Liver Fibrosis Market to Witness Rapid Growth at a CAGR of ~24% During the Forecast Period (2025-2034) with Emerging Treatment Options | DelveInsight

DelveInsight's analysis forecasts liver fibrosis market growth due to the introduction of emerging therapies, expecting an increase in market size during the study period (2020–2034). 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.

LAS VEGAS, May 13, 2025 /PRNewswire/ -- Liver fibrosis is a gradually worsening condition marked by excessive collagen buildup resulting from ongoing liver damage. This abnormal wound-healing response distorts the liver's structure, potentially progressing to cirrhosis, portal hypertension, and ultimately liver failure.

Previously, liver steatosis was categorized as NAFLD and its more inflammatory subtype, NASH. However, to better reflect its metabolic roots, updated terminology such as MASLD and MASH has been introduced. These, along with other classifications like MASL, NASL, and MetALD, fall under the broader umbrella of Steatotic Liver Disease (SLD), offering improved diagnostic precision by emphasizing metabolic dysfunction. DelveInsight's assessment estimated around 8.3 million diagnosed prevalent cases of liver fibrosis across the seven major markets in 2024, with this figure expected to rise by 2034.

Management of liver fibrosis involves a multifaceted approach due to its complex nature. Treatments include biological and pharmacological therapies, lifestyle and dietary changes, and surgical interventions, all aimed at halting disease progression and preserving liver function. Key therapeutic targets include fibrogenic pathways such as LOXL2 inhibition, antiviral treatments for viral causes, FXR agonists like obeticholic acid, and metabolic modulators to reduce inflammation and fibrotic buildup. Tailoring therapies to the underlying cause of fibrosis is crucial, underscoring the importance of personalized treatment strategies.

To know more about liver fibrosis treatment options, visit @ New Treatment for Liver Fibrosis

The approval of REZDIFFRA (resmetirom) in March 2024 represents a major advancement in the treatment of noncirrhotic MASH with moderate to advanced fibrosis. This groundbreaking therapy targets the root causes of MASH and brings renewed hope to patients affected by the condition. Clinical trials have shown impressive results, with REZDIFFRA significantly reducing inflammation and fibrosis, improving liver function, and enhancing patients' quality of life. Its approval marks a critical addition to the limited treatment options available, with the potential to lessen complications from progressive liver disease.

Madrigal Pharmaceuticals aims to roll out REZDIFFRA across Europe starting with Germany in the second half of 2025, pending EMA approval for REZDIFFRA, making it the first authorized therapy for MASH-related liver fibrosis in the region. Furthermore, updated two-year data from the MAESTRO-NAFLD-1 trial, released in February 2025, indicate possible benefits for patients with compensated MASH cirrhosis, suggesting an expanded scope of clinical effectiveness.

Madrigal's choice to commercialize REZDIFFRA independently in Europe presents both potential benefits and notable challenges. On one hand, it enables the company to retain full control and capture the entire value of the product. On the other, it faces the complexities of navigating Europe's fragmented healthcare landscape without a regional partner, which heightens the uncertainty around regulatory approvals and market uptake.

The company expects a decision from the European Medicines Agency (EMA) by mid-2025, with launches rolling out on a country-by-country basis, starting in Germany in the second half of 2025. If approved, Madrigal Pharmaceutical's REZDIFFRA would become the first authorized treatment for MASH liver fibrosis in Europe.

Learn more about the FDA-approved liver fibrosis drugs @ Drugs for Liver Fibrosis Treatment

The treatment landscape is evolving rapidly, with various competitive threats emerging. Notable competitors include Inventiva Pharma's Lanifibranor (IVA337), Akero Therapeutics' Efruxifermin, Sagimet Biosciences' Denifanstat, 89bio's Pegozafermin, Novo Nordisk's WEGOVY (semaglutide), and others.

In addition, several liver fibrosis drugs are currently being developed at various stages, including HU6 from Rivus Pharmaceuticals, LPCN 1144 from Lipocine, MN-001 from MediciNova, Icosabutate from NorthSea Therapeutics, Lixudebart (ALE.F02) from Alentis Therapeutics, PHIN-214 from PharmaIN, and FXR314 from Organovo.

Competing liver fibrosis therapies in advanced clinical stages, including Inventiva's lanifibranor and Akero Therapeutics' efruxifermin, pose direct competition. Lanifibranor, in particular, offers a differentiated pan-PPAR agonist approach, potentially competing with REZDIFFRA's efficacy and safety profile.

