A push to reshore some drug production and progress in advanced manufacturing technologies have been prominent trends this year, industry leaders say.
In 2025, the question of where medicines are made went mainstream. Once largely discussed in business terms within pharma companies, the question gained traction as the Trump administration, citing national security and sovereignty, unleashed a barrage of actions to pressure drugmakers to reshore production.
Leaders working in different parts of the production process independently called out the supply chain conversation as the trend that defined pharma manufacturing in 2025. Brian Doty, vice president of R&D and programs at the nonprofit API Innovation Center (APIIC), told BioSpace via email that the “growing urgency around reshoring critical generic medicines” was a key shift in 2025.
Doty pointed to President Donald Trump’s executive orders—including a call to bolster a stockpile of active pharmaceutical ingredients (APIs), purchasing from domestic manufacturers where possible—and a Senate Special Committee on Aging hearing that spotlighted U.S. companies making essential generic medications domestically.
Heavily prescribed generic drugs that rely on foreign APIs were a particular focus of these actions, Doty said. The APIIC leader attributed the 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), an industry group for makers of generics and biosimilars, made a similar point. He told BioSpace that the realization the U.S. needs to prioritize manufacturing was his top trend of 2025. The acknowledgment has emerged in lockstep with rising understanding that the U.S. has medicine supply vulnerabilities because “we don’t make much here,” Murphy said.
“We lead the world in generic drug shortages because of our problematic reimbursement system for medicines,” he added. “We have very little capacity to manufacture API and [key starting materials] here in the United States, and so we are wholly reliant on a number of trading partners.”
The U.S. has little capacity because it has let its generic and biosimilar manufacturing base “atrophy,” Murphy said. The tariff debate brought on by the Trump administration has sparked wider awareness of the situation, he said, and the resulting conversation was “very illuminating” for the healthcare sector.
Doty believes the message has reached healthcare systems, industry and government. “It has been encouraging to see how quickly stakeholders have recognized the value of modernizing U.S.-based pharmaceutical manufacturing,” he said. Murphy and Doty are each now working to turn recognition into action. That process remains a work in progress as 2025 draws to a close.
“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,” Doty said.
Advanced Therapy Sector Seeks Scale
Doty sees continuous flow and other advanced manufacturing technologies as part of the answer to the question of how to reshore API production. In the cell and gene therapy field, companies turned to advanced manufacturing technologies in 2025 to answer the question of how to improve scalability and reduce production costs.
Fabian Gerlinghaus, Cellares’ co-founder and CEO, told BioSpace via email that “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.” Multiple cell and gene therapies have struggled commercially, in part because of a reliance on expensive, poorly scalable manufacturing processes.
David Dismuke, chief technical officer at Forge Biologics, shared an upbeat assessment of work to tackle the challenge, telling BioSpace via email that 2025 was “a turning point where several long-anticipated manufacturing improvements finally translated into measurable performance gains.” Dismuke named yield-boosting additives known as enhancers, improved media for cell growth and improved plasmid designs as innovations that have boosted 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. “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 appear to support the changes. Gerlinghaus said the most unexpected development in 2025 was “the speed and clarity with which U.S. regulators embraced advanced manufacturing.” In the year the Advanced Manufacturing Technologies (AMT) program began to take shape, Gerlinghaus said the pace of action “was significantly faster than anticipated” and showed the FDA is serious about supporting change. The AMT is a new designation aimed at streamlining the regulatory process for early adopters of new technologies.
Just how far the advanced therapy field has come became clear in May when news emerged that a nine-month-old boy with an ultrarare disease had received a CRISPR treatment made just for him. John Maslowski, president and CEO of Forge, told BioSpace via email that the Baby KJ case showed “something fundamentally new: the ability to build a therapy even when there was no roadmap.”
To Maslowski, the story showed “rapid design, rapid manufacturing and rapid regulatory coordination for an individual patient is possible.” The significance of the case could extend beyond KJ, he said, as it demonstrates the emergence of “a new way to think about platforms and manufacturing systems that can flex to meet the needs of any patient.”
“Urgency around pharmaceutical resilience has grown significantly,” Doty said. “The coming year will be about putting those solutions into action across the industry.”
