Drug-Eluting Balloon Catheters Market

Global Drug-Eluting Balloon Catheters Market is valued at USD 529.4 Million in 2021 and is expected to reach USD 1,019.4 Million by 2028 with a CAGR of 9.8% over the forecast period.

Global Drug-Eluting Balloon Catheters Market: Global Size, Trends, Competitive, and Historical & Forecast Analysis, 2022-2029: Increasing Prevalence of Heart Diseases and Higher Efficiency Associated with Drug-eluting Balloon Catheter Over Drug-eluting Stents are some of the major factors driving the growth of the Global Drug-Eluting Balloon Catheters Market.

Scope-

The vessel wall processes the efficient homogeneous administration of anti-proliferative medications through an inflated balloon in the drug-eluting balloon, a non-stent technique. The balloon technique is based on the idea of targeted medication administration, which promotes fast artery wall repair and inhibits the growth of smooth muscle cells. In preclinical and randomized clinical trials, DEB technology proved secure and effective for patients with in-stent restenosis. Without leaving any metal behind, DCB catheters maintain the vessel's anatomical structure, promote better vascular repair, and lessen the need for continuous dual antiplatelet therapy.

COVID-19 Impact-

The outbreak of the COVID-19 pandemic slowed down the progression of this marketplace.   This was credited to the  security limitations and a decline in the number of persons seeking cardiovascular disease treatment and diagnosis. Considering revenue, the global market observed a -13.7% reduction in growth in 2020 compared to the previous year. The decrease in surgical operations for peripheral and coronary intervention was responsible for this.

For instance, according to a 2020 NCBI article, the COVID-19 pandemic significantly affected the treatment of individuals with ST-segment elevation myocardial infarction (STEMI) across Europe, resulting in a 19.0% decrease in primary percutaneous coronary intervention (PPCI) operations.

Moreover, the key players also observed a decline in the sales of their products due to low demand during the pandemic. As a result, the company's portfolio of drug-eluting products witnessed  lower sales. However, the number of angioplasty operations grew significantly in 2021 as a result of the application of COVID-19 rules, the release of lockdown limitations, and widespread immunization campaigns. Global demand for these catheters surged as a result.

Key Players-

The major players operating in this industry vertical are -

• Medtronic
• Koninklijke Philips N.V.
• Boston Scientific Corporation
• BD
• B. Braun SE
• Meril Life Sciences Pvt. Ltd.
• BIOTRONIK
• Cordis
• MicroPort Medical (Group) Co. Ltd.

Segmentation-

By Drug:

• Paclitaxel
• Sirolimus
• Others

By Indication:

• Coronary Intervention
• Peripheral Intervention

By Raw Material:

• Polyurethane Drug Eluting Balloon Catheters
• Nylon Drug Eluting Balloon Catheters
• Others

By End-user:

• Hospitals & ASCs
• Specialty Clinics and Catheterization Laboratories

By Regional & Country Level:

• North America

  • U.S.
  • Canada

• Europe

  • U.K.
  • France
  • Germany
  • Italy

• Asia Pacific

  • China
  • Japan
  • India
  • Southeast Asia

• Latin America

  • Brazil
  • Mexico

• Middle East and Africa

  • GCC
  • Africa
  • Rest of Middle East and Africa

Market Drivers:

Increasing Prevalence of Heart Diseases is Expected to Boost Drug-Eluting Balloon Catheters Market Growth:

Peripheral and coronary heart illnesses, such as heart arrhythmias, heart failure, heart valve disease, and pericardial disease, are becoming more commonplace on a global scale at a higher pace. For Instance, according to the CDC, coronary heart disease is the most prevalent kind of heart disease in the United States and will affect 382,820 lives in 2020. In the United States, 20.1 million individuals aged 20 and older had coronary artery disease.

Coronary and peripheral artery diseases are mostly carried on by cigarette smoking and a diet heavy in trans fats, saturated fats, and cholesterol. According to an NCBI article from July 2020, active and passive smoking exposure contributed to more than 30.0% of coronary heart disease cases, increasing the need for angioplasty procedures and driving up product demand in this market.

During angioplasty operations, drug-eluting balloon catheters are recommended to treat blocked or congested coronary arteries. As a result, it is anticipated that the demand for these catheters will rise as the number of angioplasty procedures rises. The NCBI article states that more than 965,000 angioplasties were carried out in the United States in March 2021.

In addition, market players now place a greater emphasis on research and development in preparation for the introduction of sophisticated catheters. The patient population's access to these products should improve as a result. The Prevail drug-coated balloon (DCB) catheter for coronary artery disease was introduced by Medtronic in Europe in July 2021. The new introduction is anticipated to increase the range of catheters available in Europe.

Long-term demand for these catheters is anticipated to be fueled by the high incidence of cardiac disorders.

