Drug Eluting Stent Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Coating Type (Polymer-based Coatings (Non-biodegradable, Biodegradable)), Polymer-free Coatings(Micro porous Surface, Micro structured Surface, Slotted tubular Surface, Nanoporous Surface)), By Application (Coronary Artery Disease, Peripheral Artery Disease), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 8.37 Billion
CAGR (2026-2031)	8.19%
Fastest Growing Segment	Polymer-based Coatings
Largest Market	North America
Market Size (2031)	USD 13.42 Billion

Market Overview

The Global Drug Eluting Stent Market will grow from USD 8.37 Billion in 2025 to USD 13.42 Billion by 2031 at a 8.19% CAGR. A drug eluting stent is a metallic mesh scaffold coated with a pharmacological agent that is deployed within a narrowed coronary artery to maintain vessel patency and release medication that inhibits restenosis. The primary drivers supporting the growth of this market include the escalating global prevalence of coronary artery disease and an aging demographic that is increasingly susceptible to cardiovascular complications. Furthermore, the sustained clinical preference for minimally invasive percutaneous coronary interventions over traditional surgical bypass procedures continues to fuel the demand for these endovascular devices.

However, stringent regulatory approval processes present a significant challenge that could impede market expansion by increasing development costs and delaying the commercialization of new technologies. Manufacturers must navigate complex compliance frameworks that vary across regions, often limiting immediate access to advanced therapies in emerging markets. According to the European Society of Cardiology, in 2024, high income countries reported a percutaneous coronary intervention rate of 2,330 procedures per million people, underscoring the substantial procedural volume that fundamentally underpins the consumption of these medical devices despite regulatory hurdles.

Key Market Drivers

Technological advancements in bioabsorbable and polymer-free stents are fundamentally reshaping the Global Drug Eluting Stent Market by addressing long-term safety concerns associated with permanent metallic implants. Manufacturers are increasingly prioritizing the development of next-generation scaffolds that provide temporary mechanical support and drug delivery before completely dissolving, thereby reducing the risk of late-stage thrombosis and restoring natural vessel vasomotor function. This innovation trajectory is exemplified by recent regulatory milestones that expand treatment options for complex vascular conditions. According to Abbott, April 2024, in the 'Abbott's Breakthrough Dissolving Stent Receives FDA Approval for Arteries Below the Knee' press release, the U.S. FDA approved the Esprit BTK Everolimus Eluting Resorbable Scaffold System, a first-of-its-kind dissolving stent designed to treat chronic limb-threatening ischemia. Such breakthroughs highlight the industry's pivot toward devices that improve long-term clinical outcomes and minimize permanent foreign body presence in the vasculature.

The rising prevalence of coronary artery diseases serves as the primary demographic engine propelling market demand, necessitating a sustained increase in interventional procedures globally. As urbanization and lifestyle changes contribute to higher rates of atherosclerosis and myocardial infarction, healthcare systems are witnessing a surge in patient volumes requiring percutaneous coronary interventions. According to the American Heart Association, January 2024, in the '2024 Heart Disease and Stroke Statistics: A Report of US and Global Data', cardiovascular disease (CVD) accounted for approximately 19.91 million global deaths in 2021, reinforcing its status as the leading cause of mortality worldwide. This escalating disease burden directly translates into substantial commercial opportunities for medical device manufacturers who are scaling operations to meet the critical need for effective revascularization therapies. According to Medtronic, May 2024, in the 'Fiscal Year 2024 Financial Results', the company reported that its Cardiovascular Portfolio generated annual revenue of $11.83 billion, underscoring the massive economic scale of the sector driven by these persistent clinical needs.

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Key Market Challenges

Stringent regulatory approval processes constitute a substantial obstacle hampering the expansion of the Global Drug Eluting Stent Market. These rigorous compliance frameworks directly increase the financial burden of product development and significantly extend the timeline required to bring advanced stenting technologies to market. As manufacturers navigate complex and often inconsistent requirements across different international jurisdictions, the commercial launch of new devices is frequently postponed. This delay restricts patient access to improved therapies and stalls revenue generation for medical device companies, effectively creating a bottleneck that suppresses the overall market growth trajectory.

The impact of these regulatory delays is evident in recent industry performance data. According to MedTech Europe, in 2024, the average time-to-certification for medical devices under the new Medical Device Regulation (MDR) extended to between 13 and 18 months, which is double the duration historically required under previous directives. Such prolonged review periods force manufacturers to divert critical resources toward compliance administration rather than research and development, thereby slowing the innovation cycle and reducing the volume of new products entering the Global Drug Eluting Stent Market.

Key Market Trends

There is a strategic trend toward developing and labeling high-safety profile stents that allow for significantly shortened Dual Antiplatelet Therapy (DAPT) regimens to reduce bleeding risks in vulnerable populations. Manufacturers are prioritizing regulatory approvals for one-month DAPT indications to address the clinical dilemma of treating complex cases where prolonged anticoagulation poses a severe threat. This shift focuses on optimizing polymer biocompatibility and drug release kinetics to ensure rapid vessel healing, thereby permitting earlier discontinuation of antiplatelet medication. According to Terumo Europe, March 2025, in the 'Ultimaster Stents Gain MDR Approval for High-Bleeding Risk Patients' announcement, patients at high risk of bleeding constitute approximately 45% of all PCI patients, highlighting the critical market need for devices that ensure safety with abbreviated drug courses.

