Drug Eluting Balloon Market Analysis & Forecast: 2025-2032

Drug Eluting Balloon Market Size and Trends – 2025 to 20232

Global drug eluting balloon market is estimated to be valued at USD 776.8 Mn in 2025 and is expected to reach USD 1,402.8 Mn by 2032, exhibiting a compound annual growth rate (CAGR) of 8.8% from 2025 to 2032.

Key Takeaways

• Based on Product Type, the Coronary Drug Eluting Balloon segment is projected to hold approximately 47.8% of the global market share in 2025, driven by the rising preference for minimally invasive treatments and its ability to deliver targeted drug therapy without leaving a permanent implant.
• Based on Technology, the FreePac segment is anticipated to account for nearly 39.8% of the market share in 2025, owing to its superior clinical performance, homogenous drug delivery, and reduced risk of target lesion revascularization compared to traditional coating methods.
• Based on End User, the Hospitals segment is estimated to secure around 36.2% of the global market share in 2025, attributed to their ability to handle complex procedures, provide outpatient treatment options, and leverage favorable reimbursement scenarios for minimally invasive angioplasty solutions.
• Based on Region, North America is expected to dominate the global drug eluting balloon market with a 43.6% share in 2025, fueled by advanced healthcare infrastructure, high cardiovascular disease prevalence, strong presence of leading players, and fast-paced adoption of new medical technologies across the U.S. and Canada.

Market Overview

An increase in the use of drug eluting balloons can be seen because there are currently more cases of cardiovascular diseases (CVDs) globally. It is estimated by global health authorities that CVDs lead to the deaths of more than 17.9 million people every year which makes them the leading cause of death. Older people, inactive lifestyles, unhealthy eating and more obesity have greatly increased the rate of both coronary artery and peripheral artery diseases. Drug eluting balloons (DEBs) have been favored in this situation because they are minimally invasive and provide treatment without leaving behind anything. Since stents aren’t used in this way, patients in higher-risk and elderly groups have fewer long-term problems and recover more easily.

Current Events and Its Impact

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Reimbursement Scenario

Reimbursement policies significantly influence the adoption and usage of drug eluting balloons across global markets. In developed countries such as the U.S. and India, partial reimbursement is available for DEB procedures when used for FDA-approved indications like in-stent restenosis. However, even in these regions, the reimbursement value often favors traditional stent-based therapies or plain balloon angioplasty. In April 2020, after years of limited recognition, the reimbursement system in France finally began to cover the drug-eluting balloon (DEB).

End-user Feedback and Unmet Needs

Clinicians and hospital procurement teams have highlighted several unmet needs in the current DEB landscape. According to interviews with interventional cardiologists and data from multi-center trials like PACT SFA II and BIOLUX P-III, users report high satisfaction with DEB outcomes in ISR and small vessel disease, citing fewer repeat procedures and lower late lumen loss. However, they express concern about limited DEB options for larger vessels or calcified lesions, as well as limited product availability in Tier 2 and Tier 3 cities. Furthermore, nurses and surgical staff in ambulatory surgical centers note the need for DEBs with better crossing profiles and lower preparation times. The push for same-day discharge has elevated demand for more efficient and ergonomically packaged DEB kits.

Segmental Insights

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Drug Eluting Balloon Market Insights, By Product Type - Growing demand for minimally invasive treatment boosts demand for Coronary drug eluting balloon

Product Type segment is sub-segmented into coronary drug eluting balloon, peripheral drug eluting balloon, others. Coronary drug eluting balloon sub-segment is estimated to hold 47.8% of the market share in 2025, owing to the growing need for minimally invasive treatments. Drug eluting balloons address this challenge by utilizing drug coated non-expandable balloons to treat lesions in a single procedure. Upon inflation, the drug is infused to the vessel walls to prevent narrowing of arteries without leaving behind a metallic implant. This saves patients from undergoing multiple procedures and allows for faster recovery times. The one-time therapy increases treatment adherence and compliance for chronic PAD patients who are often elderly with comorbidities.

