시장보고서
상품코드
2018986

대사기능장애 관련 지방간염(MASH) - 시장 인사이트, 역학, 시장 예측(2036년)

Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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한글목차
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주요 하이라이트

  • 주요 7개 시장에서 2025년 MASH의 총 시장 규모는 약 30억 달러에 달할 것으로 예상됩니다. 2036년 말까지 상당한 CAGR로 확대되어 2036년 말에는 상당한 규모에 도달할 것으로 예상됩니다.
  • 2025년, 미국은 7대 시장 중 20억 달러 이상을 차지했습니다. 델브인사이트의 분석에 따르면, 새로운 치료법의 도입에 따라 시장 성장이 예상되며, 예측 기간(2026-2036년) 동안 시장 규모가 확대될 것으로 예상됩니다. 이러한 성장은 치료 옵션의 발전, 의료 접근성 향상, 질병 유병률의 증가로 인해 혁신적이고 효과적인 치료법에 대한 수요가 증가하고 있기 때문입니다.
  • MASH 시장은 2026-2036년 주요 7개 시장 전체에서 강력한 CAGR이 예상되며, 안정적인 성장을 보일 것으로 예측됩니다. 이러한 확장은 efruxifermin(EFX), VK2809, efimosfermin alfa(BOS-580), icosabutate, denifanstat, pegozafermin과 같은 혁신적인 치료법의 도입에 의해 촉진됩니다. 또한, 비만 증가, 좌식 생활 습관, 부적절한 식습관, 고령화, 인식 및 진단의 향상으로 인한 MASH 유병률의 증가는 MASH 시장의 성장을 더욱 뒷받침할 것입니다.
  • MASH/NASH의 관리는 주로 간 지방을 줄이고 질환의 진행을 늦추기 위한 생활습관 개선에 중점을 둡니다. 현재 MASH 치료에서 미국 FDA 승인을 받은 유일한 치료제는 중등도에서 중증의 섬유화를 동반한 비간경변성 NASH를 대상으로 하는 REZDIFFRA(레스메티롬)가 유일합니다.
  • 그러나 대부분의 치료법은 섬유화를 역전시키는 것이 아니라 근본적인 원인을 해결하는 것이기 때문에 치료의 공백이 남아있고, 많은 환자들이 효과적인 치료법을 얻지 못하고 있는 실정입니다. 항섬유화 치료제의 선택이 제한적이라는 점은 안전하고 광범위하게 작용하는 항섬유화 치료제의 필요성을 강조하고 있습니다.
  • 개발 중인 혁신 치료제인 efruxifermin은 현재 MASH 임상 3상 시험을 진행 중이며, 2027년까지 MASH 치료제로 출시될 예정입니다.

MASH 시장 전망

MASH 치료 환경은 빠르게 변화하고 있으며, 특히 미국 식품의약국(USFDA)의 Madrigal의 REZDIFFRA에 대한 신속한 승인으로 인해 MASH 치료 환경은 빠르게 변화하고 있습니다. 이 약은 현재 중등도에서 중증의 간섬유증 환자에게 중요한 치료제로 여겨지고 있습니다. 이 선택적 갑상선 호르몬 수용체 베타 작용제는 침습적 간 생검에서 비침습적 진단법으로 접근 방식을 전환하여 환자의 치료 접근성을 향상시켰습니다. 또한, FXR 작용제, PPAR 조절제, GLP-1 수용체 작용제 등 다양한 작용기전을 표적으로 하는 다양한 치료제의 파이프라인이 치료 환경을 형성하고 있으며, 이 질환의 복잡한 특성에 대응하기 위한 병용요법을 검증하기 위한 임상시험도 진행 중입니다. 연구자들이 맞춤형 의료와 환자 집단을 보다 적절하게 분류하는 데 집중하는 가운데, 임상시험 참여자 모집 및 규제 요건과 같은 과제를 해결하면서 치료 전략을 개선하는 것이 최우선 과제로 떠오르고 있습니다. 새로운 치료법과 기존 생활습관 중재의 조합은 MASH/NASH 관리의 임상 업무에 지속적으로 영향을 미치고 있습니다.

MASH를 위한 새로운 파이프라인 치료제에는 efruxifermin(EFX), VK2809, efimosfermin alfa(BOS-580), icosabutate, denifanstat, pegozafermin 등이 포함됩니다.

  • DelveInsight의 애널리스트에 따르면, 유럽 4개국 및 영국의 MASH 시장 규모는 2025년 약 5억 달러 규모이며, 예측 기간(2026-2036년) 동안 더욱 확대될 것으로 예상됩니다.
  • 일본의 MASH 시장 규모는 2025년 약 1억 달러로 주요 7개 시장의 총 시장 규모의 약 3%를 차지하고 있으며, 2036년까지 변화할 것으로 예측됩니다.

