Nonalcoholic steatohepatitis (NASH) has the potential to be a large and lucrative market for pharmacotherapies owing to the lack of approved agents and the disease’s prevalence. The body of evidence for the financial costs of the disease is growing, particularly with respect to cardiovascular (CV) disease, liver failure, and the fact that NASH will soon become the leading reason for liver transplantation. The lack of treatment options and the limited awareness of the disease and its complications have resulted in low diagnosis and treatment rates. However, as education increases, novel diagnostic tools are developed, and new therapies are approved, diagnosis and treatment rates will increase, driving growth of the market overall. Currently, despite guidelines recommending certain off-label medications, prescribing is usually limited to specialists caring for patients with more-advanced disease. However, as education increases, novel diagnostic tools are developed, and approved medical therapies become available, diagnosis and treatment rates will increase and drive growth of the market overall.

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 obeticholic acid, elafibranor, cenicriviroc, and resmetirom fit into the evolving NASH treatment paradigm?

Geographies:

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

Key companies mentioned:

Intercept Pharmaceuticals, Gilead, Genfit, Allergan, Galectin Therapeutics, Galmed Pharmaceuticals, Madrigal Pharmaceuticals, Viking Therapeutics, Cirius Therapeutics, NGM Bio, Novo Nordisk, Novartis, Bristol-Myers Squibb, Enanta Pharmaceuticals

Key drugs covered:

Obeticholic acid, elafibranor, cenicrivirox, belapectin (GR-MD-02), resmetirom (MGL-3196), aramchol, VK-2809, MSDC-0602K, pegbelfermin (BMS-986036), aldafermin (NGM282), cilofexor, EDP-305, semaglutide, firsocostat, vitamin E, pioglitazone

Table of contents

  • Disease Landscape & Forecast
    • Key Findings
      • NASH - Key Findings - November 2019
    • Key Updates
      • November 2019
      • September 2019
      • June 2019
      • December 2018
    • Market Outlook
      • Key Findings
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for NASH?
        • What Factors Are Constraining the Market for NASH?
      • Drug-Class-Specific Trends
        • FXR Agonists
        • PPAR α / PPAR γ agonists
        • Chemokine Receptor Agonists
        • THR-β Agonists
        • Mitochondrial Metabolism Modulators
        • Galectin Protein Inhibitors
        • SCD-1 Modulators
        • FGF Analogues
    • Forecast
      • Market Forecast Assumptions
      • Market Forecast Dashboard
    • Etiology and Pathophysiology
      • Disease Overview
      • Etiology
      • Pathophysiology
        • Disease Pathophysiology
      • Natural History
      • Key Pathways and Drug Targets
    • Epidemiology
      • Key Findings
      • Epidemiology Populations
        • Total Prevalent Cases of NASH
        • Diagnosed Prevalent Cases of NASH
        • Drug-Treated Cases of NASH
    • Current Treatment
      • Key Findings
      • Treatment Goals
      • Key Current Therapies
        • Overview
        • Off-Label Antidiabetic Agents
        • Off-Label Lipid-Modifying Agents
        • Off-Label Vitamins
        • Other Off-Label Medications
      • Medical Practice
        • Overview
        • Region-Specific Treatment Practices
        • Diagnostics
    • Unmet Need Overview
      • Current and Future Attainment of Unmet Needs in NASH
    • Emerging Therapies
      • Key Findings
      • Key Emerging Therapies
        • FXR Agonists
        • PPAR α / PPAR γ agonists
        • Chemokine Receptor Antagonists
        • THR-β Agonists
        • Mitochondrial Metabolism Modulators
        • Galectin Protein Inhibitors
        • SCD-1 Modulators
        • FGF Analogues
        • ACC Inhibitors
        • GLP-1 Receptor Agonists
      • Early-Phase Pipeline Analysis
      • Key Discontinuations and Failures in Nonalcoholic Steatohepatitis (NASH)
    • Access & Reimbursement Overview
      • Region-Specific Reimbursement Practices
        • United States
        • EU5
        • Japan
      • Looking for More?
    • Methodology
      • Bottom-Up Forecasting Overview
        • Patient Populations
        • Drug-Specific Assumptions
      • Bottom-Up Forecast Assumptions
        • General Sources of Data
        • Agents Included in Our Market Analysis
        • General Statements About Pricing
        • Dosing, Days of Therapy, and Compliance
        • Generic Erosion
        • Out-Year Forecasting
        • Emerging Therapy Prices
      • Primary Market Research
        • Experts Interviewed
    • Appendix
      • NASH Bibliography

Author(s): Dominika Rudnicka-Noulin, PhD, MSc; Joseph Granato, MPH

Dominika Rudnicka-Noulin, PhD, MSc is a senior business insights analyst in the Cardiovascular, Metabolic and Renal division at Decision Resources Group, specializing in cardiovascular diseases, with expertise in heart failure and acute coronary syndrome. Prior to joining DRG, Dominika held a position of an associate editor at Nature Communications, working across a variety of therapy areas. Dominika 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. Dominika gained her PhD at the Institut Pasteur in Paris, France where her work was funded by the European Commission Marie Skłodowska-Curie Actions

Joseph Granato joined Decision Resources Group in 2012 and previously worked on both Market Access and Global Market Access ; Joseph is currently responsible for forecasting the prevalence and incidence of disease populations throughout the ; He is also tasked with identifying at risk populations and developing new epidemiological methods used to predict overall population health. He received his from Des Moines University where he worked on several population health projects including the delivery of continuing medical education on tick-borne ; He also holds a in Animal Science from the University of ; Prior to his time with DRG Joseph worked with the Monroe County Health Department on the surveillance of reportable diseases including Dengue Fever.