MARKET ANALYSIS

The U.S. market for interventional cardiology devices is driven by the population at risk of developing angina or suffering from myocardial infarction, which encompasses men over 45 or women over 55 years of age. The U.S. population surpassed the 300 million mark in 2006, and almost 30%—or 90 million people—are in this high-risk age group.

According to the American Heart Association, more than 13 million people suffer from coronary heart disease, 6 million from angina, and 7 million from myocardial infarction. Men are more likely to have myocardial infarctions, whereas women are more prone to develop angina. In the United States, coronary heart disease is responsible for one in every five deaths, and there are more than 1 million coronary attacks each year. With such a large population at risk of developing coronary heart disease, interventional cardiology products accounts for one of the largest markets in the medical device industry.

This article provides an overview of general trends and forecast information about the U.S. market for interventional cardiology devices. Based on research conducted by iData Research Inc. (Vancouver, BC, Canada), the information presented here is a starting point for executives seeking to learn more about the development and economic opportunities in this major industry segment.¹

Segment Breakdown

In 2006, the U.S. market for interventional cardiology devices was valued at almost $5 billion, experiencing a small increase over 2005. Despite decreasing market share, drug-eluting stents still represented the largest segment of the market, followed by coronary closure devices, percutaneous transluminal coronary angioplasty (PTCA) balloons, bare-metal stents, embolic protection devices, interventional guidewires, diagnostic catheters, intravascular ultrasound (IVUS) catheters, and interventional catheters (see Figure 1).

From 2006 to 2013, the U.S. market for interventional cardiology is expected to increase at a compound annual growth rate (CAGR) of 2.8%, driven by sales of drug-eluting stents, which are expected to overcome concerns about late-stent thrombosis and the results of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial. The following sections provide a segment-by-segment discussion of the current and projected markets for interventional cardiology products.

Bare-Metal and Drug-Eluting Stents. In 2006, the U.S. market for coronary stents suffered a decline resulting from a retrenchment in the use of drug-eluting devices. Today, the market for drug-eluting stents continues to be constrained.

One reason for the falloff in the market for drug-eluting stents is concern over evidence suggesting a heightened incidence of late-stent thrombosis related to the devices.

Another reason is the results of the COURAGE study, which asserted that drug management can be as efficient as stenting in certain cases.² With the publication of the COURAGE results, in early 2007, referring cardiologists began to avoid sending patients to the catheterization lab, causing a decrease in the number of percutaneous coronary intervention (PCI) procedures performed in the United States.

Conducted by the cooperative studies program of the U.S. Department of Veterans Affairs (VA) and the Canadian Institutes of Health Research, the COURAGE study involved 15 VA medical centers and 35 other medical centers in the United States and Canada. However, the study was conducted under very restricted circumstances, and the patients selected for participation fit a very specific profile that does not represent the whole universe of patients. In addition, the study compared drug management with bare-metal stenting, and not with the use of drug-eluting stents. For these reasons, the results of the COURAGE study cannot be generalized to the whole patient population.

Also limiting application of the COURAGE results is the fact that most patients tend to fail medical management, making it unlikely that drug treatment can be considered a replacement for angioplasty. Consequently, in spite of the current drop in PCI procedure volume, PCI stenting procedures are expected to continue to be the gold standard for the treatment of patients suffering from acute angina.

In 2008, the U.S. market for drug-eluting stents is expected to resume growth. Demographics will play a positive role in the market, as baby boomers reach the high-risk age for cardiovascular disease. From 2006, the U.S. population is expected to increase at a CAGR of approximately 1%; but in the same period, the age group most likely to undergo a cardiac intervention is expected to increase at a CAGR of 4%. Naturally enough, during this forecast period, PCI procedure volume is expected to grow.

Other developments, such as the emergence of new competitors and the introduction of stents using biodegradable polymers, are also expected to make a significant impact on this market. The arrival of new stent platforms is expected to dissipate current concern over late-stent thrombosis, while increasing use of IVUS catheters will improve PCI procedure outcomes by avoiding stent misplacement.

PTCA and Cutting Balloons. In 2006, the U.S. market for PTCA and cutting balloon catheters experienced an increase of 1.4% over 2005, to a total of approximately $400 million. The conventional PTCA balloon segment accounts for 85% of the market and is expected to increase further during the forecast period.

