Drug-Eluting Balloon Market Set for Strong Growth with CAGR 10.4% by 2031 | Koninklijke Philips N.V., Opto Circuits (India) Limited, Biotronik and Acotec Scientific.

Drug Eluting Balloon Market is expected to grow at a CAGR 10.4% during the forecast period (2024-2031).

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United States: Recent Industry Developments

✅ November 2025: Boston Scientific expanded the U.S. availability of its next-generation drug-eluting balloon for peripheral artery disease (PAD) treatment.

✅ October 2025: FDA approvals accelerated the adoption of drug-eluting balloons in coronary and below-the-knee interventions.

✅ September 2025: Hospitals increasingly adopted DEBs as an alternative to stents to reduce restenosis rates.

Japan: Recent Industry Developments

✅ November 2025: Terumo Corporation enhanced its drug-eluting balloon portfolio for complex coronary interventions.

✅ October 2025: Japan's regulatory authorities supported faster clinical adoption of DEBs for peripheral vascular diseases.

✅ September 2025: Rising preference for minimally invasive cardiovascular procedures boosted DEB utilization across cardiac centers.

GCC: Recent Industry Developments

✅ November 2025: Leading hospitals in Saudi Arabia and the UAE increased procurement of drug-eluting balloons for interventional cardiology.

✅ October 2025: Government investments in advanced cath lab infrastructure supported DEB adoption across the GCC.

✅ September 2025: Growing prevalence of cardiovascular diseases drove demand for innovative endovascular treatment solutions.

Key Players:

Medtronic, Boston Scientific Corporation, Cook Medical, B. Braun Melsungen AG, Koninklijke Philips N.V., Opto Circuits (India) Limited, Biotronik and Acotec Scientific.

Key Industry Development:

Drug shift: paclitaxel to sirolimus

✅ Segment breakdowns show sirolimus‐based balloons as the fastest‐growing drug class, due to favorable safety perception and strong late‐lumen‐loss data in de novo lesions and ISR.​

✅ 2025 reviews and trials (e.g., SeQuent SCB vs SeQuent Please Neo, SABRE, SELUTION‐related studies) report that sirolimus‐coated balloons achieve low 6‐month late lumen loss and non‐inferior outcomes to paclitaxel DCBs or even DES in selected lesions, supporting broader adoption.​

Coronary clinical and regulatory milestones

✅ In February-March 2024, Boston Scientific's AGENT DCB became the first coronary drug‐coated balloon approved by the U.S. FDA, indicated for treatment of coronary in‐stent restenosis; by 2025 it anchors the U.S. coronary DCB segment and serves as a reference for newer trials.​

✅ Medtronic secured FDA IDE approval in late 2024 for its Prevail paclitaxel‐coated balloon trial in coronary disease, with enrollment and follow‐up extending through 2025, reinforcing the trend toward DCB‐based PCI strategies that avoid leaving a permanent stent.​

Evidence expansion and comparative studies

1. A 2025 narrative review highlights expanding DCB use beyond coronary ISR into small‐vessel disease, bifurcations, and selected de novo lesions, framing "leave‐nothing‐behind" PCI as a way to reduce late stent‐related complications.​

2. Meta‐analyses and comparative RCTs published in 2025 examine DCB vs DES vs plain balloon angioplasty in de novo CAD and ACS, generally showing DCB non‐inferiority to contemporary DES in carefully selected lesions while reducing metal burden and dual antiplatelet exposure.​

Peripheral and structural indications

✅ Reviews also note investigational work on DCBs in other vascular beds (e.g., below‐the‐knee, AV access) and structural indications, though these remain largely in trial or limited‐use phases.​

Key 2025 themes for DEB/DCB

✅ High‐growth focus on sirolimus‐coated technologies, supported by non‐inferiority data vs paclitaxel DCBs and DES in de novo lesions.​

✅ Ongoing geographic and indication expansion, with Europe and parts of Asia ahead of the U.S. in coronary DCB utilization while U.S. adoption scales post‐AGENT approval.​

✅ Strong pipeline of randomized trials and registry data through 2025 to refine patient selection, optimize lesion preparation, and define DCB roles across coronary and peripheral interventions.​

Growth Forecast Projected:

The Global Drug Eluting Balloon Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Drug Eluting Balloon Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

By Product Type: (Coronary Drug Eluting Balloon, Peripheral Drug Eluting Balloon)

By Peripheral Drug Eluting Balloon: (Paccocath, FreePac, TransPax, EnduraCoat, Others)

By End-Users: (Hospitals, Cardiac Catheterization Laboratories, Ambulatory Surgery Centers, Others)

Regional Analysis for Drug Eluting Balloon Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Sirolimus vs paclitaxel adoption in 2025

✅ Market analyses describe paclitaxel‐coated balloons (PCBs) as the established workhorse segment in 2025, with sirolimus‐coated balloons (SCBs) the fastest‐growing subsegment from a smaller base.​

✅ Global reports cite sirolimus‐based DCBs as the highest‐CAGR drug class (around 9-10%), reflecting better vascular‐healing profile, alignment with DES practice, and growing clinical evidence, even though PCBs still hold the larger installed base and revenue.​

Clinical evidence and usage patterns

✅ Comparative registries and meta‐analyses up to 2025 (e.g., EASTBOURNE/PEARL pooled analysis, multiple RCT/meta‐analyses) show broadly similar 9-12‐month target lesion failure/MACE between PCB and SCB, with slightly larger follow‐up minimal lumen diameter or less late lumen loss in some PCB datasets.​

✅ A large registry comparison found new‐generation PCB and SCB produced comparable one‐year MACE across lesion types, supporting clinical interchangeability in many scenarios.​

✅ Reviews emphasize that while sirolimus is pharmacologically preferred in stents, its lower lipophilicity complicates short‐contact balloon delivery; early SCBs had weaker tissue uptake, but newer SCB platforms (e.g., micro‐reservoir and phospholipid carriers) are closing that gap.​

Regional adoption nuances

✅ European and Asian centers have multiple SCB options (e.g., MagicTouch, SELUTION), and expert reviews in 2025 describe "increasing adoption" of SCB for both ISR and selected de novo lesions as evidence accumulates and operators seek "leave‐nothing‐behind" PCI with sirolimus rather than paclitaxel.​

✅ An India‐focused 2025 review notes that PCBs still dominate available coronary DCBs, but SCBs are gaining traction thanks to favorable safety/efficacy signals and local manufacturing/clinical programs.​

✅ In the U.S., coronary DCB use in 2025 remains almost entirely paclitaxel‐based (Boston Scientific AGENT) because no sirolimus coronary DCB yet has FDA approval; SCB use is limited to trials and non‐U.S. markets.​

Regulatory approvals and key actions

United States

✅ There were no new coronary DCB device approvals in the U.S. between Nov 2024 and Sep 2025; Boston Scientific's AGENT DCB (paclitaxel) remained the only FDA‐approved coronary DCB through this window, having been approved in Feb 2024 for coronary in‐stent restenosis.​

✅ Policy support strengthened: in August 2025, the U.S. Centers for Medicare & Medicaid Services (CMS) granted New Technology Add‐On Payment (NTAP) status for the AGENT DCB, improving reimbursement for hospital use and likely accelerating clinical uptake

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