대사기능장애 관련 지방간염(MASH)의 주요 7개국(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본) 시장에 대해 조사 분석했으며, 각국의 시장 규모와 예측, 각 치료법의 시장 점유율, 현재 치료법, 미충족 수요 등의 정보를 전해드립니다.

자주 묻는 질문

  • 2025년 MASH 시장 규모는 어떻게 예상되나요?
  • 미국의 MASH 시장 규모는 2025년에 얼마로 예상되나요?
  • MASH 시장의 예측 기간 동안 CAGR은 어떻게 되나요?
  • 유럽 4개국 및 영국의 MASH 시장 규모는 2025년에 얼마로 예상되나요?
  • 일본의 MASH 시장 규모는 2025년에 얼마로 예상되나요?
  • MASH 치료에서 현재 승인된 유일한 치료제는 무엇인가요?
  • MASH 시장의 성장 요인은 무엇인가요?

목차

제1장 주요 발견

제2장 보고서 개요

제3장 시장 개요

제4장 역학 및 시장 조사 방법

제5장 주요 요약

제6장 주요 사건

제7장 질병의 배경과 개요

제8장 역학 및 환자 인구

제9장 환자 여정

제10장 시판 중인 의약품

제11장 신약

제12장 MASH - 주요 7대 시장 분석

제13장 KOL의 견해

제14장 미충족 수요

제15장 SWOT 분석

제16장 시장 진입과 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

KSM 26.05.07

Key Highlights:

  • The total market size of MASH in 2025 in the 7MM was ~USD 3 billion. It is expected to grow at a significant CAGR, reaching a notable value by the end of 2036.
  • In 2025, the US accounted for over USD 2 billion of the 7MM market. According to DelveInsight's analysis, market growth is anticipated with the introduction of emerging therapies, leading to an expansion in market size throughout the forecast period (2026-2036). This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies.
  • The MASH Market is expected to experience steady growth with a strong compound annual growth rate projected from 2026 to 2036 across the 7MM. This expansion will be driven by the introduction of innovative therapies, including efruxifermin (EFX), VK2809, efimosfermin alfa (BOS-580), icosabutate, denifanstat, and pegozafermin, among others. Additionally, the rising MASH Prevalence, fueled by increasing obesity, sedentary lifestyles, poor diets, an aging population, and improved awareness and diagnosis, will further support MASH Market Growth.
  • The management of MASH/NASH primarily focuses on lifestyle changes to reduce liver fat and slow disease progression. Currently, REZDIFFRA (Resmetirom) is the only US FDA-approved therapy available for MASH Treatment, specifically targeting noncirrhotic NASH with moderate to advanced fibrosis.
  • However, a therapeutic gap remains as most treatments address underlying causes rather than reversing fibrosis, leaving many patients without effective therapies. The limited availability of antifibrotic options highlights the need for safe, broad-spectrum antifibrotic agents.
  • Efruxifermin, an innovative therapy in development, is currently in Phase III MASH Clinical Trials and is anticipated to launch by 2027 for the MASH Treatment.

DelveInsight's "MASH Treatment Market Insights, Epidemiology, and Market Forecast - 2036" report delivers an in-depth understanding of MASH, historical and forecasted epidemiology, as well as the MASH market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The MASH Treatment Market Report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM MASH market size from 2022 to 2036. The report also covers MASH treatment market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

MASH Treatment Market: Understanding and Algorithm

MASH, previously known as NASH, is a severe and progressive form of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD). It is characterized by liver inflammation and damage along with excess fat accumulation. While MASLD results from fat buildup in the liver, MASH occurs when this buildup triggers inflammation and tissue damage, potentially leading to liver scarring and cirrhosis-a life-threatening condition.

Despite its seriousness, MASH often presents without noticeable symptoms. When symptoms do appear, they may include fatigue and mild pain in the upper right abdomen. As the disease advances to cirrhosis, patients may experience easy bleeding and bruising, jaundice, fluid retention, loss of appetite, nausea, leg swelling, confusion, drowsiness, slurred speech, and spider-like blood vessels on the skin. MASH is most commonly associated with obesity, diabetes, high cholesterol, high triglycerides, poor diet, metabolic syndrome, polycystic ovary syndrome, sleep apnea, and hypothyroidism. Typically, MASH remain asymptomatic in the early stages, but as liver damage progresses, symptoms may become more apparent.