Manufacturers are also increasingly innovating stent architecture with ultra-thin struts to enhance flexibility and improve deliverability in tortuous anatomy. These platforms, often designed with strut thicknesses below 60 microns, facilitate faster endothelialization and vessel healing compared to thicker predecessors, effectively minimizing flow disturbances and inflammation. This engineering focus on advanced structural navigability is driving substantial commercial traction in global markets as clinicians seek devices that can reach challenging lesions without compromising radial strength. According to MicroPort Scientific Corporation, October 2025, in the 'MicroPort Coronary Stents Surpass 10 Million Milestone in Global Shipments and Implantations' press release, international sales of its drug-eluting stents grew at a compound annual growth rate of 35% from 2021 to 2024, underscoring the rising adoption of these next-generation interventional technologies.

Segmental Insights

The Polymer-based Coatings segment is emerging as the fastest-growing area within the Global Drug Eluting Stent Market, driven largely by the industry-wide shift toward biodegradable polymer technologies. Unlike traditional durable coatings that remain indefinitely, these advanced polymers are designed to absorb fully after delivering the therapeutic agent, thereby reducing long-term risks such as chronic inflammation and late stent thrombosis. This capability combines the efficacy of controlled drug release with improved vascular healing, making it a preferred choice for interventional cardiologists. Continued approvals of these next-generation devices by regulatory bodies like the U.S. FDA further validate their safety profile, fueling rapid adoption across healthcare systems.

Regional Insights

North America maintains a leading position in the global drug-eluting stent market, driven primarily by the high prevalence of coronary artery disease and a well-established healthcare infrastructure. The region benefits from favorable reimbursement policies that facilitate patient access to interventional cardiology treatments. Furthermore, the presence of major medical device manufacturers supports consistent product availability and development. The rigorous approval processes maintained by the U.S. Food and Drug Administration ensure the safety and efficacy of new devices, fostering strong clinical adoption. These factors collectively substantiate North America's continued dominance in the sector.

Recent Developments

• In January 2025, Biotronik announced the approval of two new indications for its Orsiro Mission drug-eluting stent system. The new labeling allowed practitioners to utilize a one-month dual antiplatelet therapy regimen for patients at high bleeding risk, providing a personalized treatment option that aligned with recent clinical guidelines. Additionally, the approval covered the treatment of complex lesions with moderate to severe calcification. These updates were intended to expand the applicability of the ultrathin strut stent in challenging clinical scenarios, aiming to improve patient outcomes by reducing bleeding complications and offering greater flexibility in post-procedure medication management.
• In July 2024, a subsidiary of MicroPort Scientific Corporation obtained marketing approval from the National Medical Products Administration (NMPA) in China for the Firesorb Bioresorbable Scaffold System. This next-generation device was the first target-eluting bioresorbable scaffold with a strut thickness comparable to permanent metallic stents, addressing a key limitation of earlier bioresorbable technologies. The approval followed extensive clinical studies which showed that the scaffold achieved a low thrombosis rate and comparable procedural success to traditional drug-eluting stents. The device was designed to release rapamycin to prevent restenosis while gradually degrading into the body, effectively leaving no permanent metallic implant behind.
• In June 2024, Elixir Medical received Breakthrough Device Designation from the U.S. FDA for its DynamX Sirolimus-Eluting Coronary Bioadaptor System. This novel bioadaptive implant was engineered to treat symptomatic ischemic heart disease by unlocking the vessel and allowing it to pulse and function more naturally compared to rigid metallic stents. The designation was granted based on the potential of the technology to improve coronary luminal diameter and reduce plaque progression. Clinical data presented at a major conference indicated that the bioadaptor demonstrated a statistically significant reduction in target lesion failure rates compared to a leading conventional drug-eluting stent.
• In April 2024, Abbott announced that the U.S. Food and Drug Administration (FDA) had approved its Esprit BTK Everolimus Eluting Resorbable Scaffold System. This device, described as a breakthrough innovation for patients with chronic limb-threatening ischemia below the knee, was designed to keep arteries open and deliver a drug to support vessel healing before eventually dissolving. The system was the first of its kind to be approved for use in arteries below the knee in the U.S. market. The approval was based on clinical trial results which demonstrated that the scaffold significantly reduced disease progression and improved medical outcomes compared to the standard balloon angioplasty.

Key Market Players

• Abbott Laboratories ltd.
• Boston Scientific Corporation
• Terumo Corporation
• Medtronic plc
• Biosensors International Ltd
• Cook Medical pvt ltd.
• B. Braun Medical (India) Private Limited
• Biotronik, Inc.
• Lepu Medical Technology Inc.

By Coating Type	By Application	By Region
Polymer-based Coatings (Non-biodegradable, Biodegradable)	Coronary Artery Disease Peripheral Artery Disease	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Drug Eluting Stent Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Drug Eluting Stent Market, By Coating Type:

• Polymer-based Coatings (Non-biodegradable, Biodegradable)

• Drug Eluting Stent Market, By Application:

• Coronary Artery Disease
• Peripheral Artery Disease

• Drug Eluting Stent Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE