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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
More than 80% of late-stage pipeline candidates are metabolic and fibrotic-targeted therapies-ranging from -positioning the MASH landscape for unprecedented transformation between 2025 and 2033.
MASH affects an estimated , 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.
By 2030, more than are expected to enter the market, supporting both combination therapy and stage-specific therapy approaches.
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Resmetirom captured early commercial leadership in 2024, accounting for an estimated , 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.
, 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.
, 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 of the entire future market.
, with dual GLP-1/glucagon agonism, is expected to drive rapid fat reduction, potentially capturing meaningful share among obese and diabetic patients.
-high-performing FGF21 analogues-represent some of the most promising agents for resolving inflammation and reducing liver fat.
, 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 market in 2024, driven by diagnostic, monitoring, and supportive care costs.
Stage 2–3 fibrosis patients represented the , contributing more than , or approximately . 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 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 , about , with high unmet need due to limited treatment options and complex comorbidities.
Adult patients constituted of the global MASH treatment market in 2024, contributing roughly , driven by the peak prevalence of metabolic syndrome between ages 35–65.
Geriatric patients accounted for ( USD 1.10 billion ), with rising diagnoses linked to polypharmacy, insulin resistance, and long-standing obesity.
Pediatric MASH, though representing ( 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 .
Male patients represented of the market in 2024 ( USD 4.41 billion ), correlating with higher metabolic risk, visceral fat deposition, and lifestyle-driven comorbidities.
Female patients contributed ( USD 3.46 billion ), with prevalence rising significantly post-menopause due to metabolic changes and hormonal shifts.
The U.S. accounted for , representing . The country has one of the highest obesity and diabetes prevalence rates globally, making MASH a top hepatology priority.
By 2033, the U.S. market alone is expected to exceed .
Japan represented , or , driven by rising metabolic syndrome cases despite a traditionally lower-obesity population.
Japan's MASH market is expected to surpass .
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.
Lead candidate Efruxifermin shows strong MRI-PDFF and fibrosis improvement data, placing Akero at the forefront of FGF21-based therapies.
Pegozafermin demonstrates consistent efficacy across liver fat, inflammation, and fibrosis. The company is rapidly expanding into global Phase 3 programs.
Denifanstat, a potent ACC inhibitor, targets hepatic fat synthesis and is positioned for combination therapy frameworks.
Lanifibranor has shown promising NASH resolution and fibrosis reversal in Phase 3, making it a key competitor in the mid-2020s.
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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Between 2025 and 2033, the MASH treatment ecosystem will experience:
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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