A device consisting of an analysis mechanism (such as a biochip), a reservoir chamber for drug storage, and compound delivery mechanism (such as a microneedle array) used for diagnostic and therapeutic applications. Drug delivery systems can be either in vivo or in vitro such as a transdermal patch or inhalation device. For the purposes of this report, only drug delivery systems that involve a bioMEMS mechanism are considered. Thus, many oral delivery methods (i.e., pills and inhalation devices) are not considered.

Microneedle devices are used for the delivery of molecules of either a treatment drug or diagnostic compound into the body. Microneedles can be made of a biodegradable polymer and formed from a micromold. Also, the microneedle usually has an associated device that controls the flow of fluid through the microneedle such as a permeable membrane, valve or pump. Currently, a common size for microneedle arrays is 5x5mm with 100 needles in the array.

DRUG DELIVERY SYSTEM MARKET FACTORS

The main factors driving the drug delivery market include:

• the discovery of new methods of construction and the furtherance of scientific goals to make systems biocompatible and capable of being mass fabricated. Materials currently being promoted and tested by universities and corporate R&D include carbon-based materials and silicon-based materials. The main objective in microneedle manufacturing is to create a system in which the components do not bend or break. Currently, etching machines are being used to fabricate arrays and insertion guides for the arrays.

DRUG DELIVERY MARKET BY REGION

2004 was the first year which we could positively recognize a market for these products. Customers were typically corporate entities or other researchers, but products were sold for commercial purpose and eventual commercial manufacturing.

In 2004, the North American market made up nearly 50% of demand for bioMEMS-based drug delivery systems.

The market is being driven by research institutes and corporate investment in drug development and delivery.

Drug delivery companies are no longer focusing on developing products that simply enable existing drugs but are also getting further involved in the drug discovery process. This allows for the coordinated development of both drug compound and delivery system. For example, as drug discovery moves further down the nanoscale, delivery systems will be able to be developed that operate on that scale, delivering only the exact number of molecules necessary for proper therapeutic treatment, or delivery systems will also enable manipulation of drug compounds in order to control interaction with the body. Pharmaceutical companies want tangible proof that a technology will work before investing in it, and they want to know that products will come from research. Thus, drug delivery companies are being further pushed to bring products to market or at least out of the development stage more quickly.

From 2005-2010, the North America market, again largely the United States will show the strongest growth rate at 46.9% annually. Thus, by 2010 the North America market will comprise 56.1% of total demand.

This information is based on the research report entitled BioChips & BioMEMS—Global Markets, Applications & Competitors: 2005-2010 Analysis & Forecasts published in April 2005.

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