Nephrostomy Market Size, Share & Trend Analysis - Global - 2025-2031 - Includes: Percutaneous Nephrostomy Set Market, Nephrostomy Balloon Catheter Market and 1 more
Description
Global Nephrostomy Device Market Report, 2025 Edition<
Executive Summary
The global nephrostomy device market was valued at $207 million in 2024. The market is projected to grow at a 3.6 percent CAGR, reaching more than $265 million by 2032. Growth is supported by sustained procedure volumes for percutaneous nephrostomy (PCN), percutaneous nephrolithotomy (PCNL), access creation for stone removal, and urinary drainage procedures driven by urinary obstruction, stone disease, and cancer. Nephrostomy devices remain an essential component of minimally invasive urological care in both hospital and office-based settings.
This report covers the complete device categories used in nephrostomy procedures, including percutaneous nephrostomy sets, nephrostomy balloon catheters, and nephrostomy drainage tubes. A percutaneous nephrostomy set includes all devices required to gain renal access, establish a nephrostomy tract, and place a nephrostomy tube or ureteral stent. Balloon catheters are used to dilate the tract and may include sheaths, port grips, inflation ports, or other dilation tools. Nephrostomy drainage tubes, such as Malecot catheters, are essential for drainage, postoperative stabilization, re-entry, or long-term management of obstruction.
Nephrostomy devices are closely linked to PCNL and urinary drainage procedures. As stone disease and cancer rates rise worldwide, related interventions and nephrostomy access requirements grow. PCN is often the first step before definitive treatment, making demand for nephrostomy sets consistent with broader minimally invasive urology trends.
This comprehensive report provides units sold, average selling prices, market values, forecasts, procedure insights, competitive strategies, and technology trends through 2032. It offers historical data to 2022 and analyzes mergers and acquisitions, pricing dynamics, and market shares for key competitors. The report supports medical device planners, business leaders, and investors seeking detailed insight into this essential urological device sector.
Market Overview
Nephrostomy devices enable urinary drainage through direct access to the renal pelvis. These devices are required when normal urine flow is blocked, typically due to stones, tumors, strictures, inflammation, or anatomical abnormalities. Nephrostomy is used for both urgent decompression and planned access in stone removal procedures.
The market consists of three primary device categories:
Percutaneous nephrostomy sets
These include all tools required to gain access and establish the tract. They often contain needles, guidewires, dilators, sheaths, and accessories needed for safe entry into the kidney prior to catheter or stent placement.
Nephrostomy balloon catheters
These catheters create and expand the tract by balloon dilation. Complete kits may include dilation systems, sheaths, inflation ports, and balloon components. Balloon catheters are used for PCNL, complex access creation, and re-entry procedures.
Nephrostomy drainage tubes
These include Malecot catheters and other drainage options designed for postoperative stabilization, urinary diversion, or management of long-term obstruction. Malecot catheters are commonly used for re-entry when repeated access is required.
Nephrostomy procedures serve several clinical roles:
Urinary drainage in cases of obstruction caused by stones, cancer, trauma, or inflammation
PCNL access creation for stone removal
Preparation for ureteral stenting
Management of complex or recurrent stones
Preservation of kidney function in emergency cases
Demand for nephrostomy sets is directly tied to PCNL volumes, which remain high in regions with elevated stone prevalence. Additionally, access creation is essential for patients who cannot undergo less invasive stone management due to stone size, location, or anatomical constraints.
The nephrostomy market benefits from advancements in dilation tools, guidewire technologies, tract stabilization devices, and miniaturized PCNL instruments. As techniques such as “mini-perc” and “micro-perc” expand, they influence the demand profile for nephrostomy sets and catheters.
The market faces challenges related to procedural invasiveness, infection risk, training variation, and evolving preferences for tubeless procedures in selected patients. However, overall demand remains resilient due to the large number of patients requiring urgent or planned renal access.
Market Drivers
Demographic Factors
More than 70 percent of PCN procedures are performed on patients over the age of 45. This demographic will continue to expand globally, driven by longer life expectancy and aging populations in both developed and emerging countries.
