Liver Fibrosis Drugs Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Class (Interferon Therapy, Maloti Lipid, Nucleoside Analog), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 19.12 Billion
CAGR (2026-2031)	10.02%
Fastest Growing Segment	Nucleoside Analog
Largest Market	North America
Market Size (2031)	USD 33.91 Billion

Market Overview

The Global Liver Fibrosis Drugs Market will grow from USD 19.12 Billion in 2025 to USD 33.91 Billion by 2031 at a 10.02% CAGR. The Global Liver Fibrosis Drugs Market encompasses therapeutic agents aimed at inhibiting, arresting, or reversing the excessive accumulation of extracellular matrix proteins in the liver, a condition typically resulting from chronic injury. The primary drivers propelling market growth include the escalating global incidence of chronic liver conditions, particularly metabolic dysfunction-associated steatotic liver disease and alcohol-associated liver disease. This demand is further reinforced by an aging population and rising obesity rates, which serve as fundamental catalysts for hepatic damage. According to the American Liver Foundation, in 2024, nearly 100 million Americans were affected by liver disease, underscoring the vast patient population necessitating effective therapeutic intervention.

However, a significant challenge impeding market expansion is the complexity associated with clinical development and regulatory approval. The intricate pathophysiology of fibrosis often necessitates long-term trials with invasive liver biopsies to prove efficacy, creating substantial barriers to patient recruitment and retention. This reliance on invasive diagnostics, combined with a high rate of late-stage clinical failures, complicates the development pathway and delays the commercialization of novel pharmaceutical solutions.

Key Market Drivers

The escalating global prevalence of non-alcoholic steatohepatitis, increasingly recognized as metabolic dysfunction-associated steatohepatitis, serves as the primary catalyst for the expansion of the liver fibrosis drugs market. This chronic condition, deeply intertwined with the rising tides of obesity and type 2 diabetes, propels a critical demand for therapeutics capable of arresting hepatic scarring before it progresses to irreversible cirrhosis. The sheer scale of the patient population underscores the urgency for effective interventions, as the disease burden has shifted from a silent epidemic to a priority for healthcare systems globally. According to Novo Nordisk, August 2025, in the 'Wegovy Gets Accelerated US Approval' announcement, metabolic dysfunction-associated steatohepatitis affects approximately 5% of adults in the United States, creating a massive addressable market for emerging pharmacological solutions.

Simultaneously, the market is being invigorated by a robust late-stage clinical pipeline and surging R&D investments, which are finally yielding breakthrough efficacy data after years of development challenges. Pharmaceutical companies are successfully advancing next-generation candidates, such as FGF21 analogs and GLP-1 receptor agonists, which demonstrate the capability to not only resolve metabolic dysfunction but also directly reverse existing fibrosis. This clinical progress is exemplified by recent trial outcomes; according to Akero Therapeutics, January 2025, in the 'Preliminary Topline Results from Phase 2b SYMMETRY Study', 39% of patients treated with 50mg efruxifermin experienced a reversal of cirrhosis with no worsening of the underlying disease condition. The commercial viability of these scientific advancements is already evident, as according to Madrigal Pharmaceuticals, in 2025, the company reported full-year 2024 net sales of $180.1 million for its newly approved therapeutic, validating the substantial revenue potential of effective anti-fibrotic treatments.

Download Free Sample Report

Key Market Challenges

The complexity associated with clinical development and regulatory approval serves as a primary restraint on the growth of the liver fibrosis drugs sector. Regulatory bodies often require evidence of histological improvement, which necessitates the use of invasive liver biopsies during clinical trials. This requirement creates a substantial hurdle for patient recruitment and retention, as the invasive nature of the procedure deters participation and increases trial dropout rates. Consequently, pharmaceutical companies face extended study timelines and escalated research costs, which slows the pace at which new therapies can advance through the development pipeline.

Furthermore, the intricate pathophysiology of liver fibrosis contributes to a high rate of late-stage clinical failures, leaving a significant gap between the urgent medical need and the availability of approved treatments. This bottleneck prevents the market from serving a massive and growing patient base. According to the Global Liver Institute, in 2024, metabolic dysfunction-associated steatotic liver disease was estimated to affect approximately 30 percent of the global adult population. The inability to swiftly validate and commercialize drugs for such a vast demographic directly limits revenue generation and market expansion.

Key Market Trends

The integration of non-invasive biomarkers for clinical endpoints is revolutionizing the development landscape by addressing the critical bottleneck of reliance on invasive liver biopsies. Regulatory bodies and developers are increasingly validating imaging and circulating biomarkers to serve as surrogate endpoints, which facilitates easier patient recruitment and real-time monitoring of therapeutic efficacy. This shift allows for the quantification of liver stiffness and fibrosis reduction without the risks associated with histological sampling, directly accelerating the validation of new compounds. A pivotal regulatory milestone validated this approach when, according to Fierce Biotech, August 2025, in the article 'FDA considers new liver endpoint, sending MASH stocks up', the FDA accepted a letter of intent to qualify liver stiffness measured by transient elastography as a reasonably likely surrogate endpoint for clinical trials. This regulatory flexibility is expected to significantly shorten study timelines and reduce the high failure rates historically associated with fibrosis drug development.

