However, beneath this promising potential lies structural weakness, notably affecting the innovation-to-commercialisation pipeline. Despite a 13% compound annual growth rate (CAGR) in early-stage investment between 2015 and 2021, significant funding gaps remain. Promising firms are often lured abroad in their infancy or struggle to navigate the ‘valley of death’, where early-stage businesses have started operations but not generated sufficient revenues as they are unable to secure financing beyond Series A. The EU accounts for only 5% of the share of global VC funds, versus 52% in the US and 40% in China. Regulation also poses challenges. Unlike the United States’ centralised Food and Drug Administration or China’s state-led oversight system, the EU’s framework reconciles 27 national regimes with supranational rules. This complex, multilayered structure of approval pathways and regulatory obligations is regularly cited as burdensome by start-ups and established pharmaceutical firms alike. In September 2024, Mario Draghi released his Competitiveness Strategy for Europe, which highlighted that there are over 100 technology-related laws and over 270 active regulators in digital networks across Europe, limiting the appeal for investors. Moreover, the multiplicity of regulations on data access and storage across the 27 EU member states deter investors because of the complexity facing biotechnology innovation. While the European Commission’s newly established Biotech and Biomanufacturing Hub and the proposed EU Biotech Act, expected to be debated in 2026, seek to simplify these processes, delays have already fuelled investor concerns. The consequences are significant. In 2022, the median approval time for new medicines by regulatory bodies was 430 days in Europe versus 334 days in the US. Furthermore, average patient access time to new medicines in the EU is 578 days. Meanwhile, US and Chinese firms benefit from greater private and state investment, simpler data access and storage procedures, and less onerous regulatory obligations than their EU counterparts; all of which encourages shorter journeys from the lab to market. Still, Europe has advantages. Its legislation and initiatives, such as Horizon Europe, actively support small- and medium-sized enterprises (SMEs), start-ups and scale-ups, ensuring that innovation is not monopolised by large corporations. However, unless regulatory pathways are streamlined, businesses will continue to struggle with funding and regulatory fragmentation and delays. |