United States Metabolic Dysfunction-Associated Steatohepatitis Treatment Market to Reach USD 7.64 Billion by 2031 at 21.8% CAGR, Driven by GLP-1 Agonists, Antifibrotic Agents, and Combination Therapies with Gilead, Novo Nordisk, and Intercept Leading Inno

The Global Metabolic Dysfunction-Associated Steatohepatitis (MASH) Treatment Market reached US$ 1.67 billion in 2023 and is expected to reach US$ 7.64 billion by 2031, growing at a CAGR of 21.8% during the forecast period 2024-2031.as the global prevalence of metabolic disorders and advanced liver disease continues to rise and novel therapies gain regulatory approvals.

Growth is supported by increasing demand across key treatment segments such as approved pharmacological therapies, GLP‐1 agonists, antifibrotic agents, and metabolic modulators, driven by rising rates of obesity, type 2 diabetes, and metabolic dysfunction that contribute to liver inflammation and fibrosis, along with intensified R&D investment and growing commercial launches of targeted MASH treatments (including first‐in‐class medicines demonstrating histological improvements). Regulatory milestones and expanding clinical pipelines enhance the therapeutic landscape, fostering broad adoption across hospitals, specialty clinics, and chronic liver disease care programs globally.

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Metabolic Dysfunction‐Associated Steatohepatitis (MASH) Treatment Market: Competitive Intelligence
Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Novo Nordisk A/S, Eli Lilly and Company, Allergan (AbbVie Inc.), Pfizer Inc., Merck & Co., Inc., Galmed Pharmaceuticals Ltd., Nitto Denko Corporation, and others.

The Metabolic Dysfunction‐Associated Steatohepatitis (MASH) Treatment Market is strongly driven by leading players such as Gilead Sciences, Intercept Pharmaceuticals, Madrigal Pharmaceuticals, Novo Nordisk, and Eli Lilly, who are developing and commercializing novel therapeutic agents targeting the underlying drivers of MASH such as inflammation, fibrosis, lipid metabolism, and metabolic dysfunction. Their pipelines include investigational small molecules, biologics, and combination therapies aiming to improve liver histology, reduce fibrosis progression, and address comorbid conditions like obesity and type 2 diabetes. Rising prevalence of nonalcoholic steatohepatitis (NASH) and metabolic syndrome, increasing clinical trial activity, and unmet treatment needs are key factors driving market growth.
These companies' complementary strengths clinical development expertise and advanced MASH portfolios from Gilead and Intercept; innovative fibrosis‐targeted agents from Madrigal and Allergan (AbbVie); metabolic and GLP‐1‐linked therapies from Novo Nordisk and Eli Lilly; broad neurologic and metabolic drug development infrastructure from Pfizer and Merck; and emerging candidate programs from Galmed and Nitto Denko are enhancing competitive positioning. Strategic focus areas include acceleration of late‐stage clinical trials, combination therapy strategies, biomarker‐driven patient stratification, regulatory engagement for accelerated approvals, and partnerships with research institutions and healthcare providers to expand therapeutic options and improve patient outcomes globally.

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Recent Key Developments - United States & North America
✅ August 2025: The U.S. FDA granted accelerated approval to Wegovy (semaglutide) a GLP‐1 receptor agonist broadly used for obesity and diabetes for adults with MASH and moderate‐to‐advanced liver fibrosis, making it the second approved pharmacologic therapy for this condition and offering both metabolic and liver benefits.
✅ 2025: Updated clinical practice guidance from the American Association for the Study of Liver Diseases (AASLD) now includes semaglutide as a recommended therapy for MASH with advanced fibrosis, helping clinicians identify appropriate candidates and manage treatment more effectively.
✅ Ongoing Efforts: Use of AI‐based histologic assessment tools such as the FDA‐qualified AIM‐NASH system is accelerating clinical trial evaluations and standardizing biopsy scoring in MASH research, which may help bring new therapies to market faster.

Recent Key Developments - Europe & Other Regions
✅ Mid 2025: The European Medicines Agency (EMA) adopted a positive opinion supporting conditional marketing authorization of Rezdiffra (resmetirom) the first approved MASH therapy across EU member states, with launches planned in major markets like Germany.
✅ 2025: Clinical trial activity remains robust in Asia‐Pacific and Europe, with ongoing large‐scale phase III studies assessing semaglutide and pan‐PPAR agonists (e.g., lanifibranor) in MASH patients, reflecting growing global investment in effective treatments.
✅ India: National regulatory authorities have approved saroglitazar, a PPAR‐α/γ agonist, for MASH patients with earlier stages of fibrosis based on evidence of reduced liver inflammation and fat, expanding region‐specific therapeutic options.

Recent Key Developments - Product & Clinical Pipeline
✅ Resmetirom (Rezdiffra): Originally approved by the FDA in 2024 as the first targeted oral therapy for MASH fibrosis, resmetirom shows significant reductions in liver fat, inflammation, and fibrosis markers and continues to generate real‐world uptake and guidelines support.
✅ GLP‐1 Therapies: Beyond semaglutide, other GLP‐1 receptor agonists and dual agonists (e.g., tirzepatide) remain under investigation to evaluate synergistic metabolic and hepatic benefits in MASH patients.
✅ PPAR‐Targeted Therapies: Pan‐PPAR agonists like lanifibranor are in ongoing phase III trials with promising efficacy signals for MASH resolution and fibrosis improvement, while other novel mechanisms like PXL065 show positive phase II results improving liver fat and fibrosis markers.

