Non-Alcoholic Steatohepatitis Market By Drug Class (Antidiabetic Drugs, Antioxidants, Anti-inflammatory Drugs, Anti-fibrotic Drugs, Other), By Disease Stage (NASH Stage F0, NASH Stage F1, NASH Stage F2, NASH Stage F3, NASH Stage F4), By Route of Administration (Oral, Injectables, Topical), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, Clinics), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Non-Alcoholic Steatohepatitis market accounted for USD 2.67 Billion in 2024 and is expected to reach USD 43.21 Billion by 2035, growing at a CAGR of around 28.8% between 2025 and 2035. The Non-Alcoholic Steatohepatitis Market is the healthcare field associated with the identification, treatment, and management of NASH. This illness results from fatty Liver inflammation and damage, without involving alcohol intake. It is an unrelenting disease that if not managed can lead to cirrhosis of the liver or liver failure.

Some of the drug families contain Anti-diabetic drugs, Antioxidants, Anti-inflammatory drugs, and Anti-fibrotic drugs that target inflammation and liver fibrosis. Increased incidence of obesity and diabetes and the need to find a more efficient treatment for these diseases characterize the market. Since there are no approved treatments for NASH, drugs and treatment options for the disease have become a popular market among pharmaceutical businesses and healthcare facilities.

Report Scope:

Market Dynamics

Rising obesity rates are increasing the prevalence of non-alcoholic steatohepatitis (NASH) worldwide.

Obesity is among the most serious global health threats; new figures accompany emerging poor eating habits, a sedentary lifestyle, and environmental conditions. Obesity acts as a major risk factor for non-alcoholic fatty liver disease (NAFLD), thus making a direct input into the cause of non-alcoholic steatohepatitis (NASH), a more severe form of NAFLD. NASH is characterized by fat deposition in the liver leading to inflammation, injury to liver cells, and fibrosis that may progress to cirrhosis or hepatocellular carcinoma. Obesity, most especially excess central obesity has been shown to cause insulin resistance and general metabolic dysregulation, which are some of the factors that precipitate NASH. Since obesity rates are increasing globally, NASH poses a massive threat to the world's growing populations, particularly in North America, Europe, and parts of Asia.

Growing healthcare awareness is leading to earlier detection and better management of NASH.

The incidence of liver diseases such as non-alcoholic steatohepatitis has only become known recently, and therefore the symptoms of liver disease are easily recognizable, and more individuals are presented to clinicians with liver diseases. New awareness programs combined with improvement in the medical curriculum have brought a new level of awareness both among the patient population and the healthcare workers to the symptoms and risks that are associated with NASH thus fueling the non-alcoholic steatohepatitis market. Screening with different imaging techniques and biochemical tests like liver function tests for NASH has facilitated the identification of the disease at an earlier stage than when severe liver damage occurred. Further, with increased insight, healthcare workers are applying preventive measures such as dietary changes, physical activity, pharmacotherapy, and surveillance. Consequently, patients are now more likely to be provided early with correct regimens that can halt the advancement of the disease or hinder the development of complications such as liver cirrhosis or cancer.

High treatment costs make NASH therapies less accessible to a broader patient population.

The treatment of NASH is costly, making it inaccessible to many patients, especially in developing nations. New chemicals and procedures, which include the latest drugs and processes such as liver transplant are costly, and therefore inaccessible to most patients. It also becomes economically costly to healthcare systems because NASH spends a long time in the background before going to higher levels that need substantial intervention.

Consequently, many people with NASH, especially those with middle and low insurance types, or without insurance at all, do not receive proper diagnosis or proper treatment. Such economic disparities widen the health disparities, and high-risk groups are unable to obtain proper health care. Lowering the overall cost of NASH treatment is critical due to the still limited availability of this disease therapy and the potential worsening of NASH in the patient population.

The development of novel therapeutics offers hope for more effective NASH treatments.

New drugs targeting NASH appear to be on the horizon thus pointing to better treatment and which could be cheaper. Present treatments available are symptomatic and have failed to target certain pathophysiologic processes of the disease like inflammation and fibrosis of the liver. Targeting metabolic pathways, fibrosis, and liver regeneration could offer additional specific treatments that are less invasive and have fewer side effects than presently used drugs. These advances can lower more general costs of NASH treatment overall like hospitalizations and liver transplantation through a decrease in the advancement of the disease. Moreover, new treatments may result in lesser expenses as they may save additional costs occasioned by complications, which may necessitate expensive operations and other treatments. When available, these therapies and their derivatives have the potential to enhance NASH treatment availability to additional clients and the non-alcoholic steatohepatitis market.

Expanding healthcare infrastructure provides greater access to NASH diagnosis and management.

A major factor affecting NASH diagnosis and management is health facilities, and it is thus important that new ones are developed across the world, especially in developing regions. Several modalities of diagnosing NASH are currently available since the initial stages of the disease are frequently asymptomatic. Healthcare infrastructure in the context of the non-steatohepatitis market can be improved by better-trained healthcare professionals, diagnostic technologies, and availability of NASH specialists, to enable early diagnosis and to avoid expensive downstream consequences.

The availability of specialty treatment can also enhance a patient's condition and cut costs that would require the application of costly solutions including liver transplants or hospital embroidering. However, equality in access to care means that as a nation it is provided to people from all sorts of backgrounds, including rural or poorly endowed with resources, to help them contain the disease and avoid its advancement.

