Non-Alcoholic Steatohepatitis Treatment Market By Drug Class (PPAR Agonists, FXR Agonists, GDF15 Agonists, Statins, GLP-1 Agonists, SGLT-2 Inhibitors), By Treatment Type (Drug-Based Treatment, Lifestyle Modifications, Surgical Interventions), By Route of Administration (Oral, Injectable), By End-User (Hospitals, Specialty Clinics, Home Care Settings), and By Region; Global Insights & Forecast (2023 – 2030)

As per Intent Market Research, the Non-Alcoholic Steatohepatitis Treatment Market was valued at USD 9.1 Billion in 2024-e and will surpass USD 31.9 Billion by 2030; growing at a CAGR of 23.4% during 2025-2030.

The global Non-Alcoholic Steatohepatitis (NASH) treatment market is experiencing significant growth, primarily driven by the increasing prevalence of metabolic disorders such as obesity and diabetes, along with a rising awareness of liver diseases. NASH, a progressive liver disease that can lead to cirrhosis and liver failure, has created an urgent need for effective treatments. The market is characterized by a diverse range of therapeutic options, including drug-based treatments, lifestyle interventions, and innovative drug classes such as PPAR agonists and GLP-1 agonists. The sector is highly dynamic, with major pharmaceutical companies investing heavily in clinical trials and regulatory approvals to address the unmet needs of patients suffering from this condition.

PPAR Agonists Are Largest Drug Class Owing to Their Effectiveness in Liver Health

Among the various drug classes in the NASH treatment market, PPAR agonists are the largest sub-segment. These drugs target the peroxisome proliferator-activated receptors (PPARs) involved in regulating lipid metabolism, inflammation, and insulin sensitivity in the liver. PPAR agonists, such as Elafibranor and Pemafibrate, have shown promise in reducing liver fat, inflammation, and fibrosis—key components of NASH progression. Given the widespread metabolic disturbances in NASH patients, these drugs offer a comprehensive treatment option by addressing multiple pathways that contribute to the disease.

The clinical success and extensive research into PPAR agonists have solidified their dominant role in NASH treatment. Their ability to target the underlying metabolic dysfunctions of the liver, including reducing fat accumulation and improving insulin resistance, makes them a highly attractive option in managing NASH. As more PPAR agonists enter the pipeline, this drug class is expected to continue being a leading therapeutic option in the NASH market.

Drug-Based Treatment is Largest Treatment Type Owing to Its Broad Applicability

In the treatment type segment, drug-based treatments are the largest sub-segment. Pharmaceutical therapies offer a direct approach to tackling the pathophysiology of NASH by addressing liver inflammation, fibrosis, and fat accumulation. With no current FDA-approved drugs specifically for NASH, drug-based treatments remain a crucial focus of ongoing research and development. The drug-based approach includes various classes, such as PPAR agonists, FXR agonists, GLP-1 agonists, and statins, each targeting different aspects of the disease.

The large-scale adoption of drug-based treatments can be attributed to their ability to offer therapeutic solutions across a wide patient population. As pharmaceutical companies continue to advance their NASH-specific therapies, drug-based treatments are expected to remain the cornerstone of NASH management, providing hope for effective management of the disease and potentially reducing the need for liver transplants in severe cases.

Oral Route of Administration is Fastest Growing Owing to Ease of Use

Among the routes of administration, the oral route is the fastest-growing sub-segment in the NASH treatment market. Oral medications offer significant advantages in terms of patient compliance and ease of use, especially in chronic conditions like NASH that require long-term treatment. Many of the drugs in development, including PPAR agonists and GLP-1 agonists, are being designed for oral administration, aligning with patient preferences for convenient, non-invasive treatment options.

The popularity of oral therapies is also driven by the increasing demand for at-home management of chronic diseases. Oral medications enable patients to adhere to treatment regimens without the need for frequent healthcare visits or injectable treatments, which can be inconvenient and costly. As pharmaceutical companies focus on oral formulations for NASH, the sub-segment is expected to continue to grow rapidly, meeting the needs of patients seeking convenient and effective treatments.

