Coronary Stents - Global Analysis and Market Forecasts, New Report Launched

Coronary Stent Sales by Region

Coronary stents can be used for a wide range of indications in coronary artery disease (CAD), including de novo lesions, small-vessel disease (SVD), bifurcation lesions, and tortuous and narrow lesions. Coronary stents can improve the clinical outcomes for all of these indications as well as quality of life for patients suffering from this debilitating disease.

In 2013, sales of DES and BMS in the 10MM were $4.89 billion. Publisher estimates the 2014 sales of DES and BMS in the 10MM to be $4.99 billion. By 2020, sales of coronary stents, including bare metal and drug-eluting stents, will grow to $5.62 billion, at a Compound Annual Growth Rate (CAGR) of 2.0%. To date, BAS have not received regulatory approval and been launched in the US, Japanese, and Chinese markets, but are expected to enter these markets in the near future.

Of the 10MM covered in the report, the US currently has and will continue to have the largest share in the coronary stents market. Together, the US, the 5EU countries, and Japan will account for 64% of the coronary stents market for BMS and DES in 2020. Collectively, the 5EU countries are forecast to have only 10% market share in the future. Among the emerging markets, China has captured significant market share, which is expected to increase in the future. The emerging markets, including Brazil, China, and India, are expected to demonstrate the greatest growth in the market over the forecast period and will serve as an outlet of expansion for stent manufacturers to increase their global presence.

The key drivers for the coronary stents market during the forecast period are:

• The rising prevalence of CAD in the major markets covered in this report
• The need for effective therapies that reduce the risk of complications, such as restenosis (re-narrowing of the coronary artery), chronic inflammation, and thrombosis, and the need for target lesion revascularization (TLR) associated with bare metal and drug-eluting stenting
• The cost savings for healthcare payers resulting from the reduced need for repeat revascularization procedures and prolonged dual antiplatelet therapy
• Reducing the need for stent-in-stent procedures and improving the technical feasibility of future interventions
• Innovations in stent technology with regard to the platform, material, and coating
• The increase in patients’ disposable income and government insurance coverage in the emerging markets, such as China and India
• The approval and launch of BAS, such as the Absorb BVS, in the US, Japan, and China

Market Dynamics

Stenting for coronary applications has been widely adopted in clinical practice and is associated with improved outcomes. BMS and DES are effectively commodities, where the physician has a handful of stents from which to choose. Within the coronary stents market, DES currently dominate the market and will continue to do so throughout the forecast period, as they are considered the gold standard of treatment. The DES market is a vast and double-digit market, accounting for nearly 90% of the total coronary stent market. In fact, DES sales for coronary applications are nearly eight times those of BMS market sales.

Given this large market potential and the rising prevalence of CAD worldwide, device manufacturers have focused primarily on the research and development (R&D) and commercialization of innovative DES systems. The larger market sales of DES can be attributed to physicians’ extensive clinical experience and expertise in using these stents, improved outcomes, and the reduced need for repeat intervention. BMS are used in cases where the patient is not a good candidate to receive a DES, such as those planning to undergo other major surgeries in the near future.

Covered stents (CS) are used less often in practice and only in select cases, such as patients with artery perforations. BAS have only recently entered the market and are not widely adopted in clinical practice, due to the lack of clinical evidence and the high cost of these devices.

Technological Trends

Over the years, a plethora of BMS and DES have been developed, featuring innovative materials, designs, structures, coatings, and drug-elution components. The development and optimization of DES has become a primary focus for many stent manufacturers, where they utilize the BMS they have developed as the platform and foundation for their DES. These innovations in technology aim to ensure high radial strength and flexibility, low elastic recoil, optimal vessel coverage, minimal foreshortening, and rapid strut endothelialization.

Although stent technology has evolved over the years, several types of complications remain, such as late thrombosis and restenosis, negative vessel remodeling, delayed endotholelialization and healing, lack of homogenous drug distribution, and the need for prolonged dual antiplatelet therapy. Therefore, low-profile drug-delivery systems need to be developed to reduce the risk of restenosis and thrombosis, and improve long-term patency. Effective therapies also need to be developed to treat complex lesions and challenging patient populations, such as chronic total occlusions (CTOs), long lesions, acute myocardial infarction (AMI) (heart attack), and diabetes mellitus.

Emerging stent technologies in the coronary stent market, including BAS and the third generation of DES with biodegradable polymer/polymer-free coatings, aim to address these unmet needs. However, these emerging technologies have only recently entered the market and will encounter strong competition from the contemporary stents. The third generation of DES has been developed to eliminate concerns associated with the permanent polymer coating, which is a cause of late and very late stent thrombosis. Drug-eluting BAS represent the fourth generation of DES in the evolution of DES technology. Given that the stent scaffold degrades over a period of time, BAS offer several benefits, including a reduced risk of restenosis, avoiding the implantation of multiple layers of metal inside the vessel, improving the feasibility of future interventions, and enabling for late lumen gain.

Key Players in the Global Coronary Stents Market

The coronary stents market is a vast and dynamic market that is saturated with numerous players worldwide. The competitive landscape consists of large, mid-size, and small companies that have developed different types of coronary stents to target various indications, such as de novo lesions and bifurcation lesions. The coronary stents market is largely dominated by a few key players, including Abbott Vascular, Medtronic, and Boston Scientific, followed by Biosensors International and Terumo Corporation.

Companies such as B. Braun, Sahajanand Medical Technologies, MicroPort Scientific Corporation, and Balton are potential competitors to these large corporations, as they develop innovative coronary stent platforms. As the next generation of DES and BAS enter the market, the current key players will need to retain and acquire market share by improving the clinical performance of their existing products. In addition, they will need to expand into or increase their presence in the emerging markets in order to take revenue away from their competitors in the future.

The top players in the coronary stent market offer a broad product portfolio with regard to the type of stent and the number of products within each stent category. Within this market, stent manufacturers can customize the type of stent they develop for specific types of lesions in the coronary vasculature.

Future Outlook

Each year, millions of individuals worldwide are affected by CAD. Given the high burden of the disease, it is important to develop innovative technologies that can improve outcomes and disease management. Currently, DES are widely adopted in clinical practice, given the clinical evidence, improved outcomes, and physician experience with using these devices. In the US and 5EU, the coronary stents market value is expected to decline slowly in the future, given the decline in the average selling price (ASP) and number of BMS and DES used per procedure. As medical costs continue to rise, healthcare providers are implementing cost-containment policies and “appropriateness criteria” to reduce costs and overstenting.

Unlike in the west, the coronary stents market in the APAC and South American regions is expected to increase and demonstrate steady growth in the future. The APAC countries, including Japan, China, and India, have diverse populations, ethnicities, and clinical practices. Most device manufacturers regard Japan and China as their chief targets, due to their economic growth, pricing structure, and vast populations. In particular, China, with its high proportion of aging individuals and procedure volume, is expected to become a prime market for coronary stents.

Many stent manufacturers have ventured into the R&D of BAS, which is a high-growth market segment. However, BAS technology is in the early stages, where robust, long-term clinical evidence of its therapeutic benefits needs to be shown. Currently, the adoption of BAS in the clinical setting is low, which is attributable to the lack of clinical data and appropriate reimbursement, as well as the high cost of these devices. In real-world practice, the majority of patients with CAD are treated with DES, and this will continue in the future. In addition, the development and commercialization of the next generation of DES with bioresorbable polymer coatings, polymer-free coatings, and innovative platforms indicates the continued value of DES in the coronary market.

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