For many years the pharmaceutical market has relied upon excipients that are safe and available in bulk but are poorly adapted to the purpose of pharmaceutical formulation. As medicinal science has moved on, the difficulties faced by formulators have increased; bioavailability has become a key requisite and the new active molecules coming through are frequently difficult to solubilise. Furthermore, in today’s competitive marketplace where healthcare payers are driving down drug prices, manufacturing costs and productivity have become important drivers for change. At last, suppliers are making serious attempts to understand formulation issues and make excipients really work for manufacturers.
The global excipients market is expected to reach US$5.22bn by 2020, growing at a CAGR of 6.0% from 2014 to 2020, according to the latest report by Grand View Research1 but, on the whole, developments in this market tend to be incremental rather than earth shattering. In this conservative, highly regulated, data-reliant sector, totally new excipients are few and far between. Such materials are, however, increasingly tailored to solve specific issues and contract manufacturers are playing a larger role in tackling the low solubility API issue.