In February 2019, Biotronik ’s Orsiro stent received approval from the US Food and Drug Administration after study results revealed that it set new standards for safety and efficacy clinical endpoints.
GlobalData estimates that approximately 95% of all percutaneous coronary interventional (PCI) stenting procedures in the US use a drug-eluting stent (DES).
GlobalData expects this to grow at a compound annual growth rate (CAGR) of 3% until 2028. The current stent of choice is a DES due to the fact that it releases an anti-proliferative drug, which reduces the risk of in-stent restenosis, a common complication of using a bare metal stent.
The BIOFLOW-V study revealed that compared to the Xience stent, Orsiro demonstrated statistically lower complication rates at 12 months, and at two years, Orsiro showed further improvement event rates compared to the Xience.
Abbott currently holds one-third of the US DES market shares, following closely behind Boston Scientific . With Orsiro showing superior results in clinical settings compared to Xience, GlobalData expects Biotronik to take a portion of Abbott’s share in the market. However, given Abbott’s larger product portfolio and established presence in the market, Biotronik may have a difficult time taking a significant portion of shares, particularly against larger manufacturers including Medtronic and Boston Scientific.
If Orsiro can demonstrate significantly better outcomes in patients outside of a clinical setting, then that plus its ease of use and deployment by physicians indicates that Biotronik’s entrance into the DES market could provide tough competition for the other players in the space.