Non-alcoholic fatty liver disease (NAFLD) Market to Reach USD 19.1 Million by 2035, Impelled by Advancements in Diagnostic Techniques

Non-alcoholic Fatty Liver Disease (NAFLD) Market Outlook 2025-2035:

The 7 major Non-alcoholic fatty liver disease (NAFLD) market reached a value of USD 13.4 Million in 2024. Looking forward, IMARC Group expects the 7MM to reach USD 19.1 Million by 2035, exhibiting a growth rate (CAGR) of 3.29% during 2025-2035. The NAFLD market is driving due to growth in the acceptance of noninvasive and less invasive diagnostic and management options: advanced imaging, biomarker assessments, and management programs based on lifestyle. Those approaches are significantly effective in both the detection of the disease process and the ability to monitor progressive disease, rather than having patients undergo an invasive liver biopsy. Emerging technologies, such as transient elastography (FibroScan), magnetic resonance imaging-proton density fat fraction (MRI-PDFF), and serum biomarkers, offer highly accurate measurements of liver fat content and fibrosis levels, increasing the accuracy of diagnosis and improving patient compliance. Such advances avoid the discomfort and risks of more traditional diagnostic approaches, providing patients with more convenient, efficient, and patient-friendly solutions. This increased interest in non-invasive diagnostics is revolutionizing the approach to NAFLD management and is associated with improved clinical outcomes.

Advances in Early Detection and Diagnostic Technologies: Driving the Non-alcoholic Fatty Liver Disease (NAFLD) Market

Advanced technologies in diagnostic and therapeutic approaches have been significantly impacting the Non-Alcoholic Fatty Liver Disease market. These advances contribute to improvements in disease management and patient outcomes. Advanced imaging techniques, including transient elastography (FibroScan), magnetic resonance imaging-proton density fat fraction (MRI-PDFF), and shear wave elastography, can allow for more accurate visualization and quantification of liver fat and fibrosis. These technologies are reducing the use of invasive liver biopsies, providing more patient-friendly, safer alternatives. Biomarker-based diagnostics complementing imaging advancements, such as serum biomarkers CK-18, ELF scores help identify early on liver inflammation and fibrosis. Molecular diagnostics employing NGS, gene expression profiling are emerging tools for identifying genetic predispositions, metabolic factors contributing to disease progression. These will lead to a tailored treatment approach. The involvement of Artificial Intelligence in imaging and diagnostics increases accuracy, thus allowing automated grouping, severity estimation, and real-time tracking of disease progression. This reduces subjective evaluations and supports more informed clinical decisions. On the therapeutical level, there has been growing prominence in non-invasive and minimal-invasive techniques. Among the non-invasive ones, some lifestyle management intervention, coupled with digital health tools, are finding widespread adoption and popularity, accompanied by continuous observation through wearable equipment on metabolic marker tracking, which offers consultation diagnosis and prescription under telemedicine technologies. In settings with few experts on hepatology, it assures early interventions along with efficient and improved delivery. The integration of modern diagnostic and therapeutic technologies fosters a paradigm shift in NAFLD management, reducing disease burden, enhancing patient engagement, and driving better long-term outcomes.

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Development of Novel Therapies and Pharmacological Treatments: Contributing to Market Expansion

