Nonalcoholic Steatohepatitis Diagnostics Market Trends

Growth Drivers

• Increasing Prevalence of NASH and NAFLD - NAFLD includes nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH), diagnosed when there is evidence of inflammatory activity and hepatocyte injury in steatotic liver tissue. According to a National Center for Biotechnology Information (NCBI) study conducted in 2020, one-quarter of the global population is estimated to have nonalcoholic fatty liver disease (NAFLD). In addition, the incidence of nonalcoholic steatohepatitis (NASH) is projected to increase by up to 56% in the next ten years. NAFLD is already the fastest-growing cause of hepatocellular carcinoma (HCC) in the USA, France, and the UK. Globally, the prevalence of NAFLD-related HCC is likely to increase concomitantly with the growing obesity epidemic, which is also a reason for the higher demands for NASH diagnostics biomarkers globally.
• Rising Demand for Providing Novel Diagnostic Tools - Various non-invasive tests are being widely adopted by healthcare professionals to diagnose Nonalcoholic Steatohepatitis (NASH), propelling the market growth. Non-invasive tests are used for predicting the severity of fibrosis in NAFLD patients. These include both serologic tests and imaging techniques. The serologic tests include AST to Platelet Ratio Index (APRI) score, Fibrosis-4 (Fib-4) calculator, and NAFLD fibrosis score (NFS). A score of greater than 1 with APRI less than 0.676 with NFS and greater than 2.67 with Fib-4 predicts the presence of advanced fibrosis. In contrast, an NFS of less than -1.455 and a Fib-4 score of less than 1.3 suggests a low risk for advanced fibrosis. These advanced test techniques are growing the market.
• Growing Adoption of Serum Markers and Score System for NAFLD and NASH Diagnosis - In November, a study undertaken by the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE), an initiative of the Foundation for the National Institutes of Health’s Biomarkers Consortium (FNIH), confirmed that NIS4 technology reveals a unique performance in recognizing patients with at-risk Non-Alcoholic Steatohepatitis (NASH), and provided evidence that it had the best results of the five blood-based biomarker panels which were evaluated in this study, for the diagnosis of fibrosis stage≥ 2.
• Increasing Funding and Collaborations for NASH Detection Techniques - A new project involving a consortium that is part of the Innovative Medicines Initiative (IMI), the world’s most significant public-private partnership of its kind, aims to tackle the glaring lack of diagnostic tools by seeking reliable, measurable medical signs, or biomarkers, that indicate the presence of NASH. The project, co-led by Pfizer, is known as LITMUS, or “Liver Investigation: Testing Marker Utility in Steatohepatitis.” LITMUS is coordinated by Professor Quentin Anstee at Newcastle University in the U.K. and is part of IMI, which is funded jointly by the European Commission and the European pharmaceutical industry, known by its acronym, EFPIA.
• Rising Trends of Unhealthy Diet and Lack of Physical Activity- The prevalence of NAFLD rises in parallel with the increasing prevalence of obesity, metabolic syndrome (MetS), and T2D. According to the WHO, overweight and obesity are now rapidly on the rise in low and middle-income countries, particularly in urban settings. A vast majority of overweight or obese children live in developing countries, where the rate of increase has been more than 30% higher than that of developed countries.

 Challenges

• Stringent Regulations for Biomarkers Approval by Regulatory Bodies- In-vitro diagnostics are regulated by the FDA and Japan Pharmaceuticals and Medical Devices Agency (PMDA) and will soon have a formal regulatory framework in Europe. However, when the FDA approves novel targeted therapies, EMA, and PMDA, the companion diagnostic test required to select patients receiving the therapy is considered for approval concurrently with the therapy. Therefore, negatively affecting the market growth.
• Absence of NAFLD/NASH from Health Policies Focused on Obesity
• Poor Demand in the Underdeveloped Countries