The global drug eluting balloons market size was USD XX Bn in 2022 and is likely to reach USD XX Bn by 2031, expanding at a CAGR of XX% during 2023–2031. The market is driven by the increasing cases of peripheral and coronary arterial diseases across the globe.
Occurrences of peripheral vascular disease is rising, owing to multiple factors, including prior coronary artery disease, smoking habits, diabetes, and a sedentary lifestyle.Drug-elutingballoon is a newtechnique for delivering antiproliferative agents to the arterial wall, without the need for a chronically implanted delivery system. For instance,
The market report finds that the COVID-19 pandemic hampered the drug eluting balloons market, owing to the strict lockdowns imposed by the governments. Individuals with existing health conditions avoided visiting hospitals to reduce the risk of getting an infection during the pandemic.
Healthcare facilities dealt with the increasing load of infected patients during the pandemic;therefore, the treatment for other diseases was postponed or delayed. Delays in treatments for cardiovascular disease patientsled to reduced visits todiagnostic centers and hospitals, which hindered the market.
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According to the study published by the National Institutes of Health (NIH), there was around 52.7% reduction in adult cardiac surgery and around 65.5% reduction in elective cases, due to the pandemic, after the analysis of 717 103 adult cardiac surgery patients and over 20 million COVID-19 patients in the US.
Drug Eluting Balloons Market Dynamics
Major Drivers
Increasing cases of peripheral and coronary arterial disease are expected to boost the drug eluting balloons market during the forecast period. Peripheral arterial disease is a significant cause of morbidity and mortality in the US. Paclitaxel-coated devices are used to treat peripheral arterial disease (PAD).The progression of coronary artery disease (CAD) becomes clinically apparent by age 40. Individuals who are of 65 years age and above account for about 85% of deaths from coronary artery disease.
Increasing prevalence of diabetes is expected to boost the drug eluting balloon market in the coming years. Diabetes damages the blood vessels and nerves related to the heart and can lead to cardiovascular disease. Angioplasty is proven to be a safe and effective procedure in diabetic patients. Drug-eluting balloons are common semi-compliant angioplasty balloons that are protected with an anti-proliferative drug. It is circulated into the vessel wall during the inflation of the balloon, usually at minimal pressures with an exact nominal inflation time.
Increasing demand for cardiac catheterization labs, as they perform minimally invasive tests and advanced cardiac procedures to diagnose and treat cardiovascular disease, is likely to propel the market during the forecast period. Catheterization labs or Cath labs use advanced technology such as fully digital flat-panel technology with 3D reconstruction, which is developed by several market key players. Cardiovascular diseases are treated in the Cath labs by using a variety of imaging techniques, including echocardiography, angiography, and others.
Existing Restraints
Strict regulatory processes for product approvals and safety regulations are expected to hamper the market during the forecast period.Various government regulatory authorities have implemented strict regulatory frameworks and labeling requirements for drugeluting balloons. Several devices are still under investigation and require generous clinical data for regulatory approval.
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In January 2020, US Food and Drug Administration (FDA)alertedhealthcare professionals to carefully monitor patients with peripheral arterial disease, as theenlarged risk of death is linked with drug-containing balloons and stents.
Emerging Opportunities
Favorable reimbursement policies are expected to create lucrative opportunities for the market players. Innovative devices such as drug eluting balloons (DEM) aremore expensive thanbare metal stents (BMS). Hospitals and ambulatory surgery centersare unwilling to stock drug eluting balloonsif reimbursement is not available.Since 2015, the reimbursement scenario has changed,and majority of the insurance companies have started offering reimbursement for drug-eluting balloons.This helps to cover the additional cost of hospitals and ambulatory surgery centers, thus creating a favorable environment for the players in the market, to come up with innovative DEB solutions.
Scope of Drug Eluting Balloons Market Report
The market report includes an assessment of the market trends, marketsegments, and regional markets. Overview and dynamics have also been included in the report.
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Attributes
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Details
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Report Title
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Drug Eluting Balloons Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast
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Base Year
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2022
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Historic Data
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2016–2021
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Forecast Period
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2023–2031
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Segmentation
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Product (Peripheral Drug Eluting Balloons, Coronary Drug Eluting Balloons, and Others), Technology (TransPac, FreePac, EnduraCoat, and Others), and End-user (Hospitals, Clinics, Ambulatory Surgical Centers, and Others)
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Regional Scope
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Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
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Report Coverage
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Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, MarketTrends, and Revenue Forecast
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Key Players Covered in the Report
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Terumo Corporation; Cordis; Opto Circuits (India) Limited; Medtronic; Koninklijke Philips N.V.; Eurocor GmbH; Cook Group; Cardionovum GmbH; Cardinal Health; Boston Scientific Corporation; BD; and B. Braun SE
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Drug Eluting Balloons Market Segment Insights
Product Segment Analysis
Based on product, the drug eluting balloons market is divided intoperipheral drug eluting balloons, coronary drug eluting balloons, and others.The peripheral drugeluting balloons segment is expected to expand at a significant pace during the forecast period, due to the increasing usage of drug-eluting balloons in the treatment of peripheral artery disease.It is also supported by the increasing research & development activities in expanding the indications of PAD. Drug-eluting stents and balloons are the two new devicesthat are used against limb loss, from peripheral arterial disease.
