MASH Therapeutics Market Size in the 7MM is Expected to Grow Major Growth by 2034, estimates 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
• 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 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
• Forecast Period- 2025-2034
• 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 Contents
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

About Us

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