NASH market will see launches of the first agents from a rich pipeline of emerging therapies, which will fuel an exponential market expansion.

Questions Answered:

  • What is the prevalence of NASH, and what is driving the growth of this indication?
  • How is NASH being managed? With no approved medications, how are physicians using available prescription medications off-label to treat the disease?
  • Which emerging therapy will gain the greatest share in the nascent branded therapy market?
  • Where will Intercept’s obeticholic acid, Madrigal’s resmetirom, and Novo Nordisk's semaglutide fit into the evolving NASH treatment paradigm?

Geographies:

United States, France, Germany, Italy, Spain, United Kingdom, Japan

Key companies mentioned:

Intercept Pharmaceuticals, Madrigal Pharmaceuticals, Novo Nordisk, Inventiva Pharma, Galectin Therapeutics, Galmed Pharmaceuticals, Viking Therapeutics, Cirius Therapeutics, NGM Bio, Novo Nordisk, Novartis, Gilead, Bristol Myers Squibb, Enanta Pharmaceuticals

Key drugs covered:

Obeticholic acid, resmetirom (MGL-3196), cenicriviroc, belapectin (GR-MD-02), Aramchol, VK-2809, MSDC-0602K, pegbelfermin (BMS-986036), aldafermin (NGM282), efruxifermin (akr-001), EDP-305, semaglutide, lanifibranor, tropifexor, licogliflozin, cilofexor, firsocostat, vitamin E, pioglitazone

Solution enhancement:

Disease Landscape & Forecast will feature continuous updates in 2021 to provide timely insights and analyses as meaningful indication-specific news and events unfold.

