市場調查報告書
商品編碼
1529806
美國女性用外置導管市場規模、佔有率和趨勢分析報告:按材料、按應用、按失禁領域、按最終用途、按地區和細分市場預測,2024-2030 年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 |
市場規模及趨勢
2023年美國女性用外置導管市場規模預估為3.4793億美元,預估2024年至2030年複合年成長率為5.26%。對管理女性尿失禁和導尿的創新和有效解決方案不斷成長的需求推動了市場的發展。女性用外置導尿管旨在為傳統留置導尿管提供安全、舒適和衛生的替代方案,傳統留置導尿管可能導致尿道感染和膀胱損傷等併發症。塑造美國市場的趨勢包括對優先考慮舒適、衛生和易用性的女性用外置導管的需求不斷增加。可自訂和智慧外部導管的興起反映了人們對個人化醫療和以患者為中心的護理的日益重視,而遠端醫療和遠端監測技術的整合將越來越有助於管理尿失禁和導管放置變得越來越重要。
糖尿病、阿茲海默症、帕金森氏症等慢性病盛行率大幅上升,導致住院率大幅上升。根據國家糖尿病統計報告,2021年超過4,100萬個各個年齡層的人(占美國人口的12.5%)患有糖尿病,但約有940萬成年人(佔成人糖尿病患者的23.5%)被診斷為I型糖尿病。值得注意的是,65歲及以上成年人的糖尿病盛行率已增加至30.4%。根據聯合健康基金會的美國健康排名報告,到 2022 年,大約 2,930 萬成年人(佔總人口的 11.2%)將患有三種或以上慢性健康狀況。因此,慢性病盛行率的不斷上升以及由此導致的住院人數的激增預計將擴大對女性用外置導管的需求,並推動美國市場的成長。此外,根據2022年CDC行為危險因子監測系統,當年成人肥胖率最高的州是西維吉尼亞(41%)、路易斯安那州(40.1%)、奧克拉荷馬州(40.0%)和密西西比州(39.5 %) )。因此,目前肥胖人口的增加是該地區女性用外置導管市場成長的主要因素。
市場特徵及集中度
市場成長階段溫和,成長速度正在加速。美國女性用外置導尿管市場的特點是慢性疾病患者數量不斷增加、女性尿失禁盛行率不斷上升,以及女性對謹慎、便捷的泌尿管理解決方案的需求不斷增加。
公司和政府機構在美國女性用外置導管市場上實施的主要策略包括產品發布、擴大分銷管道、合作夥伴關係、聯盟、行銷和宣傳宣傳活動。
近年來,美國市場經歷了中等到高水準的技術創新。我們看到具有先進功能、改進設計和增強材料的新產品的推出,對該行業產生了重大影響。創新的主要驅動力之一是對謹慎、舒適的產品不斷成長的需求,這些產品可以滿足女性尿失禁的獨特需求。因此,製造商開發了具有人體工學設計、柔軟透氣材料以及先進排水系統的產品。
該市場由食品藥物管理局(FDA) 監管,監督包括導管在內的醫療設備的安全性和有效性。 FDA 的法規結構為新產品的開發、測試和核准提供了框架。根據風險級別,女性用外置導管分為 I 類或 II 類。 I 類設備被認為是低風險且具有最少的法規,而 II 類設備被認為是中等風險且具有更嚴格的法規。
法規通常設定安全性和有效性標準,製造商投資研發以滿足這些要求。公司優先考慮發展創新能力和推進現有技術,不僅滿足監管要求,而且最終改善患者治療結果並提高醫療保健品質。遵守這些法規是強制性的,並且可能會增加產品開發和市場進入所需的成本和時間。此外,醫療保險和醫療補助政策影響醫院籌資策略,特別是在報銷率和先進醫療設備的覆蓋範圍方面。
市場參與者正致力於擴大產品系列,以滿足更廣泛患者的需求。奈米材料和生物分解性材料等先進材料的使用預計將在新產品的開發中增加。這些材料具有改進的性能,例如增強的潤滑性、抗菌活性和生物相容性。此外,私人標籤機會正在增加,製造商與經銷商合作,為特定零售商或患者打造客製化產品。這一趨勢是由對個人化醫療保健日益成長的需求以及滿足特定患者需求的客製化產品的需求所推動的。此外,預計新參與企業將進入市場,特別是在創新材料和數位健康整合領域。現有公司必須適應這些變化,以維持市場佔有率並保持競爭力。
每家公司都專注於為多個患者群體提供服務並滿足特定的治療要求。該市場包括擁有廣泛產品和重要市場佔有率的大型老字型大小企業,例如 Stryker、BD、Boehringer Laboratories LLC、Hollister Incorporated 和 Consure Medical。這種專業化有助於市場細分,因為每家公司都專注於為特定專業領域開發客製化解決方案。
與當地經銷商、醫療保健提供者和思想領袖的策略聯盟和合作可以加速市場進入和採用。透過與老牌公司合作,您可以獲得對當地市場細微差別、監管要求和客戶偏好的寶貴見解。
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.
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