Non-Alcoholic Steatohepatitis Treatment Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Type (Vitamin E and Pioglitazone, Obeticholic Acid (OCA), Lanifibranor, Semaglutide, Resmetirom, Aramchol, Cenicriviroc, Others), By End-User (Hospital Pharmacies, Retail and Specialty Pharmacies, Others), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.39 Billion
CAGR (2026-2031)	24.36%
Fastest Growing Segment	Vitamin E And Pioglitazone Segment
Largest Market	North America
Market Size (2031)	USD 8.84 Billion

Market Overview

The Global Non-Alcoholic Steatohepatitis Treatment Market will grow from USD 2.39 Billion in 2025 to USD 8.84 Billion by 2031 at a 24.36% CAGR. The Global Non-Alcoholic Steatohepatitis Treatment Market encompasses pharmaceutical interventions designed to mitigate liver inflammation and fibrosis resulting from metabolic dysfunction. The market is primarily supported by the escalating global prevalence of risk factors such as obesity and type 2 diabetes, which necessitates effective clinical management to prevent disease progression to cirrhosis. Additionally, the recent regulatory approval of the first targeted therapeutic agents has validated the commercial viability of the sector, driving investment and development. According to the American Liver Foundation, in 2025, metabolic dysfunction-associated steatohepatitis was estimated to affect between nine and 15 million adults in the United States.

However, a significant challenge impeding rapid market expansion is the diagnostic complexity associated with accurately identifying eligible patients. The continued reliance on invasive liver biopsies as the clinical gold standard for confirming advanced fibrosis creates a substantial barrier to widespread screening and treatment adoption. This requirement complicates the patient journey and limits the diagnosis rate, thereby restricting the accessible revenue base for emerging therapies and slowing the overall commercial uptake of new treatments.

Key Market Drivers

The escalating prevalence of obesity and metabolic comorbidities functions as the primary catalyst expanding the Global Non-Alcoholic Steatohepatitis Treatment Market. As metabolic dysfunction drives liver fat accumulation and inflammation, the synchronization between rising body mass index and liver disease creates a rapidly growing patient pool necessitating pharmacological intervention. This direct correlation ensures a sustained demand for effective therapeutics as lifestyle-related risk factors intensify globally. According to the World Health Organization, March 2024, in the 'World Obesity Day 2024' news release, more than one billion people worldwide were living with obesity in 2022. This demographic shift underscores the urgency for treatments addressing the metabolic roots of liver fibrosis.

Simultaneously, the market is propelled by a robust late-stage clinical pipeline and the historic milestone of novel drug approvals which have validated the commercial potential of the sector. The transition from supportive care to targeted disease-modifying therapies has been accelerated by successful regulatory outcomes, encouraging further pharmaceutical investment in mechanism-driven candidates. According to Madrigal Pharmaceuticals, March 2024, in the 'FDA Approves Rezdiffra' press release, the wholesale acquisition cost for the first regulatory-approved treatment for this condition was set at USD 47,400 annually. This pricing benchmark establishes a tangible revenue model for future market entrants. Furthermore, clinical innovation continues to thrive; according to Boehringer Ingelheim, February 2024, in a press statement regarding Phase II trial results, up to 83 percent of patients treated with the investigational candidate survodutide achieved a statistically significant improvement in disease activity.

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Key Market Challenges

The diagnostic complexity associated with the reliance on invasive liver biopsies presents a substantial obstacle to the growth of the Global Non-Alcoholic Steatohepatitis Treatment Market. Because biopsies are resource-intensive and carry procedural risks, they deter widespread population screening and delay the clinical confirmation of fibrosis. This reliance on an invasive gold standard creates a severe bottleneck in the patient identification process, preventing the timely categorization of individuals who explicitly require pharmaceutical intervention. Consequently, the volume of patients eligible for prescription therapies remains artificially low relative to the 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, in 2024, approximately 95 percent of individuals affected by metabolic dysfunction-associated steatohepatitis remained undiagnosed globally. This extremely low diagnosis rate directly hampers commercial uptake, as pharmaceutical companies cannot effectively monetize their therapeutic products when the vast majority of the target demographic has not been clinically identified to receive treatment.

