In addition to the uncertainty triggered by the US government with serious changes at the FDA and other healthcare institutions and an unclear stance of the US Secretary of Health and Human Services on various areas of innovation, the growing demand for health care services gives a positive momentum that can provide stability.

As the global race for biosolutions intensifies, Europe is at a critical crossroads, and I am deeply concerned about the future of our continent’s biotech industry. While countries like China and the United States rapidly advance their biotech industries, Europe’s slow and not up-to-date regulatory system poses a significant risk to maintaining our leadership.

On May 12, 2025, President Donald Trump signed an executive order aiming to drastically reduce U.S. prescription drug prices by aligning them with the lowest prices paid in other developed nations—a policy known as the “Most Favored Nation” (MFN) approach. While the initiative seeks to alleviate the financial burden on American patients, it has sparked intense debate over its potential ramifications on global pharmaceutical trade, investment patterns, and the United States’ leadership in biomedical innovation.

Biotechnology provides the necessary toolbox, ranging from energy-saving biocatalysts for the chemical industry to climate-friendly production of animal feed and food proteins for more resilience, microbial recovery of rare critical materials, to the production of pharmaceutically active ingredients.

After the exuberance during the Covid-boost and the post-Covid hangover, 2024 was a rather calm year for the biotechnology sector. This provides an opportunity to take a step back and assess some emerging long-term financing trends as well as the recent events in the US, which may also impact the biotech industry.

During the conference calls on the latest quarterly reports, several recurring questions emerged: What consequences do you anticipate if Trump is to be re-elected? How will tariffs affect supply chains and operating profits? What about FDA, IRA, the healthcare system, or the bioeconomy strategy?

Therapeutic antibodies today represent a cornerstone of the treatment of various diseases including cancer, infectious, autoimmune, cardiovascular, haematological, metabolic, neurologic and ocular diseases, and make up a major proportion of blockbuster drugs with global sales of more than US$230bn in 2023.

Soo Romanoff, Analyst Edison Group; Picture: © Edison Group

2023 was another particularly tumultuous year for life sciences and, although the lingering effects of the last year are unlikely to change dramatically, the stabilisation of interest rates (off 16-year highs) and emerging direction of travel (market data points) tilt our bias to positive for the new year. 

Adrien Samson, EuropaBio; Picture: EuropaBio

The 2023 State of the Union speech saw biotechnology rise as a priority for the European Union. It has been designated as a critical technology for Europe’s economic security. In March 2024, the European Commission presented its biotechnology and biomanufacturing strategy with a clear leadership ambition for Europe’s biotech industries. The Letta Report on the future of the Single Market, published April 2024, proposed a fifth freedom on research and innovation which would directly benefit biotech.

Ion Arocena; General Manager Asebio; © Asebio

Born with the aim of harmonising the application, evaluation, and supervision process of clinical trials conducted in EU countries, there is much room for improvement for the Clinical Trial Information System CTIS, particularly with regard to SMEs and translational researchers.