The incidence of urinary stones, particularly calcium oxalate and uric acid stones, is increasing worldwide. Contributing factors include:
Higher body mass index
Increased dietary sodium and sugar
Dehydration
Metabolic disorders
Sedentary lifestyle patterns
Stone disease leads to urinary obstruction, which often requires PCN or PCNL. As a result, nephrostomy device demand aligns closely with broader stone disease trends.
Cancer incidence also contributes significantly. Tumors of the pelvis, bladder, kidney, or ureter may obstruct urine flow, necessitating nephrostomy drainage to prevent renal damage. As cancer rates rise with aging populations, associated nephrostomy procedures increase accordingly.
Technological advances in PCNL also support market growth. Anti-retropulsion devices improve stone fragmentation efficiency. Smaller instruments and mini-perc systems reduce trauma and blood loss, encouraging adoption of PCNL over less effective or less definitive procedures. PCNL typically produces higher stone clearance rates than extracorporeal shockwave lithotripsy (ESWL), reducing retreatment needs and reinforcing nephrostomy access use.
Increase in Office Procedures
Nephrostomy procedures can be performed in office-based settings for selected patients. Office procedures offer:
Greater comfort for patients
Reduced waiting times
Faster throughput compared with hospital scheduling
Lower costs of care
Increased efficiency for physicians
Office-based nephrostomy has grown due to improvements in imaging, balloon dilation systems, tract stabilization, and catheter design. Physicians can treat more patients in a single day, which supports higher procedural volumes. This shift strengthens demand for nephrostomy sets and catheters suited for minimally invasive environments outside the traditional hospital setting.
As the healthcare system prioritizes convenience, patient experience, and efficient care delivery, office-based nephrostomy procedures will continue contributing to global market growth.
Market Limiters
Healthcare Reform and Hospital-Acquired Condition Penalties
Under the Hospital-Acquired Condition (HAC) reduction program, hospitals with higher rates of adverse events face penalties up to 1 percent of Medicare reimbursement. Hospital-acquired infections (HAIs) represent a significant category of adverse events.
Nephrostomy procedures present inherent risks, including:
Perforation of the collecting system
Acute intraoperative bleeding
Postoperative infection associated with drainage tubes
Sepsis in severe cases
Because of these risks, hospitals may seek alternatives such as ESWL in suitable cases. ESWL is less invasive than PCNL and avoids the need for tract creation. While ESWL may not achieve the same stone clearance rates, its lower complication profile makes it appealing in cost-sensitive regulated environments.
These reimbursement pressures can limit nephrostomy-based interventions in certain facilities or patient scenarios.
Invasiveness of the Procedure
Nephrostomy requires puncturing the skin and placing a catheter directly into the renal pelvis. The procedure carries risks, discomfort, and potential complications. Patients may avoid nephrostomy when possible, opting for alternative treatments. However, when urinary obstruction leads to renal impairment, nephrostomy becomes mandatory, regardless of invasiveness.
The inherent invasiveness limits adoption for mild cases but continues to drive usage in urgent or severe conditions. Still, patient hesitancy and clinical caution in borderline cases can influence procedure volumes.
Reviewing Standard Practices
Traditional nephrostomy procedures involve placing a drainage tube after PCNL or access creation. However, there is growing debate among physicians about the necessity of nephrostomy tubes for all patients. Trends toward “tubeless” PCNL reduce postoperative discomfort and improve quality of life, particularly for patients with favorable anatomical and stone characteristics.
As tubeless procedures gain acceptance, nephrostomy tube use may decline in select patient subsets. This shifts demand patterns within the drainage tube segment, although access creation and balloon dilation remain essential for PCNL.
Patient quality of life, faster recovery, and pain reduction influence physician decision-making. As minimally invasive practices evolve, the need for certain nephrostomy components may be reduced, even as overall procedure demand remains relatively stable.
