In the $7 billion+ worldwide market for drug-eluting coronary stents, a consistent theme is now the myriad challenge to existing players from the host of emerging competitors, particularly since the advent of drug-eluting stents (DES). Although not so long ago the DES market was monopolized by J&J/Cordis, then split and controlled by J&J and Boston Scientific, those were the old days. The market is now being progressively divvied up by a crowd of DES manufacturers, and some, like Abbott, with its successful Xience stent, are giving J&J and Boston Scientific a real run for their money.
But the challenges for the DES market, which are significant enough in the emergence of many DES designs seeking clinical, cost and other competitive advantages, are not limited to DES competition. Angioplasty and stenting face a range of competitive challenges in the clinical management of coronary heart disease that force manufacturers to consider the advantages and limitations of DES and all of the alternatives.
Minimally invasive coronary artery bypass grafting (MIDCAB, TECAB, etc.). The primary threat that DES posed to coronary artery bypass was that, with the dramatic reduction in restenosis offered by drug-eluting stents, a percutaneous procedure had outcomes that rivaled CABG (to varying degrees, depending upon whether you talked to a cardiac surgeon or an interventional cardiologist). Given a choice between sternotomy and femoral puncture (and associated recovery and cost), the cath lab procedure won out. However, the onus on surgical instrumentation manufacturers has been fully understood, such that various minimally invasive alternatives to traditional CABG are now dramatically narrowing the gap in trauma between angioplasty/stenting and CABG.
Irreversible electroporation for anti-restenosis. This technique, using very short electric field pulses to destroy cells in the intima, is yet unproven and still needs to be fit into an overall intervention, but nonetheless offers a potential alternative to drug-elution to prevent restenosis. Whether this technology (currently under development at Hebrew University of Jerusalem) succeeds in product approval and clinical development is less the issue than the fact that multiple technologies and approaches are being developed to target restenosis.
Atherosclerosis-reducing drugs (HDL therapy). There was great fanfare when Esperion Therapeutics’ drug, ETC-1002, demonstrated preclinical results indicating an ability to reduce atherosclerosis. The ability to sidestep the entire issue of needing to be less- or minimally-invasive by drug therapy represents a real challenge to not only stents but also bypass procedures.
Drug-eluting balloons. A handful of companies are developing drug-coated balloon catheters as an alternative to balloon angioplasty and stenting and for those who would not benefit from percutaneous procedures, such as those in whom antiplatelet therapy is neither recommended nor desired.
Late-stage thrombosis. The sudden threat, in 2006, that DES products might have a major drawback as a result of the formation of life-threatening clots was ultimately tempered by data indicating the threat was not as significant as feared. However, we remain in a period during which the clinical history of drug-eluting stents has yet to fully illustrate the risks of each of the approved drug-eluting stents on the market. Indeed, some competitors whose products show great promise may ultimately prove to have unforeseen flaws.
Competition in stent alternatives, for the time being, still represents the greatest challenge to competitors. The $7 billion worldwide coronary stent market creates big incentive for players to simply displace market share from other stent manufacturers. But if competitors do not keep in view the full breadth and depth of competition — from any source — they will face obsolescence sooner or later.
See the MedMarket Diligence report #C245, "Worldwide Coronary Stent Market, 2008-2017."