MASH Diagnosis

The MASH Diagnosis is confirmed through a combination of clinical evaluation and specialized tests. Liver biopsy remains the gold standard for diagnosing MASH, providing critical information on liver inflammation, steatosis, and fibrosis staging. Non-invasive tools, such as MR-EFF and FibroScan, are gaining traction for assessing fat content and liver stiffness, offering alternatives to biopsy with reduced risk. Blood tests, including liver enzyme levels, help identify potential liver dysfunction, while imaging techniques like MRI and ultrasound are used to detect hepatic steatosis. In cases where biopsy is not feasible, these methods assist in estimating the severity of liver damage.

MASH Treatment

The MASH Treatment revolves around lifestyle modifications aimed at reducing liver fat and preventing disease progression. Weight loss of 5-10% has been shown to improve both biochemical markers and liver histology, with a combination of calorie reduction, exercise, and a balanced diet as key components. In particular, eliminating high fructose corn syrup and increasing omega-3 fatty acids in the diet have demonstrated benefits. The inclusion of one to two cups of caffeinated drip coffee daily may also reduce liver fibrosis.

Antioxidants like vitamin E can offer modest benefits in non-diabetic patients, though caution is advised with high doses due to the potential risk of increased all-cause mortality. For those with diabetes, the recommended dose of vitamin E should not exceed 400 units per day. Thiazolidinediones may improve insulin sensitivity but have side effects such as weight gain and cardiovascular risks, limiting their use. For patients with advanced liver disease and decompensated cirrhosis, liver transplantation remains the last resort, though there is a risk of NAFLD recurrence post-transplant.

MASH Epidemiology

As the market is derived using a patient-based model, the MASH epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total MASH Prevalence Cases of MASLD/NAFLD, total prevalent cases of MASH/NASH, total diagnosed prevalent cases of MASH/NASH, and severity-specific diagnosed prevalent cases of MASH/NASH in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2022 to 2036.

  • According to DelveInsight's estimates, there were more than ~200 million prevalent cases of MASLD (formerly known as NAFLD) in the 7MM in 2025, including ~30 million prevalent cases of MASH. Of the total MASH cases, ~8 million were diagnosed in the 7MM.
  • Among the 7MM, the US had the highest number of diagnosed prevalent MASH cases, with ~5 million cases in 2025, a figure projected to increase by 2036.
  • In 2025, EU4 and the UK accounted for ~3 million diagnosed prevalent cases of MASH, with Germany having the highest at ~795 thousand cases, followed by Italy with ~630 thousand cases. In contrast, Spain had the least, with ~350 thousand cases.
  • In 2025, the UK had ~580 thousand diagnosed prevalent cases of MASH.
  • In 2025, Japan recorded ~800 thousand diagnosed prevalent cases of MASH, a number expected to rise by 2036.

Recent Developments and MASH Clinical Trials

  • In January 2026, Sagimet Biosciences announced that it would present a poster at the 10th Annual MASH-TAG Conference highlighting anti-fibrotic effects observed in F3 and qFibrosis stage 4 MASH patients from the Phase IIb FASCINATE-2 trial evaluating denifanstat.
  • In November 2025, Akero Therapeutics reported additional Phase IIb SYMMETRY and HARMONY analyses at the AASLD Liver Meeting, further supporting efruxifermin's antifibrotic effect and demonstrating alignment between digital and conventional pathology findings.
  • In Sept 2025, Echosens announced FDA CDER acceptance of its Letter of Intent to qualify Liver Stiffness Measurement by FibroScan(R) as a surrogate endpoint in clinical trials for metabolic dysfunction-associated steatohepatitis (MASH).
  • In August 2025, Madrigal Pharmaceuticals announced that the European Commission granted conditional marketing authorization for Rezdiffra (resmetirom) to treat adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Rezdiffra is now the first and only approved MASH therapy in the EU.
  • In May 2025, Novo Nordisk announced that it will present new data from its portfolio in metabolic and cardiovascular health at the 32nd European Congress on Obesity (ECO) from May 11-14, 2025. The data will include real-world evidence studies on semaglutide, additional analysis of the SELECT cardiovascular outcomes trial, and part 1 of the phase 3 ESSENCE trial for metabolic dysfunction-associated steatohepatitis (MASH).
  • In May 2025, Roche announced the launch of its Elecsys(R) PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Developed in collaboration with Nordic Bioscience, the test provides clinicians with a simple and efficient way to identify patients with liver fibrosis of varying severity, facilitating timely intervention and management of the disease.
  • On November 1, 2024, Novo Nordisk announced positive results for semaglutide in treating metabolic dysfunction-associated steatohepatitis (MASH). In the Phase 3 Essence trial, a once-weekly 2.4 mg dose of semaglutide improved liver fibrosis and resolved steatohepatitis without worsening liver fibrosis in MASH patients with stage 2 or stage 3 fibrosis, meeting the primary endpoints.
  • On October 29, 2024, Sagimet Biosciences (SGMT) announced that it has successfully completed end-of-Phase 2 interactions with the FDA, paving the way for denifanstat to advance into Phase 3 trials for metabolic dysfunction-associated steatohepatitis.