The U.S. FDA's approval of Boston Scientific's Agent™ drug-coated balloon catheter for treating coronary in-stent restenosis (ISR) underscores the growing clinical adoption of DEBs in managing complex coronary sessions, further enhancing the drug eluting balloon market share.

Drug Eluting Balloon Market Insights, By Technology - Superior Clinical Results Boosts Adoption of Lead Freepac Technology

Technology segment is sub-segmented into freepac, transpac, enduracoa, others. Freepac sub-segment is estimated to hold 39.8% of the market share in 2025 due to its proven superior clinical outcomes. Among drug coating technologies, FreePac uses a innovative approach without a guiding catheter to infuse drugs onto the balloon surface. Unlike competitive TransPac or EnduraCoat technologies which rely on enclosed drug reservoirs, FreePac allows for homogenous drug transfer unconstrained by physical borders or flow restrictions. Several randomized control trials have demonstrated FreePac's ability to achieve high vessel wall concentrations with extensive, transmural drug transfer and coverage. Its unrestricted fluid dynamics minimizes residual ducts and dead spaces, addressing shortcomings of traditional systems. As a result, FreePac has shown advantages in reducing risk of target lesion revascularization compared to competing technologies. It offers durable clinical results with low vascular retreatment needs over extended follow up periods. Medtronic's recent expansion of CE Mark indications for its Prevail™ paclitaxel-coated PTCA balloon catheter underscores the growing traction of FreePac™ technology in the drug-eluting balloon (DEB) market. The Prevail™ catheter is now approved for treating complex bifurcation lesions, a challenging subset of coronary artery disease, highlighting the device's efficacy in intricate vascular anatomies. This is further propelling the drug eluting balloon market demand.

Drug Eluting Balloon Market Insights, By End User - Preference for outpatient treatment drives hospital adoption

End User segment is sub-segmented into hospitals, ambulatory surgical centers, others. Hospitals sub-segment is estimated to hold 36.2% of the market share in 2025 as these are the preferred settings for drug eluting balloon procedures. While ambulatory surgical centers also provide such services, hospitals offer logistic and personnel infrastructure required for complex cases, especially in high-risk patients. Their large scale allows for economies needed to support technological innovations like drug eluting balloons. Importantly, hospitals enable treatment in outpatient settings which is driving increased adoption. Drug eluting balloons enable same day discharge for many patients due to speed and minimally invasive nature versus stent or surgery alternatives. This reduces burden on inpatient beds and wait times. Favorable reimbursements for such same day discharges further incentivize hospitals to incorporate such technologies. The use of preoperative DEB therapy in patients undergoing elective tumor surgery with concurrent coronary heart disease. The research demonstrated that hospitals equipped with the necessary infrastructure could effectively administer DEB treatments, leading to favorable perioperative outcomes and reduced cardiac complications. This is further escalating the drug eluting balloon industry growth.

Regional Insights

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North America Drug Eluting Balloon Market Trends

North America remains the dominant region in the global drug eluting balloon market and is estimated to hold 43.6% of the market share in 2025 due to high healthcare expenditure, presence of leading players and adoption of advanced technologies at faster pace in countries like U.S. and Canada. Rising prevalence of cardiovascular diseases in North America contributes to larger patient pool undergoing angioplasty procedures, where drug eluting balloons are widely used. North America is an attractive base for many international players to set up manufacturing facilities due to availability of key resources and skilled workforce. The launch of Cordis' 10,000-patient global coronary registry for the SELUTION SLR™ drug-eluting balloon (DEB) underscores North America's pivotal role in advancing DEB technologies. This extensive registry aims to collect real-world data on the safety and efficacy of the SELUTION SLR™ DEB, reflecting the region's commitment to evidence-based medical advancements.