Table of contents

  • Non-Alcoholic Steatohepatitis - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q3 2021
        • July 2021
      • Q2 2021
        • June 2021
        • May 2021
        • April 2021
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • December 2020
      • Q3 2020
        • September 2020
      • Q2 2020
        • April 2020
    • Key Findings
      • NASH - Key Findings - June 2021
        • April 2020
    • Market Outlook
      • Key Findings
        • Market Share of Drug Classes for NASH: 2019
        • Patient Share of Drug Classes for NASH: 2019
        • Market Share of Drug Classes for NASH: 2029
        • Patient Share of Drug Classes for NASH: 2029
        • NASH SWOT Analysis
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for NASH?
        • What Factors Are Constraining the Market for NASH?
      • Drug-Class-Specific Trends
        • Patient Share of FXR Agonists by Geography: 2019-2029
        • U.S. Sales of FXR Agonists: 2019-2029
        • EU5 Sales of FXR Agonists: 2019-2029
        • Patient Share of THR-β Agonists by Market: 2019-2029
        • U.S. Sales of THR-β Agonists: 2019-2029
        • EU5 Sales of THR-β Agonists: 2019-2029
        • Patient Share of Belapectin by Market: 2019-2029
        • U.S. Sales of Belapectin: 2019-2029
        • EU5 Sales of Belapectin: 2019-2029
        • Patient Share of Aramchol by Market: 2019-2029
        • U.S. Sales of Aramchol: 2019-2029
        • EU5 Sales of Aramchol: 2019-2029
        • Patient Share of FGF Analogues by Market: 2019-2029
        • U.S. Sales of FGF Analogues: 2019-2029
        • EU5 Sales of FGF Analogues: 2019-2029
        • Japanese Sales of FGF Analogues: 2019-2029
        • Patient Share of Semaglutide by Market: 2019-2029
        • U.S. Sales of Semaglutide: 2019-2029
        • EU5 Sales of Semaglutide: 2019-2029
        • Japanese Sales of Semaglutide: 2019-2029
        • Patient Share of Lanifibranor by Market: 2019-2029
        • U.S. Sales of Lanifibranor: 2019-2029
        • EU5 Sales of Lanifibranor: 2019-2029
    • Forecast
      • Market Forecast Assumptions
      • Market Forecast Dashboard
    • Etiology and Pathophysiology
      • Disease Overview
        • Etiology
          • Risk Factors Associated with NAFLD and NASH
        • Pathophysiology
          • Disease Pathophysiology
          • Multihit Hypothesis for NASH Pathogenesis
          • Substrate Overload Lipotoxic Injury Model of NASH Pathogenesis
        • Natural History
          • Progression of NAFLD
        • Key Pathways and Drug Targets
          • Drug Targets in NASH: Nuclear Transcription Factors
          • Drug Targets in NASH: Lipotoxicity and Oxidative Stress
          • Drug Targets in NASH: Cellular Energy Homeostasis
          • Drug Targets in NASH: Inflammation and Fibrosis
          • Drug Targets in NASH: Gastrointestinal Microbiome
      • Epidemiology
        • Key Findings
          • Epidemiology Populations
            • Disease Definition
            • Methods
            • Sources Used for Prevalence Estimates of NASH
            • Total Prevalent Cases of NASH: 2019-2029 (Thousands)
            • Diagnosed Prevalent Cases of NASH: 2019-2029
            • Drug-Treated Diagnosed Prevalent Cases of NASH: 2019-2029
        • Current Treatment
          • Key Findings
            • Treatment Goals
              • Key Endpoints Used in Clinical Trials for NASH
            • Key Current Therapies
              • Overview
              • Mechanism of Action of Key Current Drugs Used for NASH
              • Current Treatments Used for NASH
              • Advantages and Disadvantages of Pioglitazone
              • Expert Insight: Pioglitazone
              • Advantages and Disadvantages of Other Off-Label Antidiabetic Agents
              • Expert Insight: Other Off-Label Antidiabetic Agents
              • Advantages and Disadvantages of Off-Label Lipid-Modifying Agents
              • Expert Insight: Off-Label Lipid-Modifying Agents
              • Advantages and Disadvantages of Vitamin E
              • Expert Insight: Vitamin E
              • Advantages and Disadvantages of Other Off-Label Medications
              • Expert Insight: Other Off-Label Medications
            • Medical Practice
              • Overview
              • Country-Specific NASH Treatment Guidelines, by Market
              • Factors Influencing Drug Selection in NASH
              • Treatment Decision Tree for NASH: United States
              • Treatment Decision Tree for NASH: Europe
              • Treatment Decision Tree for NASH: Japan
              • Introduction
              • NASH Clinical Research Network Scoring System
              • Select Commercially Available Serum Biomarker Tests for NASH
              • Imaging Tests
              • Select Commercially Available Imaging Tests for NASH
          • Unmet Need Overview
            • Current and Future Attainment of Unmet Needs in NASH
            • Top Unmet Needs in NASH: Current and Future Attainment
            • Expert Insight: Unmet Needs in NASH
          • Emerging Therapies
            • Key Findings
              • Key Emerging Therapies
                • Key Therapies in Development for NASH
                • Estimated Launch Dates of Key Emerging Therapies for the Treatment of NASH
                • Key Results from Select Clinical Trials Investigating Obeticholic Acid for the Treatment of NASH
                • Analysis of the Clinical Development Program for Obeticholic Acid
                • Key Development Milestones for Obeticholic Acid in the Treatment of NASH
                • Expert Insight: Obeticholic Acid
                • Expectations for Launch and Sales Opportunity of Obeticholic Acid in NASH
                • Key Results from Select Clinical Trials Investigating EDP-305 for the Treatment of NASH
                • Analysis of the Clinical Development Program for EDP-305
                • Expert Insight: EDP-305
                • Expectations for Launch and Sales Opportunity of EDP-305 in NASH
                • Key Results from Select Clinical Trials Investigating Cenicriviroc for the Treatment of NASH
                • Analysis of the Clinical Development Program for Cenicriviroc
                • Key Development Milestones for Cenicriviroc in the Treatment of NASH
                • Expert Insight: Cenicriviroc
                • Expectations for Launch and Sales Opportunity of Cenicriviroc in NASH
                • Key Results from Select Clinical Trials Investigating Resmetirom (MGL-3196) for the Treatment of NASH
