Onshoring Manufacturing Capabilities
Investment decisions are set to be increasingly politicised, against a post-COVID reworking of the global pharma manufacturing order.
The spree of industry manufacturing investments in the US last year – and President Donald Trump’s headline-grabbing pronouncements that preceded them – suggested a clear direction of travel.
Onshoring facilities to the US, it appeared, were the order of the day. There was certainly plenty of evidence for that, often measured in the billions of dollars.
Emblematic of this trend was Lilly’s announcement of four new facilities as part of its $50 billion manufacturing investment plans, with the pharma company subsequently settling on sites in Alabama, Pennsylvania, Texas and Virginia.
GlaxoSmithKline (GSK) also made a major injection of funds into its US manufacturing and R&D operations under a $30 billion, five-year plan to increase its infrastructure in the country. Lilly and GSK were hardly alone in their decisions, with last year also seeing Johnson & Johnson, Gilead, AbbVie, Amgen, UCB and others ramping up their US investment plans.
But were pharma’s onshoring decisions only driven by the US or can they be seen as part of a wider industry phenomenon? That was one of the topics discussed at an exclusive roundtable meeting convened by European Pharmaceutical Review in January 2026 to discuss the key manufacturing trends for this year.
Managing changing political priorities
Participants at the roundtable meeting were clear that investments in pharma manufacturing, whether the new or expanded facilities were to be based in the US or Europe, were very much part of a global trend. Within that, the political pressure from the US to onshore manufacturing was clearly an ongoing driver.
Summing up the trend towards onshoring, Nigel Stapleton, VP of Business Development – Head of Europe at the Polish biologics contract development and manufacturing organisation (CDMO) Mabion, said it comes down to “risk averseness”.
“The US administration is introducing tariffs and a huge amount of uncertainty. Europe is introducing its own protectionist measures. A lot of that is driving onshoring now.
“An interesting other question would be what is driving those moves? And that, I believe, is just the massive success of Southeast Asian CDMOs in the last couple of years, which put a lot of pressure, I think, on European and US players.”
As Stapleton suggested, looking at the bigger picture around onshoring makes a lot of sense. One of those expanding on the global aspects of an issue that is often viewed solely in terms of the US was Campbell Bunce, who is Chief Scientific Officer at San Diego bioconjugate & complex biologics CDMO and contract research organisation (CRO) Abzena.
“In parallel [with the building of capacity in the US], we were seeing an increase in global manufacture, this so-called front ending ahead of the tariffs. It’ll be interesting to see how that settles, if it does settle,” Bunce said. “To Nigel’s point about managing that risk – with our manufacturing facilities out in the US, they have been busier than ever. We signed up a tonne of contracts coming into this year, and it is that risk management, particularly around supply chain.”
An ongoing story
The announcements that dominated pharma manufacturing headlines in 2025 – and continue this year – are just the starting point for industry moves to onshore capabilities.
“I think it’s something we’re going to continue to see for some time,” said Andy Lewis, Chief Scientific Officer at Nottingham, UK-based CRDMO Quotient, expanding on this point. “Potentially some of the genesis of this [was] during COVID, as governments around the world really saw how fragile the pharma biotech supply chain could be and what that meant for their national resilience.
“There’s obviously been a lot of noise coming out of the US. The pharma industry pivoted really quite quickly, responding in terms of investing in manufacturing themselves. At Quotient, we’ve got manufacturing facilities on both sides of the Atlantic and we’re definitely seeing a lot of companies wanting to set up second sites for their commercial drug products in our US facility.”
Crucially, as Lewis noted, while there will be similar kinds of measures in Europe, a lot of these large build-outs take many years to become operational and even then may not be suitable for every case. “Some kinds of diseases, and the new modalities as well, actually lend themselves to more local, smaller scale manufacturing,” he explained.
An additional perspective on onshoring, and the tariff threats from the US, was provided at one of the industry’s banner events – Informa Market’s CPHI Europe – whose Event Director Tara Dougal said that uncertainty was the key thing, particularly for the event’s large proportion of Chinese exhibitors.
“But, at the end of the day, although a lot of the big pharma companies have been promising capital investments in the US, particularly into new sites, those aren’t going to be realised for several years. I think also, price will remain a crucial factor for whether you manufacture on home turf or if you do that in Asia.
