세계의 간섬유증 치료제 시장 : 약제 클래스별, 유통 채널별, 지역별 - 기회 및 예측(2018-2032년)

Global liver fibrosis drugs market is projected to witness a CAGR of 8.31% during the forecast period 2025-2032, growing from USD 16.68 billion in 2024 to USD 31.58 billion in 2032. The liver fibrosis drugs market is growing due to increasing disease incidence, such as NAFLD, hepatitis, and cirrhosis. These include improved drug innovation and enhanced diagnosis.

The market for liver fibrosis drugs continues its strong upward trajectory because chronic liver disease cases keep rising from obesity, type 2 diabetes, along with metabolic syndrome and other lifestyle-related disorders. The rising need for treatment solutions that control fibrosis progression in liver diseases such as non-alcoholic steatohepatitis (NASH), also known as MASH, has sparked market demand. The rising knowledge about liver disease diagnosis timing, along with effective treatment methods, has pushed the market forward. Pharmaceutical companies dedicate themselves to medical research to develop new medicines that address particular biological mechanisms that cause fibrosis. The medical field develops through an extensive drug pipeline that includes GLP-1 receptor agonists, FXR agonists, FGF21 analogs, together with siRNA-based therapies. The development of commercial opportunities gains speed through strategic partnerships along with licensing agreements between biotech firms and larger pharmaceutical companies, and their collaborative efforts. The medical field now adopts personalized medicine and combination therapies as key approaches to achieve improved outcomes for patients. The market reaches broader territories because healthcare spending increases in developing regions and regulatory frameworks provide support. The market faces ongoing obstacles because of expensive development processes, complicated regulatory systems, and limited curative treatment choices.

For instance, in May 2025, F. Hoffmann-La Roche Ltd announced the Elecsys PRO-C3 test launch as a diagnostic solution to evaluate liver fibrosis severity in metabolic dysfunction-associated steatotic liver disease (MASLD) patients. Nordic Bioscience partnered for test development which provides clinicians with an easy and effective solution to detect different levels of liver fibrosis severity so they can begin treatment and choose suitable disease management strategies.

Rising Prevalence of Liver Fibrosis Boosts Market Demand

The rising incidence of liver fibrosis is a significant contributor to the growing demand within the global treatment market. Multiple chronic liver diseases including NAFLD and MASH together with hepatitis B and C infections and excessive alcohol intake and metabolic disorders like obesity and diabetes lead to the development of liver fibrosis. The growing global prevalence of these health conditions brands both developed and emerging economies with an increasing population at risk for liver fibrosis. Most liver fibrosis cases advance without symptoms until they reach severe stages, which makes immediate detection and suitable treatment solutions more critical. The rising knowledge about the enduring effects of unhealed liver damage among both patients and healthcare professionals drives increased demand for medical interventions. Pharmaceutical companies respond to this rising burden through their research expansion, which focuses on creating specific treatments for this condition. The growing trend substantially drives the expansion of the liver fibrosis drugs market.

For instance, in November 2023, Torrent Pharmaceuticals Limited signed a licensing and supply deal with Zydus Lifesciences Limited to jointly distribute Saroglitazar Magnesium for treating NASH and NAFLD in India. Being the only approved drug for NASH and NAFLD in the country, Saroglitazar Magnesium is poised to make a significant impact in addressing and treating highly prevalent and progressive liver disorders.

Advances in Early Detection and Diagnostic Technologies Support Market Expansion

Early detection and diagnostic technology improvements serve as essential drivers for the growing liver fibrosis drugs industry. Liver biopsies functioned as the primary method to diagnose fibrosis until recent advancements introduced better alternatives which limit their use because they remain invasive procedures with potential complications. The introduction of non-invasive diagnostic tools including FibroScan and MRE together with advanced imaging techniques, has revolutionized liver fibrosis detection and monitoring procedures. These diagnostic tools enable faster and safer evaluations of liver stiffness alongside precise determination of fibrosis stages. Blood-based biomarkers and scoring systems (for example FIB-4, APRI and ELF panels) can also be used to allow diagnosis in early stages of disease, even in asymptomatic patients. The early detection of liver fibrosis by these tools expands the number of patients who require therapeutic interventions, thus boosting the market demand for antifibrotic drugs. The tools enhance clinical trial efficiency through their patient stratification capabilities and treatment response monitoring functions. The liver fibrosis treatment market experiences substantial growth due to improved diagnostics, which expand access to care while enabling timely treatment.

