Non-Alcoholic Steatohepatitis Biomarkers Market

Market Overview

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). The global prevalence of NASH is increasing as the prevalence of obesity, metabolic syndrome, and diabetes rises, promoting market growth.

Non-alcoholic steatohepatitis (NASH) biomarkers are biological indicators used in the medical field to identify, diagnose, and track the evolution of NASH, a severe form of non-alcoholic fatty liver disease (NAFLD). These biomarkers are critical in assessing liver health, detecting the extent of liver damage, and directing therapy options.

Non-alcoholic steatohepatitis biomarkers market share is increasing due to increased chronic liver disease prevalence, which is expected to drive demand for non-invasive diagnostic techniques for NASH diagnosis. Furthermore, the industry is growing due to the introducing of new diagnostic tests.

Market Dynamics

Global Non-Alcoholic Steatohepatitis Biomarkers Market Drivers:

Increasing Prevalence of NASH

The global prevalence of NASH is increasing as the prevalence of obesity, metabolic syndrome, and diabetes rises. NASH is frequently described as a "silent epidemic." better early identification and management biomarkers are required because of the increasing illness load. The United States is a notable example of the increasing frequency of NASH. NASH has become a widespread liver disease in the United States, surpassing hepatitis C as the top cause of liver transplants, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). NASH is believed to impact between 3% and 5% of the global population, affecting millions of people globally. According to data from the National Health and Nutrition Examination Survey (NHANES), the prevalence of NASH in the United States has been continuously rising due to the obesity pandemic, which affects over 80 million Americans.

In addition, according to research published in The Lancet Gastroenterology and Hepatology, the global prevalence of NASH among adults is 25.2%, with regional variations. The rising prevalence of NASH is concerning because of its link to obesity, metabolic syndrome, and diabetes. The non-alcoholic steatohepatitis biomarkers market trend highlights the need for early detection and good management. Biomarkers are critical in identifying at-risk patients and monitoring disease progression, ultimately decreasing the load on healthcare systems and improving patient outcomes.

Global Non-Alcoholic Steatohepatitis Biomarkers Market Restraints:

Lack of Standardization

The lack of established biomarker panels and diagnostic criteria for NASH can result in test result variability and diagnostic accuracy. Many biomarker panels, imaging modalities, and clinical assessments are used to diagnose NASH, but there is no universally approved strategy. This lack of standardization can impede consistent and accurate NASH diagnosis, making it difficult for healthcare providers to decide based on biomarker results.

The lack of established NASH diagnostic criteria and biomarker panels contributes to clinical decision-making confusion. Healthcare providers may experience difficulties interpreting and comparing test data, which can impede consistent and accurate NASH diagnosis. This lack of uniformity can impede the provision of consistent care to NASH patients and the development of appropriate treatment methods. It underlines the importance of working together to develop uniform diagnostic standards and validate biomarker panels for NASH diagnosis.

Global Non-Alcoholic Steatohepatitis Biomarkers Market Opportunity:

Advances in Biomarker Research

Ongoing research efforts to identify new biomarkers and evaluate their accuracy and reliability can change NASH diagnosis. Recent research has linked genetic variations to an elevated risk of NASH and its development into fibrosis and cirrhosis. The PNPLA3 gene variation, for example, has been related to an increased risk of developing NASH. Researchers are working hard to figure out how to incorporate these genetic markers into diagnostic panels. Furthermore, advances in proteomics and metabolomics have resulted in identifying distinct protein and metabolite signatures linked with NASH. These sophisticated approaches enable the detection of specific biomarkers associated with liver inflammation, fibrosis, and lipid metabolism.

Furthermore, machine learning and artificial intelligence (AI) algorithms that can analyze large datasets to uncover patterns and relationships in patient data improve biomarker research. These technologies aid in the identification of new biomarkers as well as the creation of predictive models for NASH diagnosis. The advancement of biomarker research improves the accuracy and reliability of NASH diagnosis. Healthcare practitioners are better positioned to detect at-risk individuals and stratify NASH patients based on disease stage and features by integrating genomic, proteomic, and metabolomic data. These improvements increase NASH diagnosis accuracy and help create individualized treatment options, giving them a substantial opportunity in the NASH biomarkers market.

Regional Analysis

The global non-alcoholic steatohepatitis biomarkers market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global market shareholder. North America will grow tremendously, owing to increased diagnosis rates and the early launch of novel medicines in this area. Biomarker research and development funding is plentiful, which supports pharmaceutical development initiatives and promotes corporate growth. Furthermore, North America has a robust regulatory framework and reimbursement rules that encourage using biomarker-based diagnostics in clinical practice. The increasing mobility of players and the increased availability of tests in the US market are important factors driving the industry. For example, in January 2022, the FDA granted a De Novo marketing clearance to the ELF Test, a predictive blood test for evaluating disease development in NASH patients. The test is provided through a partnership between Quest Diagnostics and LabCorp. This provides physicians with rapid access to the test, allowing them to determine the possibility of a severe form of the condition.

