NASH/MASH Treatment Market to Surpass USD 31.76 Billion by 2033 as First-in-Class Drugs Redefine Fatty Liver Disease Management | According to DataM Intelligence
AUSTIN, Texas and TOKYO, Nov. 20, 2025 /PRNewswire/ -- According to DataM Intelligence, the NASH/MASH Treatment Market Size was valued at USD 7.87 billion in 2024 and is projected to reach USD 31.76 billion by 2033, expanding at a robust 17.7% CAGR from 2025 to 2033. Fueled by rising obesity, metabolic syndrome, type 2 diabetes, and aging demographics, Metabolic Dysfunction–Associated Steatohepatitis (MASH)-formerly known as NASH-has rapidly emerged as one of the most pressing global health burdens.
The approval of the first dedicated NASH treatment, Resmetirom (Rezdiffra) in 2024, marked a historic turning point for the industry. As the first therapy targeting MASH with histological improvement and fibrosis reduction, Resmetirom has catalyzed pharmaceutical competition, accelerated pipeline investments, and reshaped the commercial landscape. Following this approval, the approved drug segment alone reached USD 178.31 million in 2024 and is expected to surge to USD 16.82 billion by 2033, growing at an extraordinary 57.05% CAGR, making it one of the fastest-growing drug categories globally.
More than 80% of late-stage pipeline candidates are metabolic and fibrotic-targeted therapies-ranging from GLP-1 agonists, FGF21 analogues, PPAR agonists, THR-β agonists, ACC inhibitors, and dual agonists-positioning the MASH landscape for unprecedented transformation between 2025 and 2033.
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Market Dynamics: Historic Drug Approvals Trigger Large-Scale Commercial Upside
MASH affects an estimated 1 in 5 adults globally, with prevalence highest in the U.S., the Middle East, China, and parts of Europe. Despite a high disease burden, the market was historically hindered by the absence of approved treatments. This changed dramatically in 2024, when Madrigal Pharmaceuticals received landmark approval for Resmetirom.
Key Growth Drivers Include:
- Increasing global obesity prevalence (projected to reach >1.9 billion people by 2030)
- Rising type 2 diabetes population (expected to hit 643 million patients by 2030)
- Improved non-invasive diagnostics (FibroScan, MRI-PDFF, blood biomarkers)
- Strong physician demand for therapies that reverse steatohepatitis & fibrosis
- Vigorous biopharmaceutical investment into metabolic diseases
- Accelerated regulatory pathways for high-burden diseases
By 2030, more than 8–10 drug classes are expected to enter the market, supporting both combination therapy and stage-specific therapy approaches.
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Market Segmentation Analysis
By Drug (Resmetirom, Lanifibranor, Semaglutide, Survodutide, Pegozafermin, Efruxifermin, Denifanstat, Others)
Resmetirom captured early commercial leadership in 2024, accounting for an estimated USD 178.31 million, making up the entirety of the approved drug market. The therapy is expected to dominate early adoption through 2027 before facing strong competitive pressure from metabolic-targeting agents.
Lanifibranor, a first-in-class pan-PPAR agonist, is positioned to be one of the major fibrosis-targeting therapies expected to compete closely with Resmetirom by 2027–2028. It is projected to capture early demand from Stage 2–3 fibrosis patients.
Semaglutide, already a global blockbuster in obesity and diabetes, is anticipated to become one of the highest-revenue metabolic drugs in MASH due to overlapping patient populations. GLP-1 agonists hold an estimated 35% commercial potential of the entire future market.
Survodutide, with dual GLP-1/glucagon agonism, is expected to drive rapid fat reduction, potentially capturing meaningful share among obese and diabetic patients.
Pegozafermin and Efruxifermin-high-performing FGF21 analogues-represent some of the most promising agents for resolving inflammation and reducing liver fat.
Denifanstat, an ACC inhibitor, is being evaluated for reducing hepatic fat synthesis, making it a competitive candidate for combination regimens.
Pipeline and emerging therapies collectively accounted for the majority of the USD 7.87 billion market in 2024, driven by diagnostic, monitoring, and supportive care costs.
By Stage (Stage 0-1, Stage 2-3, Stage 4)
Stage 2–3 fibrosis patients represented the largest share of the MASH treatment market in 2024, contributing more than 52%, or approximately USD 4.09 billion. This group is the primary target population for clinical trials and commercial therapy rollout, given that fibrosis reversal has demonstrated the strongest impact on long-term outcomes.
Stage 0–1 accounted for roughly 28% of the market (USD 2.20 billion), driven by growing screening volumes, non-invasive imaging, and metabolic therapy use.
