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Liver Fibrosis Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Therapies, Epidemiology, Revenue, Statistics, Medication, and Companies by DelveInsight

Liver Fibrosis Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Therapies, Epidemiology, Revenue, Statistics, Medication, and Companies by DelveInsight

June 17
08:20 2025
Liver Fibrosis Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Therapies, Epidemiology, Revenue, Statistics, Medication, and Companies by DelveInsight
Liver Fibrosis Drugs Market
Liver Fibrosis Companies are Beijing Continent Pharmaceutical, Gilead Sciences, Galmed R&D, Hepion Pharmaceuticals, HK inno.N Corporation, Conatus Pharmaceuticals, Dr. Falk Pharma GmbH, InterMune, Bristol-Myers Squibb, Merck Sharp & Dohme LLC, Akero Therapeutics, Inc, Pfizer, AstraZeneca, and others.

(Albany, USA) DelveInsight’s “Liver Fibrosis Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Liver Fibrosis, historical and forecasted epidemiology as well as the Liver Fibrosis market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

The latest healthcare forecast report provides an in-depth analysis of Liver Fibrosis, offering comprehensive insights into the Liver Fibrosis revenue trends, prevalence, and treatment landscape. The report delves into key Liver Fibrosis statistics, highlighting the current and projected market size, while examining the efficacy and development of emerging Liver Fibrosis therapies. Additionally, we cover the landscape of Liver Fibrosis clinical trials, providing an overview of ongoing and upcoming studies that are poised to shape the future of Liver Fibrosis treatment. This report is an essential resource for understanding the market dynamics and the evolving therapeutic options within the Liver Fibrosis space.

 

To Know in detail about the Liver Fibrosis market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Liver Fibrosis Market Forecast

 

Some of the key facts of the Liver Fibrosis Market Report:

  • The Liver Fibrosis market size was valued ~USD 2,308 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034)
  • In 2023, the United States represented the largest portion of the Liver Fibrosis market, comprising around 79% of the total market size across the 7MM, surpassing other key regions such as the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • In 2023, Germany led the EU countries with the highest Liver Fibrosis market size, reaching approximately USD 99 million, while Spain had the smallest market size at around USD 59 million.
  • In 2023, supportive therapies in Japan represented a market size of approximately USD 113 million.
  • 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.
  • 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.
  • In January 2025, Alentis Therapeutics, a clinical-stage biotech company focused on developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced promising topline results from two clinical trials of lixudebart (ALE.F02), a monoclonal antibody designed to reverse organ fibrosis.
  • In January 2025, Akero Therapeutics has released preliminary topline results from its Phase IIb SYMMETRY study, evaluating efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, caused by metabolic dysfunction-associated steatohepatitis (MASH). This placebo-controlled, multicenter, double-blind, dose-ranging, randomized trial included adult participants with the condition. The primary efficacy endpoint measured the proportion of patients achieving at least a one-stage fibrosis improvement by week 36 without MASH progression.
  • 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.
  • 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.
  • The anticipated introduction of new therapies, including Efruxifermin (AKR-001), Lanifibranor, and Aramchol, is expected to significantly impact the liver fibrosis market size in the coming years.
  • Key Liver Fibrosis Companies: Beijing Continent Pharmaceutical, Gilead Sciences, Galmed R&D, Hepion Pharmaceuticals, HK inno.N Corporation, Conatus Pharmaceuticals, Dr. Falk Pharma GmbH, InterMune, Bristol-Myers Squibb, Merck Sharp & Dohme LLC, Akero Therapeutics, Inc, Pfizer, AstraZeneca, and others
  • Key Liver Fibrosis Therapies: Hydronidone capsules, Simtuzumab, Aramchol, Rencofilstat, oltipraz, IDN-6556, ZED1227, interferon gamma-1b, BMS-986263, peginterferon alfa-2b (SCH 54031), Efruxifermin, PF-06865571, Zibotentan + dapagliflozin, and others
  • The Liver Fibrosis market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Liver Fibrosis pipeline products will significantly revolutionize the Liver Fibrosis market dynamics.
  • According to DelveInsight’s assessment, the estimated total number of diagnosed prevalent cases of liver fibrosis in the 7MM was approximately 19 million in 2023.
  • In 2023, the United States recorded the highest number of diagnosed prevalent cases of liver fibrosis, with 9 million cases, and this figure is expected to increase in the future.
  • In 2023, Germany had the highest number of diagnosed prevalent cases of liver fibrosis among European countries, followed by Italy, while Spain had the fewest cases.
  • In 2023, Japan had around 2 million diagnosed prevalent cases of liver fibrosis, representing approximately 12% of the total cases in the 7MM.
  • In the US, individuals in the F1 stage of NASH were most impacted by liver fibrosis, with approximately 3 million cases reported in 2023, based on severity-specific diagnosed prevalent cases.
  • In 2023, the total diagnosed prevalent cases of NASH-related liver fibrosis in the EU4 and the UK were approximately 1 million.

 

Liver Fibrosis Overview

Liver fibrosis is the excessive accumulation of extracellular matrix proteins, including collagen, in the liver as a result of chronic liver injury. It is a progressive condition that represents a response to liver damage caused by factors such as viral hepatitis (HBV or HCV), alcohol abuse, non-alcoholic fatty liver disease (NAFLD), autoimmune disorders, or exposure to toxins and certain medications.

Fibrosis occurs when repeated injury and inflammation trigger the activation of hepatic stellate cells, which produce fibrous scar tissue. Over time, the buildup of this scar tissue disrupts the liver’s architecture and impairs its ability to function, potentially progressing to cirrhosis, liver failure, or hepatocellular carcinoma.

