Jan 30, 2025   SOURCE: PR NewsWire

Metabolic Dysfunction-Associated Steatohepatitis Market to Register Stunning Growth at a CAGR of 17.9% in the US by 2034 | DelveInsight

The MASH treatment landscape is evolving rapidly, driven by a diverse array of therapeutic classes, each with unique mechanisms and potential impacts. The forecast period reveals significant shifts and emerging trends that will shape future market dynamics.

LAS VEGAS, Jan. 30, 2025 /PRNewswire/ -- 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].

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Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report

    --  According to DelveInsight's analysis, the market size for MASH was found
        to be USD 2.1 billion in the 7MM in 2023.


    --  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 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 @ Metabolic Dysfunction-Associated Steatohepatitis Market Report

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 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.

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

Metabolic Dysfunction-Associated Steatohepatitis 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.

Antifibrotic agents can help prevent the progression of liver fibrosis and MASLD into fibrotic MASH. The role of pioglitazone, an anti-diabetic medication, in improving MASH histology in T2DM patients is well-documented, but concerns remain regarding potential side effects like weight gain, fluid retention, cancer risk, and bone fractures. Additional therapeutic targets for MASLD and MASH include G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERR ), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery, or weight loss surgery, is the most effective intervention for treating obesity and diabetes, as it reduces food absorption while influencing gut hormone secretion and metabolic function.

To know more about MASH treatment guidelines, visit @ Metabolic Dysfunction-Associated Steatohepatitis Management

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 @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials

Metabolic Dysfunction-Associated Steatohepatitis 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.


                 Metabolic Dysfunction-Associated
                  Steatohepatitis Market Report Metrics 
     
              Details



     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 Market Market CAGR                                                                                                                    17.9 %


      Metabolic Dysfunction-Associated
       Steatohepatitis Market Size in 2023              
     USD 2.1 Billion


      Key Metabolic Dysfunction-Associated                Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim,
       Steatohepatitis Companies                           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


      Key Pipeline Metabolic Dysfunction-                 Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100
       Associated Steatohepatitis Therapies                (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

Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report

    --  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

Download the report to understand which factors are driving MASH market trends @ Metabolic Dysfunction-Associated Steatohepatitis Market Trends