For instance, in August 2024, Lumos Diagnostics deepened its partnership with Burnet Diagnostics Initiative to continue developing a point-of-care ALT test for monitoring liver health. The intention of the test is for use in future clinical trials in the United States, with rapid identification of liver injury, and eventually its use at home.

Innovative Research and Development Activities Fuel Market Growth

The liver fibrosis drugs market experiences substantial growth because of innovative research and development activities. Research institutions, together with pharmaceutical companies, create better treatment options by understanding the biological mechanisms that cause liver fibrosis. The advanced medical treatments include GLP-1 receptor agonists and FGF21 analogs, along with FXR agonists and siRNA-based therapies. The novel pharmaceutical agents work to control symptoms and work toward fibrosis progression control as well as fibrosis regression. Biotechnology, together with drug delivery system improvement, develops treatments that deliver enhanced effectiveness along with better safety profiles and patient-friendly administration. Modern tools, including artificial intelligence, together with organ-on-a-chip models as well as non-invasive diagnostic technologies, improve drug discovery processes while accelerating clinical trial efficiency. The new developments shorten development periods while improving the success rates of potentially effective candidates. The uninterrupted introduction of new therapeutic solutions in development leads to more treatment choices and stronger investor trust, which ultimately drives market expansion.

For instance, in February 2025, Sagimet Biosciences Inc. announced an oral presentation at the 9th Annual MASH-TAG Conference detailing denifanstat, their oral fatty acid synthase (FASN) inhibitor. The Phase 2b FASCINATE-2 trial results have shown anti-fibrotic effects of denifanstat in patients with MASH and advanced fibrosis and support its transition into Phase 3 studies. Denifanstat received Breakthrough Therapy designation from the FDA in non-cirrhotic MASH with moderate to advanced fibrosis (F2-F3), and Sagimet seeks to engage metabolic and fibrotic pathways in MASH, a chronic liver disease affecting more than 115 million people globally.

Hospital Pharmacies Hold Largest Market Share

Hospital pharmacies hold the largest market share in the liver fibrosis drugs market because these facilities provide essential care for severe and complex liver conditions. People who have liver fibrosis need specialized treatment, which involves diagnostic testing along with regular monitoring and advanced medication administration through hospital-based settings. These specialized drugs require proper dosage and administration for patient safety, which hospital pharmacies maintain through their storage and handling capabilities. Early commercial stage antifibrotic therapies primarily reach patients through hospital distribution channels because of reimbursement systems, physician oversight, and the need for patient observation. Hospitals treat patients who require liver biopsies and those needing imaging or pre-transplant care, while also providing care for inpatient and outpatient cases, which results in high prescription volumes. The multidisciplinary teams present in hospitals enable fast diagnosis and treatment start, which makes hospital pharmacies the most trusted distribution point for liver fibrosis medications.

For instance, in June 2024, Boehringer Ingelheim International GmbH's Phase II study of survodutide produced breakthrough data with 64.5% of adults with moderate to advanced liver fibrosis (F2 and F3) and diagnosed as having MASH improving fibrosis without worsening MASH at 48 weeks, which was significantly better than placebo. Survodutide improved liver fat as well as associated metabolic markers, making it an exciting therapeutic option for MASH. Survodutide received FDA Fast Track and EMA PRIME designations and is progressing to Phase III studies. Such an innovative study helps hospital pharmacies to treat patients more effectively.

