Global Drug-Coated Balloons Market - Focused Insights 2024-2029

MARKET INSIGHTS

The global drug-coated balloons market was valued at USD 965.41 million in 2023 and is expected to reach USD 2.31 billion by 2029, growing at a CAGR of 15.72% during the forecast period. The market growth mainly results from promising clinical outcomes over several alternative treatments that drive significant market growth. The increasing potential patient population with peripheral and coronary artery diseases is accelerating the demand for drug-coated balloons. Moreover, the continued advancements and increasing application of drug-coated balloons in large native vessel procedures are expected to deliver lucrative market growth opportunities.

Drug-coated balloon (DCB) is widely used medical devices to prevent and treat restenosis in peripheral and coronary arteries. Drug-coated balloons are also known as drug-eluting balloons. They are semi-compliant angioplasty balloons covered with antiproliferative medicine, which is delivered into the vessel during inflammation of the balloon. DCBs are designed to dilate the stenotic coronary artery while delivering drugs to suppress neointimal hyperplasia.

MARKET TRENDS & DRIVERS

Continuous Advancements in Interventional Cardiology with DCB

The growing burden of cardiovascular diseases is accelerating the continued development of interventional cardiology and has led to the development of drug-coated balloons. Traditional metallic stents represent several limitations in interventional cardiology, where DCBs have clinically proven better for transferring drugs into vessel walls. From in-stent restenosis to several other major CAD scenarios such as complex bifurcations, de novo small and large vessel disease, and diffuse coronary diseases, as well as other critical clinical conditions such as diabetes, acute coronary syndrome, and high bleeding risk patients are becoming the new approaches for drug-coated balloons. It is becoming a new trend in the DCB industry alone or as a part of blended strategies in combination with drug-eluting stents. With the consideration of all these factors, drug-coated balloons have emerged as the most promising option to tackle coronary artery disease (CAD). Currently, the use of DCB in bifurcation lesions is becoming an attractive scenario. The role of DCB in patients with diabetes mellitus is increasing. It is a high-risk health condition impacting overall vascular territories and has shown negative remolding at the coronary sites where DCB shows significantly lower MACE and myocardial infarction (MI). In patients with high bleeding risk, the risk of high bleeding is reduced. These factors indicate that the DCB has significant potential to tackle these new conditions and is expected to deliver significant revenue growth opportunities. There are important technical and scientific advances registered in DCB in interventional cardiology in recent years, and it is expected to increase its application in various cardiology treatments.

Growing Application of Drug-coated Balloons for Large Native Vessels

Drug-coated balloons have been widely accepted in small-vessel diseases in the past few years. However, continued research and efforts have increased the application of DCB in large native vessels. Several factors support the increased investigation and use of DCB in large vessels, resulting in greater safety and better clinical outcomes than other treatments. The use of DCB in large vessel procedures offers several advantages, such as releasing medicine in large vessels without leaving metal or foreign particles behind. It eliminated the risk of stent strut malapposition, specifically in vessels with irregular walls, bifurcations, or aneurismatic dilatation. Furthermore, the increasing use of drug-coated balloons is becoming a popular choice over drug-eluting stents (DES) implantation in large vessel procedures due to high bleeding risk with DES.

Increasing Promising Clinical Outcomes with DCBs

DCB catheter-based interventional procedures are more advanced than other minimally invasive endovascular and open surgical techniques. Interventional procedures with DCBs are associated with fewer complications, higher success rates, and faster recovery rates than other techniques. Owing to such advantages, vascular surgeons and manufacturers recommend using DCBs for treating a wide range of PAD, CAD, and other arterial/vascular diseases. DCBs are designed to deliver antiproliferative medicine/agent to the coronary or peripheral lesion without the use of metallic stent and were considered as an alternative treatment for CAD & PAD, specifically for in-stent restenosis. Among young adults, DCBs are becoming the leading choice due to the lack of a stent in the body for their entire lives. The increasing cases of PAD and CAD among the young population are expected to deliver significant demand for DCBs in the upcoming years. The clinical utilization of DCBs has increased significantly over the past few years due to the introduction of next-generation devices, which have significantly improved the outcome of arterial disease treatment procedures. Restenosis is one of the major challenges/complications in patients who undergo stenting procedures for treating vascular diseases. DCB technology is proven to be more efficient than angioplasty and other open surgical techniques, especially in high-risk and complicated patients whose performing open surgeries, re-stenting, and other minimally invasive procedures is difficult. Treatment with DCBs offers patients a targeted, polymer-free, and homogenous drug delivery designed to overcome angioplasty procedures' limitations/unmet needs. Also, it helps to minimize the number of unnecessary stent implantations. DCBs are considered a novel alternative therapeutic strategy for CAD due to the fast and homogenous transfer of antiproliferative drugs into the vessel wall during single balloon inflation without permanent implants.

