Drug-Coated Balloons Market to Reach $2.31 Billion by 2029, New FDA Approvals Propel US Drug-Coated Balloons Market to New Heights – Exclusive Focus Insights Report by Arizton

Drug-Coated Balloons Market to Reach $2.31 Billion by 2029, New FDA Approvals Propel US Drug-Coated Balloons Market to New Heights - Exclusive Focus Insights Report by Arizton
Drug-Coated Balloons Market Research Report by Arizton

According to Arizton’s latest research report, the drug-coated balloons market will grow at a CAGR of 15.72% during 2023-2029.

 

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Report Summary  

Market Size (2029): $2.31 Billion  

Market Size (2023): $965.41 Billion 

CAGR (2023-2029): 15.72%  

Historic Year: 2020-2022 

Base Year: 2023 

Forecast Year: 2024-2029 

Market Segmentation: Indication, Drug, End-Users, and Geography

Geographical Analysis: North America, Europe, APAC, Latin America, and Middle East & Africa 

 

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The US Leads North America in Drug-Coated Balloons Market with Major Revenue Contribution

In 2023, the US accounted for an impressive 93.59% share of the North America drug-coated balloons market, solidifying its position as the leading market in the region. Globally, the US held more than 40% of the market share and emerged as the major revenue contributor to the global drug-coated balloons market, with a value of $477.58 million.

The growing demand for drug-coated balloons is largely driven by the increasing prevalence of heart diseases, peripheral artery disease (PAD), coronary artery disease (CAD), failing arteriovenous fistulas, and other related health conditions. These conditions come with significant health expenditures, making drug-coated balloons a preferred alternative to traditional stenting procedures. The Centers for Disease Control and Prevention (CDC) reported that in 2023, the annual cost of heart diseases was estimated at around $239 billion, highlighting substantial revenue growth opportunities for vendors in the US market.

In 2023, more than 21 million individuals in the US were estimated to be affected by PAD, with limited alternative treatments available for its management. Most US healthcare settings prefer drug-coated balloon (DCB) insertion for PAD management due to its safety and efficacy. Additionally, cardiovascular diseases remain the leading cause of death in the country, with the CDC revealing that over 21 million adults in the US have CAD. Annually, around 366,000 people die from CAD, and over 800,000 new cases of cardiovascular diseases are registered.

The rising burden of PAD and CVD is significantly driven by diabetes, with over 39 million people in the US estimated to have diabetes in 2023. Diabetic patients face a 2-to-4-fold increased risk of heart diseases, further amplifying the need for effective treatment options like balloon angioplasty procedures.

The demand for balloon angioplasty procedures is rising in the US, with more than 1 million coronary angioplasty procedures performed annually, contributing to market growth. Additionally, over 9 million peripheral vascular procedures are conducted each year in the country. Atherectomies, a minimally invasive procedure often performed with a balloon, are also prevalent, with more than 190,000 procedures performed annually.

The growing prevalence of leading diseases that necessitate balloon angioplasty procedures and associated health expenditures are significantly driving market growth in the US. As the demand for drug-coated balloons continues to rise, the US remains at the forefront of this expanding market, providing ample opportunities for innovation and revenue generation.

 

Recent Approvals & Launches of DCBs

  • In 2024, Boston Scientific received US FDA approval for its AGENT DCB for CAD. It is the world’s first DCB approved by the FDA, and it is expected to expose several opportunities.
  • In 2024, Concept Medical got Investigational Device Exemptions approval from the US FDA for its DCB catheter for the treatment of stenotic lesions of arteriovenous fistula for its MagicTouch AVF in 2023. Moreover, in 2023, the company got US FDA IDE approvals for the treatment of superficial femoral arteries for its SCB MagicTouch SCB product line.
  • In 2023, Suromedic got FDA approval for its Surveil Drug-Coated Balloon for percutaneous transluminal angioplasty. Abbott have global commercialization for the SurVeil DCB.
  • In 2022, Advanced NanoTherapies received the FDA breakthrough designation for its SirPlux Duo DCB for small vessel coronary artery diseases.

 

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Market Segmentation:

Indication: Peripheral Artery Disease (PAD), Coronary Artery Disease (CAD), and Other Indications

Drug: Paclitaxel and Sirolimus

End-Users: Multi-specialty Hospitals and Specialty Hospitals  

Geography: North America, Europe, APAC, Latin America, and Middle East & Africa

 

Vendors List

  • BD
  • Boston Scientific
  • B. Braun SE
  • Medtronic
  • Koninklijke Philips N.V.
  • Terumo Corporation
  • Biosensors International Group, Ltd.
  • Biotronik
  • Concept Medical
  • Cardionovum
  • ENDOCOR GmbH & CO. KG
  • iVacular
  • Cordis
  • Meril Life Sciences
  • Nano Therapeutics
  • Genesis MedTech Group
  • INVAMED
  • Abbott
  • Laborie
  • Translumina
  • Acotec Scientific
  • Lepu Medical Technology
  • Balton
  • ZYLOX-TONBRIDGE MEDICAL TECHNOLOGY CO., LTD.
  • AR Baltic Medical

 

Key Questions Answered in the Report:  

How big is the global drug-coated balloons market?

What are the key drivers of the global drug-coated balloons market?

What is the growth rate of the global drug-coated balloons market?

Which region dominates the global drug-coated balloons market?

Who are the major players in the global drug-coated balloons market?

 

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