Nonalcoholic Steatohepatitis (NASH) Diagnostics Market size worth USD 10,253.0 Million by 2035

Research Nester assesses the growth of global nonalcoholic steatohepatitis (NASH) diagnostics market which is anticipated to be on account of the growing prevalence of NASH and NAFLD and increasing demand for providing novel diagnostic tools.

New York – March 3, 2023 - Research Nester’s recent market research analysis on Nonalcoholic Steatohepatitis (NASH) Diagnostics: Global Demand Analysis & Opportunity Outlook 2035” delivers a detailed competitors analysis and a detailed overview of the global nonalcoholic steatohepatitis (NASH) diagnostics market in terms of market segmentation by type, end user, and by region.

Growing Prevalence of NASH and NAFLD to Drive Growth of Global Nonalcoholic Steatohepatitis (NASH) Diagnostics Market

Nonalcoholic fatty liver disease (NAFLD) is defined as the ectopic buildup of fat in the liver (hepatic steatosis) when no additional reasons for secondary liver fat accumulation exist. Moreover, the growing prevalence of NASH and NAFLD, which is a major driving factor for the global nonalcoholic steatohepatitis (NASH) diagnostics market. Over the last decade, the prevalence of nonalcoholic fatty liver disease (NAFLD) is proliferating. According to a NCBI study, the overall prevalence of NAFLD was 29.38% globally between 2000 and 2021, regardless of the diagnostic techniques. Looking at the group in which the diagnosis was made by ultrasound exclusively, the pooled prevalence was 30.49%. NAFLD became more prevalent during 2011–2021 (31.63%, 95% CI 30.23–33.04) compared with the year 2000–2010 (27.94%, 95% CI 26.23–29.69). The expanding cases of NASH and NAFLD raise the demand for better diagnostics solutions for nonalcoholic Steatohepatitis (NASH).

Moreover, the surging intake of unhealthy foods, along with the lesser physical activity, is further expected to boost the growth of the global nonalcoholic steatohepatitis (NASH) diagnostics market. In addition, there are a large number of people suffering from non-alcoholic fatty liver diseases, followed by the intake of unhealthy drinks and foods. As per the data reported by the World Health Organization, overweight and obesity are currently sharply increasing, especially in metropolitan areas, in low- and middle-income countries. The bulk of overweight or obese kids are found in emerging nations, where the rate of growth has outpaced developed nations by more than 30%.

Some of the major growth factors and challenges that are associated with the growth of the global nonalcoholic steatohepatitis (NASH) diagnostics market are:

Growth Drivers:

  • Increasing Demand for Providing Novel Diagnostic Tools
  • Surge in Adoption of Serum Markers and Score System for NAFLD and NASH Diagnosis


The stringent regulations developed by the approval bodies for biomarkers and the lack of awareness and demand in underdeveloped nations are some of the major factors anticipated to hamper the growth of the global nonalcoholic steatohepatitis (NASH) diagnostics market. Furthermore, the devices used for the diagnostics of NASH require approval for further use from the regulatory authorities. In addition, the lack of demand owing to the lower healthcare expenditure in developing countries is further expected to restrain the market’s growth in the upcoming years. The FDA, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and soon a formal regulatory framework in Europe will oversee in vitro diagnostics. Nonetheless, the companion diagnostic test necessary to choose patients receiving the therapy is taken into consideration for approval concurrently with the therapy when the FDA, EMA, and PMDA approve innovative targeted therapeutics. Thus, it is anticipated that this will hinder the market's expansion.

By type, the global nonalcoholic steatohepatitis (NASH) diagnostics market is segmented into serum biomarkers, hepatic fibrosis biomarkers, oxidative stress biomarkers, apoptosis biomarkers, and others. The serum biomarkers segment is expected to garner the highest revenue by the end of 2035, growing at a significant CAGR over the forecast period. The availability of numerous serum biomarker-based assays is expected to spur the segment’s growth in the market. Furthermore, there has been a surge in the use of serum biomarkers as a diagnostic tool, and the rising initiatives of the market players on the serum biomarkers in order to get easy approval from the regulatory bodies for the market are predicted to further boost the growth of the segment in the market. For instance, CK-18-M30, IL-1Ra, and FGF-21 are just a few serum signs that are used to analyze NASH. In addition, increases in CK-18-M30 may indicate that NASH is active. There is evidence that as NASH and fibrosis stages advance, CK-18-M30 levels increase, as per the data stated in 2022.

By region, the North American nonalcoholic steatohepatitis (NASH) diagnostics market is expected to generate the highest revenue by the end of 2035. The growth of the market can be attributed to the rising prevalence of obesity in developed nations such as the U.S., which is anticipated to fuel market expansion in the area. More than 18% of children between the ages of 2 and 19 as of the data reported in 2019 Moreover, the Asia-Pacific nonalcoholic steatohepatitis (NASH) diagnostics market is anticipated to witness the fastest growth by the end of 2035. The NAFLD disease burden is expected to increase alongside rising trends in metabolic syndrome and obesity among populations in the region; these are the major factors that are predicted to increase the growth of the market in the region. Thus, the rising burden of nonalcoholic steatohepatitis (NASH) disease cases in Asia Pacific accelerates market growth.

This report also provides the existing competitive scenario of some of the key players of the global nonalcoholic steatohepatitis (NASH) diagnostics market which includes company profiling of Echosens, Prometheus Laboratories, GENFIT SA, Siemens Medical Solutions USA, Inc., BioPredictive S.A.S, and others.

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