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Metabolic Dysfunction-Associated Steatohepatitis (MASH) Treatment Market Forecast - FDA Approvals, Nanomedicine & Clinical Developments
Metabolic Dysfunction-Associated Steatohepatitis (MASH) Treatment Market
The global Metabolic Dysfunction-Associated Steatohepatitis (MASH) treatment market was valued at US$ 1.67 billion in 2023 and is projected to reach US$ 7.64 billion by 2031, growing at a compound annual growth rate (CAGR) of 21.8% during the forecast period 2024-2031.
Market Overview
Metabolic Dysfunction-Associated Steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH), is an advanced form of metabolic dysfunction-associated steatotic liver disease (MASLD), characterized by liver inflammation and damage due to fat accumulation, often linked to obesity and diabetes. The market includes drugs like Rezdiffra, therapies such as phytic acid-based nanomedicine, and lifestyle interventions like weight management and diabetes control. It serves hospitals, specialty clinics, and homecare settings. The market is driven by the rising prevalence of MASLD, technological advancements, and increasing clinical trials, though high costs and regulatory hurdles pose challenges.
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Market Opportunities
Key opportunities include developing novel therapeutics like nanomedicine and GLP-1 receptor agonists, expanding treatment access in emerging markets, and leveraging AI for drug discovery. Increasing focus on combination therapies and early diagnosis through non-invasive biomarkers also presents significant growth potential.
Key Trends
Emergence of novel drugs like Rezdiffra and pegozafermin for MASH treatment.
Growing adoption of nanomedicine and anti-inflammatory therapies.
Rising focus on lifestyle interventions alongside pharmacological treatments.
Recent Developments
March 2024: The FDA approved Rezdiffra, the first drug for MASH, developed by Madrigal Pharmaceuticals, marking a milestone in treatment options.
May 2024: 89bio initiated the Phase III ENLIGHTEN-Cirrhosis trial for pegozafermin in MASH patients with compensated cirrhosis.
June 2024: Eli Lilly's Phase II SYNERGY-NASH study reported over 50% of patients on tirzepatide achieved MASH resolution without fibrosis worsening.
August 2024: Altimmune's Phase I trial for pemvidutide showed significant reductions in liver fat and inflammation, with Phase 2b IMPACT trial ongoing.
July 2024: Research from Northwestern Polytechnical University highlighted phytic acid-based nanomedicine's potential for MASH therapy due to its antioxidant and anti-inflammatory properties.
Market Dynamics: Drivers
Increasing Prevalence of MASLD
The rising global prevalence of MASLD, affecting 30% of adults worldwide (nih.gov), is a major driver. MASH, found in 63% of MASLD patients undergoing liver biopsy in Asian cohorts, is associated with severe fibrosis and increased liver-related mortality. In the U.S., MASH is a leading cause of liver transplantation, with its burden projected to grow due to rising obesity and diabetes rates, fueling demand for effective treatments.
Market Dynamics: Restraints
High Costs and Regulatory Challenges
High treatment costs, lack of awareness, and stringent regulatory requirements for drug approvals hinder market growth. The complex approval process for novel MASH therapies, requiring extensive clinical trials to demonstrate safety and efficacy, delays market entry and increases development costs, particularly for smaller manufacturers.
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Market Segment Analysis
By Treatment: Drugs Dominate
The drug segment held a 54.3% market share in 2024, driven by the FDA approval of Rezdiffra (March 2024), the first drug for MASH, which achieved MASH resolution and fibrosis improvement in Phase 3 trials. Ongoing trials for drugs like pegozafermin and pemvidutide further bolster this segment's dominance.
By End-User
Hospitals and specialty clinics lead due to their role in advanced diagnostics and treatment, while homecare is growing with the rise of patient-centric care models.
By Region
North America dominates, while Asia-Pacific is the fastest-growing region due to rising obesity rates and healthcare investments.
Geographical Share
North America Holds Significant Share
North America accounted for a 43.2% market share in 2024, driven by high MASLD prevalence, advanced healthcare infrastructure, and significant R&D investments. Key developments, such as Eli Lilly's Phase II SYNERGY-NASH study (June 2024) showing tirzepatide's efficacy and 89bio's Phase III ENLIGHTEN-Cirrhosis trial (May 2024), underscore the region's leadership.
Asia-Pacific Grows Rapidly
Asia-Pacific is the fastest-growing region, driven by increasing obesity, diabetes, and MASLD prevalence, particularly in China and India. Investments in healthcare infrastructure and clinical research support rapid market expansion.
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Major Players
Key companies in the MASH treatment market include:
Madrigal Pharmaceuticals
Simson Pharma Limited
Dr. Reddy's Laboratories Ltd.
Thermo Fisher Scientific Inc.
Biosynth
Affgility Solutions
Conscientia Industrial Co. Ltd.
Smolecule Inc.
89bio Inc.
Sandoo Pharmaceuticals and Chemicals Co. Ltd.
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