Industry Experts Opinion

“Nearly 10-20% of SLD patients can develop fibrosis in the liver and finally end up in a condition called cirrhosis of the liver, which is irreversible. Some of them can progress to develop liver cancer as well. If SLD can be picked up early and monitored, these complications can be prevented, and fatty liver is reversible. Once there is liver cirrhosis, a liver transplant may be the only cure. Since fatty liver in early stages is reversible, early detection with appropriate lifestyle modifications and medications at the right time is the simple mantra for a healthy life."

• Dr Adarsh CK, Chief Consultant Gastroenterologist and Hepatologist at Gleneagles BGS Hospital

Segment Analysis

Based on the drug class, the Non-Alcoholic Steatohepatitis Market is classified into Antidiabetic Drugs, Antioxidants, Anti-inflammatory Drugs, Anti-fibrotic Drugs, and others. Antidiabetic drugs are used for managing insulin resistance in NASH patients, among others. Antioxidants were designed to modulate oxidative stress which is one of the mechanisms involved in liver pathology in NASH. Nonsteroidal agents are used to control inflammation in the liver while antifibrotics are useful in controlling the progression of fibrosis in the liver. Further, other drugs may encompass drugs with more extensive or ill-defined action on NASH such as metabolic drugs or experimental drugs.

Based on the disease stage, the Non-Alcoholic Steatohepatitis Market is divided into NASH Stage F0, NASH Stage F1, NASH Stage F2, NASH Stage F3, and NASH Stage F4. In Stage F0, no significant liver damage has been done and some simple lifestyle changes may be effective. NASH Stage F1 only includes mild fibrosis on liver biopsy, whereas Stage F2 and F3 depict moderate to advanced fibrosis which will require pharmacologic intervention. NASH Stage F4 involves cirrhosis – the highest degree of liver injury, which may require even more intense or investigational treatments of the accompanying manifestations. Disease stage segmentation is going to play a significant role in the overall prognosis of the disease and in which treatment planning needs to be executed for patients at any stage of NASH.

Regional Analysis

North America, there is a surge in the Non-Alcoholic Steatohepatitis Market due to such factors as obesity, diabetes, and metabolic syndrome that are prevalent in the region. Currently, the USA occupies a leading position in terms of growth rates, primarily due to the higher level of disease awareness, the availability of new diagnostic techniques, and the increased number of NASH transplants in liver disease. The government’s initiatives to support liver disease research and the growing focus on non-invasive diagnostic tools further boost market growth. Another factor that will define a generous size of the market in the coming years is the localization of the main pharmaceutical companies and their active involvement in the development of NASH drugs. Also, a large healthcare facility and reimbursement models in the North American region positively impact the market growth.

The Asia-Pacific region is the fastest-growing region in the Non-Alcoholic Steatohepatitis Market, especially China, India and Japan. It is indicated that the increase in the incidence of metabolic diseases, urbanization, and changed diet are causing the increase in the incidence of NASH in these countries. The rising number of people with risk factors like obesity and diabetes in these countries further fuels market demand. Moreover, the enhancement of healthcare structures and the growth of investment in the medical sector also contribute to the development of the products in the NASH market in the region. Due to rising knowledge of liver diseases as well as the availability and launch of new therapies, this region is forecasted to have the fastest adoption of NASH treatments in the Asia-Pacific region.

Competitive Landscape

The Non-Alcoholic Steatohepatitis market is currently characterized by increased competition as the number of patients with this disease increases, and the need for effective treatment becomes apparent. Some of the companies that are engaged in drug development include Intercept Pharmaceuticals, Gilead Sciences, Novo Nordisk, and others; most of these companies are focusing on identifying novel therapies aimed at staging the disease. These approaches include anti-fibrotic therapies, metabolic modifiers, and immunomodulatory therapy.

Currently, there is no well-accepted therapy for NASH, but late-stage contenders are Apple, leading to cutthroat competition. Also, the market is highly innovative, with a focus on creating drugs with more effective therapeutic profiles for patients with an increased risk for complications and more unmet medical needs in this diverse and difficult field. Because of this, the market is young and competitive, drawing not only traditional big pharma but also new entrants in the form of biotech companies.

Non-Alcoholic Steatohepatitis Market, Company Shares Analysis, 2024

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Recent Developments:

• In August 2024, Shilpa Medicare completed phase-3 clinical studies of its novel product SMLNUD07 - Nor Ursodeoxycholic Acid (NorUDCA) tablets that are expected to revolutionize the treatment of patients suffering from Nonalcoholic Fatty Liver Disease (NAFLD).
• In March 2024, the FDA Approves Rezdiffra, the First Drug for NASH, a Form of Fatty Liver Disease. Rezdiffra, made by Madrigal Pharmaceuticals, is a daily pill that activates a thyroid hormone receptor that reduces liver fat accumulation.

Report Coverage:

By Drug Class

• Antidiabetic Drugs
• Antioxidants
• Anti-inflammatory Drugs
• Anti-fibrotic Drugs
• Other

By Disease Stage

• NASH Stage F0
• NASH Stage F1
• NASH Stage F2
• NASH Stage F3
• NASH Stage F4

By Route of Administration

• Oral
• Injectables
• Topical

Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
• Clinics

By Region

North America

• The U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Intercept Pharmaceuticals
• Genfit
• Gilead Sciences
• Madrigal Pharmaceuticals
• Bristol-Myers Squibb
• Pfizer
• Novo Nordisk
• AbbVie
• Eli Lilly and Company
• Hepion Pharmaceuticals
• Tiziana Life Sciences
• Merrimack Pharmaceuticals
• Siegfried Holding
• Theravance Biopharma
• Durect Corporation
• Astellas Pharma
• Viatris
• Belite Bio

Frequently Asked Questions (FAQs)