U.S. Female External Catheter Market Size, Share & Trends Analysis Report By Material (Silicone, Latex), By Application (Diabetes, Strokes), By Area Of Incontinence, By End-use, By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The U.S. female external catheter market size was valued at USD 347.93 million in 2023 and is projected to grow at a CAGR of 5.26% from 2024 to 2030. The market is driven by the increasing demand for innovative and effective solutions for managing urinary incontinence and catheterization in women. Female external catheters are designed to provide a safe, comfortable, and hygienic alternative to traditional indwelling urethral catheters, which can be associated with complications such as urinary tract infections and bladder damage. Trends that are shaping the U.S. market include the growing demand for female external catheters that prioritize comfort, hygiene, and ease of use. The rise of customizable and smart external catheters reflects a growing emphasis on personalized medicine and patient-centered care, and the integration of telemedicine and remote monitoring technologies is becoming increasingly important in the management of urinary incontinence and catheterization.

Prevalence of chronic diseases, such as diabetes, Alzheimer’s, Parkinson’s, and various other conditions, is significantly increasing, leading to a considerable rise in hospital admission rates, thus driving the growth of the U.S. market for female external catheter. According to the National Diabetes Statistics Report, in 2021, more than 41 million people of all ages (12.5% of the U.S. population) had diabetes, but approximately 9.4 million adults (23.5% of adults with diabetes) were unaware that they had the condition. Notably, the prevalence of diabetes among adults aged 65 years or older increased to an alarming 30.4%.  According to the America's Health Rankings report by the United Health Foundation, approximately 29.3 million adults, equivalent to 11.2% of the overall population, reported having three or more chronic health conditions in 2022. Thus, due to the increasing prevalence of chronic diseases and the subsequent surge in hospitalizations, the demand for female external catheter is expected to grow, fueling growth in the U.S. market. Further, the CDC Behavioral Risk Factor Surveillance System, in 2022 reported that West Virginia (41%), Louisiana (40.1%), Oklahoma (40.0%), and Mississippi (39.5%) had the highest rates of adult obesity in the same year. This makes the current increase in the obese population a significant factor contributing to the growth of the Female External Catheter market in this region.

Market Characteristics & Concentration

The market growth stage is medium, and pace of the market growth is accelerating. The U.S. market for female external catheter is characterized by increasing cases of chronic diseases, growing prevalence of urinary incontinence among women coupled with growing demand for discreet and convenient urinary management solutions for women.

Key strategies implemented by players and government entities in the U.S. market for female external catheter are product launch, expanding distribution channels, partnerships, collaboration, marketing & awareness campaigns, and other strategies.

The U.S. market has witnessed a moderate to high degree of innovation in recent years. The market has seen the introduction of new products with advanced features, improved designs, and enhanced materials, which have significantly impacted the industry. One of the key drivers of innovation is the increasing demand for discreet and comfortable products that cater to the specific needs of women with urinary incontinence. As a result, manufacturers have developed products with ergonomic designs, soft and breathable materials, and advanced drainage systems.

The market is regulated by the Food and Drug Administration (FDA), which oversees the safety and effectiveness of medical devices, including catheters. The FDA's regulatory framework provides a framework for the development, testing, and approval of new products. Female external catheters are classified as Class I or II devices, depending on their level of risk. Class I devices are considered low-risk and are subject to minimal regulation, while Class II devices are considered moderate-risk and are subject to more stringent regulations.

Regulations often set standards for safety and efficacy, driving manufacturers to invest in R&D to meet these requirements. Companies prioritize the development of innovative features and advancements in existing technologies to not only meet regulatory requirements but also to ultimately enhance patient outcomes and improve healthcare quality. Compliance with these regulations is mandatory, which can increase the cost and time required for product development and market entry. Additionally, Medicare and Medicaid policies influence the procurement strategies of hospitals, especially with regards to reimbursement rates and coverage for advanced medical equipment.

Market players are focusing on expanding their product portfolios to cater to a broader range of patient needs. The use of advanced materials, such as nanomaterials and biodegradable materials, is expected to increase in the development of new products. These materials offer improved properties, such as enhanced lubricity, antimicrobial activity, and biocompatibility. Further, private labeling opportunities are increasing as manufacturers partner with distributors to create customized products for specific retailers or patients. This trend is driven by the growing demand for personalized healthcare and the need for tailored products that meet specific patient needs. In addition, new entrants are expected to enter the market, particularly in the areas of innovative materials and digital health integration. Established players will need to adapt to these changes to maintain market share and remain competitive.

Companies focus on addressing several patient demographics or meeting specific therapeutic requirements. The market includes large, established companies such as Stryker, BD, Boehringer Laboratories, LLC., Hollister Incorporated, and Consure Medical which offer a broad range of products and have significant market shares. Due to an emphasis of companies in developing customized solutions for certain specializations in the market, this specialization contributes to market fragmentation.

Forming strategic partnerships or collaborations with local distributors, healthcare providers, and key opinion leaders can facilitate market entry and accelerate adoption. Collaborating with established entities can provide valuable insights into regional market nuances, regulatory requirements, and customer preferences.

Material Insights

The silicone segment dominated the market in 2023 as silicone-based catheters offer unparalleled comfort and durability, making them a preferred choice among patients. The smooth, soft, and gentle surface of silicone reduces irritation and discomfort, while its durability ensures longer catheter lifespan and reduced replacement frequency. The dominance of silicone-based female external catheters in the U.S. market can be attributed to their superior properties and benefits. As patient awareness about bladder health and catheter care continues to grow, it is likely that silicone-based catheters will remain the preferred choice for patients seeking comfort, durability, and ease of use.

