NASH Biomarker Market

A biomarker is a biologic feature used to estimate the presence or progression of a disease in a person. Recently, the incidence of non-alcoholic steatohepatitis (NASH) is increasing at an alarming rate and thus has led to the growing need for effective diagnostic tools. According to the data published by the NASH Education Program, the prevalence of NASH is anticipated to rise by 63% between 2015 and 2030. Factors such as the increasing prevalence of diabetes and obesity, growing demand for non-invasive tests, and growing public and private sector initiatives to increase awareness about NASH are expected to fuel the growth of the global market. Despite the drivers, the unfavorable regulatory scenario is likely to affect market growth over the forecast period negatively.

Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are generally silent diseases with few or no symptoms. NASH is a stage 2 after steatosis (simple fatty liver), in which the liver is damaged, causing it to become inflamed.

Additionally, people with NAFLD are more prone to develop NASH if they are suffering from obesity, type 2 diabetes, high blood pressure, or metabolic syndrome. According to the data published by the National Center for Biotechnology Information in 2018, NAFLD occurs in about 95% of the obese people. The number of people suffering from diabetes and obesity is increasing at a fast pace. As per the data by The British Diabetic Association, in 2017 to 2018, about 3,222,559 people in England, 96,114 people in Northern Ireland, 295,753 people in Scotland, and about 3,809,119 people in the UK had diabetes.

Moreover, according to the National Diabetes Statistics, 2017, about 30.3 million people of all ages had diabetes in the US in 2015. Likewise, the prevalence of obesity is also growing at a significant rate. According to the data published by the National Health Services (NHS), about 58% of women and 68% of men were obese in England in 2017. Therefore, the prevalence of diabetes and obesity is expected to provide favorable backgrounds for the global non-alcoholic steatohepatitis (NASH) biomarkers market to grow over the forecast period.

The increasing incidence rate of NASH globally has led many companies to increase their focus on NASH disease management. The companies are entering into strategic partnerships to develop novel biomarkers. For instance, in April 2019, Novartis AG announced the acquisition of NASH Biotech IFM Tre.

Additionally, in January 2019, LabCorp Diagnostics Inc. and Genfit entered into a strategic collaboration to develop a non-invasive diagnostic test to identify NASH. Moreover, in April 2017, Bristol-Myers Squibb (BMS) and Nordic Biosciences entered into a partnership to develop biomarker technology for diagnosis and monitoring of NASH and other fibrotic diseases. Furthermore, Metanomics Health GmbH aims to partner with pharmaceutical companies for the development of diagnostic tools and drugs for NASH.

Thus, the increasing number of mergers and acquisitions is likely to pose huge opportunities for the global non-alcoholic steatohepatitis (NASH) biomarkers in the future.

High level of regulatory compliance standards set by regulatory agencies to minimize the health risks to patients has made the new product approval process difficult for manufacturers. The US Food Drug and Administration (FDA) is a globally renowned regulatory body engaged in monitoring and approving drugs and medical devices. The FDA has developed processes for the qualification of biomarkers and other medical product development tools. Although regulatory compliance standards help end-users to get quality products. These strict policies create a problem for market players to introduce novel products in the market.

Additionally, the unfavorable reimbursement system for biomarker-based tests may represent a greater problem to the development and adoption of biomarker-based diagnostics for NASH. The process for reimbursement of biomarker medical tests is complex and varies across countries. Moreover, novel molecular biomarker-based tests are more expensive to develop and perform and are not presently well positioned for widespread use in the clinical setting. Thus, the presence of stringent government regulations is likely to hamper the market growth during the forecast period.