America – once the undisputed global leader in medicine manufacturing – is today more reliant on pharma imports than at any time in its history. This dependence has steadily increased since the turn of the millennium, as large portions of the manufacturing chain were outsourced to low-cost suppliers in India and China, and led to the country’s pharma trade balance standing at negative USD 120 billion by 2024. In the same year, the US imported over 828,000 metric tons of pharmaceuticals, a figure more than seven times higher than in 2000, according to the protectionist lobby group Coalition for a Prosperous America.
Reversing this trend – which has been mirrored in other strategic national industries, including energy, semiconductors, metals and critical minerals – has been a core priority of the second Trump administration. Since retaking office in early 2025, Trump has unleashed several ‘America-first’ policies designed to compel companies to onshore the production of pharmaceuticals and repatriate their supply chains. Global drugmakers have been falling in line, with the likes of J&J, GSK, Lilly and MSD among others making multi-billion-dollar financial commitments to ramp up their US manufacturing footprints.
First came the threat of a 100 percent tariff on imported branded and patented medicines for firms unwilling to invest in localized facilities – an executive order that was eventually signed in April 2026 following a year-long Department of Commerce investigation into national security vulnerabilities. To balance these sticks with carrots, the administration unveiled a suite of regulatory rewards for companies that commit to domestic production. These include the FDA PreCheck Pilot Program, officially launched on February 1, 2026, which provides early agency feedback on quality systems and facility readiness during the build-out phase to “de-risk” construction.
Additionally, the Commissioner’s National Priority Voucher (CNPV) Pilot Program, introduced in June 2025, now offers an ultra-fast regulatory pathway. While the traditional priority review takes six months, the CNPV target is just 30 to 60 days; as of March 2026, the FDA has already issued 18 vouchers and granted four approvals under this program, including two oncology drugs approved in under 55 days.
“After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold and proactive steps to bring it back,” declared FDA Commissioner Marty Makary. “The PreCheck and CNPV programs constitute just some of a number of powerful incentives that we are putting in place to ensure America’s pharmaceutical sector regains its resilience and competitive edge,” he explains.
“The CNPV is frankly an extraordinary administrative creation that upends the rules of the game. To put it in perspective, the current baseline for a priority review of a new molecular entity is a full six months,” exclaims Paul Kim, Principal at Kendall Square Policy Strategies, who is both an ex-policy analyst in the Office of the Commissioner, and former Health Policy Counsel to Senators and Congressmen.
The dynamics driving such unprecedented moves are, however, readily apparent. “If you take a step back and reflect upon the numbers, the tensions and market distortions underpinning these decisions are clear. The American market represents roughly 50 percent of global demand, but only about 25 percent of installed manufacturing capacity, leaving the country exposed in terms of security of supply which has in turn triggered a political desire to pressure to repatriate supply chains,” reasons Alberto Santagostino, CEO at AGC Biologics, a Seattle-headquartered global contract development and manufacturing organization (CDMO) specializing in protein-based biologics.
“Looking at competitor regions, Europe is much more balanced with approximately 25 to 30 percent of both demand and capacity, and more or less the same can be said for Asia – albeit with significant concentrations of capacity anchored within certain specific countries such as China and Korea,” he adds.
Not everyone is in favor of the mechanisms being deployed to rebalance the American market, though. “There are inherent risks when policy initiatives lead ahead of scientific rigor in regulation. The capriciousness with which the CNPV trades FDA efficiency for economic concessions is completely antithetical to the stability and predictability we intentionally built into the drug approval system over 30 years through acts of Congress and layers of regulatory guidance,” warns Kim. He would rather that the regulator stays in its original lane, focusing purely upon the foundational criteria of unmet medical need and innovative therapies, rather than becoming a political instrument subject to governmental whim.
Location, Location, Location
There can be little doubt, however, that such policy developments have translated into a major upswing in demand for contract manufacturing services, as drug developers without in-country production facilities scramble to demonstrate some kind of footprint.
