The European Medicines Agency’s (EMA) support programme for small and medium-sized enterprises (SMEs) has reached its twentieth year of operation. Since 2005, when the dedicated SME Office was established, more than 5,000 companies have had their SME status officially recognised by the Agency, according to EMA’s latest report. Of these, over 3,000 have received direct assistance and support in the development of human or veterinary medicines.
Key figures on SMEs registered with EMA
In 2025, nearly 2,000 SMEs were registered with EMA, with the largest shares located in Germany (12.2%) and France (10.1%). Italian SMEs accounted for 6.3% of the total. Most companies (81%) operate exclusively in the pharmaceutical sector, while others are active in both pharmaceuticals and medical devices (16%) or solely in the medical device field. More than two-thirds (67%) of pharmaceutical SMEs currently have products under development. Academic spin-offs represent 13% of all registered SMEs, while the report also notes that 7.5% of SMEs have been acquired over the past three years.
In terms of company size, small enterprises account for 35% of the total, micro-enterprises for 38%, and medium-sized companies for 27%. The majority of registered SMEs (77%) focus on human medicines, followed by providers of regulatory and consultancy services (14%). The development pipelines of EMA-registered SMEs are primarily focused on medicinal products (52%), particularly small-molecule medicines, which also represent 52% of projects under development. In addition, nearly one-quarter of the companies are involved in the development of orphan medicines.
Strong contribution to pharmaceutical innovation
The success rate for obtaining marketing authorisations for medicines developed by registered SMEs reached 64% during the 2021–2025 period. In 2025 alone, EMA issued seven positive opinions and one negative opinion, while six applications were withdrawn before the Agency delivered its assessment. The success rate was even higher (80%) for marketing authorisation applications concerning veterinary medicines submitted during the same period.
A significant number of products developed by SMEs and authorised by EMA have addressed unmet medical needs. Around half (46%) of PRIME designations were granted to small and medium-sized enterprises, while recommendations for advanced therapies developed by SMEs accounted for 40% of the total. SMEs have also played an active role in several EMA initiatives designed to foster innovation, including scientific advice and protocol assistance procedures, applications for the qualification of novel methodologies, and participation in briefing meetings with the Innovation Task Force.
