Author: Dan Gallagher, Emerald Clinical Trials SVP, Business Development.
Dan Gallagher is a senior commercial leader on Emerald Clinical Executive Team with 17 years of drug development experience driving business development, operational transformation, and strategic growth for global CROs and biotech service providers. Currently serving as Senior Vice President, Head of Business Development and acting Chief Commercial Leader at Emerald Clinical, Dan leads a global commercial organization spanning business development, contracts & proposals, and marketing.
In the past year, China has rapidly emerged as a key strategic consideration for sponsors planning to run global studies. That marks a sharp shift from the traditional biotech and pharma regional focus, where APAC was often treated as secondary to the US and Europe and brought into development plans only later if timelines, funding, or commercial priorities allowed. That approach is changing rapidly. Across the industry, sponsors are recognizing that APAC is no longer simply an optional expansion geography.
China and the APAC region in general are increasingly becoming one of the most important operational and strategic imperatives for accelerating clinical development timelines, accessing patients faster, and unlocking therapeutic asset value earlier. In short, APAC is becoming the next innovation hub for drug development. The shift is already under way and some sponsors have adapted to it much more quickly than others. Part of the reason is simple competitive pressure. Sponsors are competing for the same investigators, the same sites, and often the same patient populations across existing geographies in the US and Europe.
For smaller and mid-sized biotech companies, that challenge becomes even more pronounced. Large pharmaceutical companies already have entrenched investigator and site relationships, established infrastructure, and recognizable brands. Competing against these factors solely within traditional Western enrollment markets can quickly become difficult. In highly competitive indications or in rare diseases, limiting enrollment strategy to the US and Europe increasingly creates operational risk and slows study enrollment timelines. There are a limited number of qualified sites and only so many eligible patients. As a result, only limited enrollment capacity is available at any given time.
Meanwhile, sponsors are starting to realize that the APAC region is a powerful enrollment multiplier. China, in particular, plays an increasingly important role in helping sponsors accelerate recruitment, especially in indications with high disease prevalence or heavily contested patient populations. Faster recruitment does more than just improve timelines. It also reduces development risk, lowers operational costs, and allows sponsors to generate meaningful data sooner. That matters because time is directly tied to asset value. The faster study data is produced and analyzed, the faster sponsors can validate whether an asset should move forward. Earlier data means earlier development decisions, earlier funding conversations, earlier partnership discussions, and potentially earlier market opportunity. This can translate into potentially tens to hundreds of millions of dollars over the patent protection time of a drug.
That means that in the current commercial environment, accelerating development not only creates operational efficiency but also strengthens competitive positioning and market access. Right now, the pharmaceutical industry has started to recognize this. China is no longer viewed simply as a lower-cost geography or a supplemental enrollment region. It is increasingly becoming a global innovation hub for drug development itself.
Why Sponsors Are Rewriting Their Global Development Strategy
China’s transformation over the last decade has played a major role in that shift. Significant overhauls and advances in regulatory modernization, improved infrastructure, growing scientific sophistication, and increased operational maturity have dramatically changed how global sponsors approach the region. Previous experiences of industry veterans form many perceptions about conducting studies in China, which are simply outdated. Some sponsors that still think about China using assumptions from five or ten years ago are often underestimating how much the country has evolved. The market for clinical trial data and patient access is increasingly moving toward APAC, particularly in areas where speed and competition matter most.
This trend becomes especially important in key therapeutic areas like oncology or renal. If multiple sponsors are pursuing similar mechanisms or indications, delays can become strategically damaging very quickly. Six months lost during enrollment is not only significant operationally, but competitively it can materially alter market position, investor confidence, and future commercial potential. The reality is that sponsors are no longer competing on therapeutic benefit and science alone but also on execution speed. This is forcing study sponsors to rethink when and how China should be integrated into global strategy. Historically, many sponsors approached China and broader APAC regions later in development. Today, more sophisticated sponsors are integrating them earlier into Phase I through IV planning. Instead of treating the region as an add-on later, they are designing global studies from the outset with local participation explicitly built into the strategy.
That creates several advantages simultaneously as it:
- Accelerates patient access,
- Broadens enrollment options,
- Improves development flexibility,
- Reduces the risk of falling behind competitors already operating globally, and
- Elevates the importance of CRO selection.
The CRO Question Is Now a Strategic One
For sponsors entering China for the first time, one of the safest ways to reduce operational uncertainty is working with a CRO partner that already has deep regional experience and established operational infrastructure across APAC markets. That experience matters because global studies rarely fail from a single catastrophic issue. More often, they lose momentum and slow down through operational friction: communication gaps, fragmented oversight, unrealistic expectations, or lack of regional familiarity. Sponsors often underestimate how difficult it can be to coordinate disconnected regional strategies through multiple providers. If one CRO manages Europe, another Australia and a third China, it frequently creates duplication, inefficiency, and slower decision-making.
The strongest CRO partners are not simply vendors executing tasks country by country. They understand how to guide sponsors through the operational realities of conducting studies across regions while maintaining continuity in strategy and execution. That includes understanding local regulatory expectations, patient access dynamics, investigator relationships, and the practical realities of running studies on the ground. For sponsors new to APAC or China, that kind of embedded experience significantly lowers the barrier to entry.
The broader point is that the global clinical trial market has already started moving in this direction. Sponsors who continue treating China as a secondary or future consideration risk finding themselves behind competitors that are already using the region to accelerate timelines and development decisions. The companies gaining momentum today are the ones building smarter global strategies earlier.