Cyclodextrin Market
Cyclodextrins have been used in a variety of food products in Japan for over 25 years. In 1999, the economic impact of Cyclodextrins on the Japanese economy was reported to be $2.6 billion. Within the last 10 years, many more European countries have approved the use of Cyclodextrins in food products. In the United States, major starch companies are renewing their earlier interest in Cyclodextrins as food additives. We believe the food additive industry world-wide will continue to increase its use of Cyclodextrins.Natural Cyclodextrins have been confirmed to be generally recognized as safe (“GRAS”) in most of the world, now including the U.S. Moreover, recent approvals of products containing Cyclodextrins by the U.S. Food and Drug Administration (“FDA”) suggest that regulatory approval for new products may be easier in the future. In 2001, Janssen Pharmaceutica, now a subsidiary of Johnson & Johnson, received FDA approval to market Sporanox®, an antifungal which contained hydroxypropyl B Cyclodextrin. In 2008, one of our clients used our product, Trappsol® HPB, in an FDA approved compassionate use clinical trial for the treatment of Niemann Pick Type C disease. We now sell this product under our Trappsol® product line as “Cyclo™.” Our customer applied to the FDA to designate Trappsol® Cyclo™ as an orphan drug in the treatment of Niemann Pick Type C disease. Under the Orphan Drug Act, companies that develop a drug for a disorder affecting fewer than 200,000 people in the United States may seek designation as an orphan drug and, if such application is approved, they have the ability to sell it without competition for seven years, and may get clinical trial tax incentives. On May 17, 2010, the FDA designated Trappsol® Cyclo™ as an orphan drug for the treatment of Niemann Pick Type C (NPC) disease.
Applications of Cyclodextrins in personal products and for industrial uses have appeared in many patents and patent applications. Procter & Gamble uses Cyclodextrins in Bounce®, a popular fabric softener and Febreze®. Avon uses Cyclodextrins in its dermal preparations using its Age Protective System (APS®). The prices of the natural Cyclodextrins have decreased enough so that use of these materials will be more price competitive.
In Japan, at least twelve pharmaceutical preparations are now marketed which contain Cyclodextrins. The Cyclodextrins permit the use of all routes of administration. Ease of delivery and improved bioavailability of such well-known drugs as nitroglycerin, dexamethasone, PGE(1&2), and cephalosporin permit these “old” drugs to command new market share and sometimes new patent lives. Because of the value added, the dollar value of the worldwide market for products containing Cyclodextrins and for complexes of Cyclodextrins can be 100 times that of the cost of the Cyclodextrins itself.
