Plenty of opportunities for excipient suppliers, says study

With increasing pressure to extend the patent life of existing drugs and shorten the time to market for new ones, pharma companies are turning to excipient suppliers help in differentiating their products, according to a newly published multivolume study from market research firm Kline & Company.

The Global Outlook for Specialty Excipients for Oral Solid-Dosage-Form Pharmaceuticals puts the overall market for specialty binders and fillers, disintegrants, lubricants and coatings in the US and Western Europe at US$800-900m and rising. As the demand for expanded functionality in excipients increases, so will the attractiveness of this profitable segment, it predicts.

'Traditionally, drug companies have been notoriously guarded about the information they are willing to release to their excipient suppliers, but this attitude has changed significantly,' says Gillian Morris, chemicals industry manager for Kline's research division. 'The drug companies are now looking to excipient suppliers for support in innovation and technology development.'

Morris cites advances in drug aesthetics and manufacturing economics that have been made possible by new developments in excipients, such as film coating to replace sugar coating, and new binders that can be used in direct-compression tablet making. Most importantly, she points out, new coating and disintegrant formulations have enabled controlled release of the active ingredient over a sustained period.

Other potential advances could include coprocessing of actives and excipients and the development of suitable systems for large molecules and gene therapy, while the main prize is non-injectable delivery forms of key compounds that currently cannot withstand the demands of oral delivery.

'Drug manufacturers are pushing their excipients suppliers for further development in coatings to gain more control over the release and absorption of actives, including site-specific action,' says Morris. 'They're also looking to combine drugs in a single dosage form. Even with their substantial r&d resources, drug companies are realising that they can't meet all of these development goals alone.'

The study provides detailed analyses of four major specialty excipient categories and more than 25 indi-vidual products in two regional volumes focusing on the US and Western Europe respectively. Each volume includes profiles of leading and niche speciality excipient and technology suppliers, as well as an overall business outlook and appraisal through 2008.