The European biotechnology sector plays a pivotal role in advancing healthcare innovation, with biopharma start-ups serving as key agents in translating scientific research into commercial medical solutions. Yet, numerous start-ups face persistent barriers to commercialization, ranging from limited access to funding and long regulatory cycles, to the challenge of building viable business models. These hurdles were further exacerbated by the COVID-19 pandemic, which reshaped global investment patterns, disrupted clinical pipelines, and triggered regulatory adaptations across Europe.

This thesis investigates the key success factors that enable biopharma start-ups to navigate commercialization challenges, particularly in the context of the pandemic and its aftermath. It focuses on Sweden and Germany as case studies of the broader European biotech landscape due to their established innovation ecosystems, strong public-private research networks, and dynamic investment environments. Special attention is paid to two defined timeframes: the COVID-influenced period (January 2020–December 2021) and the post-pandemic period(January 2023–December 2024).

A mixed-methods approach was adopted in which qualitative insights obtained from semi-structured interviews, explored perspectives on how start-ups responded to regulatory and market disruptions, funding gaps, and strategic uncertainties.

These were complimented by quantitative data from an online survey targeting a broad range of stakeholders; founders, investors, incubators, policymakers, and business development executives from large pharmaceutical companies involved in start-up partnerships or acquisitions.

Findings reveal that successful biopharma start-ups actively leveraged strategic partnerships, engaged early with regulators, diversified their funding sources, and aligned their commercialization models with shifting policy and market conditions. Government interventions such as recovery-oriented investment schemes, regulatory fast-tracking, and start-up incubation support were found to be instrumental in influencing success trajectories. In contrast, start-ups lacking proactive business strategies or adaptive capacity struggled to attract investment or gain regulatory traction.

Importantly, this study identifies distinct commercialization patterns between the two periods: during the pandemic (2020–2021), start-ups prioritized regulatory agility, pandemic-related pivots, and emergency funding opportunities, while in the post-pandemic period (2023–2024), emphasis shifted toward strategic scalability, broader market positioning, and increased challenges in attracting sustainable funding.

This study contributes to the broader understanding of biotech commercialization in Europe by identifying core business, regulatory, and financial factors that support start-up viability in dynamic, high-risk environments. Its findings provide actionable recommendations for biotech entrepreneurs, investors, and policymakers to strengthen start-up resilience, improve market readiness, and foster innovation-driven growth across the European biotech sector.