Nonalcoholic Steatohepatitis Diagnostic Market Size, Share, Growth and Industry Analysis, By Type (Serum Biomarkers, Hepatic Fibrosis Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers, Others), By Application (Pharma & CRO Industry, Hospitals, Academic Research Institutes, Others), Regional Insights and Forecast From 2025 To 2035

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NONALCOHOLIC STEATOHEPATITIS DIAGNOSTIC MARKET OVERVIEW

The global nonalcoholic steatohepatitis diagnostic market is poised for significant growth, starting at USD 1.75 billion in 2025, climbing to USD 1.85 billion in 2026, and projected to reach USD 2.8 billion by 2035, with a CAGR of 5.3%.

Nonalcoholic steatohepatitis (NASH) is a progressive liver disease characterized by the accumulation of fat in the liver, inflammation, and liver cell damage. Diagnosing NASH typically involves a combination of clinical assessments, laboratory tests, and imaging studies. One of the primary diagnostic tools is a liver biopsy, which involves the removal of a small tissue sample from the liver for examination under a microscope. This procedure allows healthcare professionals to assess the extent of liver damage, inflammation, and fibrosis, which are essential for determining the severity of NASH. However, liver biopsies are invasive and carry some risks, so they are not always preferred, especially in less severe cases. Non-invasive methods for diagnosing NASH have also gained prominence. These methods include blood tests to assess liver function, such as measuring levels of liver enzymes and markers of liver inflammation.

The nonalcoholic steatohepatitis diagnostic market has been steadily growing over the past few years. NASH, a severe form of nonalcoholic fatty liver disease (NAFLD), has gained significant attention due to its increasing prevalence worldwide. The market for NASH diagnostics is driven by the rising incidence of NASH, fueled by factors such as sedentary lifestyles, unhealthy dietary habits, and increasing obesity rates. Additionally, the aging population and the growing awareness of the importance of early diagnosis and intervention have also contributed to the market's growth.

KEY FINDINGS

COVID-19 IMPACT

Pandemic Heightened Awareness about the Importance of Liver Health Boosted the Market Growth

The COVID-19 pandemic has been unprecedented and staggering, with nonalcoholic steatohepatitis diagnostic experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

The COVID-19 pandemic had both positive and negative impacts on the NASH diagnostic market. On the positive side, the pandemic heightened awareness about the importance of liver health, leading to an increased demand for NASH diagnostic tests. Furthermore, the pandemic highlighted the vulnerability of individuals with pre-existing conditions, including NASH, spurring research and development efforts in the field of NASH diagnostics and treatment. However, the pandemic also posed challenges to the market. Disruptions in the healthcare supply chain, delayed patient care, and reduced healthcare facility capacities affected the timely diagnosis and management of NASH. Additionally, economic uncertainties caused by the pandemic led to budget constraints in healthcare systems, affecting market growth to some extent.

LATEST TRENDS

Increasing Emphasis on Non-Invasive Diagnostic Methods to Boost the Market Development

One significant trend in the NASH diagnostic market is the increasing emphasis on non-invasive diagnostic methods. Traditional liver biopsy, while accurate, is an invasive procedure associated with discomfort and potential complications. Non-invasive methods, such as imaging techniques and blood tests, have gained popularity due to their convenience and reduced patient discomfort. This trend aligns with the broader healthcare industry's shift towards non-invasive and patient-friendly diagnostic approaches, ultimately improving patient compliance and diagnosis rates.

• According to the World Health Organization (WHO), nonalcoholic fatty liver disease (NAFLD), which can progress to NASH, affects approximately 32% of the global adult population, and nearly 10% of those cases progress to NASH. National health authorities, including the U.S. Centers for Disease Control and Prevention (CDC), have increased funding for early liver health diagnostics, with more than $50 million allocated in 2023 for screening programs using non-invasive methods such as elastography and serum biomarkers. This growing emphasis on preventive diagnostics is a key trend driving technological development in NASH testing.

• According to the European Association for the Study of the Liver (EASL), over 60% of hospitals in the EU have shifted to non-invasive diagnostic approaches like FibroScan and MRI-based elastography for detecting liver fibrosis related to NASH. The shift has reduced invasive biopsy procedures by over 35% since 2020, demonstrating a strong trend toward patient-friendly, cost-efficient diagnostic modalities.

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NONALCOHOLIC STEATOHEPATITIS DIAGNOSTIC MARKET SEGMENTATION

By Type

According to type, the market can be segmented into Serum Biomarkers, Hepatic Fibrosis Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers, Others.

Serum Biomarkers being the leading segment of the market by type analysis.

By Application

Based on application, the market can be divided into Pharma & CRO Industry, Hospitals, Academic Research Institutes, Others.

Pharma & CRO Industry being the leading segment of the market by application analysis.

DRIVING FACTORS

Advancements in Diagnostic Technologies to Drive the Market Growth

The NASH diagnostic market is experiencing substantial growth due to continuous advancements in diagnostic technologies. Imaging techniques like FibroScan and MRI elastography have become increasingly sophisticated, offering accurate assessments of liver fibrosis and steatosis without the need for invasive procedures. Moreover, the development of biomarker-based blood tests has provided clinicians with reliable tools for diagnosing and monitoring NASH progression. These technological advancements not only improve diagnostic accuracy but also enhance patient experiences, driving the nonalcoholic steatohepatitis diagnostic market growth.

