Global Drug-Coated Balloons (DCBs) Market - Focused Insights 2024-2029

GLOBAL DRUG-COATED BALLOONS MARKET INSIGHTS

The global market for drug-coated balloons was valued at USD 965.41 million in 2023, with projections indicating it will reach USD 2.31 billion by 2029, reflecting a CAGR of 15.72% during the forecast period. This growth is primarily driven by the promising clinical outcomes associated with these treatments, surpassing alternative options in effectiveness. Furthermore, the rising number of patients suffering from peripheral and coronary artery diseases is significantly boosting the demand for drug-coated balloons. Ongoing advancements in technology and the expanding applications of these devices in larger native vessel procedures also present considerable opportunities for market growth.

DCBs, also referred to as drug-eluting balloons, are widely used medical devices aimed at preventing and treating restenosis in both peripheral and coronary arteries. These semi-compliant angioplasty balloons are coated with antiproliferative medications, which are released into the blood vessel during balloon inflation. DCBs facilitate the dilation of stenotic coronary arteries while simultaneously delivering drugs designed to inhibit neointimal hyperplasia.

DRUG-COATED BALLOONS MARKET TRENDS & DRIVERS

Ongoing Innovations in Interventional Cardiology with DCB

The escalating prevalence of cardiovascular diseases is propelling the advancement of interventional cardiology, leading to the innovation of drug-coated balloons. Traditional metallic stents face several limitations, whereas DCBs have demonstrated superior efficacy in drug transfer to vessel walls. They have proven beneficial in addressing in-stent restenosis and various complex coronary artery disease scenarios, including bifurcations, as well as small and large vessel disease, along with other critical clinical situations such as diabetes, acute coronary syndrome, and patients at high risk of bleeding. This shift towards DCBs—either as standalone solutions or in combination with drug-eluting stents—marks a significant trend in the industry. The application of DCBs in treating bifurcation lesions is gaining traction, particularly for patients with diabetes mellitus, a condition that adversely affects vascular health and has shown adverse remodeling at coronary sites. DCBs have demonstrated lower rates of major adverse cardiovascular events (MACE) and myocardial infarction (MI) in these high-risk patients, highlighting their potential to address emerging medical challenges effectively. Recent technical and scientific advancements in DCBs within interventional cardiology suggest an expected increase in their application across various cardiology treatments, opening up substantial revenue growth opportunities.

Enhancing Clinical Outcomes with DCBs

DCB catheter-based interventional methods represent a significant advancement over traditional minimally invasive endovascular and open surgical techniques. Procedures utilizing DCBs typically result in fewer complications, higher success rates, and quicker recovery times compared to other approaches. Because of these benefits, vascular surgeons and manufacturers advocate for DCBs in treating a variety of peripheral artery disease (PAD), coronary artery disease (CAD), and other vascular issues. DCBs are specifically engineered to deliver antiproliferative medication directly to the coronary or peripheral lesion without the use of metallic stents, making them a preferred alternative for CAD and PAD, particularly in cases of in-stent restenosis. Among younger adults, DCBs are increasingly favored as they eliminate the need for a permanent stent in the body. The rise in PAD and CAD cases in younger populations is anticipated to drive significant demand for DCBs in the future.

In recent years, the clinical adoption of DCBs has surged, thanks to the advent of next-generation devices that have markedly enhanced treatment outcomes for arterial diseases. Restenosis remains a substantial challenge for patients undergoing stent procedures for vascular disease, and DCB technology has proven to be more effective than angioplasty and other surgical options, especially for high-risk patients where traditional surgeries are complex. Treatments involving DCBs provide patients with precise, polymer-free, and uniform drug delivery mechanisms that address the limitations of standard angioplasty. This approach can also help reduce the need for unnecessary stent placements. DCBs are emerging as a new therapeutic strategy for CAD, allowing for rapid and uniform delivery of antiproliferative drugs to the vessel wall during a single balloon inflation without the installation of permanent implants.

GLOBAL DRUG-COATED BALLOONS MARKET INSIGHTS

• By Indication: The global drug-coated balloons market is categorized by indication into PAD, CAD, and other indications, with the PAD segment holding the largest market share. PAD is a prevalent condition linked to atherosclerosis, affecting over 210 million people globally in 2023. Currently available drug-coated balloons featuring paclitaxel and sirolimus have been shown to lower the risk of artery re-narrowing. Paclitaxel is clinically validated to prevent scar tissue formation in blood vessels that can lead to artery narrowing once again. In recent years, DCBs have been extensively utilized in managing PAD, as they have proven effective in enhancing blood flow to the legs and minimizing the need for repeat procedures to address blocked vessels, thus fostering growth in this segment.
• By Drug: The global drug-coated balloons market is divided into two main drug types: paclitaxel and sirolimus. The paclitaxel segment is experiencing substantial growth and has the highest CAGR projected for the forecast period. Paclitaxel is recognized as an effective treatment for coronary in-stent restenosis, making it a popular choice in percutaneous coronary intervention (PCI) procedures, which are performed on millions of patients worldwide each year. As an anti-neoplastic and cytotoxic drug, paclitaxel works by binding to microtubules, inhibiting cell mitosis, and preventing cell division and proliferation. It was the first drug developed for use in drug-coated balloon technology and continues to be extensively utilized globally. Its lipophilicity enables quick cellular penetration, enhancing its long-lasting antiproliferative effects. Improvements in excipients for paclitaxel formulations, such as urea, n-butyryl citrate, and acetyl tributyl citrate, have resulted in favorable clinical outcomes and boosted the effectiveness of paclitaxel-coated balloons, further driving growth in this segment.
• By End-Users: Multi-specialty hospitals represent the largest segment of the global drug-coated balloons market. These hospitals generate significant revenue from DCB applications, as angioplasty procedures are commonly performed there due to a higher volume of cases compared to specialty hospitals. Cardiologists at multi-specialty hospitals frequently utilize drug-coated balloons for PCI in the treatment of PAD, CAD, and other related health issues. The presence of skilled healthcare professionals and advanced services in angiography and cardiology attract more patients to these facilities. In addition, multi-specialty hospitals provide comprehensive cardiac care and diagnoses within a single location, which minimizes costs and improves communication, contributing to their growth.

Drug-Coated Balloons Market Geographical Analysis

North America holds the largest share of the global drug-coated balloons market and is anticipated to grow at the highest CAGR during the forecast period. The US leads this region due to a high volume of PCI procedures, a substantial patient population, and significant healthcare spending on treating CAD and PAD, driving the demand for balloon angioplasties. With over 22 million individuals affected by peripheral artery disease facing numerous health challenges, drug-coated balloons have become a preferred option for PAD management in the region. Recent approvals of several DCBs for PAD management in the US have further fueled market growth.

Global Drug-Coated Balloons Market Competitive Analysis

The global drug-coated balloons market report provides exclusive insights into 25 companies operating within this space. The market is relatively concentrated, with a mix of established leaders and emerging players. Major companies dominate the landscape, but there are notable opportunities for new entrants. While the market is largely led by significant players, many innovative small firms and research-oriented organizations are developing new technologies and products. Companies such as BD, Boston Scientific, B. Braun SE, Medtronic, Koninklijke Philips, and Biotronik hold considerable market shares. These firms continuously invest in the development of advanced DCBs, positioning themselves to maintain dominance in the market.