DRUG ELUTING BALLOON MARKET ANALYSIS

Market Size and Trends

Global drug eluting balloon market is estimated to be valued at USD 713.9 Mn in 2024 and is expected to reach USD 1,271.1 Mn by 2031, exhibiting a compound annual growth rate (CAGR) of 8.6% from 2024 to 2031.

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Global drug eluting balloon market has witnessed significant growth, owing to rising prevalence of cardiovascular diseases worldwide. As per estimates, cardiovascular diseases account for over 17.9 million deaths globally every year. Factors such as growing geriatric population, increasing obesity rates, and changing lifestyle habits increases the risk of cardiovascular diseases, and this  boosts demand for drug eluting balloons as a safer minimally invasive treatment alternative to stenting. Ongoing advancements in balloon material and drug coating technologies drives the market growth by introducing newer and more effective products with enhanced vessel healing, antiesthetic, and anti-proliferative properties.

Market Driver – Increasing Product Launches by Key Market Players

Market players are engaged in launching new drugs, and this is expected to drive growth of the global drug eluting balloon market over the forecast period. For instance, in July 2021, Med Alliance SA, a medical technology company, launched ORIGIN SC and ORIGIN NC, two high performance drug eluting balloons for vessel preparation. These complement SELUTION SLR, its novel sirolimus-eluting balloon. ORIGIN SC is a semi-compliant (SC) PTCA balloon with a very low crossing profile, thus, making it an excellent choice for challenging lesions. ORIGIN SC offers one of the broadest portfolios of sizes available for an semi-compliant (SC) balloon, including 1.00 mm, 1.25 mm, 1.50 mm and 1.75 mm balloon diameters to treat very small vessels and complex cases. ORIGIN NC is a non-compliant (NC) PTCA balloon, combining high pressure tolerance and controlled compliance with an optimal crossing profile for the most challenging cases.

Market Concentration and Competitive Landscape

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Increasing prevalence of cardiovascular diseases across the globe is expected to drive the growth of the drug eluting balloon market. World Health Organization, cardiovascular diseases account for over 17.9 million deaths each year globally. Some of the major cardiovascular conditions include coronary heart disease, stroke and peripheral arterial disease. Aging populations, changing environmental factors and genetic predispositions  further contribute to rising disease burden. Drug eluting balloons are being increasingly used by physicians for treating peripheral arterial diseases affecting the hips and legs as well as coronary artery diseases impacting the heart. These prevent vessel recoil and neointimal hyperplasia after angioplasty procedures through the controlled, localized delivery of anti-proliferative drugs to damaged vessel sites. This minimizes the risk of restenosis and the need for additional revascularization treatments. Recent clinical studies have demonstrated drug eluting balloons to be as effective as drug eluting stents in addressing various types of atherosclerotic lesions with fewer safety issues.

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Lack of proper reimbursement policies across different geographies can hamper the growth of global drug eluting balloon market. In the case of drug eluting balloons, the reimbursement scenarios vary significantly across countries and regions. In many developing nations, there are no established reimbursement codes or payment guidelines for procedures that utilize drug eluting balloons. Healthcare facilities have to bear the costs of procuring these high-priced medical devices from their own budgets, without any assurance of being compensated for their use. This discourages hospitals and clinics from stocking and using drug eluting balloons, especially for treating conditions like peripheral artery disease, when plain old balloon angioplasty, a much cheaper alternative, is available. Even in developed markets, the reimbursement policies favor traditional uncoated balloons over drug coated versions in some cases.

Market Opportunity – Increasing Inorganic Growth Strategies by Key Market Players

Increasing adoption of inorganic growth strategies, such as acquisition, by key market players is expected to offer lucrative growth opportunities over the forecast period. For instance, in October 2022, Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technologies, announced the acquisition of Med Alliance SA, a medical technology company. The acquisition enabled Cordis will immediately begin co-promotion of MedAlliance’s SELUTION SLR drug-eluting balloon in markets where it is commercially available.

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Product Type segment is sub-segmented into coronary drug eluting balloon, peripheral drug eluting balloon, others. Coronary drug eluting balloon sub-segment is estimated to hold 47.3% of the market share in 2024, owing to the growing need for minimally invasive treatments. Drug eluting balloons address this challenge by utilizing drug coated non-expandable balloons to treat lesions in a single procedure. Upon inflation, the drug is infused to the vessel walls to prevent narrowing of arteries without leaving behind a metallic implant. This saves patients from undergoing multiple procedures and allows for faster recovery times. The one-time therapy increases treatment adherence and compliance for chronic PAD patients who are often elderly with comorbidities. As peripheral artery disease prevalence rises with an aging global population, demand for effective therapies with fewer side effects increases. Drug eluting balloons are well-positioned to cater to this need due to their minimally invasive profile and quick treatment resolutions.

