MASH Market Forecast 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Statistics, Revenue, Patient Pool, MOA, ROA and Companies by DelveInsight

MASH Companies are Hepion Pharmaceuticals, Ionis Pharmaceuticals, Galectin Therapeutics, Novo Nordisk A/S, Cirius Therapeutics, HighTide Biopharma, Boehringer Ingelheim, Hepagene, Eli Lilly and Company, Pfizer, Lipocine, Corcept Therapeutics, Poxel SA, Enyo Pharmaceuticals, Akero Therapeutics, Zydus Therapeutics, 89bio, Viking Therapeutics, Boston Pharmaceuticals, Gilead Sciences, Merck & Co., Zealand Pharma, Hanmi Pharmaceutical, Inventiva Pharma, CytoDyn, Sagimet Biosciences, and others.
Metabolic dysfunction-associated Steatohepatitis Market Summary

According to DelveInsight, the MASH (Metabolic dysfunction-associated steatohepatitis) market across the 7MM (US, EU4, UK, Japan) was valued at approximately USD 1.8 billion in 2023 and is expected to grow at a robust CAGR of 24% from 2025 to 2034. In 2023, there were about 8 million diagnosed prevalent cases, with the US accounting for 55%, EU4 and the UK for 36%, and Japan for 9%. Market growth is fueled by rising prevalence driven by obesity, sedentary lifestyles, aging populations, and better disease awareness and diagnostics. Pipeline therapies like efruxifermin (EFX), VK2809, efimosfermin alfa, icosabutate, denifanstat, and pegozafermin are set to transform treatment. Currently, management focuses on lifestyle modifications, with REZDIFFRA (Resmetirom) being the only FDA-approved drug, specifically for noncirrhotic NASH with moderate to advanced fibrosis. Despite advancements, a therapeutic gap remains due to limited antifibrotic treatments that directly reverse fibrosis. Efruxifermin, now in Phase III trials, is anticipated to launch by 2027. Notably, Akero Therapeutics completed enrollment for the Phase III SYNCHRONY Real-World study of EFX in January 2025, with results expected in early 2026, which could further shape the future treatment landscape of MASH.

(Albany, USA) DelveInsight's Metabolic Dysfunction-Associated Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, MASH emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

The MASH market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted MASH market size from 2020 to 2034, segmented by seven major markets. The Report also covers current MASH treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the MASH market.

Explore DelveInsight's latest analysis on market trends, pipeline therapies, and future projections across the 7MM. Download the full MASH Market Report now and uncover key insights driving growth through 2034. @ @ Metabolic Dysfunction-Associated Steatohepatitis Treatment Market [https://www.delveinsight.com/sample-request/metabolic-dysfunction-associated-steatohepatitis-mash-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report

* The total MASH market size in the 7MM was approximately USD 2,114 million in 2023 and is projected to increase during the forecast period (2024-2034).

* In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM.
* Leading MASH companies such as Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, and others are developing novel MASH drugs that can be available in the MASH market in the coming years.
* The promising MASH therapies in the pipeline include Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others.
* In May 2025, Novo Nordisk revealed plans to showcase new findings from its metabolic and cardiovascular portfolio at the 32nd European Congress on Obesity (ECO), scheduled for May 11-14, 2025. Highlights will include real-world evidence on semaglutide, further analyses from the SELECT cardiovascular outcomes trial, and results from part 1 of the phase 3 ESSENCE trial targeting metabolic dysfunction-associated steatohepatitis (MASH).

* In May 2025, Roche introduced the Elecsys Registered PRO-C3 test, a novel diagnostic tool aimed at evaluating liver fibrosis severity in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Developed in partnership with Nordic Bioscience, this test offers healthcare providers a straightforward and effective method to detect varying degrees of liver fibrosis, supporting prompt intervention and disease management.
* In January 2025, Akero Therapeutics completed enrolment for the double-blind portion of the Phase III SYNCHRONY Real-World study evaluating EFX in patients with MASH or MASLD (F1-F4). Results from the study are expected in the first half of 2026.
* On November 1, 2024, Novo Nordisk reported encouraging outcomes for semaglutide in the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Results from the Phase 3 Essence trial demonstrated that a once-weekly 2.4 mg dose of semaglutide led to improvements in liver fibrosis and resolution of steatohepatitis, without worsening existing fibrosis, in patients with stage 2 or stage 3 fibrosis-successfully achieving the primary endpoints.