The Non-Alcoholic Fatty Liver Disease (NAFLD) market is expanding with the introduction of innovative therapies combined with advanced pharmacological treatments. Emerging drug classes are being developed to target key metabolic, inflammatory, and fibrotic pathways associated with NAFLD, offering more precise and effective disease management. New oral agents, including selective thyroid hormone receptor agonists (like Resmetirom) and fibroblast growth factor analogs (such as Efruxifermin), demonstrate significant efficacy with fewer side effects, improved patient satisfaction, and better long-term outcomes. Research in biologic therapies is rapidly advancing, particularly for moderate to severe cases of NAFLD involving chronic inflammation and fibrosis. Monoclonal antibodies targeting pro-inflammatory cytokines, such as interleukin-17 (IL-17) and tumor necrosis factor-alpha (TNF-α), are being explored to mitigate inflammation and halt disease progression. Such biologics can address inflammation of the liver besides regulating immune-related elements that trigger NAFLD. The modern-day drug delivery system, ranging from liposomes and nanoparticle-based carriers to hydrogels, enables drugs to be released within the livers, providing more concentration in localized areas rather than systemic absorption. Under investigation are adjunct therapies focused on recovery of the health of the gut-liver axis and metabolic equilibrium, such as probiotics, prebiotics, and immunomodulators that strengthen natural host defenses against inflammation of the liver and dysregulation of metabolism. Combination therapies that merge metabolic regulators with anti-inflammatory or fibrosis-targeting compounds will be effective treatments for the multi-faceted pathophysiology of NAFLD. Non-invasive pharmaceutical solutions include bioactive peptides, and smaller molecule inhibitors of lipid metabolism and oxidative stress, which achieve greater popularity because of ease of administration and a patient-centric approach. Collectively, these elements shape the future of NAFLD management, promoting hopeful possibilities for effectiveness and personalization in the treatment strategy.

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Marketed Therapies in Non-alcoholic Fatty Liver Disease (NAFLD) Market

Rezdiffra (resmetirom): Madrigal Pharmaceuticals

Rezdiffra (resmetirom) is an FDA-approved oral medication indicated for adults with noncirrhotic non-alcoholic steatohepatitis (NASH) and moderate to advanced liver fibrosis. As a thyroid hormone receptor beta agonist, it works by reducing liver fat accumulation and inflammation, thereby improving liver function.

Emerging Therapies in Non-alcoholic Fatty Liver Disease (NAFLD) Market

Oltipraz: PharmaKing

Oltipraz, a dithiolethione compound, has shown potential in the treatment of NAFLD due to its antioxidant and anti-fibrotic properties. It activates the Nrf2 pathway, enhancing the expression of detoxifying and cytoprotective enzymes, which help reduce oxidative stress and liver inflammation associated with disease progression.

Lanifibranor: Inventiva Pharma

Lanifibranor is a novel pan-PPAR (peroxisome proliferator-activated receptor) agonist targeting PPARα, PPARδ, and PPARγ, showing promising efficacy in the treatment of NAFLD and NASH. It helps improve liver steatosis, inflammation, and fibrosis by modulating lipid metabolism, insulin sensitivity, and anti-inflammatory pathways. Early clinical trials have demonstrated significant histological improvements and a favorable safety profile.

Pemafibrate: Kowa Pharmaceutical

Pemafibrate, a selective PPAR-α modulator (SPPARM-α), has shown potential in the treatment of NAFLD by improving lipid metabolism and reducing liver fat accumulation. Its ability to lower triglyceride levels and enhance insulin sensitivity positions it as a promising candidate for mitigating disease progression in patients with metabolic dysfunction.

Clesacostat: Pfizer

Clesacostat is an investigational acetyl-CoA carboxylase (ACC) inhibitor developed by Pfizer for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). By inhibiting ACC, clesacostat aims to reduce hepatic lipogenesis, thereby decreasing liver fat accumulation and addressing metabolic dysfunctions associated with these conditions. It is often studied in combination with ervogastat, a diacylglycerol O-acyltransferase 2 (DGAT2) inhibitor, to target multiple pathways involved in lipid metabolism. This combination has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of NASH with liver fibrosis.

