Non-alcoholic Steatohepatitis Clinical Trials Market Growth & Trends
The global non-alcoholic steatohepatitis clinical trials market size is expected to reach USD 4.2 billion by 2030, registering a CAGR of 6.5% over the forecast period, according to a new report by Grand View Research, Inc. Rising healthcare expenditure, cases of obesity, and prevalence of non-alcoholic steatohepatitis (NASH) are the factors driving the growth of this market. Due to the COVID-19 pandemic, enrollment in new drug clinical trials for NASH patients was halted, but people shifted to alternate means of data collecting methods, like virtual visits. Non-alcoholic Steatohepatitis is a fatty liver disease that causes scarring and damage to the liver.
NASH has no FDA-approved treatment and can proceed to the point where patients need a liver transplant in extreme situations. NASH, like diabetes, is linked to obesity and a high-sugar diet. Some pharmaceutical companies are testing whether diabetes drugs could help NASH patients. However, the COVID-19 pandemic has thrown a wrench into every element of NASH clinical trials, from patient recruiting to IP administration and safety monitoring to data integrity. As clinical research monitors are not allowed to travel, remote electronic monitoring is a viable alternative to traditional on-site monitoring. Monitors could receive information from research locations by paper mail, e-mail (allowing direct access to electronic medical records), or remote monitoring systems.
In December, the FDA issued guidance urging the pharmaceutical sector to develop and confirm improved biomarkers for the diagnosis and progression of NASH. In many aspects, getting past the biopsy barrier is significant compared to a lack of general awareness of NASH, that’s why it is critical for pharmaceutical companies to invest in innovations (such as a variety of imaging techniques) to alleviate this patient burden, and then persuade the FDA with positive data to accept those advancements as appropriate end-point markers for clinical trials.
Non-alcoholic Steatohepatitis Clinical Trials Market Report Highlights
- The phase III segment dominated the global market in 2021. These trials cost more than USD 100 million
- The interventional study design segment held the largest revenue share in 2021. There were 84 ongoing interventional studies with patients enrolled in December 2019 to evaluate the therapeutic efficacy of treatments for NASH
- North America dominated the global market in 2021 due to the increased number of NASH patients in the region
- According to the U.S. National Library of Medicine 2018, instances of NASH in the U.S. are expected to increase 63% from 16.52 million to 27.00 million cases by 2030
- Asia Pacific is projected to register the fastest CAGR over the forecast period owing to the increasing incidence of associated risk factors, such as obesity, type 2 diabetes (T2D), dyslipidemia, and other metabolic diseases with substantial diagnostic improvements using ultrasound and biomarkers