According to the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), in 2014, the US approved 41 new molecular entities (NMEs) and new therapeutic biological products. About 30% of these were new biologics. This growth in biologicals is highlighted in Visiongain’s market report,1 which predicts that the overall world market for biosimilar mAbs will exceed US$4bn by 2020, multiplying in value many times from 2015 to 2025. Fifteen of the NMEs targeted rare or orphan diseases, which suggests recent FDA efforts to accelerate orphan drug development is taking effect. Furthermore, according to the US Personalised Medicine Coalition (PMC) more than 20% of the 2014 approvals were personalised medicines.
In addition to the continued move towards precision drugs, there has been a further refocusing of discovery away from alleviating symptoms towards pre-emptive disease treatment. For example, Janssen R&D, part of Johnson & Johnson, has launched three research platforms focused on disease prevention, disease interception, and the microbiome – areas, it says, ‘of transformational medical innovation that are expected to change the healthcare landscape’.
There has been a further refocusing of discovery away from alleviating symptoms towards pre-emptive disease treatment
‘The future of healthcare will increasingly depend on identifying and correctly interpreting the earliest signals of disease susceptibility, preventing or intercepting disease before it even begins, and using the latest scientific insights from promising, emerging fields like the microbiome, to transform medicine,’ said William Hait, Global Head of Janssen R&D.
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