Pharma in 2025: How to meet Regulatory Compliance

Europe’s pharmaceutical sector is the second largest in the world, and the DACH region, which includes Austria, Germany, and Switzerland, is central to it—home to some of the most well-known life science brands that are an engine of growth for Europe and vital to public health globally. Production from DACH-based pharmaceutical firms was worth €94 billion in 2022, accounting for a quarter of the EU’s $363 billion output.

While the DACH region remains a global leader in pharmaceutical and chemical research and manufacturing, it faces numerous challenges to profitability and growth stemming from regulatory processes for new drug and medical device R&D and manufacturing, strict data protection laws, and new cybersecurity regulations aimed at lifting digital resilience in critical sectors and the security of connected medical devices. The sector will also need to navigate the EU’s AI Act, which will apply to high-risk use cases of AI in medical and in vitro devices. 

In this critical sector, any significant disruptions to research, development, manufacturing, and distribution can have wide-ranging impacts on public healthcare and the financial outcomes for affected companies and investors.