Non-alcoholic Steatohepatitis Treatment Market Report Size Analysis:

The Global Non-Alcoholic Steatohepatitis Treatment Market size was valued at USD 7.70 billion in 2024 and is expected to reach USD 55.52 billion by 2032, growing at a CAGR of 28.05% over the forecast period 2025-2032.

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Rising global obesity, type 2 diabetes, and metabolic syndrome are driving fast expansion in the non-alcoholic steatohepatitis treatment market.

For instance, the World Health Organization reports that 16% of adults are obese and 43% of adults are overweight, therefore greatly raising the risk for non-alcoholic fatty liver disease (NAFLD) and its development into NASH.

Major causes of the NASH epidemic in the U.S. are reportedly over 38 million persons with diabetes and a 40.3% obesity rate.  Funding for research has been raised by government organizations, including the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), with the FY2025 budget reaching $2.31 billion so supporting developments in diagnostics and therapeutics for progressive liver inflammation and NASH-related comorbidities.

The worldwide increase in obesity and metabolic diseases is driving a significant increase in NAFLD and NASH cases drives the non-alcoholic steatohepatitis treatment market mostly. The World Health Organization’s 2022 data show 2.5 billion adults overweight and 890 million obese, which directly correlates with the growing burden of fatty liver disease and liver fibrosis.

Reflecting the nation's high disease frequency, strong healthcare infrastructure, and early adoption of innovative technologies, the U.S. non-alcoholic steatohepatitis treatment market accounted for approximately 76% of the NA market share in 2024, valued USD 4.56 billion in 2024 and is expected to reach USD 32.55 billion by 2032 with a CAGR of 27.88% over the forecast period.  Offering the first targeted medication for NASH with intermediate to advanced liver fibrosis and thereby supporting the U.S. leadership in NASH treatment market growth, the FDA's March 2024 approval of Rezdiffra (resmetirom) marks a historic moment.  Government funding in clinical trials for NASH medications and the development of NAFLD treatments, with the U.S. leading in regulatory approvals and research projects, also helps to encourage these non-alcoholic steatohepatitis treatment market trends.

Non-alcoholic Steatohepatitis Treatment Market Dynamics

Drivers

• Escalating Global Obesity Epidemic and Comorbid Metabolic Conditions Drive NASH Treatment Demand

The landscape of non-alcoholic steatohepatitis (NASH) treatment demand is being fundamentally changed by the substantial increase in obesity and related metabolic diseases observed globally. With 43% of adults overweight and 16% obese worldwide, the World Health Organization estimated that over 890 million adults would be obese by 2022. Direct contribution of this spike to a 32% worldwide prevalence rate of non-alcoholic fatty liver disease (NAFLD), the forerunner of NASH. Unbelievably, NASH already makes up 25–30% of NAFLD cases and is expected to be the main cause of liver transplants by 2030. The U.S. Centers for Disease Control and Prevention (CDC) underlines even further how the rising incidence of diabetes and metabolic syndrome-key risk factors for NASH continue to aggravate the disease burden.

In response, pharmaceutical companies are accelerating research, with over 78 drugs in Phase II/III clinical trials as of 2024 targeting inflammatory and fibrotic pathways. With analysts forecasting peak annual sales reaching USD 5 billion, the recent U.S. FDA clearance of Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) in March 2024 marks a significant industry milestone. As healthcare systems worldwide prepare for an increase in demand for efficient treatments to address this growing public health concern, the convergence of epidemiological trends and regulatory advances is driving unprecedented investment and innovation in the NASH treatment industry.

Restrain

• Absence of Cost-Effective Treatment Protocols Constrains Market Penetration

The lack of affordable and effective treatment options remains a significant barrier to the widespread adoption of NASH therapies, particularly in low- and middle-income countries. Although the creation of new medications such as Rezdiffra gives optimism, most patients worldwide cannot afford modern therapies since their annual cost exceeds USD 32,600. Recent statistics show that 68% of NASH patients in areas with limited resources lack access to sophisticated care; hence, present guidelines still mostly advise lifestyle changes, which have little long-term success. 