In its early stages, liver fibrosis is often asymptomatic. As it advances, symptoms such as fatigue, abdominal discomfort, and signs of portal hypertension (e.g., varices, ascites) may develop.

Diagnosis typically involves blood tests, imaging techniques like elastography, and liver biopsy to assess fibrosis severity. The stage of fibrosis is graded on a scale, with advanced stages indicating cirrhosis.

Management focuses on treating the underlying cause, such as antiviral therapy for hepatitis or lifestyle changes for NAFLD. Emerging antifibrotic therapies are being explored, but early intervention remains critical to prevent irreversible liver damage.

 

Get a Free sample for the Liver Fibrosis Market Forecast, Size & Share Analysis Report: https://www.delveinsight.com/report-store/liver-fibrosis-market

 

Liver Fibrosis Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Liver Fibrosis Epidemiology Segmentation:

The Liver Fibrosis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

  • Total Prevalence of Liver Fibrosis
  • Prevalent Cases of Liver Fibrosis by severity
  • Gender-specific Prevalence of Liver Fibrosis
  • Diagnosed Cases of Episodic and Chronic Liver Fibrosis

 

Download the report to understand which factors are driving Liver Fibrosis epidemiology trends @ Liver Fibrosis Epidemiology Forecast

 

Liver Fibrosis Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Liver Fibrosis market or expected to get launched during the study period. The analysis covers Liver Fibrosis market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on

market share.

The report also covers the Liver Fibrosis Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

 

Liver Fibrosis Therapies and Key Companies

  • Hydronidone capsules: Beijing Continent Pharmaceutical
  • Simtuzumab: Gilead Sciences
  • Aramchol: Galmed R&D
  • Rencofilstat: Hepion Pharmaceuticals
  • oltipraz: HK inno.N Corporation
  • IDN-6556: Conatus Pharmaceuticals
  • ZED1227: Dr. Falk Pharma GmbH
  • interferon gamma-1b: InterMune
  • BMS-986263: Bristol-Myers Squibb
  • peginterferon alfa-2b (SCH 54031): Merck Sharp & Dohme LLC
  • Efruxifermin: Akero Therapeutics, Inc
  • PF-06865571: Pfizer
  • Zibotentan + dapagliflozin: AstraZeneca

 

Discover more about therapies set to grab major Liver Fibrosis market share @ Liver Fibrosis Treatment Landscape

 

Liver Fibrosis Market Drivers

  • Rising Prevalence of Chronic Liver Diseases
  • Advancements in Diagnostic Techniques
  • Ongoing Drug Development
  • Awareness Programs
  • Government Initiatives

 

Liver Fibrosis Market Barriers

  • High Treatment Costs
  • Lack of Approved Therapies
  • Slow Diagnosis in Early Stages
  • Regulatory Challenges
  • Patient Adherence Issues

 

Scope of the Liver Fibrosis Market Report

  • Study Period: 2020–2034
  • Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
  • Key Liver Fibrosis Companies: Beijing Continent Pharmaceutical, Gilead Sciences, Galmed R&D, Hepion Pharmaceuticals, HK inno.N Corporation, Conatus Pharmaceuticals, Dr. Falk Pharma GmbH, InterMune, Bristol-Myers Squibb, Merck Sharp & Dohme LLC, Akero Therapeutics, Inc, Pfizer, AstraZeneca, and others
  • Key Liver Fibrosis Therapies: Hydronidone capsules, Simtuzumab, Aramchol, Rencofilstat, oltipraz, IDN-6556, ZED1227, interferon gamma-1b, BMS-986263, peginterferon alfa-2b (SCH 54031), Efruxifermin, PF-06865571, Zibotentan + dapagliflozin, and others
  • Liver Fibrosis Therapeutic Assessment: Liver Fibrosis current marketed and Liver Fibrosis emerging therapies
  • Liver Fibrosis Market Dynamics: Liver Fibrosis market drivers and Liver Fibrosis market barriers
  • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
  • Liver Fibrosis Unmet Needs, KOL’s views, Analyst’s views, Liver Fibrosis Market Access and Reimbursement

 

To know more about Liver Fibrosis companies working in the treatment market, visit @ Liver Fibrosis Clinical Trials and Therapeutic Assessment

 

Table of Contents

1. Liver Fibrosis Market Report Introduction

2. Executive Summary for Liver Fibrosis

3. SWOT analysis of Liver Fibrosis

4. Liver Fibrosis Patient Share (%) Overview at a Glance

5. Liver Fibrosis Market Overview at a Glance

6. Liver Fibrosis Disease Background and Overview

7. Liver Fibrosis Epidemiology and Patient Population

8. Country-Specific Patient Population of Liver Fibrosis

9. Liver Fibrosis Current Treatment and Medical Practices

10. Liver Fibrosis Unmet Needs

11. Liver Fibrosis Emerging Therapies

12. Liver Fibrosis Market Outlook

13. Country-Wise Liver Fibrosis Market Analysis (2020–2034)

14. Liver Fibrosis Market Access and Reimbursement of Therapies

15. Liver Fibrosis Market Drivers

16. Liver Fibrosis Market Barriers

17. Liver Fibrosis Appendix

18. Liver Fibrosis Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

 

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

 

Related Reports:

Liver Fibrosis Pipeline

Liver Fibrosis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key liver fibrosis companies, including Galmed Research and Development, Ltd, AstraZeneca, Galectin Therapeutics, Resolution Therapeutics, AdAlta, Novo Nordisk A/S, Sagimet Biosciences Inc., Hepion Pharmaceuticals, Inc., Pliant Therapeutics, Inc., Inipharm, GAT Therapeutics, TiumBio, INVENT Pharmaceuticals, SFA Therapeutics, among others.

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