North America Urology Devices Market size to exceed USD 30.9 Billion by 2034

Selbyville, DE. - North America urology devices market was estimated at USD 15.6 billion in 2024 and is expected to grow from USD 16.7 billion in 2025 to USD 30.9 billion by 2034, at a CAGR of 7.1%, according to the latest report published by Global Market Insights Inc.

An increasing number of patients are being diagnosed with conditions such as benign prostatic hyperplasia (BPH), urinary incontinence, kidney stones, and prostate cancer, creating sustained demand for advanced urology devices.

Buttons

Key Insights:

Market Size & Growth:

• 2024 Market Size: USD 15.6 billion
  
• 2025 Market Size: USD 16.7 billion
  
• 2034 Forecast Market Size: USD 30.9 billion
  
• CAGR (2025–2034): 7.1%
  

• Regional Insights:

• Largest Market: U.S.
  
• Fastest Growing Market: Canada
  

• Key Growth Drivers:

1. Aging population: The growing elderly population across North America is more prone to urological issues, driving the need for diagnostic and therapeutic devices tailored to age-related conditions.
   
2. Technological advancements in urology devices: Innovation in minimally invasive surgical tools, robotic-assisted procedures, and smart catheters is enhancing patient outcomes, shortening recovery times, and encouraging wider adoption across healthcare facilities.
   
3. Improved healthcare infrastructure and access: Wider access to healthcare services, advanced diagnostic tools, and specialized urology centers across the U.S. and Canada is supporting early diagnosis and treatment, thereby boosting device usage.
   
4. Growing preference for minimally invasive procedures: Patients and providers are increasingly favoring procedures that reduce hospital stays and recovery times, leading to higher demand for laser technologies, endoscopes, and laparoscopic tools in urological care.
   
5. Supportive reimbursement policies and insurance coverage: Favorable insurance coverage and reimbursement frameworks for urological procedures and devices are making treatments more affordable, enhancing patient access, and driving market expansion.

• Key Players:

• Boston Scientific Corporation led the market with over 14% share in 2024.
  
• Some of the top players in this market include Intuitive Surgical, Cook Medical, Teleflex, Olympus Corporation, Boston Scientific Corporation, which together held a 36% share in 2024.
  

• Key Challenges

1. High cost of advanced urology devices: Many innovative devices, including robotic surgical systems and laser-based tools, come with high acquisition and maintenance costs, which can be a financial burden for smaller healthcare facilities and limit widespread adoption.
   
2. Reimbursement limitations and insurance constraints: Despite general coverage, reimbursement for certain urological procedures or devices can be inconsistent or delayed, discouraging providers from adopting newer technologies or offering them to all patient segments.
   
3. Regulatory hurdles and approval delays: Strict FDA regulations and complex approval processes can delay the introduction of novel devices into the market, slowing innovation and reducing the speed at which providers can access cutting-edge solutions.
   
4. Shortage of trained urologists and surgical specialists: There’s a growing demand for urological care, but not enough specialists trained in advanced and minimally invasive procedures, particularly in rural or underserved regions, which limits patient access.
   
5. Data security and privacy concern connected devices: As more urology devices incorporate digital health features and remote monitoring, issues related to cybersecurity, patient data protection, and compliance with HIPAA regulations are becoming increasingly important.
   

Browse key industry insights spread across 90 pages with 32 market data tables and figures from the report, “North America Urology Devices Market - By Product Type, By Application, By End Use - Regional Forecast, 2025 - 2034” in detail, along with the table of contents:

https://www.gminsights.com/industry-analysis/north-america-urology-devices-market

Rising Demand for Products

The product segment held a notable share in 2024, driven by the availability of a broad range of specialized tools designed to diagnose and treat urological conditions with higher precision and less invasiveness. From endoscopes and drainage devices to laser systems and urodynamic equipment, product innovation remains at the core of market expansion. Increasing demand for technologically advanced devices that are integrated with AI or offering robotic-assisted functionalities is pushing manufacturers to focus on quality, safety, and performance.

Increasing Prevalence of Urolithiasis

The urolithiasis segment will grow at a decent CAGR during 2025-2034, fueled by the rising incidence of kidney stones and related urinary tract conditions across North America. Dietary habits, dehydration, and sedentary lifestyles are contributing to a growing patient pool requiring intervention for stone removal or management. This segment is benefiting from the shift toward minimally invasive techniques such as laser lithotripsy, ureteroscopy, and shock wave therapies. These methods reduce recovery time and hospital stays, making them highly preferred by both patients and healthcare providers.

Hospitals and Clinics to Gain Traction

The hospitals and clinics segment held a significant share in 2024 owing to their critical role in delivering specialized care and performing high-volume urological procedures. Hospitals are often the first point of care for patients with acute or complex urological conditions, which supports a high adoption rate of advanced diagnostic and therapeutic equipment. Clinics, on the other hand, are increasingly integrating outpatient surgical suits and specialized urology practices, expanding the reach of these devices beyond traditional inpatient settings.

U.S. to Emerge as a Propelling Region

U.S. urology devices market held a sizeable share in 2024, supported by a well-established healthcare system, strong R&D capabilities, and high awareness of urological health issues. Leading hospitals and ambulatory surgical centers across the U.S. are investing in state-of-the-art equipment to improve procedural accuracy and patient recovery outcomes.

Major players in the North America urology devices market are Cook Medical, Olympus Corporation, Teleflex, Ambu, Richard Wolf, Boston Scientific Corporation, NIPRO, Intuitive Surgical, Siemens Healthineers, B. Braun, Coloplast, and Laborie Medical Technologies.

To strengthen their foothold in the North America urology devices market, key companies are deploying a multi-pronged strategy centered on innovation, strategic partnerships, and regional expansion. Many are investing heavily in R&D to bring next-generation products to market—particularly devices that support minimally invasive procedures, enhance patient comfort, and integrate smart technology for real-time monitoring. Collaborations with healthcare providers and academic institutions help accelerate clinical validation and market acceptance.