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대사 기능 장애 관련 지방간염(MASH) : 경쟁 구도 및 임상시험 분석(2026년)Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Competitive Landscape and Clinical Trial Analysis, 2026 |
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DelveInsight
대사 기능 장애 관련 지방간염(MASH)(구 명칭: 비알코올성 지방간염(NASH))은 대사 기능 장애 관련 지방간 질환(MASLD)의 진행성 염증형입니다. 그 특징은 간세포 손상(특히 간세포의 풍선화) 및 소엽성 염증을 동반하는 지방간이며, 다양한 정도의 섬유화가 관찰됩니다. MASH는 MASLD의 더 광범위한 스펙트럼 내에 위치하며, 대사 이상 및 지질 축적이 현저한 간 염증 및 조직 손상과 관련된 단계를 나타냅니다.
MASH의 병인은 복잡하며 다인자적입니다. 연구에 따르면, 간에 과도한 지질이 축적되는 것은 간으로의 지방산 공급 증가, 데 노보 지질 생합성의 촉진, 그리고 지질 산화 및 배출 장애에 기인하는 것으로 나타났습니다. 이러한 이상은 지질 독성 및 세포 스트레스를 유발하며, 그 결과 간세포 손상, 염증 반응, 그리고 섬유화 경로의 활성화를 촉진합니다. 간세포, 면역세포, 간성세포 간의 상호작용 및 간외 조직으로부터의 신호 전달도 질환의 진행과 섬유화의 진행에 더욱 기여하고 있습니다.
MASH는 심혈관 대사 위험 인자, 특히 비만, 인슐린 저항성, 2형 당뇨병 및 이상지질혈증과 밀접한 관련이 있습니다. 질환의 진행은 불균일하여, 일부 환자에서는 병세가 안정되거나 개선되는 반면, 다른 환자에서는 MASH에서 섬유화 진행, 간경변, 간기능 부전, 나아가 간세포암으로 진행될 수 있습니다. 조직학적 특징 중에서도 간 섬유화의 진행 단계는 장기적인 임상 예후 및 사망률의 주요 결정 요인으로 간주됩니다.
대사성 질환의 부담이 증가함에 따라, MASH는 임상 및 치료 연구에서 중요한 분야가 되었습니다. 현재의 연구는 질병 진행의 근저에 있는 상호 연관된 대사, 염증, 섬유화 메커니즘을 표적으로 삼는 동시에, 비침습적 평가 기법을 통해 임상적으로 유의미한 섬유화를 보이는 환자를 더 정확하게 식별하는 데 초점을 맞추고 있습니다. MASH의 생물학적 메커니즘에 대한 이해가 진전되고 질환 특이적 치료법이 개발됨에 따라, 특히 비간경변성 MASH 및 중등도에서 진행된 섬유화를 가진 환자에서의 치료 방식은 더욱 크게 변화했습니다.
DelveInsight's, "Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Competitive Landscape and Clinical Trial Analysis, 2026," report provides comprehensive insights about 180+ companies and 200+ drugs in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Metabolic Dysfunction-Associated Steatohepatitis (MASH): Understanding
Metabolic Dysfunction-Associated Steatohepatitis (MASH): Overview
Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly nonalcoholic steatohepatitis (NASH), is the progressive inflammatory form of metabolic dysfunction-associated steatotic liver disease (MASLD). It is characterized by hepatic steatosis accompanied by hepatocellular injury, particularly hepatocellular ballooning, and lobular inflammation, with varying degrees of fibrosis. MASH occurs within the broader spectrum of MASLD and represents the stage at which metabolic disturbances and lipid accumulation are associated with significant hepatic inflammation and tissue injury.
The pathogenesis of MASH is complex and multifactorial. Research indicates that excessive hepatic lipid accumulation results from increased delivery of fatty acids to the liver, enhanced de novo lipogenesis, and impaired lipid oxidation and export. These disturbances contribute to lipotoxicity and cellular stress, which subsequently promote hepatocyte injury, inflammatory responses, and activation of fibrogenic pathways. Interactions among hepatocytes, immune cells, hepatic stellate cells, and signals from extrahepatic tissues further contribute to disease progression and fibrosis development.
MASH is strongly associated with cardiometabolic risk factors, particularly obesity, insulin resistance, Type 2 diabetes mellitus, and dyslipidemia. Disease progression is heterogeneous; while some individuals may remain stable or experience regression, others progress from MASH to increasing stages of fibrosis, cirrhosis, hepatic decompensation, and hepatocellular carcinoma. Among histological features, the stage of liver fibrosis is considered a major determinant of long-term clinical outcomes and mortality.
