Against a backdrop of rising development and launch costs, growing regulatory complexity, geopolitical uncertainty and intensifying competition for specialist talent, many European pharma and biotech companies are reassessing the long-held ambition of “cracking the US” organically.
The US remains one of the world’s most attractive life sciences markets, but companies across pharmaceuticals, medical devices and life sciences services are increasingly re-thinking their route to access it. Rather than building US operations from the ground up, an increasing number of European companies are choosing to buy – or be bought into – US market access. M&A, strategic partnerships and minority investments are increasingly seen not as shortcuts, but as more pragmatic, lower-risk routes to scale in an environment where speed and certainty matter more than ever.
For decades, organic expansion was viewed as the gold standard, demonstrating that a business had the scientific delivery, strength, leadership depth and financial resilience to succeed independently on the global stage. Today, that model is being challenged, and not because ambition has diminished, but because the costs, complexity and risks of going it alone have changed.
Organic expansion: slower, riskier and more capital-intensive
Organic US entry has always been demanding, but it is now materially slower and more complex than it was even a decade ago. Regulatory requirements, particularly around FDA approvals, clinical trial design and post-market surveillance, have become more exacting for drug development. For medtech and device manufacturers, the challenge often lies in navigating evolving FDA device classifications, reimbursement pathways and the need for in-market sales and distribution capabilities. For pharma services businesses, from CROs to specialist advisory and supply chain providers, success in the US hinges less on product approval and more on talent density, client proximity, contracting models and state-by-state regulatory and tax considerations. In each case, the barriers to entry are different, but no less complex.
Layered onto this are geopolitical tensions that complicate supply chains, investment decisions and cross-border operations. The renewed threat of protectionist measures, most notably Donald Trump’s implementation of a 100% tariff on branded pharmaceutical products unless the manufacturer is building a plant in the country, has further sharpened the risks of standalone US expansion.
For early and mid-stage European life sciences companies, the implications are significant, with many rethinking how they secure market access and protect long-term returns. Establishing a US presence now requires deep regulatory expertise, sophisticated market-access planning and the ability to navigate a fragmented healthcare system, often years before meaningful revenues are realised. The upfront investment is substantial, and the cost of missteps can be severe, both financially and reputationally.
Why access now matters more than ownership
As a result, access to established US commercial infrastructure, regulatory expertise and specialist talent has become central to deal logic. European companies are increasingly prioritising platforms that offer immediate operational capability, whether that is an experienced US management team, existing FDA relationships or proven commercial execution. For example, in the devices and services segments specifically, that operational capability often centres on established salesforces, distribution networks, reimbursement expertise and embedded client relationships. Building those capabilities organically in the US can take years, particularly in a market where competition for experienced commercial and technical talent is intense.
In practice, this means businesses are far less willing to rely solely on internal capability building. Too many have learned, often through hard experience, that under-investing in US expertise can delay market entry by years. Speed to market is no longer just a commercial advantage; it can materially reduce R&D costs, shorten development timelines and accelerate critical go/no-go decisions across the pipeline.
Boardrooms prioritise speed, certainty and execution
This shift is being driven decisively at board level. With development costs rising and capital markets remaining selective, growth decisions are increasingly shaped by executional certainty rather than standalone ambition. Boards are asking harder questions about risk-adjusted returns and whether organic US expansion truly represents the most efficient route to value creation. This includes assessing the time and cost required to recruit US leadership teams, build compliant tax and corporate structures, and establish credible commercial footprints from scratch.
In many cases, acquiring or partnering with an established US business offers greater clarity on timelines, costs and outcomes. While headline deal values may appear higher, the ability to de-risk execution often makes these strategies more attractive over the full lifecycle of a product.
Implications for valuations and deal-making
These changing priorities are already influencing valuations, partner selection and integration planning. Assets with high-quality pipelines, differentiated technologies or established US commercial platforms and infrastructure – including experienced teams – are commanding premium valuations precisely because they offer greater certainty. Scientific promise alone is no longer enough, and buyers are placing increasing weight on regulatory credibility and commercial readiness. This reflects a broader recognition that policy and trade risk in the US has become less predictable, and therefore harder to underwrite through organic expansion alone.
Integration planning has also become more sophisticated. Successful acquirers are investing early in governance, cultural alignment and operational integration to protect value and retain critical US talent. The assumption that integration can be addressed later is rapidly falling out of favour.
What this means for the future of transatlantic growth
Looking ahead, it is difficult to predict exactly how European–US growth strategies will evolve, particularly given ongoing geopolitical turbulence. What is clear, however, is that US expansion will remain a strategic priority, but increasingly through hybrid models that combine strategic control with deep local expertise.
For European life sciences companies the question is no longer whether to enter the US, but how. Those that recognise the true cost of organic expansion, value experience over experimentation, and prioritise speed and execution over aspiration will be best placed to succeed in an increasingly competitive global market.
Author Bio
Tarifa Simpson, Partner at Forvis Mazars
Tarifa Simpson is a Partner at Forvis Mazars, a leading global professional services network. Tarifa specialises in deal advisory and transaction services, with over 20 years of experience, she has worked with investors and operators across healthcare and life sciences.
