DelveInsight’s “MASH Treatment Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of MASH, historical and forecasted epidemiology, as well as the MASH market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Discover which therapies are expected to grab the MASH Market Share @ MASH Market Outlook

Key Takeaways from the MASH Market Report

• In June 2025, Akero Therapeutics Inc. announced a study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
• In June 2025, Boehringer Ingelheim conducted a study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function. This study is to find out the effect of survodutide on MASH and liver fibrosis.
• In June 2025, 89bio Inc. organized a study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).
• According to DelveInsight’s estimates, there were ~215 million prevalent cases of MASLD (formerly known as NAFLD) in the 7MM in 2023, including ~30 million prevalent cases of MASH. Of the total MASH cases, ~8 million were diagnosed in the 7MM.
• Among the 7MM, the US had the highest number of MASH Diagnosed Prevalent Cases, with ~4 million cases in 2023, a figure projected to increase by 2034.
• In 2023, EU4 and the UK accounted for ~3 million MASH diagnosed prevalent cases with Germany having the highest at ~780 thousand cases, followed by Italy with ~615 thousand cases. In contrast, Spain had the least, with ~340 thousand cases.
• In 2023, the UK had ~480 thousand MASH Diagnosed Prevalent Cases.
• In 2023, Japan recorded ~670 thousand MASH diagnosed prevalent cases, a number expected to rise by 2034.
• In 2023, the US had the following severity-specific diagnosed prevalent cases of MASH: ~880 thousand cases at the F0 stage, ~1,610 thousand at the F1 stage, ~880 thousand at the F2 stage, ~510 thousand at the F3 stage, and ~340 thousand at the F4 stage.
• The leading MASH Companies such as 89bio, Inc., Akero Therapeutics, Galectin Therapeutics, Viking Therapeutics, Novo Nordisk A/S, Inventiva, and others.
• Promising MASH Pipeline Therapies such as TVB-2640, Survodutide, Miricorilant (Cohort B), Efimosfermin, Pegozafermin, DD01, ALG-055009, and others.

Stay ahead in the MASH Therapeutics Market with DelveInsight’s Strategic Report @ MASH Treatment Market

MASH Epidemiology Segmentation in the 7MM

• Total MASH Prevalent Cases
• Total MASH Prevalent Cases
• Total Diagnosed Prevalent Cases
• MASH Severity-specific Diagnosed Prevalent Cases

Download the report to understand which factors are driving MASH Epidemiology trends @ MASH Prevalence

MASH Marketed Drugs

• REZDIFFRA (resmetirom): Madrigal Pharmaceuticals

REZDIFFRA (resmetirom), a Thyroid Hormone Receptor-beta (THR-ß) agonist, is approved for treating adults with noncirrhotic MASH and moderate to advanced liver fibrosis (F2-F3), in conjunction with diet and exercise. It received accelerated approval due to improvements in MASH and fibrosis. In March 2024, the US FDA approved REZDIFFRA for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3).

MASH Emerging Drugs

• Efruxifermin (EFX): Akero Therapeutics

Efruxifermin (EFX), Akero Therapeutics’ leading candidate for MASH, is an engineered Fc-FGF21 fusion protein mimicking the biological activity of native FGF21. EFX has shown promise in reducing liver fat, inflammation, and fibrosis, while enhancing insulin sensitivity and lipid metabolism. It offers once-weekly dosing and a favorable tolerability profile in clinical trials. Currently, EFX is being evaluated in three Phase III studies, with encouraging results from Phase II trials showing its potential to reverse fibrosis and improve liver function. The Phase III SYNCHRONY study is expected to provide results in 2026.

• VK2809 (TRß Agonist): Viking Therapeutics

VK2809 is an orally available, liver-targeted agonist of the Thyroid Hormone Beta Receptor (TRß), designed to specifically modulate lipid metabolism. By selectively activating TRß in liver tissue, VK2809 aims to improve cholesterol and lipoprotein levels through the upregulation of genes involved in lipid clearance. The compound has shown significant therapeutic potential in lipid disorders, meeting both primary and secondary endpoints in the Phase IIb VOYAGE study for patients with NASH/MASH and fibrosis, as well as in a Phase IIa study for patients with elevated LDL-C and MASLD.

• Efimosfermin alfa (formerly BOS-580): Boston Pharmaceuticals

Efimosfermin alfa (BOS-580), developed by Boston Pharmaceuticals, is a long-acting variant of FGF21 designed to regulate metabolic pathways, reducing liver fat, inflammation, and fibrosis in MASH patients. Manufactured in mammalian cells for human-like glycosylation, it is administered as a once-monthly subcutaneous injection. BOS-580 is currently undergoing Phase II trials for MASH treatment. In September 2020, Boston Pharmaceuticals licensed the genetically engineered FGF21 variant from Novartis, positioning it as a potential best-in-class treatment for MASH.

To learn more about MASH Treatment guidelines, visit @ MASH Clinical Trials Assessment

MASH Companies

89bio, Inc., Akero Therapeutics, Galectin Therapeutics, Viking Therapeutics, Novo Nordisk A/S, Inventiva, and others.

MASH Drugs Market Insights

Efruxifermin (EFX) is an investigational Fc-FGF21 fusion protein developed by Akero Therapeutics for the treatment of MASH. Designed to mimic the biological activity of FGF21, EFX aims to address key drivers of MASH by reducing liver fat and inflammation, reversing fibrosis, and improving insulin sensitivity and lipid metabolism. In a 96-week Phase IIb study, 39% of patients with compensated cirrhosis due to MASH experienced a reversal of cirrhosis without worsening of the disease, compared to 15% in the placebo group. These promising results have led to the initiation of the Phase III SYNCHRONY clinical program, which includes trials evaluating EFX in patients with pre-cirrhotic MASH (F2-F3 fibrosis) and those with compensated cirrhosis (F4) due to MASH.

MASH Treatment Market

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 to 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. As researchers focus on personalized medicine and better patient stratification, the priority remains refining treatment strategies while navigating challenges in trial recruitment and regulatory requirements. The combination of emerging therapies and existing lifestyle interventions continues to influence clinical practice in managing MASH/NASH.

Learn more about the FDA-approved drugs for MASH @ Drugs for MASH Treatment

Scope of the MASH Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• MASH Companies- 89bio, Inc., Akero Therapeutics, Galectin Therapeutics, Viking Therapeutics, Novo Nordisk A/S, Inventiva, and others.
• MASH Pipeline Therapies- TVB-2640, Survodutide, Miricorilant (Cohort B), Efimosfermin, Pegozafermin, DD01, ALG-055009, and others.
• MASH Market Dynamics: MASH Market Drivers and Barriers
• MASH Market Access and Reimbursement, Unmet Needs and Future Perspectives

Table of Contents

1. Key Insights

2. MASH Market Report Introduction

3. MASH Market Overview at a Glance

4. Methodology of Epidemiology and Market

5. Executive Summary

6. Key Events

7. Disease Background and Overview

8. MASH Epidemiology and Patient Population

9. Patient Journey

10. MASH Marketed Drugs

11. MASH Emerging Drugs

12. MASH – 7MM Market Analysis

13. Key Opinion Leaders’ Views

14. MASH Unmet Needs

15. MASH SWOT Analysis

16. MASH Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

About Us

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