The specialty excipient market is a tale of two markets. Growth prospects in the established markets in the United States
and Western Europe are moderate, but strong potential is projected for emerging markets such as China as that country's pharmaceutical
market and supplier base grows. On a product-development basis, excipient manufacturers are responding to demand by pharmaceutical
companies for improved performance and multifunctionality.
Market outlook
The market for specialty excipients used in oral solid-dosage form (OSDF) pharmaceuticals in the United States, Western Europe,
and China is nearly $800 million on a value basis and 225,000 metric tons on a volume basis, based on 2005 estimates, according
to Kline & Company, Inc. (Little Falls, NJ) (1). Kline classifies specialty excipients as binders and fillers, disintegrants, and lubricants.
Figure 1
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On a volume basis, consumption of specialty excipients in the United States and Western Europe is projected to increase at
an average annual rate of 2.3% and 2.6%, respectively, through 2010. In China, annual average growth is estimated at roughly
8% (see Figure 1) (1).
"If we look at this business on a global basis, future demands on excipient technology will continue to be driven by drug
industry developments such as new production methods, outsourcing, globalization, and reduced timelines to launch new products,"
said Eric Vogelsbeg, senior vice-president and head of Kline and Company's materials consulting practice, in commenting on
its recent study. "At the same time, you have growing demand for excipients in emerging markets and imports of low-cost generic
excipients into mature markets. All of these forces need to be considered to formulate an effective strategy for the global
market."
In the established markets in the United States and Western Europe, drug companies are turning to excipient suppliers for
innovation and technology developments. Driven by advancements in drug delivery and strategies to improve manufacturing economics,
excipient suppliers increasingly are seeking multifunctionality and enhanced performance for their products, says Kline and
Company (1).
In China, however, the specialty excipients market for OSDF pharmaceuticals is still evolving based on the country's production
methods for OSDFpharmaceuticals, a developing position for GMP-certified excipients, and the role of traditional Chinese medicines
in the country's pharmaceutical market.
"The current dominance of wet-granulation production techniques in China is a particular hindrance to multinational firms
whose product portfolios are more suited to direct compression techniques," said Gillian Morris, industry manager at Kline
and Company, in commenting on the study.
Figure 2
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Wet granulation accounts for more than 90% of tablet production in China. In contrast, in the United States, wet-granulation
is the least-preferred production technology. Instead, direct compression is the preferred production method. Chinese pharmaceutical
makers have been slow to adopt the direct- compression method because of an abundance of inexpensive labor, notes the Kline
analysis (1).
Figure 3
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China's preference for wet granulation drives its specialty excipient product mix toward locally produced starches and other
products. Production technology, the nature of the pharmaceutical products, and manufacturing economics are drivers in the
various product mixes in the US, European, and Chinese markets for specialty excipients (see Figure 2 and 3) (1).