* On October 29, 2024, Sagimet Biosciences (SGMT) announced the successful completion of end-of-Phase 2 discussions with the FDA, clearing the path for denifanstat to progress into Phase 3 trials targeting MASH.
* In March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-Ss agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2-F3 fibrosis.

Discover which therapies are expected to grab the major MASH market share @ [https://www.delveinsight.com/report-store/metabolic-dysfunction-associated-steatohepatitis-mash-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Metabolic Dysfunction-Associated Steatohepatitis Overview

Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease that stems from metabolic dysfunction, often linked to obesity, diabetes, and other conditions of metabolic syndrome. MASH is characterized by the accumulation of fat in liver cells, accompanied by inflammation and liver cell injury, which can progress to fibrosis, cirrhosis, or even liver cancer.

The primary drivers of MASH include insulin resistance, obesity, type 2 diabetes, and dyslipidemia. Genetic predisposition and a sedentary lifestyle also play significant roles. Environmental factors, such as a poor diet high in sugars and fats, exacerbate the condition.

MASH is often asymptomatic in its early stages. When MASH symptoms occur, they can include fatigue, vague abdominal discomfort, or pain in the upper right quadrant. In advanced stages, signs of liver dysfunction such as jaundice, swelling of the abdomen or legs, and confusion may arise.

MASH Diagnosis involves a combination of clinical history, physical examination, and diagnostic tests. Blood tests measuring liver enzymes (ALT, AST) often indicate liver inflammation. Imaging techniques like ultrasound, MRI, or FibroScan can identify liver fat and fibrosis. In some cases, a liver biopsy is required to confirm the diagnosis and assess disease severity.

Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation

The MASH epidemiology section provides insights into the historical and current MASH patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.

The MASH market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

* Prevalent Cases of MASH
* Diagnosed Prevalent Cases of MASH
* Gender-specific Diagnosed Prevalent Cases of MASH
* Severity-specific Diagnosed Prevalent Cases of MASH

MASH Treatment Market

The approval of REZDIFFRA (resmetirom) in March 2024 represents a pivotal achievement in medical innovation, transforming the treatment landscape for MASH disease. This groundbreaking therapy addresses the root causes of MASH, offering renewed hope to patients grappling with this challenging condition. Clinical trials have shown impressive results, with REZDIFFRA effectively reducing symptoms like inflammation and fibrosis, enhancing liver function, and improving patients' quality of life. By providing healthcare professionals with a robust treatment option, this approval addresses a critical unmet need and has the potential to significantly alleviate the complications linked to advanced liver disease.

The prevalence of MASLD is strongly linked to type 2 diabetes mellitus and obesity, particularly in individuals with a higher body mass index. However, MASLD occurrence is reduced in T2DM patients receiving treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor agonists, and insulin. Vitamin E, with its antioxidant properties, is regarded as a first-line pharmacological option for managing MASH, especially when dietary and lifestyle interventions are insufficient.

To know more about MASH treatment guidelines, visit @ [https://www.delveinsight.com/sample-request/metabolic-dysfunction-associated-steatohepatitis-mash-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapies and Key Companies

* Lanifibranor (IVA337): Inventiva Pharma
* Semaglutide: Novo Nordisk A/S
* Azemiglitazone (MSDC-0602K): Cirius Therapeutics
* Efruxifermin (EFX): Akero Therapeutics
* BIO89-100 (Pegozafermin): 89bio
* Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma
* GR-MD-02 (Belapectin): Galectin Therapeutics
* LPCN1144: Lipocine
* VK2809: Viking Therapeutics
* Tirzepatide: Eli Lilly and Company
* BOS-580: Boston Pharmaceuticals
* Ervogastat (PF-06865571) + Clesacostat (PF-05221304): Pfizer
* HTD1801: HighTide Biopharma
* Leronlimab (PRO 140): CytoDyn
* Efinopegdutide: Merck & Co./Hanmi Pharmaceutical
* HPG1860: Hepagene (Shanghai)
* Rencofilstat (CRV431): Hepion Pharmaceuticals
* EYP001 (Vonafexor): Enyo Pharmaceuticals
* Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences
* PXL065: Poxel SA
* Saroglitazar Magnesium: Zydus Therapeutics
* Denifanstat (TVB-2640): Sagimet Biosciences
* ION224: Ionis Pharmaceuticals
* Miricorilant (CORT118335): Corcept Therapeutics

