Drug Eluting Balloons - Market Insights, Competitive Landscape, and Market Forecast - 2028

Drug Eluting Balloons - Market Insights, Competitive Landscape, and Market Forecast - 2028

Drug-Eluting Balloon Market By Product Type (Coronary Drug-Eluting Balloon, Peripheral Drug-Eluting Balloon, And Others), End-User (Hospitals, Ambulatory Surgical Centers, And Others), and geography is expected to grow at a steady CAGR forecast till 2028 owing to the increasing prevalence of peripheral and coronary artery diseases and rising demand for minimally invasive procedures across the globe

Global drug-eluting balloon market is estimated to grow at a CAGR of 8.31% during the forecast period from 2023 to 2028. The demand for drug-eluting balloons is primarily being boosted by the increasing prevalence of numerous heart diseases including peripheral and coronary artery diseases. Furthermore, the increasing preference for minimally invasive procedures, the advantages of balloon catheters over drug-eluting stents, the rising elderly population base, and others will propel the demand for drug-eluting balloons in the upcoming years. In addition, growing healthcare spending, especially in emerging countries, rising product launches and approvals, and surging research and developmental activities by the key players, among others are thereby contributing to the overall growth of the drug-eluting balloon market during the forecast period from 2023-2028.

Drug-Eluting Balloon Market Dynamics:

The drug-eluting balloon market is witnessing a growth in product demand owing to various factors, one of the key factors being the rising figures of heart diseases comprising peripheral and coronary artery disease.

For instance, according to the American Heart Association 2022, globally, it was estimated that in 2020, 244.1 million people were living with ischemic heart disease (IHD), also known as coronary heart or coronary artery disease. The same source estimated that it was more prevalent in males than in females, 141.0 and 103.1 million people, respectively.

Further, British Heart Foundation 2023 estimated that the peripheral arterial (vascular) disease accounted for 110 million cases in 2019, globally.

Thus, the increasing prevalence of coronary and peripheral artery disease will increase the demand for drug-eluting balloons as they are frequently used to treat and manage the disease.

Additionally, various advantages of these catheters over drug-eluting stents in targeted drug delivery have increased their use in angioplasty surgeries for a number of cardiovascular indications. These devices provide better angiographic and clinical outcomes as compared to stents or open surgeries. Also, the drug-coated balloons are the most adaptive therapeutics approach for coronary disease due to their various advantages including minimal side effects. Further, drug-coated balloon catheter usage with minimally invasive procedures is a preferable replacement over risky stent treatment for myocardial infarction.

Also, market participants frequently develop new products to increase their visibility. For instance, in June 2023, Surmodics, Inc., a leading provider of medical devices and in vitro diagnostic technologies to the healthcare industry, received the US Food and Drug Administration (FDA) approval for the SurVeil™ drug-coated balloon (DCB).

Therefore, the above-mentioned factors are contributing to the growth of the drug-eluting balloon market during the forecast period from 2023-2028.

However, adverse effects and product recalls, stringent regulatory procedures and others may restrict the drug-eluting balloon market growth.

Drug-Eluting Balloon Market Segment Analysis:

Drug-eluting Balloon Market by Product Type (Coronary Drug-Eluting Balloon, Peripheral Drug-Eluting Balloon, and Others), End-User (Hospitals, Ambulatory Surgical Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and the Rest of the World)

In the product type segment of the drug-eluting balloon market, the peripheral drug-eluting balloon category is expected to amass a significant revenue share in the year 2022. This was primarily owing to the benefits that various the segment and the rising figures of peripheral artery disease (PAD) across the globe.

According to DelveInsight estimates, the US accounted for approximately 9 million cases, which was the highest diagnosed prevalent cases of peripheral artery disease, followed by EU4 and the UK with 5 million cases, and Japan with 2 million cases in 2022. Further, among the European countries, Germany had the highest diagnosed prevalent population of peripheral artery disease (approximately 2 million cases), followed by Italy (approximately 1 million cases) in 2022. On the other hand, Spain (0.7 million cases) had the lowest diagnosed prevalent population in EU4 and the UK countries and the 7MM.

