Global Nonalcoholic Steatohepatitis Treatment Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

The global nonalcoholic steatohepatitis (NASH) treatment market is segmented by drug, test type, and distribution channel, reflecting the multifaceted approach to diagnosing and managing this chronic liver condition.

By drug, the market includes insulin sensitizers, antioxidants, bile acid derivatives, and anti-inflammatory drugs. Insulin sensitizers, such as pioglitazone, dominate this segment, given their ability to improve insulin resistance—a key contributor to NASH. Antioxidants like vitamin E are widely used due to their role in mitigating oxidative stress, a critical factor in NASH progression. Emerging treatments, including bile acid derivatives and anti-inflammatory agents, are gaining attention as they target underlying pathophysiological mechanisms, offering promise for disease modification. The pipeline for NASH drugs remains robust, with numerous candidates undergoing clinical trials, highlighting significant growth potential.

By test type, the market is categorized into blood tests, imaging tests, and liver biopsy. Imaging tests, such as elastography and MRI-based techniques, hold a significant share due to their non-invasive nature and ability to assess liver fibrosis. Blood tests, including biomarkers like ALT, AST, and emerging panels, are essential for initial screening and monitoring. Despite its invasive nature, liver biopsy remains the gold standard for definitive diagnosis, particularly in research and cases requiring histological confirmation. The increasing reliance on non-invasive diagnostic tools is anticipated to drive the adoption of advanced technologies in this segment.

By distribution channel, the market includes hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies dominate due to the critical nature of NASH management, often requiring specialized care and access to prescribed therapies. Retail pharmacies play a significant role in serving outpatient and long-term management needs, particularly for oral medications and supplements. Online pharmacies are witnessing growth, driven by the convenience of remote ordering and rising digital adoption among patients managing chronic conditions. This channel is particularly advantageous in regions with limited access to physical healthcare facilities.

This segmentation underscores the evolving landscape of the NASH treatment market, driven by advancements in drug development, diagnostic capabilities, and accessibility. The increasing prevalence of NASH, attributed to rising obesity and metabolic syndrome rates, underscores the urgency for effective treatments and diagnostic solutions. As research and awareness progress, the market is poised for growth, with a focus on innovative therapies and improved diagnostic methods to enhance patient outcomes and disease management.

Global Nonalcoholic Steatohepatitis Treatment Segment Analysis

In this report, the Global Nonalcoholic Steatohepatitis Treatment Market has been segmented by Drug, Test Type, Distribution Channel and Geography.

Global Nonalcoholic Steatohepatitis Treatment Market, Segmentation by Drug

The Global Nonalcoholic Steatohepatitis Treatment Market has been segmented by Drug into Cenicriviroc, Elafibranor, Ocaliva (Obeticholic acid) and Selonsertib.

Cenicriviroc is an investigational drug that targets inflammation and fibrosis in NASH. It works by blocking two chemokine receptors, CCR2 and CCR5, which are involved in the recruitment and activation of inflammatory cells in the liver. Clinical trials have shown promising results in reducing fibrosis progression in NASH patients, positioning it as a potential therapy for those with advanced liver damage.

Elafibranor is another investigational drug that acts as a dual agonist of PPAR-alpha and PPAR-delta receptors. By targeting these receptors, Elafibranor aims to improve lipid metabolism, insulin sensitivity, and reduce inflammation in the liver. It has shown efficacy in improving liver enzymes and histology in NASH patients with or without diabetes in clinical trials, making it a promising candidate for the treatment of this complex metabolic disorder.

Ocaliva is currently approved for the treatment of primary biliary cholangitis (PBC) and has been investigated for its potential in treating NASH. It is a potent agonist of the farnesoid X receptor (FXR), which regulates bile acid synthesis and plays a role in lipid metabolism. Clinical studies have demonstrated improvements in liver enzymes and fibrosis markers in NASH patients, although its use requires careful monitoring due to potential side effects such as pruritus.

Selonsertib is an investigational drug that targets apoptosis signal-regulating kinase 1 (ASK1), a protein involved in cell death and inflammation pathways. By inhibiting ASK1, Selonsertib aims to reduce inflammation and fibrosis in the liver. Clinical trials have shown mixed results, with some studies demonstrating improvements in liver fibrosis but others not meeting primary endpoints. Further research is ongoing to determine its efficacy and safety profile.

Global Nonalcoholic Steatohepatitis Treatment Market, Segmentation by Test Type

The Global Nonalcoholic Steatohepatitis Treatment Market has been segmented by Test Type into Blood Tests; Liver Biopsy, and Imaging Procedures.