The increasing burden of metabolic disease has made MASH an important area of clinical and therapeutic research. Current research is focused on targeting the interconnected metabolic, inflammatory, and fibrogenic mechanisms underlying disease progression, while improving identification of patients with clinically significant fibrosis through non-invasive assessment approaches. Recent advances in the understanding of MASH biology and the development of disease-specific therapies have further transformed the management landscape, particularly for patients with non-cirrhotic MASH and moderate-to-advanced fibrosis.
Metabolic Dysfunction-Associated Steatohepatitis (MASH): Company and Product Profiles (Marketed Therapies)
Madrigal Pharmaceuticals, Inc. is a United States-based biopharmaceutical company focused on the development and commercialization of novel therapies for metabolic and liver diseases. The company has concentrated its research efforts on diseases with significant unmet medical needs, particularly metabolic dysfunction-associated steatohepatitis (MASH) and related liver conditions. Madrigal's lead product, Rezdiffra, represents a major advancement in the treatment landscape for MASH and became the first therapy approved in the United States specifically for patients with noncirrhotic MASH and moderate-to-advanced liver fibrosis.
Product Description: REZDIFFRA
Rezdiffra (resmetirom) is an orally administered, liver-directed thyroid hormone receptor beta (THR-B) agonist developed by Madrigal Pharmaceuticals. It selectively activates THR-B in the liver, helping reduce hepatic fat accumulation, inflammation, and fibrosis. The U.S. Food and Drug Administration approved Rezdiffra on March 14, 2024, for use in combination with diet and exercise for adults with noncirrhotic MASH/NASH and moderate-to-advanced liver fibrosis, consistent with fibrosis stages F2 to F3. Rezdiffra is administered orally once daily, with the recommended dose based primarily on patient body weight. It subsequently received authorization in the European Union and the United Kingdom for eligible adults with MASH and F2-F3 fibrosis.
Novo Nordisk A/S is a Denmark-based global healthcare company founded in 1923 and headquartered in Bagsvaerd, Denmark. The company specializes in the discovery, development, manufacturing, and commercialization of innovative therapies for serious chronic diseases, with a longstanding heritage and global leadership in diabetes care. Its current strategy is primarily focused on obesity, diabetes and related comorbidities, and rare diseases, supported by extensive expertise in protein and peptide science and incretin biology. Novo Nordisk markets its products in approximately 170 countries and employs approximately 68,800 people across 80 countries. The company continues to strengthen its metabolic disease portfolio through internal research, strategic partnerships, licensing agreements, and acquisitions, including investments in therapies for obesity-related comorbidities and MASH.
Product Description: WEGOVY
Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist administered as a once-weekly subcutaneous injection. Semaglutide works by mimicking the activity of GLP-1, thereby regulating appetite, reducing caloric intake, improving metabolic parameters, and promoting weight loss. On August 15, 2025, the US Food and Drug Administration approved Wegovy for the treatment of adults with noncirrhotic MASH and moderate-to-advanced liver fibrosis, consistent with fibrosis stages F2 to F3. The approval was based on histological outcomes demonstrating improvements in MASH resolution and liver fibrosis in the ESSENCE clinical trial. Wegovy's MASH indication was granted under the FDA's accelerated approval pathway, with continued approval contingent on confirmation of clinical benefit in an ongoing long-term study.
Zydus Lifesciences Limited is an India-based global life sciences company engaged in the discovery, development, manufacturing, and commercialization of pharmaceutical products, biologics, vaccines, and novel therapies. The company has established research capabilities across multiple therapeutic areas, including cardio-metabolic diseases, inflammation and immunology, neuroscience, oncology, and rare diseases. Zydus has also developed innovative new chemical entities through its internal research programs, including saroglitazar, which became the first new chemical entity from an Indian research pipeline to progress from laboratory development to commercialization.
Product Description: LIPAGLYN/BILYPSA
Lipaglyn/Bilypsa (saroglitazar magnesium) is an orally administered dual peroxisome proliferator-activated receptor alpha/gamma (PPAR-a/Y) agonist developed by Zydus. It has predominant PPAR-a activity and targets metabolic abnormalities associated with dyslipidemia, insulin resistance, and liver disease. In India, saroglitazar received approval from the Drug Controller General of India for the treatment of noncirrhotic non-alcoholic steatohepatitis (NASH), now referred to as MASH, in March 2020, and Zydus subsequently received approval for its use in non-alcoholic fatty liver disease. The therapy is administered orally at a dose of 4 mg once daily. Saroglitazar is currently authorized for sale in India, while its use for MASH/NASH remains investigational in the United States.
