Urology Devices - Market Insights, Competitive Landscape, and Market Forecast - 2032

Urology Devices Market Summary

• The global urology devices market is expected to increase from USD 34,898.97 million in 2024 to USD 63,320.19 million by 2032, reflecting strong and sustained growth.
• The global urology devices market is growing at a CAGR of 7.77% during the forecast period from 2025 to 2032.
• The global urology devices market is growing due to the rising prevalence of kidney stones, urinary incontinence, BPH, and prostate and bladder cancers, particularly among the aging population. Advancements in minimally invasive and robotic-assisted procedures, along with improved diagnostics, are boosting adoption. Additionally, increasing healthcare spending, expanding infrastructure in emerging economies, and rising lifestyle-related risk factors such as obesity and diabetes are further driving market demand.
• The leading companies operating in the urology devices market include Medtronic plc, Boston Scientific Corporation, Fresenius Medical Care AG, Becton, Dickinson and Company (BD), Olympus Corporation, Karl Storz SE & Co. KG, B. Braun SE, Coloplast A/S, Baxter, Cook Medical, Intuitive Surgical, Inc., Stryker Corporation, Teleflex Incorporated, Siemens Healthineers, Richard Wolf GmbH, Dornier MedTech, Laborie Medical Technologies, Convatec Inc., Cardinal Health, NIPRO Corporation, and others.
• The North America urology devices market is growing due to the high prevalence of kidney stones, urinary incontinence, BPH, and prostate and bladder cancers, particularly among the aging population. Strong healthcare infrastructure, favorable reimbursement policies, and rapid adoption of advanced technologies such as minimally invasive and robotic-assisted procedures are further driving demand. Additionally, continuous R&D investments, new product launches, and the rising burden of lifestyle-related risk factors like obesity and diabetes are fueling sustained market expansion.
• In the product type segment of the urology devices market, the urology pumps category is estimated to account for the largest market share in 2024.

Factors Contributing to the Growth of the Urology Devices Market

• Rising Global Prevalence of Urological Diseases Leading to a Surge in Urology Devices: The incidence of urological conditions is increasing worldwide, creating a larger patient pool that requires diagnosis, treatment, and ongoing management. Key conditions driving this demand include:
• Kidney Stones (Urolithiasis): The prevalence of kidney stones is rising due to lifestyle factors such as poor diet, sedentary habits, and obesity. This has led to a growing demand for devices like lithotripters and ureteroscopes for stone fragmentation and removal.
• Benign Prostatic Hyperplasia (BPH): As a condition common in aging men, the global increase in the elderly population directly translates to a higher number of BPH cases, driving demand for devices used in procedures like transurethral resection of the prostate (TURP) and newer minimally invasive options like the UroLift system.
• Urological Cancers: The incidence of cancers affecting the prostate, bladder, and kidneys is on the rise, particularly in high-income regions. The need for effective diagnostic tools (e.g., biopsy needles) and advanced surgical devices (e.g., robotic surgical systems) for treatment is a major market driver.
• Chronic Kidney Disease (CKD) and End-Stage Renal Disease (ESRD): The increasing prevalence of chronic conditions like diabetes and hypertension, which are major risk factors for kidney disease, is fueling the demand for dialysis devices, a significant segment of the urology devices market.
• Technological Advancements and Innovation: Rapid innovation is transforming the field of urology, offering more effective, less invasive, and safer treatment options.
• Minimally Invasive Surgery (MIS): There is a strong and growing preference for MIS procedures over traditional open surgery due to benefits like reduced patient trauma, less blood loss, shorter hospital stays, and faster recovery times. This trend is driving the development and adoption of advanced endoscopes, lasers, and other MIS instruments.
• Robotic-Assisted Surgery: Systems like the da Vinci Surgical System provide surgeons with enhanced precision, control, and 3D visualization, making them ideal for complex procedures like prostatectomies. The increasing adoption of these robotic platforms is a major growth factor.
• Smart and AI-Enabled Devices: The integration of artificial intelligence (AI) and machine learning in urology devices is improving diagnostic accuracy (e.g., AI-based imaging for cancer detection) and optimizing treatment planning.
• Single-Use and Disposable Devices: The growing demand for single-use devices, such as disposable ureteroscopes and catheters, is driven by the need to minimize the risk of cross-contamination and the increasing volume of procedures performed in ambulatory surgical centers (ASCs).
• Laser Technology: Advancements in laser technology, such as Holmium and Thulium lasers, have revolutionized the treatment of kidney stones and BPH by offering more precise and efficient tissue ablation and stone fragmentation.
• Aging Global Population: The world's population is aging, particularly in developed regions. As people live longer, they become more susceptible to age-related urological conditions, including BPH, urinary incontinence, and urological cancers. This demographic shift is a fundamental driver of market growth, as the elderly are the primary consumers of many urology devices.