Asia Pacific Drug Eluting Balloon Market Trends

One of the fastest growing regions for drug eluting balloon market is Asia Pacific. The growth can be attributed to rising healthcare infrastructure, growing medical tourism industry and increasing disposable incomes in developing economies like China and India. Both China and India have a huge population base with growing disease burdens and rising cases of lifestyle diseases. This serves as a huge patient pool and potential market for all medical devices including drug eluting balloons. Additionally, many Asian countries are focusing on enhancing healthcare access through various governmental initiatives, and this boosts demand for cost-effective treatment alternatives like drug eluting balloons. Reflow Medical's establishment of its European subsidiary in Landsberg am Lech, Germany, marks a strategic expansion that extends beyond Europe, targeting the Asia-Pacific (APAC) region among others. This move is poised to influence the APAC drug-eluting balloon (DEB) market by enhancing access to Reflow's innovative cardiovascular devices, including the Spur® Peripheral Retrievable Scaffold System.

United States Drug Eluting Balloon Market Trends

The United States represents one of the most advanced markets for drug eluting balloon (DEB) technologies, driven by a combination of robust healthcare infrastructure, high disease prevalence, and early adoption of minimally invasive interventions. The increasing incidence of coronary artery disease (CAD) and peripheral artery disease (PAD), particularly among aging populations and those with comorbidities such as diabetes and obesity, has spurred demand for alternative treatment options that avoid permanent implants. Drug eluting balloons offer a compelling solution by enabling localized drug delivery without leaving a stent behind, thereby reducing risks associated with stent-related complications such as restenosis and thrombosis. The completion of U.S. enrollment in the PACT SFA II trial marks a significant milestone in the advancement of drug-eluting balloon (DEB) therapies within the United States. This prospective, multi-center, randomized controlled trial enrolled 181 patients across more than 40 sites, evaluating the efficacy of paclitaxel-coated balloons in treating superficial femoral artery (SFA) lesions. The successful enrollment underscores the growing clinical interest and adoption of DEB technologies in U.S. vascular interventions.

India Drug Eluting Balloon Market Trends

India’s drug eluting balloon market is rapidly evolving, supported by a growing healthcare infrastructure, increasing prevalence of cardiovascular and peripheral vascular diseases, and the nation’s strong push toward affordable and minimally invasive surgery options. With a large and aging population, and rising incidence of lifestyle-related conditions such as diabetes and hypertension, the country is witnessing greater demand for advanced interventional cardiology solutions. DEBs are gaining traction as a stent-free alternative that minimizes hospital stays and reduces long-term follow-up care, making them particularly appealing in resource-constrained settings. SIRONA trial signifies a pivotal advancement in India's drug-eluting balloon (DEB) market, particularly in the treatment of peripheral artery disease (PAD). The trial's findings position sirolimus-coated balloons (SCBs) as a viable alternative to the traditionally used paclitaxel-coated balloons, addressing previous safety concerns associated with paclitaxel.

Market Concentration and Competitive Landscape

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Market Report Scope

Drug Eluting Balloon Market Report Coverage

Drug Eluting Balloon Market Driver – Increasing Product Launches by Key Market Players

Market players are engaged in launching new drugs, and this is expected to drive growth of the global drug eluting balloon market over the forecast period. For instance, in July 2021, Med Alliance SA, a medical technology company, launched ORIGIN SC and ORIGIN NC, two high performance drug eluting balloons for vessel preparation. These complement SELUTION SLR, its novel sirolimus-eluting balloon. ORIGIN SC is a semi-compliant (SC) PTCA balloon with a very low crossing profile, thus, making it an excellent choice for challenging lesions. ORIGIN SC offers one of the broadest portfolios of sizes available for an semi-compliant (SC) balloon, including 1.00 mm, 1.25 mm, 1.50 mm and 1.75 mm balloon diameters to treat very small vessels and complex cases. ORIGIN NC is a non-compliant (NC) PTCA balloon, combining high pressure tolerance and controlled compliance with an optimal crossing profile for the most challenging cases.

Growing Incidence of Cardiovascular Diseases

Increasing prevalence of cardiovascular diseases across the globe is expected to drive the growth of the drug eluting balloon market. World Health Organization, cardiovascular diseases account for over 17.9 million deaths each year globally. Some of the major cardiovascular conditions include coronary heart disease, stroke and peripheral arterial disease. Aging populations, changing environmental factors and genetic predispositions further contribute to rising disease burden. Drug eluting balloons are being increasingly used by physicians for treating peripheral arterial diseases affecting the hips and legs as well as coronary artery diseases impacting the heart. These prevent vessel recoil and neointimal hyperplasia after angioplasty procedures through the controlled, localized delivery of anti-proliferative drugs to damaged vessel sites. This minimizes the risk of restenosis and the need for additional revascularization treatments. Recent clinical studies have demonstrated drug eluting balloons to be as effective as drug eluting stents in addressing various types of atherosclerotic lesions with fewer safety issues.

