JAPAC Emerges as a Global Accelerator for Clinical Development as Sponsors Seek to Overcome Enrollment Delays

Nearly 80% of clinical trials miss their original enrollment timelines, often by months, contributing to higher costs, delayed decision-making, and lost commercial windows. Against this backdrop, emerging biopharma companies are increasingly looking to Japan and the broader Asia-Pacific (JAPAC) region as a means of accelerating clinical development and strengthening trial resilience, according to a recent survey conducted by IQVIA查看公司主页.

The survey, which gathered feedback from emerging biopharma leaders across North America and Europe, found that overall sentiment toward further utilizing the region was overwhelmingly positive, with an expected 13% year-on-year increase in R&D spend into JAPAC over the next three years. The findings were published by David Horsburgh, Head of Strategy, Site and Patient Solutions at IQVIA查看公司主页 R&D Solutions Japan and Asia-Pacific.

A Structural Enrollment Problem

The scale of the enrollment challenge is substantial. Traditional geographies in North America and Europe are struggling under site saturation, tighter eligibility criteria, and rising operational complexity. At the same time, protocols are increasingly complex, competition for patients is intense, and enrollment delays now carry outsized financial and strategic consequences.

"Tapping into the large patient populations and experienced investigators within JAPAC could well be part of the solution," the report notes. However, for many biotech sponsors, the opportunity remains a question of balancing acceleration potential against logistical concerns, perceived communication hurdles, and limited experience navigating the region's regulatory and trial landscapes.

Rising Stakes in Regional Selection

The research highlights a rise in later-phase studies conducted in single regions or even single countries, which raises the stakes on regional selection. JAPAC-generated data is increasingly being used for submissions to US and EU regulatory authorities, which de-risks single-region strategies by providing high-quality, relevant data while maintaining the speed needed to hit critical market access windows.

Asia represents 43% of total global developmental assets, underscoring the region's growing importance in the global drug development landscape.

Knowledge, Not Willingness, Is the Barrier

The survey identified a striking finding: the biggest barrier to JAPAC adoption was not regulation, logistics, or cost, but 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 significant patient and site potential.

"In other words, confidence — not capability — is the often-limiting factor," the report states. Many sponsors admit they default to North America or Europe simply given familiarity, even if JAPAC has the potential to deliver faster timelines when executed correctly.

What Sponsors Need Most

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

Timing also matters. 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.

Distinct Roles Across the Region

The survey respondents recognized that treating JAPAC as a single market does not work, with distinct rationales for 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. 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," the report concludes.

The Role of Partnerships

Given the diversity of the region and varying levels of sponsor experience, the majority of respondents indicated prior engagement with global and local-based research partners and contract research organizations (CXOs) when pursuing JAPAC. The number one driver for engaging a partner was accessing knowledge and expertise to navigate individual regulatory landscapes, closely followed by leveraging a partner's existing site and investigator relationships.

Investor Momentum and a Changing Landscape

Investors are already ahead of the curve: more than 55% of respondents said their investors have specifically encouraged the exploration of JAPAC as a development destination. This urgency is compounded by changing regulatory landscapes in the US and Europe, including discussions about the sources of patient data accepted for submissions, which make it critical for biotech companies to keep an open mind to development opportunities across the globe.

"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 report states. "With the right support and earlier conversations, sponsors are ready to move."