How JAPAC Is Accelerating Global Clinical Development Strategy

Q1. IQVIA recently completed a survey of emerging biopharma leaders on clinical development in Asia Pacific. What prompted this research - and what did the findings tell you?

The research was designed to answer a very practical question: how can leveraging Japan and Asia-Pacific mitigate some of the most pressing challenges on development timelines? Protocols are increasingly complex, competition for patients is intense, and enrolment delays now carry outsized financial and strategic consequences. JAPAC felt like an underexplored part of the answer.

What the findings showed was that the overall sentiment toward JAPAC is overwhelmingly positive - respondents expect a 13% year-on-year increase in R&D spend into JAPAC over the next three years. But the research also surfaced some honest commentary on how well understood the opportunity truly is, and what continues to stand in the way of fully realising it.

Q2. One of the common findings is pressure on timelines and enrollment. How serious is this issue today - and how does Asia Pacific factor into the solution?

The scale of the problem is real: nearly 80% of clinical trials miss their original enrolment timelines, often by months, contributing to higher costs, delayed decision-making, and lost commercial windows. Traditional geographies in North America and Europe are struggling under site saturation, tighter eligibility criteria, and rising operational complexity.

Tapping into the large patient populations and experienced investigators within JAPAC could well be part of the solution. But for many biotech sponsors, it remains a question of balancing the opportunity for acceleration against logistical concerns, perceived communication hurdles, and limited experience navigating the regulatory and trial landscapes within the region. That is exactly the tension the survey was designed to explore.

Q3. The research notes a rise in later-phase studies conducted in single regions. Does that put more pressure on the regional selection process?

It raises the stakes significantly. The proportion of later-phase studies conducted in single regions or even single countries has continued to rise. When you are focusing your efforts on one geography, the choice of that region must be resilient. JAPAC-generated data is increasingly being used for submissions to US and EU regulatory authorities, which de-risks that single-region strategy by providing high-quality, relevant data while maintaining the speed needed to hit critical market access windows.

Q4. If the advantages are so clear, why aren’t more customers running trials in the region today?

The biggest barrier highlighted was not regulation, logistics, or cost – it was simply having less knowledge and experience working within the region.

The clinical research landscape in JAPAC is extremely diverse - ranging from well-established global hubs to regions with limited global trial experience but great patient and site potential. Each country offers different regulatory timelines, pathways, and cultural nuances that can be challenging even for large pharmaceutical companies, let alone emerging biotechs.

Understandably, many sponsors admit they default to North America or Europe simply given the familiarity, even if JAPAC has the potential to deliver faster timelines, if done right. This runs the risk of creating a self-reinforcing cycle: with a preference for past experience, leading to greater experience with well-known destinations, and the cycle repeats.

In other words, confidence - not capability - is the often-limiting factor.

Q5. JAPAC has many countries - how should customers think about the region?

Good point. Treating JAPAC as a single market doesn't work. Each location can play a distinct role in successful global site strategies. The survey respondents recognised this clearly, with distinct rationales for when and why they would look to each country:

Australia is consistently positioned as an early phase accelerator, valued for its fast start up timelines, regulatory efficiency, and highly experienced sites. Japan and South Korea serve as depth markets, offering disciplined execution, strong investigators, and long term commercial relevance, while China and India provide scale and access to large patient populations—though sponsors tend to be more selective in these markets due to perceived regulatory, geopolitical, or operational complexity.

Sponsors who succeed are those who match each country to the specific job it needs to do in the trial - not defaulting based on comfort.

Q6. What does the research tell us about how sponsors are engaging with CROs and research partners from JAPAC?

Perhaps unsurprisingly - given the diversity of the region and the varying levels of experience sponsors bring to it - the majority of respondents indicated prior engagement with global and local-based research partners and CXOs when pursuing JAPAC.

The number one driver for engaging a partner was accessing knowledge and expertise to navigate individual regulatory landscapes. That was also the leading factor in the eventual decision to select a specific vendor. Closely aligned with that was leveraging a partner's existing site and investigator relationships - which is critical both for identifying the right study locations and for building long-term relationships with JAPAC therapeutic experts and opinion leaders.

Q7. What should sponsors - and the research industry - be doing differently to unlock JAPAC's potential?

The survey is very clear on what sponsors need most: 75% of respondents said that greater clarity on timelines, requirements, and regulatory best practices in key countries is their number one ask in order to further consider JAPAC's potential. That is an actionable brief for the research industry - move from regional narratives to country-level specificity.

Early engagement with site and therapeutic leaders within potential countries is equally critical - for understanding fit with development plans and identifying any adjustments required to study designs before they become costly.

On timing, the when matters as much as the what. 60% of respondents felt that earlier discussions on potential JAPAC destinations would directly influence their clinical development programs, with one third indicating a high level of interest in engaging global research partners in those conversations. The potential to consider JAPAC earlier - as a core component of de-risking timelines and strengthening trial resilience - is real and growing.

There is also a broader context that makes this urgent. Changing regulatory landscapes in the US and Europe - including discussions about the sources of patient data accepted for submissions - make it critical that biotech companies keep an open mind to development opportunities across the globe. And investors are already ahead of this: more than 55% of respondents said their investors have specifically encouraged the exploration of JAPAC as a development destination.

JAPAC's role as a research destination continues to evolve - with real benefits to patient availability, overall timelines, and increasing access to leading therapeutic voices. The combination of expanding evidence and growing curiosity in the market means the opportunity is there. What the research shows is that with the right support and earlier conversations, sponsors are ready to move.