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.
"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.