Table of Contents



     1      
     Key Insights



     2      
     Report Introduction



     3      
     Country-wise MASH Market Overview at a Glance



     3.1      Country-wise Market Share (%) Distribution of MASH in 2020



     3.2      Country-wise Market Share (%) Distribution of MASH in 2034



     4      
     MASH Market Overview by Therapeutic Class



     4.1      Market Share (%) Distribution of MASH by Therapeutic Class
                in 2020



     4.2      Market Share (%) Distribution of MASH by Therapeutic Class
                in 2034



     5      
     Methodology of MASH Epidemiology and Market



     6      
     Executive Summary



     7      
     Key Events



     8      
     Disease Background and Overview



     8.1    
     Introduction



     8.2    
     Risk factors associated with MASLD and MASH



     8.3    
     Etiology of MASLD and MASH



     8.4    
     Molecular Pathogenesis of MASH



     8.5    
     Symptoms of MASH



     8.6    
     Diagnostic Approach for MASH


      8.6.1  
     Diagnostic Algorithm for MASH



     8.7    
     Treatment for MASH


      8.7.1  
     Treatment Guidelines



     9      
     Epidemiology and Patient Population



     9.1    
     Key Findings



     9.2    
     Assumptions and Rationale: 7MM



     9.3    
     Total Prevalent Cases of MASH in the 7MM



     9.4      Total Diagnosed Prevalent Cases of MASH in the 7MM



     9.5    
     The United States


      9.5.1    Total Prevalent Cases of MASH in the United States


      9.5.2    Total Diagnosed Prevalent Cases of MASH in the United States


      9.5.3    Gender-specific Diagnosed Prevalent Cases of MASH in the
                United States


      9.5.4    Severity-specific Diagnosed Prevalent Cases of MASH in the
                United States



     9.6    
     EU4 and the UK


      9.6.1  
     Total Prevalent Cases of MASH


      9.6.2  
     Total Diagnosed Prevalent Cases of MASH


      9.6.3  
     Gender-specific Diagnosed Prevalent Cases of MASH


      9.6.4    Severity-specific Diagnosed Prevalent Cases of MASH



     9.7    
     Japan


      9.7.1  
     Total Prevalent Cases of MASH in Japan


      9.7.2  
     Total Diagnosed Prevalent Cases of MASH in Japan


      9.7.3    Gender-specific Diagnosed Prevalent Cases of MASH in Japan


      9.7.4    Severity-specific Diagnosed Prevalent Cases of MASH in
                Japan



     10     
     Patient Journey



     11     
     Marketed Drugs



     11.1   
     REZDIFFRA (Resmetirom): Madrigal Pharmaceuticals


      11.1.1 
     Product Description


      11.1.2 
     Regulatory Milestones


      11.1.3 
     Other development activities


      11.1.4 
     Clinical trials information


      11.1.5 
     Safety and efficacy



     12     
     Emerging Drugs



     12.1   
     Key Cross Competition



     12.2   
     Lanifibranor (IVA337): Inventiva Pharma


      12.2.1 
     Product Description


      12.2.2 
     Other Developmental Activities


      12.2.3 
     Clinical Trials Information


      12.2.4 
     Safety and Efficacy


      12.2.5 
     Analyst Views



     12.3   
     Semaglutide: Novo Nordisk A/S



     12.4   
     Azemiglitazone (MSDC-0602K): Cirius Therapeutics



     12.5   
     Efruxifermin (EFX): Akero Therapeutics



     12.6   
     BIO89-100 (Pegozafermin): 89bio



     12.7     Survodutide (BI 456906): Boehringer Ingelheim/Zealand
                Pharma



     12.8   
     GR-MD-02 (Belapectin): Galectin Therapeutics



     12.9   
     LPCN1144: Lipocine



     12.10  
     VK2809: Viking Therapeutics



     12.11  
     Tirzepatide: Eli Lilly and Company



     12.12  
     BOS-580: Boston Pharmaceuticals



     12.13    Ervogastat (PF-06865571) + Clesacostat (PF-05221304):
                Pfizer



     12.14  
     HTD1801: HighTide Biopharma



     12.15  
     Leronlimab (PRO 140): CytoDyn



     12.16  
     Efinopegdutide: Merck & Co./Hanmi Pharmaceutical



     12.17  
     HPG1860: Hepagene (Shanghai)



     12.18  
     Rencofilstat (CRV431): Hepion Pharmaceuticals



     12.19  
     EYP001 (Vonafexor): Enyo Pharmaceuticals



     12.20    Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences



     12.21  
     PXL065: Poxel SA



     12.22  
     Saroglitazar Magnesium: Zydus Therapeutics



     12.23  
     Denifanstat (TVB-2640): Sagimet Biosciences



     12.24  
     ION224: Ionis Pharmaceuticals



     12.25  
     Miricorilant (CORT118335): Corcept Therapeutics



     13     
     MASH: Market Analysis



     13.1   
     Key Findings



     13.2   
     Key Market Forecast Assumptions


      13.2.1 
     Cost Assumptions and Rebates


      13.2.2 
     Pricing Trends


      13.2.3 
     Analogue Assessment


      13.2.4 
     Launch Year and Therapy Uptake



     13.3   
     Market Outlook



     13.4   
     Attribute Analysis



     13.5   
     Total Market Size of MASH in the 7MM



     13.6   
     Total Market Size of MASH by Therapies in the 7MM



     13.7   
     Market Size of MASH in the United States


      13.7.1 
     Total Market Size of MASH


      13.7.2 
     Market Size of MASH by Therapies



     13.8   
     Market Size of MASH in EU4 and the UK


      13.8.1 
     Total Market Size of MASH


      13.8.2 
     Market Size of MASH by Therapies



     13.9   
     Market Size of MASH in Japan


      13.9.1 
     Total Market Size of MASH


      13.9.2 
     Market Size of MASH by Therapies



     14     
     Key Opinion Leaders' Views



     15     
     SWOT Analysis



     16     
     Unmet needs



     17     
     Market Access and Reimbursement



     18     
     Appendix



     18.1   
     Bibliography



     18.2   
     Acronyms and Abbreviations



     19     
     Report Methodology



     20     
     DelveInsight Capabilities



     21     
     Disclaimer

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