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Are Drug-Coated Balloons Improving MI procedures

Published date : Dec-2018

According to the analysts at Arizton, the global drug-coated balloons market is forecasted to reach revenues more than $1 billion by 2024 and the CAGR growing at a rate of 17% during the forecast period of 2018-2024.


The major innovation in transcatheter technology for performing MI procedures is the Drug-eluting balloons, also known as Drug-coated balloons (DCB). The major limitations of using Drug-eluting Stents (DES) in MI procedures are high in-stent restenosis (ISR) and revascularization rates. These limitations are overcome by using Drug-coated balloons.

Arizton’s recent market research report on the Drug-coated Balloons market offers an analysis of market share, market size, forecast, industry trend, growth drivers and competitor analysis. The segmentation of DCB is based on indication (DCB for peripheral artery diseases, DCB for coronary artery diseases and other indications), the end user (Hospitals, Cardiac catheterization labs and ASCs) and geography (North America, Europe, APAC, Latin America and MEA).

Medtronic, BD, B. Braun Melsungen and Koninklijke Philips are the major key players in the Drug-coated Balloon market.

The research report also offers a study on the prominent vendors in the global DCB markets which include Boston Scientific, Opto Circuits (India), Acotec Scientific, AR Baltic Medical, Acrostak, Biosensors International Group, Cardionovum, Endocor, iVascular SLU, Minvasys, QT Vascular, BioMed , SurModics, Concept Medical, Hexacath Sverige, RD Global-Invamed, MedAlliance, Terumo, and Wellinq. 

During 2018-2024 forecasts, the market in North America will grow at a CAGR of 18%. The advancement and opportunity in this drug-coated balloon market are due to the growing risks of Obesity and other major cardiac problems in the North American region.

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Top 3 trends and drivers of the Global Drug-coated balloons market are:

Availability of Latest Generation Drug-Coated Balloons

There has been an increasing usage of Drug-coated balloons over the standard PTA Balloons for treating peripheral and coronary arterial diseases. The rapid growth and need for significant improvement in MI procedures and MI surgical techniques have led to this technical improvement in the balloon catheter segment. This significant development and launch of several drug-coated balloons have enhanced the safety, effectiveness and clinical outcomes of angioplasty procedures. The notable players such as Medtronic, B. Braun Melsungen, Koninklijke Philips provides the latest generation DCB such as IN.PACT Admiral DCB, Stellarex DCB and SeQuent Please OTW for PAD. The improvements have also led to the launching of several latest products and increased demand for this market.

Robust Pipeline

There are tremendous growth opportunities for the players in the drug-coated balloon market in peripheral, coronary, AVG and AVF space. A lot of vendors have a rich pipeline of devices for arterial, AVF, and AVG indications. Significant players in the market have their own in-house R&D activities to develop and commercialize DCB’s. They have promising investigational DCBs under development and most of the small players are also actively involved in the development of novel and advanced drug-coated balloon devices. The vendors are conducting clinical trials to ensure the safety and for seeking regulatory approval from the USFDA in the coming years.

For example, MedAlliance is in the clinical research development stage for indication of PAD using Selution drug-coated balloon (Sirolimus drug-coated balloon), Orchestra BioMed is in the clinical research development stage for indication of CAD using Virtue Sirolimus-Eluting Balloon and a lot of other players are in the clinical or pre-clinical research stage. The regulatory approvals are likely to happen for the players in the clinical research stage which influences the stable growth of this market.

Expanded Indication Approvals of Existing Drug-Coated Balloons

Previously drug-coated balloons were only used for treating SFA in patients with PAD. Due to improvements in technological innovations, and increased clinical trials the application of this is expanded and used to treat other endovascular diseases. These days PAD patients with BTK artery lesions, small vessel disease, complex CAD, AVG, and AVF are also treated with advanced drug-coated balloon’s. In recent years, the regulatory bodies gave expanded indication approvals for the existing commercial drug-coated balloons.

These include IN.PACT admiral drug-coated balloon (200mm) by Medtronic which enables to treat long and complex SFA lesions to a shorter procedure and reduced cost. Similarly, the Lutonix 035 drug-coated balloon by BD is used to treat end-stage renal disease patients with stenotic lesions in dialysis arteriovenous (AV) fistulae. In addition, Vendors also launched different size versions of already approved drug-coated balloons for treating arterial lesions with complex anatomy and small vessel diseases. These approvals have fuelled the growth of this market globally during the forecast period.

All the currently marketed drug-coated balloon use paclitaxel as an anti-restenotic agent, but it has limitation such as less-effective in suppressing reactive hyperplasia and has a narrow therapeutic range. So a replacement drug known as sirolimus (rapamycin) is used as an alternative. This offer more benefits than paclitaxel and has the capability to treat other vascular diseases, including BTK arterial diseases and cerebrovascular diseases.

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The report also offers a detailed study of major trends, drivers, challenges, and also provides the market size and forecast for major geographical regions and key countries.

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