市场调查报告书
商品编码
1529806
美国女性用外置导管市场规模、份额和趋势分析报告:按材料、按应用、按失禁领域、按最终用途、按地区和细分市场预测,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 |
市场规模及趋势
2023年美国女性用外置导管市场规模预估为3.4793亿美元,预估2024年至2030年复合年增长率为5.26%。对管理女性尿失禁和导尿的创新和有效解决方案不断增长的需求推动了市场的发展。女性用外置导尿管旨在为传统留置导尿管提供安全、舒适和卫生的替代方案,传统留置导尿管可能导致尿道感染和膀胱损伤等併发症。塑造美国市场的趋势包括对优先考虑舒适、卫生和易用性的女性用外置导管的需求不断增加。可自订和智慧外部导管的兴起反映了人们对个人化医疗和以患者为中心的护理的日益重视,而远端医疗和远端监测技术的整合将越来越有助于管理尿失禁和导管放置变得越来越重要。
糖尿病、阿兹海默症、帕金森氏症等慢性病盛行率大幅上升,导致住院率大幅上升。根据国家糖尿病统计报告,2021年超过4,100万个各个年龄层的人(占美国人口的12.5%)患有糖尿病,但约有940万成年人(占成人糖尿病患者的23.5%)被诊断为I型糖尿病。值得注意的是,65岁及以上成年人的糖尿病盛行率已增加至30.4%。根据联合健康基金会的美国健康排名报告,到 2022 年,大约 2,930 万成年人(占总人口的 11.2%)将患有三种或以上慢性健康状况。因此,慢性病盛行率的不断上升以及由此导致的住院人数的激增预计将扩大对女性用外置导管的需求,并推动美国市场的成长。此外,根据2022年CDC行为危险因子监测系统,当年成人肥胖率最高的州是西维吉尼亚(41%)、路易斯安那州(40.1%)、奥克拉荷马州(40.0%)和密西西比州(39.5 %) )。因此,目前肥胖人口的增加是该地区女性用外置导管市场成长的主要因素。
市场特征及集中度
市场成长阶段温和,成长速度正在加速。美国女性用外置导尿管市场的特点是慢性疾病患者数量不断增加、女性尿失禁盛行率不断上升,以及女性对谨慎、便捷的泌尿管理解决方案的需求不断增加。
公司和政府机构在美国女性用外置导管市场上实施的主要策略包括产品发布、扩大分销管道、合作伙伴关係、联盟、行销和宣传宣传活动。
近年来,美国市场经历了中等到高水准的技术创新。我们看到具有先进功能、改进设计和增强材料的新产品的推出,对该行业产生了重大影响。创新的主要驱动力之一是对谨慎、舒适的产品不断增长的需求,这些产品可以满足女性尿失禁的独特需求。因此,製造商开发了具有人体工学设计、柔软透气材料以及先进排水系统的产品。
该市场由食品药物管理局(FDA) 监管,监督包括导管在内的医疗设备的安全性和有效性。 FDA 的法规结构为新产品的开发、测试和核准提供了框架。根据风险级别,女性用外置导管分为 I 类或 II 类。 I 类设备被认为是低风险且具有最少的法规,而 II 类设备被认为是中等风险且具有更严格的法规。
法规通常设定安全性和有效性标准,製造商投资研发以满足这些要求。公司优先考虑发展创新能力和推进现有技术,不仅满足监管要求,而且最终改善患者治疗结果并提高医疗保健品质。遵守这些法规是强制性的,并且可能会增加产品开发和市场进入所需的成本和时间。此外,医疗保险和医疗补助政策影响医院筹资策略,特别是在报销率和先进医疗设备的覆盖范围方面。
市场参与者正致力于扩大产品系列,以满足更广泛患者的需求。奈米材料和生物分解性材料等先进材料的使用预计将在新产品的开发中增加。这些材料具有改进的性能,例如增强的润滑性、抗菌活性和生物相容性。此外,私人标籤机会正在增加,製造商与经销商合作,为特定零售商或患者打造客製化产品。这一趋势是由对个人化医疗保健日益增长的需求以及满足特定患者需求的客製化产品的需求所推动的。此外,预计新参与企业将进入市场,特别是在创新材料和数位健康整合领域。现有公司必须适应这些变化,以维持市场占有率并保持竞争力。
每家公司都专注于为多个患者群体提供服务并满足特定的治疗要求。该市场包括拥有广泛产品和重要市场占有率的大型老字型大小企业,例如 Stryker、BD、Boehringer Laboratories LLC、Hollister Incorporated 和 Consure Medical。这种专业化有助于市场细分,因为每家公司都专注于为特定专业领域开发客製化解决方案。
与当地经销商、医疗保健提供者和思想领袖的策略联盟和合作可以加速市场进入和采用。透过与老牌公司合作,您可以获得对当地市场细微差别、监管要求和客户偏好的宝贵见解。
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