MASH Drugs Market Chapters

The drug chapter segment of the MASH drugs market report encloses a detailed analysis of MASH-marketed drugs and mid to late-stage (Phase III and Phase II) MASH Pipeline Drugs analysis. It also helps understand the MASH Clinical Trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

MASH Marketed Drugs

  • REZDIFFRA (resmetirom): Madrigal Pharmaceuticals

REZDIFFRA (resmetirom), a Thyroid Hormone Receptor-beta (THR-B) agonist, is approved for treating adults with noncirrhotic MASH and moderate to advanced liver fibrosis (F2-F3), in conjunction with diet and exercise. It received accelerated approval due to improvements in MASH and fibrosis.

In March 2024, the US FDA approved REZDIFFRA for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3).

Madrigal Pharmaceuticals plans a country-by-country launch in Europe, starting in Germany in the second half of 2025, pending EMA approval, making it the first therapy for MASH liver fibrosis in the region. REZDIFFRA's recommended dosage varies based on body weight, with adjustments for CYP2C8 inhibitors. It works as a partial agonist of THR-B, primarily reducing intrahepatic triglycerides.

In February 2025, Madrigal announced new two-year data from the compensated MASH cirrhosis arm of the MAESTRO-NAFLD-1 trial, showing the potential benefit of REZDIFFRA in patients with compensated MASH cirrhosis.

MASH Emerging Drugs

  • Efruxifermin (EFX): Akero Therapeutics

Efruxifermin (EFX), is Akero's lead product candidate for MASH. It is a differentiated Fc-FGF21 fusion protein engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is designed to offer convenient once-weekly SC dosing and is active in the pipeline for Pre-cirrhotic MASH (F2-F3) and Compensated Cirrhosis due to MASH (F4).

In November 2025, Akero Therapeutics reported additional Phase IIb SYMMETRY and HARMONY analyses at the AASLD Liver Meeting, further supporting efruxifermin's antifibrotic effect and demonstrating alignment between digital and conventional pathology findings.

In May 2025, at the EASL Congress, the company presented Phase IIb SYMMETRY data showing efruxifermin significantly improved fibrosis without worsening MASH in compensated cirrhosis, indicating disease-modifying potential.

  • VK2809 (TRB Agonist): Viking Therapeutics

VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid hormone beta receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders.

In November 2024, Viking Therapeutics presented results from the Phase IIb VOYAGE study of VK2809 in biopsy-confirmed NASH/MASH at the 75th Liver Meeting, hosted by the AASLD, including Week 52 secondary endpoint results.

In June 2024, Viking Therapeutics reported positive 52-week histologic data from the Phase IIb VOYAGE study of VK2809, highlighting achievement of secondary endpoints showing histologic improvements via biopsy after 52 weeks. The study had previously met its primary endpoint, with significant liver fat reductions by Week 12 compared to placebo.

VK2809 also successfully achieved primary and secondary endpoints in a Phase IIa study for the treatment of patients with elevated LDL-C and Non-alcoholic Fatty Liver Disease (NAFLD).

  • Efimosfermin alfa (formerly BOS-580): Boston Pharmaceuticals

BOS-580 also known as Efimosfermin Alfa is a long-acting, once-monthly FGF21 analogue under development for the treatment of MASH, previously known as NASH. It is an investigational Phase III fusion protein with extended half-life, targeting three FGF21 receptors for a balanced pharmacological effect.

In July 2025, GSK reported the completion of its acquisition of efimosfermin alfa from Boston Pharmaceuticals.

In November 2024, Boston Pharmaceuticals reported positive Phase II data on (BOS-580) in F2/F3 MASH at AASLD 2024. The once-monthly treatment showed significant fibrosis improvement (>=1 stage) without worsening of MASH after 24 weeks. Two-thirds of efimosfermin-treated patients achieved significant MASH resolution without worsening fibrosis compared to placebo.

MASH Drugs Market Insights

Efruxifermin (EFX) is an investigational Fc-FGF21 fusion protein developed by Akero Therapeutics for the treatment of MASH. Designed to mimic the biological activity of FGF21, EFX aims to address key drivers of MASH by reducing liver fat and inflammation, reversing fibrosis, and improving insulin sensitivity and lipid metabolism. In a 96-week Phase IIb study, 39% of patients with compensated cirrhosis due to MASH experienced a reversal of cirrhosis without worsening of the disease, compared to 15% in the placebo group. These promising results have led to the initiation of the Phase III SYNCHRONY clinical program, which includes trials evaluating EFX in patients with pre-cirrhotic MASH (F2-F3 fibrosis) and those with compensated cirrhosis (F4) due to MASH.

