Summary

The urology devices help in the diagnosis and treatment of various urological disorders such as urolithiasis, urethral malignancies, bladder disorders, and kidney diseases. It includes various consumables such as catheters, dilators, and sheaths. These devices consist of urodynamic systems, urology robotic systems, laser & lithotripsy devices, cystoscopes, and ureteroscopes, which are used to diagnose bladder and urethra-related disorders. The growth is attributed to the increasing prevalence of kidney stones, bladder cancer, prostate cancer, and chronic kidney diseases. Moreover, technological advancements in urology products are expected to propel the demand for these devices to treat these diseases. Furthermore, the growing demand for single-use cystoscopes and the rising number of acquisitions and mergers by the market players are anticipated to boost the global urology devices market growth during the forecast period. The emergence of COVID-19 pandemic has declined the demand for urology devices due to lower patient volumes and delays in elective surgeries. The reallocation of healthcare resources for COVID-19 treatment, the declining number of patient visits to hospitals & specialty clinics, the disruptions in supply chains, and other major parameters impacted the sales of cystoscopes, laser & lithotripsy, and urology accessories across the globe. However, in 2021, elective surgeries were resumed as the regulations imposed by the governments across various countries were relaxed. According to the research report "Global Urology Devices Market Outlook, 2030," published by Bonafide Research, the Global Urology Devices market was valued at more than USD 37.03 Billion in 2024, and expected to reach a market size of more than USD 56.31 Billion by 2030 with the CAGR of 7.39% from 2025-2030. The increasing investments by the leading medical technology companies and research institutions across the globe to bolster the development and availability of novel urology devices are providing lucrative growth opportunities to the urology devices market. In April 2024, UnivLabs Technologies Pvt Ltd partnered with Indian Institute of Technology (IIT) Roorkee to translate research findings into devices with real world applications in the field of urology care. The partnership aims to support the commercialization and development of products developed by the educational institute with the help of resources from UnivLabs. IIT Roorkee’s patented technology is based on ureteral stents that are often used for maintaining fluid drainage which is often obstructed due to post-operative infection and swelling, tumors, kidney stones, and blood clot. The rising emphasis on research and development activities can also be attributed to the growing demand for urology devices that enhance both physician and patient convenience due to the rising incidences of urological disorders across the globe. Leading medical device companies are also investing in research and development activities to support technological innovations and bolster the development of devices with enhanced diagnostic abilities, positively influencing the expansion of the market. The urology devices market is also influenced by global trade dynamics, including the import and export of raw materials and finished products. Europe is major contributors to the market, with robust manufacturing capabilities and established healthcare infrastructures. Market Drivers • Rising Prevalence of Urological Disorders: The global urology devices market is significantly driven by the increasing prevalence of urological disorders such as urinary incontinence, benign prostatic hyperplasia (BPH), kidney stones, and prostate cancer. Aging populations, lifestyle changes, obesity, diabetes, and sedentary behavior are contributing factors, leading to higher incidence rates of urological conditions worldwide. As the number of patients seeking diagnosis and treatment rises, hospitals, clinics, and ambulatory centers are increasingly investing in advanced urology devices to provide efficient and minimally invasive solutions. • Technological Advancements in Urology Devices: Advancements in medical technology have fueled the adoption of innovative urology devices, boosting market growth. Innovations such as minimally invasive endoscopic systems, laser lithotripsy devices, robotic-assisted surgical systems, and smart catheters enhance surgical precision, reduce patient recovery time, and improve overall treatment outcomes. The integration of imaging technologies like high-definition cameras, 3D visualization, and AI-powered diagnostic tools enables more accurate detection and treatment of urological disorders. Market Challenges • High Cost of Advanced Urology Devices: One of the key challenges in the urology devices market is the high cost of sophisticated equipment, particularly robotic-assisted surgical systems and advanced lithotripters. The initial investment, maintenance, and recurring costs of consumables make these devices less accessible for smaller hospitals and clinics, especially in developing regions. This cost barrier limits widespread adoption despite the clear clinical benefits. Furthermore, reimbursement policies for urology procedures vary significantly across regions, adding another layer of financial complexity for healthcare providers. • Stringent Regulatory Frameworks: The global urology devices market faces challenges due to stringent regulatory requirements imposed by authorities such as the U.S. FDA, European Medicines Agency (EMA), and other national health agencies. Regulatory approvals for new urology devices often