In an uncertain world, Europe – with Switzerland at its heart – is reclaiming its role as an epicentre for testing, scaling, and integrating new medical technologies.
While much of the global narrative around the European life sciences market centres on doom and gloom (access delays for innovative medicines, a dwindling share of global clinical trial activity, politicised pricing cuts, and shortages of generics and antibiotics), the continent still has much to recommend it.
The world’s second-largest pharma market by sales, behind only the US, Europe remains a key location for research and development. Pharma spent EUR 55 billion on R&D in Europe last year, according to EFPIA, leveraging the continent’s world-class academic and medical institutions, as well as its deep well of talent and expertise.
Over 450 million people live in the EU, an increasing number of whom are ageing and high-income, representing a healthcare challenge but also driving increased demand for medicines and an incentive for R&D localisation. There are clear and improving pathways for bringing the most advanced products to Europe, with centralised EU approvals via the European Medicines Agency (EMA), giving a single marketing authorisation for all EU/EEA states.
There are also accelerated access routes for high-need therapies, while joint EU health technology assessments (HTA) have been in place since January, a big step towards companies only needing to submit one dossier for many national payers.
Meanwhile, after years of dwindling investment and the shock of shortages in the immediate post-COVID period, European manufacturing is back on the table. A proposed ‘Critical Medicines Act’ aims to foster self-reliance within the EU for certain key medicines and ingredients and encourages tendering processes for generics that do not focus solely on cost.
The US, as by far the world’s largest market, and China, as perhaps the leading source of biopharma innovation today, have squeezed Europe out of the headlines. However, multinational companies have not forgotten Europe and – ensuring they can navigate the continent’s myriad disparities and complexities – are having a genuine impact on European patients as well as their bottom lines.
Getting Clinical
Since establishing European operations in 2018, oncology challenger BeOne Medicines has achieved some impressive milestones. The firm has seen rapid adoption of its BTK inhibitor across virtually all EU markets, has launched a PD-1 checkpoint inhibitor in eight, and saw 87 percent year-over-year European revenue growth in Q2 2025.
As BeOne transitions into a truly global company, European operations – led by SVP Giancarlo Benelli – will assume increasing importance. The firm plans to roll out its latest product in even more European markets in the coming years, with in-Europe clinical research forming a core pillar of its strategy.
While European clinical trial numbers have plateaued, BeOne has actually increased its European clinical trial footprint by almost 50 percent in the past four years, showing that Europe can still deliver speed and data quality despite regulatory complexity.
“We have strategically internalised the vast majority of clinical operations activities in Europe, from Phase I through Phase IIIb development,” explains Benelli.
“As we operate approximately 30 percent faster than industry norms, this approach enables speed and cost optimisation while retaining critical know-how internally. It also allows us to move more quickly and get submissions in sooner; an advantage in Europe, where payers value strong evidence and patients are in urgent need of faster access to innovation.”
Underdiagnosis & Access Disparities
Certain European markets have also become growth drivers for Alnylam, which has four EMA-approved drugs for rare, genetic conditions, three of which were reviewed under accelerated assessment procedures. However, as SVP International Kasha Witkos outlines, significant diagnostic disparities between European countries are threatening patient access to these breakthrough therapies.
“In hereditary transthyretin amyloidosis, for example, France and Belgium have the highest diagnostic rates globally, while neighbouring countries have much lower rates,” she notes.
“Underdiagnosis creates significant hidden healthcare costs through misdiagnosis, delayed treatment, and resource waste. In some rare conditions, patient journey analyses reveal individuals sometimes spend 15 to 20 years seeking a proper diagnosis while consuming substantial healthcare resources across multiple specialists, diagnostic procedures and ineffective treatment.”
Then there is the age-old challenge of securing reimbursement from Europe’s publicly funded healthcare systems for high-cost breakthrough innovations. Witkos warns that, without a rethink on healthcare spending, European patients risk losing out.
“International markets such as those in Europe possess structural advantages over the US system with their centralised healthcare delivery and unified payer systems. However, we are not fully realising these advantages. China and the US are advancing rapidly in healthcare innovation integration, and Europe risks losing its historical innovative edge here.”
Unmet Need in Vaccination
Europe also represents a crucial region for Moderna, best known as the company behind one of the most well-sold COVID-19 vaccines and now leveraging its mRNA platform to become a multi-product company.
