Non-alcoholic Steatohepatitis | Landscape & Forecast | Disease Landscape & Forecast

Publish date: June 2019

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Nonalcoholic steatohepatitis (NASH) has the potential to be a large and lucrative market for pharmacotherapies owing to the lack of approved agents and the prevalence of the disease. 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, only off-label medications are available for NASH; they will sustain the small market over the first half of the 2017-2027 forecast period, until the launch of the first wave of emerging therapies: Intercept Pharmaceutical’s obeticholic acid, Gilead’s selonsertib, Genfit’s elafibranor, and Allergan’s cenicriviroc. We expect gradual uptake of the new therapies, but if their long-term safety, liver-related benefits, and reductions in mortality are demonstrated later in the forecast period, their uptake will accelerate. These novel therapies will be able to command high prices owing to the innovation they provide for an indication without pharmacotherapeutic options. However, pricing strategies must take into account payers’ budgets and patients’ compliance owing to the relatively slow natural history of NASH and the need for long-term treatment.

Questions Answered:

  • Prescribing medication off-label for NASH is common practice, given the lack of approved medications. How will the availability of the first novel branded NASH agents affect the prescribing landscape?
  • Physicians, especially in the primary care environment, are not aware of the importance of diagnosis and treatment of NASH. Is their attitude expected to change over the forecast period? How will physicians’ lack of experience with NASH affect the uptake of novel medications?
  • Diagnosis rates in the United States, EU5, and Japan remain exceptionally low due to the lack of noninvasive diagnostic tests. How will the availability of new noninvasive diagnostic tests for NASH (i.e., serum biomarkers or imaging) affect the diagnosis and treatment rates in the countries under study?

Scope:

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

Primary research: 20 country-specific interviews with NASH thought leaders.

Epidemiology: Prevalent cases of NASH.

Emerging therapies: Phase II: 40 drugs; Phase III: 4 drugs; preregistration: 0 drugs; registered: 0 drugs. Coverage of select preclinical and Phase I products.

Key Companies: Intercept Therapeutics, Gilead, Genfit, Allergan, Galectin Therapeutics, Galmed Pharmaceuticals, Madrigal Pharmaceuticals, Viking Therapeutics, Immuron, NGM Bio, Novartis, Bristol-Myers Squibb, Conatus Pharmaceuticals.

Key Drugs: Obeticholic acid, elafibranor, cenicrivirox, GR-MD-02, Aramchol, MGL-3196, VK-2809, IMM-124E, NGM-282, tropifexor, BMS-986036, emricasan, vitamin E, ursodeoxycholic acid, pioglitazone, metformin, GLP-1 receptor agonists, SGLT inhibitors, statins.

Table of contents

  • Disease Landscape & Forecast
    • Key Updates
      • June 2019
      • December 2018
      • August 2018
    • Market Outlook
      • Key Findings
        • Market Overview
      • 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
        • ASK-1 Inhibitors
        • PPAR Agonists
        • Chemokine Receptor Agonists
        • SCD-1 Modulators
        • Galectin Protein Inhibitors
        • THR-ß Agonists
    • Forecast
      • Market Forecast Assumptions
      • Market Forecast Dashboard
    • Etiology and Pathophysiology
      • Disease Overview
      • Etiology
      • Pathophysiology
        • Disease Pathophysiology
      • Natural History
      • Key Pathways and Drug Targets
    • Epidemiology Overview
      • 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
        • Other Off-Label Medications
      • Medical Practice
        • Overview
        • Treatment Guidelines
        • Region-Specific Treatment Practices
        • Diagnostics
    • Unmet Need Overview
      • Current and Future Attainment of Unmet Needs in NASH
    • Emerging Therapies
      • Key Findings
        • Key Findings
      • Key Emerging Therapies
        • FXR Agonists
        • PPAR Agonists
        • Chemokine Receptor Antagonists
        • ASK-1 Inhibitors
        • Caspase Protease Inhibitors
        • SCD-1 Modulators
        • Galectin Protein Inhibitors
        • Thyroid Hormone Receptor-Beta Agonists
      • Early-Phase Pipeline Analysis
    • 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): Andrew Frost; Joseph Granato, MPH

Andrew Frost is a Business Insights Analyst in Decision Resources Group’s Cardiovascular, Metabolic, Renal, and Hematologic Disorders team focusing on obesity and non-alcoholic steatohepatitis (NASH). In this role, he evaluates the latest primary and secondary research, as well as available commercial information, to forecast the potential of developmental drugs and provide insight on the various dynamics affecting relevant markets. Prior to joining DRG, Andrew worked as a Senior Drug Analyst at Citeline in the Cardiovascular and Metabolic Team. Andrew holds a BSc (Hons) degree in Pharmacology, awarded by King’s College London, and he has previously worked in the Immunopharmacology team at UCB.  

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.