Phase I Trials Global Clinical Trial Landscape – Focus On Asia Pacific

Over the last decade, Asia Pacific has been the fastest-growing region in Phase I trials, reaching a share of 58% in 2022, with China leading the Phase I trials globally. According to reports, Big Pharma conducted most of its early-stage clinical studies in the West before incorporating Asian locations in later phase studies.

However, as researchers and local regional experience and capabilities began improving, the Asian region was able to begin leading early-phase clinical studies, such as first-in-human (FIH) trials. With time, pharmaceutical sponsors gained confidence, and early-phase trials in Asia moved from FIH investigations to pharmacokinetic studies. It is anticipated that there will be more early-stage trials employing biomarkers and that these trials will cover more locations outside of the US and Europe. With this uptick in competition, it is expected that Asian locations will expand their research infrastructure and human capital investments, too.

Advantages that set the country apart from the rest begin with its ability to collect pharmacokinetic/ pharmacodynamic, safety/tolerability profiles of Asian patients in a timely manner. Before licensing new medications, certain regional regulatory agencies require efficacy and safety information relevant to Asian patients. Early in the process, companies will be able to change their clinical development plans as necessary, identify any disparities between how Asian patients respond to new drugs compared to Caucasian patients or patients of other ethnic groups, and omit those variances. Early-phase clinical studies in Asia have other advantages too, such as lower costs, faster enrolment in some nations, highly motivated investigators willing to take part in early-phase trials, and fewer competing trials at study centers.1

Access the white paper to discover key trends in global Phase I trials, including highlights from the top therapeutic areas, indications, and biologic drug types in the last five-year period in popular trial regions of Asia Pacific, the United States, and Europe.