Pegozafermin is an investigational glycoPEGylated analog of Fibroblast Growth Factor 21 (FGF21) developed by 89bio for the treatment of MASH and fibrosis. Engineered to mimic and extend the activity of native FGF21, pegozafermin aims to address metabolic abnormalities underlying liver diseases. In a Phase IIb trial, pegozafermin demonstrated significant improvements in liver fibrosis among MASH patients, supporting its progression to Phase III studies. Notably, the ENLIGHTEN-Cirrhosis Phase III trial has been initiated to evaluate its efficacy in MASH patients with compensated cirrhosis (F4), marking the first FGF21 analog to reach this advanced stage in such a population.

MASH Market Outlook

The MASH treatment landscape is rapidly evolving, particularly with the USFDA's accelerated approval of Madrigal's REZDIFFRA, now considered a key therapy for patients with moderate to advanced liver fibrosis. This selective thyroid hormone receptor-beta agonist has shifted the approach from invasive liver biopsies to non-invasive diagnostic methods, improving patient access to treatment. The landscape is further shaped by a diverse pipeline of therapies targeting various mechanisms, such as FXR agonists, PPAR modulators, and GLP-1 receptor agonists, with clinical trials exploring combination therapies to address the complex nature of the disease. As researchers focus on personalized medicine and better patient stratification, the priority remains refining treatment strategies while navigating challenges in trial recruitment and regulatory requirements. The combination of emerging therapies and existing lifestyle interventions continues to influence clinical practice in managing MASH/NASH.

Emerging pipeline treatments for MASH include efruxifermin (EFX), VK2809, efimosfermin alfa (BOS-580), icosabutate, denifanstat and pegozafermin, among others.

  • The total market size of MASH in 2025 in the 7MM was ~USD 3 billion. It is expected to grow at a significant CAGR, reaching a notable value by the end of 2036.
  • In 2025, the US accounted for over USD 2 billion of the 7MM market. According to DelveInsight's analysis, market growth is anticipated with the introduction of emerging therapies, leading to an expansion in market size throughout the forecast period (2026-2036). This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies.
  • According to DelveInsight's analysts, the total EU4 and the UK market size of MASH was found to be ~USD 500 million in 2025, which is further expected to increase in the forecast period (2026-2036).
  • The market size for MASH in Japan was ~USD 100 million in 2025 accounting for nearly 3% of the total market of the 7MM, and it is anticipated to change by 2036.

Metabolic Dysfunction-Associated Steatohepatitis Drugs Uptake

This section focuses on the uptake rate of potential MASH drugs expected to be launched in the market during 2022-2036.

Metabolic Dysfunction-Associated Steatohepatitis Pipeline Development Activities

The MASH pipeline segment report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key MASH Companies involved in developing targeted therapeutics.

Pipeline Development Activities

The MASH pipeline segment report covers information on collaborations, acquisitions and mergers, licensing, and patent details for MASH emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on MASH evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of California, US, Arizona Liver Health, US, Houston Research Institute, US , University of Bonn, Germany, Hospital Saint-Antoine - Ap-Hp Sorbonne University, France, Fondazione Policlinico Universitario Agostino Gemelli, Italy, Instituto de Investigaciones Biomedicas August Pi i Sunyer (IDIBAPS), Spain, Royal Infirmary of Edinburgh, UK , and Aichi Medical University, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or MASH market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

As per the KOLs from the US, MASH affects approximately 5% of the US adult population, driven by the growing burden of obesity, diabetes, and metabolic syndrome. Despite up to 75% of individuals with MASLD having underlying MASH, many remain undiagnosed due to gaps in screening and inconsistent diagnostic pathways. The lack of standardized criteria and reliance on varied data sources contribute to discrepancies in MASH Prevalence estimates, underscoring the urgent need for real-world epidemiological studies. Improved risk stratification and broader adoption of noninvasive diagnostic tools are essential to identifying high-risk patients earlier and mitigating long-term disease burden.

As per the KOLs from France, MASLD is a growing public health challenge in France, particularly among men and those with metabolic risk factors. The link between diabetes and advanced fibrosis highlights the urgency of national screening programs. Strengthening preventive strategies through metabolic health initiatives and physician education is key to reducing long-term disease burden

As per the KOLs from Japan, the increasing prevalence of MASLD and MASH in Japan reflects global trends, yet lean-MASH remains a distinct concern. The interplay between metabolic health and fibrosis progression remains incompletely understood, emphasizing the need for longitudinal studies and improved noninvasive diagnostics to refine risk stratification and treatment pathways

MASH Therapeutics Market: Qualitative Analysis

We perform Qualitative and MASH Therapeutics Market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving MASH treatment market landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

MASH Therapeutics Market Access and Reimbursement

REZDIFFRA

Madrigal offers a Co-pay Savings Card for eligible, commercially insured patients, allowing them to save on REZDIFFRA, with costs as low as USD 10. In 2025, the Inflation Reduction Act (IRA) introduces new affordability options for those on Medicare Part D, aiming to reduce prescription drug costs. These changes focus on making prescription costs more manageable for seniors living in the US.