Market Opportunity – Increasing Inorganic Growth Strategies by Key Market Players

Increasing adoption of inorganic growth strategies, such as acquisition, by key market players is expected to offer lucrative growth opportunities over the forecast period. For instance, in October 2022, Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technologies, announced the acquisition of Med Alliance SA, a medical technology company. The acquisition enabled Cordis will immediately begin co-promotion of MedAlliance’s SELUTION SLR drug-eluting balloon in markets where it is commercially available.

Drug Eluting Balloon Industry News

• In May 2025, Cordis launched the SELUTION Global Coronary Registry, a prospective study enrolling up to 10,000 patients worldwide. This large registry will monitor real-world outcomes of the SELUTION SLR™ Drug-Eluting Balloon (DEB) for up to five years, complementing ongoing randomized trial results.
• In April 2025, iVascular introduced its Luminor drug-coated balloon (DCB) in Japan.
• In September 2024, Shockwave Medical launched its next-generation intravascular lithotripsy (IVL) catheter for PAD. The new E8 catheter features eight shock emitters over an 80 mm balloon, and a working length of 150 cm – enabling treatment of longer, calcified lesions above and below the knee. IVL uses acoustic pulses to break up calcium. The FDA clearance (Sep 2024) followed successful trials in complex PAD.
• In April 2024, Abbott’s Espirit BTK Resorbable Stent drug-eluting scaffold for below-the-knee (BTK) PAD is a major innovation. It is the first-ever FDA-approved dissolving stent for peripheral arteries. The Esprit BTK delivers everolimus to maintain vessel patency and then gradually dissolves over ~3 years. In clinical trials (LIFE-BTK), it showed superior outcomes to balloon angioplasty alone. Abbott’s success (also highlighted in a recent press report) provides a new option for critical limb ischemia and could shift practice below the knee.
• In March 2024, Boston Scientific Corporation, a medical device company, announced that the U.S. Food and Drug Administration had approved the AGENT Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease
• In January 2023, Med Alliance SA, a medical technology company, announced that it had received conditional U.S. FDA investigational device exemption (IDE), for its its novel sirolimus-eluting balloon

Analyst Opinion (Expert Opinion)

• The drug eluting balloon market is undergoing a pivotal shift, driven by mounting clinical evidence that positions DEBs as superior alternatives to stents in specific indications.With trials like the BIOLUX P-III and the IN. PACT SFA demonstrating statistically significant reductions in late lumen loss and target lesion revascularization, DEBs are becoming essential tools in the treatment of peripheral artery disease and in-stent restenosis. Their stentless approach offers long-term safety benefits, especially in patients contraindicated for dual antiplatelet therapy.
• Despite promising outcomes, adoption remains uneven due to gaps in reimbursement policies and clinician familiarity, particularly in low-to-middle income countries. Studies from the European Heart Journal reveal that procedure costs for DEBs are often 20–40% higher than standard balloon angioplasty in public hospitals in Southeast Asia, which creates barriers in regions where price sensitivity is high. Unless governments integrate DEBs under public health schemes, their usage will remain confined to urban tertiary centers.
• Strategic market expansion is evident in the Asia Pacific region, where public-private partnerships are enabling faster trials and local manufacturing. For example, the Indian government’s Production Linked Incentive (PLI) scheme is already attracting global DEB producers to establish production bases, reducing import dependency. Simultaneously, the rise in lifestyle-related PAD cases—projected to increase by 30% in urban India by 2030 (Lancet, 2022)—creates a favorable demand-supply equation for scalable, non-implant therapies like DEBs.
• North America continues to set the benchmark for clinical adoption and innovation.The U.S. remains the most progressive DEB market globally, supported by robust data collection through initiatives like the Cordis SELUTION SLR 10,000-patient global registry. These real-world evidence programs not only de-risk new product approvals but also catalyze evidence-based treatment protocols that other regions emulate.

