United States Catheters Market 2031 | Growth Drivers, Trends & Market Forecast, Competitive Landscape & Investment Opportunities

Market Size and Growth

The Catheters Market is expected to grow at a CAGR of 9.6% during the forecast period 2024-2031.

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Key Development:

United States: Recent Catheter Developments

✅ In September 2025, AngioSafe received FDA 510(k) clearance for its Santreva‐ATK Endovascular Revascularization Catheter, enabling wire‐free intraluminal crossing of chronic total occlusions (CTOs) and simplifying peripheral artery disease interventions.

✅ In October 2025, Cagent Vascular launched the Serranator PTA Serration Balloon Catheter (in 7.0 mm and 8.0 mm diameters), expanding the balloon‐catheter options for peripheral and vascular procedures in the U.S.

✅ In August 2025, BioCardia, Inc. filed for FDA regulatory submission for its Helix Transendocardial Delivery Catheter a system for intramyocardial delivery in cell/gene-therapy for heart failure signaling potential upcoming approval.

✅ In August 2025, Nuwellis, Inc. obtained FDA 510(k) clearance for a new 15 cm insertable‐length version of its Dual Lumen Extended Length Catheter (dELC), enhancing peripheral venous access options for ultrafiltration therapy.

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Japan: Recent Catheter Developments

✅ In August 2025, Recor Medical's Paradise uRDN Renal Denervation Catheter System received regulatory approval for manufacturing and marketing in Japan, offering a minimally invasive option for sympathetic renal denervation therapy.

✅ In March 2025, BioCardia, Inc. was granted a Japanese patent (No. 7641330) for its "Radial and Transendocardial Delivery Catheter" technology strengthening its intellectual-property position for cardiac biotherapeutic delivery.

✅ In Q4 2025 (expected), BioCardia plans to submit its Helix Transendocardial Delivery Catheter for approval in Japan's regulatory framework, as part of the broader approval process for its cell‐therapy system for ischemic heart failure.

Key Players:

=> Boston Scientific, Abbott Laboratories, CardioMed Supplies, Cook Medical, Penumbra, Lepu Medical, Biotronik, Smiths Medical, Stryker Corporation, Nipro Corporation, Teruma Medical, Medica S.P.A, Vyarie Medical and Becton, Dickinson, and Company.

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Key Segments:

By Product Type

Balloon catheters lead with 25% share, driven by high adoption in cardiovascular interventions, angioplasty procedures, and vascular therapies. Lumen catheters account for 20%, supported by versatility in fluid delivery, sampling, and drainage applications across multiple therapeutic areas. Hydrophilic catheters hold 15%, reflecting their ease of insertion, reduced friction, and growing use in urology and minimally invasive procedures. Steerable catheters represent 15%, fueled by demand in complex cardiovascular, neurological, and pulmonary interventions. Drug-eluting catheters account for 15%, supported by localized drug delivery, reduced restenosis risk, and adoption in interventional cardiology. Permanent catheters make up 10%, including long-term vascular and urinary access devices for chronic care patients.

By Therapeutic Area

Cardiovascular dominates with 30% share, driven by coronary artery disease prevalence, interventional procedures, and rising minimally invasive therapies. Urology accounts for 20%, supported by increasing adoption of hydrophilic and lumen catheters in urinary management. Neurology holds 15%, reflecting use in neurological interventions and targeted drug delivery. Pulmonary represents 10%, fueled by airway management and minimally invasive respiratory procedures. Gastroenterology accounts for 10%, supported by diagnostic and therapeutic interventions such as drainage and aspiration. Ophthalmology holds 5%, reflecting specialized catheter usage in ocular therapies. Other therapeutic areas make up 10%, including oncology, pediatrics, and emergency medicine applications.

By Applications

Drainage leads with 25% share, driven by urinary, biliary, and percutaneous fluid management. Dilatation accounts for 20%, reflecting balloon catheter use in vascular and urological procedures. Diagnostics hold 15%, fueled by catheter-based imaging, sampling, and monitoring. Ablation represents 10%, supported by cardiovascular and neurological interventions. Aspiration accounts for 10%, including removal of fluids, thrombi, or lesions. Dialysis makes up 10%, reflecting long-term vascular access for renal care. Other applications represent 10%, including drug delivery, interventional therapies, and specialized clinical procedures.

By Region

North America - 35% Share
North America leads with 35%, driven by advanced healthcare infrastructure, high adoption of interventional and minimally invasive procedures, and strong cardiovascular care in the U.S. and Canada.

Europe - 25% Share
Europe holds 25%, supported by cardiovascular interventions, urology care, and specialized hospital procedures across Germany, France, U.K., Italy, Spain, and neighboring countries.

Asia Pacific - 25% Share
Asia Pacific accounts for 25%, fueled by growing healthcare access, rising cardiovascular and urology disease burden, and expanding hospital infrastructure in China, India, Japan, and Southeast Asia.

Latin America - 7% Share
Latin America holds 7%, driven by increasing interventional procedures, hospital modernization, and adoption of minimally invasive catheters in Brazil, Mexico, and neighboring countries.

Middle East & Africa - 8% Share
The Middle East & Africa represent 8%, supported by investments in healthcare infrastructure, growing prevalence of cardiovascular and urological diseases, and expanding adoption of advanced catheter technologies in GCC countries, South Africa, and other emerging markets.

Q: What is the growth rate of the Catheters Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 9.6% during the forecast period from 2024 to 2031.

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Phone: +1 877 441 4866
Website: https://www.datamintelligence.com

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