Each year in the United States, more than 500,000 people with coronary artery disease are treated with percutaneous transluminal coronary angioplasty (PTCA). Unfortunately, restenosis occurs within three to six months in 40% to 50% of PTCA patients due to either thrombosis or abnormal tissue growth. As a result, restenosis constitutes the major limitation to the effectiveness of PTCA.
To improve on this condition, medical science created stents in an attempt to keep coronary arteries open. However, one of the early limitations of stent use was the development of “subacute” stent closure, when thrombosis occurred within the stent. Anti-platelet drugs were necessary for the prevention of subacute closure. With modern stenting techniques and the use of aspirin and oral anti-platelet drugs, many cases of restenosis could be prevented. This combination of specialty stents and anti-thrombotic medication led to the development of drug-coated stents.
The technology of drug-coated stents such as heparin-coated stents, however, has progressed to the more advanced drug-eluting stents. But challenges remain and this report, Drug-Eluting Stents: Technologies and Markets, delivers thorough analysis of the new era of stent products. The report provides cogent, intelligent analysis of the trends shaping this fast-growing and ever-changing market, including:
- The real outlook on market size and growth for specialty stents
- The technical advances in materials and pharmaceuticals that will lead to product innovation before the market gels.
- The legal, regulatory, and competitive challenges that marketers will be faced with.
- The latest clinical trial information that will drive the success and failure of products.
This report focuses on the market application of current and advanced technology to the development of drug-eluting stents. The field of drug-eluting stents promises to be an exciting technological innovation that will be but one part of the array of cardiovascular intervention technologies, but the major part through the end of the decade. This report focuses solely on drug-eluting stents and not on bare stent design or materials, technology and markets. Neither does it consider, in depth, other cardiovascular modalities.
Because all of the current work in drug-eluting stents has been focused on coronary artery disease, this report shares that focus. Stents may be used for peripheral vascular applications and for the treatment of closure of other physiological vessels, including the esophagus. Such applications are not discussed in this report.
This report considers the options that the current technologies present, the progress that is being made in these fields, and the reception these new products are likely to experience in the marketplace. The major market effects of new and advanced drug-eluting stent technology are expected to begin to be seen in the relatively short term, that is, within the 2003-2004 period.
This report does discuss the economics of drug-eluting stent technologies and applications, and their impact on hospitals and insurers. In general, it is the current products and technologies used in the marketplace, leaving significant unmet need with regard to the prevention of restenosis, which have made today’s market vulnerable to new technologies and products.
Market analysis for this report considers the drug-eluting stent markets only in the United States through 2010. The focus of the report is on the application of drug-eluting stents in the prevention of restenosis following percutaneous intervention for coronary artery disease. This is the only application toward which drug-eluting stents have been directed at this time. This report does not cover bare stent technology and products, guide wires, catheters, and other hardware used in percutaneous intervention procedures. It does discuss some of the alternative technologies to drug-eluting stents in the prevention of restenosis and their potential impacts on the market.
The analysis presented in this report is based on data from a combination of company, government, industrial, institutional and private sources. It includes information from extensive literature reviews, as well as interviews and discussions with experts in the field, including experts in cardiology and cardiac surgery (vascular surgeons and interventional radiologists), as well as pathologists, research scientists, and business development and marketing managers engaged in the field.