Cardiac Rhythm Management, Electrophysiology and Ablation Device MarketIn 2012, the U.S. market for cardiac rhythmmanagement (CRM), electrophysiology and ablationdevices market was valued at nearly $6.8 billion.The CRM, electrophysiology and ablation device market includespacemakers, cardiac resynchronization therapy (CRT) devices,implantable cardioverter defibrillators (ICDs), cardiac stimulationleads, external defibrillators, ablation catheters, diagnosticelectrophysiology (EP) catheters, intracardiac ultrasound (ICE)catheters, electrophysiology (EP) stimulators, diagnostic ECGand cardiac monitoring devices. Over the forecast period, theCRM, electrophysiology and ablation device market will bedriven by the aging population, rise in cardiac ablationprocedures and adoption of advanced CRM devices. However,the aftermath of the economic recession of 2008 and thesluggish U.S. economy that followed have continued to stiflemuch of the growth in the markets.
Chart 1-1: Cardiac Rhythm Management, Electrophysiology and Ablation Device Market, U.S., 2009 – 2019 Annual Growth Rate (%)Market Value (US$M) 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Year Source: iData Research Inc.
Pacemaker MarketBy 2019, dual chamber pacemakers are expected toaccount for 53.5% of the total pacemaker market.The market for pacemakers is segmented into single and dual chamber devices.Single chamber pacemakers only pace one chamber of the heart, typically theright ventricle. In contrast, dual chamber pacemakers sense and control thepacing of both the right atrium and the right ventricle. The added clinical benefitis believed to be well worth the higher initial cost of placing a dual chamberpacemaker; however, many patients have been opting for a less expensivesingle chamber pacemaker implant if offered a choice, due to costconsiderations. As the economy recovers, the growth rate over the forecastperiod for dual chamber devices will outpace that of single chamber devices.
Chart 1-2: Total Pacemaker Market by Segment, U.S., 2012 and 2019 Segment A Segment B 2019Year 2012 Market Value (US$M) Source: iData Research Inc.
Implantable Defibrillator MarketThe total implantable defibrillator market is expectedto grow over $4 billion by 2019.Implantable defibrillators include implantable cardioverter defibrillators (ICDs)and cardiac resynchronization therapy defibrillators (CRT-Ds). In 2011 a studyby the Journal of the American Medical Association suggested that a largenumber of physicians have not been following the evidence-based guideline forICD implementations. Following this study, the Department of Justice has beeninvestigating the issue, and this has been one of the main factors in shrinkage ofICD sales, with many physicians, surgeons and hospitals now on the defensive.This investigation into hospital’s ICD implant practices has disrupted thepurchasing pattern of the buyers, resulting in overall reductions of the amount ofimplantable defibrillator devices purchased; however, the market is expected torecover as the life-saving capabilities of ICDs and CRT-Ds have made them anecessity for patients who have survived an episode of SCA or who are at highrisk of suffering from one in the future.
Chart 1-3: Total Implantable DefibrillatorMarket by Segment, U.S., 2019 Segment A Segment B Source: iData Research Inc.
Cardiac Lead MarketIn 2012, number of pacing leads accounted for 70.7% of thetotal units sold as they are utilized in multiple cardiac rhythmmanagement devices.Cardiac leads include pacing, defibrillation and left ventricle (LV) leads.The type of lead implanted depends on the CRM device prescribed to apatient. Numerous clinical studies have shown that cardiacresynchronization therapy defibrillators (CRT-Ds) and implantablecardioverter defibrillators (ICDs) cause a significant reduction in deathand heart failure. As these devices become more popular, a greaternumber of cardiac leads, especially defibrillation leads, will be placed.Pacemakers are a much more cost-effective treatment option; howeverthe device can only treat certain types of arrhythmias. Pacing leads areplaced in all CRM devices, and the market will grow parallel to thenumber of CRM devices sold.
Chart 1-4: Percentage of Units Sold by Segment, Cardiac Leads Market, U.S., 2012 (US$M) Segment A Segment B Segment C Source: iData Research Inc.
External Defibrillator MarketThe exit of Medtronic from the market caused some disruption in thesales of external defibrillators. However, the market is expected togrow at a CAGR of 2.5% over the forecast period.The economic recession and slow recovery of the U.S. economy whichfollowed had a significant negative impact on the external defibrillator market.The public access segment for automated external defibrillators (AEDs) wasparticularly affected as businesses, educational institutions and governmentagencies delayed purchasing AEDs. External defibrillators are the primarymethod of restoring normal heart rhythm after sudden cardiac arrest (SCA) forpatients who do not have ICDs or CRT-Ds. Decreasing the length of timebetween an SCA event and defibrillation is crucial to improving a patient’schance of survival and to reducing the likelihood of serious complications. Asmany businesses are being held responsible for the safety of their patrons,there is increasing pressure to install AEDs in order to avoid liability. Thereforethere is an incentive to have automated external defibrillators on hand in asmany locations as possible.