Only about 10% of patients achieve sustained weight loss through behavioural interventions, and off-label use of existing medications like vitamin E and pioglitazone provides only modest benefits, with histologic improvement seen in just 35-40% of cases. U.S. Medicare data emphasizes, even more, the financial load associated with advanced NASH since beneficiaries of this condition pay annual pharmaceutical expenses almost twice those of the average population. These financial and therapeutic constraints not only limit patient access but also deter healthcare professionals from implementing novel treatments, therefore limiting market development and leaving a significant number of the global NASH population underserved.

Non-alcoholic Steatohepatitis Treatment Market Segment analysis

By Drug

The Vitamin E and pioglitazone segment dominated the non-alcoholic steatohepatitis treatment market, with 87% of global revenue in 2024.  Strong clinical evidence and first-line management guidelines for NASH, especially in patients with insulin resistance and NASH-related comorbidities, anchor their leadership. Government and regulatory bodies such as the American Association for the Study of Liver Diseases (AASLD) have underlined a 40% increase in the accuracy of non-invasive diagnostic methods, therefore allowing early intervention with these hepatoprotective medications.  Late-stage NASH pipeline candidates, including semaglutide, which has shown dose-dependent improvements in NASH resolution in Phase 2 clinical trials, further excite the NASH drugs market.

In 2024, the FDA recognized the urgent need for advanced therapies, accelerating the approval process for anti-NASH drugs and incentivizing clinical trials for NASH drugs with fast-track and breakthrough designations.

The semaglutide, a GLP-1 receptor agonist is expected to drive significant non-alcoholic steatohepatitis treatment market growth, acting both on weight loss and liver inflammation. Significant NASH resolution rates revealed by data from a 2024 Phase 2 trial position semaglutide as a future leader in the NASH treatment market. Rising obeticholic acid market candidates and continuous clinical trials for PPAR agonists for NASH and FXR agonists reflect the worldwide liver disease burden and the need for efficient liver cirrhosis prevention.

By Disease Stage

With a 35% share in 2024, NASH Stage F1 dominated the non-alcoholic steatohepatitis treatment market, reflecting the effect of enhanced early detection and government-backed screening campaigns. Early diagnosis of growing liver inflammation made possible by the CDC's enlarged metabolic disease surveillance and adoption of non-invasive diagnostics has allowed timely management with hepatoprotective medications and lifestyle modification in NASH. NIH budgets USD 2.31 billion for metabolic and digestive disease research in FY2025, supporting early intervention programs and NASH drug clinical trials.

NASH Stage F0 is projected to experience the fastest growth, driven by the integration of advanced screening in primary care and increased public health funding for NAFLD therapeutics.  Early-stage detection has been given top priority by the NIH and CDC; the CDC notes a 10% increase in early-stage NASH diagnosis among adults with type 2 diabetes in 2024. The FDA's 2024 guidance supporting earlier therapeutic intervention supports these initiatives; this is expected to hasten the acceptance of anti-NASH drugs and liver fibrosis treatment in the F0 and F1 segments. Early-stage NASH treatment market trends are being highlighted by phase III trials for new NASH medications progressively enrolling F0 and F1 patients.

By Distribution Channel

Hospital pharmacies held a 62% non-alcoholic steatohepatitis treatment market share in 2024, supported by their management of complicated NASH cases, delivery of advanced therapies, and participation in key clinical trials for NASH drugs. Through post-marketing surveillance agreements with hospital pharmacies, the FDA guarantees a thorough investigation of drug-induced hepatotoxicity and efficacy of newly developed anti-NASH drugs.

Driven by accessibility, convenience, and the expansion of pharmacy networks, retail and specialty pharmacies are expected to see the most notable non-alcoholic steatohepatitis treatment market growth. Within five miles, over 67,000 American pharmacies service 88.9% of the population, so improving access to NAFLD treatments and hepatoprotective drugs.

