Overview of the North America MASH Treatment Market

The North America Metabolic Dysfunction-Associated Steatohepatitis Treatment Market is experiencing unprecedented growth, primarily fueled by rising rates of obesity, diabetes, and metabolic syndrome, which are major risk factors for MASH, formerly known as NASH (Nonalcoholic Steatohepatitis). As of 2024, the market reached a value of US$3.70 billion and is projected to expand to around US$17.15 billion by 2033, registering a remarkable CAGR of 19.3% over the forecast period.

MASH is characterized by fat accumulation and inflammation in the liver, leading over time to fibrosis and, in severe cases, cirrhosis, liver failure, and even cancer. With obesity and diabetes rates rising steadily in North America, the population at risk and, therefore, potential demand for effective therapies continues to grow rapidly. At present, therapeutic options for MASH remain limited, but 2024 was a pivotal year with the FDA’s accelerated approval of the first drug Rezdiffra (resmetirom) by Madrigal Pharmaceuticals for noncirrhotic MASH with moderate to advanced liver fibrosis. This has heightened industry focus on clinical development and innovation in this space, making North America not just the largest but also the most dynamic market worldwide.

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Market Segmentation

By Stage (Stage 4, Stage 2-3, Stage 0-1)
By Age Group (Geriatrics, Adults, Pediatrics)
By Gender (Male, Female)

Regional Market Share

The North America Metabolic Dysfunction-Associated Steatohepatitis (MASH) treatment market holds a dominant position globally, accounting for the majority share of the overall market revenue. The United States leads the region with the largest market share, driven by its advanced healthcare infrastructure, high prevalence of metabolic disorders such as obesity and diabetes, and strong focus on research and development in MASH therapeutics. The presence of major pharmaceutical companies actively developing and commercializing novel treatments, such as resmetirom, further cements the U.S.'s leading role. Robust government support, favorable reimbursement policies, and extensive clinical trial activities also contribute to accelerated adoption of innovative MASH therapies across hospitals, specialty clinics, and outpatient care centers.

Canada represents a growing secondary market within North America, registering increasing shares due to rising awareness, improved diagnostic capabilities, and expanding healthcare programs targeting metabolic and liver diseases. While smaller in absolute terms relative to the U.S., the Canadian market benefits from growing patient advocacy and government-driven initiatives to support early diagnosis and treatment access. Together, the U.S. and Canada drive the regional momentum, enabling North America to maintain its position at the forefront of global MASH treatment advancements and market growth.

Market Drivers

• Rising Prevalence of Obesity and Diabetes: Around 38 million North Americans have diabetes, while adult obesity rates surpass 40%.
• FDA Approval of Resmetirom (Rezdiffra): First-ever approved drug for MASH, representing a major milestone and setting a precedent for further approvals.
• Robust Biopharma Innovation: Numerous drugs in Phase II/III trials; Madrigal Pharmaceuticals, Novo Nordisk, 89bio, Akero Therapeutics, Sagimet Biosciences, and Inventiva are active in this space.
• Healthcare Infrastructure and Access: North America’s robust facilities, insurance, and regulatory environment support rapid adoption and higher diagnosis rates.
• Expanding Screening and Early Diagnosis Programs: Improved imaging, biomarkers, and AI-driven diagnostics increase detection of at-risk patients.

Recent Developments

Eli Lilly’s tirzepatide mid-stage study: Achieved MASH resolution without progression of fibrosis in over 50% of patients.

89bio’s Phase III ENLIGHTEN-Cirrhosis trial: Focused on pegozafermin for compensated cirrhosis associated with MASH, targeting improved outcomes in advanced patients.

Key Players

The North America MASH treatment market features a blend of pharmaceutical leaders and biotechnology innovators:

• Madrigal Pharmaceuticals: Market leader with first-to-market resmetirom, an oral thyroid hormone receptor beta agonist for MASH with liver fibrosis.
• Novo Nordisk: Developing semaglutide (GLP-1) and other metabolic agents for MASH and diabetes overlap.
• Boehringer Ingelheim: SGLT2-based therapies in pipeline.
• Eli Lilly: Advanced clinical programs including tirzepatide showing promise for MASH resolution.
• 89bio: Conducting Phase III trial of pegozafermin for MASH with compensated cirrhosis.
• Inventiva: Focused on pan-PPAR agonists for broader liver benefit.
• Sagimet Biosciences, Akero Therapeutics, and others: Targeting metabolic pathways and fibrosis resolution via novel molecules.
• Emerging contributors include Intercept Pharmaceuticals, Gilead Sciences, and Metacrine.

Outlook and Conclusion

The North America metabolic dysfunction-associated steatohepatitis (MASH) treatment market is set for rapid growth over the next decade, propelled by surging obesity and diabetes, biopharma innovation, regulatory momentum, and robust healthcare infrastructure. With FDA approval of resmetirom heralding a new era in clinical care, multi-modality treatment approaches incorporating lifestyle, drug, and device-based interventions are likely to become standard practice. Hospitals and specialty clinics are leading uptake, while retail and online pharmacies expand access as more oral drugs enter the market. Key industry leaders—including Madrigal, Novo Nordisk, Lilly, and 89bio are shaping a competitive landscape rich with clinical pipeline activity and investment.

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