Metabolic Dysfunction-Associated Steatohepatitis (MASH) Market Size in the 7MM is Projected to Grow at a Significant CAGR by 2036, Estimates DelveInsight

DelveInsight's "MASH Treatment Market Insights, Epidemiology, and Market Forecast - 2036" report delivers an in-depth analysis of MASH epidemiology, market, and clinical development understanding. In addition, this report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the MASH therapeutics market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Download DelveInsight's comprehensive report to explore market trends, pipeline analysis, and emerging therapies: https://www.delveinsight.com/report-store/mash-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=mpr

Key Takeaways from the MASH Market Report
• In August 2025, the European Commission granted conditional marketing authorization for Rezdiffra (resmetirom) by Madrigal Pharmaceuticals to treat adults with noncirrhotic MASH with moderate to advanced liver fibrosis, making it the first and only approved MASH therapy in the EU.
• The total market size of MASH in 2025 in the 7MM was approximately USD 3 billion, expected to grow at a significant CAGR, reaching a notable value by the end of 2036.
• In 2025, the US accounted for over USD 2 billion of the 7MM market - the largest share among all geographies covered.
• According to DelveInsight's estimates, there were more than ~200 million prevalent cases of MASLD in the 7MM in 2025, including ~30 million prevalent cases of MASH, of which ~8 million were diagnosed.
• Among the 7MM, the US had the highest number of diagnosed prevalent MASH cases, with ~5 million cases in 2025, a figure projected to increase by 2036.
• In 2025, EU4 and the UK accounted for ~3 million diagnosed prevalent cases of MASH, with Germany recording the highest at ~795 thousand cases.
• In 2025, Japan recorded ~800 thousand diagnosed prevalent MASH cases, a number expected to rise by 2036.
• The total EU4 and UK market size of MASH was found to be ~USD 500 million in 2025, which is expected to increase through the forecast period (2026-2036).
• Market growth is anticipated with the introduction of emerging therapies, including efruxifermin (EFX), VK2809, efimosfermin alfa (BOS-580), icosabutate, denifanstat, and pegozafermin, among others.
• Leading MASH Companies include Madrigal Pharmaceuticals, Akero Therapeutics, Sagimet Biosciences, 89bio, Viking Therapeutics, Boston Pharmaceuticals, NorthSea Therapeutics, and others.
• Promising MASH therapies in the pipeline include Efruxifermin (EFX), VK2809, Efimosfermin alfa (BOS-580), Pegozafermin, Denifanstat, Icosabutate, and others.

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MASH Epidemiology Segmentation in the 7MM
• Total Prevalent Cases of MASLD/NAFLD
• Total Prevalent Cases of MASH/NASH
• Total Diagnosed Prevalent Cases of MASH/NASH
• Severity-specific Diagnosed Prevalent Cases of MASH/NASH
• Total Treated Cases of MASH

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MASH Marketed Drugs
REZDIFFRA (resmetirom): Madrigal Pharmaceuticals
REZDIFFRA (resmetirom) is a Thyroid Hormone Receptor-beta (THR-β) agonist approved for treating adults with noncirrhotic MASH and moderate to advanced liver fibrosis (F2-F3), in conjunction with diet and exercise. In March 2024, the US FDA approved REZDIFFRA for adults with noncirrhotic MASH with moderate to advanced liver fibrosis. It received accelerated approval due to improvements in MASH and fibrosis. In August 2025, the European Commission granted conditional marketing authorization, making it the first approved MASH therapy in the EU.

MASH Emerging Drugs

Efruxifermin (EFX): Akero Therapeutics
Efruxifermin (EFX) is a differentiated Fc-FGF21 fusion protein engineered to mimic the balanced biological activity profile of native FGF21. It aims to reduce liver fat and inflammation, reverse fibrosis, and improve insulin sensitivity. In a 96-week Phase IIb study, 39% of patients with compensated cirrhosis experienced cirrhosis reversal without worsening of disease, versus 15% in the placebo group. The drug is currently in Phase III SYNCHRONY clinical trials for pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4).

Efimosfermin alfa (formerly BOS-580): Boston Pharmaceuticals / GSK
Efimosfermin alfa is a long-acting, once-monthly FGF21 analogue under development for the treatment of MASH. Positive Phase II data showed significant fibrosis improvement (≥1 stage) without worsening of MASH after 24 weeks. In July 2025, GSK completed its acquisition of efimosfermin alfa from Boston Pharmaceuticals. The drug is in Phase II/III development.

VK2809 (TRβ Agonist): Viking Therapeutics
VK2809 is an orally available, tissue- and receptor-subtype-selective thyroid hormone beta receptor agonist with selectivity for liver tissue. In June 2024, Viking Therapeutics reported positive 52-week histologic data from the Phase IIb VOYAGE study of VK2809, achieving primary and secondary endpoints including significant liver fat reductions by Week 12 and histologic improvements via biopsy after 52 weeks.