For instance, Government projects such as the HHS grant program started in January 2025 help to support the integration of NASH treatment in retail environments, thus strengthening the NASH treatment market.

Non-alcoholic Steatohepatitis Treatment Market Regional Analysis

With a 78% market share in 2024, North America remains the dominant region in the non-alcoholic steatohepatitis treatment market.  The high frequency of metabolic risk factors, including obesity, type 2 diabetes, and hypertension, drives the predominance of this area.

For instance, the Centers for Disease Control and Prevention (CDC) estimates that 40.3% of U.S. adults will be obese in 2024, with over 38 million Americans living with diabetes-90–95% of them type 2 diabetics. Nearly half of all U.S. adults (116 million) also have hypertension. With the U.S. reporting around 17.5 million prevalent instances of NASH in 2024, expected to climb to 23.33 million by 2030, these figures translate into a significant patient population at risk for NAFLD and NASH.

The region also benefits from a robust biopharmaceutical ecosystem, leading non-alcoholic steatohepatitis treatment companies such as Madrigal Pharmaceuticals and Novo Nordisk drive innovation in NASH medications and NAFLD treatments.  The first liver-specific medication approved by the FDA recently has strengthened North America's position as a center for clinical trials for NASH drugs and regulatory advancement. The combination of high disease burden, advanced healthcare infrastructure, and rapid adoption of new therapies ensures that the U.S. non-alcoholic steatohepatitis treatment market will continue to set global benchmarks for market growth and innovation.

The Asia-Pacific region is set to experience the fastest CAGR of 30.2% of the non-alcoholic steatohepatitis treatment market, driven by both a large patient base and rapid healthcare innovation. China, in particular, stands out as the country with the highest number of NAFLD-afflicted individuals globally, with projections indicating 314.5 million cases by 2030. The country’s rapidly aging population is expected to reach 402 million people aged 60 and above by 2040, further increasing the risk for NASH and related comorbidities. India is emerging as a hub for drug innovation, with government initiatives promoting early diagnosis and advanced care.

For instance, in April 2024, Apollo Hospitals launched a dedicated Fatty Liver Clinic in Chennai equipped with state-of-the-art diagnostic and pharmacological solutions.

These developments, combined with rising economic prosperity and government investment, are fueling robust non-alcoholic steatohepatitis treatment market growth and expanding the regional market share.

Europe is experiencing significant non-alcoholic steatohepatitis treatment market growth, propelled by an aging population, rising obesity rates, and strong public health initiatives. For example, in Germany, the demand for new NASH drugs-including Lanifibranor and obeticholic acid (OCA)-is increasing, particularly in hospital settings that are adapting to the growing need for liver fibrosis treatment and progressive liver inflammation management. The shift toward generic drug alternatives and improved accessibility through retail and specialty pharmacies is also enhancing market penetration.  A 2020 study published by the National Library of Medicine (NLM) found that annual direct medical expenses per NASH patient ranged from USD 402 to USD 1,321 in Europe, prompting ongoing efforts to develop cost-effective treatment pathways.

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Non-alcoholic Steatohepatitis Treatment Market Key Players

The major non-alcoholic steatohepatitis treatment companies are Madrigal Pharmaceuticals Inc., Intercept Pharmaceuticals, Inc., Galmed Pharmaceuticals Ltd, Inventiva, Galectin Therapeutics Inc., Novo Nordisk A/S, NGM Biopharmaceuticals, Inc., AbbVie Inc., The Bristol-Myers Squibb Company, Gilead Sciences, Inc., and others.

Recent Developments in the Non-alcoholic Steatohepatitis Treatment Market

• In August 2024, Shilpa Medicare shares surged over 11% to a new high following positive Phase 3 trial results for SMLNUD07 (NorUDCA), a potential treatment for Nonalcoholic Fatty Liver Disease (NAFLD), a condition with limited therapeutic options.