The Bare Metal Stents Market is projected to grow at a CAGR of 3.8% from 2024 to 2031. The market value is expected to rise from USD XX million in 2024 to USD YY million by 2031.
North America currently dominates the market, accounting for the largest share of global revenue. Key metrics include the number of coronary and peripheral artery disease cases, stent implantation procedures, and regulatory approvals for new stent designs.
The rising prevalence of cardiovascular diseases, technological advancements in stent design, and the cost-effectiveness of bare metal stents in certain patient groups are all contributing to the market's continued growth. However, the business is facing difficulties from the increasing use of drug-eluting stents and bioresorbable vascular scaffolds.
Market Trend: Increasing focus on thin-strut bare metal stents
The development and use of thin-strut bare metal stents is a major market trend. These innovative designs are intended to reduce the risk of restenosis while enhancing overall patient outcomes. Thin-strut stents provide more flexibility, deliverability, and the potential for lower rates of in-stent restenosis than thicker stents.
Recent study has shown that thin-strut bare metal stents can have similar safety and efficacy profiles to some first-generation drug-eluting stents, particularly in patients with a high risk of bleeding disorders. This result has reignited interest in bare metal stents among interventional cardiologists, particularly in specific patient populations.
Market Driver: Rising prevalence of cardiovascular diseases globally
The increasing global prevalence of cardiovascular illnesses, particularly coronary artery disease and peripheral artery disease, is a major driver of the bare metal stents market. According to the World Health Organisation, cardiovascular disease is the leading cause of death globally, killing an estimated 17.9 million people each year.
According to the Centres for Disease Control and Prevention, heart disease kills over 655,000 Americans each year, accounting for one out of every four deaths. This high prevalence results in a rising number of percutaneous coronary interventions (PCIs) performed each year. While drug-eluting stents have grown in popularity, bare metal stents continue to be useful in specific patient populations and therapeutic contexts.
Bare metal stents are less expensive than drug-eluting stents, especially in developing countries with limited funds, hence they are increasingly being used in healthcare systems around the world.
Market Restraint: Competition from drug-eluting stents and newer technologies
Drug-eluting stents and future technologies, such as bioresorbable vascular scaffolds, present a significant challenge to the bare metal stent market. Drug-eluting stents have shown better success in terms of reducing restenosis rates and the need for additional revascularisation procedures.
Many countries' clinical recommendations now propose drug-eluting stents as the first choice for the majority of patients undergoing PCI, with bare metal stents utilised only in specific circumstances. For example, the European Society of Cardiology guidelines advocate bare metal stents for patients who are at high risk of bleeding or are unable to adhere to long-term dual antiplatelet therapy.
This shift in preference has led in a decline in the market share of bare metal stents, with some estimates claiming that they currently account for less than 20% of all coronary stents used in developed countries.
Coronary Artery Disease segment dominates the Bare Metal Stents market:
The Coronary Artery Disease category presently commands the largest market share in the Bare Metal Stents business. This dominance stems primarily from the high global prevalence of coronary artery disease and the lengthy history of percutaneous coronary intervention (PCI) as a standard treatment option.
Coronary artery disease is a leading cause of death and morbidity worldwide. According to the American Heart Association, coronary heart disease caused about 13% of all deaths in the United States in 2018, killing approximately 365,744. This high disease burden necessitates a large number of PCI procedures each year, many of which entail stent implantation.
While drug-eluting stents are the preferred option for many patients, bare metal stents nevertheless play an important role in several therapeutic situations. Patients who cannot tolerate long-term dual antiplatelet therapy, such as those at high risk of bleeding or those who require emergency non-cardiac surgery, may be better candidates for bare metal stents.
Recent advances in bare metal stent design have assisted its continued use in coronary operations. For example, the development of cobalt-chromium alloys has allowed for the production of thinner strut stents, potentially minimising the risk of restenosis while maintaining the mechanical strength required for vascular support.
A study published in the Journal of the American College of Cardiology found that newer-generation thin-strut bare metal stents were non-inferior to first-generation drug-eluting stents in terms of target arterial failure at one year in patients with acute coronary syndrome. This finding suggests that advanced bare metal stents may have a renewed role in certain patient populations.
North America leads the Bare Metal Stents market:
North America now dominates the global bare metal stent market, accounting for the vast majority of sales. This top ranking is attributable to a variety of factors, including a high prevalence of cardiovascular diseases, a well-established healthcare system, and significant healthcare spending.
The region's dominance is due in part to the presence of significant medical device manufacturers and a strong regulatory environment that fosters medical technology innovation. The United States Food and Drug Administration (FDA) has played an important role in reviewing and approving novel stent designs, ensuring that patients have access to safe and effective devices.
