As the biopharma industry moves into 2026, there is growing pressure to strengthen U.S. manufacturing capacity through reindustrialization. Experts emphasize that simply building new facilities will not be enough; efforts must also focus on modernizing existing infrastructure to secure upstream inputs and improve quality control in line with faster production speeds.
New policies introduced by the Trump administration last year are designed to encourage domestic drug production. John Murphy, CEO of the Association for Accessible Medicines (AAM), stated to BioSpace that a central priority in 2026 will be reindustrializing sectors of the U.S. economy. According to Murphy, this involves adopting policy and legislative changes that prioritize drug supply resilience and sustainability, which could enhance domestic capacity and generate jobs in the United States.
Murphy highlighted particular concerns about antibiotic supply, noting that the country relies heavily on one or two countries for critical antibiotics. He argued that diversifying the supply chain could reduce risks related to medicine availability.
However, Murphy warned against trying to manufacture all pharmaceuticals domestically. Instead, he explained that AAM supports creating a reliable supply chain supporting domestic availability so that “the U.S. [is able] to pick up the slack if one of our trading partners has an issue in supply.” Under this approach, some production would return to U.S. soil while maintaining involvement in global supply chains.
Brian Doty, vice president of R&D and programs at the nonprofit API Innovation Center (APIIC), described his vision for reshoring production: “widespread adoption of advanced manufacturing that will allow domestic manufacturers to match or exceed the efficiency of global competitors.” While initiatives like the FDA’s PreCheck program encourage construction of new plants in the U.S., Doty pointed out opportunities exist in 2026 to upgrade current facilities as well.
Doty added: “From my vantage point in R&D, it became clear that the solution is not just to build new facilities, but to modernize how we manufacture these ingredients within facilities with excess capacity so domestic producers can compete with foreign suppliers on reliability, cost and quality.”
Both Doty and Murphy identified reliance on other countries for key starting materials (KSMs)—essential chemicals used in making active pharmaceutical ingredients—as a vulnerability for U.S. drug makers. Doty noted these KSM supply chains are “opaque, globally concentrated and exposed to geopolitical and environmental pressures,” making them susceptible to disruptions leading to shortages further down the line.
Doty stressed: “For the U.S. to meaningfully strengthen its generic drug supply, securing these chemical building blocks is just as important as expanding domestic API production.” He added: “Without addressing upstream inputs, true resilience cannot be achieved and the supply chain will remain at risk for disruptions.”
In cell therapies—a field distinct from generics—Fabian Gerlinghaus, co-founder and CEO of Cellares, echoed similar themes regarding automation and resilience: “[D]emand is increasing, regulatory expectations are rising and geopolitical pressures are accelerating the push for domestic, resilient manufacturing capacity.” Gerlinghaus believes that establishing globally standardized manufacturing networks built around automation will be crucial for delivering advanced therapies at commercial scale.
He said: “Leaders who embrace this shift will be positioned to scale therapies globally. Those relying on manual, fragmented systems will struggle to keep pace.”
Gerlinghaus also cautioned about potential challenges arising from greater automation; he suggested industry may underestimate quality control issues as automated processes become more widespread. If manufacturing scales up but quality control remains manual or slow-moving, bottlenecks could simply shift downstream.
David Dismuke, chief technical officer at gene therapy manufacturer Forge Biologics, expressed similar concerns regarding product verification amid advances in productivity: “Advancing automated analytical platforms will be essential to keep pace with next-generation processes,” Dismuke said via email. “Better testing and real-time insight ultimately determine how reliably we can deliver high-quality product at scale.”
