Industry leaders are focused on the resilience of key starting material supply and the knock-on effects of automation in the new year.
Under pressure to drive resilience through reindustrialization, the biopharma industry enters 2026 with a mandate to bolster U.S. manufacturing capacity. Experts warn the transformation needs more than new construction. To them, pushes to modernize existing infrastructure are needed to secure upstream inputs and ensure quality control evolves to match production speeds.
Last year saw new policies from the Trump administration aimed at incentivizing domestic drug production. John Murphy, CEO of the Association for Accessible Medicines (AAM), an industry group for makers of generics and biosimilars, told BioSpace that reindustrializing parts of the U.S. economy will be a key focus in 2026. That will mean embracing policy and legislative changes that prioritize drug supply resilience and sustainability and could shore up domestic capacity and create U.S. jobs, Murphy said.
Antibiotic supply is a particular concern. Murphy said the U.S. relies very heavily on one or two countries to supply all of its critical antibiotics. A more diverse supply chain could mitigate threats to the availability of these key medicines.
Yet Murphy cautioned against trying to manufacture everything in the U.S. Instead, the AAM is lobbying for building a reliable supply chain that supports domestic availability and thereby enables the U.S. “to pick up the slack if one of our trading partners has an issue in supply,” he said. Under that plan, the U.S. would reshore some production while remaining part of global supply chains.
Brian Doty, vice president of R&D and programs at the nonprofit API Innovation Center (APIIC), set out a vision for how to reshore production in an email to BioSpace. Doty called for “widespread adoption of advanced manufacturing that will allow domestic manufacturers to match or exceed the efficiency of global competitors.”
While initiatives such as the FDA’s PreCheck program are focused on encouraging manufacturers to build new U.S. production plants, Doty said there are opportunities in 2026 to upgrade existing facilities as well.
“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,” he said.
Doty and Murphy independently raised the supply chain for key starting materials (KSMs), foundational chemicals used to make APIs, as an issue that deserves attention in 2026. Murphy said reliance on other countries for KSMs makes the U.S. vulnerable to supply chain shocks.
Similarly, Doty said that KSM supply chains are “opaque, globally concentrated and exposed to geopolitical and environmental pressures,” and small disruptions can thus cascade into API and drug shortages. That risk informs his view that KSM supply should be central to efforts to ensure U.S. patients can reliably get the medicines they need.
“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,” Doty said. “Without addressing upstream inputs, true resilience cannot be achieved and the supply chain will remain at risk for disruptions.”
Automation’s Unintended Consequences
Though cell therapies are far removed from generic drugs and small molecule APIs, Fabian Gerlinghaus, Cellares’ co-founder and CEO, echoed Doty and Murphy when discussing the items that will top manufacturers’ agenda in 2026.
“[D]emand is increasing, regulatory expectations are rising and geopolitical pressures are accelerating the push for domestic, resilient manufacturing capacity,” Gerlinghaus told BioSpace via email. Those forces informed his assessment that for the cell therapy field in 2026, “the top priority will be establishing globally standardized, automation-native manufacturing networks capable of reliably delivering advanced therapies at commercial scale.”
He added, “Leaders who embrace this shift will be positioned to scale therapies globally. Those relying on manual, fragmented systems will struggle to keep pace.”
While Gerlinghaus advocates for more automation, he sees the potential for better manufacturing platforms to create new challenges. In his view, the industry is underestimating quality control (QC) challenges that could emerge as manufacturing becomes more automated and high-throughput. If manufacturing scales but QC remains manual, the supply bottleneck may simply move downstream.
David Dismuke, chief technical officer at gene therapy manufacturer Forge Biologics, flagged a similar risk. Dismuke told BioSpace via email that the gene therapy field “has made real progress in improving productivity and recovery in manufacturing.” Yet in his view, the gains only matter if the gene therapy sector can characterize and verify product quality with equal sophistication.
“Advancing automated analytical platforms will be essential to keep pace with next-generation processes,” Dismuke said. “Better testing and real-time insight ultimately determine how reliably we can deliver high-quality product at scale.”
