Metabolic Dysfunction-Associated Steatohepatitis Therapeutics Market Size in the 7MM was ~USD 2114 Million in 2023, is expected to grow by 2034 and estimated DelveInsight

DelveInsight's "Metabolic Dysfunction-Associated Steatohepatitis Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the Metabolic dysfunction-associated steatohepatitis (MASH), historical and forecasted epidemiology as well as the Metabolic dysfunction-associated steatohepatitis (MASH) market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

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Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report
• In January 2025:- Akero Therapeutics Inc.:- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
• In January 2025:- Boehringer Ingelheim- This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function.
• Based on DelveInsight's estimates, the United States had the highest number of diagnosed prevalent cases of MASH in 2023, with a total of ~9.7 million cases. Following the US, EU4 and the UK had ~3.8 million cases, while Japan had ~2.6 million cases.
• The categorization based on gender, showed that diagnosed prevalent cases in males were higher than in females in the 7MM. The male-diagnosed prevalent cases accounted for 56% of the total cases in the 7MM.
• Japan accounted for approximately 16% of the total MASH Diagnosed Prevalent Cases in the 7MM in 2023. These cases are expected to increase in the study period (2020-2034).
• The leading MASH Companies such as Corcept Therapeutics, Aligos Therapeutics, Akero Therapeutics Inc., Regeneron Pharmaceuticals, Merck Sharp & Dohme LLC, 89Bio Inc., and others.
• Promising MASH Therapies such as Efinopegdutide, Efruxifermin, Pegozafermin, ALN-HSD, ALG-055009, Miricorilant, and others.

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Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation in the 7MM
• Metabolic Dysfunction-Associated Steatohepatitis Prevalent Cases
• Metabolic Dysfunction-Associated Steatohepatitis Diagnosed Prevalent Cases
• Metabolic Dysfunction-Associated Steatohepatitis Gender-specific Diagnosed Prevalent Cases
• Metabolic Dysfunction-Associated Steatohepatitis Severity-specific Diagnosed Prevalent Cases

Metabolic Dysfunction-Associated Steatohepatitis Market Insights
MASH is a condition in which fat builds up in liver. It is the most common chronic liver disease, affecting at least a quarter of the global adult population. MASH is the progressive form of MASLD associated with persistent liver cell injury leading to fibrosis and in a subset may progress to cirrhosis and end-stage liver disease.

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Metabolic Dysfunction-Associated Steatohepatitis Treatment Market
MASH treatment market marks a significant milestone in medical advancements, revolutionizing the landscape of MASH treatment. REZDIFFRA has emerged as a breakthrough therapy specifically designed to target the underlying mechanisms of MASH, offering new hope to patients suffering from this debilitating condition. Clinical trials have demonstrated remarkable efficacy in reducing MASH symptoms such as inflammation and fibrosis, while also improving overall liver function and patient quality of life. This approval has provided healthcare providers with a powerful tool to combat MASH disease, filling a critical gap in treatment options and potentially reducing the burden of complications associated with advanced liver disease.

Metabolic Dysfunction-Associated Steatohepatitis Marketed Drugs
• REZDIFFRA (resmetirom): Madrigal Pharmaceuticals
REZDIFFRA is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). The emergence of the inaugural medication for MASH is a true game-changer for healthcare providers, the research community, and, most importantly, patients living with this serious liver condition. Based on the robust efficacy and safety data generated in two large Phase III MAESTRO studies, it is believed that REZDIFFRA will become the foundational therapy for patients with MASH with moderate to advanced liver fibrosis. As well as since now that the FDA has approved REZDIFFRA for MASH, pharmaceutical companies will have a better understanding of the thresholds they must meet to get future approvals.

Metabolic Dysfunction-Associated Steatohepatitis Emerging Drugs

• Pegozafermin: 89bio, Inc
Pegozafermin or BIO89-100 is a compound that specifically targets and activates a receptor known as fibroblast growth factor 21 (FGF21). FGF21 is a hormone involved in regulating glucose and lipid metabolism, and it has been shown to have potential therapeutic effects in MASH.

• Efruxifermin (EFX): Akero Therapeutics, Inc.
Efruxifermin (EFX), is Akero's lead product candidate for MASH. It is a differentiated Fc-FGF21 fusion protein engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is designed to offer convenient once-weekly SC dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treating MASH.

• Belapectin: Galectin Therapeutics
Belapectin a complex carbohydrate drug, targets galectin-3, a critical protein in fatty liver disease and fibrosis pathogenesis. Galectin-3 plays a major role in organ scarring diseases, including the liver, lung, kidney, heart, and vascular systems fibrotic disorders. The drug binds to galectin-3 proteins and disrupts its function.

Metabolic dysfunction-associated Steatohepatitis Market Outlook
Until mid-March, the therapeutic landscape of NASH lacked FDA, EMA, or PMDA-approved medications, relying primarily on lifestyle adjustments like diet and exercise. Supplemental interventions encompassed off-label usage of vitamin E and antidiabetic agents (e.g., pioglitazone, liraglutide) and liver transplantation in case of severe stages. Given NASH's multifaceted pathogenesis, effective treatment demands comprehensive targeting of various cellular and molecular pathways.

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Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report
• Coverage- 7MM
• Metabolic Dysfunction-Associated Steatohepatitis Companies- Corcept Therapeutics, Aligos Therapeutics, Akero Therapeutics Inc., Regeneron Pharmaceuticals, Merck Sharp & Dohme LLC, 89Bio Inc., and others.
• MASH Therapies- Efinopegdutide, Efruxifermin, Pegozafermin, ALN-HSD, ALG-055009, Miricorilant, and others.
• Metabolic Dysfunction-Associated Steatohepatitis Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Metabolic Dysfunction-Associated Steatohepatitis Unmet Needs, KOL's views, Analyst's views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement

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Table of Content
1. Key Insights
2. Report Introduction
3. Country-wise MASH Market Overview at a Glance
4. MASH Market Overview by Therapeutic Class
5. Methodology of MASH Epidemiology and Market
6. Executive Summary
7. Key Events
8. Disease Background and Overview
9. Epidemiology and Patient Population
10. Patient Journey
11. Marketed Drugs
12. Emerging Drugs
13. MASH: Market Analysis
14. Key Opinion Leaders' Views
15. SWOT Analysis
16. Unmet needs
17. Market Access and Reimbursement
18. Appendix
19. Report Methodology
20. DelveInsight Capabilities
21. Disclaimer

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