• In February 2024, Intercept Pharmaceuticals acquired a pipeline of NASH drug candidates from a smaller biotech, bolstering its therapeutic pipeline for NASH and fatty liver disease. This strategic move aims to accelerate drug development and expand treatment options.

• In September 2022, Gilead Sciences received approval for its NASH therapy, broadening its offerings in liver disease treatment. This milestone enhances Gilead’s ability to address the growing NASH treatment market with innovative therapeutics.

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 Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Rising global obesity and diabetes prevalence
• Increasing awareness of liver-related disorders
• Growing demand for non-invasive diagnostics

• Advances in biomarker-based diagnostic tools - Playing a transformative role in the NASH diagnostics landscape. The traditional reliance on liver biopsy—a painful, invasive, and often expensive procedure—is rapidly being replaced by non-invasive biomarker technologies that offer quicker and safer diagnosis. These innovations are not only increasing physician and patient confidence but are also accelerating the detection of early-stage NASH, which is critical for effective therapeutic intervention.

  Companies and research institutions are heavily investing in genomic, proteomic, and metabolomic biomarkers that can pinpoint disease progression with high specificity and sensitivity. Blood-based markers such as cytokeratin-18, and imaging techniques like FibroScan and MR elastography, are gaining clinical traction. These solutions reduce patient burden and support broader population screening, making diagnostics more accessible and acceptable.

  Moreover, the development of companion diagnostics integrated with emerging therapeutic candidates is enabling precision medicine approaches in NASH care. This convergence of diagnostics and therapeutics is streamlining treatment decisions and improving patient outcomes. As these technologies evolve, the market is likely to witness stronger regulatory approvals, reimbursement support, and product adoption.

  In summary, the shift toward advanced biomarker diagnostics is a pivotal driver for the NASH diagnostics market. It supports early detection, facilitates real-time monitoring, and aligns with the global move toward personalized healthcare. As stakeholders prioritize innovation and data-driven diagnostics, the sector is poised for sustainable growth.

Restraints

• Lack of approved pharmacological treatments
• High cost of NASH drug development
• Invasive diagnostic procedures limiting adoption

• Limited awareness among general population - A significant barrier in the growth of the NASH diagnostics and therapeutics market. Despite the rising prevalence of obesity and metabolic syndrome, the lack of clear symptoms in early NASH stages leads to underdiagnosis. Many individuals remain unaware of the condition until it progresses to irreversible liver damage, often requiring intensive treatment or even transplant.

  Public health initiatives and educational campaigns around liver health and NASH are still in their infancy, especially in developing regions. Compared to better-known liver diseases like hepatitis B or C, NASH receives considerably less attention, resulting in fewer health check-ups, screenings, or referrals. This results in a lower number of diagnosed cases and limited market penetration for diagnostic and therapeutic products.

  The issue is further compounded by insufficient training and awareness among primary care providers. Many general practitioners are not fully equipped to detect early signs or refer patients for specialized diagnostics. As a result, the condition often gets misdiagnosed or overlooked entirely, impacting early intervention and timely treatment.

  Until significant efforts are made to improve public and healthcare professional awareness of NASH, this restraint will continue to hinder market growth. Collaborative efforts by government agencies, pharmaceutical companies, and healthcare providers are necessary to address this gap and drive early diagnosis through better outreach and educational strategies.

Opportunities

• Development of innovative diagnostic technologies
• Expansion of clinical research funding
• Collaborations in drug discovery pipelines

• Increasing focus on early disease detection - A powerful growth opportunity for the NASH diagnostics and therapeutics market. With the disease often remaining silent in its early stages, there is growing consensus on the need for proactive screening, especially among high-risk populations such as those with obesity, type 2 diabetes, and metabolic syndrome. This proactive approach enables intervention before severe liver fibrosis or cirrhosis develops.

  Healthcare systems across the globe are adopting preventive healthcare frameworks to reduce long-term costs and disease burden. This paradigm shift is driving investments in screening programs and the integration of NASH testing into routine check-ups. Government agencies and private stakeholders are launching pilot programs that include liver function screening panels, particularly in regions with high prevalence of lifestyle diseases.

  Additionally, advancements in AI-powered imaging tools and algorithm-based screening platforms are making it easier to identify early-stage NASH non-invasively. These tools enable primary care settings to screen and triage patients efficiently, reducing referral delays and increasing diagnostic throughput. As these technologies become more scalable and cost-effective, their uptake is expected to grow.

  Overall, the global healthcare shift toward early detection and disease prevention aligns perfectly with the need to identify NASH before it progresses. This opportunity not only improves patient prognosis but also supports market expansion across diagnostics, therapeutics, and healthcare services targeting chronic liver conditions.

Key players in 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
• Market Share Analysis
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis