The West’s wake-up call to China’s biotech dominance

This legislation reflects shifting political, economic, and military forces. U.S. companies will need new suppliers, leading to immediate challenges in the biopharma supply chain. However, the broader impact involves rebalancing global biotech dominance, with long-term implications for competitiveness and supply chain sustainability.

China has invested in biotech for decades, positioning itself as a global leader. In contrast, the West was slow to prioritize biotech. The
BIOSECURE Act may shift this, encouraging the U.S. and Europe to bring resources back home. Yet, in the short term, the consequences for manufacturing, clinical trials, and intellectual property are significant.

Western companies heavily rely on Chinese Contract Development and Manufacturing Organizations (CDMOs) for biotech productivity. A survey of U.S. biopharma companies revealed that 79% rely on at least one Chinese CDMO. China also supplies APIs and antibiotics to the U.S. and Europe, raising national security concerns. Shifting manufacturing out of China will be slow, taking years to establish new suppliers and affecting millions of patients. Geographic diversification of clinical trial sites also faces delays, increasing challenges in drug development.

China’s growing dominance in clinical trials may lead to data sharing restrictions under the BIOSECURE Act, affecting patient access and trial timelines. China’s share of global clinical trials grew by 57% in recent years, while Western Europe’s share dropped by 21%. Further tensions could slow innovation and limit access to treatments.

Biopharma executives must continue to carefully monitor China’s efforts to acquire Western biotech IP which threatens the industry’s competitive edge. The BIOSECURE Act also provides an opportunity. The West must respond with a comprehensive “BIOBUILD” strategy to maintain biotech leadership. This strategy should include tax incentives, regulatory reforms to accelerate drug development and approval, and investments in education of a bio­pharmaceutical workforce. It should also provide concrete support to ventures affected by BIOSECURE including providing incentives to those reliant on low-cost Chinese suppliers. China is committed to becoming the global biotech leader. If the West remains uncoordinated, it risks falling further behind a superpower that began its push decades ago. The BIO­SECURE Act is a critical wake-up call. The West ignores it at its peril. We need a BIOBUILD plan.

Author: Dr Jeremy M. Levin

Levin has held leadership roles in major pharmaceutical and biotechnology companies. He is currently Chairman and CEO of Ovid Therapeutics and Chairman of Opthea. Previously, he served as President and CEO of Teva Pharmaceutical Industries and was on Bristol-Myers Squibb’s Executive Committee. He has also been Global Head of Strategic Alliances at Novartis. Besides numerous board positions, Dr. Levin serves on the Board and Executive Committee of the Biotechnology Innovation Organization as Emeritus Chairman.

This article was originally published in European Biotechnology Magazine Autumn 2024.