North America Dominates Liver Fibrosis Drugs Market

North America dominates the global liver fibrosis drugs market through its combination of strategic and structural benefits. The region's advanced healthcare infrastructure, together with its pharmaceutical industry, enables fast drug development and efficient regulatory processes as well as advanced distribution systems. The significant number of patients with liver conditions, which result from obesity and metabolic disorders, together with alcohol use and viral hepatitis, drives immediate investment and innovation in the region. The robust research and development infrastructure, which receives support from pharmaceutical companies (Gilead, Merck, and Bristol Myers Squibb), sustains North America's global leadership for therapies targeting fibrosis. The combination of substantial reimbursement structures and well-informed patients enables new medical treatments to achieve both market success and clinical implementation. Strong public and private investment drives pipeline activity at an accelerated pace, which helps maintain long-term leadership status. The combination of critical factors such as medical need and available capital, along with established infrastructure and innovative capabilities, cements North America's leadership position in liver fibrosis drug development, which will persist through treatment advancements.

For instance, in March 2024, Madrigal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) provided accelerated approval for Rezdiffra which represents the first oral therapeutic agent to treat noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis (stages F2 to F3) when used with diet and exercise. The approval was based on Phase 3 data showing improvement of liver fibrosis and resolution of NASH, without requiring a liver biopsy to diagnose NASH.

Impact of U.S. Tariffs on Liver Fibrosis Drugs Market

The U.S. government applies tariffs to drugs imported from China and India that contain APIs and raw materials, which heavily impact the liver fibrosis drugs market. The tariffs cause manufacturers to face higher production expenses because they depend on worldwide distribution networks for creating advanced anti-fibrotic medications. The increased production expenses lead to higher drug prices, which might restrict patient availability and increase healthcare cost burdens.

The increased costs push companies to accept reduced profit margins, which may lead to R&D delays in new liver fibrosis treatment development.

The push for domestic manufacturing as a permanent solution encounters multiple obstacles because of time constraints and infrastructure requirements, together with regulatory complexities.

The process of changing supply chains creates bigger chances of drug shortages while also increasing supply chain instability.

U.S. tariffs create financial and operational obstacles that may decrease the accessibility of liver fibrosis therapies while also slowing down their development.

Key Players Landscape and Outlook

The competitive landscape for liver fibrosis drugs is primarily driven by companies focusing on advancements in treatments that provide the basis for the regression of fibrosis. Growth is driven by robust investment in clinical trials, partnerships with clinical research institutions, and novel drug classes such as GLP-1 agonists, FGF21 analogs, and siRNA drugs are coming to market. Another way companies can compete is through regulatory pathways, utilizing fast-track reviews, and expanding indications for previously marketed drugs. The outlook remains positive as demand continues to rise due to the increased prevalence of disease and the introduction of targeted and improved diagnostics. Innovation continues to emerge relative to both single agents and combination therapy strategies. Overall, we expect continuing significant competitive activity in the liver fibrosis drugs market.

In November 2024, Novo Nordisk A/S announced headline results from part 1 of the ongoing ESSENCE trial, a pivotal Phase 3 double-blinded trial lasting 240 weeks with 1,200 Adults with metabolic dysfunction-associated steatohepatitis (MASH) with Fibrosis stages 2 or 3. In part 1 of the trial, the impact of semaglutide 2.4 mg once weekly vs a placebo in addition to standard care on liver histology was assessed over 72 weeks for the first 800 randomized participants.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Impact of U.S. Tariffs

4. Executive Summary

5. Global Liver Fibrosis Drugs Market Outlook, 2018-2032F

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Drug Class
    • 5.2.1.1. Interferon Therapy
    • 5.2.1.2. Maloti Lipid/Bile Acid Receptor Modulators/FXR Ligands
    • 5.2.1.3. Nucleoside Analog
    • 5.2.1.4. Others
  • 5.2.2. By Distribution Channel
    • 5.2.2.1. Hospital Pharmacies
    • 5.2.2.2. Retail Pharmacies
    • 5.2.2.3. Online Pharmacies
  • 5.2.3. By Region
    • 5.2.3.1. North America
    • 5.2.3.2. Europe
    • 5.2.3.3. Asia-Pacific
    • 5.2.3.4. South America
    • 5.2.3.5. Middle East and Africa
  • 5.2.4. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 5.3. Market Map Analysis, 2024
  • 5.3.1. By Drug Class
  • 5.3.2. By Distribution Channel
  • 5.3.3. By Region