Higher Efficiency Associated with Drug-eluting Balloon Catheter Over Drug-eluting Stents is Expected to Accelerate Drug-Eluting Balloon Catheters Market Development:

Through minimally invasive surgery, drug-eluting balloon catheters release an antiproliferative medication directly into the vascular wall without the need of stents. The use of these devices is a strategy that shows potential in the treatment of coronary artery disease.

Numerous studies have demonstrated the benefits of using these catheters for angioplasty in the treatment of conditions like in-stent restenosis, high bleeding risk, and small-vessel disease. Additionally, by using these catheters, drug-eluting stent drawbacks such insufficient stent apposition, harmful medication interactions, and higher in-stent thrombosis rates can be eliminated.

The advantages of using these catheters over drug-eluting stents and the growing trend for less invasive heart surgery have thereby increased its demand.

Market Restraints:

Limitations Associated with Drug-eluting Balloon Catheters and stringent government regulations for the commercialization and approval of These catheters are expected to Hinder Drug-Eluting Balloon Catheters Market Growth:

Even though it has been demonstrated that these catheters are more effective than drug-eluting stents, there are a number of issues that are anticipated to restrain the market growth during the forecast period.

According to several studies, using paclitaxel-coated balloon catheters to treat the leg's femoropopliteal artery has a substantial risk of mortality. It is projected that this aspect would restrain market expansion. For instance, the American Heart Association (AHA) reported in December 2018 that all patient fatalities following the use of paclitaxel-coated balloon catheters for therapy happened within 1 to 5 years.

Furthermore, the expansion of the market for these catheters is constrained by the severe government rules governing their approval and marketing. For instance, the United States has not licensed any drug-eluting balloon catheters for use in coronary operations. Although there is a substantial market for these catheters in Europe, there is no official regulatory clearance in the United States. During the projection period, these usage restrictions are anticipated to impede the market's expansion.

Geography Analysis:

North America is expected to Capture a Major Share of the Global Drug-Eluting Balloon Catheters Market:

In 2021, the North American market generated USD 256.9 million. The rising incidence of heart disease and the increased focus of market players on new product developments in the region are related to the region's market dominance. For instance, according to a study by MDPI in, there were 8 to 12 million people in the United States who had peripheral artery disease (PAD), with a prevalence range of 3.0% to 10.0%.

Europe Drug-Eluting Balloon Catheters Market Is Expected to Grow At A Considerable Pace Over The Forecast Period:

The market in Europe held a considerable market share in 2021 and is anticipated to rise significantly over the next five years. The rising incidence of peripheral artery disease in the continent and the significant market presence of companies like MicroPort Medical (Group) Co., Ltd., and B. Braun SE are both credited with the market expansion in Europe.

Asia Pacific Drug-Eluting Balloon Catheters Market Is Expected To Grow At A Considerable Pace Over The Forecast Period:

In the projected years, the market in the Asia Pacific region is anticipated to grow at the quickest CAGR. The rising desire for minimally invasive procedures among patients and the rising incidence of peripheral artery disease in the area are both factors contributing to the high growth market in the area.

For instance, according to a study by Frontiers Media S.A., 1.4% of the people in East Asia, or around 23.86 million individuals, were affected by peripheral artery disease in 2019. This figure represents the subregion's whole population.

News-

• To investigate the safety and effectiveness of peripheral sirolimus drug-coated balloons, BD recently announced the beginning of the first-in-human prevision trial in August 2022. The studies' objective was to assess sirolimus' potential as a future therapy for people with peripheral artery disease (PAD).
• In February 2021 L2Mtech GmbH received its first CE certification for six items. This confirms the effectiveness and safety of the company's cutting-edge cardiovascular and endovascular applications and represents a significant shift in its history. The business intends to commercially introduce items that bear the CE mark. 

Report Analysis	Details
Historical data	2016 - 2021
Forecast Period	2022 - 2029
Market Size in 2021:	USD 529.4 Million
Base year considered	2021
Forecast Period CAGR %:	9.8%
Market Size Expected in 2028:	USD 1,019.4 Million
Tables, Charts & Figures:	175
Pages	300
Companies	Medtronic, Koninklijke Philips N.V., Boston Scientific Corporation, BD, B. Braun SE, Meril Life Sciences Pvt. Ltd., BIOTRONIK, Cordis, and MicroPort Medical (Group) Co., Ltd.
Segments Covered	By Drug, By Indication, By End-User, By Raw Material
Regional Analysis	North America, U.S., Mexico, Canada, Europe, UK, France, Germany, Italy, Asia Pacific, China, Japan, India, Southeast Asia, South America, Brazil, Argentina, Columbia, The Middle East and Africa, GCC, Africa, Rest of the Middle East and Africa