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June 9, 2022

Non-Alcoholic Steatohepatitis (NASH) accounts for 6.3% share of global Gastrointestinal clinical trial activity in 2021

By Carmen

Non-Alcoholic Steatohepatitis (NASH) accounted for a 6.3% share of the global clinical trials within the Gastrointestinal therapy area in 2021, registering an increase of 2.6% when compared with the last ten-year average of 3.7% share, according to GlobalData.

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Industry sponsored trials outnumber non-industry sponsored trials for NASH

Industry sponsored trials held an 85.8% share of all the clinical trials for NASH indication in 2021, registering an increase of 31.3% when compared with the ten-year average of 54.5%. Non-industry sponsored trials accounted for a 14.2% share in 2021, marking a decrease of 31.3% over the ten-year average of 45.5%.

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Top regions of industry sponsored NASH trials

Asia-Pacific was the top region for industry sponsored NASH trials, accounting for a 55.3% share in 2021, when compared with the five-year average of 34.5% and ten-year average of 29.7%.

North America was at the second position with a 47.4% share in 2021, over the five-year average of 64.4% and ten-year average of 56.1%, followed by Europe with a 19.7% share in 2021, as against five-year and ten-year averages of 35.1% and 42.7% respectively.

Middle East and Africa stood fourth with an 11.8% share in 2021, compared with the five-year average of 10.5% and ten-year average of 11.8%, followed by South and Central America with a 5.3% share in 2021, over five-year and ten-year averages of 7.1% and 4.3% respectively.

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The US was the top country for industry sponsored NASH trials, accounting for a 47.4% share in 2021, as against the five-year average of 63.2% and ten-year average of 54.8%.

Australia held a 26.3% share in 2021, over the five-year average of 15.9% and ten-year average of 13.5%, followed by Japan with a 15.8% share in 2021, compared with the five-year and ten-year averages of 9.6% and 6.8% respectively.

Canada held a 13.2% share in 2021, as against the five-year average of 14.4% and ten-year average of 12.2%.

Poland held an 11.8% share in 2021, over the five-year and ten-year averages of 7.4% and 7.0% respectively.

Top regions of non-industry sponsored NASH trials

North America was the top region for non-industry sponsored NASH trials, accounting for a 35.7% share in 2021 when compared with the five-year average of 19.4% and ten-year average of 19.7%.

Asia-Pacific was at the second position with a 28.6% share in 2021, over the five-year and ten-year averages of 43.8% and 38.4% respectively, followed by Europe with a 28.6% share in 2021, as against the five-year average of 13.6% and ten-year average of 16.9%.

Middle East and Africa stood at the fourth position with a 7.1% share in 2021, compared with the five-year average of 23.2% and ten-year average of 25.0%, followed by South and Central America with a 0.0% share in 2021, over the five-year and ten-year averages of 0.0% and 0.5% respectively.

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The US was the top country for non-industry sponsored NASH trials, accounting for a 35.7% share in 2021, as against the five-year average of 16.7% and ten-year average of 15.4%.

China held a 14.3% share in 2021, over the five-year average of 19.4% and ten-year average of 13.2%, followed by Denmark with a 14.3% share, compared with the five-year and ten-year averages of 2.5% and 1.9% respectively.

Japan held a 14.3% share in 2021, as against the five-year average of 7.1% and ten-year average of 11.0%.

Iran held a 7.1% share in 2021, over the five-year average of 19.0% and ten-year average of 20.4%.

Phase I trials lead industry sponsored clinical trials for NASH in 2021

Phase I trials held a 56.0% share of industry sponsored clinical trials for NASH in 2021, over the five-year average of 51.5% and ten-year average of 51.4%.

Phase II trials held a 37.4% share in 2021, as against the five-year average of 43.2% and ten-year average of 41.1%. Phase III trials held a 4.4% share in 2021, compared with the five-year and ten-year averages of 4.4% and 7.0% respectively.

Phase IV trials held a 2.2% share in 2021, over the five-year average of 0.9% and ten-year average of 0.4%.

Phase II trials lead non-industry sponsored clinical trials for NASH in 2021

Phase II trials held a 73.3% share of non-industry sponsored clinical trials for NASH in 2021, over the five-year average of 62.1% and ten-year average of 66.6%.

Phase III trials held a 20.0% share in 2021, as against the five-year average of 11.0% and ten-year average of 15.3%. Phase IV trials held a 6.7% share, compared with the five-year and ten-year averages of 13.2% and 9.9% respectively.

Phase I trials held a 0.0% share in 2021, over the five-year average of 13.8% and ten-year average of 8.2%.

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.

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