A new article by Tyler Patchen writing for Biospace highlight how the BIOSECURE Act, a U.S. House bill that aims to restrict American biopharma companies from working with certain Chinese contract development and manufacturing organizations (CDMOs), particularly WuXi AppTec and WuXi Biologics will impact biopharma companies in the U.S.
The bill labels these Chinese companies as “companies of concern” due to alleged ties to the Chinese government and potential national security threats, according to Patchen’s research.
The BIOSECURE Act would set a deadline for U.S. drugmakers to cut existing ties with these Chinese companies. It would also prohibit new agreements or extensions of existing contracts with these firms. The bill’s impact could be significant, as WuXi AppTec is deeply embedded in the U.S. pharmaceutical industry, reportedly involved in developing one-fourth of the drugs used in the country.
The potential restrictions have created uncertainty in the market but also opened opportunities for competitors to fill the gap. India’s CDMOs may step in to capture some of the business that may be lost by Chinese companies. India’s contract manufacturing market is substantial, estimated at over $22 billion and projected to reach $44 billion by 2029, even without any shift from China.
Several experts weigh in on the situation:
1. Gil Roth, suggests the fallout could be very significant for both CDMOs and their customers.
2. Pushpa Vijayaraghavan, notes that Indian CDMOs have been trying to increase their share of the U.S. market and sees this as a potential opportunity.
3. Bikash from Pharmatech Associates, highlights the significant impact on organizations with government-funded development programs or those planning to engage the government as a customer.
4. Brian Scanlan, from Edgewater Capital Partners, points out that recent allegations of WuXi AppTec sharing client data with the Chinese government may give biotech companies additional incentives to break ties with Chinese firms.
The article also discusses the challenges in replacing WuXi’s services, especially given the current all-time high in U.S. drug shortages. It notes that Indian CDMOs have been investing in building production capacity and capabilities but may need to accelerate these efforts to meet potential demand.
The article from BioSpace notes that while the BIOSECURE Act presents opportunities for Indian and potentially U.S.-based CDMOs, the transition may not be simple.