On the other hand, the North American NASH biomarkers market is confronted with the issue of harmonizing diagnostic criteria and verifying biomarker panels. However, given its superior healthcare infrastructure and research skills, the region provides substantial prospects for biomarker development and tailored therapy in NASH.

Europe is anticipated to exhibit a healthy CAGR over the forecast period. The increased disease burden and the economic effect of NASH in the region drives non-alcoholic steatohepatitis biomarkers market growth. According to The European Journal of Health Economics in 2021, NASH diagnosis is frequently accidental as a result of a normal visit to the GP. However, 79.8% of the population goes undiagnosed, signifying a large 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 have produced NASH diagnosis and management guidelines, emphasizing the use of biomarkers in the clinical approach. Many clinical trials for NASH medication development are held in Europe, and biomarkers are used for patient selection and therapy monitoring. Pharmaceutical businesses in the region are making significant investments in NASH therapy.

The Asia-Pacific market for non-alcoholic steatohepatitis biomarkers is predicted to develop the fastest during the projection period. As obesity is becoming more prevalent, more people are becoming sedentary, and eating habits are changing. Furthermore, patients and healthcare providers are becoming more aware of the importance of early detection and management of NASH. As a result, biomarker-based diagnostics are becoming increasingly popular in this field. Furthermore, China's market for non-alcoholic steatohepatitis biomarkers had the greatest market share, while India's market for non-alcoholic steatohepatitis biomarkers was the Asia-Pacific region's fastest expanding market.

Latin America, the Middle East and Africa all confront similar issues, such as limited access to healthcare resources and the need for specialized methods of NASH treatment, according to global non-alcoholic steatohepatitis biomarkers market insights. These places, however, provide considerable prospects for early identification and intervention via biomarkers, and they contribute to worldwide efforts to battle NASH.

Segmental Analysis

The global non-alcoholic steatohepatitis biomarkers market is segmented based on type, end-use, and region. 

By Type, the market is further segmented into Serum Biomarkers, Hepatic Fibrosis Biomarkers, Apoptosis Biomarkers, and Oxidative Stress Biomarkers.

The Serum Biomarkers segment mostly influences the market growth. serum biomarkers are blood-based markers detected with a simple blood test. They frequently represent bloodstream chemicals and can reflect various aspects of liver health. The segment's dominance is related to the effectiveness and widespread use of serum biomarkers as a NASH diagnostic tool. Furthermore, its ability to distinguish between basic steatosis and NASH offers it a competitive advantage. The anticipated release of novel blood biomarkers such as apolipoprotein B, apolipoprotein A1, leptin, adiponectin, ghrelin, free fatty acids, and tumor necrosis factor-alpha will drive market expansion. Furthermore, prominent market participants are focusing on obtaining approvals for marketing serum biomarker-based tests to address the demand for diagnostic tools. 

Apoptosis biomarkers are associated with the process of apoptosis, also known as programmed cell death. These indicators are linked to liver cell death in the context of NASH. Multiple studies have shown that apoptotic markers assist in discriminating between NASH and basic steatosis, which increases the population's acceptance of apoptosis biomarkers.

The market can be bifurcated by end-use into the Pharma and CRO Industry, Hospitals, Diagnostic Labs, and Academic Research Institutes.

Pharma and CRO Industry holds the major market share. Clinical trials and research related to NASH drug development are frequently conducted in collaboration between the pharmaceutical industry and Contract Research Organizations (CROs). Biomarkers are crucial in these endeavors. The rising frequency of liver illnesses drives demand for non-invasive diagnostic methods to diagnose chronic liver disease, driving market growth. Furthermore, as diagnostics improve, the treatment market expands, increasing demand for pharmaceutical medications and fueling the entire segment's growth. 

Diagnostic laboratories specialize in performing a wide range of medical tests, including those for liver illnesses such as NASH. They are in charge of evaluating patient samples and producing biomarker data. Over the projection period, the end-use category of diagnostic laboratories is expected to increase profitably. The expansion of diagnostic laboratories is due to increased public awareness of diagnosing Nonalcoholic fatty liver disease and NASH. Furthermore, as the number of items for diagnosis laboratories grows, they are gaining acceptance worldwide.

Recent Developments

• September 2023- GENFIT announced Nature Medicine Publication confirming the performance of their NASH Diagnostic Technology. 
• August 2023- Prometheus Laboratories announced Anser® Testing Collaboration with Fresenius Kabi.
• September 2023- Siemens Healthineers received FDA approval for MAGNETOM Viato.Magnetic Resonance Scanner on the Go.