Considering all of the different businesses, areas of clinical focus or types of products to market/sell that are among options open to medtech manufacturers, one would have to look at coronary stents as a pretty attractive market.
- The worldwide market for coronary is at around $7.4 billion, with emerging growth in select segments at double-digit rates over the next five years.
- Coronary artery disease remains a prevalent disease with high enough annual incidence to sustain the coronary stent market (and other revascularization technologies) for years to come.
- There are only a few significant competitors in this market, and while there may be many in the wings looking to enter, the market is still ripe for novel technologies that demonstrate clinical efficacy.
- The framework for the introduction of even a potentially radical new stent technology is well established. Interventional radiology is a high volume practice, with a large population of experienced clinicians delivering stent technology to patients. Unless a new stent design demands a radically different deployment method, and clinical data is otherwise strong for safety and efficacy, clinical adoption should not be a problem.
- While there is plenty of discussion about the FDA scrutinizing the 510(K) process, and this does raise a cautionary flag, the worst case scenario would be that stents would have to provide additional data than has been required in the past.
- Although stents are small, there are opportunities for multiple participants in an individual stent’s design and construction, from the metal, polymer or other material used, the coating(s) used, the coating process or other elements. (For example, the paclitaxel drug-eluting stent technology behind the successful TAXUS stent of Boston Scientific was developed by Angiotech.)
As we note in our Report #C245 on coronary stents, there are numerous technologies for revascularization of coronary arteries, with new stent and other technologies under development. Coronary stents nonetheless remain a dominant option with good staying power.
Consider the alternative medtech opportunities, given regulatory, reimbursement, cost, R&D and other hurdles, and it is reason enough for there still to be opportunities in the coronary stents business.