Tracking Excipients - Pharmaceutical Technology

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Tracking Excipients
A review of recent product innovations, policy developments, and growth prospects in the excipients market.


Pharmaceutical Technology
Volume 33, Issue 4, pp. 44-51

Carbohydrates represent the largest share of global organic excipients on a value basis, followed by petrochemicals, oleochemicals, and proteins. Carbohydrates account for 39%, or $1.2 billion, of the global organic excipient market, based on 2006 data. Petrochemicals account for 30.3%, or $941 million, and oleochemicals 28.3%, or $880 million. Proteins represent a small percentage, only 2.2%, or $68 million, according to BCC Research (3, 4). Carbohydrates are the leading organic excipients because of their filling and taste-masking properties, according to BCC. Cellulosics hold the top spot in the carbohydrates segment on a value basis. Sugars comprise the bulk of the market volume for carbohydrates. Micronized cellulose phthalate and hydroxypropyl cellulose compositions that have been converted to gels for transmucosal delivery systems are driving growth for cellulosics. BCC projects increased demand for compendial sugars for biopharmaceuticals and growth for artificial sweeteners, particularly in thin-film strips (3, 4).

Glycols and povidones are the leading petrochemical-based excipients. In glycols, the trend is toward more refined grades that can increase the stability of APIs. For povidones, an important trend is their use in very small tablets with rapid bioavailability, according to BCC (3, 4).

Inorganic chemicals used as pharmaceutical excipients include calcium salts, halites, metal oxides, and silicates. Calcium salts hold 73.2%, or $266 million, of the global inorganic excipients market, according to BCC.

Halites and metal oxides each comprise 8.5%, or $31 million, of the global market for inorganic excipients. Demand for sodium chloride as an osmotic agent in injections and sustained-release tablets provides halites at a CAGR greater than that of other inorganic excipients, according to BCC. The established use of titanium dioxide as a colorant is driving sales growth of metal oxides (3, 4).

Silicates account for 4.8%, or $17 million, of the global market for inorganic excipients. Small loading levels and the maturity of the glidant segment keep the market value for silicates low. Other inorganic excipients account for 5%, or $18 million, according to BCC (3, 4).

BCC Research classifies USP water as a general chemical in its analysis of the global excipient market. USP water includes water for injection (WFI) and purified water. Water must comply with USP standards for chemical purity and microbial content (i.e., < 0.25 ppm of endotoxins). WFI accounts for 76.5% of the USP water market, or $52 million, and purified water 23.5%, or $16 million. Pharmaceutical grades of water used in drug-process applications (i.e., enema and medical-irrigating fluids) and other than those used to formulate excipients are excluded from the analysis. Also excluded is water used in the following applications: a pharmaceutical manufacturing process aid (i.e., wet granulation); a solvent for aqueous-based, film-coating materials; a cleaning and rinsing material for containers and closures; a fermentation or cell-culture media ingredient; an extraction and purification solvent; a chemical-reaction solvent; or any other purpose except in a formulated drug-dosage form (3, 4).

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072,

References

1. IPEC–Europe, "Excipient Insights," Mar. 2009, http://www.ipec-europe.org/, accessed Mar. 16, 2009.

2. IPEC–Americas, "IPEC Americas News," Dec. 2008, http://www.ipec-americas.org/, accessed Mar. 16, 2009.

3. P. Van Arnum, "Measuring Excipient-Market Growth," Pharm. Technol. 32 (4), 56–62.

4. "Excipients in Pharmaceuticals," Report No. PHM010E, BCC Research (Norwalk, CT, 2006).


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