Amidst geopolitical uncertainty, healthcare remains a unifying priority across different regions.
Patients, providers and industry all, ultimately, share the same goal: access to high-quality, effective therapies that improve patient outcomes and drive efficiencies in healthcare management.
For US biotech companies, tariffs and geopolitics may dominate the headlines, but they are forging ahead with strategic investments and partnerships across the Asia-Pacific region (APAC) and the Middle East.
However, it is a tricky market to navigate, with each country having its own unique timelines, documentation requirements and clinical infrastructure.
Therefore, a standardised approach to regulatory frameworks is ineffective.
US-APAC collaboration
Working in partnerships is an excellent way to negotiate these regulatory, cultural and infrastructure differences.
These partnerships give biotech companies vital market access, provide regulatory advantages and allow resources to be shared.
Jackie Kunzler, Senior Vice President, Global Research and Development at Terumo Blood and Cell Technologies, said: "At Terumo Blood and Cell Technologies, we have found that the best way to achieve this is through partnerships."
"This means working together in person and taking the time to understand the local regulatory frameworks and operational nuances, as well as cultural needs."
"One example in APAC is our manufacturing collaboration in China, where success has hinged on a truly integrated US-China approach."
"As we expand our manufacturing capabilities in China, regular in-country engagement and consistent knowledge exchange have helped us to navigate both regulatory and operational complexities."
"We've applied this same model across other international markets with similar success."
Bev Menner, CEO at Cell Therapies, also commented: "US biotech companies are navigating regulatory, cultural and infrastructure differences to build sustainable, high-impact partnerships across APAC and the Middle East by approaching these regions with greater intentionality."
"Although both areas present significant opportunities for advanced therapies, they also involve complex regulatory environments, diverse cultural expectations, variable infrastructure and geopolitical uncertainty, all of which require careful management."
Because each country has its own regulatory framework—with distinct timelines, documentation requirements and clinical infrastructure—navigating this landscape presents a significant challenge.
Companies that want to see successful partnerships should partner with experienced regional experts who can bridge global expectations and local realities.
For example, Australia has a fast ethics approval process, plus a transparent science-driven regulatory system, R&D incentives and established clinical networks.
These make it an ideal starting point for broader regional expansion.
Of course, geopolitical uncertainty adds another layer of complexity, underscoring the importance of establishing distributed but integrated supply chains and regional partnerships.
"Companies that succeed in these regions prioritise building local relationships and cultural alignment early on, fostering trust through consistent transparency, reliability and sustained collaboration," added Menner.
The Middle East
With governments in the UAE and Saudi Arabia investing in biotechnology infrastructure, the Middle East is becoming an increasingly attractive prospect.
These markets highly value local manufacturing, technology transfer and capability building, which therefore requires companies to establish genuine long-term collaborative models instead of just providing products.
Menner continued: "At Cell Therapies (CTPL), we have supported global cell and gene therapy (CGT) developers for more than two decades."
"To support their expansion, we established the Asia-Pacific Alliance Model (APAM), which allows global companies to transfer their CGT programmes once in Australia and then scale across multiple APAC markets via a single coordinated tech transfer and aligned regulatory framework."
"This helps to reduce duplication and accelerates timelines. We are applying this disciplined, partnership-driven model as we explore potential collaborations in the Middle East."
In conclusion
For US biotech firms, building high-impact, sustainable partnerships in APAC and the Middle East requires the right combination of technical execution, local insight and long-term commitment.
Lasting impact emerges from ongoing presence, dependable execution and collaborative growth with time.