Urology Devices Market Report Segmentation

This urology devices market report offers a comprehensive overview of the global urology devices market, highlighting key trends, growth drivers, challenges, and opportunities. It covers detailed market segmentation by Product Type (Instruments {Endoscopic Devices [Cystoscopes, Ureteroscopes, Nephroscopes, Resectoscopes, and Laparoscopes], Dialysis Devices [Hemodialysis Devices, Peritoneal Dialysis Devices], Laser and Lithotripsy Devices, Robotic Surgical Systems, Urodynamic Systems, and Others}, Consumables & Accessories {Dialysis Consumables, Urology Catheters & Guidewires, Implants & Stents, Urinary Drainage Bags, and Others}), Application (Urinary Stones (Urolithiasis), Benign Prostatic Hyperplasia (BPH), Kidney Diseases, Urological Cancer, Urinary Incontinence, and Others), End-Users (Hospitals, Ambulatory Surgical Centers (ASC), Dialysis Centers, Homecare Settings, and Others), and Geography. The report provides valuable insights into the competitive landscape, regulatory environment, and market dynamics across major markets, including North America, Europe, and Asia-Pacific. Featuring in-depth profiles of leading industry players and recent product innovations, this report equips businesses with essential data to identify market potential, develop strategic plans, and capitalize on emerging opportunities in the rapidly growing urology devices market.

Urology devices are specialized medical instruments, equipment, and supplies used in the field of urology for the diagnosis, treatment, and management of conditions affecting the male and female urinary tract system and the male reproductive system. These devices are designed to be precise, safe, and efficient, often enabling minimally invasive procedures that reduce patient discomfort and recovery time. Urology encompasses a wide range of conditions, including kidney stones, urinary incontinence, prostate problems, urinary tract infections, and various cancers. As a result, urology devices are diverse, serving different functions from diagnostics to complex surgical interventions.

The growth of the global urology devices market is being driven by several key factors, primarily the rising prevalence of urological disorders such as kidney stones, urinary incontinence, benign prostatic hyperplasia (BPH), and prostate and bladder cancers. An aging population worldwide further fuels demand, as elderly individuals are more prone to such conditions. Technological advancements, including the development of minimally invasive and robotic-assisted procedures, are improving treatment outcomes and boosting adoption rates among healthcare providers. Increasing awareness and early diagnosis through advanced imaging and diagnostic tools are also supporting market growth. Furthermore, growing healthcare expenditure, favourable reimbursement policies in developed regions, and the expansion of healthcare infrastructure in emerging economies are contributing to higher device uptake. The rising focus on personalized and patient-friendly treatment approaches, coupled with the introduction of portable and home-based devices, is also widening market opportunities. Additionally, strategic collaborations, product launches, and investments by leading companies are accelerating innovation. The increasing prevalence of lifestyle-related risk factors such as obesity, diabetes, and hypertension further strengthens demand for urology devices. Collectively, these factors position the urology devices market for sustained expansion over the coming years.

What are the latest Urology Devices Market Dynamics and Trends?

The global urology devices market is witnessing strong growth, driven by the rising global prevalence of urological diseases, technological advancements, and demographic shifts. Urolithiasis alone is a major contributor, with global incidence rates estimated at 1,800 per 100,000 in men and 815 per 100,000 in women in 2021, and nearly 12% of the U.S. population is expected to experience kidney stones during their lifetime, creating significant demand for advanced stone removal devices such as flexible ureteroscopes and laser lithotripters.

