For two decades the case for running a clinical trial in Asia was essentially arithmetic: the same study, for less money. That argument has not gone away, but it is no longer the one APAC’s own CRO leaders make.
Asia Pacific is now the only region in the world where trial activity has grown consistently over the past five years. China alone registered 5,215 trials in 2025, double its 2020 total and the first time the annual figure has passed 5,000. But the APAC clinical trial story does not begin and end with China. The five hubs featured below – mainland China, Japan, Korea, Taiwan, and Hong Kong – are moving in noticeably different directions, and at least two of them are doing something that would have looked implausible five years ago.
Read on to learn how the people who actually run these trials are thinking about the state of play in each.
China: Scale is solved, reach is not
The regulatory clock has been reset. In late 2025 China’s regulator, the NMPA, rolled out a nationwide 30-working-day IND pathway for eligible innovative drugs, sitting on top of the existing 60-day implicit approval mechanism and bringing China broadly into line with the FDA. The operational gains behind that headline are just as significant: enrolment can run two to three times faster than in non-Chinese markets, and the average gap between trial approval and first patient enrolled shortened by four months in 2025, with 74 percent of projects securing first informed consent within six months of approval, up from 66 percent a year earlier.
Long Jiang, CEO of GCP ClinPlus – a mid-sized Chinese CRO of around 400 staff with a 23-year history and more than 2,300 completed projects – puts the aggregate effect at roughly 30 percent off traditional global development timelines. He attributes it to a combination of direct sponsor-investigator coordination, hospital trial teams that are now experienced and well organised, and investigators who are highly motivated, particularly on programmes addressing serious unmet need. “Site activation, investigator alignment, patient screening, and operational coordination are all substantially faster than they were even ten years ago,” he says.
The client base has flipped alongside the timelines. Where Chinese CROs once existed largely to serve multinationals running local registration studies, Jiang reports that most of his clients are now domestic biotechs – and that they are increasingly pursuing global rather than domestic-only registrations. Industry focus has now moved on from speed alone. “The more important question – and I think the more honest one – is not simply whether China is fast,” Jiang says. “It is whether China can generate data that global regulators fully trust.”
The evidence increasingly suggests it can. Ken Lee, managing director for Asia Pacific clinical development at Syneos Health, a global CRO with around 5,000 staff in the region, points to audit performance as the measure that matters. Syneos has supported multiple international studies in which mainland Chinese sites contributed data to US new drug approval packages, and those sites have been inspected by the FDA at several locations. Their performance, Lee says, is now comparable to that of US sites by any metric – a quality standard that finally matches a scale advantage China has always had.
The gap that remains is geographic rather than technical. Toshiaki Nagafuji, executive officer and CTO at Japanese CRO Linical, cites analysis showing that 88 percent of clinical trials run by Chinese companies take place solely within China. “While Chinese companies account for 77 percent of clinical trials conducted in China,” he notes, “their share stands at just two percent in the US and five percent in Europe.” For a country now generating a substantial share of the world’s new molecules, that is a striking concentration – and it sits awkwardly against an FDA that has signalled it will no longer accept single-country data as sufficient to support a marketing application.
The direction of travel is clear enough. Vera Zheng, SVP Asia/Pacific strategy and head of Greater China at Parexel – one of the world’s largest CROs, with more than 2,000 people in Greater China after 25 years in the market – describes China’s role as having moved from a market you entered for commercial access, running studies to support domestic registration, to something closer to a development partner. “I describe this shift as moving from selling in China to creating with China,” she says. Her supporting numbers track it: China accounted for roughly four percent of the global innovation pipeline in 2015 and around 30 percent last year, alongside a fifth of global licensing transactions.
Geopolitics, meanwhile, has proved an unlikely business generator for China’s mid-tier CROs. Restrictions aimed at the largest players have left global pharmaceutical companies looking for Chinese partners who do not carry the same regulatory or political risk profile. Jiang fielded more than 30 inbound enquiries from international sponsors last year wanting to run trials in China – a level of interest he describes as a significant change from even three years ago.
Japan: Reformed, and cheaper than you think
Two reversals have taken place in Japan over a short period, and neither has been fully absorbed by sponsors still working from decade-old assumptions.
One of them has a single, well-documented driver behind it. By the Japan CRO Association’s count, more than 70 percent of cutting-edge products approved by the FDA in the past five years remain unapproved or unavailable to Japanese patients – the gap the industry calls drug loss, and one the government has spent the past three years trying to close.
