US onshoring is too slow, complex to drive near-term tailwind in bioprocessing

Despite a “tangible” buildout of U.S. infrastructure, standing up Good Manufacturing Practice (GMP) facilities takes about 32 months due to “large permitting hurdles” while technology transfer from China has long timelines, according to contract development and manufacturing organizations (CDMOs) cited by Leerink Partners analysts. 

Last week, the analysts attended the annual 2025 Bioprocess International Conference and Exhibition in Boston and hosted key opinion leaders (KOLs) from U.S. CDMOs with “extensive experience” in manufacturing for monoclonal antibodies, adeno-associated viruses, peptides, and other modalities.

“The bottom line was that the evidence for a sweeping domestic shift is inconsistent; there is real U.S. [capital expenditure] activity, but its scale and sustainability are not yet clear, and in several cases the safest interpretation is that sponsors are hedging rather than fully relocating long-cycle production,” the analysts wrote in a Sept. 18 report to investors.

Amid the threat of tariffs and pressure from President Donald Trump to onshore manufacturing, Big Pharma companies have made high-profile announcements in 2025 pledging to invest a total of more than $300 billion in U.S. infrastructure over several years. 

However, one KOL “challenged the idea that this proves a broad repatriation of large-scale drug substance capacity, reminding that Samsung primary stainless capacity remains in Korea, and that public ‘onshoring’ announcements can be more performative in nature vs. authentic,” according to the analysts.

The KOLs also pointed out that the timelines for technology transfers to the U.S. from overseas also have their own challenges.

“If a program originates in China and is later moved into a U.S. facility, the U.S. site cannot simply rely on comparability and a foreign data package; the U.S. location must still run 3 [Process Performance Qualification] batches and shoulder the facility-level validation burden,” the analysts wrote, while noting that several KOL examples stressed that sponsors “underestimate the cost and time of that facility move, especially the re-validation of raw materials/disposables.”

While the “fastest path” to tech transfer can be a dual qualification strategy with an early clinical stream in China and a parallel U.S. stream brought up in time for Process Performance Qualification (PPQ), it is an expensive option with increasing risk for programs aiming to out-license in the U.S. or Europe, according to the analysts.

The KOLs also pointed out that “if you are importing earlier-phase materials for clinical work, research-grade customs strategies will not survive commercial launch given the significant financial and logistical burden/bottleneck of PPQ,” the analysts wrote.

BIOSECURE Act drives onshoring

At the same time, the analysts said there is some evidence of drug manufacturers “hedging” GMP capacity in the U.S., with the BIOSECURE Act cited as a potential contributor and influence for sponsors looking to avoid dealing with China-based CDMOs.

The BIOSECURE Act, which the House of Representatives overwhelmingly passed in 2024 but failed to include in last year’s military spending package, has recently been proposed as an amendment to the Fiscal Year 2026 National Defense Authorization Act (NDAA). However, unlike prior legislative drafts, the amendment does not specifically name WuXi AppTec and WuXi Biologics as biotechnology companies of concern to U.S. national security.

Still, even without the BIOSECURE Act being passed into law, it is already changing the behavior of some drug sponsors and is an incremental driver of onshoring, according to KOLs cited by the analysts.

“One KOL said explicitly that the reputational and policy risk has been enough for many sponsors to bring development work back to U.S. CDMOs or demand a China-for-China/U.S. for-U.S. split to keep global options open without commingling data/materials,” the analysts wrote.

They also noted that the BIOSECURE Act has raised broader concerns about data, cybersecurity, and shared enterprise systems.

“Even if a China site is GMP-clean, shared information systems and patient data flows remain flashpoints,” the analysts said. “Meaning the safest operational choice for many programs is to re-establish a U.S. chain of custody and keep the clinical-to-commercial data package local.”