PTCA balloons are used for stenting and preimposed dilation. The use of direct stent placement procedures, which do not require the use of balloon catheters, has limited the unit growth of this segment. This trend has stabilized, however, and the number of PTCA balloons per procedure is not expected to decline further, remaining essentially flat.

In the future, growth in the number of procedures will be the main driver of this market, as prices are expected to decrease.

IVUS Catheters. The market for intravascular ultrasound catheters is one of the fastest-growing segments in the U.S. market for interventional cardiology.

Penetration rate is an important tool for gauging the growth of a particular market, as it compares interventions performed with the device to the total number of procedures. Sales of IVUS catheters are being driven by an increase in penetration rates, as technological innovations are simplifying use of the devices. In addition, concerns over stent thrombosis are helping to foster further growth.

In 2006, the market for IVUS catheters increased at a staggering rate of 22% over the previous year (see Figure 2). From 2006, the U.S. market for IVUS catheters is expected to increase at a CAGR of 18.8%.

Even though the U.S. penetration rate for IVUS catheters is expected to more than double by 2013, it is still considered a small increase when compared with penetration rates in Japan.

Interventional Catheters. The U.S. market for interventional coronary catheters remained relatively stagnant in 2006, increasing at a rate of 1% over 2005. The market for guiding catheters represented the largest segment, at $70.6 million, whereas the market for support catheters was valued at $8 million.

From 2006 through 2013, the market for guiding catheters is expected to maintain its top-of-segment position, with a small gain in market share. Meanwhile, it is expected that the market for support catheters will be surpassed by the emergence of markets for more-specialized devices.

Interventional Guidewires. In 2006, the U.S. market for interventional coronary guidewires experienced an increase of 4.1% over 2005, for a total of almost $120 million.

Sales of conventional guidewires form the largest portion of this market, representing 83% of total revenues, with specialty devices accounting for the rest. This makeup is expected to change, however, as specialty guidewires become better understood and utilized by surgeons. Specialty guidewires are currently considered the most-efficient devices for chronic total occlusion (CTO) crossings, and are expected to boost confidence in the treatment of difficult lesions.

Balloon-Inflation Syringes and Angioplasty Kits. From 2006, the U.S. market for balloon-inflation syringes is projected to increase at a CAGR of 5.8%, rising to a total of $32.9 million. This above-average growth rate is due to the adoption and higher average selling price for digital syringes in the market.

Angioplasty kits, which contain a manifold, a pressure transducer, and a fluid administration set, are used in every angioplasty procedure. Increasing competition and the commoditization of the market are expected to force price erosion in this segment.

Embolic Protection Devices. In terms of penetration rates, embolic protection devices are currently used in almost 4% of all conventional angioplasty procedures. This rate is expected to undergo a slight increase during the forecast period.

Despite increasing penetration of embolic protection devices in both saphenous vein graft and conventional procedures, because of falling prices, the value of the market for embolic protection devices is expected to grow at a CAGR of only 2.8% during the forecast period.

Atherectomy Devices. The coronary market for atherectomy devices is limited by the efficiency of drug-eluting stents, which are usually placed directly in the lesion without plaque debulking. This clinical practice is expected to persist during the forecast period, meaning that the coronary atherectomy market will continue to be a niche segment.

From 2006 to 2013, the U.S. market for coronary atherectomy devices is forecast to experience low single-digit growth rates.

Brachytherapy Catheters. The advent of drug-eluting stents has negatively affected the market for coronary brachytherapy. In 2006, the penetration rate of brachytherapy catheters in angioplasty procedures was 1%. However, this rate is expected to increase by the end of the forecast period, as the advantages of the technology for the treatment of longer lesions are recognized.

Chronic Total Occlusion Crossers. In 2006, the U.S. market for coronary chronic total occlusion (CTO) crossers was barely existent. Acquisitions have affected the shape of the market, as the two companies providing coronary CTO devices were bought by larger players.

Using the number of diagnostic procedures as a reference, specialized CTO devices could be used in up to 75% of the cases in which guidewires have failed.

Thrombectomy Devices. Thrombosis has received great attention from the clinical and scientific community because of concerns associated with drug-eluting stents. With conferences, journals, and the media focusing on the issue, cardiologists are more likely to increase screening for the condition.