INDUSTRY RESTRAINTS

Alternative Interventional Procedures for Drug-coated Balloons

The availability of standard treatment options, the high initial cost of the device, and low awareness regarding DCB technology are hindering the growth prospects of DCBs globally. Over the past decade, major progress has been made in the percutaneous treatment of vascular diseases. Surgical bypass and endovascular procedures such as standard balloon angioplasty, stenting, and endograft are the most widely used treatment procedures for arterial diseases. Conventional balloon angioplasty, which uses standard balloon catheters, is considered the first line of treatment for several arterial diseases. Initially, the advent of balloon angioplasty offered an alternative treatment option for revascularization. Even for ESRD patients undergoing dialysis, physicians opt for plain balloon angioplasty due to their widespread acceptance and the availability of a broad range of commercial balloon catheters. In percutaneous coronary intervention cases, more than 80% of cases proceed with coronary stents over drug-coated balloons. Even for ESRD patients undergoing dialysis, physicians opt for plain balloon angioplasty due to their widespread acceptance and the availability of a broad range of commercial balloon catheters.

SEGMENTATION INSIGHTS

INSIGHTS BY INDICATION

The global drug-coated balloons market by indication type is segmented into peripheral artery disease (PAD), coronary artery disease (CAD), and other indications. The peripheral artery disease segment dominates, with the largest market share. Peripheral artery disease (PAD) is one of the prevalent health conditions associated with atherosclerosis, affecting more than 210 million people in 2023, worldwide. Drug-coated balloons with paclitaxel and sirolimus drug are currently available in the market, which reduces the risk of re-narrowing arteries. Paclitaxel is clinically proven to prevent scar tissue formation in blood vessels that can re-narrow the artery. DCBs have been used in high proportion in recent years in PAD management, as they have proven to improve blood flow to the legs and reduce the requirement for repeat procedures to reopen blocked vessels, thus helping the segment's growth.

INSIGHTS BY DRUG

The global drug-coated balloons market by drug type is categorized into paclitaxel and sirolimus. The paclitaxel drug segment shows significant growth, with the fastest-growing CAGR during the forecast period. In drug-coated balloons, paclitaxel is an effective treatment for coronary in-stent restenosis. Globally, millions of people undergo percutaneous coronary intervention (PCI) annually, where paclitaxel-coated balloons are considered an effective treatment. This anti-neoplastic, cytotoxic drug binds to the microtubules in the cell mitosis procedure and restricts cell division and proliferation. It was the first developed drug for a drug-coated balloon module and is still widely used across the global markets. In DCB, paclitaxel is the most widely used drug due to its physiochemical characteristics. The lipophilicity of the drugs enables rapid penetration into the cell and supports longer antiproliferative action. Furthermore, the advancement in excipient for paclitaxel-coated blood, such as the development of urea, n-butyryl citrate, and acetyl tributyl citrate, delivers positive clinical outcomes and has proven to increase the effectivity of paclitaxel-coated balloons accelerating the segmental growth.

INSIGHTS BY END-USERS

The multi-specialty hospital end-user segment accounted for major global drug-coated balloons market share. Multi-specialty hospitals are leading revenue generators for DCB markets. Angioplasty procedures are commonly performed in multi-specialty hospitals across several health conditions where the uptake volume of DCB is higher than in specialty hospitals. Cardiologists in multi-specialty hospitals widely used drug-coated balloons for PCI procedures in PAD, CAD, and other diseases treatment and management of patients who are suffering from several consequences of cardiovascular diseases. The presence and access of skilled healthcare professionals and high-class services of angiogram, angioplasty, and cardiology interventions with deep understanding and expertise in CVD management get more patients' attention to multi-specialty hospitals than other healthcare settings. Multi-specialty hospitals offer high-class services, specialties, infrastructure, bulk-order medical devices, and more access and revenue growth opportunities. In addition, multi-specialty hospitals cover several cardiac procedures and diagnoses under one facility, which reduces the cost burden, travel, and challenges associated with diagnosis and related communication barriers. These settings help the segment to grow.

GEOGRAPHICAL ANALYSIS

North America accounted for the largest share and stands first in the global drug-coated balloons market. North America is expected to grow at the highest CAGR during the forecast period. The U.S. dominates the region due to the high volume of percutaneous coronary interventions, a large pool of patient population, and high healthcare expenditure regarding treating CAD PAD, which leads to demand for balloon angioplasties. More than 22 million people suffer from peripheral artery disease and witnessed several health risks. DCB is the preferred choice in PAD management in the region. Furthermore, several DCBs in PAD management have been approved in the U.S. in the past few years, accelerating the market growth.

COMPETITIVE LANDSCAPE

The global drug-coated balloons market report contains exclusive data on 25 companies. The market is fairly concentrated, with several prominent and upcoming players. Large corporations dominate the market. However, there are significant growth opportunities for new entrants. Though the market is dominated by major players, many investigational and small companies are coming into existence with innovative products and technologies. BD, Boston Scientific, B. Braun SE, Medtronic, Koninklijke Philips, and Biotronik are some leading companies accounting for significant shares in the global drug-coated balloons market. These vendors are continuously developing and investing in drug-coated balloons and are expected to dominate the market with continued engagement in advanced DCB development.