Key Market Trends

The Integration of GLP-1 Receptor Agonists for Treatment represents a transformative shift in the market, moving therapeutic focus from exclusively liver-centric targets to systemic metabolic regulation. This trend leverages the mechanism of incretin mimetics to address the underlying metabolic drivers of steatohepatitis, such as insulin resistance and lipotoxicity, which are intrinsic to disease progression. The efficacy of this approach has been robustly demonstrated in late-stage clinical evaluations, establishing these agents as a cornerstone of future treatment paradigms rather than merely supportive care for comorbidities. According to Novo Nordisk, November 2024, in the 'Semaglutide 2.4 mg demonstrates superior improvement in both liver fibrosis and MASH resolution' press release, 62.9 percent of adults treated with semaglutide 2.4 mg achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to only 34.1 percent of those receiving a placebo in the Phase 3 ESSENCE trial.

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 alignment of non-invasive tests with histological outcomes is critical for regulatory acceptance and broadening the accessible patient population for commercial therapies. According to Akero Therapeutics, November 2024, in the 'Akero Therapeutics Announces Results of Analyses Supporting Clinical Activity of Efruxifermin' press statement, over 40 percent of participants treated with efruxifermin 50mg for 96 weeks showed regression of liver fibrosis by all three orthogonal measures, including liver stiffness by FibroScan and the Enhanced Liver Fibrosis (ELF) score, compared to zero percent for placebo.

Segmental Insights

The Vitamin E and Pioglitazone segment is identified as the fastest-growing category within the global Non-Alcoholic Steatohepatitis treatment market due to its established role as a primary line of defense in clinical settings. This rapid expansion is driven by practice guidelines from respected institutions, such as the American Association for the Study of Liver Diseases, which recommend these therapies for specific patient groups in the absence of broadly approved pharmacological alternatives. Consequently, healthcare providers increasingly rely on these cost-effective and accessible treatments to manage liver conditions, fueling significant market adoption.

Regional Insights

North America dominates the Global Non-Alcoholic Steatohepatitis Treatment Market primarily due to the rising prevalence of metabolic disorders such as obesity and diabetes. The region benefits from extensive research initiatives and significant healthcare expenditure that supports drug development. The presence of major pharmaceutical companies drives the clinical pipeline, while the U.S. Food and Drug Administration plays a critical role in facilitating market entry through established regulatory pathways. Furthermore, strong diagnostic protocols and favorable reimbursement structures ensure that patients have timely access to approved treatments, thereby sustaining the region's market leadership.

Recent Developments

• In November 2024, Novo Nordisk announced positive headline results from Part 1 of the ongoing Phase 3 ESSENCE trial, which evaluated the efficacy of once-weekly semaglutide 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. The study demonstrated that the treatment achieved its primary endpoints, showing statistically significant resolution of steatohepatitis and improvement in liver fibrosis compared to placebo. Following these results, the company confirmed plans to file for regulatory approvals in the United States and Europe, signalling a major potential expansion in the Global Non-Alcoholic Steatohepatitis Treatment Market.
• In June 2024, Eli Lilly and Company presented detailed results from the Phase 2 SYNERGY-NASH study evaluating tirzepatide in adults with biopsy-proven metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis. The data, shared at the European Association for the Study of the Liver (EASL) Congress, showed that 51.8% to 73.3% of participants taking various doses of tirzepatide achieved an absence of MASH with no worsening of fibrosis after 52 weeks, compared to roughly 13% on placebo. These significant efficacy results underscored the potential of GLP-1/GIP dual agonists to treat patients within the Global Non-Alcoholic Steatohepatitis Treatment Market effectively.
• In March 2024, Madrigal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis. This regulatory decision marked a historic milestone as Rezdiffra became the first and only medication approved by the FDA specifically for this condition. The approval was based on Phase 3 data which demonstrated that the drug resolved NASH and improved liver fibrosis, addressing a critical unmet need in the Global Non-Alcoholic Steatohepatitis Treatment Market.
• In February 2024, Zealand Pharma and Boehringer Ingelheim reported positive top-line results from a Phase 2 trial investigating survodutide for the treatment of people with non-alcoholic steatohepatitis (NASH), now often referred to as metabolic dysfunction-associated steatohepatitis (MASH). The companies announced that up to 83.0% of adults treated with survodutide achieved a statistically significant improvement in disease activity versus 18.2% in the placebo group. The trial also met its secondary endpoints, including a significant improvement in liver fibrosis stages. These findings highlighted the potential of this glucagon/GLP-1 receptor dual agonist as a leading therapy in the Global Non-Alcoholic Steatohepatitis Treatment Market.

Key Market Players

• 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.

By Drug Type	By End-User	By Region
Vitamin E and Pioglitazone Obeticholic Acid (OCA) Lanifibranor Semaglutide Resmetirom Aramchol Cenicriviroc Others	Hospital Pharmacies Retail and Specialty Pharmacies Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Non-Alcoholic Steatohepatitis Treatment Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• 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
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE