U.S Nephrostomy Bags Market By Type (Sterile and Non-sterile), By Usage (Disposable and Reusable), By Capacity (100-500 ml, 500-1000 ml, and Above 1000 ml), By Material (PVC and PU, Silicone, Others), By End-User (Hospitals & Clinics, Homecare, Ambulatory Surgical Centers, and Others), By Region, and Key Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2025-2034

Report Overview

The U.S Nephrostomy Bags Market was valued at USD 142.3 Million in 2024 and is anticipated to register substantial growth of USD 229.6 million by 2034, with 4.9% CAGR.

The U.S. nephrostomy bags market is driven by the increasing prevalence of chronic kidney diseases (CKD), kidney failure, and surgical procedures requiring renal drainage, which leads to higher demand for nephrostomy bags. Technological advancements in bag design, including features like odour control, anti-reflux valves, and skin-friendly materials, are enhancing patient comfort and encouraging adoption. Additionally, the shift toward home healthcare and patient-managed care is boosting demand for user-friendly, discreet products.

However, the market faces challenges such as high treatment costs, limited insurance coverage, and potential complications from prolonged use, such as infections. While hospitals remain the primary consumers, there is growing market potential in homecare settings as patients prefer managing their condition outside of clinical environments. The U.S. market also benefits from robust healthcare infrastructure and an aging population, but concerns regarding product safety and regulatory compliance continue to impact market dynamics, requiring manufacturers to maintain strict quality controls and innovate continuously.

• According to the U.S. Census Bureau, the aging population in the U.S. is growing significantly. In the U.S., Americans 65 and older numbered 57.8 million in 2022. They represented 17.3% of the population, and this percentage is expected to increase. By 2030, all baby boomers will be age 65 or older, leading to the number of older adults in the U.S. rising to around 73 million, nearly double the 2019 total of 46 million. This shift is contributing to the growing demand for healthcare services, including those related to chronic conditions like kidney disease, which in turn is driving the need for products like nephrostomy bags.

The U.S nephrostomy bags market, 2020-2024 (US$ Million)

Key Takeaways

• The U.S nephrostomy bags market was valued at USD 142.3 million in 2024 and is anticipated to register substantial growth of USD 229.6 million by 2034, with 4.9% CAGR.
• In 2024, the sterile segment took the lead in the global market, securing 88.02% of the total revenue share.
• The disposable segment took the lead in the global market, securing 82.72% of the total revenue share.
• The 500-1000 ml segment took the lead in the global market, securing 58.73% of the total revenue share.
• The hospitals & clinics segment took the lead in the global market, securing 53.09% of the total revenue share.

Type Analysis

Based on type the market is fragmented into sterile and non-sterile. Amongst these, sterile segment dominated the U.S nephrostomy bags market capturing a significant market share of 88.02% in 2024. The segment’s dominance is attributed to their critical role in infection prevention and compliance with stringent healthcare standards. These bags are essential in managing urine drainage for patients undergoing nephrostomy procedures, where maintaining a sterile environment is crucial to avoid complications such as urinary tract infections (UTIs) or sepsis.

The direct connection of nephrostomy catheters to the kidneys elevates the risk of infections, making sterile solutions the preferred choice for healthcare professionals. Regulatory standards in the U.S., enforced by organizations like the FDA, emphasize infection control, further driving the adoption of sterile nephrostomy bags.

• According to CDC, approximately 75% of hospital-acquired urinary tract infections (UTIs) are linked to the use of urinary catheters.

The demand for sterile nephrostomy bags is amplified by the rising prevalence of kidney-related conditions, such as hydronephrosis, kidney stones, and urological cancers, particularly among the aging population. This demographic requires safe, reliable products that align with their long-term care needs, further bolstering the market for sterile options.

The U.S Nephrostomy Bags Market, Type Analysis, 2020-2024 (US$ Billion)

Usage Analysis

The market is fragmented by usage into disposable and reusable. Disposable dominated the U.S nephrostomy bags market capturing a significant market share of 82.72% in 2024. The dominance is significantly driven by their convenience, cost-effectiveness, and strong alignment with infection control protocols. These single-use devices are integral in managing urinary drainage for patients with nephrostomies, offering a hygienic and low-risk alternative to reusable options.

