In 2025, the issue of where medicines are produced became a central topic in the United States. The Trump administration introduced several measures to encourage pharmaceutical companies to move manufacturing back to the country, citing concerns about national security and sovereignty.
Brian Doty, vice president of R&D and programs at the nonprofit API Innovation Center (APIIC), described a significant shift in focus toward reshoring critical generic medicines. Doty noted that President Donald Trump’s executive orders included efforts to increase stockpiles of active pharmaceutical ingredients (APIs) and promote purchasing from domestic manufacturers when possible. He also referenced a Senate Special Committee on Aging hearing that highlighted U.S. companies producing essential generic medications domestically.
Doty explained that these actions particularly targeted heavily prescribed generic drugs dependent on foreign APIs. He attributed this development to “a growing recognition of our nation’s overreliance on foreign suppliers as a national health security risk.”
John Murphy, CEO of the Association for Accessible Medicines (AAM), echoed this sentiment. He said that realizing the need for domestic manufacturing was his top trend for 2025. According to Murphy, this awareness grew alongside an understanding that medicine supply vulnerabilities exist because “we don’t make much here.” Murphy added, “We lead the world in generic drug shortages because of our problematic reimbursement system for medicines,” and pointed out that there is little capacity in the U.S. to manufacture APIs and key starting materials, making the country reliant on trading partners.
Murphy further stated that America’s limited capacity results from allowing its generic and biosimilar manufacturing base to decline over time. The tariff debate initiated by the Trump administration brought broader attention to this issue within healthcare.
Doty commented on how quickly stakeholders have responded: “It has been encouraging to see how quickly stakeholders have recognized the value of modernizing U.S.-based pharmaceutical manufacturing.” Both Murphy and Doty are working toward turning this recognition into action, though they acknowledge progress is ongoing as 2025 ends.
Doty also warned, “Our nation’s overdependence on foreign API supply for some of the most commonly prescribed generic drugs persists, and few backup options are available when disruptions occur.”
Looking at solutions, Doty identified continuous flow and other advanced manufacturing technologies as ways to reshore API production. In cell and gene therapy sectors, companies sought advanced methods in 2025 to improve scalability and reduce costs.
Fabian Gerlinghaus, co-founder and CEO of Cellares, said via email: “the defining challenge of 2025 was the industry’s realization that scaling complex, labor-intensive manufacturing workflows across fragile supply chains is no longer commercially viable.” Many cell and gene therapies faced commercial challenges due partly to expensive production processes.
David Dismuke, chief technical officer at Forge Biologics, provided an optimistic view: 2025 was “a turning point where several long-anticipated manufacturing improvements finally translated into measurable performance gains.” Dismuke mentioned innovations such as yield-boosting additives called enhancers, improved media for cell growth, and better plasmid designs as factors increasing productivity.
“These advancements matter because they expand the kinds of programs gene therapy developers can target. As manufacturing performance improves, developers can pursue programs for larger populations and more prevalent diseases that were previously out of reach,” Dismuke said. He added: “We are already seeing this shift among some of our own clients, such as Fractyl Health, which is developing an AAV-based gene therapy aimed at metabolic diseases like obesity and type 2 diabetes.”
Regulators have shown support for these changes. Gerlinghaus remarked that one unexpected development in 2025 was “the speed and clarity with which U.S. regulators embraced advanced manufacturing.” With the Advanced Manufacturing Technologies (AMT) program beginning in 2025—a new designation designed to streamline regulatory processes—Gerlinghaus observed that action came faster than expected from agencies like the FDA.
The field's progress was evident when news broke in May about a nine-month-old boy with an ultrarare disease receiving a CRISPR treatment made specifically for him. John Maslowski, president and CEO of Forge Biologics said: "the Baby KJ case showed 'something fundamentally new: the ability to build a therapy even when there was no roadmap.'"
Maslowski continued: "rapid design, rapid manufacturing and rapid regulatory coordination for an individual patient is possible." He suggested this could signal "a new way to think about platforms and manufacturing systems that can flex to meet the needs of any patient."
Doty concluded by saying: "Urgency around pharmaceutical resilience has grown significantly," adding that implementing solutions will be key moving forward.
