INTRODUCTION
STUDY GOALS AND OBJECTIVES
This report 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 through 2014. Company profiles and a patent analysis are provided as well. Example product categories that are covered include drug-eluting stents (DES), drug-eluting beads (DEB), antimicrobial catheters, antibiotic-loaded bone cements, glass ionomer cements, bone graft substitutes, antibacterial releasing dental restorative materials, biologic wound care products such as collagen-based dressings as therapeutic agents for wound healing, drug device combination products for ocular applications, photodynamic therapy, and other important niches.
REASONS FOR DOING THIS STUDY AND ITS IMPORTANCE
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 centers 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.
INTENDED AUDIENCE
With its broad scope and in-depth analyses, this study will prove to be a valuable resource, particularly for anyone involved with or interested in the future of the fast growing drug device combination market. This study will be particularly useful for researchers, laboratory and government personnel working in research or company settings, as well as business professionals involved with drug and device development. It also will be of value to potential investors and members of the general public interested in acquiring a business-oriented view of a key health care sector in the economy. The projections, forecasts, and trend analyses found in this report provide readers with the necessary data and information for decision-making.
SCOPE AND FORMAT OF REPORT
In preparing this report, an overall study of the drug device combination market was undertaken. Related areas, such as drug delivery systems and nanotechnology, were key to the analysis as well, as newer areas such as nanotechnology, foreshadow likely product developments in the years ahead. All major aspects of the drug device combination market are addressed including identification of current and future technologies, products, market segments/end markets, and government and regulatory agencies. Participating companies are discussed in light of technological strengths and weakness, relative market share, marketing strengths, and innovative marketing practices. Included is a detailed discussion of the current regulatory environment for drug-device combination products and how this is affecting development and approval of such products.
METHODOLOGY AND INFORMATION SOURCES
Data for this study were collected using both primary and secondary data research techniques. A literature search was conducted covering scientific, medical, business and technical documents, as well as patents. Since most segments of the drug device combination market are not routinely measured, BCC derived estimates from a variety of sources. Whenever market estimates are derived, they are fully noted. All forecasts are in current (nominal) dollars, unadjusted for inflation.
ANALYST CREDENTIALS
Research analyst Kevin Gainer holds both B.A. and M.A. degrees in quantitative economic analysis and has 25 years of economic, industry intelligence and market research experience. He is the author of six published books and dozens of technical papers, analyses, and studies published in conference proceedings, including many unpublished within corporations. He has worked as a Research Editor and Project Analyst at BCC Research since 1985, and has authored numerous BCC technology market research reports.
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DISCLAIMER
The information developed in this report is intended to be as reliable as possible at the time of publication and of a professional nature. This information does not constitute managerial, legal, or accounting advice; nor should it serve as a corporate policy guide, laboratory manual, or an endorsement of any product, as much of the information is speculative in nature. The author assumes no responsibility for any loss or damage that might result from reliance on the reported information or its use.
Report Code: PHM045B, Published: January 2010, Analyst: Kevin Gainer