Blood tests are fundamental for initial screening and monitoring disease progression in NASH patients. Commonly used biomarkers include alanine aminotransferase (ALT) and aspartate aminotransferase (AST), which indicate liver inflammation or damage. Other emerging blood panels, such as the NAFLD fibrosis score and FibroTest, provide non-invasive means to assess fibrosis levels, reducing reliance on invasive procedures. These tests are widely adopted due to their accessibility, cost-effectiveness, and suitability for regular monitoring.

Liver biopsy remains the gold standard for definitive diagnosis of NASH, particularly in cases requiring detailed assessment of inflammation, steatosis, and fibrosis. While highly accurate, it is an invasive procedure associated with potential risks and patient discomfort. Due to these limitations, liver biopsy is typically reserved for cases where non-invasive tests yield inconclusive results or when histological confirmation is essential for clinical decision-making.

Imaging procedures, such as ultrasound elastography, magnetic resonance elastography (MRE), and computed tomography (CT) scans, are gaining prominence due to their non-invasive nature and ability to assess liver fat content and fibrosis levels effectively. These advanced techniques enable comprehensive evaluation of liver health without the need for invasive interventions. As technology evolves, imaging procedures are becoming more accurate and widely accessible, complementing blood tests in routine NASH management.

This segmentation highlights the diverse diagnostic approaches available in the NASH treatment market, emphasizing the balance between accuracy, invasiveness, and patient convenience. The growing preference for non-invasive methods is driving advancements in blood tests and imaging technologies, reducing reliance on traditional biopsy procedures.

Global Nonalcoholic Steatohepatitis Treatment Market, Segmentation by Distribution Channel

The Global Nonalcoholic Steatohepatitis Treatment Market has been segmented by Distribution Channel into Hospital Pharmacy, Retail Pharmacy and Online Pharmacy.

Hospital pharmacies play a critical role in the distribution of medications for severe cases of NASH where close monitoring and specialized care are required. They typically stock a wide range of medications, including those used in advanced stages of liver disease management. Hospital pharmacies ensure that patients receive appropriate dosages and are closely monitored for any adverse effects or interactions with other medications.

Retail pharmacies serve as the primary distribution channel for medications used in the ongoing management of NASH. Patients visit retail pharmacies to fill prescriptions for medications that help manage symptoms, improve liver function, or support overall health. These pharmacies provide convenience and accessibility, allowing patients to easily refill prescriptions and receive counseling from pharmacists on proper medication use.

The rise of online pharmacies has revolutionized access to medications for chronic conditions like NASH. Online pharmacies offer convenience by allowing patients to order medications from the comfort of their homes and have them delivered directly. This channel is particularly beneficial for patients who may have difficulty accessing traditional brick-and-mortar pharmacies due to mobility issues or geographic constraints. Online pharmacies also provide a platform for patients to access specialty medications that may not be readily available locally.

Each distribution channel plays a crucial role in ensuring that patients with NASH have access to the medications they need for effective management and treatment. The choice of distribution channel may depend on factors such as the severity of the disease, patient preferences, and the availability of specific medications. As the landscape of healthcare delivery evolves, these channels continue to adapt to meet the growing demand for NASH treatments worldwide.

Global Nonalcoholic Steatohepatitis Treatment Market, Segmentation by Geography

In this report, the Global Nonalcoholic Steatohepatitis Treatment Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Nonalcoholic Steatohepatitis Treatment Market Share (%), by Geographical Region, 2024

North America, particularly the United States, holds a prominent position in the global NASH treatment market. The region is characterized by a high prevalence of obesity and related metabolic disorders, which are primary risk factors for NASH. The healthcare system in North America supports extensive research and development efforts, leading to a robust pipeline of novel therapies. Clinical trials and approvals for NASH drugs are often initiated or first implemented in this region, making it a key driver of innovation.

Europe follows closely behind North America in terms of market size and innovation in NASH treatment. Countries in Western Europe, such as Germany, France, and the United Kingdom, have well-established healthcare systems that prioritize chronic disease management. The prevalence of NASH is rising in Europe due to changing lifestyles and dietary habits, prompting increased investments in both pharmaceutical development and healthcare infrastructure.

The Asia Pacific region is experiencing rapid growth in the NASH treatment market, driven by rising obesity rates, urbanization, and changing dietary patterns. Countries like China, Japan, and India are witnessing an increase in diagnosed cases of NASH, leading to heightened awareness and demand for effective treatments. Pharmaceutical companies are expanding their presence in Asia Pacific to capitalize on these emerging opportunities, although regulatory challenges and varying healthcare access across different countries remain significant factors.

In the Middle East and Africa, the prevalence of NASH is also on the rise, paralleling global trends in obesity and metabolic syndrome. Access to healthcare varies widely across the region, with countries like Saudi Arabia and the UAE investing heavily in healthcare infrastructure and pharmaceutical imports. However, challenges such as underdiagnosis and limited access to specialized treatments remain barriers to effective NASH management in many parts of this region.