Discover more about MASH drugs in development @ [https://www.delveinsight.com/sample-request/metabolic-dysfunction-associated-steatohepatitis-mash-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

MASH Market Dynamics

The MASH market dynamics are expected to change in the coming years. Growing research activities and multiple clinical trials for MASH, driven by the rapid surge in its prevalence due to rising obesity and type 2 diabetes rates, highlight an active drug development pipeline and an expanding market size. The large pool of patients and lucrative growth opportunities present attractive prospects for key players, further supported by ongoing preclinical studies aimed at advancing imaging techniques for MASH diagnosis, potentially eliminating the need for invasive biopsy-based histopathological confirmation.

Furthermore, potential therapies are being investigated for the treatment of MASH, and it is safe to predict that the treatment space will significantly impact the MASH market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the MASH market in the 7MM.

However, several factors may impede the growth of the MASH market. Lack of awareness and negligence in the early stages of MASH by physicians often lead to disease progression, culminating in irreversible damage where liver transplantation becomes the only viable option. Diagnosing advanced MASH typically requires procedures like liver biopsy, which are costly, invasive, and risky. Regulatory challenges also pose hurdles, as the FDA mandates achieving one MASH endpoint for approval, while the EMA's draft guidance requires efficacy in both endpoints, potentially delaying first-mover approvals in major European markets. Additionally, access to expensive MASH treatments may be limited in certain regions, further hindering patient adoption.

Moreover, MASH treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, MASH market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact MASH market growth.

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Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report

* Study Period: 2020-2034
* Coverage: 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
* Metabolic Dysfunction-Associated Steatohepatitis CAGR: 17.9 %
* Metabolic Dysfunction-Associated Steatohepatitis Market Size in 2023: USD 2.1 Billion
* Key Metabolic Dysfunction-Associated Steatohepatitis Companies: Hepion Pharmaceuticals (NASDAQ: HEPG), Ionis Pharmaceuticals (NASDAQ: IONS), Galectin Therapeutics (NASDAQ: GALT), Novo Nordisk A/S (NYSE: NVO), Cirius Therapeutics (Private), HighTide Biopharma (TSX-V: HBT), Boehringer Ingelheim (Private), Hepagene (Private), Eli Lilly and Company (NYSE: LLY), Pfizer (NYSE: PFE), Lipocine (NASDAQ: LPCN), Corcept Therapeutics (NASDAQ: CORT), Poxel SA (EPA: POXEL), Enyo Pharmaceuticals (Private), Akero Therapeutics (NASDAQ: AKRO), Zydus Therapeutics (NSE: ZYDUSLIFE), 89bio (NASDAQ: ETNB), Viking Therapeutics (NASDAQ: VKTX), Boston Pharmaceuticals (Private), Gilead Sciences (NASDAQ: GILD), Merck & Co. (NYSE: MRK), Zealand Pharma (CPH: ZEAL), Hanmi Pharmaceutical (KRX: 128940), Inventiva Pharma (EPA: IVA), CytoDyn (OTCQB: CYDY), Sagimet Biosciences (NASDAQ: SGMT).
* Key Pipeline Metabolic Dysfunction-Associated Steatohepatitis Therapies: Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others
* Therapeutic Assessment: Metabolic Dysfunction-Associated Steatohepatitis current marketed and emerging therapies
* Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics: Key Market Forecast Assumptions of Emerging Metabolic Dysfunction-Associated Steatohepatitis Drugs and Market Outlook
* Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
* Unmet Needs, KOL's views, Analyst's views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement

Table of Contents

1. Key Insights

2. Report Introduction

3. Country-wise MASH Market Overview at a Glance

4. MASH Market Overview by Therapeutic Class

5. Methodology of MASH Epidemiology and Market

6. Executive Summary

7. Key Events

8. Disease Background and Overview

9. MASH Epidemiology and Patient Population

10. MASH Patient Journey

11. Marketed MASH Drugs

12. Emerging MASH Drugs

13. MASH Market Analysis

14. Key Opinion Leaders' Views

15. SWOT Analysis

16. Unmet needs

17. Market Access and Reimbursement

18. Appendix

19. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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