Non-Alcoholic Steatohepatitis Treatment Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Non-Alcoholic Steatohepatitis Treatment Market is projected to experience substantial growth, expanding from USD 2.39 Billion in 2025 to USD 8.84 Billion by 2031 at a CAGR of 24.36%. This market involves pharmaceutical interventions aimed at mitigating liver inflammation and fibrosis caused by metabolic dysfunction, driven largely by the rising global prevalence of obesity and type 2 diabetes which necessitates clinical management to prevent cirrhosis. Furthermore, the sector's commercial viability has been confirmed by recent regulatory approvals of targeted therapeutics, stimulating investment; the American Liver Foundation estimated that metabolic dysfunction-associated steatohepatitis would affect between nine and 15 million adults in the United States in 2025.

However, rapid market expansion is hindered by the diagnostic complexity involved in accurately identifying eligible patients, specifically the continued reliance on invasive liver biopsies as the gold standard for confirming advanced fibrosis. This requirement creates a significant barrier to widespread screening and treatment adoption, complicating the patient journey and limiting diagnosis rates. Consequently, the dependence on invasive procedures restricts the accessible revenue base for emerging therapies and slows the overall commercial uptake of new treatments.

Market Drivers

The primary catalyst expanding the Global Non-Alcoholic Steatohepatitis Treatment Market is the escalating prevalence of obesity and metabolic comorbidities, as metabolic dysfunction leads to liver fat accumulation and inflammation. The synchronization between rising body mass index and liver disease creates a rapidly growing patient pool that requires pharmacological intervention, ensuring sustained demand for effective therapeutics as lifestyle-related risk factors intensify globally. This urgency is highlighted by the World Health Organization's 'World Obesity Day 2024' release, which noted that over one billion people worldwide were living with obesity in 2022, underscoring the need for treatments targeting the metabolic roots of liver fibrosis.

Simultaneously, the market is propelled by a robust late-stage clinical pipeline and historic regulatory approvals that have validated the sector's commercial potential, accelerating the transition from supportive care to targeted disease-modifying therapies. Successful regulatory outcomes have encouraged further investment; for instance, Madrigal Pharmaceuticals reported in March 2024 that the wholesale acquisition cost for Rezdiffra, the first approved treatment, was set at USD 47,400 annually, establishing a tangible revenue model. Clinical innovation remains active, as evidenced by Boehringer Ingelheim's February 2024 statement that up to 83 percent of patients treated with survodutide achieved significant disease improvement in Phase II trials.

Market Challenges

A substantial obstacle to the growth of the Global Non-Alcoholic Steatohepatitis Treatment Market is the diagnostic complexity associated with the reliance on invasive liver biopsies. Because these procedures are resource-intensive and carry risks, they deter widespread population screening and delay the clinical confirmation of fibrosis, creating a severe bottleneck in the patient identification process. This reliance on an invasive gold standard prevents the timely categorization of individuals who explicitly require pharmaceutical intervention, keeping the volume of patients eligible for prescription therapies artificially low relative to actual disease prevalence.

This persistent gap significantly restricts the revenue potential for approved treatments, as the market cannot expand without a validated patient base. According to the Global Liver Institute, approximately 95 percent of individuals affected by metabolic dysfunction-associated steatohepatitis remained undiagnosed globally in 2024. This extremely low diagnosis rate directly hampers commercial uptake, as pharmaceutical companies are unable to effectively monetize their therapeutic products when the vast majority of the target demographic has not been clinically identified to receive treatment.

Market Trends

The integration of GLP-1 receptor agonists represents a transformative shift in the market, moving the therapeutic focus from exclusively liver-centric targets to systemic metabolic regulation. By leveraging incretin mimetics to address underlying metabolic drivers such as insulin resistance and lipotoxicity, this approach has demonstrated robust efficacy in late-stage clinical evaluations, establishing these agents as cornerstones of future treatment paradigms. For example, Novo Nordisk reported in November 2024 that 62.9 percent of adults treated with semaglutide 2.4 mg in the Phase 3 ESSENCE trial achieved resolution of steatohepatitis without worsening fibrosis, compared to only 34.1 percent of those receiving a placebo.

Simultaneously, the adoption of non-invasive diagnostic biomarkers is reshaping clinical development and patient stratification by reducing reliance on histological verification. Pharmaceutical developers are increasingly validating surrogate endpoints using imaging and circulating markers to streamline trial recruitment and monitor therapeutic response without the procedural risks of biopsies. This trend is illustrated by Akero Therapeutics' November 2024 announcement, which stated that over 40 percent of participants treated with efruxifermin 50mg showed regression of liver fibrosis across three orthogonal measures, including FibroScan and the ELF score, compared to zero percent for the placebo group.

Key Players Profiled in the Non-Alcoholic Steatohepatitis Treatment Market

• Intercept Pharmaceuticals Inc.
• Galmed Research & Development Ltd.
• INVENTIVA S.A.
• AbbVie Inc.
• Galectin Therapeutics Inc.
• Madrigal Pharmaceuticals Inc.
• NGM Biopharmaceuticals Inc.
• Novo Nordisk A/S
• Bristol Myers Squibb
• Gilead Sciences Inc.

Report Scope

In this report, the Global Non-Alcoholic Steatohepatitis Treatment Market has been segmented into the following categories:

Non-Alcoholic Steatohepatitis Treatment Market, by Drug Type:

• Vitamin E and Pioglitazone
• Obeticholic Acid (OCA)
• Lanifibranor
• Semaglutide
• Resmetirom
• Aramchol
• Cenicriviroc
• Others

Non-Alcoholic Steatohepatitis Treatment Market, by End-User:

• Hospital Pharmacies
• Retail and Specialty Pharmacies
• Others

Non-Alcoholic Steatohepatitis Treatment Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Non-Alcoholic Steatohepatitis Treatment Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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