Worldwide sales of pharmaceutical excipients for oral dosage formulations were $4.6bn (€2.92bn) in 2007, showing average annual growth of 6 per cent in both volume and value terms, according to the report by Kalorama Information. The market is expected to continue expanding at the same rate over the next five years, reaching $6.1m in 2012, forecasts Pharmaceutical Excipients for Oral Formulations, 2nd Edition. This will reflect increasing demand created by new drug targets, new biologicals, new formulations and synthetic agents.
There has been a renewed focus on excipients as the pharmaceutical industry "continues to be weighed down by the pressures on costs, generics, and lack of innovation", the report comments. With profit margins shrinking, companies are looking for ways to cut development costs without compromising the quality of their products, it points out. Excipients can be used to enhance functionality and help lengthen patent life without affecting the bottom line.
As such, the report says, they are becoming a more important aspect of tablet manufacture than they once were, even contributing to innovative formulations such as sustained-release drug delivery formats. "The line between active ingredients and excipients has become more blurred as the latter increasingly are coming to be seen as functional materials rather than inactive bulking agents," it notes.
Not that the innovative drive extends to excipients themselves. Rather, Kalorama paints a conservative and still highly fragmented market in which no one company offers a complete range of excipients and no one player claims more than 5 per cent of sales. There are more than 200 companies involved in producing excipients of one kind or another, ranging from stand-alone suppliers to the pharmaceutical divisions of chemicals manufacturers. "The level of innovation in the industry has been limited," Kalorama suggests. "There is very little investment in innovation."
If the composition of the excipients market by supplier suggests room for consolidation, geographically the market is already heavily skewed. According to the report, the US accounts for 60 per cent of worldwide pharmaceutical excipient sales for oral dosage formulations, followed by Europe with a 20 per cent share and then Japan and the rest of Asia with 10 per cent apiece. In all, there are some 1,200 different excipients in use in all types of pharmaceuticals, the report says. Among the five key segments, binders and fillers accounted for 21.7 per cent of overall sales worldwide in 2007, a leading share expected to dip slightly to 21.5 per cent by 2012 on the basis of a 5.6 per cent compound annual growth rate (CAGR).
Disintegrants come next, with a 20.6 per cent market share in 2007, forecast to reach 21.2 per cent in 2012 (CAGR: 6.5 per cent). Sweeteners made up 13.2 per cent of sales last year and are expected to take a 13.0 per cent share in five years' time (5.4 per cent CAGR). The fourth and fifth largest categories are lubricants and coatings, with market shares of 10.6 per cent and 8.7 per cent respectively in 2007. By 2012, lubricants are projected to account for 10.4 per cent of overall excipient sales (5.3 per cent CAGR) and coatings for 8.2 per cent (4.8 per cent CAGR).
While observing the growing trend towards regulatory harmonisation between the US, Europe and Japan in the excipients sector, which "will certainly eradicate the difficulty faced by companies that intend to market the unique finished formulation internationally", the Kalorama Information report also sounds a warning note. Scrutiny of excipient quality has intensified in the wake of various safety scares, such as the glycerine contamination issues that emerged in Kenya and other cases of excipient impurities that have led to drug toxicities and a number of deaths, it points out.
"Generally it is no longer sufficient for excipient manufacturers to ensure that their product is of the correct quality when it leaves the factory," the report comments. "They must be certain their reputation will not be adversely affected by issues further down the supply chain, which could end up in litigation claims and loss of reputation