Detailed list of emerging therapies in Non-alcoholic Fatty Liver Disease (NAFLD) is provided in the final report…

Leading Companies in the Non-alcoholic Fatty Liver Disease (NAFLD) Market:

The market research report by IMARC encompasses a comprehensive analysis of the competitive landscape in the market. Across the global Non-alcoholic Fatty Liver Disease (NAFLD) market, several leading companies are at the forefront of developing integrated platforms to enhance the management of Non-alcoholic Fatty Liver Disease (NAFLD). Some of the major players include Madrigal Pharmaceuticals, PharmaKing, Inventiva Pharma, Kowa Pharmaceutical, Pfizer, and others. These companies are driving innovation in the Non-alcoholic Fatty Liver Disease (NAFLD) market through continuous research, diagnostic tools, and expanding their product offerings to meet the growing demand for Non-alcoholic Fatty Liver Disease (NAFLD).

In March 2024, The U.S. Food and Drug Administration (FDA) has approved Rezdiffra (resmetirom) for adults with noncirrhotic non-alcoholic steatohepatitis (NASH) and moderate to advanced liver fibrosis, in conjunction with diet and exercise.

Key Players in Non-alcoholic Fatty Liver Disease (NAFLD) Market:

The key players in the Non-alcoholic Fatty Liver Disease (NAFLD) market who are in different phases of developing different therapies are Madrigal Pharmaceuticals, PharmaKing, Inventiva Pharma, Kowa Pharmaceutical, Pfizer, and Others.

Regional Analysis:

Key customers of Non-alcoholic Fatty Liver Disease are the United States, Germany, France, United Kingdom, Italy, Spain and Japan. This study estimates to be the leader in the population for Non-alcoholic Fatty Liver Disease cases in the world, and on its projections from IMARC the largest market. Recently, some new therapies have been identified in Non-Alcoholic Fatty Liver Disease: advanced pharmacological agents, targeted biologics, and metabolic modulators. These are the most crucial approaches for liver inflammation, lipid accumulation, and fibrosis that give more specific treatment options. For example, selective thyroid hormone receptor agonists and fibroblast growth factor analogs are under investigation to modulate underlying metabolic dysfunctions aimed at reducing liver fat and improving fibrosis in order to eventually lead to improved clinical outcomes with fewer side effects.

Recent advances in diagnostic tools include non-invasive biomarkers and sophisticated imaging modalities, such as magnetic resonance elastography (MRE) and transient elastography (FibroScan), which help to detect NAFLD much earlier and identify progression to NASH. This aids in early targeted treatment approaches and reduces the potential for adverse effects and further deteriorating outcomes. In the meanwhile, the rising interest in research and development, new guidelines accepted for treatment, and partnerships between pharmaceutical companies, diagnostic technology providers, and research institutions have been contributing to the expansion of the NAFLD market. AI diagnostic tools and telemedicine platforms are helping to provide advanced care to remote and underserved areas, democratizing access to high-quality treatment. Regions such as North America and Europe are at the forefront of innovation with cutting-edge therapies and diagnostic solutions, thereby driving the NAFLD market toward sustained growth.

Recent Developments in Non-alcoholic Fatty Liver Disease (NAFLD) Market:

· In January 2024, Sagimet Biosciences reported positive topline results from its FASCINATE-2 Phase 2b clinical trial. The trial used denifanstat versus a placebo in NASH patients that had biopsy-confirme.stage 2 or 3 fibrosis; at week 52, with results showing oral, selective inhibitor of FASN denifanstat to make statistically significant differences from placebo as measured by improvement on both NASH resolution in the absence of worsening of fibrosis with reduction in NAS scores ≥2 units and reduction of NAS scores of ≥2 in the absence of worsening of fibrosis. Additionally, denifanstat-treated patients experienced significant fibrosis improvement by ≥1 stage without worsening NASH, and a higher proportion of patients achieved ≥30% MRI-PDFF response compared to placebo.

Key information covered in the report.

Base Year: 2024

Historical Period: 2019-2024

Market Forecast: 2025-2035

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the Non-alcoholic Fatty Liver Disease (NAFLD) market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the Non-alcoholic Fatty Liver Disease (NAFLD) market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report offers a comprehensive analysis of current Non-alcoholic Fatty Liver Disease (NAFLD) marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

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