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According to the American Heart Association(AHA), low extremity peripheral arterial disease affects more than 230 million adultsglobally and is associated with increasing risk for various adverse clinical outcomes.Although PAD prevalence is significant, it has been historically underappreciated by healthcare professionals and patients.
The coronary drugeluting balloons segment is anticipated to hold a key share of the market in the coming years, due to the increasing use of drug-eluting stents in coronary interventions. These coronaryinterventionballoons areadopted by physicians,as they aremore likely to eliminate the risk of stent failure and show high efficiency than drug-eluting stents.Additionally, increasing product launches and developments by market key players are expected to boost the segment in the coming years.
Technology Segment Analysis
On the basis of technology, the global market is segregated into Transpac, FreePac, Enduracoat, and others. The FreePac segment is projected to register a considerable CAGR during the forecast period, owing to the increasing adoption of new drug coating technologies.
FreePac drug coating consists of the drug paclitaxel and the excipient urea. It reduces the drug elution time to 30 to 60 seconds. Beyond 60 seconds balloon inflation can be maintained without extra drug release.
End-user Segment Analysis
Based onend-user, the drug eluting balloons market is segregated intohospitals, clinics, ambulatory surgical centers, and others.The hospitals segment is anticipated to expand at a robust growth rate during the forecast period, owing to the increasing number of patients undergoing peripheral and coronary arterial disease treatments in hospital settings.
Modern hospitals are equipped to provide a wide range of critical healthcare services, including 24/7 emergency and other high-acuity care. The rising introduction of new innovative healthcare technology at healthcare facilitiesis enabling hospitals to availadvanced procedures and products that are highly efficient and minimally invasive.
Regional Analysis
In terms of region, the global drug eluting balloons market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the forecast period, owing to the increasing spending on healthcare and the high rate of treatment and diagnosis of cardiovascular diseases such as strokes, coronary artery disease, and atrial fibrillation.
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According to Cedars Sinai Medical Center, more than 300,000 peopleundergo successfulbypass surgery in the US each year. It is sometimes also referred to as coronary artery bypass graft surgery (CABG), coronary bypass, or bypass surgery.
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According to the Centers for Disease Control and Prevention, in 2021, around 375,476 people died from coronary heart disease in the US. About two in ten deaths from coronary heart disease happen in adults,who are below 65 years old.
The market in Asia Pacific is anticipated to expand at a rapid pace in the coming years, due to the increasing awareness about drug eluting balloons for the treatment of coronary and peripheral artery disease. The regional market growth is further attributed to the increasing investments by market key players to develop new productsand launches.
Segments
The global drug eluting balloons market has been segmented on the basis of
Product
- Peripheral Drug Eluting Balloon
- Coronary Drug Eluting Balloon
- Others
Technology
- TransPac
- FreePac
- EnduraCoat
- Others
End-user
- Hospitals
- Clinics
- Ambulatory Surgical Centers
- Others
Region
- Asia Pacific
- North America
- Latin America
- Europe
- Middle East & Africa
Key Players
- Terumo Corporation
- Cordis
- Opto Circuits (India) Limited
- Medtronic
- Koninklijke Philips N.V.
- Eurocor GmbH
- Cook Group
- Cardionovum GmbH
- Cardinal Health
- Boston Scientific Corporation
- BD
- B. Braun SE
Competitive Landscape
Key players competing in the globaldrug eluting balloons market are Terumo Corporation; Cordis; Opto Circuits (India) Limited; Medtronic; Koninklijke Philips N.V.; Eurocor GmbH; Cook Group; Cardionovum GmbH; Cardinal Health; Boston Scientific Corporation; BD; and B. Braun SE
These key players adopt various strategies including mergers, acquisitions, collaboration, partnerships, product launches, and production expansion to expand their consumer base globally.
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On October 24, 2022, M.A. Med Alliance SAreceived US FDA Investigational Device Exemption (IDE) nod to establish its coronary pivotal clinical trial forSELUTION SLR. It is the first sustainedlimusrelease coronary drug eluting balloon(DEB),to obtain FDA IDE approval for in-stent restenosis (ISR) indication.
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On October 18, 2022, Cordis, which develops and manufactures medical devices, acquired Med Alliance, a company at the forefront of transformative drug-eluting balloons.Cordis has the probability to serve two million patients all over the world by 2027 with SELUTION SLR drug-eluting balloon with the acquisition of Med Alliance.
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