Metabolic Dysfunction-Associated Steatohepatitis (MASH) Drugs Market to Reach 18.1% CAGR, Driven by Rising NAFLD Prevalence and Breakthrough Therapies

According to DataM Intelligence, the global Metabolic Dysfunction-Associated Steatohepatitis (MASH) drugs market reached US$ 180.1 million in 2024 and is expected to reach US$ 929.05 million by 2033, growing at a CAGR of 18.1% during 2025-2033, driven by increasing prevalence of metabolic dysfunction-associated steatohepatitis (formerly NASH), growing obesity and diabetes epidemics, strong pipeline advancements in FXR agonists, PPAR agonists, and GLP-1-based therapies, regulatory approvals for first-in-class treatments, and rising healthcare investments in liver disease management.

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Key Mergers and Acquisitions
✦ January 2026: Novo Nordisk acquired a clinical-stage biotech specializing in next-generation GLP-1 and FGF21 dual agonists to accelerate its MASH drug pipeline and expand beyond semaglutide-based therapies.
✦ December 2025: Madrigal Pharmaceuticals secured a strategic licensing agreement with a global pharma partner to co-develop and commercialize resmetirom (Rezdiffra) combinations for advanced MASH fibrosis.
✦ November 2025: Inventiva entered into a collaboration and equity investment deal with a major pharmaceutical company to advance lanifibranor Phase III trials and expand its MASH therapeutic portfolio.

Key Industry Developments
☑️ January 2026: Madrigal Pharmaceuticals, Novo Nordisk, and Boehringer Ingelheim announced positive interim Phase III data for resmetirom, semaglutide, and survodutide in MASH resolution and fibrosis improvement, strengthening confidence in upcoming regulatory milestones.
☑️ December 2025: Inventiva and Hepalys Pharma advanced lanifibranor and GLP-1 combination trials, with new partnerships to accelerate patient enrollment in Asia-Pacific and North America for stage 3-4 MASH patients.
☑️ November 2025: Industry leaders including Madrigal and Novo Nordisk expanded real-world evidence programs and post-marketing studies for approved and late-stage MASH therapies, targeting broader reimbursement and adoption in North America.

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Market Segmentation Analysis
By Disease Stage: Stage 4 (advanced fibrosis/cirrhosis) holds the largest revenue share of 45.1% in 2024 due to high unmet need for effective therapies in severe MASH, significant healthcare burden, and focus of late-stage pipelines on fibrosis reversal; Stage 3 (bridging fibrosis) grows rapidly with increasing diagnosis rates and potential for earlier intervention; Stages 1-2 remain emerging with preventive and early-stage treatments gaining traction.

By Medication: GLP-1 receptor agonists (e.g., semaglutide) and FXR agonists (e.g., resmetirom) dominate due to proven efficacy in metabolic improvement and fibrosis reduction; PPAR agonists (e.g., lanifibranor) grow fastest for pan-PPAR activity addressing multiple MASH pathways; Others include FGF21 analogs, thyroid hormone receptor agonists, and combination therapies.
By Route of Administration: Oral medications lead with high patient compliance and convenience; Injectable therapies (GLP-1 agonists) follow closely for superior efficacy in weight loss and metabolic control; Others include emerging subcutaneous and novel delivery systems.

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Competitive Landscape / Key Players
✦ Madrigal Pharmaceuticals, Inc. - In January 2026, presented positive long-term data for resmetirom (Rezdiffra), the first FDA-approved MASH therapy, demonstrating sustained fibrosis improvement and NASH resolution in stage 3-4 patients, with expanded access programs launched in North America.
✦ Novo Nordisk - Advanced semaglutide (Ozempic/Wegovy) Phase III trials in MASH throughout 2025, reporting significant liver fat reduction and fibrosis regression in January 2026, positioning it as a potential blockbuster for metabolic liver disease.
✦ Boehringer Ingelheim - Reported encouraging Phase II results for survodutide (GLP-1/glucagon dual agonist) in late 2025, with plans to initiate Phase III in early 2026 for MASH patients with advanced fibrosis.
✦ Inventiva - Presented positive Phase IIb long-term data for lanifibranor (pan-PPAR agonist) in December 2025, showing robust NASH resolution and fibrosis improvement, and advanced toward Phase III initiation in 2026.
✦ Hepalys Pharma - In November 2025, entered a co-development partnership with a global pharma leader to accelerate clinical trials of its novel MASH candidate targeting inflammatory and fibrotic pathways, with first patient dosing expected in 2026.

Regional Insights
North America dominates the global Metabolic Dysfunction-Associated Steatohepatitis (MASH) drugs market with the largest revenue share of 43.5% in 2024, supported by high prevalence of obesity and NAFLD/MASH, advanced clinical research infrastructure, early regulatory approvals (e.g., resmetirom), strong reimbursement frameworks, and heavy investments by leading biotech and pharma companies in late-stage pipelines.

Asia-Pacific remains the fastest-growing region and is expected to grow at the fastest CAGR of 8.1% over the forecast period, fueled by rapidly rising metabolic syndrome and NAFLD burden in China, India, and Southeast Asia, increasing healthcare expenditure, growing clinical trial activity, government initiatives for liver disease management, and aggressive market entry by global players targeting underserved populations.

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