RESEARCH
EMA horizon scanning signals nanotechnology is moving from niche science to a core tool in European drug delivery strategies
3 Feb 2025

A shift is under way in Europe’s pharmaceutical sector as nanotechnology moves from experimental use into routine drug development, according to the European Medicines Agency’s January 2025 Horizon Scanning Report.
The agency’s analysis places nanotechnology-enabled drug delivery among the technologies most likely to shape future medicines, signalling that it is becoming part of standard development strategies rather than a niche option. While the report does not constitute formal regulatory guidance, it offers insight into how the EMA’s scientific and regulatory priorities are evolving.
Nanotechnology-based delivery systems use ultra-small carriers to control how medicines move through the body, allowing developers to influence where and when drugs are released. The EMA says such approaches can improve effectiveness, reduce side effects and support better patient adherence, addressing growing pressure on the industry to deliver improved outcomes without raising costs.
The report notes that activity now extends well beyond the lipid nanoparticles used in mRNA vaccines. Nanotechnology-enabled platforms are being tested across oncology, infectious disease and rare disease programmes in Europe. These include lipid nanoparticles, liposomal formulations, albumin-bound cytotoxins and polymeric nanoparticles, applied across a broad development pipeline.
This expansion reflects a wider industry trend as drug pipelines increasingly feature complex molecules that are difficult to formulate using conventional methods. Delivery technology is therefore becoming more central to product design. One regulatory expert involved in EMA scientific assessment activities observed that “delivery is moving from a secondary consideration to a core element of product strategy”.
The EMA’s analysis also sends a signal to companies and investors that Europe is preparing for a larger role for nanotechnology-based medicines. The agency highlights progress in regulatory science, including more refined tools to assess quality, safety and performance, which it says should help reduce uncertainty and support earlier investment in new delivery platforms.
The report acknowledges ongoing challenges, notably manufacturing consistency, long-term safety assessment and the need for specialised testing methods. However, its overall tone is supportive, emphasising early dialogue and collaboration between regulators and developers.
For pharmaceutical companies, the EMA’s horizon scanning suggests that early investment in advanced delivery technologies could shorten development timelines and strengthen product differentiation. For patients, the potential gains include more targeted treatments with fewer side effects. As horizon scanning continues to shape expectations, nanotechnology is emerging as a strategic priority for Europe’s drug development agenda.
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