United States Metabolic Dysfunction-Associated Steatohepatitis (MASH) Drugs Market to Reach $278.71 Million by 2033 | Exclusive report by DataM Intelligence

Leander, Texas and Tokyo, Japan - Dec.10.2025
As per DataM intelligence research report" The global metabolic dysfunction-associated steatohepatitis (MASH) market size reached US$ 180.1 million in 2024 is expected to reach US$ 929.05 million by 2033, growing at a CAGR of 18.1% during the forecast period 2025-2033." Breakthrough therapies and increasing disease awareness are driving momentum in MASH drug development.

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United States: Recent Industry Developments

✅ In November 2025, Madrigal Pharmaceuticals announced expanded insurance coverage for Rezdiffra (resmetirom) The policy change improves patient access to the first approved therapy for MASH with fibrosis It marks a significant commercial milestone for the MASH treatment landscape in the U.S.

✅ In October 2025, Eli Lilly presented Phase 3 data for Tirzepatide showing fibrosis reversal in MASH patients The results position the GLP-1/GIP agonist as a potent competitor in the liver disease space It highlights the potential for weight-loss drugs to treat downstream metabolic organ damage

✅ In September 2025, Akero Therapeutics initiated a global Phase 3 trial for its FGF21 analog in cirrhotic MASH The trial targets the most advanced and difficult-to-treat stage of the disease It addresses the high unmet need for patients at risk of liver failure

✅ In August 2025, The FDA released draft guidance on non-invasive biomarkers for MASH clinical trials The guidance encourages the use of imaging and blood tests over painful liver biopsies It aims to accelerate drug development and patient recruitment in the U.S.

Japan: Recent Industry Developments

✅ In December 2025, Takeda Pharmaceutical partnered with a U.S. biotech to co-develop an RNAi therapy for MASH The collaboration focuses on silencing a gene associated with lipid accumulation in the liver It brings cutting-edge genetic medicine to the Japanese hepatology field

✅ In November 2025, Shionogi received PMDA orphan designation for a novel MASH drug targeting inflammation The designation expedites the review process for this specific mechanism of action It signals regulatory support for diverse therapeutic approaches in Japan

✅ In October 2025, Mitsubishi Tanabe Pharma published results on a combination therapy for MASH and diabetes The study showed that controlling blood sugar alone is insufficient for reversing fibrosis It guides Japanese clinicians toward multi-modal treatment strategies

✅ In September 2025, A Japanese university hospital validated a new ultrasound elastography AI for MASH screening The tool allows for mass screening of fatty liver disease in primary care clinics It improves the early detection rate of MASH in the Japanese population

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Drugs Market: Drivers
The market for MASH drugs is advancing as metabolic dysfunction-associated steatohepatitis emerges as a significant unmet medical need linked to obesity, diabetes, and cardiovascular risk. Novel therapeutics targeting inflammation, fibrosis, and lipid metabolism are under development, including FXR agonists, PPAR modulators, and anti-fibrotic agents. Clinical trials focus on reducing liver fat accumulation, preventing progression to cirrhosis, and improving long-term outcomes. Personalized medicine approaches and biomarker-driven therapy selection enhance treatment precision.

Pharmaceutical companies are investing heavily in pipeline development and combination therapies, while regulatory frameworks adapt to accelerated approval pathways. Rising prevalence of metabolic syndrome globally, coupled with limited approved treatments, drives urgency in MASH drug innovation. Advances in non-invasive diagnostic tools and real-world evidence studies support early intervention and monitoring. With growing awareness and scientific progress, the MASH drug market is poised for significant growth in the coming years.

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Metabolic Dysfunction-Associated Steatohepatitis (MASH) Drugs Market: Major Players
Madrigal Pharmaceuticals, Novo Nordisk, Boehringer Ingelheim, Inventiva, and Hepalys Pharma, all investing heavily in next-generation MASH therapies targeting metabolic, inflammatory, and fibrotic pathways.

Segment Covered in the Metabolic Dysfunction-Associated Steatohepatitis (MASH) Drugs Market:
By Drug Class
The market is segmented into insulin sensitizers 30%, lipid-lowering agents 25%, anti-fibrotic drugs 20%, antioxidants 15%, and others 10%. Insulin sensitizers dominate due to their efficacy in improving metabolic function and reducing liver fat accumulation. Lipid-lowering agents grow steadily with increasing prevalence of dyslipidemia and cardiovascular comorbidities. Anti-fibrotic and antioxidant drugs see rising adoption in clinical trials and specialty care. Innovation in combination therapies supports market expansion.

By Mechanism of Action
Mechanisms include PPAR agonists 35%, FXR agonists 25%, GLP-1 receptor agonists 20%, and others 20%. PPAR agonists dominate due to proven efficacy in reducing liver inflammation and fibrosis. FXR agonists and GLP-1 receptor agonists grow with strong clinical trial pipelines targeting metabolic and liver function improvements. Advancements in targeted therapy and precision medicine enhance adoption and patient outcomes.

By Route of Administration
Routes include oral 70%, injectable 25%, and others 5%. Oral administration dominates due to patient convenience, adherence, and chronic treatment suitability. Injectable drugs grow with adoption of GLP-1 receptor agonists and other advanced biologics. Development of patient-friendly formulations and novel delivery systems supports market growth.

By End-User
End-users include hospitals 50%, specialty clinics 30%, and research institutions 20%. Hospitals dominate due to large patient volumes and integrated treatment programs. Specialty clinics grow with focus on metabolic disorders and liver care. Research institutions contribute through clinical trials and early adoption of emerging therapies. Increasing awareness of MASH and availability of advanced therapeutics drive adoption.

Regional Analysis
North America - 40% Share
North America leads with 40% share due to high prevalence of obesity, diabetes, and metabolic disorders. Oral PPAR agonists and GLP-1 receptor agonists dominate. Hospitals and specialty clinics drive patient access. Strong clinical research, regulatory support, and pharmaceutical innovation support market expansion.

Europe - 25% Share
Europe holds 25% share driven by rising incidence of fatty liver disease and growing adoption of novel therapies. FXR and PPAR agonists are widely used. Hospitals and specialty liver clinics dominate. Government health programs and reimbursement frameworks support growth.

Asia Pacific - 20% Share
Asia Pacific accounts for 20% share with increasing prevalence of obesity, type 2 diabetes, and metabolic syndromes in Japan, China, India, and South Korea. Oral therapies dominate. Specialty clinics and hospitals are primary end-users. Rising awareness, healthcare infrastructure expansion, and clinical research support market growth.

Latin America - 10% Share
Latin America records 10% share with moderate adoption in Brazil, Mexico, and Argentina. Oral PPAR agonists lead treatment. Hospitals and clinics are key distribution points. Increasing metabolic disorder awareness and evolving healthcare infrastructure support growth.

Middle East and Africa - 5% Share
MEA holds 5% share with gradual growth in UAE, Saudi Arabia, and South Africa. Oral and injectable therapies see moderate adoption. Hospitals and specialty clinics dominate. Investments in healthcare facilities and metabolic disease management programs drive market penetration.

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