Market Coverage and Data Scope
Quantitative Coverage
Device-level market size
Company shares
Market growth rates
Unit sales by device category
Average selling prices
Forecasts through 2032
Qualitative Coverage
Market dynamics and clinical adoption
Limiters and pricing challenges
Competitor profiles and strategies
Portfolio strengths and SWOT insights
Regulatory considerations
Reimbursement factors
Trends influencing access creation and drainage techniques
Data Sources
Interviews with urologists, interventional radiologists, and medical device executives
Government and hospital procedural data
Regulatory databases and radiation safety reports
Import and export data
Private hospital purchasing datasets
iData Research internal forecasting models
Markets Covered and Segmentation
Global Nephrostomy Device Market by Device Type
Percutaneous nephrostomy sets
Includes needles, guidewires, dilators, sheaths, and accessories required to establish renal access and create a tract.
Nephrostomy balloon catheters
Balloon catheters used to dilate tracts, often supplied in comprehensive kits with ports, grips, inflation devices, and sheaths.
Nephrostomy drainage tubes
Includes Malecot catheters and other drainage devices used for postoperative stabilization, long-term management, or re-entry.
Each category is analyzed for unit sales, ASPs, and market values across major global regions.
Competitive Analysis
Cook Medical
Cook Medical was the leading competitor in the nephrostomy device market in 2024. The company’s portfolio includes well-established products such as the Cook-Cope Loop, Ultrathane nephrostomy sets, and a broad selection of access and drainage tools.
Cook’s strong reputation in minimally invasive urology contributes to its leadership. The company’s comprehensive range of dilation, access, and drainage equipment enables it to meet diverse needs in PCN and PCNL. Its continuous product development, long history in interventional devices, and worldwide distribution channels support ongoing market dominance.
Boston Scientific
Boston Scientific ranked as the second-leading competitor in 2024. The company markets the NephroMax High Pressure Nephrostomy Balloon Catheter and the UroMax Ultra, both widely used for tract dilation in PCNL and complex access cases.
Boston Scientific’s presence in stone management, paired with advanced balloon dilation technologies, strengthens its position in nephrostomy. Integration with broader urology portfolios and global sales channels contributes to its competitive footprint.
Becton Dickinson (BD)
Becton Dickinson was the third-leading competitor in the nephrostomy device market in 2024. BD offers a wide range of urological products, including the X-Force Renal Sheath, Malecot catheters, and ureteral stents. BD’s established reputation in access devices and drainage solutions, combined with its strong relationships with hospitals, supports its market share.
BD continues to leverage its expertise in interventional products and commitment to product reliability, ensuring consistent placement within nephrostomy procurement cycles.
Technology and Practice Trends
Ongoing improvements in dilation systems and guidewires for safer and more efficient tract creation
Increased utilization of mini-perc and micro-perc PCNL, influencing demand for smaller instrument-compatible access devices
Rising adoption of anti-retropulsion devices that improve stone clearance and reduce the need for retreatment
Growing acceptance of office-based nephrostomy where appropriate equipment and imaging are available
Evolution toward tubeless PCNL in select patients, reducing postoperative discomfort and drainage tube use
Enhanced catheter materials and coatings to reduce infection rates and improve patient comfort
Continued importance of precise imaging, including ultrasound and fluoroscopy, for accurate access creation
As nephrostomy procedures evolve, device requirements continue to shift toward tools that support safe, fast, and minimally traumatic access creation and drainage.
Geography
This report provides global coverage across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.
Why This Report
This report allows manufacturers, distributors, healthcare leaders, and investors to answer key strategic questions:
What is the current and future size of the global nephrostomy device market
How will demographic shifts influence nephrostomy and PCNL procedure volumes
Which device categories will experience the strongest growth and why
How will reimbursement changes, HAC penalties, and patient quality of life trends affect adoption
Which competitors lead the market, and what differentiates their product portfolios
How do regional differences affect demand patterns and pricing
How should companies position products as office-based nephrostomy and mini-perc PCNL expand
This report supports decisions related to product development, portfolio strategy, market entry, pricing, geographical prioritization, and technology investment.
About iData Research
iData Research is a premium market intelligence firm headquartered in Canada with offices across North America and Europe.
Over the last 20 years, the company has specialized in device-level sizing, procedure models, pricing trends, and competitive share across MedTech.
Since 2005, iData has supported global OEMs, mid-market innovators, and investors with triangulated data based on units and ASPs, with country-level forecasts and analyst access across Europe, North America, Latin America, the Middle East, Africa, and APAC.
