Table of Contents
Overview
New York, NY – July 03, 2025 – Global Drug Eluting Balloon Market size is expected to be worth around US$ 3.2 Billion by 2034 from US$ 1.9 Billion in 2024, growing at a CAGR of 5.4% during the forecast period 2025 to 2034. In 2024, North America led the market, achieving over 36.7% share with a revenue of US$ 0.7 Billion.
Drug Eluting Balloons (DEBs) represent a significant advancement in interventional cardiology and peripheral vascular therapy. These angioplasty balloons are coated with antiproliferative drugs, typically paclitaxel, which are delivered directly to the arterial wall during balloon inflation. Unlike drug-eluting stents (DES), DEBs do not leave behind a permanent implant, making them particularly valuable in treating restenosis, small vessel disease, and in-stent restenosis.
The core design of DEBs involves a semi compliant balloon catheter coated with a drug-polymer or excipient matrix. This formulation allows for rapid drug transfer to the vessel wall during inflation typically lasting 30 to 60 seconds followed by rapid absorption into the tissue. The primary therapeutic objective is to inhibit neointimal hyperplasia, a leading cause of vascular re-narrowing post-angioplasty.
The adoption of DEB technology has expanded across coronary and peripheral applications. Clinically, DEBs are preferred in cases where stent placement may be undesirable due to anatomical or procedural constraints. Regulatory authorities such as the U.S. FDA and European Medicines Agency have approved various DEB systems based on clinical trial evidence demonstrating safety, efficacy, and reduced need for repeat revascularization.
Ongoing innovation in coating materials and drug delivery mechanisms continues to improve the therapeutic potential of DEBs, with research increasingly focused on sirolimus-coated balloon technologies for broader clinical utility. The global demand is driven by rising cardiovascular disease prevalence and the need for less invasive, implant-free treatment options.
Key Takeaways
- In 2024, the global Drug Eluting Balloon (DEB) market was valued at approximately USD 1.9 billion. The market is projected to expand at a compound annual growth rate (CAGR) of 5.4%, reaching an estimated value of USD 3.2 billion by 2034.
- Based on product type, the market is categorized into peripheral drug eluting balloons, coronary drug eluting balloons, and others. The peripheral drug eluting balloon segment dominated in 2023, accounting for 50.4% of the total market share.
- In terms of technology, the market is segmented into Paccocath, EnduraCoat, FreePac, TransPax, and others. Among these, Paccocath emerged as the leading technology, capturing a significant 56.3% share of the overall market.
- Regarding end-user segmentation, the market comprises hospitals & ambulatory surgery centers, catheterization (CATH) laboratories, and others. Hospitals and ambulatory surgery centers held the largest revenue share in 2023, representing 59.2% of the global market.
- Geographically, North America remained the leading regional market, contributing 36.7% of the global revenue share in 2023. This dominance is attributed to a strong healthcare infrastructure, high prevalence of cardiovascular conditions, and early adoption of advanced interventional technologies.
Segmentation Analysis
- AProduct Type Analysis: The peripheral drug eluting balloon segment accounted for 50.4% of the market, driven by the rising prevalence of peripheral artery disease (PAD), especially in aging populations. Increased demand for minimally invasive procedures and technological improvements in drug delivery have supported adoption. Growing awareness about PAD treatments and the clinical benefits of drug-eluting balloons, such as reduced restenosis and improved vascular outcomes, are expected to further drive market expansion in this segment.
- ATechnology Analysis: Paccocath technology captured a leading 56.3% market share due to its effective combination of drug delivery and mechanical dilation. This dual mechanism enhances the treatment of restenosis, especially in coronary interventions. Clinical validation and strong performance in maintaining vessel patency have reinforced its position. As more evidence supports Paccocath’s superior outcomes, its use is expected to grow in hospitals and surgical centers, supported by ongoing innovation in drug-eluting technologies and next-generation balloon catheter designs.
- AEnd-User Analysis: Hospitals and ambulatory surgery centers held a 59.2% revenue share, attributed to their advanced infrastructure and growing preference for minimally invasive, outpatient-based care. These settings offer high procedural volumes and efficient post-operative management. Increasing adoption of drug-eluting balloons for PAD and coronary artery disease in such facilities reflects their role in improving clinical outcomes and lowering costs. Healthcare investments and the shift toward outpatient vascular therapies are likely to further strengthen this segment’s market dominance.