Recent developments in the North American market include the ongoing testing of thin-strut bare metal stents for specific patient populations. For example, a multicenter research done across several US institutions reported that a unique thin-strut bare metal stent exhibited positive results in patients with a high bleeding risk, potentially expanding the indications for bare metal stents in modern practice.
The region has also seen a shift towards cost-effective healthcare services. As healthcare expenses rise, there is growing interest in comparing the correct use of bare metal and drug-eluting stents. According to a study published in the American Heart Journal, using bare metal stents in low-risk patients may result in significant cost savings while maintaining clinical outcomes.
In Canada, the Canadian Cardiovascular Society's antiplatelet therapy recommendations for coronary artery disease allow the use of bare metal stents in some clinical circumstances, notably for patients who cannot tolerate long-term dual antiplatelet treatment. This validation in clinical guidelines helps to sustain demand for bare metal stents in the region.
The Bare Metal Stents market is dominated by a few well-known medical device companies, with competition focussing on technological advancements, clinical performance, and pricing strategies. Key market participants are investing in R&D to develop stent designs and expand their product portfolio.
Medtronic plc, Abbott Laboratories, Boston Scientific Corporation, and Biosensors International Group, Ltd. are among the industry's leading companies. These companies have established themselves as market leaders by combining innovative products, strong distribution networks, and strategic partnerships with healthcare providers.
Medtronic, for example, has maintained a dominant market position with the Integrity Bare Metal Coronary Stent System. The company has focused on developing thin-strut designs to improve deliverability while lowering the risk of restenosis. Medtronic's coronary and peripheral vascular sector, which includes stents, generated $2.354 billion in revenue in fiscal year 2021, indicating a large market for these devices.
Abbott Laboratories has also been a key player in the bare metal stent business, with its MULTI-LINK stent series. The company applied its materials science expertise to develop cobalt-chromium alloy stents with improved radial strength and fluoroscopic visibility. Abbott's vascular division, which includes stents and related treatments, generated $2.892 billion in 2020.
Boston Scientific Corporation has maintained its market leadership by continuously developing in stent technology. The company's Rebel Platinum Chromium Coronary Stent System was designed to improve deliverability and conformability. Boston Scientific's interventional cardiology division, which includes coronary stents, had a net sales of $2.208 billion in 2020.
In recent years, the medical device industry has seen a trend of consolidation, which has impacted the bare metal stent market. For example, Becton, Dickinson, and Company (BD) expanded its foothold in the vascular care industry, including stents, with the $24 billion acquisition of C. R. Bard in 2017.
Looking ahead, the competitive landscape is expected to be characterised by ongoing clinical trials that compare the performance of newer-generation bare metal stents to drug-eluting stents in certain patient populations. Companies who can demonstrate superior clinical outcomes or cost-effectiveness may gain a competitive advantage in this evolving industry.
The bare metal stent market is at a crossroads, with both challenges and opportunities in the evolving landscape of interventional cardiology. While the increasing use of drug-eluting stents has had an influence on the market, several factors suggest that bare metal stents will continue to play a role in specific clinical scenarios.
One of the most promising innovations is the development of ultra-thin structural bare metal stents. These newer designs aim to address the primary limitation of traditional bare metal stents, notably the risk of restenosis, while maintaining their benefits in terms of shorter dual antiplatelet medication duration and lower cost. Early clinical data for these devices has been promising, and their efficacy in real-world circumstances will be critical in determining the market's future path.
Another trend to watch is the increased emphasis on customised medicine in cardiology. As our understanding of the specific patient variables that influence stent results improves, we may see a more nuanced approach to stent selection. This could carve out specific niches in which bare metal stents offer great benefit-risk profiles, such as in patients with a high risk of bleeding or those who are unable to adhere to long-term antiplatelet therapy.
The economics of healthcare delivery will also be essential in shaping the market. In many healthcare systems, particularly in emerging economies, bare metal stents remain more cost-effective than drug-eluting stents. As these markets improve their cardiovascular care skills, there may be room for more bare metal stent adoption.
However, the market faces challenges, particularly due to changing clinical guidelines and physician preferences. Long-term outcomes for patients treated with newer-generation drug-eluting stents have been excellent, raising the bar for bare metal stents to compete. Companies in this industry will need to invest in robust clinical data to justify the use of their products in certain patient populations.
Overall, while the market for bare metal stents is unlikely to reclaim its former dominance, it is predicted to maintain a consistent niche in coronary and peripheral operations. Success in this market will be decided by further stent design innovation, strategic positioning for specific patient subgroups, and the ability to demonstrate value in an increasingly cost-conscious healthcare system.
