In 2025, 193 innovative drugs received approval in Europe, including 133 new molecular entities (NMEs). Over half – 56% – of the NME sponsors were based outside of Europe, and 27% were private companies.[i] While many of the publicly listed sponsors were large-cap companies, just over a quarter are classed as small to medium sized.
For emerging pharmaceutical companies launching in Europe for the first time, success depends on far more than regulatory approval. Unlike more unified markets such as the U.S., Europe’s 44 sovereign states – 27 of which are in the EU – form a patchwork of healthcare systems, reimbursement processes, and commercial 3PL expectations, each complete with their own languages and currencies.
On one hand, there is major supply chain complexity caused by local language requirements for product packaging and leaflets. Companies must also grapple with the EU’s new serialisation rules, which mandate anti-counterfeiting identifiers on each individual pack. At the same time, pricing, reimbursement and market access systems are fragmented across nations, making Europe-wide access challenging and potentially resource-intensive for marketing authorisation (MA) holders.
As a result, launch timelines are disjointed. Across Europe’s nations, data from the European Federation of Pharmaceutical Industries and Associations (EFPIA) reveals an average duration of 578 days between market authorisation and access. This varies from a 128-day average in Germany to 840 days in Portugal.[ii]
Faced with so much uncertainty, companies launch products in a phased manner, typically prioritising EU big 4 and the UK where patient populations are large and pharmaceutical drug prices high. Since many countries are impacted by international reference pricing, this strategy helps companies maximise revenue in handpicked countries while also protecting them from potential price adjustment risks and impact on U.S. pricing for U.S.-based manufacturers.
What can go wrong?
One company that understands the challenges and complexities of Europe’s commercial landscape all too well is Cencora. Having acquired Alloga in 2021, Cencora is one of Europe’s largest pharmaceutical 3PL partners, with a central hub in the Netherlands where customers import products into the EU for distribution across Europe.
Gert Jan Van Der Hulst, VP Integrated Solutions and Commercialisation, explains that even experienced companies make mistakes. “In one situation we saw with an established partner, they were gearing up to launch but forgot a minor detail – the European Medicines Agency had to approve their U.S. manufacturing facilities. They thought it was done, it wasn’t, and it pushed out their launch by several months.”
Early visibility into what distribution licenses you need as a company and when you need them is critical.
The repercussions, as in Van Der Hulst’s example, are often quite impactful. “Most of the implications for lack of commercial readiness are related to a delayed launch. Early visibility into what (distribution) licenses you need as a company and when you need them is critical. The same is applicable for a company’s choice for a European legal entity. Often Switzerland is considered, however the country is not part of the European Union,” he says. “You have an approved product, think you are ready to go, however you cannot distribute your product across Europe.” A legal entity in an EU member state is required for that.
“Postponed launches are one of the largest pitfalls that we see,” agrees David de Wit, Director Regional Specialty Solutions, Cencora Alloga. In another example he shares, a company failed to secure its wholesale distribution authorisation (WDA) within time to meet the intended launch date. The WDA is a mandatory license required to supply pharmaceuticals in Europe. Reflecting on the outcomes in this scenario, de Wit says: “Emerging biotechs usually make promises to internal and/or external stakeholders that they are going to launch by a certain date, but we quite often see significant delays in the actual go-live date.”
Outsourcing opportunities
So, is it possible to stick to a launch plan in Europe? Yes, with an early start, strong planning, and effective administrative support. Local resources in areas like market access, supply chain, regulatory affairs and pharmacovigilance are essential, de Wit adds. “In most cases non-Europe-based clients don’t have boots on the ground in Europe, and you need them,” he says. “Usually that means they can benefit from outsourcing strategic activities to a company with extensive experience, like Cencora.”
Outsourcing some commercial services offers many benefits for emerging biotechs looking to mitigate supply chain risks and accelerate their time-to-market. Since local resources are essential for commercialising in Europe, they need to be in place prior to the intended country’s launch. Outsourcing helps biopharma companies launching in Europe overcome the challenges of building out European footprint at risk before local country approvals. Alternatively, by partnering with Cencora, Van Der Hulst says biotechs can weigh in on the extensive resources, local expertise, and infrastructure that Cencora has across Europe.
“It has been a strategic decision to continue building out our European presence and capabilities,” he says. “Cencora owns key elements required for commercial success. As such we do not depend on external partners and/or contractors who may have other interests.”
The need for lean 3PL models
Understanding the challenges and hurdles that emerging companies too-often encounter in Europe, many of Cencora’s complementary services are aimed at streamlining the go-to-market process and relieving the administrative burden involved. For example, in France and Italy, Cencora often participates in hospital tenders on behalf of the MA holder, preparing compliant bids and ensuring on-time delivery once contracts are rewarded.
De Wit explains one very unique service the company offers to mitigate the risk of late-stage commercialisation: “If a client is not yet ready and did not manage to obtain their own licenses, we can allow them to use our own wholesale distribution license [WDA]. This means Cencora takes title of the product. We call it a Title Model,” he says, adding that it is particularly useful when MA holders require a rapid pathway to market due to tight launch deadlines and unforeseen regulatory delays.
Where companies have not yet set up business operations in Europe, or would rather avoid the added costs and risks associated, Cencora can also help with order fulfilment. The company’s end-to-end fulfilment solution involves receiving orders, scheduling delivery, dispatching products, and issuing invoices.
“We also take care of cash collection and the whole reminders process, and we then reconcile with the emerging biotech client every 10 days for example,” de Wit explains. “For the client, it’s a lean model where we act as the customer service agent to their end customers. We take orders locally from the end customers in the countries, but the order fulfilment is done centrally in our European hub, which gives them more efficiency in their supply chain.”
A strategic partnership for first-time launchers
From securing regulatory licenses and planning complex European launch strategies to winning hospital tenders, executing on-time deliveries, and meeting order fulfilment requirements across various countries, bringing new therapies to European patients is no small feat. For emerging biotechs, especially those based outside of the region, the challenges can feel impossible to overcome alone.
In about nine out of ten cases, we’re engaging with companies who do not fully understand the European landscape and its requirements.
“In about nine out of ten cases, we’re engaging with companies who do not fully understand the European landscape and its requirements, either because they’ve been badly advised by external consultants or they simply did not have the time to do the proper desk research internally,” says Van Der Hulst.
With launches often falling behind schedule, such companies require strategic services that accelerate their speed-to-market, reduce the administrative headaches involved, and minimise the risk associated with setting up new operational teams and logistics infrastructure in unknown markets. With Cencora, they can access a large and robust European network, streamlined support services, and invaluable expertise, unlocking new possibilities in Europe and beyond.
[i] Data provided by GlobalData Pharmaceutical Intelligence Center, Drugs database. [ii] https://www.efpia.eu/about-medicines/access-to-medicines/back-innovation-boost-access/