In 2006, the U.S. market for coronary thrombectomy devices increased at a rate of 14% over 2005. Physicians' awareness and increasing familiarity with the procedure are the main driving forces of this market. From 2006 to 2013, the U.S. market for coronary thrombectomy devices is estimated to grow at a CAGR of 6.4%, to a total value of $67.7 million.

Introducer Sheaths: Coronary and Peripheral Markets. In 2006, the U.S. market for introducer sheaths, comprising both coronary and peripheral segments, experienced an increase of 5.7% over 2005. The peripheral market is growing at a higher rate than the coronary market.

From 2006, the market for introducer sheaths is forecast to increase at a CAGR of 5.8%. The market for introducer sheaths is limited by the physician's option to use a guiding catheter directly, particularly in the coronary segment, where guiding catheters are widely deployed.

Vascular Closure Devices. The U.S. market for coronary vascular closure devices grew at a rate of 5.3% in 2006. Closure devices are widely used in coronary applications, with high penetration rates among cardiologists.

The penetration rate of closure devices in interventional procedures is lower than in diagnostic procedures, because patients stay in the hospital overnight following interventional procedures, allowing time for manual compression. However, there is a trend toward the use of closure devices during angioplasties, making the interventional market more likely to experience higher growth rates.

Diagnostic Coronary Catheters and Guidewires. In 2006, the U.S. market for diagnostic coronary catheters and guidewires increased at a rate of 6.4% over 2005. Sales of catheters represented 80% of the total market, while guidewires accounted for the rest.

As the number of catheters per procedure decreases during the forecast period, however, the market for guidewires is expected to grow at a higher rate than the market for catheters. In addition, the growth rate of conventional diagnostic procedures is expected to decline, as such technologies as computed tomography and magnetic resonance imaging are becoming increasingly efficient for diagnosing cardiovascular disease.

Competitive Analysis

In 2006, Boston Scientific was the leading competitor in the U.S. market for interventional cardiology (see Figure 3). The company is the major player in the markets for drug-eluting stents, PTCA balloons, IVUS catheters, embolic protection devices, atherectomy devices, and angioplasty kits.

Boston Scientific's archrival in the drug-eluting stent market, Cordis Corp., a Johnson & Johnson company, was the second-leading competitor in the market. Cordis led the markets for interventional and diagnostic catheters, and coronary introducer sheaths.

In 2006, Boston Scientific and Abbott acquired Guidant, a former competitor, after a lengthy bidding war with Cordis. Guidant's cardiac rhythm management and electrophysiology units stayed with Boston Scientific, while Abbott purchased the interventional cardiology division. As a consequence of this acquisition, Abbott has become the third-leading provider of interventional cardiology devices in the United States and is poised to participate in the lucrative drug-eluting stent market.

The Way Ahead: Potential Markets

Because of the recent disturbances in the market for drug-eluting stents, companies are looking into new applications for interventional cardiology devices. Among the potential markets that are emerging, the most advanced segment comprises devices for the combined treatment of patent foramen ovale, atrial septal defect, and ventricular septal defect. A number of companies have already entered the market with products cleared under an FDA humanitarian device exemption.

A second promising segment is the market for percutaneous mitral valve repair (PMVR). Patients requiring PMVR tend to avoid open surgery and are more likely to undergo an interventional procedure.

The most promising field of all is the market for vulnerable plaque. Vulnerable plaque is currently regarded as the most important factor in the explanation of sudden cardiac arrests, and the condition may be responsible for more than 70% of all myocardial infarctions.

The development of products for these emerging market segments will undoubtedly help to shape the overall U.S. interventional cardiology market. With reasonable success, adoption of new products in these three areas may result in significant growth as they become incorporated into the mainstream market (see Figure 4).

References

1. U.S. Market for Interventional Cardiology Devices (Vancouver: iData Research Inc., 2007).

2. WE Boden, RA O'Rourke, KK Teo, et al., "Optimal Medical Therapy with or without PCI for Stable Coronary Disease," New England Journal of Medicine 356, no. 15 (12 April 2007): 1503-1516; available from Internet: http://content.nejm.org/cgi/content/abstract/356/15/150.

Kamran Zamanian, PhD, is a partner and research manager at iData Research Inc. (Vancouver, BC, Canada), an international market research and consulting group. Milton Tosto Jr., PhD, was previously a research analyst at iData Research. Tosto has disclosed that he holds securities and short positions in some companies mentioned herein.

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