Starting January 2025, a key change to the Medicare Part D program includes a USD 2,000 annual cap on out-of-pocket prescription drug costs, down from USD 3,250 in 2024. Additionally, the "donut hole" coverage gap will be eliminated. Once the USD 2,000 limit is reached, Medicare will cover any remaining prescription costs for the year.

For individuals who find the USD 2,000 cap financially challenging, the Medicare Prescription Payment Plan (MPPP) can help. The MPPP allows eligible participants to spread their prescription costs across monthly payments. They will receive a monthly statement from their Part D plan showing their costs, which will be evenly distributed over the year. Individuals can join the MPPP at any time, including during open enrollment, by contacting the number on their Part D plan ID card, visiting the plan website, or mailing in a form.

Furthermore, the Extra Help program, also known as the Low-Income Subsidy (LIS), will expand its full benefits to assist people with limited income in obtaining Part D prescription drug coverage. In 2024, participants may qualify for this subsidy if they earn up to USD 22,590 annually (for a single person) or USD 30,660 (for a couple) and meet other requirements. Additionally, their assets must be below USD 17,220 (for a single person) or USD 34,360 (for a couple) to be eligible. The income limits are updated annually based on the Federal Poverty Level.

The MASH Therapeutics Market Report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

MASH Therapeutics Market Report Scope

  • The MASH therapeutics market report covers a segment of key events, an executive summary, and a descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
  • Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current MASH Treatment Market Landscape.
  • A detailed review of the MASH Therapeutics Market, historical and forecasted MASH Treatment Market Size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The MASH Therapeutics Market Report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM MASH drugs market.

MASH Therapeutics Market Report Insights

  • Patient-based MASH Market Forecasting
  • Therapeutic Approaches
  • MASH Pipeline Drugs Analysis
  • MASH Market Size and Trends
  • Existing and Future MASH Drugs Market Opportunity

MASH Therapeutics Market Report Key Strengths

  • 11 years MASH Market Forecast
  • The 7MM Coverage
  • MASH Epidemiology Segmentation
  • Key Cross Competition
  • Attribute analysis
  • MASH Drugs Uptake and Key MASH Market Forecast Assumptions

MASH Therapeutics Market Report Assessment

  • Current MASH Treatment Market Practices
  • MASH Unmet Needs
  • MASH Pipeline Drugs Profiles
  • MASH Drugs Market Attractiveness
  • Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions:

MASH Treatment Market Insights

  • What was the MASH Treatment Market Size, the MASH Market Size by therapies, and MASH Drugs Market Share (%) distribution in 2022, and what would it look like by 2036? What are the contributing factors for this growth?
  • How will REZDIFFRA affect the treatment paradigm of MASH?
  • How will efruxifermin (EFX) compete with other upcoming products and marketed therapies?
  • Which drug is going to be the largest contributor by 2036?
  • What are the pricing variations among different geographies for approved and marketed therapies?
  • How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

MASH Epidemiology Insights

  • What are the disease risks, burdens, and MASH Unmet Needs? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to MASH?
  • What is the historical and forecasted MASH patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
  • Out of the countries mentioned above, which country would have the highest diagnosed prevalent MASH population during the forecast period (2026-2036)?
  • What factors are contributing to the growth of MASH cases?

Current MASH Treatment Market Scenario, Marketed Drugs, and Emerging Therapies

  • What are the current options for the treatment of MASH? What are the current clinical and treatment guidelines for treating MASH?
  • How many companies are developing therapies for the MASH Treatment?
  • How many emerging therapies are in the mid-stage and late stage of development for treating MASH?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
  • What is the cost burden of current treatment on the patient?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the accessibility issues of approved therapy in the US?
  • What is the 7MM historical and forecasted MASH Drugs Market?