The most consequential response has been regulatory. The mandatory Japanese Phase I study, long the single biggest deterrent for smaller companies, has gone; sponsors can now proceed directly to later-phase studies given sufficient scientific justification to the PMDA. Nagafuji, whose innovative drug development unit at Linical exists largely to guide overseas biotechs through exactly this process, describes a further change that goes beyond it. Where a pivotal Phase III has completed entirely outside Japan with positive results, and the target indication involves a serious condition with no available treatment, the PMDA may now accept an NDA with no Japan-specific data at all. It is, he says, a very significant change, and one that reflects how seriously the Japanese government is taking the drug lag and drug loss problem.
The second reversal owes nothing to policy. Japan spent years as a market sponsors agreed was excellent but prohibitively expensive. Hideyasu Matsuda, vice chairman of the Japan CRO Association, is blunt that the reputation no longer holds. “The depreciation of the Japanese Yen has reduced the effective cost of conducting clinical trials in Japan to roughly half what it was 20 years ago,” he says – a shift he believes has not yet reached the decision-making of many emerging biopharma sponsors. It is worth noting what that advantage rests on: an exchange rate rather than a commitment, and one that could move the other way.
What makes the situation unusual is that the underlying infrastructure was never the issue. On IQVIA Institute’s composite assessment of trial readiness – operational infrastructure, clinical infrastructure and patient availability – Japan ranks third globally, behind only the US and Germany. Matsuda’s point is the distance between that ranking and the volume of trials the country actually hosts. Toru Fujieda, the association’s chairman, fills in the operating detail: a PMDA review window of 30 days for a first IND and 14 days for an amendment, correspondingly rapid site opening, and patient completion rates of around 90 percent that translate directly into cleaner data and fewer protocol deviations than high-volume markets typically deliver.
There is a downstream argument for investing in Japanese clinical trials too. Noriyuki Takai, CEO of EPS Corporation – Japan’s leading CRO, with roughly 4,000 staff in its CRO business and a site management network covering more than 70 percent of Japanese trial sites – points out that Japanese approval data can serve as reference data for regulatory submissions elsewhere in Asia. On that reading, a Japan approval is not a terminal filing in a market of declining share but a foundation for broader regional expansion.
Korea: Fewer trials, but more complex ones
On the headline data, Korea is going backwards. Its share of global industry-sponsored clinical trials fell from 4.04 percent and fourth place in 2023 to 3.46 percent and sixth in 2024, and Seoul – for years the most active trial city on the planet – was displaced at the top by Beijing.
Youngshin Lee, CEO of KRPIA, the Korean Research-based Pharmaceutical Industry Association representing 51 multinational members, says the government came to the association wanting to understand what was happening. What its survey of 33 member affiliates found was not a general contraction: domestic Korean company trials are declining, but the multinational base in Korea is holding. And beneath the declining trial count, the money is moving the other way. Member-company trial expenditure rose 18.8 percent year on year while trial numbers fell about 1.9 percent, with Phase III subject numbers up 17 percent.
“The number of trials is slightly down, but the expense is significantly up,” Lee says. “That tells me the trials are becoming more complex and sophisticated – biologics, advanced therapies, late-stage confirmatory studies. That is not a negative signal for Korea as a clinical destination. It is a signal that Korea is being selected for the most demanding work.”
The underlying commercial case is unchanged. Jinhak Kim, executive director and president US at C&R Research – Korea’s first and largest CRO, founded in 1997, with over 500 clinical specialists – puts the cost differential at a level that materially extends the runway of a capital-constrained biotech: “Conducting a clinical trial in Korea costs approximately 60 percent or less of the equivalent US cost,” driven primarily by investigator and labour fees. Site density compounds it. More than 220 MFDS-certified institutions operate in Korea, over half of them concentrated in Seoul and surrounding Gyeonggi province, many within an hour of each other, which makes multi-centre recruitment unusually efficient. Kim also makes a portability argument that matters increasingly to sponsors weighing where their data will eventually land: because MFDS standards align closely with the FDA’s, a package acceptable to the Korean regulator is generally acceptable in the US.