Urinary incontinence impacts more than 400 million people worldwide, particularly affecting women and the elderly, fuelling the adoption of catheters, urodynamic systems, and implants.

The aging population further strengthens the market outlook, as the number of people aged 60 years and above will rise from 1 billion in 2020 to 1.4 billion by 2030, increasing cases of BPH and prostate cancer, which account for 1.4 million new cases globally each year.

At the procedural level, treatment patterns are shifting from extracorporeal shock wave lithotripsy (ESWL) toward minimally invasive endourological procedures such as URS and PCNL, boosting demand for high-performance imaging systems, disposable endoscopes, and consumables.

In parallel, rising healthcare expenditure, favourable reimbursement policies in developed regions, and expanding access to care in emerging economies are accelerating adoption.

Additionally, growing awareness, early diagnosis, and patient preference for home-based and portable solutions, such as intermittent catheters and home dialysis devices, are creating new growth avenues. With continuous R&D, product launches, and AI/robotics integration in surgical systems, the global urology devices market is positioned for sustained high growth, addressing a large and expanding patient pool.

The urology devices market, while growing, is subject to several significant restraints and challenges. A primary challenge is the high cost associated with advanced devices, such as robotic surgical systems and sophisticated lasers, which present a substantial capital investment hurdle for healthcare facilities, particularly in developing economies. This financial burden is compounded by the ongoing costs of single-use consumables and accessories, which can be expensive and impact treatment affordability for patients. Furthermore, the market faces a critical shortage of skilled urologists and other trained professionals needed to operate this complex equipment, which limits the adoption of cutting-edge technologies and creates a significant mismatch between the growing patient population and the available specialist workforce. The industry is also constrained by a complex and ever-changing regulatory landscape, which involves lengthy and costly approval processes and can delay the market entry of innovative products. Finally, inadequate and non-standardized reimbursement policies for new devices and procedures create financial uncertainty for providers, discouraging them from investing in the latest technology and hindering overall market expansion.

Urology Devices Market Segment Analysis

Urology Devices Market by Product Type (Instruments {Endoscopic Devices [Cystoscopes, Ureteroscopes, Nephroscopes, Resectoscopes, and Laparoscopes], Dialysis Devices [Hemodialysis Devices, Peritoneal Dialysis Devices], Laser and Lithotripsy Devices, Robotic Surgical Systems, Urodynamic Systems, and Others}, Consumables & Accessories {Dialysis Consumables, Urology Catheters & Guidewires, Implants & Stents, Urinary Drainage Bags, and Others}), Application (Urinary Stones (Urolithiasis), Benign Prostatic Hyperplasia (BPH), Kidney Diseases, Urological Cancer, Urinary Incontinence, and Others), End-Users (Hospitals, Ambulatory Surgical Centers (ASC), Dialysis Centers, Homecare Settings, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

Urology Devices Market Regional Analysis

North America Urology Devices Market Trends

North America is projected to dominate the global urology devices market in 2024, accounting for approximately 38% of the total share. This is primarily driven by the high disease burden, advanced healthcare infrastructure, and strong adoption of innovative technologies. The United States leads with a large patient pool; over 37 million Americans are affected by chronic kidney disease (CKD), and more than 810,000 people live with end-stage renal disease (ESRD), with about 70% on dialysis and 30% living with a kidney transplant, fueling steady demand for dialysis devices and consumables. Urolithiasis is also common, with nearly 1 in 11 people in the U.S. expected to experience kidney stones in their lifetime, supporting high utilization of ureteroscopes, lithotripters, and laser systems.

Prostate cancer further contributes, with the U.S. recording ~299,000 new prostate cancer cases in 2024, making it one of the most commonly diagnosed cancers. In Canada, CKD affects about 3.5 million people, and over 50,000 Canadians live with ESRD, the majority requiring ongoing dialysis, which drives procurement of dialysis machines and accessories.

Beyond epidemiology, the region benefits from favorable reimbursement systems, high healthcare spending (U.S. healthcare expenditure exceeds 17% of GDP), and rapid uptake of minimally invasive and robotic-assisted surgeries. Hospitals and specialized urology centers in North America are early adopters of robotic surgery platforms, single-use cystoscopes, and AI-powered diagnostic tools, further boosting device penetration. Additionally, a strong presence of key market players (e.g., Boston Scientific, Baxter, Medtronic, Stryker) ensures continuous product launches and technological innovation. Collectively, these factors make North America the largest regional market, with the U.S. as the clear growth engine supported by Canada's expanding dialysis and surgical infrastructure.

