The global sales of drug-eluting balloons across the 10 major markets are expected to witness a significant increase over the coming years, from US$164m in 2012 to US$477m in 2019, at a Compound Annual Growth Rate of 16%, following the product’s launch in the USA and Japanese markets, according to a new report from GlobalData.
The company’s latest report states that by 2019, the USA, UK, France, Germany, Italy, Spain and Japan will account for approximately 70% of the drug-eluting balloon market for coronary artery disease and peripheral arterial disease in the lower extremity. Among the 10 countries covered in the report, the USA is forecast to have the largest share in the drug-eluting balloon market, with 26% by 2019.
The demand for effective therapies targeting indications such as in-stent restenosis and complex lesions, and reducing complications associated with drug-eluting stenting, will be primary drivers behind the market growth, it says in the report. Downstream cost-saving measures are also expected to contribute, along with an increasing prevalence in coronary artery disease and peripheral arterial disease.
Priya Madhavan, GlobalData’s analyst covering cardiovascular devices, says: “The drug-eluting balloon market is a dynamic one, where the technology has the potential to be an alternative therapy option for patients suffering from coronary artery disease and peripheral arterial disease. Drug-eluting balloons can be utilised for select coronary and peripheral indications, including for patients who are not eligible for drug-eluting stents, and we expect this to expand the market over the coming years by targeting challenging patient populations.”
Despite the anticipated level of drug-eluting balloons market growth by 2019, GlobalData also expects a number of barriers to prevent any further increase in revenue.
These include a lack of clinical data and numerous reimbursement issues. The fact that drug-eluting balloons are not reimbursed in the public healthcare system in countries such as France, Brazil and India means that adoption of the technology among these countries is slow. The high-selling price and regulatory challenges surrounding drug-eluting balloons are also proving a hindrance to their take-up, according to the report.
Madhavan continues: “Physicians and regulatory authorities want to see long-term clinical data that demonstrate the superiority of drug-eluting balloon angioplasty when compared with stenting.
“Comparative studies looking at the efficacy of different drug-eluting balloon products are essential for developing therapies that improve patient outcomes, and robust clinical data will assist drug-eluting balloons in receiving approval from the US Food and Drug Association (FDA) and Japanese Pharmaceuticals Medical Devices Agency (PMDA) in order to launch in these markets.”