The global market value for bioabsorbable scaffolds will expand rapidly from US$143.7m in 2014 to just under US$2.1bn by 2021, driven primarily by new product approvals and a paradigm shift in the clinical treatment of vascular diseases towards minimally-invasive procedures, says research and consulting firm GlobalData.
The company’s latest report states that this significant increase, which will occur across the ten major markets of the USA, France, Germany, Italy, Spain, the UK, Japan, Brazil, China and India, represents an compound annual growth rate of 42.1%.
Amen Sanghera, GlobalData’s analyst covering medical devices, says that while bioabsorbable scaffold devices have yet to gain regulatory approval in the USA, China and Japan, there are already four CE-marked bioabsorbable scaffold devices approved in the five European countries.
Sanghera comments: “Abbott Vascular is the primary player in this market with its drug-eluting bioabsorbable scaffold, Absorb BVS, which is available across five European countries and in selected Latin-American and Asian countries. The product is expected to gain US Food and Drug Administration approval by 2016.”
Sanghera continued, “Abbott Vascular recently gained the CE mark for a package incorporating both Absorb BVS and the company’s state-of-the-art catheter delivery system, the GlideTrack. This package is expected to increase the uptake of the Absorb BVS system, as it addresses clinical concerns surrounding the delivery of its device to occluded coronary vessels.”
With sufficient improvements, GlobalData anticipates that bioabsorbable scaffolds could begin to challenge drug-eluting stents as the gold standard of coronary and peripheral artery disease stenting, as these devices aim to directly confront the current issues with permanent metallic stents, such as late in-stent restenosis, vessel scarring and late stent thrombosis.
“Technological trends in the market are aimed at reducing the thickness of bioabsorbable scaffolds and providing better delivery systems, more efficient drug-elution characteristics, and faster resorption times,” noted Sanghera.
“As long-term clinical data demonstrating their efficacy become available, the uptake of bioabsorbable scaffolds will gradually increase across the ten major markets. The expanding presence of these products, along with a reduction in their prices, will drive substantial growth during the forecast period,” the analyst concludes.