“Presently, we’re witnessing significantly stronger demand for support in manufacturing finished products, and even for assistance with US-based API production,” reports Philip Macnabb, CEO at the Albany-based CDMO, Curia. “Many companies have announced plans to establish their own US facilities, but these big-ticket projects take years to construct and commission, while contract manufacturers like us have the ready capacity available today, offering immediate access to US-based production,” he explains. “This is especially relevant for biotech companies that cannot finance multi-billion-dollar investments to build API or sterile manufacturing plants. By design, they are compelled to rely on CDMO partners and therefore, we have been experiencing powerful tailwinds for our American operations.”
Enzene Biosciences, an India-headquartered CDMO and subsidiary of Alkem, has, for its part, been reorientating its offering to better consider evolving customer needs. “While India traditionally holds a well-forged reputation for affordable manufacturing, many of our clients active in the American market are now expressing a firm preference for having both the fabrication and development work performed locally. In view of that, we’ve opened a 54,000 sq feet biologics-focused, continuous manufacturing plant in Hopewell, New Jersey, utilizing our proprietary EnzeneX platform,” confirms Norman Stoffregen, senior vice president and site head.
Meanwhile, some drug developers have elected to go it alone but have purchased existing facilities so as to speed up the process. “Recent discussions on tariffs highlighted the criticality of maintaining a US-based production footprint as a precondition to operating effectively in the marketplace and Celltrion’s strategy has been to achieve immediate utilization of such a facility. That’s why we acquired an existing plant in New Jersey from Eli Lilly and retained its workforce to ensure continuity and leverage existing expertise. The plant’s significant capacity will primarily serve US demand, helping reduce costs and mitigate tariff-related risks,” explains the South Korean biopharma’s chief commercial officer, Thomas Nusbickel.
“Our peers were surprised at how quickly we executed this acquisition. Building a new biologics facility can take two to three years and cost hundreds of millions. By acquiring an existing site, we accelerated our American expansion dramatically and thus maximized our prospects for making the most out of this important market,” he continues.
Others, such as the Indian generics player, Lupin, could afford to take it a little more slowly by virtue of already possessing meaningful in-country infrastructure, but have nonetheless announced big plans for further integration. “Bringing more of our manufacturing to the US is a deliberate commitment to serving the national interest by strengthening supply chain security, supporting access, and ensuring that American patients receive consistent, high-quality medicines. As the third-largest generic supplier by volume in the US, we recognize the tremendous responsibility that comes with that position, and are more than happy to align with the federal agencies and their strategic policy direction,” says Spiro Gavaris, President of the drug developer’s US Generics business.
“We already held a strong manufacturing presence thanks to our facility in Somerset, New Jersey, but, as our portfolio continues to shift toward higher-complexity products, we have now committed to investing approximately USD 250 million over a five-year period for the construction of a new 70,000 square foot state-of-the-art manufacturing facility in Coral Springs, Florida, that shall serve as a major hub for respiratory therapy production,” he elaborates.
Regionalization
That’s not to suggest that Trump administration policies are the sole driver of the prevailing tendencies, however. On the contrary, many market insiders point out that there was already a clear trend towards onshoring that predates the recent Make America Great Again (MAGA)-inspired regulatory interventions.
“While current discussions often focus on economic incentives, the present near-shoring momentum is best understood as an extension of what began during COVID, when the industry reassessed supply chain resilience and risk mitigation,” opines Curia’s Macnabb. “For many years, manufacturing strategies prioritized low cost, often resulting in single-sourced materials or production. The initial shift was toward diversification to ensure continuity across inputs, intermediates, and finished products, and what’s changed recently is that conversation has now expanded to include industrial policy and location-based incentives,” he posits.