The latex segment is expected to register the fastest CAGR of 5.59% during the forecast period. Silicone-based catheters have traditionally been the dominant material segment, but some patients may prefer latex-based catheters due to concerns about silicone allergies or sensitivity. Further, The Food and Drug Administration (FDA) has issued guidelines and regulations regarding the use of latex-containing medical devices, which has led to increased adoption of latex-based catheters as a safer alternative.

Application Insights

Diabetes dominated the market in 2023due to the growing prevalence of diabetes-related incontinence and advances in technology in the U.S. As the market continues to evolve, companies will need to focus on developing innovative products that address compliance and cost-effectiveness challenges while leveraging digital health solutions to improve patient outcomes. Further, companies are also investing in research and development to create more comfortable, convenient, and effective catheters for patients with diabetes-related incontinence.

The segment is also expected to register the fastest CAGR of 5.98% during the forecast period driven by the steady and increasing prevalence of diabetes year over year. For instance, according to the Centers for Disease Control and Prevention (CDC), between 2021 and 2022, diabetes rates increased by 6%, rising from 10.9% to 11.5% of adults, with nearly 31.9 million adults affected.

Area of Incontinence Insights

Stress Urinary Incontinence (SUI) dominated the market in 2023. The dominance of the segment can be attributed to the growing awareness about urinary incontinence and its impact on mental and physical health. The rise in geriatric population, increasing obesity rates, and sedentary lifestyle are also contributing factors to the growing demand for SUI products. Moreover, advancements in technology have led to the development of innovative products that cater to the specific needs of women suffering from SUI.

According to a comprehensive analysis of data collected between 2015-2018, published in the official journal of the American Urogynecologic Society, a staggering 61.8% of adult women in the U.S. suffer from urinary incontinence (UI), translating to approximately 78.3 million women. Moreover, 32.4% of all women reported experiencing UI symptoms at least once a month. Of those afflicted with UI, a significant proportion presented with specific types of incontinence: 37.5% experienced stress urinary incontinence, 22.0% suffered from urgency urinary incontinence, 31.3% had mixed symptoms, and 9.2% experienced unspecified incontinence.                   

End-use Insights

Hospitals dominated the market in 2023 due to their high patient volume, increasing prevalence of urinary incontinence, and government initiatives driving adoption of evidence-based treatments. As the market continues to evolve, companies must prioritize innovation, digital health solutions, and patient engagement to stay competitive and capitalize on growth opportunities.

Further, home care segment is expected to register the fastest CAGR of 7.41% during the forecast period due to its growing demand for convenience, comfort, and cost-effective solutions. As the market continues to evolve, companies must prioritize innovation, digital health solutions, and patient education to stay competitive and capitalize on growth opportunities. Key players in the home care segment include BD, Consure Medical, among others. These companies are investing in research and development to stay ahead of the competition and capitalize on market growth opportunities.

U.S. number of hospital data for the years 2023 and 2022

The growing demand for Female External Catheters in the U.S. is expected to be fueled by the increasing number of hospitals, driven by various factors such as improved healthcare access initiatives, modernization efforts, and a shifting focus toward patient-centric care. As healthcare systems in the country continue to evolve and expand to meet the diverse needs of a growing patient population, this trend is likely to persist, presenting opportunities for market growth and development.

U.S. hospital statistics for the years 2023 and 2022 :

Americas Health Rankings 2023: Prevalence of Chronic Disease Statistics

The prevalence of multiple chronic conditions in West Virginia (21.1%) was 3.0 times higher than in Hawaii and the District of Columbia (both 7.0%).

• West Virginia exhibited the highest prevalence of:

  • Diabetes (17.4%), which was 2.1 times higher than in Colorado (8.1%)

  • Cardiovascular diseases (14.6%), 2.2 times higher than in Utah (6.6%)

  • Arthritis (40.1%), COPD (14.0%), and cancer (10.8%)

• Asthma was highest in Rhode Island (13.3%), and depression reached its peak in Tennessee (29.2%).

• Hawaii reported the lowest prevalence of cancer (6.6%), while the District of Columbia had the lowest value at 6.2%. Both areas also recorded low rates of COPD (3.5%) and depression (12.5%).

• Arthritis was lowest in California (20.4%) and the District of Columbia (18.0%). Asthma reached its lowest prevalence in Texas (7.9%), cardiovascular diseases were lowest in Utah (6.6%) & the District of Columbia (6.3%), chronic kidney disease was lowest in Alaska (2.4%), and diabetes was lowest in Colorado (8.1%) & the District of Columbia (8.0%).

Recent Developments

• In July 2022, a team of experts from of experts from across the University of Alabama at Birmingham and Children’s of Alabama, in collaboration with local entrepreneurs, launched Zorro-Flow Inc., the latest startup to emerge from the UAB Harbert Institute for Innovation and Entrepreneurship. The pioneering product is a neonatal external urine-collection device specifically designed to safely and effectively collect urine in critically ill female neonates and infants under the age of one.  

U.S. Female External Catheter Market Report Scope

U.S. Female External Catheter Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. female external catheter market report based on material, application, area of incontinence, end-use, and region

• Material Outlook (Revenue, USD Million, 2018 - 2030)

  • Silicone

  • Latex

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Diabetes

  • Strokes

  • Alzheimer's disease

  • Parkinson's disease

  • Spinal Cord Injury

  • Bladder Cancer

  • Ovarian Cancer

  • Multiple Sclerosis

  • Others

• Area of Incontinence Outlook (Revenue, USD Million, 2018 - 2030)

  • Stress Urinary Incontinence

  • Urge/OAB (Overactive Bladder)

  • Overflow

  • Functional

  • Mixed

  • Reflex

  • Severe Incontinence

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Home Care

  • Hospitals

  • Other End-use