To outcompete China, unhandcuff America’s biotech innovators

America’s long-held dominance in biotechnology is slowly slipping away . China now conducts more clinical drug trials than the U.S. , and its share of global drug-development activity has grown dramatically over the past decade.

This is a problem that goes well beyond the biotech industry. The countries that can discover, develop, manufacture and commercialize the next generation of medical breakthroughs will have an enormous advantage in economic competitiveness, national security and public health.

But America still has opportunities to outcompete China, and regenerative medicine could be one of them. Regenerative treatments involve biotechnologies such as engineered tissues, biomaterials, and gene editing that seek to repair or replace damaged cells, tissues and organs. While China is active in the field , the market for this technology in the U.S. is expected to balloon to $90 billion by 2030.

The U.S. can outpace the rest of the world in this next frontier of healthcare, but only with a policy environment that encourages innovation and enables American companies to compete on equal footing with their global counterparts. That requires a nimble and dynamic regulatory process — one that makes timely decisions and gives innovators the certainty they need to create products that meet patient needs.

The consequences of delayed regulatory decisions are not hypothetical. One Florida biotechnology company has spent years living them.

Based in Pensacola, Regenative Labs develops products for patients derived from donated human birth tissue. Although patients and physicians across the U.S. have benefited from Regenative’s cutting-edge biotech, the company can’t serve patients overseas. That’s because the FDA won’t make a decision on the company’s applications for a Certificate of Foreign Government, a document needed to sell to foreign markets. For three years, dating back to the Biden administration, the company has been mired in bureaucratic delay , waiting endlessly for a decision that federal law requires the FDA to make within 20 days.

While bureaucrats have dithered, foreign competitors unbound by the FDA’s rules have gained a leg up and a chunk of market share abroad. The easy solution for Regenative would be to pack up and move its operations offshore, but it wants to stay and grow in Florida, where it began. An American company with American-developed technology has been put at a competitive disadvantage and held back from expanding its workforce, not because of a lack of demand for its products, but because bureaucrats have ignored their congressional mandate to act.

This case is about more than one company’s export applications. It demonstrates how regulatory inaction can limit biotech growth, slow manufacturing, and weaken America’s position in one of the world’s fastest-growing industries. Every delayed decision is a missed opportunity for American workers, domestic manufacturing, and the homegrown companies developing the next generation of medical innovation.

The situation reflects a broader reality. Biotechnology is rapidly becoming one of the defining industries of the 21st century. The countries that discover, develop and produce tomorrow’s medical breakthroughs will shape the future and come out on top. Maintaining American leadership in biotech means ensuring that pipeline journey happens here at home.

The U.S. has long been the world’s standard bearer in medical innovation, but that status is in jeopardy. China has its sights on overtaking us as the global leader in biotech. We cannot take our leadership in this arena for granted. Every time unnecessary bureaucracy hamstrings American innovators while competitors abroad move ahead, we risk surrendering a strategic advantage that has taken half a century to build.

The benefits of American biotechnology extend far beyond commercial markets and America’s borders. American-developed medical innovations have the potential to improve care for hundreds of thousands of U.S. service members, military families and other Americans living overseas. Why would we prevent America’s service men and women and their families abroad from accessing new treatments that could improve their health?

Making America Healthy Again isn’t just about discovering new ways to be healthy. It’s about creating conditions that allow innovation to reach patients. Our regulatory system must provide the clarity American companies need to succeed. Transparency and timely action from our agencies are as important as anything else to advancing better health and preserving U.S. leadership in biotechnology for years to come.

David Mansdoerfer is the former Deputy Assistant Secretary for Health and currently serves as an adjunct professor in health policy and politics at Pepperdine University School of Public Policy.