OBJECTIVES: Smaller biotech companies have pioneered transformative discoveries and therapeutic tools, such as gene therapies, CAR-Ts, and antisense DNA. On the precipice of commercialization, biotechs have an important decision to make: "Should we commercialize in Europe as well as the USA?” The $246 bn potential European market offers substantial opportunity for smaller biotech companies however, navigating its highly localized HTA systems is daunting. We explore European commercialization & market access strategies for smaller biotechs, and discuss the critical questions to be addressed to ensure delivery of in-demand therapies to customers and patients.

METHODS: A literature review was conducted to evaluate the critical success factors and potential challenges of first-time European launches from >15 biotech companies. An evaluation framework was developed to highlight scenarios for biotech companies to consider for future launches in Europe.

RESULTS: Our research found that biotechs opting to commercialize in Europe tend to adopt one of three go-to-market (GtM) strategies: ‘go-it-alone’, ‘partner’ or ‘acquire’. In the last ~7 years, almost half (~48%) have decided to ‘go-it-alone’, owing to the promise of substantial returns. However, this approach is risky, as seen in the case of US-based Bluebird Bio who, after months of invested time and effort, withdrew from the European market altogether, following failed pricing negotiations for β-thalassemia gene therapy ZYNTEGLO. To support future ‘go-it-alone’ scenarios, we developed a ‘European Commercialization Pillars for Success’ framework, a key pillar being timely patient access to essential therapies. We highlight the criticality of having well-trained resources in place pre-launch to develop compelling value dossiers, coordinate launch sequencing, and become experts in navigating local HTAs and negotiation.

CONCLUSIONS: Preparation is equally as important as execution. Our framework prompts biotechs to answer the right questions ahead of navigating local HTA systems and take optimal actions during execution to deliver therapeutics to patients.