Big Pharma being challenged in innovation by smaller players, says EMA

More than 27% of medicines approved between 2010 and 2012 came from SMEs

More than 40% of innovative medicines recommended for marketing authorisation in the European Union (EU) between 2010 and 2012 came from small or medium-sized enterprises (SMEs), academics, public bodies and public-private partnerships, according to European Medicines Agency (EMA) officials.

Writing in the Nature Reviews Drug Discovery academic journal, they found that 27% of approved medicines during these years came from SMEs.

They indicated that some of these smaller businesses were prolific, given that SMEs account for only 13% of EU marketing-authorisation holders. They added that 61% of approved orphan medicines were from small and medium-sized businesses.

Meanwhile, 17% of approved drugs came from academic institutions, public bodies and public-private partnerships. And 11% of orphan medicines came from these sources.

The EMA authors said: 'Understanding the factors that could affect drug innovation, such as the nature of the organisations involved, could help in developing strategies to catalyse further advances.'

They said SMEs, academic institutions, public bodies and public-private partnerships were 'an important source of innovation and bolster the product pipelines of larger companies'.

EMA argued that it supported SMEs throughout all stages of medicine development. Melanie Carr, Head of EMA’s SME office, said: 'This analysis underlines the importance of the support that the EMA offers early in development.'

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