AGC’s Alberto Santagostino mirrors this sentiment. “Historically, both drug substance and drug product manufacturing were global businesses with very little reason to think regionally. Raw materials could be sourced from anywhere in the world, and decisions were largely driven by quality, reliability, cost, and efficiency rather than geography. However, we now inhabit a profoundly different reality to that of the old business model where most production was concentrated in a single market. The negative experience of supply chain disruption during the pandemic coupled with nationalistic policymaking which has rendered cross-border supply chains more complex and, in some cases, less reliable, has led to a thorough revaluation of priorities,” he believes.
Indeed, Santagostino is keen to point out that the scramble to start producing in America is not occurring in a vacuum, but reflective of broader worldwide trends. “I foresee a new normal emerging, whereby pharmaceutical production is now organizing itself around a small number of macro-regions: notably North America, led by the United States, Europe, China, which increasingly functions as a region in itself, and Asia-Pacific more broadly,” he opines. “More customers are explicitly requesting dual-region supply strategies and, for non-US demand, there is often a clear expectation that supply should also be non-US based. So rather than a simple shift in one direction, we see a geographical splintering along regional lines.”
Gordon Bates, head of integrated biologics at Swiss contract manufacturing heavyweight, Lonza, very much concurs. “The future of global supply chains is being re-written,” he notes. “Determining the optimal geographic footprint for reliable, resilient supply will be a major strategic question for the CDMO industry going forward and those entities best primed to compete look like they’re going to be the ones with a global reach, but with significant regionally embedded capabilities and infrastructure.”
Indeed, Lonza is already conspicuous for the extent to which it has invested repeatedly in developing a sizeable North American platform. Their Portsmouth, New Hampshire, site has been a cornerstone of their mammalian manufacturing network for over 20 years. Houston, Texas houses their growing cell and gene and viral vector fabrication capability, and in Walkersville, Maryland they produce media to support both in-house operations and external customers.
Closer Integration
Many market insiders also highlight the growing complexity of next generation, biological medicines and how, especially in the more mature and sophisticated markets like US, it is increasingly imperative for drug developers to now have manufacturing capabilities close at hand.
Brent Ragans, president of Ferring Pharmaceuticals’ American affiliate, for instance, describes why the Swiss biopharma considered it essential to establish their own cell and gene manufacturing capabilities locally. “For this kind of therapy, not only is there a very sound business logic to co-locating the development and production functionalities, but you crucially also need to be ensuring close proximity to the patient, so given that America represents our largest and most important market for these therapies, it was a no-brainer,” he reveals.
Meanwhile, such therapies necessitate a much more entwined outsourcing relationship. “Traditionally, contract manufacturers, were primarily order-driven. An innovator would place an order, and the CMO would execute it with very limited deeper integration, but next-generation, advanced therapies often require something more,” observes Norman Stoffregen, remarking how “Enzene nowadays partners with clients across the entire development lifecycle providing a ‘white glove’ level of depth of collaboration so as to deliver bespoke solutions, wholly aligned to needs.”
Likewise, Fujifilm Biotechnologies sees itself very much as an extension of its clients’ manufacturing networks rather than as an external supplier. “In practice, this means working alongside our partners onsite, involving them in performance discussions, and aligning priorities together rather than operating at a distance,” details the Japanese CDMO’s SVP and Head of North Carolina Operations, Laurie Braxton. “Our partners are actively involved in how we plan, execute, and improve, which extends the relationship well beyond the traditional notion of CMOs just being a representative tasked with overseeing operations,” he adds.
Indeed, closer interaction between client and contractor can be considered fundamental in the successful bringing to market of cell and gene therapies. “The science behind CGT is still a learning curve. The challenge now is understanding how to execute and operationalize these therapies effectively of which decisions around manufacturing have to be placed front and center,” reveals Orla Cloak, CEO of Minaris Advanced Therapies. She explains how, owing to the starting material being highly variable and the manufacturing needing to be performed in small batches, it becomes far too risky for such tasks to be performed at arm’s length in some distant land. “Risk, variability, and cost must all be carefully managed within the production process, and even release presents further potential pitfalls because only limited material is available for testing, making potency and assay development critical,” argues Cloak.