Medtronic plc
Abbott Laboratories
Boston Scientific Corporation
Biosensors International Group, Ltd.
Terumo Corporation
B. Braun Melsungen AG
Biotronik SE & Co. KG
Stentys SA
Hexacath
MicroPort Scientific Corporation
March 2023: Boston Scientific Corporation received FDA approval for its AGENT Drug-Coated Balloon, which is designed to treat coronary in-stent restenosis, including restenosis in bare metal stents.
In November 2022, Medtronic announced the results of the Onyx ONE Clear Study, which demonstrated the safety and efficacy of its Resolute Onyx Drug-Eluting Stent in high bleeding risk patients receiving one month of dual antiplatelet therapy, potentially influencing the use of bare metal stents in this population.
1. INTRODUCTION
1.1. Market Definitions & Study Assumptions
1.2. Market Research Scope & Segment
1.3. Research Methodology
2. EXECUTIVE SUMMARY
2.1. Market Overview & Insights
2.2. Segment Outlook
2.3. Region Outlook
3. COMPETITIVE INTELLIGENCE
3.1. Companies Financial Position
3.2. Company Benchmarking -- Key Players
3.3. Market Share Analysis -- Key Companies
3.4. Recent Companies Key Activities
3.5. Pricing Analysis
3.6. SWOT Analysis
4. COMPANY PROFILES (Key Companies list by Country) (Premium)
5. COMPANY PROFILES
5.1. Medtronic plc
5.2. Abbott Laboratories
5.3. Boston Scientific Corporation
5.4. Biosensors International Group, Ltd.
5.5. Terumo Corporation
5.6. B. Braun Melsungen AG
5.7. Biotronik SE & Co. KG
5.8. Stentys SA
5.9. Hexacath
5.10. MicroPort Scientific Corporation (*LIST NOT EXHAUSTIVE)
6. MARKET DYNAMICS
6.1. Market Trends
6.1.1. Increasing focus on thin-strut bare metal stents
6.1.2. Growing interest in personalized medicine in cardiology
6.1.3. Economic considerations driving stent selection in emerging markets
6.2. Market Drivers
6.2.1. Rising prevalence of cardiovascular diseases globally
6.2.2. Cost-effectiveness compared to drug-eluting stents
6.2.3. Technological advancements in stent design
6.3. Market Restraints
6.3.1. Competition from drug-eluting stents and newer technologies
6.3.2. Changing clinical guidelines favoring drug-eluting stents
6.4. Market Opportunities
6.5. Porter's Five Forces Analysis
6.5.1. Threat of New Entrants
6.5.2. Bargaining Power of Buyers/Consumers
6.5.3. Bargaining Power of Suppliers
6.5.4. Threat of Substitute Products
6.5.5. Intensity of Competitive Rivalry
6.6. Supply Chain Analysis
6.7. Value Chain Analysis
6.8. Trade Analysis
6.9. Pricing Analysis
6.10. Regulatory Analysis
6.11. Patent Analysis
6.12. SWOT Analysis
6.13. PESTLE Analysis
7. BY MATERIAL (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
7.1. Stainless Steel
7.2. Cobalt Chromium
7.3. Others
8. BY APPLICATION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
8.1. Coronary Artery Disease
8.2. Peripheral Artery Disease
9. BY END USER (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
9.1. Hospitals
9.2. Ambulatory Surgical Centers
9.3. Cardiac Catheterization Laboratories
10. REGION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
10.1. North America
10.1.1. United States
10.1.2. Canada
10.1.3. Mexico
10.2. South America
10.2.1. Brazil
10.2.2. Argentina
10.2.3. Rest of South America
10.3. Europe
10.3.1. Germany
10.3.2. United Kingdom
10.3.3. France
10.3.4. Italy
10.3.5. Spain
10.3.6. Russia
10.3.7. Rest of Europe
10.4. Asia-Pacific
10.4.1. China
10.4.2. Japan
10.4.3. India
10.4.4. Australia
10.4.5. South Korea
10.4.6. Rest of Asia-Pacific
10.5. Middle-East
10.5.1. UAE
10.5.2. Saudi Arabia
10.5.3. Turkey
10.5.4. Rest of Middle East
10.6. Africa
10.6.1. South Africa
10.6.2. Egypt
10.6.3. Rest of Africa
*NOTE: All the regions mentioned in the scope will be provided with (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
By Material:
Stainless Steel
Cobalt Chromium
Others
By Application:
Coronary Artery Disease
Peripheral Artery Disease
By End User:
Hospitals
Ambulatory Surgical Centers
Cardiac Catheterization Laboratories
By Region:
North America
Europe
Asia-Pacific
Latin America
Middle East & Africa
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