A comparison of the innovation and regulatory environments for biotechnology and biosolutions across the European Union and the United States

Biotechnology has significant potential to drive economic growth and address major societal challenges, but realising this potential across sectors requires effective and well-designed policies. This OECD Working Paper strengthens the evidence base for biotechnology policymaking by examining two critical dimensions: innovation-enabling conditions and regulatory practices. It provides quantitative and qualitative analysis comparing innovation performance and regulatory environments in the European Union and the United States. The paper first assesses innovation conditions through indicators related to venture capital, patenting, financing, workforce skills and manufacturing capacity. It then compares regulatory frameworks across the two jurisdictions, highlighting shared challenges such as regulatory uncertainty, fragmentation and complexity, limited adaptability, insufficient pre-submission engagement, and lengthy approval processes with high associated costs. Together, the findings support policymakers on both sides of the Atlantic in designing policies that foster innovation, unlock the economic potential of biotechnology, and facilitate market entry to strengthen competitiveness.