Europe Urology Devices Market Trends

The European urology devices market is defined by several key trends, primarily driven by its rapidly aging population, which is leading to a higher prevalence of conditions like BPH, urinary incontinence, and urological cancers, and advanced healthcare infrastructure across Germany, the UK, France, Italy, and Spain.

This demographic shift, combined with a strong preference for advanced medical technologies, is fueling a widespread adoption of minimally invasive and robotic-assisted surgery, which offers benefits such as faster patient recovery and reduced hospital stays. Concurrently, there is a growing emphasis on patient-centric and home-based care, with an increasing number of procedures moving to outpatient settings and a rising demand for home dialysis systems and user-friendly consumables.

According to the European Association of Urology (2023), more than 10% of Europeans will experience kidney stones during their lifetime, while prostate cancer remains the most diagnosed cancer in men, with over 470,000 new cases reported annually in the EU. In addition, the rising prevalence of urinary incontinence, affecting nearly 36% of women over 60 in Europe, is boosting the demand for catheters and consumables, which dominate by volume due to frequent replacement needs.

The market is also shaped by a stringent regulatory environment under the EU's Medical Device Regulation (MDR) and significant R&D investment, which ensures a steady flow of innovative products. Despite being highly competitive, with major global and regional players, the market continues to see strategic mergers and acquisitions aimed at expanding product portfolios and geographical reach.

Asia-Pacific Urology Devices Market Trends

The Asia-Pacific (APAC) urology devices market is a dynamic and high-growth sector, positioned to be the fastest-expanding region at a CAGR of 8.5% through 2032 globally, primarily driven by its massive, aging population. Countries like China and India are seeing a dramatic increase in the number of elderly individuals, which directly translates to a higher prevalence of age-related urological conditions. For instance, the prevalence of Benign Prostatic Hyperplasia (BPH) among men aged 40 and older in mainland China is estimated to be over 36.6%, a figure that rises significantly to nearly 70% in men aged 80 and above.

Similarly, the region faces a substantial burden of chronic diseases like diabetes and hypertension, which are major risk factors for kidney diseases, boosting the demand for dialysis equipment. Furthermore, epidemiological statistics underscore the scale of the market opportunity; the prevalence of urolithiasis in parts of West, Southeast, and South Asia can be as high as 19.1%, with some regions considered a "stone belt." China has the highest number of new bladder cancer cases globally.

This growing disease burden is being met by a rapid rise in healthcare expenditure and significant government investment in modernizing hospital infrastructure, particularly in emerging economies. The market's growth is further accelerated by the increasing adoption of advanced technologies, including minimally invasive surgical techniques and robotic-assisted surgery, for which countries like Japan, South Korea, and Singapore are early adopters. The trend is also supported by the rise of local medical device manufacturers, which offer competitively priced products and improve accessibility across the region.

Who are the major players in the urology devices market?

The following are the leading companies in the urology devices market. These companies collectively hold the largest market share and dictate industry trends.

• Medtronic plc
• Boston Scientific Corporation
• Fresenius Medical Care AG
• Becton, Dickinson and Company (BD)
• Olympus Corporation
• Karl Storz SE & Co. KG
• B. Braun SE
• Coloplast A/S
• Baxter
• Cook Medical Corporation
• Intuitive Surgical, Inc.
• Stryker Corporation
• Teleflex Incorporated
• Siemens Healthineers
• Richard Wolf GmbH
• Dornier MedTech
• Laborie Medical Technologies
• Convatec Inc.
• Cardinal Health
• NIPRO Corporation
• Others

How is the competitive landscape shaping the urology devices market?