Hospitals Are Largest End-User Owing to High Patient Volume and Advanced Medical Infrastructure

In the end-user segment, hospitals are the largest sub-segment. Hospitals play a central role in the treatment of NASH due to their ability to provide comprehensive care for patients suffering from advanced stages of liver disease. They have the infrastructure to offer both medical and surgical interventions, including diagnostic tests, liver biopsies, and liver transplantation for patients with end-stage liver disease. Hospitals are equipped with specialized liver disease departments and highly trained healthcare professionals capable of managing the complexities of NASH treatment.

As hospitals continue to serve as the primary point of care for NASH patients, they are expected to maintain their dominance in the treatment market. With increasing investments in healthcare infrastructure and the growth of specialized centers for liver diseases, hospitals are likely to remain the largest consumer of NASH treatment drugs and therapies.

North America Leads the Market Owing to High Disease Prevalence and Advanced Healthcare Systems

North America is the largest region in the NASH treatment market, driven by the high prevalence of risk factors such as obesity, diabetes, and metabolic syndrome, all of which are major contributors to NASH. The United States, in particular, holds a significant share of the market due to its well-established healthcare infrastructure, high healthcare spending, and the increasing burden of liver diseases. Additionally, the region is home to several key players in the pharmaceutical and biotechnology industries, accelerating the development and commercialization of NASH-specific treatments.

The region's leadership in the NASH treatment market is also supported by a robust regulatory environment that facilitates the approval of new therapies, along with increasing patient awareness of liver diseases. As healthcare providers and pharmaceutical companies continue to collaborate on research and development, North America is expected to maintain its position as the dominant region in the global NASH market.

Leading Companies and Competitive Landscape

The competitive landscape of the NASH treatment market is driven by both established pharmaceutical giants and emerging biotech firms focused on liver diseases. Leading companies such as Intercept Pharmaceuticals, Gilead Sciences, Eli Lilly, and Novo Nordisk are at the forefront of developing therapies for NASH, with a strong pipeline of drug candidates in various stages of clinical trials. These companies are leveraging their expertise in metabolic diseases and liver health to advance NASH treatments that could revolutionize care for patients.

The market is highly competitive, with firms vying to gain first-mover advantage as the first FDA-approved drug for NASH. In addition to large pharmaceutical companies, smaller biotech firms are playing a critical role in innovation, especially in the development of novel therapeutic agents. Partnerships, collaborations, and mergers and acquisitions are common strategies in this sector, as companies look to strengthen their portfolios and accelerate the development of treatments. The growing market opportunity, combined with the urgent need for effective therapies, ensures that competition will remain fierce in the NASH treatment space.

List of Leading Companies:

• Intercept Pharmaceuticals, Inc.
• Gilead Sciences, Inc.
• Eli Lilly and Co.
• Novo Nordisk A/S
• Bristol-Myers Squibb Company
• Pfizer, Inc.
• Hepion Pharmaceuticals, Inc.
• Merck & Co., Inc.
• Galmed Pharmaceuticals Ltd.
• Horizon Therapeutics PLC
• Novartis AG
• Boehringer Ingelheim International GmbH
• AbbVie Inc.
• Amgen, Inc.
• Sierra Oncology, Inc.

Recent Developments:

• Intercept Pharmaceuticals received positive regulatory feedback from the FDA in early 2025 for its novel NASH treatment, expected to enter Phase III trials later in the year.
• Gilead Sciences announced a partnership with Novo Nordisk in Q4 2024 to co-develop a combination therapy for NASH, targeting liver fibrosis and metabolic disorders.
• Eli Lilly expanded its NASH drug pipeline in January 2025 with the launch of a new clinical trial for its GLP-1 agonist-based therapy aimed at addressing liver inflammation and fat accumulation.
• Bristol-Myers Squibb acquired Galmed Pharmaceuticals in December 2024 to strengthen its presence in the NASH market and add the latter's promising NASH drug candidate to its portfolio.
• Merck & Co. announced in Q1 2025 that it has completed a successful Phase II trial of its PPAR agonist for NASH treatment, marking a significant step toward regulatory submission.

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