Major drugmakers accelerating domestic CGMP investment and turning to modular, flexible and continuous-manufacturing designs
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Even as U.S. tariffs on imported pharmaceuticals climb toward 200% and the Food and Drug Administration undergoes deep restructuring, major drugmakers are expanding domestic biomanufacturing capacity, according to CRB’s Horizons: Life Sciences 2025 report and firm executives.
The survey of 400 global R&D and manufacturing leaders shows that half of large companies are accelerating investment in U.S. facilities, with 65% pursuing continuous-manufacturing systems to boost efficiency.
“These aren’t quick political reactions,” said Peter Walters, CRB’s fellow for advanced therapies. “Buildings take years to plan and validate. What’s being accelerated now are long-term master-plan projects that were already in motion—but they’re being repackaged to align with U.S. priorities.”
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The administration’s mid-2025 tariff escalation on imported drugs has prompted large manufacturers to highlight domestic projects as a gesture toward policy alignment. Walters said some firms “are re-strategizing existing investment portfolios” to emphasize U.S. buildouts that could win tariff leniency or faster regulatory coordination.
The data align with recent industry moves by multinational firms such as Eli Lilly, which announced a $2.5-billion facility in Virginia to mitigate trade-risk exposure.
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Beyond tariffs, Walters said the bigger shift is philosophical: production plants are now treated as strategic, flexible infrastructure rather than single-product assets.
“Companies are spending hundreds of millions on therapies that might never reach commercial scale,” he said. “Facilities must pivot easily—handling multiple product profiles or even entirely different modalities—so capital investment doesn’t become stranded the moment clinical priorities change.”
CRB’s report notes that 88% of surveyed firms are pursuing process standardization and modular design to build flexibility across scales and settings.
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The study’s most striking finding is the widespread adoption of end-to-end continuous biomanufacturing, a once-experimental approach now viewed by two-thirds of large companies as essential for resilience and sustainability.
“After a decade of incremental advances—perfusion, inline filtration, intensified processing—the enabling technologies are mature,” Walters said. “Continuous systems let you produce more drug with less space, energy and manpower. It’s greener, faster and ultimately cheaper once the capital hurdle is cleared.”
Download the Report:
CRB | Horizons: Life Sciences 2025 Report
The FDA’s willingness to approve small-molecule facilities using continuous lines has eased concerns over regulatory precedent. Walters expects the first commercial-scale biologics plant to follow within a couple of years.
While pandemic-era projects prioritized schedule, cost discipline now dominates decision-making. Walters said 47% of respondents listed capital containment as their top project driver, with only 11% citing schedule speed.
Progressive design-build and target-value design models are gaining traction for aligning cost certainty across teams. “Modularity still makes sense when it saves labor or utilities long term,” he said, “but the market has pivoted hard back to value engineering.”
CRB’s findings echo federal data showing biomanufacturing job growth outpacing available talent. Walters said companies face “selective scarcity”—validation and automation specialists are in short supply even as layoffs hit other functions. That gap, he added, “is pushing design teams to automate processes and reduce dependence on hard-to-find human expertise.”
While North America gains manufacturing share, Asia continues to expand rapidly in R&D, driven by government investment and bioeconomy initiatives, with Europe maintaining steady growth in early-stage research.
Walters said the current reshoring narrative may be overstated: “The global network isn’t contracting—it’s expanding everywhere. What’s really happening is a rebalancing of messaging and risk tolerance.”
Despite economic uncertainty, the Horizons data point to continued expansion. Forty-three percent of respondents expect overall investment to increase in 2026, led by antibody-drug conjugates, cell and gene therapies, and GLP-1 manufacturing.
“The innovation pipeline is as healthy as it’s ever been,” Walters said. “The question now is how to build facilities that can adapt as fast as the science.”
