Launching a new therapeutic is a monumental achievement for any biotech company, but successfully bringing a product to market in Europe presents a unique set of challenges. For US biotech companies, the fragmented market landscape can be particularly daunting. Here, we explore some of the key hurdles and offer insights on navigating them successfully. 

Challenge 1 – David vs Goliath 

Competing against established pharmaceutical giants can feel like an uphill battle; generating awareness for your company and its innovative product is crucial. This requires a strategic approach to corporate branding, communications and stakeholder engagement – consider, for example, the balance between the first product being the vehicle to introduce the company, and the company introducing themselves corporately to then announce their first product. Building strong relationships with key opinion leaders (KOLs) and leveraging platforms like congresses and social media can help you stand out and build a name for your company. Biotech companies will often discover and develop truly transformative therapeutics and bring them to market – where a product’s potential to transform patient outcomes provides a clear opportunity to gain “cut-through”, allowing it to compete and win against much bigger, more established organisations. 

Challenge 2 – Resource constraints 

Launching a new drug is resource-intensive, especially while simultaneously building out your organisation, and many biotech companies face limitations in terms of budget and personnel. It’s essential to define and maintain clear responsibilities and prioritise activities that deliver the maximum impact. Partnering with experienced agencies can provide access to specialised expertise and additional resources, allowing you to focus on core competencies. Selecting the right agency partners who understand how to successfully collaborate in this space will ensure that when the organisation’s resources are stretched, the agency can truly act as an extension of their team, allowing an agile, adaptive, fast-learning approach to be employed. 

Challenge 3 – Understanding the European market 

Navigating the complexities of the European healthcare landscape can be overwhelming, as standard practice for pricing and reimbursement, regulatory requirements, governance and patient access vary significantly across countries. For instance, Germany’s fast access to market contrasts sharply with the lengthy processes in countries such as Italy and Spain, where local and regional health authorities have more influence. Tailoring strategies to account for these national and regional variations is key to ensuring a smooth commercialisation journey. A deep understanding of these nuances can be acquired by recruiting new employees or onboarding an agency with the right expertise and is essential for successful launch planning. 

Challenge 4 – Maintaining focus and alignment 

As a biotech company rapidly expands its team during the initial launch phases, it can be challenging to preserve a strong company culture and maintain alignment around shared goals. The influx of new employees, often with diverse company backgrounds and experiences, can lead to miscommunication, conflicting priorities and a diluted company culture. A strong internal branding and communications strategy alongside training and engagement programmes can help maintain a sense of unity and shared purpose. 

Conclusion 

Launching your first drug in Europe is undoubtedly challenging, but with careful planning and execution, and the right support, it can be a rewarding experience. By thinking big, being realistic about budgets and fostering a culture of innovation and agility, you can position your company for long-term success. 

At Cognite, we have over a decade of first-hand experience supporting biotech companies navigating the complexities of their first commercialisation in the European market. With a deep understanding of the rare disease and specialty medicine landscapes, we offer tailored solutions to help you overcome challenges and achieve your launch objectives. 

Feel free to reach out to Stephen Piotrowski, our US Business Lead, to explore anything discussed here in more detail or review case studies of companies we have supported in the past. We’d be delighted to share our insights and support your company in transforming patients’ lives.