Global Non-Alcoholic Steatohepatitis Biomarkers Market Grow Significantly at a CAGR of 22.8%

Introduction

Non-alcoholic steatohepatitis (NASH) biomarkers are biological indicators used in medicine to identify, diagnose, and track the progression of NASH, a severe form of non-alcoholic fatty liver disease (NAFLD). These biomarkers are important for monitoring liver health, determining the extent of liver damage, and directing therapy options.

Non-alcoholic steatohepatitis biomarkers market share is expanding due to increased chronic liver disease prevalence, which will likely fuel demand for non-invasive NASH diagnostic approaches. Furthermore, the sector is expanding due to introduction of new diagnostic tests.

Market Dynamics

Increasing Prevalence of NASH Drives the Global Market

As the incidence of obesity, metabolic syndrome, and diabetes rises, so does the global prevalence of NASH. NASH is often referred to as a "silent epidemic." Better early diagnosis and management biomarkers are necessary due to the rising sickness load. The United States is a prime illustration of the rising prevalence of NASH. According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NASH has become a common liver disease in the United States, surpassing hepatitis C as the leading cause of liver transplants. NASH is estimated to afflict 3% to 5% of the global population, affecting millions of people worldwide.

The prevalence of NASH in the United States has been steadily increasing due to the obesity pandemic, which affects over 80 million Americans, according to data from the National Health and Nutrition Examination Survey (NHANES). Furthermore, a study published in The Lancet Gastroenterology and Hepatology found that the global prevalence of NASH among adults is 25.2%, with regional variations. The increased prevalence of NASH is alarming due to its relation to obesity, metabolic syndrome, and diabetes. The non-alcoholic steatohepatitis biomarkers market trend emphasizes the need for early detection and management. Biomarkers are essential for identifying at-risk individuals and tracking disease development, reducing the burden on healthcare systems, and improving patient outcomes.

Advances in Biomarker Research Creates Tremendous Opportunities

Research on novel biomarkers and their accuracy and reliability could change NASH diagnosis. Recently, genetic polymorphisms have been associated with NASH and its progression to fibrosis and cirrhosis. For instance, the PNPLA3 gene variant increases NASH risk. Scientists are trying to include these genetic markers into diagnostic panels. Advances in proteomics and metabolomics have identified NASH-related protein and metabolite signatures. These advanced methods identify liver inflammation, fibrosis, and lipid metabolism indicators.

Additionally, biomarker research is also improved by machine learning and AI algorithms that examine vast datasets to find patient data patterns and linkages. These technologies help find novel biomarkers and develop NASH prediction models. Biomarker research improved NASH diagnostic accuracy and reliability. Integrating genetic, proteomic, and metabolomic data helps doctors identify at-risk individuals and stratify NASH patients by disease stage and characteristics. These innovations improve NASH diagnosis accuracy and enable personalized treatment, offering them a large NASH biomarkers market opportunity.

Regional Insights

North America dominates the market owing to higher diagnostic rates and early drug launches. Biomarker research and development funding is abundant, supporting pharmaceutical development and corporate expansion. North America also has strong regulations and reimbursement laws that promote biomarker-based diagnostics in clinical practice. The industry is driven by player movement and US test availability. The FDA awarded De Novo marketing authorization to the ELF Test, a predictive blood test for NASH disease development, in January 2022. The Quest Diagnostics-LabCorp cooperation provides the test. This allows doctors to test for a severe ailment quickly. 

However, the North American NASH biomarkers industry must harmonize diagnostic standards and verify biomarker panels. The region's outstanding healthcare facilities and research talents offer promising biomarker development and NASH-customized therapeutic chances.

European markets are expected to grow substantially. The region's NASH burden and economic impact fuel market expansion. In 2021, The European Journal of Health Economics reported that GP visits often lead to NASH diagnosis by accident. However, 79.8% of the population stays undiagnosed, signaling a big opportunity and unmet need due to a lack of understanding about the condition's symptoms. The European Association for the Study of the Liver (EASL) and other regional organizations recommend biomarkers for NASH diagnosis and treatment. Europe hosts many NASH medicine development clinical studies using biomarkers for patient selection and therapy monitoring. Pharmaceutical companies in the region are investing heavily in NASH therapy.

 

Key Highlights

• The global non-alcoholic steatohepatitis biomarkers market size was valued at USD 950 million in 2022. It is estimated to reach USD 6.03 Billion by 2031, growing at a CAGR of 22.8% during the forecast period (2023–2031).
• Based on type, the market is divided into Serum Biomarkers, Hepatic Fibrosis Biomarkers, Apoptosis Biomarkers, and Oxidative Stress Biomarkers. Serum biomarkers had an impact on market growth.
• Based on end-use, the segment can be divided into the Pharma and CRO Industry, Hospitals, Diagnostic Labs, and Academic Research Institutes. The pharmaceutical and CRO industries dominate the market.
• Depending on the region, the market is analyzed in North America, Asia-Pacific, Europe, and LAMEA. North America is the most significant global market shareholder and is estimated to grow at a healthy CAGR over the forecast period.

Competitive Players

 Competitive Landscape

The key players in the global non-alcoholic steatohepatitis biomarkers market are Genfit, Prometheus Laboratories, Siemens Medical Solutions USA Inc., BioPredictive, Quest Diagnostics, AstraZeneca, Exalenz Bioscience Ltd, Laboratory Corporation of America Holdings, Pfizer Inc., and Bristol-Myers Squibb Company.

Recent Developments

Market News

• In September 2023, GENFIT announced Nature Medicine Publication confirming NASH Diagnostic Technology Performance.
• In August 2023, Anser® Testing Collaboration with Fresenius Kabi was announced by Prometheus Laboratories.
• In September 2023, the FDA approved Siemens Healthineers' MAGNETOM Viato Mobile Magnetic Resonance Scanner.

 

Segmentation

Global Non-Alcoholic Steatohepatitis Biomarkers Market: Segmentation

By Type 

• Serum Biomarkers
• Hepatic Fibrosis Biomarkers
• Apoptosis Biomarkers
• Oxidative Stress Biomarkers
• Others

By End-Use 

• Pharma and CRO Industry
• Hospitals
• Diagnostic Labs
• Academic Research Institutes

By Region

• North America
• Asia-Pacific
• Europe
• The Middle East and Africa
• Latin America