Market Segmentation

• By Product Type
  • Coronary Drug Eluting Balloon
  • Peripheral Drug Eluting Balloon
  • Others
• By Technology
  • FreePac
  • TransPac
  • EnduraCoa
  • Others
• By End User
  • Hospitals
  • Ambulatory Surgical Centers
  • Others
• By Region
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Company Profiles
  • Boston Scientific Corporation
  • BD
  • Terumo Corporation
  • Medtronic
  • B. Braun SE
  • Surmodics, Inc.
  • Biotronik
  • Cook Medical
  • Opto Circuits (India) Limited
  • Lepu Medical Technology
  • Cardionovum GmbH
  • Shanghai MicroPort Medical (Group) Co., Ltd.
  • Wellinq
  • Philips Healthcare 
  • Biosensors International Group, Ltd.

Sources

Primary Research Interviews

• Interventional cardiologists at tertiary care hospitals in the U.S., Germany, and India
• Product R&D teams at global cardiovascular device manufacturers
• Clinical trial investigators from FDA-approved drug-eluting balloon studies
• Procurement and regulatory officers from public and private cardiac specialty hospitals

Databases

• PubMed – Clinical studies and meta-analyses on coronary and peripheral DEB interventions
• ScienceDirect – Peer-reviewed journals on drug-elution technologies and biocompatibility
• Google Scholar – Academic literature on ISR (in-stent restenosis) treatment outcomes
• ClinicalTrials.gov – Trial protocols and status of global DEB investigations

Magazines & News Articles

• Fierce Biotech – Updates on FDA device designations and DEB pipeline progress
• Medical Device Network – Product launches and CE mark announcements in interventional cardiology
• MedTech Dive – Regulatory trends and hospital adoption of drug-eluting technologies
• Boston Scientific Newsroom – Official FDA approvals and trial milestones (e.g., AGENT DCB)
• Business Wire – Manufacturer press releases on drug-coated balloon studies and launches
• Kilgore News Herald – Launch of 10,000-patient registry for SELUTION SLR by Cordis (2024)

Journals

• Journal of the American College of Cardiology (JACC) – Comparative studies on DEB vs. DES outcomes
• European Heart Journal – Insights on DEB application in small vessel disease
• Catheterization and Cardiovascular Interventions – Research on DEB efficacy and restenosis
• Journal of Interventional Cardiology – Innovations in drug-eluting balloon delivery mechanisms
• International Journal of Cardiology – Global usage patterns and outcomes in DEB procedures

Newspapers & Reports

• The Economic Times (India) – Adoption of drug-eluting technologies in Indian cath labs
• The New York Times Health – Growing U.S. interest in device-based cardiac interventions
• Financial Express – Public-private partnerships driving cardiovascular device deployment in Asia
• MedPage Today – Regulatory approvals and clinical data summaries
• Reuters Health – Updates on cardiovascular clinical studies in the U.S. and EU

Associations

• U.S. Food and Drug Administration (FDA) – Device approvals and IDE listings for DEBs
• European Medicines Agency (EMA) – Device certification and post-market surveillance
• Cardiovascular Research Foundation (CRF) – Symposia proceedings and investigator-led DEB trials
• American College of Cardiology (ACC) – Guidelines and position statements on DEB usage
• National Institutes of Health (NIH) – Funding data and research summaries on DEB mechanisms

Public Domain Sources

• U.S. National Library of Medicine – Full-text biomedical literature for DEB research
• Ministry of Health and Family Welfare, India – Initiatives to promote interventional cardiology access
• European Commission – Health Technology Assessment Unit – DEB cost-benefit analysis reports
• Centers for Medicare & Medicaid Services (CMS) – Reimbursement guidelines impacting DEB uptake
• World Health Organization (WHO) – Cardiovascular disease burden and intervention trends by region

Proprietary Elements

• CMI Data Analytics Tool, Proprietary CMI Existing Repository of information for last 8 years