involve rigorous clinical trials, documentation, and compliance with safety and efficacy standards, which can be time-consuming and expensive. Delays in approvals, varying regional requirements, and the need for post-market surveillance add complexity to market entry and expansion strategies. Market Trends • Growing Adoption of Minimally Invasive Surgery: Minimally invasive procedures, supported by robotic-assisted technologies, are increasingly becoming the preferred choice in urology due to reduced surgical risks, shorter recovery times, and improved precision. Hospitals are investing heavily in robotic systems for procedures like prostatectomies, kidney surgeries, and bladder interventions. This trend not only drives the demand for robotic urology devices but also encourages ongoing innovation in surgical tools, imaging integration, and AI-based navigation systems. • Rising Focus on Home Healthcare: with an increasing number of patients seeking convenience and continuous monitoring, home-based urology devices and telemedicine solutions are gaining traction. Remote monitoring systems, smart catheters, and wearable diagnostic devices enable patients to track urinary health and communicate data with healthcare providers in real-time. This trend is reshaping the market by extending care beyond hospital settings, enhancing patient compliance, and reducing the burden on healthcare facilities. Accessories, including catheters, stents, lubricants, and other consumables, are the largest and fastest-growing segment in the market due to their high recurring demand and rising prevalence of urological disorders worldwide. The accessories segment in the global urology devices market, encompassing catheters, stents, lubricants, gels, and other consumables, dominates both in size and growth rate due to a combination of clinical, economic, and demographic factors. Catheters remain one of the most frequently used urology accessories because they are indispensable in managing urinary retention, incontinence, post-operative drainage, and bladder disorders. Their widespread use in hospitals, nursing homes, and home care settings ensures consistent, recurring demand. Similarly, ureteral and urinary stents are critical for maintaining urine flow in patients with obstructions, kidney stones, or after surgical interventions, driving routine adoption in both inpatient and outpatient procedures. The rising prevalence of urological disorders, particularly in aging populations, directly fuels the demand for these accessories. Conditions like benign prostatic hyperplasia (BPH), kidney stones, urinary tract infections, incontinence, and post-surgical recovery require repeated or long-term use of catheters, stents, and lubricants. For instance, patients with chronic urinary retention or neurogenic bladder may require intermittent or indwelling catheters, sometimes on a daily basis, which significantly contributes to the rapid growth of this segment. Similarly, stents and related consumables are routinely used in minimally invasive urological surgeries, which are gaining popularity due to their reduced recovery time, lower complication rates, and improved patient comfort. Technological advancements also play a key role in boosting the segment’s growth. Modern accessories are increasingly designed with biocompatible materials, antimicrobial coatings, flexible designs, and user-friendly mechanisms, enhancing patient safety, comfort, and treatment efficacy. Lubricants and gels are being formulated to reduce infection risks, improve catheter insertion, and enhance overall procedural outcomes. These innovations increase adoption rates among hospitals, clinics, and home care patients, further expanding market size. Urolithiasis is the largest application segment in the global urology devices market due to its increasing prevalence worldwide and the critical need for advanced diagnostic for effective management. Urolithiasis, commonly referred to as kidney or urinary stones, represents the largest application segment in the global urology devices market, driven by its growing incidence and the significant clinical burden it imposes on healthcare systems. The prevalence of stone disease has been rising steadily, particularly in regions with changing dietary habits, sedentary lifestyles, and higher rates of obesity and metabolic disorders. Factors such as dehydration, high salt intake, excessive consumption of animal protein, and imbalances in calcium and oxalate metabolism contribute to stone formation. Many patients who have experienced kidney stones are prone to recurrence, sometimes multiple times over a lifetime, necessitating repeated diagnostic evaluations, treatment procedures, and follow-up care. Devices such as extracorporeal shock wave lithotripters (ESWL), ureteroscopes, laser lithotripsy systems, stents, and catheters are critical in both the removal of stones and the management of associated complications. The routine and repetitive requirement for these interventions ensures that urolithiasis remains the largest application segment. Technological advancements in urology devices have further enhanced the treatment of urolithiasis, driving market growth. High-precision laser lithotripsy systems, flexible and miniaturized ureteroscopes, and advanced imaging modalities allow for more accurate detection and targeted treatment of stones with minimal patient discomfort. These innovations reduce surgical time, lower complication rates, and improve overall recovery, making minimally invasive procedures the preferred approach in modern urological practice. Hospitals and clinics are the largest end-user