The report “Drug-device Combinations: The Global Market” discusses key markets for drug device combination products. It provides descriptions of technologies and products, a review of the status of R&D initiatives and a forecast of the market to 2014.
Products that combine a drug or biologic with a device, such as drug-eluting stents and drug-delivery systems, can offer valuable approaches for treating diseases. In addition, developments in cell-based therapeutics, progenitor cell exploitation, growth factor delivery and advanced formulation strategies are becoming the basis of even more advanced combination device strategies. Technology advancements in the drug device combination market have been of considerable import in recent years and the pace of activity seems to be quickening with the appearance of many development-stage companies.
Especially since the approval of Johnson & Johnson's Cypher drug-eluting stent in 2003 and Boston Scientific's Taxus drug-eluting stent in 2004, drug-device combination products have attracted significant medical and media attention, but, combination products are subject to intense regulatory scrutiny for the issues of safety and effectiveness. Teams of device and drug product reviewers at a number of FDA centres are dedicated to evaluating such products. Thus, the bar is very high for FDA product approvals and consequently some combination products in certain categories are very small in number. for example, the entire fibrin sealant market is shared by only five FDA-approved products. Beyond drug-eluting stents and other categories noted above, combination products subject to FDA scrutiny include innovative drug-delivery systems, hemostatic sealants, photodynamic-therapy systems, gene-therapy systems, and products for many other investigational treatments.
The development of the market for combination products is closely related to another dynamic and fast growing healthcare segment generally termed "drug-delivery systems". "Delivery systems" represents a vast area of research and development within biomaterials and medicine and the demand for sophisticated drug-delivery devices is behind many novel product developments. Advanced drug-delivery devices offer increased efficiency, improved performance and convenience.