The competitive landscape of the urology devices market is best described as a mix of intense competition and strategic consolidation. The market is dominated by a few large, diversified multinational companies like Medtronic, Boston Scientific, and Olympus, which have extensive product portfolios, strong global distribution networks, and substantial R&D budgets. The market for high-capital equipment, such as robotic surgical systems (e.g., Intuitive Surgical's da Vinci), advanced laser systems, and dialysis machines, is highly consolidated. A handful of major, multinational corporations like Medtronic, Boston Scientific, Olympus, and Fresenius Medical Care dominate this space. Their market power comes from vast R&D budgets, strong brand reputation, and well-established global distribution networks. The high cost and complexity of these devices act as a significant barrier to entry, making it difficult for new or smaller companies to compete.

However, the market for consumables and accessories, such as catheters, stents, and guidewires, is more fragmented, with numerous smaller and regional players competing on price, quality, and specialized products. A key trend shaping this landscape is the strategic acquisition of smaller, innovative companies by larger players, who are seeking to expand their product offerings and gain a technological edge. This consolidation not only reduces the number of competitors but also raises barriers to entry for new entrants due to high R&D costs and complex regulatory hurdles. This dual structure, high concentration in capital equipment, and fragmentation in consumables define the competitive dynamics of the market.

Recent Developmental Activities in the Urology Devices Market

• In September 2025, Johnson & Johnson received U.S. FDA approval for INLEXZO(TM), a groundbreaking gemcitabine intravesical system for treating Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer. This is the first and only intravesical drug-releasing system for this condition.
• In June 2025, Boston Scientific's Rezum Water Vapor Thermal Therapy received FDA clearance for a label expansion, allowing treatment of BPH in larger prostate volumes up to 150 g, broadening the eligible patient population for this minimally invasive therapy.
• In April 2025, Bright Uro's Glean Urodynamics System received FDA 510(k) clearance. The wireless ambulatory urodynamics system is catheter-free, offering improved patient comfort and more physiologically accurate measurement of lower urinary tract function.

Urology Devices Market Segmentation

• Urology Devices by Product Type Exposure
• Instruments
• Endoscopic Devices
• Cystoscopes
• Ureteroscopes
• Nephroscopes
• Resectoscopes
• Laparoscopes
• Dialysis Devices
• Hemodialysis Devices
• Peritoneal Dialysis Devices
• Laser and Lithotripsy Devices
• Robotic Surgical Systems
• Urodynamic Systems
• Others
• Consumables & Accessories
• Dialysis Consumables
• Urology Catheters & Guidewires
• Implants & Stents
• Urinary Drainage Bags
• Others
• Urology Devices by Application Exposure
• Urinary Stones (Urolithiasis)
• Benign Prostatic Hyperplasia (BPH)
• Kidney Diseases
• Urological Cancer
• Urinary Incontinence
• Others
• Urology Devices End-Users Exposure
• Hospitals
• Ambulatory Surgical Centers (ASCs)
• Dialysis Centers
• Homecare Settings
• Others
• Urology Devices Geography Exposure
• North America Urology Devices Market
• United States Urology Devices Market
• Canada Urology Devices Market
• Mexico Urology Devices Market
• Europe Urology Devices Market
• United Kingdom Urology Devices Market
• Germany Urology Devices Market
• France Urology Devices Market
• Italy Urology Devices Market
• Spain Urology Devices Market
• Rest of Europe Urology Devices Market
• Asia-Pacific Urology Devices Market
• China Urology Devices Market
• Japan Urology Devices Market
• India Urology Devices Market
• Australia Urology Devices Market
• South Korea Urology Devices Market
• Rest of Asia-Pacific Urology Devices Market
• Rest of the World Urology Devices Market
• South America Urology Devices Market
• Middle East Urology Devices Market
• Africa Urology Devices Market

Impact Analysis

AI-Powered Innovations and Applications:

AI is profoundly impacting the urology devices market by revolutionizing diagnostics, enhancing surgical precision, and improving patient care. In diagnostics, AI algorithms are analyzing medical images from MRI, CT, and ultrasound scans with a level of accuracy that can surpass human interpretation, enabling earlier and more precise detection of urological conditions like prostate and kidney cancers. This helps to reduce the number of unnecessary biopsies and guides surgeons to target suspicious areas with greater efficiency. In the surgical realm, AI is a game-changer for robotic-assisted procedures, providing surgeons with real-time feedback and guidance by analyzing live video feeds. This enhances dexterity and precision, which can lead to better patient outcomes, less blood loss, and faster recovery times. Furthermore, AI-driven predictive analytics are used to process vast amounts of patient data, allowing for the creation of highly personalized treatment plans and the ability to predict disease progression and potential complications. Beyond clinical applications, AI is also improving workflow efficiency and patient management through remote monitoring via smart devices and automated data analysis, which streamlines clinical operations and empowers patients to take a more active role in their health.