Simultaneously, the utilization of artificial intelligence in drug discovery is fundamentally altering the speed and precision with which anti-fibrotic candidates are identified and developed. By leveraging deep learning algorithms to analyze vast omics datasets, companies can now predict novel therapeutic targets and optimize molecular structures with unprecedented efficiency, bypassing years of trial-and-error experimentation. This technological integration is proving essential for de-risking early-stage research and accelerating the transition of compounds into clinical phases, effectively lowering the cost of innovation. The impact of this efficiency was highlighted when, according to Insilico Medicine, December 2025, in the 'Insilico Medicine Lists on Hong Kong Stock Exchange' press release, the company reported that its AI-powered platform enabled the completion of the early discovery phase for its lead fibrosis candidate in just 18 months. Such advancements underscore the critical role of computational biology in delivering viable treatments to the market more rapidly.

Segmental Insights

The Nucleoside Analog segment is recognized as the fastest-growing category in the Global Liver Fibrosis Drugs Market, driven by its essential role in treating chronic Hepatitis B infections. Since viral hepatitis is a primary precursor to liver scarring, these agents are critical for suppressing viral replication and mitigating further tissue damage. Their adoption is accelerated by a superior safety profile and higher patient tolerance compared to traditional therapies. Furthermore, consistent approvals from regulatory bodies like the U.S. FDA for antiviral regimens continue to solidify the dominant growth trajectory of this segment.

Regional Insights

North America maintains the leading position in the global liver fibrosis drugs market, driven by a high incidence of chronic liver diseases and consistent investment in pharmaceutical research. This dominance is reinforced by the presence of major industry players and a robust healthcare infrastructure that aids early disease detection. Additionally, the United States Food and Drug Administration actively supports the sector by providing clear regulatory frameworks for drug development and approval. Favorable reimbursement policies and increased focus on patient care further solidify the region's status as the primary market for liver fibrosis therapeutics.

Recent Developments

• In November 2024, Novo Nordisk announced positive headline results from Part 1 of the pivotal Phase 3 ESSENCE trial evaluating the efficacy of once-weekly semaglutide 2.4 mg. The study, which focused on adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis, met its primary endpoints. The data demonstrated a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis compared to placebo. Additionally, the company reported that a significant proportion of patients achieved resolution of steatohepatitis, supporting the planned regulatory filings for this expanded indication in the United States and Europe.
• In August 2024, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), a rare, chronic fibrotic liver disease. The approval was supported by data from the Phase 3 RESPONSE trial, where the oral PPAR delta agonist showed statistically significant improvements in biochemical markers of liver disease compared to placebo. The company noted that this new therapy offers a differentiated mechanism of action to manage inflammation and prevent the progression of liver damage in patients who do not respond adequately to standard treatments.
• In June 2024, Boehringer Ingelheim and its partner Zealand Pharma presented groundbreaking detailed data from a Phase 2 clinical trial evaluating survodutide at the European Association for the Study of the Liver (EASL) Congress. The results revealed that the dual glucagon/GLP-1 receptor agonist demonstrated a breakthrough improvement in liver health, with up to 83% of treated adults achieving statistically significant improvement in metabolic dysfunction-associated steatohepatitis (MASH). Furthermore, the study highlighted that the treatment led to clinically meaningful improvements in liver fibrosis stages without the worsening of the disease, positioning the candidate as a potentially best-in-class therapy for fibrotic liver conditions.
• In March 2024, Madrigal Pharmaceuticals achieved a historic milestone with the U.S. Food and Drug Administration (FDA) granting accelerated approval for Rezdiffra (resmetirom). This regulatory decision marked the first time a treatment was approved specifically for adults with noncirrhotic nonalcoholic steatohepatitis (NASH) and moderate to advanced liver fibrosis. The approval was based on positive Phase 3 MAESTRO-NASH trial data, which demonstrated that the once-daily oral therapy significantly resolved NASH and improved fibrosis without worsening the condition. The company highlighted that this development addresses a significant unmet medical need for patients at risk of progressing to cirrhosis.

Key Market Players

• Gilead Sciences Inc
• Merck & Co Inc
• Bristol-Myers Squibb Co
• Johnson & Johnson Services, Inc.
• Novartis AG
• Vertex Pharmaceuticals Inc
• Pfizer Inc
• FibroGen Inc
• Pharmaxis Ltd

By Drug Class	By Distribution Channel	By Region
Interferon Therapy Maloti Lipid Nucleoside Analog	Hospital Pharmacies Retail Pharmacies Online Pharmacies	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Liver Fibrosis Drugs Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Liver Fibrosis Drugs Market, By Drug Class:

• Interferon Therapy
• Maloti Lipid
• Nucleoside Analog

• Liver Fibrosis Drugs Market, By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

• Liver Fibrosis Drugs Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE