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

• In June 2022, Echosens, and Novo Nordisk A/S, announced a collaboration to advance the early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease among patients, healthcare providers, and other stakeholders.

• In May 2022, Pfizer Inc. announced that the United States Food and Drug Administration (FDA) had granted Fast Track designation to Pfizer's investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi).

In this report, the Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market has been segmented by Therapeutics, Diagnostics, Diagnostic Technique, Therapeutics Technique, and Geography.

Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market, Segmentation by Therapeutics

The Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market has been segmented by Therapeutics into Elafibranor, Ocaliva, Selonsertib, Cenicriviroc, Emricasan, and Others.

Elafibranor

Elafibranor is a dual PPAR α/δ agonist under development for treating inflammation and fibrosis associated with NASH. Elafibranor is one of the most advanced drugs in the pipeline and shows promise in improving liver histology. This therapeutic segment holds 24% of the market share.

Ocaliva

Ocaliva is an FXR agonist used to treat fibrosis due to NASH. It works by regulating bile acid pathways and reducing inflammation. Ocaliva has gained significant attention in clinical trials. This segment accounts for 22% of the market share.

Selonsertib

Selonsertib is an ASK1 inhibitor aimed at reducing hepatic inflammation and fibrosis. Although some trials have shown mixed results, Selonsertib remains a notable option in therapeutic research. This segment represents 18% of the market share.

Cenicriviroc

Cenicriviroc is a CCR2/CCR5 antagonist that targets fibrotic pathways in NASH patients. It has demonstrated potential in reducing liver scarring and inflammation. This segment contributes 15% of the market share.

Emricasan

Emricasan is a pan-caspase inhibitor designed to reduce apoptosis and inflammation in NASH. It is undergoing trials for its effects on portal hypertension and liver function. This segment holds 12% of the market share.

Others

This category includes emerging treatments such as Aramchol, NGM282, and FXR agonists still in various phases of development for NASH treatment and fibrosis reversal. These therapies together represent 9% of the market share.

Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market, Segmentation by Diagnostic

The Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market has been segmented by Diagnostic into Imaging Techniques, Diagnostic Tests, and Biopsy.

Imaging Techniques

Imaging techniques such as transient elastography (FibroScan), MRI-PDFF, and ultrasound elastography are increasingly used for non-invasive assessment of liver fat and fibrosis. Imaging techniques enable early detection and treatment monitoring. This segment holds 38% of the market share.

Diagnostic Tests

Diagnostic tests include blood-based biomarkers, liver function tests, and scoring systems like FIB-4 and NAFLD fibrosis score. These tools offer less invasive and cost-effective ways to evaluate liver health and disease progression. This segment accounts for 34% of the market share.

Biopsy

Biopsy remains the gold standard for diagnosing NASH, enabling direct analysis of liver inflammation, steatosis, and fibrosis stages. Though invasive, it offers the most accurate assessment. This segment represents 28% of the market share.

Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market, Segmentation by Diagnostic Technique

The Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market has been segmented by Diagnostic Technique into Imaging - Ultrasonography (US), Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and Others, Liver Biopsy & Biomarker Diagnostics - Serum Biomarkers, Hepatic Fibrosis Biomarkers, Apoptosis Biomarkers, Oxidative Stress Biomarker, and Others.

Imaging

Imaging includes techniques such as ultrasonography (US), computed tomography (CT), and magnetic resonance imaging (MRI) which are used to assess hepatic fat accumulation and fibrosis. These non-invasive tools allow repeated monitoring of disease progression and treatment response. This segment accounts for 42% of the diagnostic technique market.

Liver Biopsy & Biomarker Diagnostics

Liver biopsy & biomarker diagnostics involve serum biomarkers, hepatic fibrosis markers, apoptosis markers, and oxidative stress biomarkers. While biopsy remains the definitive method, biomarkers are gaining traction for their non-invasive nature and growing clinical validation. This segment represents 58% of the market share in diagnostic techniques.

Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market, Segmentation by Therapeutics Technique

The Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market has been segmented by Therapeutics Technique into Pharmacologic Therapy, Steatosis/Insulin Resistance, Anti-Cytokines, and Surgical Interventions.

Pharmacologic Therapy

Pharmacologic therapy involves the use of investigational and off-label drugs targeting NASH-related inflammation, fibrosis, and metabolic dysfunction. Agents like FXR agonists, PPAR agonists, and anti-fibrotic compounds dominate this approach. This technique holds 46% of the market share.

Steatosis/Insulin Resistance

Therapies addressing steatosis and insulin resistance include metformin, pioglitazone, and newer agents that improve glucose metabolism and lipid accumulation in the liver. This segment accounts for 28% of the therapeutic technique market.

Anti-Cytokines

Anti-cytokine strategies focus on blocking pro-inflammatory pathways such as TNF-α and IL-1 to reduce liver inflammation and fibrosis. These are emerging as adjunct therapies in combination treatments. This technique represents 16% of the market share.

Surgical Interventions

Surgical interventions, including bariatric surgery, are used in advanced or co-morbid cases to reduce obesity-related hepatic damage. These are considered when pharmacologic management fails. This segment holds 10% of the therapeutic technique market.

Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market, Segmentation by Geography

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

Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market Share (%) by Geographical Region

North America

North America leads the NASH diagnostics and therapeutics market due to high prevalence of obesity and type 2 diabetes, and strong adoption of innovative treatment approaches. The region, especially the United States and Canada, also benefits from advanced clinical research infrastructure. It holds 41% of the market share.

