The APAC region —with an approximate ten percent growth in trial numbers between 2017 and 2022— is rapidly becoming the world’s leading market for clinical trials. Karen Chu, CEO of Harvest Integrated Research Organization (HiRO), a CRO that serves Asian, US and European clients, has experienced the boom first hand. In a recent PharmaBoardroom interview she comments on the factors behind APAC’s success as a clinical trials hub such as its high medical standards and data quality, its cost-effectiveness, and the streamlined approvals processes in certain countries.
A Huge Population and High Medical Standards
Asia Pacific (APAC) has a lot going for it as a clinical trials destination and pharma and biotech companies looking to diversify their clinical trial locations have taken note. As a result the number of trial sites in APAC has increased at a combined annual growth rate of 6.9 percent since 2017 while the APAC CRO market is expected to expand from USD 7.6 billion in 2021 to USD 12 billion by 2025.
The medical standards are up to par with the US and Europe, which makes it easier for global trials to come in [to APAC]
Karen Chu, HiRO
One of the basic reasons for APAC’s attractiveness a clinical trial location is the huge population numbers available in such a geographically vast region. Inhabited by 4.3 billion people, the Asia Pacific region represents no less than 60 percent of the world’s total population. “In terms of fundamental factors, APAC is very densely populated,” confirms HiRO CEO Karen Chu.
Beyond its sheer numbers, APAC is a region that encompasses a number of countries with very well-established medical infrastructures. “The medical standards are up to par with the US and Europe, which makes it easier for global trials to come in,” says Chu.
Cost-Effectiveness
Another obviously compelling reason for conducting clinical trials in the region is cost, particularly for American companies. “Especially post-COVID, many US hospitals and sites are complaining of a lack of resources, including for positions like study coordinators and nurses,” says Chu. “This makes enrolment slower and costs increase, creating even more of a push towards Asia.”
Australia, one of APAC’s major economic and geopolitical powers, has put measures in place to incentivise clinical research in the country, such as the Research and Development Tax Incentive (R&DTI), a programme that offers tax incentives for R&D activities. As a result, by certain estimations, the total cost of running clinical research in Australia can be up to 40 percent less expensive than in the United States.
HiRO was quick to recognise the potential of Australia, says Chu, and acquired the Australia and New Zealand-based CRO, PharmaSols, to access those markets. “[The acquisition] provides an opportunity for our Asian clients to tap into a location where first-in-human Phase I trials can be set up very quickly and at a very high quality,” she asserts. “Thanks to these fundamentals, many of our European and US clients are also looking towards Australia and New Zealand as trial locations.”
Streamlined Approvals
Certain countries within the APAC region, including Japan, Korea, and China, require local data for drug approvals and conducting clinical trials in these countries enables companies to seek approval there while also obtaining data for their US and European drug approval applications. “Japan and China still represent exceptionally large pharmaceutical markets which companies across the world want to tap into,” Chu maintains.
Moreover, the streamlined approval processes in some APAC countries is another advantage. In Japan, thanks to the Clinical Trials Act of 2018, the approval process has been accelerated and simplified and can be accomplished in under three months, making it the second fastest country in the world for clinical trials approvals. Meanwhile, China has also made progress in stepping up its approval timelines. Once companies complete a Clinical Trial Application (CTA) they can expect a response within two months.
Quality Data
Data quality that translates well to other markets is yet another factor that puts APAC in a favourable position for clinical research. “After countries in APAC began to join the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), we have seen a great deal of improvement in terms of the data being generated,” Chu confirms.
Obtaining high quality data makes it easier for companies to seek approval in other markets and for Chu partnering with CROs helps to ensure global standards are maintained. “CROs like HiRO which maintain global standards, can really uphold and gatekeep the quality of this data.”
Chu stresses the importance of taking global norms into account from the start. “If from the outset the data package is intended to meet global standards, there are usually no problems,” she says. “We have seen around 30-40 percent of the data of a New Drug Application (NDA) package coming from Asia Pacific countries.”
The Role of a “Local” CRO
For companies looking to conduct clinical trials in APAC, having a CRO on the ground that is familiar with the local environment is fundamental, not just for conducting the research itself.
In Chu’s view, an integrated approach like HiRO’s is essential. “We aim to be a an integrated and consultative one-stop-shop for our clients,” she affirms. To meet the needs of their clients, HiRO provides services ranging from connections to financing support to vendor selection and consulting.
“Our consulting arm is very strong, and we are able to work with biotech companies on their clinical development every step of the way, from answering questions such as in which geography they should conduct a Phase I study and what the ethnic makeup of trial participants needs to be,” she claims.
Digitalisation
As in other regions, the COVID-19 pandemic accelerated digitisation in APAC and enabled trials to become more decentralised and virtual. According to Clinical Trials Arena, decentralised Phase I trials in the region grew 60 percent between 2017 and 2022 while APAC also became the region with the highest usage of in-home devices for clinical trials in in 2022.
“There has definitely been a push to digitalise more information and make it easier to access,” says Chu. “We are also seeing a more decentralised process emerging whereby face-to-face contact is now seen as a luxury rather than a necessity. Patients and trial participants are more cognizant of how logistically cumbersome some of the face-to-face contact with doctors and pharmacists is, although these visits will continue.”