Reasons to Buy:

  • The MASH Drugs Market Report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the MASH market.
  • Insights on patient burden/disease MASH Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing MASH drugs market opportunities in varying geographies and the growth potential over the coming years.
  • The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
  • Identifying upcoming solid players in the MASH drugs market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • Highlights of Access and Reimbursement policies for MASH, barriers to accessibility of approved therapy, and patient assistance programs.
  • To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing MASH drugs market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Market Overview at a Glance

  • 3.1. Market Share (%) Distribution of MASH in 2022
  • 3.2. Market Share (%) Distribution of MASH in 2036

4. Methodology of Epidemiology and Market

5. Executive Summary

6. Key Events

7. Disease Background and Overview

  • 7.1. Introduction
  • 7.2. Signs and Symptoms
  • 7.3. Causes
  • 7.4. Related Conditions
  • 7.5. Etiology
  • 7.6. Risk Factors
  • 7.7. Pathophysiology
  • 7.8. Complications
  • 7.9. Diagnosis
    • 7.9.1. Diagnostic Algorithm
    • 7.9.2. Diagnostic Guidelines
  • 7.10. Management and Treatment
    • 7.10.1. Treatment Algorithm
    • 7.10.2. Treatment Guidelines

8. Epidemiology and Patient Population

  • 8.1. Key Findings
  • 8.2. Assumptions and Rationale: The 7MM
    • 8.2.1. Prevalent Cases of MASLD/NAFLD
    • 8.2.2. Prevalent Cases of MASH/NASH
    • 8.2.3. Diagnosed Prevalent Cases of MASH/NASH
    • 8.2.4. Severity-specific Diagnosed Prevalent Cases of MASH/NASH
  • 8.3. Total Diagnosed Prevalent Cases of MASH/NASH in the 7MM
  • 8.4. The US
    • 8.4.1. Total Prevalent Cases of MASLD/NAFLD in the US
    • 8.4.2. Total Prevalent Cases of MASH/NASH in the US
    • 8.4.3. Total Diagnosed Prevalent Cases of MASH/NASH in the US
    • 8.4.4. Severity-specific Diagnosed Prevalent Cases of MASH/NASH in the US
  • 8.5. EU4 and the UK
    • 8.5.1. Total Prevalent Cases of MASLD/NAFLD in EU4 and the UK
    • 8.5.2. Total Prevalent Cases of MASH/NASH in EU4 and the UK
    • 8.5.3. Total Diagnosed Prevalent Cases of MASH/NASH in EU4 and the UK
    • 8.5.4. Severity-specific Diagnosed Prevalent Cases of MASH/NASH in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Prevalent Cases of MASLD/NAFLD in Japan
    • 8.6.2. Total Prevalent Cases of MASH/NASH in Japan
    • 8.6.3. Total Diagnosed Prevalent Cases of MASH/NASH in Japan
    • 8.6.4. Severity-specific Diagnosed Prevalent Cases of MASH/NASH in Japan

9. Patient Journey

10. Marketed Drugs

  • 10.1. REZDIFFRA (resmetirom): Madrigal Pharmaceuticals
    • 10.1.1. Product Description
    • 10.1.2. Regulatory Milestones
    • 10.1.3. Other Developmental Activities
    • 10.1.4. Clinical Trials Information
    • 10.1.5. Safety and Efficacy

