Non-Alcoholic Steatohepatitis Biomarkers Market Report 2025

The non-alcoholic steatohepatitis biomarkers market size has grown exponentially in recent years. It will grow from $1.36 billion in 2024 to $1.7 billion in 2025 at a compound annual growth rate (CAGR) of 24.8%. The growth in the historic period can be attributed to diabetes and metabolic syndrome, awareness and screening programs, liver biopsy limitations, regulatory support, shift towards personalized medicine, clinical trials in NASH.

The non-alcoholic steatohepatitis biomarkers market size is expected to see exponential growth in the next few years. It will grow to $3.86 billion in 2029 at a compound annual growth rate (CAGR) of 22.8%. The growth in the forecast period can be attributed to emergence of novel therapies, expansion of precision medicine approaches, patient advocacy initiatives, integration of multi-omics data, enhanced patient engagement. Major trends in the forecast period include telemedicine and remote monitoring, innovative diagnostic platforms, global collaborations in research, technological advancements in biomarker discovery, integration of artificial intelligence (AI), inclusion of imaging biomarkers.

The increasing incidence of liver cancer is anticipated to drive the expansion of the non-alcoholic steatohepatitis (NASH) biomarkers market in the future. Liver cancer involves the formation of malignant tumors in the liver, which can originate in the liver itself (primary liver cancer) or spread from other areas of the body (secondary or metastatic liver cancer). NASH biomarkers are utilized in liver cancer for early detection, monitoring disease progression, and evaluating treatment response, providing prognostic information while potentially reducing the necessity for invasive procedures. For example, in 2022, the World Cancer Research Fund, a UK-based non-profit organization, reported approximately 866,136 new liver cancer cases globally, ranking it as the sixth most common cancer worldwide. As a result, the rising prevalence of liver cancer is fueling the growth of the non-alcoholic steatohepatitis biomarkers market.

The increasing demand for personalized medicine is poised to fuel the growth of the non-alcoholic steatohepatitis biomarkers market. Personalized medicine involves tailoring medical decisions, interventions, and drug therapies to individual patients. In the context of non-alcoholic steatohepatitis (NASH) biomarkers, personalized medicine facilitates precise and individualized diagnosis, the development of tailored treatment strategies, optimized drug selection, treatment response monitoring, and minimization of adverse effects. Reports from October 2022 indicate over 75,000 genetic testing products and 300 personalized medicines, highlighting the growing demand for personalized medicine and its role in driving the non-alcoholic steatohepatitis biomarkers market.

Technological advancements have emerged as a prominent trend in the non-alcoholic steatohepatitis biomarkers market, with major companies focusing on innovative solutions to enhance their market position. In October 2022, GENFIT and LabCorp entered a five-year exclusive licensing deal for GENFIT's NIS4 technology, a multi-biomarker-based algorithm designed to identify patients at risk of non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis. LabCorp will develop and commercialize a blood-based molecular diagnostic test utilizing NIS4 technology in the United States and Canada. This partnership aims to provide widespread access to healthcare professionals, demonstrating the importance of technological advancements in driving the non-alcoholic steatohepatitis biomarkers market.

Key companies in the non-alcoholic steatohepatitis (NASH) biomarkers market are concentrating on implementing Enhanced Liver Fibrosis (ELF) tests to enhance the diagnosis and monitoring of liver fibrosis, a critical aspect of NASH. The ELF Test is a blood-based diagnostic tool designed to evaluate the prognosis for patients with advanced fibrosis (F3 or F4) resulting from non-alcoholic steatohepatitis, which is a form of non-alcoholic fatty liver disease (NAFLD) characterized by liver inflammation. For instance, in January 2022, Siemens Healthineers, a Germany-based company, introduced the Enhanced Liver Fibrosis (ELF) Test. This test was the first blood test to receive De Novo marketing authorization from the FDA specifically for assessing disease progression in NASH patients. By using a simple blood sample, the ELF Test evaluates three biomarkers linked to liver fibrosis: hyaluronic acid, tissue inhibitor of metalloproteinases 1 (TIMP-1), and aminoterminal propeptide of type III procollagen (P3NP). This method eliminates the need for invasive procedures, such as liver biopsies. The test is widely available through partnerships with Labcorp and Quest Diagnostics, ensuring accessibility for patients and healthcare providers throughout the U.S.