U.S. Tariff Impact Analysis on the Urology Devices Market:

The U.S. government's tariffs on imported medical devices are fundamentally reshaping the global urology devices market. The most immediate effect is a significant increase in product costs, as a universal 10% baseline tariff and much higher, country-specific rates on goods from major producers like China (up to 54%) directly raise the price for both finished devices and their components. This financial burden forces manufacturers to either absorb the cost, which erodes profit margins, or pass it on to healthcare providers, potentially limiting patient access to advanced technologies. To mitigate these impacts, companies are actively re-evaluating their intricate global supply chains, shifting manufacturing and sourcing away from heavily-tariffed countries and towards alternatives in regions like India, Mexico, and Taiwan, or even back to the U.S. This strategic realignment, while aimed at reducing tariff exposure, introduces its own complexities and costs. Furthermore, the tariffs have triggered retaliatory measures from key trading partners, creating a two-way street of tariffs that can make U.S.-made products less competitive in crucial international markets. This climate of uncertainty and trade friction is driving a market-wide trend toward regionalization and is forcing a fundamental reassessment of global supply chain logistics.

How This Analysis Helps Clients

• Cost Management: By understanding the tariff landscape, clients can anticipate cost increases and adjust pricing strategies accordingly, ensuring profitability.
• Supply Chain Optimization: Clients can identify alternative sourcing options and diversify their supply chains to reduce dependency on high-tariff regions, enhancing resilience.
• Regulatory Navigation: Expert guidance on navigating the evolving regulatory environment helps clients maintain compliance and avoid potential legal challenges.
• Strategic Planning: Insights into tariff impacts enable clients to make informed decisions about manufacturing locations, partnerships, and market entry strategies.

Key takeaways from the Urology Devices market report study

• Market size analysis for the current urology devices market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the urology devices market.
• Various opportunities available for the other competitors in the urology devices market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current urology devices market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for the urology devices market growth in the future?

Frequently Asked Questions for the Urology Devices Market

1. What is the growth rate of the urology devices market?

• The urology devices market is estimated to grow at a CAGR of 7.77% during the forecast period from 2025 to 2032.

2. What is the market for urology devices?

• The urology devices market was valued at USD 34,898.97 million in 2024, and is expected to reach USD 63,320.19 million by 2032.

3. Which region has the highest share in the urology devices market?

• The global urology devices market is growing due to the rising prevalence of kidney stones, urinary incontinence, BPH, and prostate and bladder cancers, particularly among the aging population. Advancements in minimally invasive and robotic-assisted procedures, along with improved diagnostics, are boosting adoption. Additionally, increasing healthcare spending, expanding infrastructure in emerging economies, and rising lifestyle-related risk factors such as obesity and diabetes are further driving market demand.

4. What are the drivers for the urology devices market?

• The global urology devices market is growing due to the rising prevalence of kidney stones, urinary incontinence, BPH, and prostate and bladder cancers, particularly among the aging population. Advancements in minimally invasive and robotic-assisted procedures, along with improved diagnostics, are boosting adoption. Additionally, increasing healthcare spending, expanding infrastructure in emerging economies, and rising lifestyle-related risk factors such as obesity and diabetes are further driving market demand.

5. Who are the key players operating in the urology devices market?

• Some of the key market players operating in the urology devices market include Medtronic plc, Boston Scientific Corporation, Fresenius Medical Care AG, Becton, Dickinson and Company (BD), Olympus Corporation, Karl Storz SE & Co. KG, B. Braun SE, Coloplast A/S, Baxter, Cook Medical, Intuitive Surgical, Inc., Stryker Corporation, Teleflex Incorporated, Siemens Healthineers, Richard Wolf GmbH, Dornier MedTech, Laborie Medical Technologies, Convatec Inc., Cardinal Health, NIPRO Corporation, and others.