Metabolic Dysfunction-Associated Steatohepatitis (MASH): Company and Product Profiles (Pipeline Therapies)
GSK plc is a United Kingdom-based global biopharmaceutical company focused on the discovery, development, and commercialization of specialty medicines, vaccines, and general medicines. Headquartered in London, the company operates in approximately 70 markets worldwide and reported EUR 32.7 billion in group turnover in 2025. GSK's research and development strategy is centered on four core therapeutic areas-respiratory, immunology and inflammation; oncology; HIV; and infectious diseases-with its innovation efforts supported by advanced technologies and a broad pipeline of medicines and vaccines. In addition to its internal R&D activities, GSK actively expands its portfolio through targeted business development and acquisitions to strengthen its presence in areas of significant unmet medical need.
Product Description: Efimosfermin
Efimosfermin is an investigational, once-monthly fibroblast growth factor 21 (FGF21)-based therapy designed to address metabolic dysfunction and liver fibrosis in patients with MASH. The therapy has demonstrated improvements in liver fibrosis, MASH resolution, liver biomarkers, and cardiometabolic parameters in clinical studies. In April 2026, efimosfermin received Breakthrough Therapy Designation from the U.S. FDA and Priority Medicines (PRIME) designation from the European Medicines Agency for MASH. Following positive Phase II results, GSK advanced the candidate into its Phase III ZENITH clinical program for patients with MASH and moderate-to-advanced fibrosis.
Altimmune, Inc. is a United States-based, late clinical-stage biopharmaceutical company incorporated in Delaware and headquartered in Gaithersburg, Maryland. The company is focused on developing novel therapies for serious liver diseases, with its development strategy centered on metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). Altimmune's lead and principal product candidate is an investigational peptide-based therapy acquired through the acquisition of Spitfire Pharma, Inc. in 2019, and the company is advancing its clinical development through late-stage and registrational programs. Altimmune is publicly traded on the Nasdaq Global Market under the ticker symbol ALT.
Product Description: Pemvidutide
Pemvidutide is an investigational, once-weekly, balanced 1:1 dual GLP-1/glucagon receptor agonist designed to address both metabolic dysfunction and liver disease in patients with MASH. Activation of the GLP-1 receptor contributes to weight loss and metabolic improvements, while glucagon receptor activity is intended to enhance energy expenditure and support reductions in hepatic fat. In the Phase IIb IMPACT trial, pemvidutide demonstrated improvements in MASH-related histological and non-invasive measures, including markers of fibrosis, liver stiffness, and cardiometabolic risk. The U.S. FDA has granted pemvidutide both Fast Track and Breakthrough Therapy Designation for MASH. Currently, the drug is in Phase III stage of its development for the treatment of MASH.
D&D Pharmatech is a clinical-stage biopharmaceutical company focused on developing revolutionary medicines for patients with metabolic, fibrotic, and neurodegenerative diseases. Its liver pipeline includes zabopegdutide and TLY012 for MASH and cirrhosis, with TLY012 demonstrating reversal of established fibrosis in multiple preclinical models, including liver cirrhosis, chronic pancreatitis, and systemic sclerosis. In neuroscience, pegsebrenatide (NLY01) and NLY02 target neuroinflammation and glial activation to slow neurodegeneration; pegsebrenatide has demonstrated clinical benefit in a Phase 2 Parkinson's disease study, particularly in patients younger than 60, and is currently being evaluated in progressive multiple sclerosis.
Product Description: Zabopegdutide
Zabopegdutide (DD01) is an investigational, once-weekly subcutaneous dual glucagon-like peptide-1 (GLP-1) and glucagon receptor agonist being developed for MASH. The therapy has a differentiated GLP-1-to-glucagon potency profile designed to provide metabolic benefits while also directly targeting hepatic disease mechanisms. In a 48-week Phase II MASH trial, zabopegdutide demonstrated statistically significant improvements versus placebo across key histological endpoints, including MASH resolution without worsening of fibrosis and improvement in fibrosis without worsening of MASH.
Alnylam Pharmaceuticals, Inc. is a United States-based biopharmaceutical company focused on the discovery, development, and commercialization of RNA interference (RNAi) therapeutics. The company has established a proprietary RNAi platform designed to selectively silence disease-associated genes and has developed a broad pipeline across rare, cardiovascular, metabolic, neurological, and other therapeutic areas.