Market Segments
By Product Type
- Peripheral Drug Eluting Balloon
- Coronary Drug Eluting Balloon
- Others
By Technology
- Paccocath
- EnduraCoat
- FreePac
- TransPax
- Others
By End-user
- Hospitals & Ambulatory Surgery Centers
- CATH Laboratories
- Others
Regional Analysis
North America led the global Drug Eluting Balloon (DEB) market in 2024, capturing a revenue share of 36.7%. This dominance is attributed to rising regulatory approvals and the growing need for advanced revascularization strategies in managing peripheral and coronary artery diseases. A notable development was the U.S. FDA’s approval of Boston Scientific’s AGENT Drug-Coated Balloon in March 2024, marking the first coronary DEB approved for treating in-stent restenosis in the U.S. This milestone offers patients an effective alternative to repeat stenting procedures.
Medtronic reported a 6.6% increase in revenue from its Cardiovascular Portfolio (7.8% organically) in Q4 FY2025, reflecting rising demand for interventional cardiovascular devices. Boston Scientific’s Peripheral Interventions segment generated US$2.410 billion in revenue for 2024, registering a 14.2% reported and 15.5% operational growth over 2023.
Asia Pacific is projected to register the fastest CAGR during the forecast period, driven by increasing cardiovascular disease prevalence and improved healthcare infrastructure. In 2024, China’s NMPA approved over 6,200 imported medical device items, many related to cardiovascular care. India’s healthcare budget rose to Rs 89,155 crore (US$10.6 billion) for 2023–2024, indicating strong government support for advanced medical technologies and expanded patient access across the region.
Emerging Trends
- Sirolimus-Coated Balloons: New drug-eluting balloons are being coated with sirolimus instead of paclitaxel to improve drug release and reduce vessel inflammation. Early trials like SELUTION SLR™ are underway to test safety and effectiveness in coronary and peripheral vessels.
- Expansion into Dialysis Access: Drug-coated balloons are increasingly used to treat stenosis in arteriovenous dialysis fistulae. Since FDA approval on November 21, 2019, for the IN.PACT AV DCB, clinical practice has seen wider adoption in dialysis centers.
- Heightened Safety Monitoring: After signals of increased late mortality around 2–3 years post-treatment with paclitaxel-coated devices, regulators and clinicians are conducting long-term follow-up studies to better understand risks and optimize patient selection.
- Combination Therapies: Research is exploring combined use of biomimetic stents with drug-eluting balloons for complex or recurring blockages, aiming to leverage mechanical scaffolding and local drug delivery together.
Use Cases
- Femoropopliteal Artery Disease: In a randomized trial, the Ranger™ DCB achieved 82.9% primary vessel patency at 12 months versus 66.3% with standard angioplasty, reducing re-intervention rates substantially.
- In-Stent Restenosis Prevention: The SurVeil™ DCB demonstrated non-inferior efficacy to the IN.PACT Admiral® balloon, with primary patency of 81.7% at one year in both groups, supporting its use when treating lesions within existing stents.
- Dialysis Fistula Maintenance: The IN.PACT AV DCB is indicated for percutaneous angioplasty of native arteriovenous fistulae up to 100 mm in length and vessel diameters of 4–12 mm, offering a minimally invasive option for maintaining dialysis access.
- Overall Patency Improvement: A recent meta-analysis found that paclitaxel-coated balloons deliver an average 80.9% vessel patency at 12 months, compared to 57.5% with uncoated balloons, underscoring their broad utility in peripheral artery disease.
Conclusion
The global Drug Eluting Balloon (DEB) market is poised for steady growth, driven by rising cardiovascular disease prevalence, increasing demand for minimally invasive therapies, and regulatory advancements. With strong adoption across peripheral and coronary applications, DEBs offer a valuable alternative to permanent stents, especially in complex or restenotic lesions.
Innovations such as sirolimus-coated balloons and expanded use in dialysis access further broaden clinical utility. North America remains the leading region, while Asia Pacific shows promising growth potential. Ongoing clinical research, combined with healthcare infrastructure improvements, is expected to sustain market expansion and enhance patient outcomes over the forecast period.
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