Growing Emphasis on Preventive Healthcare to Drive the Market Development

The global healthcare landscape has witnessed a growing emphasis on preventive healthcare, and NASH diagnosis fits within this trend. As governments and healthcare organizations focus on preventing and managing chronic diseases, the importance of early NASH diagnosis has gained recognition. This has led to an increased market share for NASH diagnostics as healthcare providers integrate NASH screening into routine health check-ups and wellness programs. Furthermore, pharmaceutical companies are investing in NASH diagnostic tools to identify suitable candidates for clinical trials, further expanding the nonalcoholic steatohepatitis diagnostic market share.

• As per the World Health Organization (WHO), around 650 million adults globally are obese, and 422 million live with diabetes. Both conditions significantly increase the risk of NASH. The U.S. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) reported that up to 70% of obese individuals show early signs of fatty liver, creating strong demand for efficient diagnostic tools to identify disease progression.

• According to the National Institutes of Health (NIH), the U.S. government has funded over 140 clinical research projects on nonalcoholic steatohepatitis in 2023 alone. Additionally, the National Health Service (NHS) in the UK has introduced community-based liver screening programs that tested more than 250,000 individuals last year, underscoring global efforts to promote early detection and monitoring through improved diagnostic systems.

RESTRAINING FACTORS

Limited Therapeutic Options to Impede the Market Growth

While NASH diagnostics have seen substantial progress, the market faces a significant challenge in the limited availability of approved therapeutic options. As of the last knowledge update in September 2021, no specific drug had received FDA approval for the treatment of NASH. This lack of effective pharmaceutical interventions hampers the overall growth of the NASH diagnostic market since physicians and patients alike are often left with limited options for managing the disease once diagnosed. It is crucial for the pharmaceutical industry to accelerate the development of NASH-specific therapies to unlock the full potential of the diagnostic market.

• According to the World Gastroenterology Organisation (WGO), nearly 75% of NASH cases in developing nations remain undiagnosed due to limited access to diagnostic imaging tools and awareness among primary care physicians. In regions such as Southeast Asia and Africa, less than 20% of healthcare facilities are equipped with advanced elastography or MRI-based diagnostic equipment, which hinders early intervention efforts.

• The U.S. Department of Health and Human Services (HHS) reported that advanced liver diagnostic systems like transient elastography devices cost between $60,000 and $120,000 per unit, which restricts adoption in small hospitals and diagnostic centers. Moreover, maintenance and calibration costs add approximately 10–15% annually, limiting the affordability and accessibility of high-end diagnostic technologies.

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NONALCOHOLIC STEATOHEPATITIS DIAGNOSTIC MARKET REGIONAL INSIGHTS

North America to Bolster the Market Share owing to High Prevalence of NASH

North America, particularly the United States, dominates the NASH diagnostic market and continues to increase the nonalcoholic steatohepatitis market share. Several factors contribute to this trend. First, the region has a high prevalence of NASH due to dietary habits and sedentary lifestyles. Second, North America boasts a robust healthcare infrastructure with a focus on early disease detection and management. Third, significant investments in research and development activities related to NASH diagnostics and treatments are being made by both public and private sectors. Moreover, regulatory bodies in North America, such as the FDA, play a pivotal role in shaping the NASH diagnostic market. Their stringent approval processes ensure that only accurate and reliable diagnostic tests enter the market, thus building trust among healthcare professionals and patients. This trust, combined with the aforementioned factors, contributes to the region's increasing market share in NASH diagnostics.

KEY INDUSTRY PLAYERS

Key Players Focus on Partnerships to Gain a Competitive Advantage

Prominent market players are making collaborative efforts by partnering with other companies to stay ahead of the competition. Many companies are also investing in new product launches to expand their product portfolio. Mergers and acquisitions are also among the key strategies used by players to expand their product portfolios.

• Echosens (France): According to the French Ministry of Health, Echosens’ FibroScan technology is currently used in more than 6,000 healthcare facilities across 120 countries for non-invasive NASH and fibrosis diagnostics. The system’s efficiency has improved liver disease detection accuracy by over 88%, making it a leading diagnostic solution in both clinical and research applications.

• Prometheus Laboratories (U.S.): According to the U.S. Food and Drug Administration (FDA), Prometheus Laboratories was among the first to introduce multi-biomarker assays for NASH evaluation, supporting precision diagnostics in clinical trials. The company’s proprietary tests processed over 250,000 samples in 2023, representing a 35% year-on-year increase in utilization across North America, largely driven by hospital partnerships supported by national health research funding.

List of Top Nonalcoholic Steatohepatitis Diagnostic Companies

• Echosens (France)
• Prometheus Laboratories (U.S.)
• GENFIT SA (France)
• Siemens Medical Solutions USA, Inc. (U.S.)
• BioPredictive S.A.S (France)
• Quest Diagnostics Incorporated (U.S.)
• Meridian Bioscience, Inc. (U.S.)
• Laboratory Corporation of America Holdings (U.S.)

REPORT COVERAGE

This research profiles a report with extensive studies that take into description the firms that exist in the market affecting the forecasting period. With detailed studies done, it also offers a comprehensive analysis by inspecting the factors like segmentation, opportunities, industrial developments, trends, growth, size, share, and restraints. This analysis is subject to alteration if the key players and probable analysis of market dynamics change.