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MASH Market Outlook
The MASH treatment landscape is rapidly evolving, particularly with the USFDA's accelerated approval of Madrigal's REZDIFFRA, now considered a key therapy for patients with moderate to advanced liver fibrosis. This selective thyroid hormone receptor-beta agonist has shifted the approach from invasive liver biopsies toward non-invasive diagnostic methods, improving patient access to treatment. The landscape is further shaped by a diverse pipeline of therapies targeting various mechanisms, such as FXR agonists, PPAR modulators, and GLP-1 receptor agonists, with clinical trials exploring combination therapies to address the complex nature of the disease.
The management of MASH primarily focuses on lifestyle changes to reduce liver fat and slow disease progression. Currently, REZDIFFRA (resmetirom) is the only US FDA-approved therapy available for MASH, specifically targeting noncirrhotic NASH with moderate to advanced fibrosis. A therapeutic gap remains, as most treatments address underlying causes rather than reversing fibrosis, leaving many patients without effective therapies. The limited availability of antifibrotic options highlights the need for safe, broad-spectrum antifibrotic agents.

MASH Drugs Market
The drug market for MASH predominantly features agents targeting metabolic pathways. REZDIFFRA (resmetirom), as the only approved therapy, is currently the cornerstone of pharmacological management. The emerging pipeline is rich with FGF21 analogs, which aim to reduce hepatic steatosis, inflammation, and fibrosis through multiple complementary mechanisms. Efruxifermin (EFX), currently in Phase III development by Akero Therapeutics, represents one of the most advanced investigational agents and is anticipated to potentially launch by 2027.
Among the emerging pipeline, pegozafermin is the first FGF21 analog to reach Phase III evaluation in MASH patients with compensated cirrhosis (F4), marking a significant milestone for a patient population with limited options. Additionally, semaglutide, a GLP-1 receptor agonist, has shown positive Phase 3 ESSENCE trial results in MASH with stage 2 or stage 3 fibrosis, further broadening the therapeutic landscape.

Explore comprehensive forecasts, competitive intelligence, and future market opportunities in MASH: https://www.delveinsight.com/report-store/mash-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=mpr

MASH Treatment Market
The treatment landscape for MASH has recently begun to evolve with the development of targeted immunotherapies and metabolic agents designed to address the underlying pathophysiology while minimizing adverse reactions. The approval of REZDIFFRA marked a milestone as the first approved pharmacological therapy for MASH liver fibrosis. Drugs including efruxifermin, efimosfermin alfa, VK2809, pegozafermin, and denifanstat are in advanced phases of clinical development. Efruxifermin, in the Phase III SYNCHRONY program, is anticipated to be the next major entrant into the MASH treatment market, potentially by 2027.
The future treatment landscape for MASH is poised for significant transformation, driven by innovative therapies and a deeper understanding of the disease's metabolic mechanisms. As research progresses, the exploration of combination therapies that tackle various disease pathways is expected to enhance treatment efficacy and patient outcomes. The integration of real-world evidence and advanced data analytics will further refine therapeutic strategies, signaling a hopeful era for those affected by MASH.

From market size to emerging drugs - find it all in DelveInsight's latest MASH market report: https://www.delveinsight.com/report-store/mash-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=mpr

Scope of the MASH Market Report
• Coverage: 7MM (US, EU4, UK, Japan)
• Study Period: 2022-2036
• MASH Companies: Madrigal Pharmaceuticals, Akero Therapeutics, Sagimet Biosciences, 89bio, Viking Therapeutics, Boston Pharmaceuticals, NorthSea Therapeutics, and others
• MASH Pipeline Therapies: Efruxifermin (EFX), VK2809, Efimosfermin alfa (BOS-580), Pegozafermin, Denifanstat, Icosabutate, and others
• MASH Therapeutic Assessment: Current Marketed and Emerging Therapies
• MASH Market Dynamics: Market drivers and barriers
• MASH Unmet Needs, KOL Views, Analyst Views, Market Access and Reimbursement

Table of Contents
1. Key Insights
2. Report Introduction
3. MASH Market Overview at a Glance
4. MASH Methodology
5. MASH Executive Summary
6. MASH Background and Overview
7. MASH Treatment and Management
8. MASH Epidemiology and Patient Population
9. MASH Patient Journey
10. Emerging MASH Therapies
11. MASH Market Analysis
12. MASH KOL Views
13. MASH SWOT Analysis
14. MASH Unmet Needs
15. MASH Market Access and Reimbursement
16. Appendix
17. DelveInsight Capabilities
18. Disclaimer

Contact Information
Company Name: DelveInsight Business Research LLP
Contact Person: Mehul Malhotra
Email: mmalhotra@delveinsight.com
Phone: 09650213330
Address: 304 S. Jones Blvd #2432, Las Vegas, NV, United States
Website: https://www.delveinsight.com

About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

This release was published on openPR.