                • Analysis of the Clinical Development Program for Resmetirom (MGL-3196)
                • Key Development Milestones for Resmetirom (MGL-3196) in the Treatment of NASH
                • Expert Insight: Resmetirom (MGL-3196)
                • Expectations for Launch and Sales Opportunity of Resmetirom (MGL-3196) in NASH
                • Key Results from Select Clinical Trials Investigating VK-2809 for the Treatment of NASH
                • Analysis of the Clinical Development Program for VK-2809
                • Key Development Milestones for VK-2809 in the Treatment of NASH
                • Expert Insight: VK-2809
                • Expectations for Launch and Sales Opportunity of VK-2809 in NASH
                • Key Results from Select Clinical Trials Investigating MSDC-0602K for the Treatment of NASH
                • Analysis of the Clinical Development Program for MSDC-0602K
                • Expert Insight: MSDC-0602K
                • Expectations for Launch and Sales Opportunity of MSDC-0602K in NASH
                • Key Results from Select Clinical Trials Investigating Belapectin (GR-MD-02) for the Treatment of NASH
                • Analysis of the Clinical Development Program for Belapectin (GR-MD-02)
                • Key Development Milestones for Belapectin in the Treatment of NASH
                • Expert Insight: Belapectin
                • Expectations for Launch and Sales Opportunity of Belapectin in NASH
                • Key Results from Select Clinical Trials Investigating Aramchol for the Treatment of NASH
                • Analysis of the Clinical Development Program for Aramchol
                • Key Development Milestones for Aramchol in the Treatment of NASH
                • Expert Insight: Aramchol
                • Expectations for Launch and Sales Opportunity of Aramchol in NASH
                • Key Results from Select Clinical Trials Investigating Pegbelfermin (BMS-986036) for the Treatment of NASH
                • Analysis of the Clinical Development Program for Pegbelfermin (BMS-986036)
                • Key Development Milestones for Pegbelfermin (BMS-986036) in the Treatment of NASH
                • Expert Insight: Pegbelfermin (BMS-986036)
                • Expectations for Launch and Sales Opportunity of Pegbelfermin (BMS-986036) in NASH
                • Key Results from Select Clinical Trials Investigating Aldafermin (NGM282) for the Treatment of NASH
                • Analysis of the Clinical Development Program for Aldafermin (NGM282)
                • Key Development Milestones for Aldafermin (NGM282) in the Treatment of NASH
                • Expert Insight: Aldafermin (NGM282)
                • Expectations for Launch and Sales Opportunity of Aldafermin (NGM282) in NASH
                • Key Results from Select Clinical Trials Investigating Efruxifermin (AKR-001) for the Treatment of NASH
                • Analysis of the Clinical Development Program for Efruxifermin (AKR-001)
                • Expectations for Launch and Sales Opportunity of Efruxifermin (AKR-001) in NASH
                • Key Results from Select Clinical Trials Investigating Semaglutide for the Treatment of NASH
                • Analysis of the Clinical Development Program for Semaglutide
                • Expert Insight: Semaglutide
                • Expectations for Launch and Sales Opportunity of Semaglutide in NASH
                • Key Results from Select Clinical Trials Investigating Lanifibranor for the Treatment of NASH
                • Analysis of the Clinical Development Program for Lanifibranor
                • Key Development Milestones for Lanifibranor in the Treatment of NASH
                • Expert Insight: Lanifibranor
                • Expectations for Launch and Sales Opportunity of Lanifibranor in NASH
                • Key Results from Select Clinical Trials Investigating Cilofexor / Firsocostat for the Treatment of NASH
                • Analysis of the Clinical Development Program for Cilofexor / Firsocostat
                • Expert Insight: Cilofexor / Firsocostat
                • Expectations for Launch and Sales Opportunity of Cilofexor / Firsocostat in NASH
                • Key Results From Select Clinical Trials Investigating Tropifexor / Licogliflozin for the Treatment of NASH
                • Analysis of the Clinical Development Program for Tropifexor / Licogliflozin
                • Expectations for Launch and Sales Opportunity of Tropifexor / Licogliflozin in NASH
              • Early-Phase Pipeline Analysis
                • Select Compounds in Phase II Development for NASH
              • Key Discontinuations and Failures in Nonalcoholic Steatohepatitis
              • Access & Reimbursement Overview
                • Region-Specific Reimbursement Practices
                  • Key Market Access Considerations in NASH: United States
                  • General Reimbursement Environment: United States
                  • Key Market Access Considerations in NASH: EU5
                  • General Reimbursement Environment: EU5
                  • Key Market Access Considerations in NASH: Japan
                  • General Reimbursement Environment: Japan
                • Looking for More?
              • Appendix
                • Key Abbreviations Related to NASH
                • Brands, Marketers, and Generic Availability of Key Therapies for NASH: by Market
                • NASH Bibliography

            Author(s): Dominika Rudnicka-Noulin, Ph.D., M.Sc.; Joseph Granato, M.P.H.

            Dominika Rudnicka-Noulin, Ph.D., M.Sc., is a senior business insights analyst on the Cardiovascular, Metabolic, Renal, and Hematologic (CMRH) Disorders team at. She has authored reports on heart failure, acute coronary syndrome, and NASH. Previously, Dr. Rudnicka-Noulin was an associate editor at Nature Communications, working in a variety of therapy areas. She also worked for three years as a postdoctoral research associate on a joint project between Imperial College London and MedImmune aimed at developing more-potent antibody-based drugs. She earned her Ph.D. at the Institut Pasteur in Paris, France, where her work was funded by the European Commission's Marie Skłodowska-Curie Actions.

            Joseph Granato, M.P.H., is a senior epidemiologist at DRG, part of Clarivate. Before joining DRG, he worked with the Monroe County Health Department on the surveillance of reportable diseases, including dengue fever. He received his M.P.H. from Des Moines University, where he worked on several population health projects, including tick-borne diseases. He also holds a B.S. in animal science from the University of Tennessee.