Regeneron Pharmaceuticals, Inc. is a United States-based biotechnology company focused on the invention, development, and commercialization of medicines for serious diseases. The company has established a broad research and development portfolio spanning immunology and inflammation, oncology, cardiovascular and metabolic diseases, ophthalmology, hematology, infectious diseases, neurological disorders, and rare diseases.
Product Description: ALN-CIDEB
ALN-CIDEB is an investigational small interfering RNA (siRNA) therapeutic designed to target CIDEB (cell death-inducing DFFA-like effector B), a gene involved in hepatic lipid metabolism and lipid droplet biology. The therapy is intended to reduce CIDEB expression in the liver and thereby address hepatic lipid accumulation and underlying disease mechanisms associated with MASH. Development of ALN-CIDEB is led by Regeneron Pharmaceuticals under its collaboration with Alnylam. The candidate had completed Phase I clinical development, demonstrated encouraging safety and tolerability findings. Currently, the drug is in Phase II stage of its development for the treatment of MASH.
Changchun Intellicrown Pharmaceutical Co., Ltd. is a China-based pharmaceutical company founded in 2013 and headquartered in Changchun, Jilin Province. The company is engaged in pharmaceutical research and development, manufacturing, commercialization, and related technology development and transfer activities, with capabilities spanning biopharmaceuticals and small-molecule drug development. Its research activities include programs in digestive and metabolic diseases as well as oncology, and the company has collaborated with research institutions, including the Institute of Materia Medica, Chinese Academy of Medical Sciences, on pharmaceutical innovation and drug development.
Product Description: IMM-H014
IMM-H014 is an investigational therapeutic candidate being developed for MASH and is currently in Phase I/II clinical development. The therapy acts as a stimulator of nuclear factor erythroid 2-related factor 1 (Nrf1) and nuclear factor erythroid 2-related factor 2 (Nrf2). These transcription factors play important roles in regulating cellular responses to metabolic stress, oxidative stress, and lipid homeostasis. Stimulation of the Nrf1/Nrf2 pathways is intended to enhance cellular antioxidant and protective responses, reduce oxidative stress, and improve hepatic metabolic homeostasis.
Company Overview: Tasly Biopharmaceuticals Co., Ltd.
Tasly Pharmaceutical Group Co., Ltd. is a China-based pharmaceutical company headquartered in Tianjin, with operations spanning the research, development, manufacturing, and commercialization of modern traditional Chinese medicines, chemical drugs, and biologics. Founded in 1994 and listed on the Shanghai Stock Exchange in 2002, the company focuses on therapeutic areas including cardiovascular and metabolic diseases, neurology and psychiatry, and digestive diseases. Its biopharmaceutical subsidiary, Tasly Biopharmaceuticals Co., Ltd., develops innovative biologics across metabolic, cardiovascular, oncology, and autoimmune diseases.
Product Description: B1344
B1344 is an investigational, long-acting site-specific PEGylated human FGF21 analog developed by Tasly for MASH and other metabolic diseases. The molecule was engineered to improve the biopharmaceutical properties of native FGF21, including extending its half-life and improving pharmacokinetic properties. B1344 selectively activates signaling through the BKlotho/FGFR1c receptor complex, a key pathway involved in the metabolic actions of FGF21. Activation of this pathway is intended to regulate glucose and lipid metabolism and improve metabolic homeostasis. B1344 is currently in Phase I clinical development. In its preclinical evaluation, subcutaneous administration of B1344 for 11 weeks in cynomolgus monkeys with NAFLD resulted in reductions in hepatic steatosis, inflammation, and fibrosis, together with improvements in liver injury and hepatocyte death.
Metabolic Dysfunction-Associated Steatohepatitis (MASH) Analytical Perspective by DelveInsight
The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.
The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).
Metabolic Dysfunction-Associated Steatohepatitis (MASH) Clinical Trial Assessment
The report comprises of comparative assessment of clinical trial analysis (by status, development stage, therapy area, enrolled participants by age, study completion year, end point status).
The report comprises of comparative assessment of clinical trial design analysis (by allocation, interventional model, enrolled participants by status, masking).
The report comprises of comparative assessment of sponsor and geographical analysis (by top sponsors, developmental stage, clinical trials sponsored by countries, therapies by countries).
Current Treatment Scenario and Emerging Therapies:
Key Players
Key Products