Reports are available with flexible licensing to fit commercial, strategy, and investment workflows.
Executive Summary
The global nephrostomy device market was valued at $207 million in 2024. The market is projected to grow at a 3.6 percent CAGR, reaching more than $265 million by 2032. Growth is supported by sustained procedure volumes for percutaneous nephrostomy (PCN), percutaneous nephrolithotomy (PCNL), access creation for stone removal, and urinary drainage procedures driven by urinary obstruction, stone disease, and cancer. Nephrostomy devices remain an essential component of minimally invasive urological care in both hospital and office-based settings.
This report covers the complete device categories used in nephrostomy procedures, including percutaneous nephrostomy sets, nephrostomy balloon catheters, and nephrostomy drainage tubes. A percutaneous nephrostomy set includes all devices required to gain renal access, establish a nephrostomy tract, and place a nephrostomy tube or ureteral stent. Balloon catheters are used to dilate the tract and may include sheaths, port grips, inflation ports, or other dilation tools. Nephrostomy drainage tubes, such as Malecot catheters, are essential for drainage, postoperative stabilization, re-entry, or long-term management of obstruction.
Nephrostomy devices are closely linked to PCNL and urinary drainage procedures. As stone disease and cancer rates rise worldwide, related interventions and nephrostomy access requirements grow. PCN is often the first step before definitive treatment, making demand for nephrostomy sets consistent with broader minimally invasive urology trends.
This comprehensive report provides units sold, average selling prices, market values, forecasts, procedure insights, competitive strategies, and technology trends through 2032. It offers historical data to 2022 and analyzes mergers and acquisitions, pricing dynamics, and market shares for key competitors. The report supports medical device planners, business leaders, and investors seeking detailed insight into this essential urological device sector.
Market Overview
Nephrostomy devices enable urinary drainage through direct access to the renal pelvis. These devices are required when normal urine flow is blocked, typically due to stones, tumors, strictures, inflammation, or anatomical abnormalities. Nephrostomy is used for both urgent decompression and planned access in stone removal procedures.
The market consists of three primary device categories:
Percutaneous nephrostomy sets
These include all tools required to gain access and establish the tract. They often contain needles, guidewires, dilators, sheaths, and accessories needed for safe entry into the kidney prior to catheter or stent placement.
Nephrostomy balloon catheters
These catheters create and expand the tract by balloon dilation. Complete kits may include dilation systems, sheaths, inflation ports, and balloon components. Balloon catheters are used for PCNL, complex access creation, and re-entry procedures.
Nephrostomy drainage tubes
These include Malecot catheters and other drainage options designed for postoperative stabilization, urinary diversion, or management of long-term obstruction. Malecot catheters are commonly used for re-entry when repeated access is required.
Nephrostomy procedures serve several clinical roles:
Urinary drainage in cases of obstruction caused by stones, cancer, trauma, or inflammation
PCNL access creation for stone removal
Preparation for ureteral stenting
Management of complex or recurrent stones
Preservation of kidney function in emergency cases
Demand for nephrostomy sets is directly tied to PCNL volumes, which remain high in regions with elevated stone prevalence. Additionally, access creation is essential for patients who cannot undergo less invasive stone management due to stone size, location, or anatomical constraints.
The nephrostomy market benefits from advancements in dilation tools, guidewire technologies, tract stabilization devices, and miniaturized PCNL instruments. As techniques such as “mini-perc” and “micro-perc” expand, they influence the demand profile for nephrostomy sets and catheters.
The market faces challenges related to procedural invasiveness, infection risk, training variation, and evolving preferences for tubeless procedures in selected patients. However, overall demand remains resilient due to the large number of patients requiring urgent or planned renal access.
Market Drivers
Demographic Factors
More than 70 percent of PCN procedures are performed on patients over the age of 45. This demographic will continue to expand globally, driven by longer life expectancy and aging populations in both developed and emerging countries.