Latin America presents a growing market for NASH treatment, driven by increasing urbanization, dietary changes, and a rising prevalence of obesity and diabetes. Countries like Brazil, Mexico, and Argentina are seeing a rise in NASH cases, prompting greater attention from healthcare providers and pharmaceutical companies. Regulatory frameworks and healthcare access are improving in some Latin American countries, facilitating better diagnosis and treatment options for patients with NASH.

This report provides an in depth analysis of various factors that impact the dynamics of Global Nonalcoholic Steatohepatitis Treatment Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Obesity
• Diabetes
• Metabolic syndrome

• Awareness - Awareness about Nonalcoholic Steatohepatitis (NASH) is crucial for early diagnosis, effective management, and prevention of disease progression. NASH is often asymptomatic in its early stages, making awareness campaigns essential to educate both healthcare providers and the general public about its risks and implications. These efforts aim to promote timely screenings and interventions, reducing the burden of advanced liver disease and associated complications.

  Healthcare professionals play a pivotal role in raising awareness by integrating NASH screening protocols into routine health assessments, especially for patients with risk factors such as obesity, diabetes, and metabolic syndrome. Educational initiatives targeted at clinicians emphasize the importance of recognizing subtle signs of liver dysfunction and conducting appropriate diagnostic tests like imaging and blood work. Early detection allows for timely interventions, potentially halting disease progression and improving long-term outcomes for patients.

  In addition to healthcare providers, public awareness campaigns are essential for empowering individuals to recognize symptoms like fatigue, abdominal discomfort, and unexplained weight loss that could indicate underlying liver problems. These campaigns also emphasize lifestyle modifications such as adopting a healthy diet, regular physical activity, and avoiding excessive alcohol consumption, all of which can mitigate the risk of developing NASH. By fostering a proactive approach to liver health and disease prevention, increased awareness contributes to better health outcomes and reduced healthcare costs associated with managing advanced stages of NASH.

Restraints

• Limited approved treatments
• Diagnostic complexity
• Stringent regulatory hurdles

• High development costs - High development costs pose a significant challenge in the field of Nonalcoholic Steatohepatitis (NASH) treatment, impacting both pharmaceutical companies and healthcare systems. The complexity of NASH as a disease, coupled with stringent regulatory requirements and the need for extensive clinical trials, contribute to these elevated costs. Developing effective treatments for NASH involves various stages, from early research and preclinical studies to large-scale clinical trials involving thousands of patients over several years.

  Pharmaceutical companies face substantial expenses in conducting comprehensive research to understand the underlying mechanisms of NASH and identify potential therapeutic targets. This initial phase often requires significant investment in scientific expertise, laboratory resources, and experimental models to validate drug candidates before advancing to human trials. Moreover, the lengthy and resource-intensive clinical trial process, which includes phases for safety, efficacy, and regulatory approval, adds to the overall development costs.

  For healthcare systems and providers, the high cost of developing NASH treatments translates into increased expenses for accessing and providing these therapies to patients. The pricing of approved drugs reflects the investment made by pharmaceutical companies, often resulting in higher treatment costs. This financial burden can limit patient access to medications, especially in regions with constrained healthcare budgets or where reimbursement policies are restrictive.

Opportunities

• Increasing patient population
• Advancements in diagnostics and therapeutics
• Expanded drug pipeline

• Personalized medicine approaches - Personalized medicine approaches offer promising avenues for improving the treatment of Nonalcoholic Steatohepatitis (NASH), tailoring therapies to individual patient characteristics for enhanced efficacy and safety. These approaches utilize advancements in genetics, biomarkers, and patient data to customize treatment strategies, moving away from a one-size-fits-all approach to healthcare.

  One key aspect of personalized medicine in NASH involves genetic profiling and identifying specific genetic variations that predispose individuals to the disease or influence their response to treatment. Genetic markers can help predict disease progression, severity, and likelihood of response to certain medications. This information enables healthcare providers to make informed decisions about treatment options and adjust therapies accordingly, optimizing outcomes for patients.

  Personalized medicine in NASH integrates biomarker testing to monitor disease progression and treatment response more accurately. Biomarkers such as liver enzymes, fibrosis markers, and lipid profiles provide real-time insights into the efficacy of interventions, allowing for timely adjustments in treatment plans. Non-invasive imaging techniques, such as transient elastography (FibroScan), also play a crucial role in assessing liver fibrosis progression and guiding personalized treatment decisions.

Key players in Global Nonalcoholic Steatohepatitis Treatment Market include;

• AstraZeneca Plc.
• Conatus Pharmaceuticals
• Enzo Biochem, Inc.
• GENFIT SA
• Galmed Pharmaceuticals Ltd.
• Gilead Sciences
• Immuron Ltd.
• Intercept Pharmaceuticals

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis