Non-Alcoholic Steatohepatitis Therapeutics and Diagnostics Market Trends

Growth Drivers

• Increase in the prevalence of obesity and metabolic disorders: Unhealthy eating and sedentary living contribute to the rise in obesity and metabolic disorders that are increasing the cases of NASH. Furthermore, obesity and metabolic syndrome remain central among all the risk factors of fatty liver diseases, so there is an urgent need to enhance diagnostic and therapeutic solutions. Advanced tools are increasingly critical to better manage and monitor the conditions. In November 2023, Echosens received FDA clearance for a device known as FibroScan, a non-invasive test that measures stiffness and fat content in the liver. This technology enhances both early diagnosis and ongoing monitoring of patients with NASH, providing a safer alternative compared to the traditional approaches.

• Improvement in diagnostics and non-invasive technologies: Non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market for better safety and convenience for patients. These innovations reduce the need for invasive procedures such as biopsies, making early detection more accessible. For example, in October 2023, Siemens Healthineers launched the Enhanced Liver Fibrosis (ELF) test. The diagnostic tool gives important insights into liver fibrosis that help in the better management of the disease. Such a development underlines the industry's commitment to enhancement in diagnostics by addressing comfort for the patient and efficiency of care.

• Increased R&D investments in targeted therapies: Several pharmaceutical companies are accelerating efforts to develop targeted therapies for the treatment of NASH to respond appropriately to the increasing demand. This is also enabling newer approaches in patient care through substantial research and development investments. In January 2024, 89bio initiated a Phase III clinical trial with their promising drug candidate, specifically for the treatment of NASH. Such a strategic step in the competitive environment would help to realize patient-oriented solutions. Such focus on R&D will lead toward advancements that provide more accessible therapeutic options in the non-alcoholic steatohepatitis therapeutics and diagnostics market.

Challenges

• Limited awareness and underdiagnosis: Despite its increasing prevalence, non-alcoholic steatohepatitis (NASH) remains significantly underdiagnosed, largely due to limited awareness among patients and healthcare providers. Many individuals with NASH remain asymptomatic until the disease progresses, delaying timely intervention. Additionally, the lack of standardized diagnostic tools contributes to the underdiagnosis, as invasive liver biopsies remain the primary method for confirmation.

• Regulatory and clinical challenges: The development of effective therapies for NASH has various challenges due to complex regulatory pathways and the essentials of trials. Drug approval requires sound clinical data on safety and efficacy, which can only be achieved by large-volume, long-term studies. From the disease perspective, heterogeneity in NASH further makes it difficult to design a clinical trial because the different patient populations need to be considered and, in addition, at diverse stages of the disease. Another important barrier to developers is regulatory investigations into the side effects a given drug may have.