The dominance of disposable bags is largely attributed to their ability to minimize infection risks. Unlike reusable counterparts, which require rigorous cleaning and sterilization, disposable bags are designed for single-use, ensuring sterility and reducing cross-contamination. This feature is particularly valued in hospitals, outpatient facilities, and home care settings, where infection control is a top priority. Ease of use and availability further support the widespread adoption of disposable nephrostomy bags.

The U.S Nephrostomy Bags Market, Usage Analysis, 2020-2024 (US$ Billion)

Capacity Analysis

The market is fragmented by capacity into 100-500 ml, 500-1000 ml, and above 1000 ml. 500-1000 ml dominated the U.S nephrostomy bags market capturing a significant market share of 58.73% in 2024. The 500-1000 ml segment benefits from advancements in design and material technology, which enhance comfort, durability, and ease of use. Features such as anti-reflux valves, secure drainage ports, and ergonomic designs further boost their appeal in both clinical and home care scenarios.

The strong market share of this capacity segment reflects its ability to meet the demands of a diverse patient population while ensuring optimal convenience and efficiency. As the prevalence of conditions requiring nephrostomy procedures grows, this segment is poised to maintain its leadership position, supported by continuous innovation in product development.

• Remington Medical offers a 600ml disposable drainage bag designed for efficient fluid management in procedures such as abscess drainage, biliary drainage, and nephrostomy applications. The product features a 24-inch soft, kink-resistant drainage tube that can be customized by cutting it to the desired length. To enhance patient safety, the bag is equipped with an anti-reflux valve that helps prevent backflow contamination. For added comfort, it includes a fully adjustable soft waist belt. The bag also features a twist-type outlet valve for quick and convenient emptying. Constructed without natural rubber latex, this single-use device prioritizes both safety and user convenience.

The U.S Nephrostomy Bags Market, Capacity Analysis, 2020-2024 (US$ Billion)

Material Analysis

The market is fragmented by material into PVC and PU, silicone, and others. PVC and PU dominated the U.S nephrostomy bags market capturing a significant market share of 48.35% in 2024. Polyvinyl chloride (PVC) and polyurethane (PU) are widely favored materials in the production of nephrostomy bags, attributed to their unique combination of durability, flexibility, and cost-effectiveness. PVC, known for its strength and affordability, offers reliable performance in clinical and home care settings. It is resistant to tearing and puncturing, making it ideal for patients requiring long-term drainage solutions.

Additionally, PVC’s compatibility with various sterilization processes enhances its safety profile, which is a critical requirement in medical applications.  On the other hand, PU is valued for its soft, lightweight, and biocompatible properties, providing enhanced comfort for patients. Its flexibility ensures a snug fit and minimizes irritation, particularly for patients with sensitive skin. Furthermore, PU’s transparency facilitates visual monitoring of fluid levels, aiding in timely drainage management.

The U.S Nephrostomy Bags Market, Material Analysis, 2020-2024 (US$ Billion)

End-User Analysis

The market is fragmented by end-user into hospitals & clinics, homecare, ambulatory surgical centers, and others. Hospitals & clinics dominated the U.S nephrostomy bags market capturing a significant market share of 53.09% in 2024. The dominance of the segment is driven by their critical role in providing comprehensive urological care and managing complex patient cases. These healthcare facilities accounted for a significant market share due to their high patient intake, specialized care capabilities, and access to advanced medical infrastructure.

Hospitals and clinics are the primary settings for performing nephrostomy procedures, which are often required for patients with severe urological conditions, such as kidney stones, obstructions, or infections. The use of nephrostomy bags is integral to post-procedure care, ensuring effective urine drainage and preventing complications. The volume of procedures performed in these facilities contributes significantly to their dominant position in the market.

• As per Office of Disease Prevention and Health Promotion, every year in the United States, there are about 36 million hospital stays.

