Non-alcoholic Steatohepatitis Treatment Market Summary
and Market Overview
Non-alcoholic steatohepatitis (NASH) treatments, including vitamin E, obeticholic acid, and resmetirom, address a progressive liver disease driven by obesity (650 million adults globally), type 2 diabetes (537 million cases), and metabolic syndrome. NASH, projected to affect 27 million U.S. patients by 2030, is a leading cause of liver transplants and increases cardiovascular risk by 50%. The market is propelled by rising prevalence, non-invasive diagnostics improving accuracy by 40%, and accelerated regulatory approvals, such as Rezdiffra in 2024. Government funding, including USD 2.31 billion from NIDDK, and 60% OECD reimbursement coverage further drive growth. The global NASH treatment market is estimated at USD 5.0-9.0 billion in 2025, with a CAGR of 22%-30% through 2030.
Regional Market Trends
North America: The U.S. leads with high obesity rates and Rezdiffra adoption, while Canada emphasizes metabolic health programs.
Europe: Germany, France, and the UK drive growth with advanced liver disease management and biomarker adoption.
Asia Pacific: China and India see rising NASH cases due to lifestyle changes, with Japan focusing on novel therapies.
Rest of the World: Brazil expands diagnostic infrastructure, while the Middle East addresses diabetes-related NASH.
Distribution Channel Analysis
Hospital Pharmacies: Expected growth of 22.5%-30.5%, driven by novel therapies like resmetirom. Trends focus on specialized liver care.
Retail and Specialty Pharmacies: Projected growth of 22.0%-30.0%, linked to outpatient management. Advances emphasize patient access.
Other Pharmacies: Anticipated growth of 21.5%-29.5%, covering online platforms. Trends highlight digital prescriptions.
Type Analysis
Vitamin E and Pioglitazone: Expected growth of 20.0%-28.0%, used for early-stage NASH. Trends focus on cost-effective options for mild cases.
Obeticholic Acid (OCA): Projected growth of 22.5%-30.5%, effective for fibrosis. Advances emphasize regulatory progress and combination therapies.
Lanifibranor: Anticipated growth of 23.0%-31.0%, valued for multi-pathway action. Trends highlight metabolic and anti-fibrotic benefits.
Semaglutide: Expected growth of 22.8%-30.8%, leveraging weight loss and diabetes synergy. Developments prioritize dual indications.
Resmetirom: Expected growth of 24.0%-32.0%, a first-in-class therapy reducing liver fat. Trends focus on transformative outcomes.
Aramchol: Expected growth of 21.5%-29.5%, targeting steatosis. Trends highlight potential in combination regimens.
Cenicriviroc: Expected growth of 21.0%-29.0%, addressing inflammation. Developments prioritize anti-fibrotic effects.
Other Drugs: Expected growth of 20.5%-28.5%, covering pipeline candidates. Trends focus on diverse mechanisms.
Key Market Players
Madrigal Pharmaceuticals: Pioneers resmetirom for NASH treatment.
Intercept Pharmaceuticals: Develops obeticholic acid for fibrosis.
Inventiva: Focuses on lanifibranor for metabolic benefits.
Novo Nordisk: Offers semaglutide, leveraging diabetes expertise.
Pfizer: Innovates combination therapies for NASH.
Porter’s Five Forces Analysis
Threat of New Entrants: Moderate, as high R&D costs and regulatory hurdles exist, but unmet medical needs attract new players.
Threat of Substitutes: Moderate, with lifestyle interventions competing, but advanced NASH requires pharmacological solutions.
Bargaining Power of Buyers: Moderate, as insurers negotiate prices, but limited approved therapies strengthen providers.
Bargaining Power of Suppliers: Low, with multiple suppliers of active pharmaceutical ingredients.
Competitive Rivalry: High, with companies competing on efficacy, safety, and speed to market.
Market Opportunities and Challenges
Opportunities:
Addressing NASH, projected to affect 27 million U.S. patients by 2030.
Leveraging obesity and diabetes, impacting 650 million and 537 million people, respectively.
Utilizing non-invasive diagnostics, improving accuracy by 40%.
Benefiting from USD 2.31 billion NIDDK funding for research.
Expanding 60% OECD reimbursement coverage for NASH therapies.
Developing combination therapies for comprehensive management.
Challenges:
High costs of novel therapies limiting patient access.
Regulatory delays for pipeline drugs.
Limited NASH awareness and diagnostics in developing regions.
Competition from lifestyle-based interventions.
Complexity in managing advanced NASH and comorbidities.
Learn how to effectively navigate the market research process to help guide your organization on the journey to success.
Download eBook