NON-ALCOHOLIC STEATOHEPATITIS (NASH) THERAPEUTICS AND DIAGNOSTICS MARKET ANALYSIS

Market Challenges And Opportunities

One of the key factors expected to augment the growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market over the forecast period is the rise in NASH-affected population across the world. According to the Global Liver Institute (or International NASH Day), around 25-30% of people worldwide currently have NAFLD and around 2-6% have NASH, and the prevalence of NASH could increase by over 50% by 2030. This in turn is expected to increase the demand for safe and effective NASH therapeutics and diagnostics, driving the growth of the NASH therapeutics and diagnostics market.

Another factor which is driving the growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is the rise in diabetic and obese population across the globe. For instance, it is common for patients to have both NASH and diabetes and, individuals with both conditions have a higher risk of liver-related and non-liver related illness and premature death than those without liver disease. NASH is also closely related to triple epidemic of obesity. According to the Global Liver Institute, over 9.3% of the global population (463 million people) had diabetes in 2019 and project that number to increase 25% by 2030 and 51% by 2045.

Increase in demand for safe and effective NASH therapeutics and diagnostics is expected to offer significant growth opportunities for players in the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market. For instance, in May 2022, Pfizer Inc. announced that U.S. Food and Drug Administration (FDA) granted Fast Track designation to Pfizer’s investigational combination (ervogastat/clesacostat) therapy for the treatment of NASH. Receiving the Fast Track designation from FDA reinforces Pfizer’s belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies.

Favorable initiatives by government/non-government organizations are expected to offer lucrative growth opportunities for players in the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market. Because NASH symptoms are often not overt, it is often underdiagnosed and underreported. For instance, in June 2018, the public education campaign, International NASH Day (the NASH Day), is launched to raise visibility and urgency around fatty liver disease and its more advanced form, nonalcoholic steatohepatitis (NASH), which affects more than 115 million people around the world. This in turn is driving the market growth.

One of the key factors expected to hamper the growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is the slow advancements in the therapeutic field. It has been observed that an increasing number of people worldwide are being diagnosed with NASH and NAFLD each year, and the only primary method of treatment is weight loss. Moreover, it has been observed that after almost 35 years its formal description and 15 years of intense study from researchers worldwide, there is still no approved drug for the treatment of NASH.

However, with the increase in research and development (R&D) and technological advancements, the market is expected to witness robust growth during the forecast period.

Another factor which is hampering the growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is the lack of effective diagnostics for non-alcoholic fatty liver disease (NAFLD). Screening is not generally recommended, and thus, doctors use medical history, physical exams, and tests to diagnose NAFLD and NASH. Thus, diagnosis and staging of NAFLD remain complex. Furthermore, there are no FDA-cleared diagnostic tests, specifically designed for the identification of NASH. This in turn is restraining the market growth.