Thus, the above statistics show that PAD is increasing at a faster pace, which is ultimately driving the segment for peripheral drug-eluting balloons.

Numerous businesses and key players in this field are also working to create technologically advanced peripheral drug-eluting balloons. For instance, in August 2022, BD (Becton, Dickinson, and Company), a leading global medical technology company, announced the start of enrollment in a first-in-human trial of a peripheral sirolimus drug-coated balloon (DCB). The PREVISION trial is a prospective, multicenter, single-arm, non-randomized study designed to evaluate the safety of the BD sirolimus DCB in the treatment of peripheral arterial disease in the femoropopliteal arteries.

Also, in November 2020, Boston Scientific received US Food and Drug Administration (FDA) approval for the Ranger™ Drug-Coated Balloon, developed for the treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

Thus, the above-mentioned factors are likely to propel the demand for peripheral drug-eluting balloons, thereby contributing to the growth of the drug-eluting balloon market during the forecast period from 2023-2028.

North America is expected to dominate the overall Drug-Eluting Balloon Market:

Among all the regions, North America is estimated to account for the largest share in the drug-eluting balloon market in the year 2022. This domination is due to the increasing application of drug-eluting balloons in the treatment and management of peripheral and coronary artery disease, increasing sedentary lifestyle lacking physical activity, lack of proper diet, anxiety, and stress resulting in chronic diseases, such as diabetes and obesity, leading to an increase in the prevalence of multiple cardiovascular diseases, rising product launch and approvals, presence of favorable regulatory authority, among others will propel the market of drug-eluting balloon in North America.

For instance, as per the study conducted by the Centre for Disease Control and Prevention (CDC) in 2023, it was stated that in 2021, about 1 in 20 adults age 20 and older have coronary artery disease (CAD). Coronary heart disease is the most common type of heart disease in the US, killing 375,476 people in 2021. In 2021, about 2 in 10 deaths from CAD happen in adults less than 65 years old. Thus, the high burden of cardiovascular diseases in the region demands the availability of drug-eluting balloons.

The American Heart Association in the latest study estimated that over 500,000 percutaneous coronary intervention (PCI) procedures are carried out annually in the US. Percutaneous coronary intervention with a drug-coated balloon (DCB) is a novel treatment that seeks to acutely dilate coronary stenosis and deliver an anti-proliferative drug to the vessel wall. Thus, the surging number of PCI procedures in the region will increase the demand for drug-eluting balloons.

Further, the availability of various major manufacturers, the launch and approval of new and technologically advanced devices, and favorable reimbursement regulations are all important factors responsible for driving the demand for drug-eluting balloons in the region. For instance, in November 2022, Genesis MedTech Group announced that the Food and Drug Administration (FDA) has approved the Chocolate Touch® Drug-coated Balloon PTA Catheter, developed by TriReme Medical LLC, for the treatment of patients with peripheral artery disease in the superficial femoral artery and the popliteal artery.

Thus, all the above-mentioned factors will lead to an increase in the North America drug-eluting balloon market growth during the forecasting period of 2023-2028.

Drug-Eluting Balloon Market Key Players:

Some of the key market players operating in the drug-eluting balloon market include Boston Scientific Corporation, BD, Terumo Corporation, Medtronic, Koninklijke Philips N.V., M.A. Med Alliance SA., Cook, BIOTRONIK, SurModics Inc., B. Braun SE, Aachen Resonance Entwicklungsgesellschaft mbH, Biosensors International Group, Ltd., Eurocor GmbH, iVascular, Innvolution, Cardiovascular Systems, Inc., Genesis Medtech, Concept Medical, Cardionovum GmbH, YINYI (LIAONING) BIOTECH CO., LTD., and others.

