Report: China Biopharma Closing Gap on U.S. ‘Far Faster Than Anticipated’

In April, a bipartisan committee warned Congress that America’s global biosector leadership was potentially on borrowed time, advising that if not for urgent regulatory corrections, China will overtake the U.S. within three years.

That same committee has issued an update.

The clock is ticking even faster than feared.

“Since the publication of that assessment, the trajectory the Commission identified has continued – and in several respects intensified,” said the National Security Commission on Emerging Biotechnology (NSCEB) in its updated report. “Emerging evidence indicates that China is now surpassing the United States in certain domains of biopharmaceutical innovation, marking a new inflection point in this great-power competition…

“While the Commission previously identified a three-year window for decisive action, new evidence indicates that this window is closing far faster than anticipated, underscoring the urgency for an accelerated U.S. policy response.”

 In its new analysis, NSCEB cited a Morgan Stanley Research report from September.

Morgan Stanley, among its findings, quantified China’s long-term pivot from me-too drugs to truly innovative therapies, projecting China-origin drugs will account for 35% of U.S. Food and Drug Administration approvals by 2040. Today, the share is just 5%. Annual revenue from China-origin drugs could reach an estimated $220 billion by 2040.

Among other details, NCSEB explained that continued advantages of China's innovation clusters, which “physically co-locate research institutes, regulatory authorities, and industrial-scale manufacturing within the same geographic area" could deliver the industry dominance that China seeks.

Those dynamic districts, in conjunction with private and public investment, streamlined regulatory process for clinical trials and other factors, create a high-stakes environment for U.S. policymakers to navigate in the new year.

“Unless the U.S. government adopts the necessary policies to catalyze its own domestic biotechnology industry,” NSCEB said in its follow-up report, “China’s competitive edge in biopharmaceuticals may soon expand into an unsurmountable lead.”

Learn more about the U.S.-China drug innovation race from a Hill briefing that We Work For Health recently hosted.