Non-Alcoholic Steatohepatitis (NASH) accounted for a 6.3% share of the global clinical trials within the Gastrointestinal therapy area in 2020, registering an increase of 3.0% when compared with the last ten-year average of 3.3% share, according to GlobalData.

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Industry sponsored trials outnumber non-industry sponsored trials for NASH

Industry sponsored trials held an 80.5% share of all the clinical trials for NASH indication in 2020, registering an increase of 32.0% when compared with the ten-year average of 48.5%. Non-industry sponsored trials accounted for a 19.5% share in 2020, marking a decrease of 32.0% over the ten-year average of 51.5%.

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Top regions of industry sponsored NASH trials

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North America was the top region for industry sponsored NASH trials, accounting for a 53.4% share in 2020, when compared with the five-year average of 69.4% and ten-year average of 53.2%.

Asia-Pacific was at the second position with a 44.8% share in 2020, over the five-year average of 31.9% and ten-year average of 28.5%, followed by Europe with a 22.4% share in 2020, as against five-year and ten-year averages of 33.5% and 42.4% respectively.

Middle East and Africa stood fourth with an 8.6% share in 2020, compared with the five-year average of 11.2% and ten-year average of 13.6%, followed by South and Central America with a 6.9% share in 2020, over five-year and ten-year averages of 6.6% and 3.3% respectively.

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The US was the top country for industry sponsored NASH trials, accounting for a 51.7% share in 2020, as against the five-year average of 67.2% and ten-year average of 52.1%.

China held a 19.0% share in 2020, over the five-year average of 4.8% and ten-year average of 2.4%, followed by Australia with a 17.2% share in 2020, compared with the five-year and ten-year averages of 15.6% and 11.9% respectively.

Canada held a 12.1% share in 2020, as against the five-year average of 14.5% and ten-year average of 11.2%.

Japan held a 12.1% share in 2020, over the five-year and ten-year averages of 7.4% and 5.7% respectively.

Top regions of non-industry sponsored NASH trials

Asia-Pacific was the top region for non-industry sponsored NASH trials, accounting for a 52.9% share in 2020 when compared with the five-year average of 39.4% and ten-year average of 36.0%.

Middle East and Africa was at the second position with a 17.6% share in 2020, over the five-year and ten-year averages of 26.3% and 25.9% respectively, followed by North America with a 17.6% share in 2020, as against the five-year average of 23.4% and ten-year average of 19.7%.

Europe stood at the fourth position with an 11.8% share in 2020, compared with the five-year average of 10.9% and ten-year average of 18.4%, followed by South and Central America with a 0.0% share in 2020, over the five-year and ten-year averages of 1.1% and 0.5% respectively.

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China was the top country for non-industry sponsored NASH trials, accounting for a 23.5% share in 2020, as against the five-year average of 16.4% and ten-year average of 11.4%.

Iran held a 17.6% share in 2020, over the five-year average of 21.2% and ten-year average of 20.4%, followed by South Korea with a 17.6% share, compared with the five-year and ten-year averages of 2.1% and 1.0% respectively.

The US held a 17.6% share in 2020, as against the five-year average of 18.6% and ten-year average of 15.3%.

India held a 5.9% share in 2020, over the five-year average of 4.5% and ten-year average of 5.0%.

Phase I trials lead industry sponsored clinical trials for NASH in 2020

Phase I trials held a 57.1% share of industry sponsored clinical trials for NASH in 2020, over the five-year average of 48.2% and ten-year average of 44.1%.

Phase II trials held a 37.1% share in 2020, as against the five-year average of 45.6% and ten-year average of 48.4%. Phase III trials held a 5.7% share in 2020, compared with the five-year and ten-year averages of 5.2% and 6.9% respectively.

Phase IV trials held a 0.0% share in 2020, over the five-year average of 1.1% and ten-year average of 0.6%.

Phase II trials lead non-industry sponsored clinical trials for NASH in 2020

Phase II trials held a 58.8% share of non-industry sponsored clinical trials for NASH in 2020, over the five-year average of 61.2% and ten-year average of 66.8%.

Phase I trials held a 23.5% share in 2020, as against the five-year average of 12.7% and ten-year average of 7.1%. Phase III trials held an 11.8% share, compared with the five-year and ten-year averages of 14.1% and 15.1% respectively.

Phase IV trials held a 5.9% share in 2020, over the five-year average of 12.0% and ten-year average of 11.0%.

Methodology:
The clinical trials data used for the analyses were extracted from the Clinical Trials Database of GlobalData’s Pharma Intelligence Center. Clinical Trials are sourced from numerous government, non-government and company clinical trial registries worldwide alongside clinical research publications, scientific conferences, company websites, SEC filings and more. The information is gathered by a combination of automation and secondary research to ensure accuracy and validity. A small number of Phase 0, Phase I/II, Phase II/III, and Phase III/IV trials were combined with Phase I, Phase II, Phase III, and Phase IV trials, respectively.