Insights, By Technology: Superior clinical results boosts adoption of lead freepac technology  

Technology segment is sub-segmented into freepac, transpac, enduracoa, others. Freepac sub-segment is estimated to hold 39.3% of the market share in 2024 due to its proven superior clinical outcomes. Among drug coating technologies, FreePac uses a innovative approach without a guiding catheter to infuse drugs onto the balloon surface. Unlike competitive TransPac or EnduraCoat technologies which rely on enclosed drug reservoirs, FreePac allows for homogenous drug transfer unconstrained by physical borders or flow restrictions. Several randomized control trials have demonstrated FreePac's ability to achieve high vessel wall concentrations with extensive, transmural drug transfer and coverage. Its unrestricted fluid dynamics minimizes residual ducts and dead spaces, addressing shortcomings of traditional systems. As a result, FreePac has shown advantages in reducing risk of target lesion revascularization compared to competing technologies. It offers durable clinical results with low vascular retreatment needs over extended follow up periods

Insights, By End User: Preference for outpatient treatment drives hospital adoption

End User segment is sub-segmented into hospitals, ambulatory surgical centers, others. Hospitals sub-segment is estimated to hold 35.7% of the market share in 2024 as these are the preferred settings for drug eluting balloon procedures. While ambulatory surgical centers also provide such services, hospitals offer logistic and personnel infrastructure required for complex cases, especially in high-risk patients. Their large scale allows for economies needed to support technological innovations like drug eluting balloons. Importantly, hospitals enable treatment in outpatient settings which is driving increased adoption. Drug eluting balloons enable same day discharge for many patients due to speed and minimally invasive nature versus stent or surgery alternatives. This reduces burden on inpatient beds and wait times. Favorable reimbursements for such same day discharges further incentivize hospitals to incorporate such technologies.

Regional Insights

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North America remains the dominant region in the global drug eluting balloon market and is estimated to hold 43.9% of the market share in 2024 due to  high healthcare expenditure, presence of leading players and adoption of advanced technologies at faster pace in countries like U.S. and Canada. Rising prevalence of cardiovascular diseases in North America contributes to larger patient pool undergoing angioplasty procedures, where drug eluting balloons are widely used. North America is an attractive base for many international players to set up manufacturing facilities due to availability of key resources and skilled workforce.

One of the fastest growing regions for drug eluting balloon market is Asia Pacific excluding Japan (APEJ). The growth can be attributed to rising healthcare infrastructure, growing medical tourism industry and increasing disposable incomes in developing economies like China and India. Both China and India have a huge population base with growing disease burdens and rising cases of lifestyle diseases. This serves as a huge patient pool and potential market for all medical devices including drug eluting balloons. Additionally, many Asian countries are focusing on enhancing healthcare access through various governmental initiatives, and this boosts demand for cost-effective treatment alternatives like drug eluting balloons.

Market Report Scope

Key Developments

• On March 1, 2024, Boston Scientific Corporation, a medical device company, announced that the U.S. Food and Drug Administration had approved the AGENT Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease
• In January 2023, Med Alliance SA, a medical technology company, announced that it had received conditional U.S. FDA investigational device exemption (IDE), for its its novel sirolimus-eluting balloon
• In September 2022, Advanced NanoTherapies, Inc., a privately-held medical device company, announced that the U.S. Food and Drug Administration had granted the company a Breakthrough Device designation for its SirPlux Duo Drug-Coated Balloon (DCB) for coronary artery disease in vessels less than 3.0mm
• In July 2021, Medtronic, a medical device company, launched Prevail drug coated balloon (DCB) Catheter in Europe, following CE (Conformité Européene) mark. It is designed to treat complex lesions with superior deliverability, rapid absorption of paclitaxel

*Definition: A drug-eluting balloon is a non-stent technology in which the effective homogenous delivery of anti-proliferative drugs is processed by the vessel wall through an inflated balloon. The drug eluting balloon consists of balloon catheters coated with an anticancer or anti-restenotic drug which is delivered to the treatment site during balloon inflation. These drug coated balloons provide an alternative to drug eluting stents for treating arterial blockages and openings in superficial arteries. The drug eluting balloons are used in coronary and peripheral artery disease to prevent renarrowing of arteries post angioplasty. 

Market Segmentation

•  Product Type Insights (Revenue, USD Mn, 2019 - 2031)
  • Coronary Drug Eluting Balloon
  • Peripheral Drug Eluting Balloon
  • Others
•  Technology Insights (Revenue, USD Mn, 2019 - 2031)
  • FreePac
  • TransPac
  • EnduraCoa
  • Others
•  End User Insights (Revenue, USD Mn, 2019 - 2031)
  • Hospitals
  • Ambulatory Surgical Centers
  • Others
• Regional Insights (Revenue, USD Mn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Boston Scientific Corporation
  • BD
  • Terumo Corporation
  • Medtronic
  • B. 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.