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.
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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
Grand View Research has segmented the global non-alcoholic steatohepatitis clinical trials market based on phase, study design, and region:
NASH Clinical Trials Phase Outlook (Revenue, USD Million, 2018 - 2030)
Phase I
Phase II
Phase III
Phase IV
NASH Clinical Trials Study Design Outlook (Revenue, USD Million, 2018 - 2030)
Interventional
Observational
Expanded Access
NASH Clinical Trials Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Europe
U.K.
Germany
France
Italy
Spain
Asia Pacific
Japan
China
India
Australia
South Korea
Latin America
Brazil
Mexico
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE
List of Key Players of Non-alcoholic Steatohepatitis Clinical Trials Market
Pfizer Inc.
Novartis AG
Icon Plc
LabCorp
Allergan Plc
Cadila Healthcare Ltd.
Shire Plc (Takeda Pharmaceuticals)
Eli Lilly
Novo Nordisk
Gilead Sciences Inc.
Glaxosmith Kline
Arrowhead Pharmaceuticals
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