United States Urology Devices Market Overview,2030

The United States urology devices market stands among the most advanced globally, shaped by decades of innovation, strong regulatory oversight, and continuous adoption of digital and robotic technologies in clinical practice. The evolution of urological technology in the U.S. can be traced back to pioneering institutions such as the Mayo Clinic and Cleveland Clinic, which helped transition from open surgeries to minimally invasive and image-guided interventions. Urology today forms a critical component of American healthcare, with devices supporting diagnostics, treatment, and chronic condition management across hospitals and home-care environments. The rise of fiber-optic and flexible endoscopy has been transformative, enabling urologists at centers like Johns Hopkins Hospital and Massachusetts General Hospital to perform intricate bladder and ureteral procedures with minimal trauma. Home-based urology devices such as intermittent catheters, wearable urinary sensors, and portable dialysis systems have expanded access to care, supported by tele-urology initiatives from organizations like the Veterans Health Administration that connect patients in remote regions with specialists. Artificial intelligence and imaging systems are now integral to diagnostics, with platforms such as IBM Watson Health and Siemens Healthineers’ AI-Rad Companion enhancing predictive accuracy for prostate and kidney disease. The aging U.S. population, with nearly 17 percent over 65 according to the U.S. Census Bureau, drives demand for advanced devices addressing benign prostatic hyperplasia, renal disorders, and urinary incontinence. The integration of robotic systems such as Intuitive Surgical’s da Vinci platform and smart catheter technologies has improved surgical precision and patient safety. Regulatory oversight by the Food and Drug Administration ensures stringent device approvals and patient protection, while national attention to waste management has encouraged hospitals to adopt eco-friendly reprocessing and disposable solutions. Cloud-based data systems, supported by HIPAA regulations, safeguard patient privacy as digital transformation continues to redefine the landscape of urology in the United States.

According to the research report, ""United States Urology Devices Market Overview, 2030,"" published by Bonafide Research, the United States Urology Devices market is expected to reach a market size of more than USD 16.84 Billion by 2030. Major advancements include the shift toward outpatient and day-care procedures, supported by hospitals such as UCLA Health and NewYork-Presbyterian, which have expanded same-day surgery programs for kidney stone and prostate treatments using compact laser and endoscopic systems. The adoption of robotic and minimally invasive technologies has surged, with the da Vinci Xi system by Intuitive Surgical and Medtronic’s Hugo robotic platform transforming surgical precision and reducing hospital stays. Patient comfort and hygiene innovations, including antimicrobial catheters from Becton Dickinson and hydrophilic-coated products from Coloplast, have improved recovery outcomes and infection prevention. Companies like Dornier MedTech and Karl Storz maintain strategic partnerships with major health systems and research institutions such as the University of Michigan Health System and Stanford Medicine to advance clinical training and technology adoption. Venture capital investment has accelerated in startups like Butterfly Network and Virtuoso Surgical, focusing on AI-assisted imaging and micro-robotic tools for urological applications. Federal healthcare programs like Medicare and Medicaid continue to reimburse for essential urology procedures, while private insurers including UnitedHealth Group and Blue Cross Blue Shield are expanding coverage for minimally invasive treatments. The U.S. Department of Health and Human Services supports national kidney disease initiatives, including the KidneyX Innovation Accelerator, fostering collaboration between government and private sector manufacturers. Cold chain logistics and sterile packaging for urology equipment are maintained by distributors such as Cardinal Health and Owens & Minor, ensuring nationwide supply. Continuous R&D in biocompatible materials, nano-coatings, and smart implants underscores the ongoing modernization of the U.S. urology devices market, reinforcing its position as a global innovation hub for precision urological care.

In the United States, the urology devices market by type includes two major segments products and accessories each serving distinct yet interrelated roles in urological care. The product segment comprises core diagnostic and therapeutic instruments such as cystoscopes, ureteroscopes, nephroscopes, endoscopic video systems, and laser and lithotripsy devices used for minimally invasive treatment of urinary tract disorders. Hospitals like the Cleveland Clinic and Mayo Clinic commonly use high-definition cystoscopes and digital ureteroscopes from manufacturers such as Olympus, Karl Storz, and Boston Scientific for procedures including stone retrieval and bladder visualization. Laser and lithotripsy systems, particularly those utilizing Holmium:YAG or Thulium fiber lasers, have become standard in U.S. stone management and prostate tissue ablation, driven by precision, reduced bleeding, and faster recovery times. Dialysis devices, including hemodialysis machines from Baxter and Fresenius Medical Care, remain indispensable for renal failure patients managed in nephrology–urology cross-specialty settings. The accessories segment covers essential consumables such as Foley catheters, intermittent catheters, and external drainage systems widely used in post-operative care and long-term urinary management. Ureteral stents from Cook Medical and Boston Scientific are standard for ensuring urine flow post-lithotripsy or tumor resection. Additionally, lubricants and gels are critical in maintaining patient comfort and reducing friction during catheterization and endoscopic procedures. The U.S. Food and Drug Administration has strengthened sterilization and safety regulations, leading to greater adoption of single-use accessories and disposable scopes to prevent cross-contamination. Healthcare systems across New York, Texas, and California report rising demand for disposable instruments, reflecting the national shift toward infection control and workflow efficiency.