Discover which therapies are expected to grab major liver fibrosis market share @ Liver Fibrosis Market Report

Efruxifermin (EFX) is Akero Therapeutics' primary candidate for MASH treatment. This Fc-FGF21 fusion protein is designed to replicate the natural activity of FGF21, a hormone that reduces cellular stress and helps regulate metabolism. EFX offers the convenience of once-weekly subcutaneous injections and is being developed for pre-cirrhotic MASH (F2-F3) and compensated cirrhosis due to MASH (F4). Early results suggest that EFX could potentially become a leading treatment for MASH if approved. In January 2025, Akero Therapeutics announced the completion of patient enrollment in the Phase III SYNCHRONY Real-World study for MASH or MASLD (F1-F4), with results expected in the first half of 2026.

Pegozafermin (BIO89-100) is a compound that activates the fibroblast growth factor 21 (FGF21) receptor, a hormone involved in glucose and lipid metabolism. It has shown promise as a therapeutic for MASH. In January 2025, the company emphasized its strong position for the year, with ongoing Phase III trials in MASH. It expects to release topline data from its first Phase III trial in late 2025. The company is also conducting two Phase III trials—ENLIGHTEN-Fibrosis for non-cirrhotic MASH (F2-F3) patients and ENLIGHTEN-Cirrhosis for compensated cirrhotic MASH (F4) patients—both of which are actively enrolling global patients.

BOS-580 (Efimosfermin Alfa) is a long-acting, once-monthly FGF21 analogue in development for MASH. This investigational fusion protein targets three FGF21 receptors for a balanced pharmacological effect. In November 2024, Boston Pharmaceuticals reported positive Phase II data for BOS-580 in F2/F3 MASH at AASLD 2024. The treatment showed significant improvement in fibrosis (≥1 stage) with no worsening of MASH after 24 weeks. Two-thirds of patients treated with BOS-580 achieved significant MASH resolution without worsening fibrosis, compared to placebo. The Phase II trial also showed reductions in liver injury markers, fibrosis, and improvements in metabolic health. BOS-580 has demonstrated low discontinuation rates in clinical trials, with gastrointestinal issues being the most common side effects. In June 2024, data presented at EASL Congress 2024 highlighted significant improvements in lipid profiles with BOS-580 treatment.

Denifanstat, a selective fatty acid synthase (FASN) inhibitor, is advancing in Phase III trials for MASH, targeting De Novo Lipogenesis (DNL) to reduce palmitate production. In October 2024, Sagimet Biosciences concluded successful end-of-Phase II discussions with the US FDA, moving denifanstat into Phase III trials. The FASCINATE-3 trial focuses on non-cirrhotic MASH (F2/F3), and FASCINIT examines patients with suspected or confirmed MASLD/MASH. In February 2025, Sagimet announced lipidomic data from the Phase IIb FASCINATE-2 trial, focusing on triglycerides and LDL cholesterol in advanced fibrosis, which will be presented at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium. The US FDA granted denifanstat Breakthrough Therapy (BTD) and Fast Track Designation (FTD) for non-cirrhotic MASH with moderate to advanced fibrosis.

Survodutide, a dual GLP-1/glucagon receptor agonist, is also in Phase III development for MASH and fibrosis, targeting key metabolic pathways. In October 2024, Boehringer Ingelheim initiated the LIVERAGE trials, including LIVERAGE for MASH with fibrosis and LIVERAGE-Cirrhosis for MASH with cirrhosis. The US FDA granted Survodutide BTD for non-cirrhotic MASH with fibrosis, while the European Medicines Agency (EMA) included it in its Priority Medicines (PRIME) scheme for NASH. Boehringer Ingelheim and Zealand Pharma received US FDA support, highlighting Survodutide's potential to address unmet needs in MASH treatment.

Discover more about drugs for liver fibrosis in development @ Liver Fibrosis Clinical Trials

The anticipated launch of these emerging therapies for liver fibrosis are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the liver fibrosis treatment market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

DelveInsight estimates that the market size for liver fibrosis is expected to grow from USD 2.1 billion in 2024, with a significant CAGR of ~24% by 2034. This anticipated growth in the liver fibrosis market is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of liver fibrosis, which together foster higher demand for innovative and effective therapies.

DelveInsight's latest published market report, titled as Liver Fibrosis Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the liver fibrosis country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The liver fibrosis market forecast report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Liver Fibrosis Diagnosed Prevalent Cases
• Liver Fibrosis Severity-specific Diagnosed Prevalent Cases
• Total Liver Fibrosis Diagnosed Prevalent Cases (≥F2 Stage) in MASH

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM liver fibrosis market. Highlights include:

• 10-year Forecast
• 7MM Analysis
• Epidemiology-based Market Forecasting
• Historical and Forecasted Market Analysis upto 2034
• Emerging Drug Market Uptake
• Peak Sales Analysis
• Key Cross Competition Analysis
• Industry Expert's Opinion
• Access and Reimbursement

Download this liver fibrosis market forecast report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the liver fibrosis treatment market. Also, stay abreast of the mitigating factors to improve your market position in the liver fibrosis therapeutic space.

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