May 10th 2010
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All major current and future stent technologies are covered
The development of the coronary stent market is dependent on the number of people with Coronary Artery Disease (CAD) requiring treatment. The number of Percutaneous Coronary Interventions (PCI) procedures performed, the percentage of PCIs in which stents are used, the number of stents used in each procedure and average selling prices for stents, all influence market values. In addition, whether a Bare Metal Stent (BMS) or Drug-Eluting Stent (DES) is used in the procedure impacts the market, as DESs command a much higher selling price than BMSs, while increased competition in the DES market has a major impact on the price companies can command for their DES products.
A recovering sector...
The coronary stent sector was knocked back when, in 2006, there emerged safety fears regarding the use of DESs when some longer-term clinical data indicated there was a small risk of late stent thrombosis for DES patients. It is believed this risk of late stent thrombosis relates to the use of a polymer on the DES and potentially the doses of drug used, both of which impair re-endothelialisation. While endothelialisation can take place within two months for a BMS, it can take up to a year for this process to be completed when a DES is used.
...Looking to a new generation of technology
The industry has responded with a range of new approaches, and the next-generation technologies have received much interest from the medical community due to their potential to address the problems of current coronary stents. These products would also be able to command a higher selling price than current stents and competition for the products would initially be limited. However, as relatively new products with little clinical and longer-term safety data, their potential for success cannot be assured. It therefore remains to be seen if they can reinvigorate the market for coronary stents and provide an effective alternative to current products.
The coronary stent market is expected to exceed US$5.3 billion by 2015 but new technologies must surmount clinical and regulatory hurdles
A regional perspective
Unlike many medical technology sectors, the coronary stent market is not reliant on the USA – this is both a limitation and an opportunity. Since clinical and regulatory concerns over stent safety emerged in 2006, the number of procedures has fallen, although numbers are recovering now. Even so, in 2009 the leading region for the number of PCI procedures was Europe with 1,230,000, a 39% share of the global market. While around 30 companies now have DES products available, only four have a DES available in either Japan or the US, which represent the largest two markets for such products.
Advanced technology will drive the sector
Given the limitations of currently-available coronary stenting products, which include higher rates of restenosis for BMSs and the potential for thrombosis for DESs, there is currently a major drive by manufacturers to develop products that improve on these designs. There are three main approaches being undertaken by coronary stent manufacturers, which can be summarised as follows:-
Polymer-free DESs –
These entirely eliminate use of the polymer, which is believed to lead to increased rates of thrombosis. Instead, these products include coatings or surface modification technologies that control drug elution. Only four companies are developing or sell such a product, mainly due to the difficulties of developing a product that does not release the drug too quickly without the polymer in place to control drug elution.
Bioabsorbable polymer DESs –
These include a BMS, a drug and a polymer that biodegrades once it has eluted the drug. In the longer-term, only a BMS is left in place in the vessel. These products are currently the most widely-developed next-generation stenting technologies. They offer the benefit of continuing to have a polymer to control drug elution, but one that is not left in the body over the longer-term. The idea is that once the polymer has dissolved, the risk of thrombosis would be reduced and patients would not require long-term dual anti-platelet therapy.
Bioabsorbable BMSs and DES –
These are stents that totally dissolve after a certain period of time. The aim is to provide the initial scaffolding needed by the vessel and to reduce the risk of restenosis, but then the stent would dissolve, leaving a natural, healed vessel. The main challenge is the development of a suitable stent material that can provide the initial strength required, not dissolve too quickly and not fail on deployment or as its properties change.