The U.S Nephrostomy Bags Market, End-User Analysis, 2020-2024 (US$ Billion)

Key Segments Analysis

By Type

• Sterile
• Non-sterile

By Usage

• Disposable
• Reusable

By Capacity

• 100-500 ml
• 500-1000 ml
• Above 1000 ml

By Material

• PVC and PU
• Silicone
• Others

By End-User

• Hospitals & Clinics
• Homecare
• Ambulatory Surgical Centers
• Others

Drivers

Increasing Prevalence of Kidney Diseases

The increasing prevalence of kidney diseases, particularly chronic kidney disease (CKD) and kidney failure, is a major driver of growth for the U.S. nephrostomy bags market. Kidney-related health issues are becoming more common due to factors such as an aging population, rising rates of diabetes, hypertension, and lifestyle-related diseases.

As kidney function deteriorates, many patients require renal drainage, leading to a significant demand for nephrostomy bags. These bags play a critical role in managing patients who undergo procedures like kidney surgeries, dialysis, or those with urinary obstructions, as they collect urine directly from the kidneys through nephrostomy tubes.

• For example, an article published by the Centers for Disease Control and Prevention (CDC) in May 2024 reported that approximately 35.5 million people in the U.S. were affected by chronic kidney disease (CKD) in 2023. Furthermore, CKD is more common among individuals aged 65 years and older, with 34% of this age group affected, compared to 12% of those aged 45-64 years and 6% of people aged 18-44 years.
• The increasing occurrence of kidney and ovarian cancers, which are often associated with sedentary lifestyles, has led to a greater demand for advanced medical equipment to support treatment. According to the American Cancer Society, an estimated 81,610 new cases of kidney cancer are expected to be diagnosed in 2024. This rising prevalence of kidney disease and cancer has heightened the need for effective medical solutions, including nephrostomy bags, which play a crucial role in managing these conditions as part of ongoing treatment efforts.

Restraints

Risk of Infections and Complications during Placement

The risk of infections and complications during the placement of nephrostomy bags is a major factor restraining the growth of the U.S. nephrostomy bags market. Nephrostomy bags, which are used to drain urine from the kidneys in cases of urinary obstructions or post-surgical recovery, require precise placement to ensure proper functioning and minimize the risk of complications. Improper insertion or inadequate care can lead to a range of issues, including urinary tract infections (UTIs), kidney infections, and skin irritation. These complications not only hinder patient recovery but also increase healthcare costs due to the need for additional treatments, longer hospital stays, or follow-up surgeries.

Moreover, infections can severely affect patient quality of life, leading to discomfort, increased hospital admissions, and prolonged use of antibiotics, which can cause further health concerns. As a result, both healthcare providers and patients are often cautious about the long-term use of nephrostomy bags, especially when the risks of complications are not properly mitigated. The need for strict hygiene protocols, high-quality materials, and proper training for healthcare professionals and patients is critical to reducing these risks. Consequently, the market faces a challenge in terms of improving safety standards and patient compliance, which slows overall adoption and growth of nephrostomy bags.

Opportunities

Rising Focus on Sustainability

Rising focus on sustainability is increasingly creating growth opportunities for the U.S. nephrostomy bags market, as both healthcare providers and manufacturers are recognizing the importance of environmental friendly practices in medical device production. The healthcare industry, including nephrostomy bag manufacturers, is under increasing pressure to reduce its environmental impact, particularly in response to growing concerns about medical waste and plastic pollution. As a result, there is a shift towards sustainable, recyclable, and biodegradable materials in the production of nephrostomy bags, creating new market opportunities and improving patient care.

One of the key areas of focus is the use of eco-friendly materials in the design and production of nephrostomy bags. Traditional nephrostomy bags are primarily made from single-use plastics, contributing to significant environmental waste. However, manufacturers are now exploring alternatives, such as biodegradable or recyclable materials, that can reduce the environmental footprint of these medical devices. This shift aligns with broader sustainability goals in healthcare, as hospitals and medical institutions seek to decrease their waste and carbon emissions. By adopting more sustainable production practices, nephrostomy bag manufacturers can differentiate themselves in a competitive market and appeal to environmentally conscious consumers, patients, and healthcare facilities.