6. North America Liver Fibrosis Drugs Market Outlook, 2018-2032F

• 6.1. Market Size Analysis & Forecast
  • 6.1.1. By Value
• 6.2. Market Share Analysis & Forecast
  • 6.2.1. By Drug Class
    • 6.2.1.1. Interferon Therapy
    • 6.2.1.2. Maloti Lipid/Bile Acid Receptor Modulators/FXR Ligands
    • 6.2.1.3. Nucleoside Analog
    • 6.2.1.4. Others
  • 6.2.2. By Distribution Channel
    • 6.2.2.1. Hospital Pharmacies
    • 6.2.2.2. Retail Pharmacies
    • 6.2.2.3. Online Pharmacies
  • 6.2.3. By Country Share
    • 6.2.3.1. United States
    • 6.2.3.2. Canada
    • 6.2.3.3. Mexico
• 6.3. Country Market Assessment
  • 6.3.1. United States Liver Fibrosis Drugs Market Outlook, 2018-2032F*
    • 6.3.1.1. Market Size Analysis & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share Analysis & Forecast
      • 6.3.1.2.1. By Drug Class
        • 6.3.1.2.1.1. Interferon Therapy
        • 6.3.1.2.1.2. Maloti Lipid/Bile Acid Receptor Modulators/FXR Ligands
        • 6.3.1.2.1.3. Nucleoside Analog
        • 6.3.1.2.1.4. Others
      • 6.3.1.2.2. By Distribution Channel
        • 6.3.1.2.2.1. Hospital Pharmacies
        • 6.3.1.2.2.2. Retail Pharmacies
        • 6.3.1.2.2.3. Online Pharmacies
  • 6.3.2. Canada
  • 6.3.3. Mexico

All segments will be provided for all regions and countries covered

7. Europe Liver Fibrosis Drugs Market Outlook, 2018-2032F

• 7.1. Germany
• 7.2. France
• 7.3. Italy
• 7.4. United Kingdom
• 7.5. Russia
• 7.6. Netherlands
• 7.7. Spain
• 7.8. Turkey
• 7.9. Poland

8. Asia-Pacific Liver Fibrosis Drugs Market Outlook, 2018-2032F

• 8.1. India
• 8.2. China
• 8.3. Japan
• 8.4. Australia
• 8.5. Vietnam
• 8.6. South Korea
• 8.7. Indonesia
• 8.8. Philippines

9. South America Liver Fibrosis Drugs Market Outlook, 2018-2032F

• 9.1. Brazil
• 9.2. Argentina

10. Middle East and Africa Liver Fibrosis Drugs Market Outlook, 2018-2032F

• 10.1. Saudi Arabia
• 10.2. UAE
• 10.3. South Africa

11. Value Chain Analysis

12. Porter's Five Forces Analysis

13. PESTLE Analysis

14. Pricing Analysis

15. Market Dynamics

• 15.1. Market Drivers
• 15.2. Market Challenges

16. Market Trends and Developments

17. Regulatory Framework

• 17.1. Clinical Trials
• 17.2. Regulatory Approvals

18. Patent Landscape

19. Case Studies

20. Competitive Landscape

• 20.1. Competition Matrix of Top 5 Market Leaders
• 20.2. SWOT Analysis for Top 5 Players
• 20.3. Key Players Landscape for Top 10 Market Players
  • 20.3.1. Gilead Sciences Inc.
    • 20.3.1.1. Company Details
    • 20.3.1.2. Key Management Personnel
    • 20.3.1.3. Products and Services
    • 20.3.1.4. Financials (As Reported)
    • 20.3.1.5. Key Market Focus and Geographical Presence
    • 20.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 20.3.2. Merck & Co., Inc.
  • 20.3.3. Bristol-Myers Squibb Company
  • 20.3.4. Johnson & Johnson Services, Inc.
  • 20.3.5. Novartis AG
  • 20.3.6. Vertex Pharmaceuticals Inc.
  • 20.3.7. Pfizer Inc.
  • 20.3.8. Fib Rogen Inc.
  • 20.3.9. Pharmaxis Group
  • 20.3.10. Galectin Therapeutics, Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

21. Strategic Recommendations

22. About Us and Disclaimer