John Crowley, CEO of Bio, argues the best strategy for US biotech dominance is not protectionism. Instead, the focus should be on improving the US's own competitive advantages, like streamlining regulations and lowering innovation costs, to maintain its lead rather than trying to stifle Chinese research.
Related Insights
The high cost and time required for US clinical trials create a rational economic incentive for companies and investors to move operations to China. The solution isn't to match China's low costs, but to significantly improve US efficiency to make domestic investment more competitive.
Bio CEO John Crowley defines "winning" in the biotech race as a two-part victory. It's not enough to lead in scientific discovery; the US must also dismantle systemic barriers like insurance hurdles and high out-of-pocket costs to ensure Americans can access these advanced medicines.
China has developed a first-rate biotech effort, enabling U.S. firms to buy or license preclinical assets more efficiently than building them domestically. This creates an arbitrage opportunity, leveraging China's R&D capabilities while relying on U.S. expertise and capital for global commercialization.
China is no longer just a low-cost manufacturing hub for biotech. It has become an innovation leader, leveraging regulatory advantages like investigator-initiated trials to gain a significant speed advantage in cutting-edge areas like cell and gene therapy. This shifts the competitive landscape from cost to a race for speed and novel science.
The US is losing the biotech race not just at the FDA, but due to slow hospital Institutional Review Boards (IRBs) and contracting. A Phase 1 trial takes four weeks in China, while a simple university survey in the US can take over a year for approval, creating a major competitive disadvantage.
Driven by significant government investment, China is rapidly becoming a leader in biotech R&D, licensing, and outsourcing. This shift is a top-of-mind concern for US biotech and pharma executives, with China now involved in a majority of top R&D licensing deals.
Faced with China's superior speed and cost in executing known science, the U.S. biotech industry cannot compete by simply iterating faster. Its strategic advantage lies in
Top biotech VC Bob Nelsen contends the U.S.'s competitive edge is eroding because of slow, burdensome FDA processes. He points to Australia's model, where human trials can be approved in days, as the standard the US must adopt to compete with agile global players like China.
The industry's negative perception of FDA leadership and regulatory inconsistency is having tangible consequences beyond investment chilling. Respondents report actively moving clinical trials outside the U.S. and abandoning vaccine programs. This self-inflicted wound directly weakens America's biotech ecosystem at the precise moment its race with China is intensifying.
The next decade in biotech will prioritize speed and cost, areas where Chinese companies excel. They rapidly and cheaply advance molecules to early clinical trials, attracting major pharma companies to acquire assets that they historically would have sourced from US biotechs. This is reshaping the global competitive landscape.
