Drug Eluting Balloon Market Set to Hit USD 1,402.8 Million by 2032, Expanding at a 8.8% CAGR | Biotronik, Cook Medical

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.

BURLINGAME, CA, UNITED STATES, December 3, 2025 /EINPresswire.com/ -- The 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. The adoption of drug-eluting balloons is rising globally, driven by the growing prevalence of cardiovascular diseases (CVDs). According to global health authorities, CVDs account for more than 17.9 million deaths annually, making them the leading cause of mortality worldwide. The increasing incidence of coronary artery and peripheral artery diseases is further fueled by an aging population, sedentary lifestyles, poor dietary habits, and rising obesity rates, collectively contributing to higher demand for advanced cardiovascular treatment options.

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Drug Eluting Balloon Market Key Takeaways

In 2025, coronary drug eluting balloon segment holds the largest share of 47.8% because many patients and doctors prefer minimally invasive treatments without permanent implants.

Among technologies, FreePac leads with almost 39.8% share in 2025, helped by its good drug delivery performance and lower risk of re-narrowing arteries.

Hospitals segment is slated to account for 36.2% of the global drug eluting balloon market share in 2025.

Regionally, North America leads in 2025 with about 43.6% share, thanks to advanced healthcare infrastructure, high incidence of cardiovascular diseases, and quick adoption of new interventional technologies.

Technological Advancements Improving Drug Delivery Efficiency

The evolution of drug eluting balloon catheters has significantly improved outcomes in angioplasty. A recent international study demonstrated that a new drug eluting balloon may be as safe and effective as conventional metal stents, especially for patients needing repeated procedures because of in-stent restenosis. This reinforces that modern DEB angioplasty devices are a viable alternative to stents, reducing risks associated with permanent implants while delivering therapeutic drugs directly to the vessel wall.

Innovations in drug coated balloon technology have also enhanced how medication is delivered during angioplasty. For example, newer balloons use improved coatings and excipients to ensure uniform drug transfer and minimize washout during inflation. As a result, both coronary drug-eluting balloons and peripheral drug-eluting balloons are increasingly preferred for treating complex lesions, or restenosis.

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Limited Clinical Evidence for Long-Term Safety in Some Indications

The long-term safety of drug-eluting balloon catheters is still not fully known because there are only a few studies that track patients for many years. Although early results show that these devices help blood vessels heal well in the short term, there is not enough proof about how they perform in the long run. Because of this, some doctors are careful about using them in complicated cases. Hospitals also keep a close watch on real-world patient results to better understand how effective these devices are over time.

In specific cases like recurrent blockages, in-stent restenosis treatment balloons and paclitaxel drug-eluting balloons offer promising benefits, but extended safety data is still evolving. Newer drug-coated balloon technology aims to improve durability, yet long-term follow-up remains limited in many studies. This gap also affects decision-making in both coronary and peripheral procedures. As the drug-eluting angioplasty market grows, ongoing clinical trials are expected to provide clearer long-term insights.

Product Innovation and New Formulations Creating Competitive Edge

Continuous improvements in drug-eluting balloon catheters are helping manufacturers offer safer and more consistent treatment outcomes. New coating methods are allowing the drug to transfer more effectively during procedures, supporting better vessel healing. This is especially useful for patients who do not respond well to traditional stents. As innovation grows, next-gen paclitaxel drug-eluting balloons are gaining strong clinical relevance.

Advancements in drug-coated balloon technology are also expanding the use of these devices across coronary and peripheral procedures. Companies are introducing updated formulations that improve drug retention and reduce the chances of restenosis. This shift is boosting confidence in modern DEB angioplasty devices, particularly for complex or recurrent blockages. With ongoing R&D, the drug-eluting angioplasty market is seeing steady growth supported by safer and more adaptable device designs.

Emerging Trends in the Drug-Eluting Balloon Market

Demand for advanced drug-coated balloon technology is rising as hospitals look for safer, non-stent alternatives for vascular treatment. Newer coatings and improved drug-release profiles are enhancing the performance of drug-eluting balloon catheters, especially in complex lesions.

Growing adoption of DEB angioplasty devices for in-stent restenosis (ISR) is becoming a strong trend. Physicians prefer in-stent restenosis treatment balloons because they help avoid additional stent placements and reduce long-term complications, improving overall patient outcomes.

Peripheral drug-eluting balloons are gaining traction globally due to increasing cases of peripheral artery disease (PAD). Advancements in endovascular drug-eluting devices are supporting better limb-saving treatments, especially in elderly populations.

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Analyst View
“The global drug eluting balloon market is expected to grow steadily, driven by increasing prevalence of cardiovascular diseases, rising demand for minimally invasive procedures, advancements in drug-coated balloon technology, and growing adoption of coronary and peripheral drug-eluting balloons,” said a lead CMI analyst.

Competitor Insight

Key companies in drug eluting balloon market report include:

Boston Scientific Corporation
BD
Terumo Corporation
Medtronic
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.

Recent Development

In March 2024, Boston Scientific received U.S. FDA approval for the AGENT™ drug‑coated balloon, the first drug‑coated balloon for treating coronary in‑stent restenosis (ISR) in the U.S.

In May 2025, Medtronic announced that its Prevail Drug‑coated Balloon gained CE‑mark approval for expanded indications (multivessel disease, acute coronary syndrome, diabetes) across the European Union.

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