Its Respiratory Syncytial Virus (RSV) vaccine is also approved in Europe, while it also has several vaccines in regulatory review and late-stage development, including products for flu and flu + COVID-19 combination.
Many Europeans are at risk from these illnesses, with a full 20 percent of the EU population aged 65 or older, creating a major potential health impact (and market opportunity) for next generation vaccines.
However, as Moderna’s SVP for Europe and the Middle East Chantal Friebertshäuser laments, “Vaccination coverage rates across Europe remain problematically low. This trend is both concerning from a public health perspective and economically problematic, creating a substantial burden on hospitalisation systems already facing healthcare worker shortages and budget constraints across the region.”
She continues, “If we take the example of influenza, Europe still hasn’t met the long-standing 75 percent target for older adults, with only two EU/EEA countries having reached it in 2023/24. That’s a critical gap heading into winter.”
Friebertshäuser has high hopes that Moderna’s combined flu/COVID-19 vaccine, by simplifying the act of vaccination, can support healthcare professionals in their daily work and contribute to improving vaccination coverage in Europe.
“Our regional priorities are collaborative engagement with regulatory agencies, scientific communities, government payers, and other stakeholders to establish common approaches and objectives for population protection,” she adds.
A New Era for Affordable Medicines?
Well-established in the European generics market, Indian-headquartered Lupin already boasts a significant continental presence in respiratory disease, rare disease in neuroscience, injectables for hospitals, and women’s health. Now moving into biosimilars and ophthalmology via the recent acquisition of VISUfarma, further European expansion “represents the logical evolution of our global footprint,” in the words of SVP and Europe Head Laurent Renaudie.
“We are looking at strengthening Europe’s contribution to Lupin’s overall revenues, while creating meaningful impact for patients,” he notes, with the VISUfarma acquisition set to accelerate the timeframe for Europe to exceed 20 percent of Lupin’s global turnover.
“European markets represent substantial volume opportunities that, combined with our manufacturing capabilities and research centres, create internal and external value generation.”
Renaudie also foresees an important role for global affordable medicine players like Lupin, with their economies of scale and well-developed supply chains, in addressing Europe’s medicine supply issues.
“The current European market dynamics reveal significant supply reliability challenges,” he notes. “Multiple markets experience persistent shortages. Within this context, our additional supply capabilities address unquestionable market needs for reliable access.”
Why Switzerland?
For multinational life science firms with headquarters outside of Europe’s borders, capitalising on European opportunity requires a strong regional base. Switzerland has emerged as a key hub for many.
BeOne Medicines, for its part, chose to situate its European headquarters out of Basel, and even redomiciled its parent company to Switzerland earlier this year as it attempts to position itself as a truly global player.
“Basel represents an impressive biotechnology hub with more than 32,000 life-science professionals within the canton,” explains Giancarlo Benelli. “This positioning provides access to exceptional talents, infrastructure, networks, and partnership opportunities essential for business and pipeline development.”
It is a similar story over at Alnylam, where Kasha Witkos oversees international commercial operations from Switzerland. “We selected Switzerland based on multiple strategic advantages,” says Witkos, “central European positioning enabling comprehensive time zone coverage, an exceptional talent pool from established biotechnology and pharmaceutical presence, governmental support for innovation, and proximity to strategic partners, including Roche and Novartis.”
Neil Archer, EVP International at Madrigal – an early-mover in treating MASH (Metabolic Dysfunction-Associated Steatohepatitis), a progressive liver disease with no prior approved therapies – agrees that Swiss talent is a major selling point when choosing where to situate a burgeoning international business.
“At a networking event during my first visit to Zug, I was amazed to bump into several industry professionals I recognised from two decades of prior experience,” he states, adding that “The local talent pool represents a significant advantage, with exceptional professionals accessible within a 15-minute drive.”
The country’s advantages extend to the medical devices sector, with cancer-focused Varian choosing to base its Europe, Middle East and Africa headquarters in Switzerland. “The country is an established hub for both pharma and medtech, with a strong ecosystem of life sciences companies and institutions clustered in proximity,” explains EVP and Head of EMEA Virve Sarja.
“This creates opportunities for collaboration and access to expertise, while Switzerland’s central location makes it an ideal base for coordinating activities across such a large and diverse region. There is also a genuine curiosity and openness to healthcare innovation here, which contributes to an environment that feels supportive and well-connected.”