“Going forward, Asian players will continue to be very relevant because domestic capacity is not there yet to cover all of the needs and it’s not going to be there in the near to short term either. For 2026, we’re not going to see a huge amount of difference, or a huge amount of impact, on actual sites opening on US turf.”
Given the time it takes to get a manufacturing plant built and up to code, 2026 is likely to be one of a series of stepping stones towards the drawing of a new map of pharma’s working manufacturing sites. Amid US pressure for inward investment, measures in Europe such as the planned Critical Medicines Act will also be on pharma’s watchlist. In January the European Parliament agreed proposals for the legislation and a key element of them is for Europe to invest in its pharma manufacturing capacity to increase its regional autonomy.
Drug development innovation brings manufacturing complexity
The continued growth of new modalities challenges manufacturers to be creative about how they manage risk, select teams and where they specialise.
From bispecifics to multi-specifics to antibody drug conjugates, newer modalities are experiencing significant growth across the industry, particularly with the rise in the number of new cargoes that are getting put on to antibodies, such as oligonucleotides.
A clear marker for the potential of these evolving areas of research, and the manufacturing skills it requires, can be seen in Novartis’ $12 billion acquisition of RNA specialist Avidity Biosciences last October.
The deal, sizable even by pharma standards, didn’t just bring the Swiss company access to Avidity’s RNA drug discovery platform, it also added to its pipeline the antibody-oligonucleotide conjugate (AOC) delpacibart zotadirsen (del-zota), a potential Duchenne muscular dystrophy treatment due to be filed for US approval in the coming weeks.
The ramifications of this kind of drug development innovation was one of the topics covered at an exclusive roundtable meeting convened by European Pharmaceutical Review in January 2026 to discuss the key manufacturing trends for this year.
Beyond plug-and-play
The types of drug candidates involved in Novartis’ Avidity deal, and across many other firms’ pipelines and portfolios, are not straightforward in terms of design. They’re also not straightforward in terms of how they fit into the currently available manufacturing platforms.
Highlighting the creativity he sees in molecule design, Goran Verspui, Head of Drug Development at the contract research organisation (CRO) Symeres, said this level of ingenuity was not without its issue.
“It’s getting more and more complicated. So you really need to have your skilled team to be able to make those molecules. In the discovery stage, this may still be feasible, but then you come to the development space and then a lot of other important things come into play, like scalability and stability of these compounds. And in the end you need to have a process in place to deliver these materials.”
It’s the kind of technical challenge that the industry regularly rises to. Nevertheless, the complexity involved means thinking beyond a simple plug-and-play approach.
Aaron Moulin, a Field Application Scientist at water, hygiene and infection prevention and services company Ecolab, said: “Being on the vendor side and working in that bio process space, it becomes clearer talking with customers that new modalities demand some sort of new manufacturing logic. It’s got to be more flexible, it’s got to be more connected, and it’s got to be more efficient.
“You’re getting these diverse biological structures, tri-specifics and bispecifics, and along with that comes diverse chemical properties, diverse impurity profiles and that tests the limits of traditional purification and manufacturing techniques.
“So, what we see is a lot of the customers and segments in the industry trying to become more adaptable, more efficient across a lot of different chemical space – repurposing, realigning existing technologies. We see the manufacturers really trying to develop a lot of flexible unit operations – standardised but customisable, so that they can adjust quickly for the current pipelines.”
Increasing efficiency and innovation
Campbell Bunce, Chief Scientific Officer at Abzena, agreed that drug developers are getting innovative about what they can do – and how they work with often limited budgets. “But CDMOs as well, you know, we’re getting innovative about how we can draw down in timelines and manage risk for customers. We see a lot more use of the sort of stable pools to take a lot of things off the critical path. If you’ve got that kind of robust platform that’s consistent in the material, pools, clones and scale, then you can support customers to meet their fast timelines and de-risk.”
One of the outcomes of modality complexity, Ecolab’s Moulin noted, was “there’s more pressure on both upstream and downstream, and both segments in the industry are responding exceptionally well”.
“But they often require, more intensive processing, specialised handling, which traditional monoclonal antibodies and things like that didn’t have. All that specialisation brings a likelihood of higher costs. So we definitely see customers trying to make what they do more efficient.
“We see a movement towards intensification – making more with less, higher output/smaller footprint, faster timelines.”
As the range of molecules continues to expand, taking a more innovative, flexible approach to their manufacturing requirements can only be a good thing.