✅ 1. M&A / Strategic Developments
Gilead & Galmed Strategic Collaboration
Sept 2025 Gilead Sciences entered into a strategic collaboration with Galmed Pharmaceuticals to co‐develop genetically stratified therapies for NASH/MASH, combining Gilead's development infrastructure with Galmed's aramchol program insights. While this is structured as collaboration rather than acquisition, it signifies major pharma commitment to MASH therapeutic innovation in advanced fibrosis subpopulations.
Novo Nordisk Pipeline Strengthening
2025 Novo Nordisk expanded its metabolic disease portfolio with internal investments into GLP‐1/GIP dual agonists showing promise in NASH-related endpoints, aligning its obesity/metabolic disease leadership with evolving MASH treatment opportunities.

✅ 2. New Product Launches & Clinical Developments
Regulatory Progress in Key Therapeutic Agents
Resmetirom (MGL‐3196) - Pivotal Results (2025)
Resmetirom demonstrated positive phase 3 results for NASH/MASH with significant improvements in liver fat reduction and histologic endpoints, expanding momentum for potential future regulatory submissions in multiple regions. This agent targets thyroid hormone receptors to improve metabolism and is one of the furthest‐along late‐stage assets.
Semaglutide & Tirzepatide Metabolic Liver Effects
Updated clinical data suggests GLP‐1/GIP agonists (semaglutide/ tirzepatide) approved for obesity and T2DM demonstrate clinically meaningful liver fat and NASH resolution effects, making them de‐facto options in metabolic steatosis management in real‐world practice, though not yet fully labeled at regulatory agencies for MASH.
FXR Agonists & Combination Regimens
Multiple late‐stage candidates (e.g., obeticholic acid class, non‐steroidal FXR agonists) continue phase 3 evaluation. Several consortiums are exploring combination regimens (e.g., FXR + SGLT‐2/GLP‐1) to amplify histologic and metabolic benefits in MASH patients with fibrosis.

✅ 3. R&D & Innovation Trends
Shift Toward Combination Therapeutics
A key trend is the movement from single‐mechanism drugs to rational combination strategies that address metabolic dysfunction, inflammation, and fibrosis simultaneously. Such approaches aim to improve clinical responses and reduce progression to cirrhosis.
Biomarker & Enrichment Strategies
Efforts to validate non‐invasive biomarkers (imaging, serum markers) to enrich clinical trial populations and predict response are maturing, improving trial efficiency and regulatory confidence in endpoint selection.
Precision Medicine / Genotype‐Stratified Approaches
Companies are integrating genetic stratification into trial designs (e.g., PNPLA3/ TM6SF2 risk alleles), aiming to personalize therapy and potentially improve therapeutic indices across heterogeneous metabolic liver disease populations.
Advanced Imaging Endpoints & AI Analysis
Imaging modalities (MRI‐PDFF, elastography) combined with AI‐assisted histologic interpretation are increasingly used as surrogate endpoints in R&D settings, enabling more responsive assessment of therapeutic effect in phase 2/3 frameworks.

Segments Covered in the Metabolic Dysfunction-Associated Steatohepatitis (MASH) Treatment Market:
By Treatment
The market is segmented into Pharmacological Therapy 60% and Non-Pharmacological Therapy 40%, with pharmacological treatments dominating due to the growing pipeline of drugs targeting inflammation, fibrosis, and metabolic dysfunction in MASH patients. Non-pharmacological approaches, including lifestyle modification, dietary interventions, and exercise programs, remain critical as first-line management strategies. Rising prevalence of obesity, type 2 diabetes, and metabolic syndrome drives demand for both treatment types, with combination approaches increasingly recommended by healthcare professionals.
By End-User
End-users include Hospitals 50%, Specialty Clinics 30%, Outpatient Care Centers 15%, and Others 5%, with hospitals dominating due to high patient volume, availability of diagnostic facilities, and multi-disciplinary care teams for MASH management. Specialty clinics are expanding with targeted metabolic and liver care programs. Outpatient care centers support ongoing monitoring and lifestyle interventions, especially in early-stage patients. Growing awareness of liver health and metabolic disorders drives adoption across all end-user segments.

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By Region
North America - 40% Share
North America leads with 40% share, driven by high prevalence of metabolic syndrome, obesity, and type 2 diabetes. Advanced healthcare infrastructure and ongoing clinical trials for pharmacological therapies fuel market growth. Hospitals and specialty clinics dominate adoption. Pharmacological therapy remains the preferred treatment type.
Europe - 25% Share
Europe holds 25% share, supported by rising liver disease prevalence and well-established healthcare systems. Pharmacological and non-pharmacological treatments are both widely used. Hospitals and outpatient care centers lead end-user adoption. Government initiatives for metabolic and liver disease awareness drive growth.
Asia-Pacific - 20% Share
Asia-Pacific accounts for 20% share, driven by increasing obesity rates, rising incidence of metabolic disorders, and growing access to healthcare in countries like China, India, and Japan. Non-pharmacological interventions are common, while pharmacological adoption is rapidly increasing. Hospitals are primary end-users.

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