The global landscape for Phase I clinical trials is changing, and over the last ten years, the APAC region has taken centre stage. APAC was the fastest growing region for early-stage clinical trials between 2013 and 2022, with a combined annual growth rate 12 times higher than that of the US and four times higher than Europe. In 2022, APAC accounted for 58% of all global Phase I clinical trials.
APAC offers biopharmaceutical companies faster enrolment, lower costs, highly motivated investigators and less competition. As the region expands its infrastructure and human capital, and regulators increasingly require ethnicity-specific data, APAC is expected to continue to dominate Phase I clinical trial growth. In a recent paper, titled Phase I Trials – Global Clinical Trial Landscape – Focus on Asia Pacific, leading Asia Pacific centred biotech contract research organisation Novotech and GlobalData present the trends that are making global biopharmaceutical companies take note.
The race to market
The pharmaceutical industry is becoming ever more competitive, and sponsors are seeking fast turnaround times. Since 2018, APAC has offered the shortest patient enrolment duration and fastest recruitment for Phase I clinical trials, thanks to a wide patient base.
Median enrolment time in APAC was two times shorter than in Europe and three times shorter than the US. At a median rate of 22.47 subjects per site per month, recruitment in APAC was three times faster than in Europe and seven times shorter than the US. For sponsors, this means trials are quicker to initiate, reducing their overall duration and resulting in drugs being brought to market sooner.
Moving with the market
Today’s most exciting therapeutic areas include oncology, infectious disease, central nervous system, cardiovascular and metabolic disorders, and APAC leads the way for Phase I studies across these themes. The majority of Phase I clinical trials in APAC and the US were oncology trials, with infectious disease being the second largest therapeutic area in APAC and Europe.
Compared to Europe and the US, APAC had the highest trial numbers in all the top therapeutic areas between 2018 and 2022. The most important geographies were China, Australia, South Korea, Japan and India, with China accounting for over 80% of Phase I trials when all the top areas were considered together.
In the same period, APAC was home to the majority of Phase I trials for top biologic drug therapies, which includes immunomodulatory, immune-oncology, adoptive cell therapy, vaccines and gene-based therapies. In the adoptive cell therapy and gene-based areas in particular, APAC accounted for 60% of trials, as well as over 45% of targeting therapy and vaccine trials and over 40% of immunomodulatory, immune-oncology and multi-specific monoclonal antibody-based trials.
Over the past ten years, APAC has attracted domestic and foreign drug developer firms seeking new drug pipelines. The top five locations for Phase I clinical trials in Asia are China, Australia, South Korea, Japan and India. These countries are building a reputation for research excellence, and together they account for over 50% of Phase I trials globally. China alone is responsible for nearly 40%.
China is the global leader for Phase I adoptive cell therapy trials and ranks second behind the US in the majority of the top therapeutic areas. Meanwhile, Australia is an important player in immunomodulatory therapy, targeting therapy and immune-oncology, and Japan and South Korea are frequently involved in Phase I trials for targeting therapy and immune-oncology. China, Australia and India rank highly in Phase I vaccine trials, an area that is expanding due to the growing presence of global biotech firms.
A leading location
Sponsors can find cutting-edge precision oncology in APAC. For example, patients can undergo molecular pre-screening using next generation sequencing-based molecular profiling, which could make it easier to match candidates’ genomes to Phase I drug trials for targeting therapies.
Pioneering medical infrastructure, favourable governmental regulations and funding initiatives make APAC a desirable and competitive location for biopharmaceutical companies to initiate Phase I clinical trials.
To find out more, download the report below.