Metabolic Dysfunction-Associated Steatohepatitis: The Global Epidemic Fueling a New Era in Liver Disease Innovation

MASH prevalence nears 500M globally. With the first FDA-approved drug now available, the market is poised for explosive growth through 2032.

AUSTIN, TX, UNITED STATES, June 6, 2025 /EINPresswire.com/ -- Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly recognized as Nonalcoholic Steatohepatitis (NASH), is redefining the global liver disease treatment landscape. Once a largely underrecognized public health threat, MASH is now commanding center stage in pharmaceutical R&D and clinical development pipelines as its global burden soars.

With 350.42 million people estimated to be affected globally in 2024, and projections indicating a rise to 476.10 million by 2030, MASH is not just an emerging concern-it is a healthcare crisis in motion.

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Understanding the Disease: A Closer Look at MASH
MASH is caused by the excessive accumulation of fat in the liver not due to alcohol, leading to hepatic inflammation and potentially irreversible liver damage. As the condition progresses, fibrosis sets in and can advance to cirrhosis (F4 stage), severely impairing liver function and increasing the risk of liver failure and hepatocellular carcinoma (HCC).

Staging of the disease ranges from F0 (no fibrosis) to F4 (cirrhosis), with most patients remaining asymptomatic until significant liver damage has occurred. This silent progression is what makes MASH particularly insidious.

Epidemiology: A Global Health Burden
DataM Intelligence estimates that global MASH cases increased from 333.90 million in 2023 to 350.42 million in 2024. Asia-Pacific is the hardest-hit region, accounting for more than half of the global burden with 190.28 million cases-expected to swell to 256.42 million by 2030.

Despite these staggering figures, diagnosis remains poor. In 2024, only 37.84 million patients were diagnosed, and among those, just 12.71 million were receiving treatment. The disparity between prevalence and treatment reflects both clinical challenges in early detection and a historical void of approved pharmacologic therapies.

Breakthrough Moment: First FDA-Approved Therapy for MASH
Until recently, MASH treatment was limited to lifestyle modifications and management of comorbidities like obesity, type 2 diabetes, and dyslipidemia. That changed with the U.S. FDA approval of Rezdiffra (resmetirom), developed by Madrigal Pharmaceuticals-a first-in-class thyroid hormone receptor-beta (THR-β) agonist approved for adults with noncirrhotic MASH and moderate to advanced liver fibrosis.

Rezdiffra marks a critical milestone. It not only offers patients the first pharmacologic option but also validates MASH as a druggable condition. Its mechanism of action-reducing hepatic fat and inflammation through modulation of lipid metabolism-has demonstrated statistically significant efficacy in reversing fibrosis without worsening other histologic parameters.

Analysts forecast strong uptake in the U.S. market with sales expected to surpass $1.5 billion by 2030, contingent on reimbursement support and global regulatory approvals, particularly in Europe where the drug is currently under review.

Pipeline Momentum: A Wave of Therapeutics on the Horizon
The therapeutic pipeline for MASH is rapidly maturing. Key candidates in late-stage clinical development include:

- Obeticholic Acid (Intercept Pharmaceuticals) – FXR agonist
- Efruxifermin (Akero Therapeutics) – FGF21 analog
- Pegozafermin (89bio) – FGF21 analog with strong Phase II results
- Semaglutide (Novo Nordisk) – GLP-1 receptor agonist with secondary MASH benefits
- Lanifibranor (Inventiva) – Pan-PPAR agonist with promising anti-fibrotic action
- Saroglitazar Magnesium (Zydus Therapeutics) – Dual PPAR α/γ agonist under investigation in India

These candidates are exploring diverse mechanisms including metabolic modulation, anti-inflammatory signaling, and fibrosis reversal. The European Medicines Agency’s recent approval of AIM-NASH, an AI-powered diagnostic platform, also supports faster trial recruitment and outcome assessment, accelerating the pace of innovation.

Market Outlook: MASH Therapeutics on a High-Growth Trajectory
The global MASH therapeutics market, valued at $7.88 billion in 2024, is projected to reach $28.52 billion by 2032, growing at a CAGR of 18.7% during 2025–2032. The growth is fueled by improved diagnostics, expanding patient awareness, favorable regulatory movements, and robust investment in clinical innovation.

This surge offers not only a large addressable market but also opportunity for first-to-market and best-in-class differentiation. As more therapies cross the regulatory finish line, the market will become increasingly competitive.

Current Gaps and Future Needs
Despite the optimism, several challenges remain. The primary unmet needs include:

- Early Diagnosis: Most MASH patients are diagnosed only when symptoms emerge in advanced stages.
- Treatment for Cirrhotic MASH: Rezdiffra is not approved for patients with cirrhosis.
- Combination Therapies: No currently approved treatment regimen targets all three pathways-steatosis, inflammation, and fibrosis-simultaneously.
- Access and Affordability: Payer coverage, especially in emerging markets, will shape access to first- and second-generation MASH therapies.

To address these, stakeholders must advance real-world evidence generation, develop biomarker-guided therapy algorithms, and pursue strategic collaborations for diagnostic outreach.

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Competitive Landscape: Who’s Leading the Race?
Madrigal Pharmaceuticals leads the market with the only approved drug, but several players are fast approaching:

- Novo Nordisk is expected to file for approval of semaglutide for MASH by mid-2025.
- Akero Therapeutics reported a 39% reversal in cirrhosis among Efruxifermin-treated patients in Phase IIb trials.
- Viking Therapeutics is positioning VK2809 as a promising metabolic modulator with favorable safety data.
- Eli Lilly is developing Tirzepatide, a dual GLP-1/GIP agonist, originally approved for diabetes and weight loss, now in MASH trials.
- Pfizer and Gilead Sciences continue evaluating pipeline candidates and potential licensing deals.

Strategic mergers, licensing deals, and multi-pronged combination therapies are expected to characterize the next phase of the market.

Conclusion: A New Chapter in Liver Health
Metabolic Dysfunction-Associated Steatohepatitis is no longer an invisible epidemic. With rising global awareness, robust pipeline momentum, and regulatory breakthroughs like Rezdiffra, MASH is set to become a central focus in hepatology.

For patients, the approval of a targeted therapy is a long-awaited shift from managing symptoms to potentially reversing disease. For the pharmaceutical industry, MASH offers not just a commercial opportunity but a chance to impact millions of lives with transformative innovation.

As we look toward 2030, the challenge will not just be to treat MASH-but to detect it early, personalize therapy, and ensure equitable access globally.

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Kailas Disale
DataM Intelligence 4market Research LLP
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