European Markets for Interventional Cardiology Devices 2011

Introduction:

The European interventional cardiology (IC) device market consists of devices used in the minimally invasive treatment and diagnosis of coronary artery disease (CAD). In 2010, revenues were generated from sales of coronary stents, percutaneous transluminal coronary angioplasty (PTCA) balloon catheters, accessory devices, intravascular imaging catheters, and pressure guidewires. The European IC market will remain relatively flat through 2015 because continued price erosion across all device types and regions—resulting from competitive pricing, high volume and bundling discounts, and deficits in reimbursement—will offset the rising number of CAD patients in Europe that continue to expand due to the aging population and increasing rates of diabetes and obesity. Slow growth in percutaneous coronary intervention (PCI) volumes will also restrict the market. High penetration of the eligible patient population, fewer repeat procedures being performed, and the use of alternative methods of treating CAD will all limit PCI volumes. The market will, however, be supported by recent and ongoing clinical trials that examine the efficacy of PCI in unique CAD patient groups, such as those with acute myocardial infarction (AMI) or diabetes. Improvements made to next-generation stents have also demonstrated superior clinical outcomes, which will support overall market growth. Furthermore, as drug-eluting stents (DES) become more affordable, rising DES penetration will offset the market decline due to the devices’ price premium over bare-metal stents (BMS). Overall, the European IC device market will remain stable through 2015.

Questions Answered in This Report:

• Ongoing clinical trials are examining the use of drug-coated balloons in the treatment of CAD. What niche roles will drug-coated balloons fill in the treatment of CAD? How will positive clinical trial data affect the penetration of drug-coated balloons?
• In 2010, the European Society of Cardiology (ESC) guidelines classified fractional flow reserve (FFR)-guided treatment as Class I, with level of evidence A. How many PCIs currently involve the use of FFR technology? What impact will the guideline changes have on the adoption of FFR guidewires? How will their adoption impact the coronary stent market?
• Diagnosis-related group (DRG) reimbursement systems in France, Germany, and Italy provide general reimbursement for IC procedures; the UK's National Institute for Health and Clinical Excellence (NICE) limits the premium that can be charged for DES. What reimbursement changes are happening in each country? How is legislation affecting the use and pricing of IC devices? How does this affect the competitive landscapes between countries?
• Having received CE marking in 2010, a second optical coherence tomography (OCT) catheter will be available on the European market in 2011. How will growing competition affect the OCT catheter market? How high is intravascular ultrasound penetration in Europe, and how will this be affected by the increased availability of OCT catheters?
• European physicians vary widely in their preference for either PTCA-with-stent or direct stenting methods of implanting coronary stents. In which countries is each method the most popular? How will evolving device capabilities affect physicians' preferences?

Scope:

Regions covered: France, Germany, Italy, UK

Procedure segmentation: Our analysis uses the following breakdown of procedures:

• IC procedures
• Angiography only
• Same-session
• PCI only
• PCIs
• PTCA-with-stent
• Direct stenting
• Plain old balloon angioplasty (POBA)
• Coronary stent procedures
• By type (PTCA-with-stent and direct stenting)
• By segment (DES and BMS)
• PTCA balloon catheter procedures
• PTCA-with-stent
• POBA
• Intravascular imaging catheter and pressure guidewire procedures
• IVUS procedures
• OCT procedures
• FFR procedures

Market segmentation: Our analysis uses the following breakdown of the market:

• Coronary stents
• DES
• BMS
• PTCA balloon catheters
• Normal balloons
• Cutting balloons
• Drug-coated balloons
• Accessory devices
• PTCA guidewires (workhorse and specialty)
• Diagnostic catheters
• PTCA guiding catheters
• Introducer sheaths
• Intravascular imaging catheters and pressure guidewires
• IVUS catheters
• FFR guidewires
• OCT catheters

Market forecast features: Based on primary research with industry professionals, we use our proprietary forecasting model to provide an in-depth examination of current and future trends in procedure volumes, unit sales, average selling prices, and market values over a 7-year period (2009–2015).

Competitive analysis: We provide a detailed analysis of the competitive landscape in the market, as well as market shares and qualitative discussions of the leading competitors in each market segment.