In the United States, urology devices are used across multiple clinical applications that reflect the country’s aging population and evolving treatment preferences. Urolithiasis, or stone disease, is one of the most common urological conditions treated with laser lithotripters, ureteroscopes, and percutaneous nephrolithotomy tools. Medical centers such as Johns Hopkins Hospital and UCLA Health use advanced digital ureteroscopes to manage complex kidney and ureteral stones with minimally invasive precision. Benign Prostatic Hyperplasia (BPH) is another leading indication, particularly in men over 50, treated using systems such as Boston Scientific’s GreenLight laser therapy and Teleflex’s UroLift implant, both offering reduced recovery times and outpatient convenience. In urological cancers like prostate, bladder, and kidney cancer, endoscopes, robotic surgical systems such as Intuitive Surgical’s da Vinci platform, and resection instruments are widely employed in institutions like MD Anderson Cancer Center for precision tumor removal and staging. Urinary incontinence and pelvic organ prolapse are treated using female slings, bulking agents, and artificial urinary sphincters like the AMS 800, with increasing demand driven by post-prostatectomy and post-menopausal cases. For erectile dysfunction, inflatable penile prostheses and malleable implants from Coloplast and Boston Scientific are commonly used in refractory cases. Kidney diseases necessitate dialysis devices and drainage systems to manage chronic renal failure, supported by home-based peritoneal dialysis systems from Baxter. Other applications, such as pediatric urology, strictures, and infections, utilize specialized instruments including smaller-caliber catheters and flexible cystoscopes tailored for children and delicate anatomy. Across the U.S., the integration of robotics, imaging, and laser technologies in these applications reflects a move toward precision medicine, outpatient care, and patient comfort.

In the United States, urology devices are deployed across hospitals and clinics, dialysis centers, and home care settings, reflecting a wide distribution of care delivery models. Hospitals and clinics represent the largest end-use segment, encompassing leading academic centers such as Mayo Clinic, Cleveland Clinic, and Massachusetts General Hospital, where urology departments perform advanced diagnostic, surgical, and minimally invasive procedures daily. These facilities rely on high-end cystoscopes, robotic systems like the da Vinci Surgical System, and laser platforms for prostate and stone surgeries. Ambulatory surgical centers across states such as Florida and California have adopted compact urology suites equipped with disposable cystoscopes and office-based lithotripsy systems, supporting same-day outpatient procedures. Dialysis centers form another crucial segment, serving patients with end-stage renal disease through networks like Fresenius Kidney Care and DaVita. These centers employ advanced dialysis machines, drainage tubing, and vascular access management devices, often integrating urology tools for managing concurrent urinary tract complications. The close collaboration between nephrologists and urologists in these centers has led to improved patient monitoring and device interoperability. Home care settings are rapidly expanding as part of the U.S. shift toward patient-centered chronic care. Home-use urinary catheters, external drainage bags, wearable incontinence management systems, and portable peritoneal dialysis machines allow patients to manage conditions like urinary retention and chronic kidney disease outside institutional settings. Companies such as Coloplast and Becton Dickinson have developed user-friendly home catheters and closed drainage systems that promote independence and infection prevention. Veterans Affairs healthcare facilities have also introduced home urology care kits for long-term management of spinal cord injury patients. American healthcare providers prioritize infection control, cost-efficiency, and digital integration, ensuring that devices used in hospitals, clinics, dialysis networks, and home settings align with national standards for safety and performance. 

Considered in this report
• Historic Year: 2019
• Base year: 2024
• Estimated year: 2025
• Forecast year: 2030

Aspects covered in this report
• Urology Devices Market with its value and forecast along with its segments
• Various drivers and challenges
• On-going trends and developments
• Top profiled companies
• Strategic recommendation

By Product Type
• Product
• Accessories

By Application
• Urolithiasis (Stone Disease)
• Benign Prostatic Hyperplasia (BPH)
• Urological Cancers
• Urinary Incontinence & Pelvic Organ Prolapse
• Erectile Dysfunction
• Kidney Diseases
• Other Applications (Pediatrics, Strictures, Infections, etc.)

By End Use
• Hospitals and clinics
• Dialysis centers
• Others (Home care settings) Show more