segment in the global urology devices market due to their high patient volumes and central role in both inpatient and outpatient urological care. Hospitals and clinics dominate the global urology devices market as the primary end-users due to their comprehensive capabilities in managing a wide range of urological disorders. These healthcare facilities serve as the first point of contact for patients suffering from conditions such as kidney stones, benign prostatic hyperplasia (BPH), urinary incontinence, prostate cancer, and other complex urinary tract disorders. The high prevalence of urological diseases across different age groups, combined with an increasing awareness of treatment options, ensures that hospitals and specialized clinics consistently witness a large influx of patients seeking diagnosis, surgical intervention, and post-operative care. One of the key factors contributing to the dominance of hospitals and clinics is their capacity to invest in technologically advanced urology devices. This includes equipment such as laser lithotripters, endoscopes, robotic-assisted surgical systems, imaging modalities, and a wide range of consumables like catheters, stents, and surgical accessories. The availability of these sophisticated devices allows hospitals to perform minimally invasive and high-precision procedures that improve patient outcomes and reduce recovery times. Moreover, hospitals often act as referral centers for complex cases, further increasing the utilization of advanced urology devices. Another reason for the dominance of hospitals and clinics is their ability to handle a high patient throughput, which directly translates into frequent use of urology devices. For example, routine procedures such as catheterizations, stent placements, and lithotripsy treatments are performed repeatedly, generating continuous demand for both capital equipment and consumables. North America is the largest market for global urology devices due to high prevalence of urological disorders, widespread adoption of minimally invasive technologies, and strong R&D investments. North America dominates the global urology devices market, primarily driven by a combination of demographic, clinical, technological, and economic factors that collectively create a high demand for urological interventions and related devices. One of the foremost reasons for the region’s leading position is the high prevalence of urological disorders among its population. Conditions such as benign prostatic hyperplasia, kidney stones, urinary incontinence, prostate cancer, and other urinary tract diseases are widespread in both the elderly and middle-aged populations. The aging population, particularly in the United States and Canada, has resulted in an increasing number of patients requiring regular urological care, including diagnostic assessments, surgical interventions, and long-term management using catheters, stents, and other urology devices. The advanced healthcare infrastructure in North America further reinforces its market leadership. Hospitals and specialized urology clinics are equipped with state-of-the-art diagnostic and surgical technologies, including laser lithotripters, endoscopes, robotic-assisted surgical systems, and imaging modalities, which enable highly precise and minimally invasive procedures. The widespread availability of these advanced systems not only improves patient outcomes but also encourages the adoption of modern devices, including accessories and consumables. Technological innovation is another key factor propelling North America to the forefront of the global urology devices market. Continuous R&D investments by leading medical device manufacturers have led to advancements in minimally invasive procedures, digital diagnostics, telemedicine integration, and biocompatible materials for catheters and stents. • July 2025: Boston Scientific and Merck, a leading pharmaceutical company, entered into a strategic collaboration to co-develop and commercialize a new generation of combination therapies for the treatment of urological conditions. • March 2025: the European Commission granted marketing authorization for the use of Coloplast's new urology device, the GentleLase Laser System, for the treatment of benign prostatic hyperplasia (BPH). • September 2024: Teleflex, a global provider of medical technologies, completed the acquisition of Ardian Medical Technologies, a pioneer in the field of renal denervation systems. • February 2024: Medtronic, a leading medical technology company, announced the launch of its new renal denervation system, the Ardian 1014, for the treatment of resistant hypertension. • January 2024: Boston Scientific Corporation entered into a definitive agreement to acquire Axonics, Inc. This acquisition would expand the urology portfolio of Boston Scientific Corporation with differentiated technologies to treat urinary and bowel dysfunction. • September 2023: Cook Medical’s Motion Hybrid Wire Guide is commercially available in Canada. This wire guide is an excellent choice for clinicians in urological specialties given that it functions as both an access wire guide and a safety wire guide in one. • December 2022: Precision Optics Corporation, Inc. a manufacturer of advanced optical instruments for the medical and defense industry announced new product development order for single use urology program with an aim to expand its focus on the medical device market. • September 2022: Advanced MedTech Solutions Pvt. acquired Shenzhen Huikang Medical Apparatus Co., Ltd., a Chinese market leader in urology with an aim to strengthen its market position in China.