Excipients coming out of API shadow?

The number of new active substances launched into world markets - a widely used benchmark for R&D productivity in the pharma industry - is currently running at half the level of the mid-1990s, when tallies in the fifties were commonplace. At the same time, industry's R&D spending has nearly doubled to more than €26 billion. So faced with the need to eke more euros out of every product, drug companies are using inactives to extend product lifetimes.

This has created a wealth of opportunities for suppliers of excipients in the US and Western Europe, according to data from a study published by Kline & Co​.

The report, called 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 Western Europe and the US at $800 million (€650m) to $900 million and rising. And as the demand for expanded functionality in excipients increases, so will the attractiveness of this profitable segment, it adds.

"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,"​ said Gillian Morris, chemicals industry manager at Kline's research division.

Drug companies are now looking to excipient suppliers for support in innovation and technology development, not only to extend the patent life of existing drugs but also to shorten the time to market for new ones, she noted.

So how can excipients help? In the report, Morris points to advances in drug aesthetics and manufacturing economics that have been made possible by new developments in excipients. For example, film formers have increased the potential for film coating, which is a far faster and more economical process than sugar coating. And new binders have also been introduced that can be used in direct-compression tablet making, which is more cost-efficient than wet granulation methods.

Delivery​

Most importantly, she said, new coating and disintegrant formulations have enabled controlled release of the active ingredient over a sustained period, a key marketing issue for medications that has nothing to do with the active.

Innovations in delivery form like sustained release allow pharmaceutical companies to extend the patent life on existing products. In fact, for many new actives, advanced delivery systems based on traditional or novel excipients are the only way forward in creating an effective oral solid dosage form.

"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,"​ noted Morris. "They're also looking to combine drugs in a single dosage form."​

Meanwhile, other advancements will likely include ways of processing actives and excipients at the same time - such coprocessing can provide functional improvements and reduce costs, as well as extending patent life - and the development of suitable systems for large molecules and gene therapy.

However the grand prize for the pharmaceutical companies is non-injectable delivery forms of key compounds that currently cannot withstand the demands of oral delivery.

"Even with their substantial R&D resources, drug companies are realizing that they can't meet all of these development goals alone, particularly if they want to be first to market with a new delivery form,"​ according to Morris.

For more information on the report, contact Jonathan Duff​.