In June 2022, Novo Nordisk A/S partnered with Echosens SA to promote early diagnosis of non-alcoholic steatohepatitis (NASH) and raise awareness among patients, medical professionals, and other stakeholders. Echosens SA, a France-based manufacturer, specializes in therapeutic monitoring and diagnostic devices.

Major companies operating in the non-alcoholic steatohepatitis biomarkers market include Genfit SA, Prometheus Laboratories Inc., Siemens Medical Solutions USA Inc., BioPredictive, Quest Diagnostics, AstraZeneca Plc., Laboratory Corporation of America Holdings, Pfizer Inc., Bristol-Myers Squibb Company, NGM Biopharmaceuticals Inc., Gilead Sciences Inc., Perspectum Diagnostics Ltd., One Way Liver SL, Enterome SA, Echosens SA, Cisbio Bioassays SAS, Celerion Inc., Boehringer Ingelheim GmbH Inc., Exalenz Bioscience Ltd., Novartis AG, Novo Nordisk A/S, Allergan PLC., Glympse Bio, HistoIndex Pte Ltd, Cirius Therapeutics, Intercept Pharmaceuticals, Viking Therapeutics, Madrigal Pharmaceuticals, Galmed Pharmaceuticals, Immuron Ltd, Metacrine.

North America was the largest region in the non-alcoholic steatohepatitis biomarkers market in 2024. Asia-Pacific is expected to be the fastest-growing region in the non-alcoholic steatohepatitis biomarkers market during the forecast period. The regions covered in the non-alcoholic steatohepatitis biomarkers market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the non-alcoholic steatohepatitis biomarkers market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Non-alcoholic steatohepatitis (NASH) is a form of liver inflammation and damage resulting from the accumulation of fat in the liver. NASH biomarkers serve as diagnostic tools to evaluate the severity of non-alcoholic steatohepatitis and assess liver damage. This condition can lead to inflammation and damage to liver cells, potentially causing cirrhosis (liver scarring) and liver failure. Biomarkers, in this context, are specific qualities that can be tested to reveal pathogenic processes, healthy biological processes, or reactions to exposure or treatment.

The primary types of NASH biomarkers include hepatic fibrosis biomarkers, serum biomarkers, oxidative stress biomarkers, apoptosis biomarkers, and others. Hepatic fibrosis biomarkers are specifically designed to assess hepatic fibrosis, an exaggerated wound healing response leading to excessive connective tissue formation in the liver. These biomarkers are utilized in the treatment of various diseases, including hypertension, heart disease, high blood lipids, type 2 diabetes, and obesity. NASH biomarkers find applications across various end-users, including research institutes and academics, diagnostic centers, pharmaceutical companies and contract research organizations (CROs), hospitals and clinics, among others.

The non-alcoholic steatohepatitis biomarkers market research report is one of a series of new reports that provides non-alcoholic steatohepatitis biomarkers market statistics, including non-alcoholic steatohepatitis biomarkers industry global market size, regional shares, competitors with a non-alcoholic steatohepatitis biomarkers market share, detailed non-alcoholic steatohepatitis biomarkers market segments, market trends and opportunities, and any further data you may need to thrive in the non-alcoholic steatohepatitis biomarkers industry. This non-alcoholic steatohepatitis biomarkers market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The non-alcoholic steatohepatitis biomarkers market consists of sales of biomarkers such as apolipoprotein A1, apolipoprotein B, leptin and adiponectin. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

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