Characterisation of biopharmaceuticals

Abstract

Biopharmaceuticals are drugs which are primarily (glyco)protein in nature, that are produced in living cells using recombinant DNA technology – the combination of genetic material from multiple sources, creating sequences that would not otherwise be found in the genome. They have become an essential component of modern pharmacotherapy, and are the only effective treatment option available for many severe, often lifethreatening, diseases. Biopharmaceutical products have seen unprecedented sales growth in the last decade, particularly when compared with the conventional drug market. Most of the world’s top-selling drugs in 2015 were biopharmaceuticals, accounting for over 70% of the sales revenue for the top ten drug products in that year – see Table 1. The global biopharmaceuticals market currently enjoys a compound annual growth rate of approximately 9%, and is expected to reach an estimated value of over US$250 billion by 2017.