Drug-Coated Balloons Market Report 2025

The drug-coated balloons market size has grown rapidly in recent years. It will grow from $1.08 billion in 2024 to $1.24 billion in 2025 at a compound annual growth rate (CAGR) of 15.4%. The growth in the historic period can be attributed to increased cardiovascular disease burden, demand for minimally invasive procedures, prevalence of peripheral artery disease (pad), reducing restenosis rates, advancements in interventional cardiology.

The drug-coated balloons market size is expected to see rapid growth in the next few years. It will grow to $2.22 billion in 2029 at a compound annual growth rate (CAGR) of 15.6%. The growth in the forecast period can be attributed to increasing aging population, expansion of indications and applications, focus on outpatient and ambulatory care, integration with drug delivery innovations, global health initiatives. Major trends in the forecast period include regulatory approvals for new formulations, focus on minimizing side effects, emergence of bioresorbable coatings, market expansion in emerging economies, patient-centric approaches.

The increasing prevalence of coronary artery disease (CAD) is projected to drive the growth of the drug-coated balloons market in the future. CAD is a medical condition characterized by the narrowing or blockage of the coronary arteries that supply blood to the heart muscle, often leading to heart attacks. Drug-coated balloons are medical devices used to treat coronary artery disease, releasing medication into the artery during the procedure to help prevent restenosis, which is the re-narrowing of the artery following angioplasty. For instance, a study published in the Journal of the American College of Cardiology in August 2022 indicated that all four cardiovascular risk factors are expected to rise among the general U.S. population from 2025 to 2060. Diabetes is projected to see the most significant increase at 39.3%, followed by dyslipidemia at 27.6%, hypertension at 25.1%, and obesity at 18.3%. Additionally, the researchers found that rates of heart failure (33.4%) and ischemic heart disease (30.7%) are expected to experience the largest increases, along with heart attacks (16.9%) and strokes (33.8%). Consequently, the rise in coronary artery disease prevalence is anticipated to boost the drug-coated balloon market.

The increasing number of ambulatory surgery centers is anticipated to propel the growth of the drug-coated balloon market. Ambulatory Surgical Centers (ASCs) are medical facilities dedicated to conducting surgical procedures that do not necessitate an overnight hospital stay. Drug-coated balloons play a crucial role in ASCs by offering shorter procedure times compared to standard balloons, resulting in improved patient throughput and reduced operational costs. For instance, VMG Health reported in September 2023 that the total number of Medicare-certified ambulatory surgery centers increased by 2.9% from 1752 in 2021 to 1804 in 2022. Hence, the growing prevalence of ambulatory surgery centers is a driving force behind the drug-coated balloon market's expansion.

Product innovations are emerging as a significant trend in the drug-coated balloon market. Leading companies in this sector are concentrating on developing new technological and innovative solutions to enhance their market position. For example, in August 2022, Becton, Dickinson, and Company (BD), a U.S.-based medical technology firm, initiated the PREVISION first-in-human trial for a peripheral sirolimus drug-coated balloon (DCB). This trial is designed to evaluate the safety and effectiveness of the sirolimus DCB for treating patients with peripheral artery disease, a condition that greatly affects mobility and quality of life.

Leading companies in the drug-coated balloon sector are dedicated to advancing their technologies, including paclitaxel-coated balloon catheters, to improve treatment efficacy for conditions such as coronary in-stent restenosis. These advancements aim to enhance patient outcomes and minimize the risk of complications associated with traditional therapies. Paclitaxel-coated balloon catheters are specialized devices that release the drug paclitaxel into the artery wall upon inflation, helping to prevent re-narrowing after angioplasty. For instance, in March 2024, Boston Scientific Corporation, a U.S.-based medical device manufacturer, received approval from the U.S. Food and Drug Administration (FDA) for its AGENT™ Drug-Coated Balloon (DCB). This device is designed specifically for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease, which occurs when a previously stented blood vessel becomes obstructed or narrowed due to plaque or scar tissue.

In November 2022, Cordis, a US-based manufacturer of interventional cardiovascular technologies, completed the acquisition of Med Alliance SA for $1.1 billion. Through this acquisition, Cordis aims to globally provide the drug-eluting balloon SELUTION SLRTM (Sustained Limus Release) to two million patients by 2027. Med Alliance SA, based in Switzerland, is a developer of the sirolimus micro-reservoir drug-coated balloon.

Major companies operating in the drug-coated balloons market include Acotec Scientific AG, B. Braun Melsungen AG, Biosensors International Group Ltd, Medtronic Inc., Boston Scientific Corporation, Opto Circuits, Concept Medical, Cardionovum GmbH, Endocor GmbH, Hexacath Sverige, iVascular SLU, Minvasys SAS, MedAlliance, QT Vascular Ltd, Terumo Corporation, Biotronik, Cook Medical, Cordis Corporation, Abbott Laboratories, Surmodics Inc., Hexacath SAS, MicroPort, SurModics Inc., Orchestra BioMed.

North America was the largest region in the global drug-coated balloons market in 2024, and is expected to be the fastest-growing region in the forecast period. The regions covered in the drug-coated balloons market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the drug-coated balloons market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

A drug-coated balloon (DCB) is a medical device employed in the intervention of narrowed or obstructed blood vessels, particularly in interventional cardiology and interventional radiology. Its design facilitates the direct delivery of medication to the site of vascular disease while concurrently performing angioplasty.

The primary categories of products encompassed within drug-coated balloons include those tailored for peripheral artery disease, coronary artery disease, and other indications. Drug-coated balloons (DCBs) for peripheral artery disease are a specific type of medical device utilized in addressing peripheral artery disease (PAD). PAD is characterized by the narrowing or blockage of blood vessels outside the heart or in the lower extremities. Various drug types, such as paclitaxel and sirolimus, are employed, and the end-users encompass hospitals, cardiac catheterization labs, and ambulatory surgical centers.

The drug-coated balloons market research report is one of a series of new reports that provides drug-coated balloons market statistics, including drug-coated balloons industry global market size, regional shares, competitors with a drug-coated balloons market share, detailed drug-coated balloons market segments, market trends and opportunities, and any further data you may need to thrive in the drug-coated balloons industry. This drug-coated balloons market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The drug-coated balloons market consists of sales of everolimus and zotarolimus drug-coated balloons. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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