The incidence of urinary stones, particularly calcium oxalate and uric acid stones, is increasing worldwide. Contributing factors include:
Higher body mass index
Increased dietary sodium and sugar
Dehydration
Metabolic disorders
Sedentary lifestyle patterns
Stone disease leads to urinary obstruction, which often requires PCN or PCNL. As a result, nephrostomy device demand aligns closely with broader stone disease trends.
Cancer incidence also contributes significantly. Tumors of the pelvis, bladder, kidney, or ureter may obstruct urine flow, necessitating nephrostomy drainage to prevent renal damage. As cancer rates rise with aging populations, associated nephrostomy procedures increase accordingly.
Technological advances in PCNL also support market growth. Anti-retropulsion devices improve stone fragmentation efficiency. Smaller instruments and mini-perc systems reduce trauma and blood loss, encouraging adoption of PCNL over less effective or less definitive procedures. PCNL typically produces higher stone clearance rates than extracorporeal shockwave lithotripsy (ESWL), reducing retreatment needs and reinforcing nephrostomy access use.
Increase in Office Procedures
Nephrostomy procedures can be performed in office-based settings for selected patients. Office procedures offer:
Greater comfort for patients
Reduced waiting times
Faster throughput compared with hospital scheduling
Lower costs of care
Increased efficiency for physicians
Office-based nephrostomy has grown due to improvements in imaging, balloon dilation systems, tract stabilization, and catheter design. Physicians can treat more patients in a single day, which supports higher procedural volumes. This shift strengthens demand for nephrostomy sets and catheters suited for minimally invasive environments outside the traditional hospital setting.
As the healthcare system prioritizes convenience, patient experience, and efficient care delivery, office-based nephrostomy procedures will continue contributing to global market growth.
Market Limiters
Healthcare Reform and Hospital-Acquired Condition Penalties
Under the Hospital-Acquired Condition (HAC) reduction program, hospitals with higher rates of adverse events face penalties up to 1 percent of Medicare reimbursement. Hospital-acquired infections (HAIs) represent a significant category of adverse events.
Nephrostomy procedures present inherent risks, including:
Perforation of the collecting system
Acute intraoperative bleeding
Postoperative infection associated with drainage tubes
Sepsis in severe cases
Because of these risks, hospitals may seek alternatives such as ESWL in suitable cases. ESWL is less invasive than PCNL and avoids the need for tract creation. While ESWL may not achieve the same stone clearance rates, its lower complication profile makes it appealing in cost-sensitive regulated environments.
These reimbursement pressures can limit nephrostomy-based interventions in certain facilities or patient scenarios.
Invasiveness of the Procedure
Nephrostomy requires puncturing the skin and placing a catheter directly into the renal pelvis. The procedure carries risks, discomfort, and potential complications. Patients may avoid nephrostomy when possible, opting for alternative treatments. However, when urinary obstruction leads to renal impairment, nephrostomy becomes mandatory, regardless of invasiveness.
The inherent invasiveness limits adoption for mild cases but continues to drive usage in urgent or severe conditions. Still, patient hesitancy and clinical caution in borderline cases can influence procedure volumes.
Reviewing Standard Practices
Traditional nephrostomy procedures involve placing a drainage tube after PCNL or access creation. However, there is growing debate among physicians about the necessity of nephrostomy tubes for all patients. Trends toward “tubeless” PCNL reduce postoperative discomfort and improve quality of life, particularly for patients with favorable anatomical and stone characteristics.
As tubeless procedures gain acceptance, nephrostomy tube use may decline in select patient subsets. This shifts demand patterns within the drainage tube segment, although access creation and balloon dilation remain essential for PCNL.
Patient quality of life, faster recovery, and pain reduction influence physician decision-making. As minimally invasive practices evolve, the need for certain nephrostomy components may be reduced, even as overall procedure demand remains relatively stable.
Market Coverage and Data Scope
Quantitative Coverage
Device-level market size
Company shares
Market growth rates
Unit sales by device category
Average selling prices
Forecasts through 2032
Qualitative Coverage
Market dynamics and clinical adoption
Limiters and pricing challenges
Competitor profiles and strategies
Portfolio strengths and SWOT insights
Regulatory considerations
Reimbursement factors
Trends influencing access creation and drainage techniques
Data Sources
Interviews with urologists, interventional radiologists, and medical device executives
Government and hospital procedural data
Regulatory databases and radiation safety reports
Import and export data
Private hospital purchasing datasets
iData Research internal forecasting models
Markets Covered and Segmentation
Global Nephrostomy Device Market by Device Type
Percutaneous nephrostomy sets
Includes needles, guidewires, dilators, sheaths, and accessories required to establish renal access and create a tract.