The pressure point sits elsewhere in the ecosystem. Kwunho Jeong, CEO of JNPMEDI, a Korean clinical technology and CRO firm founded in 2020 with over 300 completed trials, argues that Korea’s capital markets are undermining the value of its own science. Korean biotechs are selling assets to global pharma before Phase I completes, at average upfront rates of around 1.7 percent, because KOSDAQ requires them to demonstrate a global licensing deal before they can list. “It is forcing companies to sign deals too early, at terrible terms, just to access the capital markets,” he says. In his view the rule is “killing the golden goose” – the outcome, whatever the intent, being the systematic undervaluation of Korean innovation.
Taiwan: Fast reviews, fragmented resources
Taiwan competes on regulatory speed, and the numbers are difficult to beat anywhere in the region. A standard TFDA IND review runs around 45 calendar days. Under the Multinational Clinical Trial Notification fast-track, available where the same protocol has been filed with the FDA or EMA, that drops to roughly 14 days – and CTNs already account for 30 percent of IND trials. IND and IRB submissions can proceed in parallel, and Taiwan has held full ICH membership since 2018, which means data generated there is recognised by every major health authority.
The therapeutic concentration is equally pronounced. Oncology accounted for 47 percent of IND applications in 2024, supported by a population-based cancer registry and National Health Insurance coverage of 99.9 percent of cancer diagnosis and treatment. The cell and gene therapy track record is more substantial than the market’s size would suggest, with 46 gene therapy and 103 cell therapy INDs submitted to date.
Samuel Su, founder and CEO of Bestat Pharmaservices – a Taipei CRO building an integrated preclinical-to-clinical platform – credits accelerated TFDA review mechanisms, the establishment of the Taiwan Clinical Trial Alliance and sustained government policy support for the improvement. But he is unusually direct about what has not been solved. “There is still room for improvement within Taiwan’s ecosystem,” he says, “particularly in better integrating clinical trial resources across hospitals, developing more professionals with global clinical development experience, and strengthening collaboration among the many smaller organisations that make up the country’s biotech sector.”
The diagnosis is corroborated from outside. Karen Chu, CEO of HiRO, a 400-person CRO operating across the US, Canada and Asia Pacific, identifies the same constraint independently, noting that Taiwan is working to improve trial efficiency by aligning hospital systems and streamlining processes such as site contracting.
Hong Kong: Building a regulator, betting on a border
Hong Kong is attempting the most dramatic regulatory reinvention in the region, from a standing start as a market that previously did not independently assess drugs. Historically the territory required approval from two of 36 recognised overseas regulators before local registration. The “1+” mechanism, introduced in November 2023, cut that to one where supporting local or Asian clinical data exists. Phased “primary evaluation” – independent assessment of safety and efficacy on clinical data alone – began on 31 March 2026, with full coverage targeted by 2030 and the Hong Kong Centre for Medical Products Regulation due to be established by the end of this year.
The pitch to sponsors is therefore jurisdictional rather than operational. Bernard Cheung, CEO of the Greater Bay Area International Clinical Trial Institute, set up in October 2023 as a single entry point for trial application, conduct and marketing authorisation across Hong Kong and the wider GBA, argues that the territory’s value lies in what a single set of data can be used for. Trials run in Hong Kong to international GCP standards have supported medicines in use today, with data accepted by regulators in the United States, Europe and the Chinese Mainland. “That ability to support regulatory submissions across three major markets from a single jurisdiction is an important differentiator,” he says.
Execution supports the claim at the early-phase end. Roche initiated a first-in-human oncology trial at CUHK within two months, and HKU’s Faculty of Medicine achieved global first-patient-first-visit in a Novartis Phase 1/2 prostate cancer study in 77 days, ahead of every other participating site worldwide.
The ceiling is demographic and well understood locally. Hong Kong’s population is 7.5 million; the Greater Bay Area’s is 87 million. The entire strategy rests on cross-boundary patient access working in practice.
A lack of convergence?
None of these five markets is a substitute for another, and none is trying to be. China offers scale and start-up speed that nothing else in the region matches. Japan offers data quality and, for the moment, a cost profile it has not had in 20 years. Korea offers site density and a regulatory standard that travels. Taiwan offers the fastest review in Asia across a narrow band of indications. Hong Kong offers a jurisdiction whose data three major regulators accept.
What none of them offers is a shortcut through the others. Every market keeps its own regulatory framework, its own language and privacy regime, its own institutional culture. “We are still very much siloed, and I do not see meaningful harmonisation happening anytime soon,” says Syneos’ Lee, who notes the conversation has been running throughout his career with limited progress. Running a study across Asia still means understanding each market on its own terms – a constraint that has outlasted every attempt to remove it.
