The numbers of new molecular entities (NMEs) launched worldwide show that, since 2014, the relative share of new biopharmaceutical molecular entities has increased in particular, and this is anticipated as more of the pipeline includes these technologies. To compile this analysis, annual surveys of the global pharmaceutical industry were undertaken to identify all new molecular entities launched for the first time anywhere in the world between 2006 and 2016.
A new biopharmaceutical entity (NBE) is a biological substance that has been produced or extracted from a biological source for therapeutic, prophylactic or in vivo diagnostic use in humans. This includes i) a substance isolated directly from animal tissues e.g. hormones; ii) a naturally occurring or modified polypeptide, protein, DNA or RNA product (produced by recombinant DNA or hybridoma technology and expressed in cell lines, transgenic animals or transgenic plants). A new chemical entity (NCE) is a chemical substance that has been created or synthesised using physical or chemical manufacturing methods capable of a high degree of consistency.
Source: 2017 CMR Factbook from Clarivate Analytics; Drawn from Annual Survey of New Molecular Entity First Launches / New Medicine Launches 2016. A complete guide to New Molecular Entities (NMEs) launched world-wide. Reproduced with permission.