Nephrostomy balloon catheters
Balloon catheters used to dilate tracts, often supplied in comprehensive kits with ports, grips, inflation devices, and sheaths.
Nephrostomy drainage tubes
Includes Malecot catheters and other drainage devices used for postoperative stabilization, long-term management, or re-entry.
Each category is analyzed for unit sales, ASPs, and market values across major global regions.
Competitive Analysis
Cook Medical
Cook Medical was the leading competitor in the nephrostomy device market in 2024. The company’s portfolio includes well-established products such as the Cook-Cope Loop, Ultrathane nephrostomy sets, and a broad selection of access and drainage tools.
Cook’s strong reputation in minimally invasive urology contributes to its leadership. The company’s comprehensive range of dilation, access, and drainage equipment enables it to meet diverse needs in PCN and PCNL. Its continuous product development, long history in interventional devices, and worldwide distribution channels support ongoing market dominance.
Boston Scientific
Boston Scientific ranked as the second-leading competitor in 2024. The company markets the NephroMax High Pressure Nephrostomy Balloon Catheter and the UroMax Ultra, both widely used for tract dilation in PCNL and complex access cases.
Boston Scientific’s presence in stone management, paired with advanced balloon dilation technologies, strengthens its position in nephrostomy. Integration with broader urology portfolios and global sales channels contributes to its competitive footprint.
Becton Dickinson (BD)
Becton Dickinson was the third-leading competitor in the nephrostomy device market in 2024. BD offers a wide range of urological products, including the X-Force Renal Sheath, Malecot catheters, and ureteral stents. BD’s established reputation in access devices and drainage solutions, combined with its strong relationships with hospitals, supports its market share.
BD continues to leverage its expertise in interventional products and commitment to product reliability, ensuring consistent placement within nephrostomy procurement cycles.
Technology and Practice Trends
Ongoing improvements in dilation systems and guidewires for safer and more efficient tract creation
Increased utilization of mini-perc and micro-perc PCNL, influencing demand for smaller instrument-compatible access devices
Rising adoption of anti-retropulsion devices that improve stone clearance and reduce the need for retreatment
Growing acceptance of office-based nephrostomy where appropriate equipment and imaging are available
Evolution toward tubeless PCNL in select patients, reducing postoperative discomfort and drainage tube use
Enhanced catheter materials and coatings to reduce infection rates and improve patient comfort
Continued importance of precise imaging, including ultrasound and fluoroscopy, for accurate access creation
As nephrostomy procedures evolve, device requirements continue to shift toward tools that support safe, fast, and minimally traumatic access creation and drainage.
Geography
This report provides global coverage across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.
Why This Report
This report allows manufacturers, distributors, healthcare leaders, and investors to answer key strategic questions:
What is the current and future size of the global nephrostomy device market
How will demographic shifts influence nephrostomy and PCNL procedure volumes
Which device categories will experience the strongest growth and why
How will reimbursement changes, HAC penalties, and patient quality of life trends affect adoption
Which competitors lead the market, and what differentiates their product portfolios
How do regional differences affect demand patterns and pricing
How should companies position products as office-based nephrostomy and mini-perc PCNL expand
This report supports decisions related to product development, portfolio strategy, market entry, pricing, geographical prioritization, and technology investment.
About iData Research
iData Research is a premium market intelligence firm headquartered in Canada with offices across North America and Europe.
Over the last 20 years, the company has specialized in device-level sizing, procedure models, pricing trends, and competitive share across MedTech.
Since 2005, iData has supported global OEMs, mid-market innovators, and investors with triangulated data based on units and ASPs, with country-level forecasts and analyst access across Europe, North America, Latin America, the Middle East, Africa, and APAC.
Reports are available with flexible licensing to fit commercial, strategy, and investment workflows.
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