Europe

Europe contributes significantly with increasing awareness and early detection efforts, particularly in countries like Germany, France, and the United Kingdom. Widespread access to diagnostics and clinical trials supports steady growth. The region holds 26% of the market share.

Asia Pacific

Asia Pacific is rapidly expanding due to growing incidences of metabolic syndrome, lifestyle diseases, and improving healthcare access. Key markets such as China, India, and Japan are seeing rising demand for NASH screening and therapy. This region accounts for 22% of the market share.

Middle East and Africa

Middle East and Africa are witnessing gradual adoption of NASH solutions driven by increasing urbanization, dietary changes, and initiatives in public health awareness. Countries like Saudi Arabia, UAE, and South Africa are key contributors. This region holds 6% of the market share.

Latin America

Latin America is growing steadily with enhanced focus on obesity-related liver diseases and government-backed health programs. Markets such as Brazil, Mexico, and Argentina are leading the regional adoption. This segment represents 5% of the market share.

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

Drivers

• Rising obesity prevalence
• Increasing diabetes cases
• Aging population dynamics
• Advancements in diagnostic technology

• Growing awareness campaigns: As the understanding of nonalcoholic steatohepatitis (NASH) grows globally, so too does the urgency to develop effective diagnostics and therapeutics. NASH, a severe form of nonalcoholic fatty liver disease (NAFLD), has emerged as a significant health concern worldwide due to its association with obesity, diabetes, and metabolic syndrome. With the prevalence of these risk factors rising, the incidence of NASH is also on the ascent, making it a pressing public health issue.

  To combat this growing epidemic, awareness campaigns are crucial in educating both healthcare professionals and the general public about the risks, symptoms, and consequences of NASH. These campaigns aim to promote early detection and intervention to prevent the progression of the disease to more severe stages, such as cirrhosis and liver cancer. Moreover, they advocate for lifestyle modifications, including diet and exercise, as key components of NASH management. Through these efforts, the hope is to reduce the burden of NASH on individuals and healthcare systems globally.

  Concurrently, research and development efforts are intensifying to advance the field of NASH diagnostics and therapeutics. Innovations in imaging techniques, biomarker identification, and drug discovery are underway to improve early detection and develop targeted treatments for NASH. Collaborative initiatives between academia, industry, and regulatory bodies are fostering the translation of scientific discoveries into clinical practice. Ultimately, the goal is to curb the progression of NASH and improve outcomes for affected individuals worldwide.

Restraints

• Lack of effective treatments
• Regulatory hurdles in drug development
• High diagnostic costs
• Limited healthcare access

• Potential adverse effects: The global market for nonalcoholic steatohepatitis (NASH) diagnostics and therapeutics is poised for significant growth, driven by the rising prevalence of obesity, diabetes, and other metabolic disorders worldwide. However, alongside this growth potential come several potential adverse effects.

  Firstly, despite the promising advancements in diagnostic technologies and therapeutic interventions for NASH, there remains a considerable gap in access to healthcare services, particularly in low- and middle-income countries. The high cost associated with diagnostic tests and treatment regimens could exacerbate healthcare disparities, leaving many patients undiagnosed or untreated.

  Secondly, the current lack of highly effective pharmacological treatments for NASH presents a challenge. While several drugs are in development and some have shown promise in clinical trials, none have yet received regulatory approval for the treatment of NASH. This uncertainty surrounding the efficacy and safety of emerging therapeutics may lead to patient reluctance or physician skepticism, slowing adoption rates and market growth.

  Addressing these challenges will require concerted efforts from healthcare stakeholders, including policymakers, pharmaceutical companies, and healthcare providers, to improve access to diagnostics and therapeutics, reduce healthcare costs, and accelerate the development of effective treatments for NASH. Failure to do so risks impeding progress in combating this growing public health threat and exacerbating the burden of liver disease worldwide.

Opportunities

• Novel therapeutic approaches
• Emerging markets expansion
• Collaborative research initiatives
• Personalized medicine trends

• Telemedicine integration: The integration of telemedicine into the diagnostics and therapeutics landscape for Global Nonalcoholic Steatohepatitis (NASH) presents a promising avenue for improving patient care and disease management. With NASH becoming increasingly prevalent worldwide due to factors such as sedentary lifestyles and poor dietary habits, the demand for efficient diagnostic and therapeutic solutions is escalating. Telemedicine offers a convenient and accessible platform for patients to consult with healthcare professionals remotely, facilitating early detection, monitoring, and management of NASH.

  In addition to enhancing patient access to healthcare services, telemedicine integration in NASH diagnostics enables timely screenings and early interventions, potentially reducing the progression of the disease to more severe stages. Moreover, telemedicine platforms can support comprehensive care coordination by connecting patients with multidisciplinary teams comprising hepatologists, dietitians, and mental health professionals. This holistic approach not only addresses the medical aspects of NASH but also promotes lifestyle modifications and psychosocial support, contributing to better patient outcomes and quality of life. As telemedicine continues to evolve and gain acceptance, its integration into the NASH diagnostics and therapeutics market holds significant promise for addressing the growing global burden of this metabolic disorder.

Key players in Global Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market include:

• Gilead Sciences, Inc.
• Allergan plc (now part of AbbVie)
• Novartis AG
• Pfizer Inc.
• Intercept Pharmaceuticals, Inc.
• Bristol-Myers Squibb Company
• Novo Nordisk A/S
• Genfit SA
• Madrigal Pharmaceuticals, Inc.
• Merck & Co., Inc.

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