Chart 1-5: External Defibrillator Market by Segment, U.S., 2012 (US$M) Segment A Segment B Annual Growth Rate (%) Market Value (US$M)Note: Bubble size represents number of units sold. Source: iData Research Inc.
Cardiac Ablation MarketIn 2012, over 85% of surgical procedures used RF ablation, howevercryoablation is expected to increase in popularity by 2019.Cardiac arrhythmias can be treated by catheter-based ablation withradiofrequency (RF) energy or with cryoablation. This procedure is used fortreating various types of arrhythmia, but atrial fibrillation (A-Fib) is consideredthe most promising target because the condition is relatively common anddoes not respond well to existing treatments. There has been much researchsurrounding the treatment of arrhythmia through cardiac ablation, and manyfirms in this space have been heavily investing in the R&D of new exploratorymethods. Recently, the market was boosted by the FDA approval ofcryoablation and balloon cryoablation for the treatment of atrial fibrillation.While cryoablation will still be used far less frequently than RF ablation, it isexpected that the number of cryoablation procedures performed will increasemuch faster than the number of RF procedures. Due to recent FDA approvalof the Arctic Front® Cardiac CryoAblation Catheter, Medtronic was able tocapture market share within the cryoablation segment and will be establishinga strong foothold against competitors due to its first mover advantage.
Chart 1-6: Procedure Volume Growth Rate by Segment, Cardiac Ablation Market, U.S., 2009 - 2019 Segment A Segment BAnnual Growth Rate (%) 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Year Source: iData Research Inc.
Diagnostic Electrophysiology Device MarketSteerable electrophysiology catheters are expected to represent nearly58% of the market for diagnostic electrophysiology catheters by 2019.The market for diagnostic electrophysiology (EP) devices includes EPstimulators, diagnostic EP catheters and intracardiac echocardiography(ICE) catheters. This market is expected to grow due to the increasing useof premium-priced catheters that have mapping or ultrasound capabilities,as well as the rising number of cardiac ablation procedures. Steerablecatheters have more maneuverability and can be used in conjunction withrobotic or magnetic steering. These catheters also represent a greaterproportion of the total diagnostic EP device market as compared with tofixed curve catheters. Over the forecast period, the decline of fixed curvecatheters is expected to stabilize due to their lower price and suitability forcertain EP and cardiac ablation procedures.
Chart 1-7: Total Diagnostic ElectrophysiologyDevice Market by Segment, U.S., 2019 Segment A Segment B Source: iData Research Inc.
Electrocardiograph and Cardiac Monitoring Device MarketThe total electrocardiograph (ECG) and cardiac monitoring devicemarket is expected to experience strong growth, led by both the office-based and hospital stress testing markets.Electrocardiograph (ECG) and cardiac monitoring devices are used fordiagnosing and monitoring arrhythmia. The market for cardiac monitoringdevices includes resting ECG devices, stress testing systems, Holter monitors,event monitoring and ECG data management systems (ECG DMS). Hospitalbudget constraints have caused delays in the purchase of capital equipment.Reimbursement cuts for diagnostic cardiac monitoring procedures such asstress testing, Holter and event monitoring have limited market growth. Themarkets for Holter monitoring and resting ECG devices are expected toexperience minimal increases as unit growth is offset by declining prices.
Chart 1-8: Segment A, Unit Growth Rate, Electrocardiographand Cardiac Monitoring Device Market, U.S., 2009 – 2019 2009 2019 2010 2018 2011 2017 2012 2016 2013 2015 2014 Source: iData Research Inc.
Competitive AnalysisIn 2012, Medtronic was the leading competitor in the U.S. market forcardiac rhythm management, electrophysiology and ablation devices.Medtronic dominated the pacemaker, implantable cardioverter defibrillator(ICD) and cardiac resynchronization therapy (CRT) market segments in2012. They also made considerable gains in the cardiac ablation market.Biosense Webster was the market leader in the cardiac ablation anddiagnostic electrophysiology markets. Philips Healthcare had a strongpresence in the external defibrillator market and nearly all segments of thecardiac monitoring market.Other competitors of note in the cardiac rhythm management,electrophysiology and ablation device market included BardElectrophysiology, Boston Scientific, Cardiac Science, GE Healthcare, St.Jude Medical, and Zoll Medical. In-depth competitive analysis by segmentcan be found in the main chapters of this report.
Chart 1-9: Leading Competitors, Cardiac Rhythm Management,Electrophysiology and Ablation Market, U.S., 2012 Others Medtronic Source: iData Research Inc.