List: The companies behind 38 new pharmaceutical substances in the EU
In 2025, the European Medicines Agency (EMA) recommended 104 medicines for approval. Of these, 38 contained a new active substance that had never before been authorised in the EU. Life Science Sweden has mapped the companies and countries behind the new substances.
The oncology field clearly dominates. Sixteen of the 38 new active substances are cancer medicines, underlining the continued strong pace of innovation in oncology.
At the same time, the geographical concentration is striking. More than half of the substances have been developed by, or are owned by, US biotech and pharmaceutical companies. However, the list of companies itself is relatively dispersed: no single company appears more than twice among the 38 new substances.