11. Emerging Drugs

  • 11.1. Key Cross Competition
  • 11.2. Efruxifermin (EFX): Akero Therapeutics
    • 11.2.1. Drug Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Trials Information
    • 11.2.4. Safety and Efficacy
    • 11.2.5. Analysts' View
  • 11.3. Denifanstat (TVB-2640): Sagimet Biosciences
    • 11.3.1. Drug Description
    • 11.3.2. Other Developmental Activities
    • 11.3.3. Clinical Trials Information
    • 11.3.4. Safety and Efficacy
    • 11.3.5. Analysts' View
  • 11.4. Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma
    • 11.4.1. Drug Description
    • 11.4.2. Other Developmental Activities
    • 11.4.3. Clinical Trials Information
    • 11.4.4. Safety and Efficacy
    • 11.4.5. Analysts' View
  • 11.5. Pegozafermin (BIO89-100): 89bio
    • 11.5.1. Drug Description
    • 11.5.2. Other Developmental Activities
    • 11.5.3. Clinical Trials Information
    • 11.5.4. Safety and Efficacy
    • 11.5.5. Analysts' View
  • 11.6. Lanifibranor (IVA337): Inventiva Pharma
    • 11.6.1. Drug Description
    • 11.6.2. Other Developmental Activities
    • 11.6.3. Clinical Trials Information
    • 11.6.4. Safety and Efficacy
    • 11.6.5. Analysts' View
  • 11.7. Aramchol: Galmed Pharmaceuticals
    • 11.7.1. Drug Description
    • 11.7.2. Other Developmental Activities
    • 11.7.3. Clinical Trials Information
    • 11.7.4. Safety and Efficacy
    • 11.7.5. Analysts' View
  • 11.8. WEGOVY (semaglutide 2.4 mg): Novo Nordisk A/S
    • 11.8.1. Drug Description
    • 11.8.2. Other Developmental Activities
    • 11.8.3. Clinical Trials Information
    • 11.8.4. Safety and Efficacy
    • 11.8.5. Analysts' View
  • 11.9. VK2809 (TRB Agonist): Viking Therapeutics
    • 11.9.1. Drug Description
    • 11.9.2. Other Developmental Activities
    • 11.9.3. Clinical Trials Information
    • 11.9.4. Safety and Efficacy
    • 11.9.5. Analysts' View
  • 11.10. Rencofilstat (CRV431): Hepion Pharmaceuticals
    • 11.10.1. Drug Description
    • 11.10.2. Other Developmental Activities
    • 11.10.3. Clinical Trials Information
    • 11.10.4. Safety and Efficacy
    • 11.10.5. Analysts' View
  • 11.11. Ervogastat (DGAT2i; PF-06865571) + Clesacostat (ACCi; PF-05221304): Pfizer
    • 11.11.1. Drug Description
    • 11.11.2. Other Developmental Activities
    • 11.11.3. Clinical Trials Information
    • 11.11.4. Safety and Efficacy
    • 11.11.5. Analysts' View
  • 11.12. Berberine ursodeoxycholate (HTD1801): HighTide Biopharma
    • 11.12.1. Drug Description
    • 11.12.2. Other Developmental Activities
    • 11.12.3. Clinical Trials Information
    • 11.12.4. Safety and Efficacy
    • 11.12.5. Analysts' View
  • 11.13. Efimosfermin alfa (formerly BOS-580): Boston Pharmaceuticals
    • 11.13.1. Drug Description
    • 11.13.2. Other Developmental Activities
    • 11.13.3. Clinical Trials Information
    • 11.13.4. Safety and Efficacy
    • 11.13.5. Analysts' View
  • 11.14. HU6: Rivus Pharmaceuticals
    • 11.14.1. Drug Description
    • 11.14.2. Other Developmental Activities
    • 11.14.3. Clinical Trials Information
    • 11.14.4. Safety and Efficacy
    • 11.14.5. Analysts' View
  • 11.15. LPCN 1144: Lipocine
    • 11.15.1. Drug Description
    • 11.15.2. Other Developmental Activities
    • 11.15.3. Clinical Trials Information
    • 11.15.4. Safety and Efficacy
    • 11.15.5. Analysts' View
  • 11.16. ALG-055009: Aligos Therapeutics
    • 11.16.1. Drug Description
    • 11.16.2. Other Developmental Activities
    • 11.16.3. Clinical Trials Information
    • 11.16.4. Safety and Efficacy
    • 11.16.5. Analysts' View
  • 11.17. MN-001 (tipelukast): MediciNova
    • 11.17.1. Drug Description
    • 11.17.2. Other Developmental Activities
    • 11.17.3. Clinical Trials Information
    • 11.17.4. Safety and Efficacy
    • 11.17.5. Analysts' View
  • 11.18. Icosabutate: NorthSea Therapeutics
    • 11.18.1. Drug Description
    • 11.18.2. Other Developmental Activities
    • 11.18.3. Clinical Trials Information
    • 11.18.4. Safety and Efficacy
    • 11.18.5. Analysts' View
  • 11.19. Tirzepatide (LY3298176): Eli Lilly
    • 11.19.1. Drug Description
    • 11.19.2. Other Developmental Activities
    • 11.19.3. Clinical Trials Information
    • 11.19.4. Safety and Efficacy
    • 11.19.5. Analysts' View

12. MASH - 7MM Market Analysis

  • 12.1. Key Findings
  • 12.2. Key Market Forecast Assumptions
    • 12.2.1. Cost Assumptions and Rebates
    • 12.2.2. Pricing Trends
    • 12.2.3. Analogue Assessment
    • 12.2.4. Launch Year and Therapy Uptake
  • 12.3. Market Outlook
  • 12.4. Attribute Analysis
  • 12.5. Total Market Size of MASH in the 7MM
  • 12.6. Market Size of MASH by Therapies in the 7MM
  • 12.7. The US Market Size
    • 12.7.1. Total Market Size of MASH in the US
    • 12.7.2. Market Size of MASH by Therapies in the US
  • 12.8. EU4 and the UK Market Size
    • 12.8.1. Total Market Size of MASH in EU4 and the UK
    • 12.8.2. Market Size of MASH by Therapies in EU4 and the UK
  • 12.9. Japan Market Size
    • 12.9.1. Total Market Size of MASH in Japan
    • 12.9.2. Market Size of MASH by Therapies in Japan

13. Key Opinion Leaders' Views

14. Unmet Needs

15. SWOT Analysis

16. Market Access and Reimbursement

  • 16.1. The US
    • 16.1.1. CMS
  • 16.2. EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. The UK
  • 16.3. Japan
    • 16.3.1. MHLW

17. Appendix

  • 17.1. Acronyms and Abbreviations
  • 17.2. Bibliography
  • 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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