• A recent study published in January 2025 by Wolters Kluwer Health, Inc. examines the use of a 4D-printed biodegradable bag which was examined for treating benign giant hydronephrosis. The material has shown promising, however, further research is needed to assess the long-term outcomes of this new material in application.

Impact of macroeconomic factors / Geopolitical factors

The U.S. nephrostomy bags market is influenced by various macroeconomic and geopolitical factors that shape demand, pricing, and supply chain stability. Macroeconomic conditions such as inflation, healthcare spending, and reimbursement policies play a critical role. Rising healthcare costs and budget constraints can limit patient access to advanced medical devices, while favorable insurance policies and Medicare/Medicaid coverage support market growth. Additionally, economic downturns may impact hospital and patient purchasing power, affecting market expansion.

Geopolitical factors, including global trade policies, supply chain disruptions, and international conflicts, also have significant implications. The nephrostomy bag market relies on raw material imports and medical device manufacturing, making it vulnerable to tariffs, trade restrictions, and supply shortages. The COVID-19 pandemic and ongoing geopolitical tensions, such as U.S.-China trade disputes and the Russia-Ukraine conflict, have strained global logistics, leading to price fluctuations and delays in medical device production.

Latest Trends

The U.S. nephrostomy devices market is experiencing significant growth, driven by the increasing prevalence of chronic kidney diseases, such as kidney stones and cancers, particularly among the aging population. This surge in kidney-related ailments has heightened the demand for nephrostomy procedures, which are minimally invasive and offer benefits like reduced hospital stays and quicker recovery times. Technological advancements have led to the development of more efficient and patient-friendly devices, including improved nephrostomy catheters and drainage tubes.

Leading companies, such as Boston Scientific Corporation and Becton Dickinson, are investing in innovative solutions to enhance procedural outcomes and patient comfort. Additionally, there is a growing preference for outpatient settings, like ambulatory surgical centers, for these procedures, owing to their convenience and cost-effectiveness. Government initiatives aimed at raising awareness about kidney health and the importance of early intervention are further propelling market expansion. Overall, the U.S. nephrostomy devices market is poised for continued growth, supported by medical advancements and an increasing focus on minimally invasive treatment options.

Key Players Analysis

The U.S. nephrostomy bags market is competitive, with several established medical device manufacturers and specialized companies competing for market share. Key players include B. Braun, Coloplast, and Merit Medical, which offer a range of nephrostomy bags and related products. These companies focus on continuous product innovation, such as incorporating features like odour control, anti-reflux valves, and skin-friendly materials to enhance patient comfort and satisfaction.

In addition, the market is seeing increased investment in the development of user-friendly, discreet, and eco-friendly products to meet the growing demand for homecare solutions. To stay competitive, companies are leveraging strategic partnerships, mergers, and acquisitions to expand their portfolios and strengthen their market positions. However, regulatory compliance, pricing pressures, and the need for strong distribution networks remain critical factors in maintaining a competitive edge in this market.

Top Key Players in the Cell Therapy Market

• Remington Medical
• Coloplast A/S
• Merit Medical
• UreSil LLC
• Urocare Products Inc.
• TERUMO Corporation
• Cardinal Health Inc.
• Teleflex Incorporated
• B. Braun SE
• Becton Dickinson and Company.

Recent Developments

• In November 2024, Cardinal Health announced definitive agreements to acquire two companies as part of its strategic growth initiatives aimed at enhancing patient care. The company also outlined its capital deployment plans. Among these acquisitions, Cardinal Health secured a majority stake in GI Alliance (GIA), the leading gastroenterology management services organization (MSO) in the U.S. The transaction, valued at approximately US$2.8 billion in cash, involved acquiring shares from GIA’s physician owners and funds managed by Apollo affiliates. This acquisition grants Cardinal Health a 71% ownership stake in GIA, which will function as a platform within its Pharmaceutical and Specialty Solutions segment.

Report Scope