
Why US-Based Manufacturing Is Becoming a Strategic Imperative for Biopharma
In the second part of his Pharma Commerce video interview, Franco Stevanato, CEO of Stevanato Group, describes how from FDA validation to dual-site redundancy and reshoring momentum, the expansion of US capacity is a competitive advantage for pharma clients navigating increasingly complex global supply chains.
According to Franco Stevanato, CEO of Stevanato Group, tariff policies are beginning to influence how pharmaceutical companies think about manufacturing location and supply chain resilience, but the shift toward localization will take time. While tariffs have created temporary cost pressures for the company, including surcharges passed on to customers, those impacts have largely been accepted by clients and are not yet driving immediate supply chain reconfiguration.
Stevanato operates 13 sites across nine countries and generally supplies products regionally, though certain items continue to be manufactured in Europe. Capacity expansion in the US—particularly at the company’s facility in Fishers, IN—is underway, but meaningful ramp-up will take several more years. In the short term, the company cannot quickly redirect production or fully restructure its global supply network.
Despite these near-term headwinds, Stevanato sees tariffs as a catalyst for longer-term opportunity. The company already has significant campus infrastructure in place, positioning it to benefit as customers reassess their footprint strategies. Over a three- to four-year horizon, leadership expects more pharmaceutical manufacturers to increase investment in US-based production as they seek to mitigate trade risks, improve regional supply continuity, and align manufacturing closer to end markets.
However, the pace of change is constrained by the realities of pharmaceutical operations. Site development, validation, regulatory approvals, and capacity scaling require long lead times, making rapid shifts impractical. Decisions around localization must also align with pharma companies’ internal investment cycles and long-term network planning.
Overall, tariffs are not triggering immediate supply chain realignment, but they are accelerating strategic discussions around regionalization and domestic capacity. For packaging companies like Stevanato, this evolving landscape presents a medium-term growth opportunity as customers gradually move toward more localized and resilient manufacturing models—particularly in North America—while managing short-term operational and cost pressures.
Stevanato also discussed the strategic advantages to expanding production within the US and much more.
A transcript of his conversation with PC can be found below.
PC: Beyond tariff mitigation, what strategic advantages does expanding production within the US offer for biopharma clients?
Stevanato: Beside the tariff, the pharma companies want to always have a strategic partner, because we say that we sell critical containment solution, because our product is entering contact with the drugs. So this is going to require to have validation filings with the FDA. The stability of the drugs is a very complex, expensive process—because we are filing with the FDA, the pharma customer automatically wants to secure the supply chain. They want always at least two sites.
Now, they want two sides for certain critical molecules, particularly for certain blockbusters that are also in two different regions. This is why, already in 2021, we decided to build these Greenfield plants. Now, the fact that we have this big campus in the United States with the possibility to accelerate will make Stevanato even more attractive compared to certain competitors, to sign future additional potential contracts.
This is what we see, starting from many clients. They are changing their supply chain. They are reshoring a little bit—for some biosimilars, they usually they use a supplier in the Far East. They're starting to build the supply chain in United States. These are all positive signals that will help enhance Stevanato eventually further boost our business plan in the medium term.
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