Recent Developmental Activities in the Drug-Eluting Balloon Market:

In May 2023, the US FDA granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc’s novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.

In September 2022, the FDA granted Advanced NanoTherapies a Breakthrough Device Designation (BDD) for its SirPlux Duo Drug-Coated Balloon (DCB) to treat coronary artery disease.

In October 2022, Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technologies, announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance, a Switzerland-based company at the forefront of transformative drug-eluting balloons.

In February 2021, Cardiovascular Systems, Inc. partnered with Chansu Vascular Technologies, LLC (CVT) to develop novel peripheral and coronary everolimus drug-coated balloons (DCBs). This partnership brings together CSI’s leadership in the treatment of calcified arterial lesions with Dr. Philippe Marco, a pioneer in the successful development of several drug-coated devices.

Key Takeaways from the Drug-Eluting Balloon Market Report Study

Market size analysis for current drug-eluting balloon market size (2022), and market forecast for 5 years (2023-2028)

Top key product/services/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years

Key companies dominating the global drug-eluting balloon market.

Various opportunities available for the other competitor in the drug-eluting balloon market space.

What are the top-performing segments in 2022? How these segments will perform in 2028.

Which are the top-performing regions and countries in the current drug-eluting balloon market scenario?

Which are the regions and countries where companies should have concentrated on opportunities for drug-eluting balloon market growth in the coming future?

Target Audience who can be benefited from this Drug-Eluting Balloon Market Report Study

Drug-eluting balloon products providers

Research organizations and consulting companies

Drug-eluting balloon-related organizations, associations, forums, and other alliances

Government and corporate offices

Start-up companies, venture capitalists, and private equity firms

Distributors and Traders dealing in a drug-eluting balloon

Various End-users who want to know more about the drug-eluting balloon market and the latest technological developments in the drug-eluting balloon market.

Frequently Asked Questions for the Drug-Eluting Balloon Market:

1. What is a drug-eluting balloon?

Drug-eluting balloons also known as drug-eluted balloon catheters are semi-compliant angioplasty balloons that are used to elute the drug in the targeted vessel.

2. What is the market for global drug-eluting balloons?

Global drug-eluting balloon market is estimated to grow at a CAGR of 8.31% during the forecast period from 2023 to 2028.

3. What are the drivers for the global drug-eluting balloon market?

The demand for drug-eluting balloons is primarily being heightened by the rise in the number of patients suffering from atherosclerosis, obstructive coronary artery disease, peripheral vascular disease, and others. Additionally, technological improvements in the devices, rising the demand for minimally invasive surgical treatments, the increasing elderly population base, and surging market players' concentration on creating cost-efficient, accurate, and effective drug-eluting balloon catheters among others are thereby contribute to the overall growth of the drug-eluting balloon market during the forecast period from 2023-2028.

4. Who are the key players operating in the global drug-eluting balloon market?

Some of the key market players operating in the drug-eluting balloon market include Boston Scientific Corporation, BD, Terumo Corporation, Medtronic, Koninklijke Philips N.V., Cordis, Cook, BIOTRONIK, SurModics Inc., B. Braun SE, Aachen Resonance Entwicklungsgesellschaft mbH, Biosensors International Group, Ltd., Eurocor GmbH, iVascular, Innvolution, Cardiovascular Systems, Inc., Genesis Medtech, Concept Medical, Cardionovum GmbH, YINYI (LIAONING) BIOTECH CO., LTD., and others.

5. Which region has the highest share in the drug-eluting balloon market?

North America is expected to dominate the overall drug-eluting balloon market during the forecast period from 2023-2028. Factors such as the increasing prevalence of peripheral and coronary artery disease, rising geriatric population base in the region, surging demand for minimally invasive surgeries, availability of various major manufacturers in the region, increasing launches and approvals of new and technologically advanced devices, and favorable reimbursement regulations among others will positively impact the North American drug-eluting balloon market.


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