Moreover, when biotechs nowadays seek funding for these kinds of medical breakthroughs, it no longer suffices just to demonstrate clinical promise. “The conversation has shifted to being able to demonstrate sound execution and the ability to bring a product to market in a way that is feasible, operationally robust, and commercially viable, so clients are wanting and needing to be much closer involved in the production process,” she confirms.
In view of all these tendencies, “early-stage materials and initial synthesis steps may feasibly remain globally distributed for some time, but as the complexity of medical science increases and you get closer to fabrication of the final product, proximity to drug development capabilities and the end-patient inevitably becomes ever more sought after,” conjectures Curia’s Macnabb.
Competitive Edge
The American market enjoys structural advantages as a host for next-generation medicine production that extend far beyond simple geography. A primary driver of this competitive edge is the efficiency of the regulatory environment. In the Cell and Gene Therapy (CGT) sector, the FDA’s Center for Biologics Evaluation and Research (CBER) has significantly outpaced its European counterparts in both throughput and speed. In 2024, the FDA reached a record high of 27 CGT approvals (including gene therapies, cell-based immunotherapies, and related products), whereas the EMA (European Medicines Agency) managed fewer than 10 in the same period.
This regulatory velocity has created a massive upstream concentration of innovation in the US. Currently, approximately 50 percent of the world’s development-stage molecules originate from US-based companies. In the CGT space specifically, the US is home to over 1,100 active regenerative medicine developers, representing nearly 45 percent of the global total. This concentration ensures a robust pipeline of demand that justifies massive domestic capital expenditure.
“There is a strong base of technical expertise and operational maturity that supports complex biologics manufacturing at scale in the US compared to most other markets,” reports Laurie Braxton. This maturity is evidenced by Fujifilm Biotechnologies’ landmark investment in Holly Springs, North Carolina. Initially a USD 2 billion project, the company announced an additional USD 1.2 billion expansion in 2024, bringing the total investment to USD 3.2 billion. The site’s scale is unprecedented: the initial build comprises two large-scale manufacturing suites, each equipped with four 20,000-liter mammalian cell culture bioreactors. By 2028, a further eight 20,000-liter bioreactors will be added, bringing the overall site footprint to 1.6 million square feet.
“Monoclonal antibodies have become foundational therapies… and a single molecule can expand into multiple indications,” Braxton reflects. This reality places sustained pressure on large-scale manufacturing capacity, which continues to lag demand. Braxton points out that prevailing demand is so intense that “capacity is often committed to US-based facilities well in advance of them actually becoming fully operational.”
Additionally, while the industry previously focused on sheer scale, the landscape is now fragmenting between broad providers and pure-play specialists. Gordon Bates, Head of Integrated Biologics at Lonza, notes that the US is the vital anchor for this evolving model. Lonza recently reinforced this with its USD 1.2 billion acquisition of a major manufacturing site in Vacaville, California, adding 330,000 liters of large-scale mammalian capacity to its network.
“The US is central to Lonza’s global footprint… roughly half of the world’s development-stage molecules originate from US-based companies. It would be impossible to serve the sector effectively without a strong and established presence here,” says Bates. Bates argues that the real differentiator in the American market is the ability to navigate the “phenomenal difficulty” of sustaining complex facilities. Under the “One Lonza” strategy, the company is moving away from autonomous divisions toward a unified structure that handles the full value chain, from late-stage discovery to commercial supply.
Indeed, as the market matures, the demand for niche manufacturing expertise is rising. Minaris’ Orla Cloak predicts “less emphasis on breadth and greater demand for niche manufacturing expertise with an increased focus on specific modalities.” Bates concurs, noting that for the majority of Lonza’s US customers – which are small and medium-sized biotechs rather than Big Pharma – the value lies in a partner who can provide deep CMC expertise across modalities like ADCs, CGT, and mRNA that are otherwise unattainable for all but a handful of very large organizations.