Stage 4 patients, including compensated cirrhosis, represented 20% of the total market, about USD 1.58 billion, with high unmet need due to limited treatment options and complex comorbidities.
By Age-Group (Pediatrics, Adults, Geriatrics)
Adult patients constituted nearly 83% of the global MASH treatment market in 2024, contributing roughly USD 6.53 billion, driven by the peak prevalence of metabolic syndrome between ages 35–65.
Geriatric patients accounted for 14% (USD 1.10 billion), with rising diagnoses linked to polypharmacy, insulin resistance, and long-standing obesity.
Pediatric MASH, though representing 3% (USD 236 million), is expected to grow fastest due to the alarming rise in childhood obesity, which has tripled over the past two decades across North America and Europe.
By Gender (Male, Female)
Male patients represented 56% of the market in 2024 (USD 4.41 billion), correlating with higher metabolic risk, visceral fat deposition, and lifestyle-driven comorbidities.
Female patients contributed 44% (USD 3.46 billion), with prevalence rising significantly post-menopause due to metabolic changes and hormonal shifts.
U.S. and Japan Market Insights: Two Epicenters of MASH Disease Burden
United States
The U.S. accounted for 42% of the global MASH treatment market in 2024, representing USD 3.30 billion. The country has one of the highest obesity and diabetes prevalence rates globally, making MASH a top hepatology priority.
Key Factors:
- Over 25 million Americans are estimated to have some stage of MASH.
- Resmetirom prescriptions increased by >12% month-over-month since launch.
- More than 160 clinical trial sites across the U.S. are evaluating emerging NASH therapeutics.
By 2033, the U.S. market alone is expected to exceed USD 13 billion.
Japan
Japan represented 9% of the market in 2024, or USD 708 million, driven by rising metabolic syndrome cases despite a traditionally lower-obesity population.
Key Factors:
- Japan recorded a 6.2% year-over-year rise in metabolic fatty liver diagnoses.
- Hospitals have increased FibroScan utilization by 22%, boosting detection rates.
- Japanese regulatory agencies are fast-tracking GLP-1–based NASH therapies due to overlapping diabetes benefits.
Japan's MASH market is expected to surpass USD 3.1 billion by 2033.
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Competitive Landscape: Key Players Reshaping the MASH Treatment Ecosystem
The competitive landscape is shifting rapidly with the emergence of metabolic and fibrosis-targeted therapies. Madrigal Pharmaceuticals currently leads the approved market with Resmetirom but faces significant competition from global metabolic drug innovators.
Top Industry Players Include:
- Madrigal Pharmaceuticals (current market leader)
- Novo Nordisk A/S (GLP-1 dominance: semaglutide, survodutide collaboration)
- Boehringer Ingelheim (dual agonist research pipeline)
- 89bio, Inc. (Pegozafermin – strong late-stage FGF21 profile)
- Inventiva (Lanifibranor PPAR agonist)
- CHIA TAI TIANQING
- Sagimet Biosciences (Denifanstat)
- Akero Therapeutics (Efruxifermin – FGF21 class leader)
Top 5 Emerging Companies to Watch (High-Growth Innovators)
1. Akero Therapeutics (USA)
Lead candidate Efruxifermin shows strong MRI-PDFF and fibrosis improvement data, placing Akero at the forefront of FGF21-based therapies.
2. 89bio, Inc. (USA)
Pegozafermin demonstrates consistent efficacy across liver fat, inflammation, and fibrosis. The company is rapidly expanding into global Phase 3 programs.
3. Sagimet Biosciences (USA)
Denifanstat, a potent ACC inhibitor, targets hepatic fat synthesis and is positioned for combination therapy frameworks.
4. Inventiva (France)
Lanifibranor has shown promising NASH resolution and fibrosis reversal in Phase 3, making it a key competitor in the mid-2020s.
5. Boehringer Ingelheim (Europe)
With a strong metabolic drug development platform and partnerships in GLP-1/glucagon dual agonists, BI is emerging as a global metabolic powerhouse.
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Strategic Outlook: The MASH Era Will Redefine the Metabolic Pharmaceutical Market
Between 2025 and 2033, the MASH treatment ecosystem will experience:
- Rapid expansion of multi-drug combination therapies
- Massive commercial demand in the U.S., Japan, China & Middle East
- Up to 6–8 new drug approvals across metabolic and fibrotic pathways
- Intensified competition among GLP-1 and FGF21 class innovators
- Rising adoption of non-invasive diagnostics enabling earlier treatment
- Pharmaceutical investment exceeding USD 30+ billion in late-stage R&D
By 2033, MASH will represent one of the largest non-oncology drug markets globally, reshaping the treatment paradigm for metabolic disease.
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