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2046803

男性人工尿道括約肌市場－全球產業規模、佔有率、趨勢、機會及預測：按類型、最終用戶、地區和競爭格局分類，2021-2031年

Male Artificial Urinary Sphincter Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Type (AUS with a balloon reservoir, AUS with a spring ), By End-user, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 180 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球男性人工尿道括約肌市場預計將從 2025 年的 5.1177 億美元成長到 2031 年的 6.7299 億美元，複合年成長率為 4.67%。

該市場包括旨在透過模擬健康尿道括約肌的自然功能來解決中度至重度應力性尿失禁的植入式醫療設備。主要成長要素包括前列腺癌根治術後尿失禁發生率的增加，以及易患泌尿器官系統疾病的老年人口不斷成長，凸顯了對長期尿功能維持解決方案的強勁需求。然而，挑戰依然存在，特別是這些器械的高成本以及相關風險，例如再次手術、機械故障和尿道侵蝕。儘管臨床需求非常高，正如美國泌尿系統協會2024年的統計數據顯示，14%至25%接受根治性前列腺切除術的男性會出現令人痛苦的尿液滲漏，但這些顧慮可能會阻礙患者的接受度和市場進一步滲透。

市場概覽
預測期 2027-2031
市場規模：2025年 5.1177億美元
市場規模：2031年 6.7299億美元
複合年成長率：2026-2031年 4.67%
成長最快的細分市場 醫院
最大的市場 北美洲

市場促進因素

男性尿道括約肌人工裝置市場的主要促進因素是攝護腺癌發生率的上升，這直接導致根治性護腺切除術後需要恢復排尿功能的患者數量增加。美國癌症協會預測，到2025年，美國將新增313,780例前列腺癌病例，且2014年至2021年間年發病率成長3%，凸顯了術後尿失禁管理的持續需求。此外，技術進步提高了裝置的可靠性，並最大限度地降低了再次手術的風險，從而顯著推動了市場擴張。新一代尿道括約肌人工裝置採用改良材料和人性化組件，減少了尿道萎縮和裝置故障等併發症，這促使臨床醫生和患者擴大接受此類裝置。這些創新體現在強勁的財務業績上。例如，波士頓科學公司醫療和外科部門報告稱，2025 年第三季銷售額成長了 16.4%，證實了市場對先進且可靠的尿失禁解決方案的積極反應。

市場挑戰

男性人工尿道括約肌市場的主要挑戰之一是裝置容易發生機械故障，導致需要再次手術。裝置故障、尿道侵蝕和感染疾病等固有風險令患者和醫療服務提供者都深感擔憂。這種對侵入性再次手術的擔憂往往促使合格的患者選擇創傷較小的治療方法，從而降低患者對裝置的信心，並限制了整體市場潛力。此外，高再次手術率也帶來了巨大的經濟和臨床負擔，包括加重醫療預算壓力，並降低治療的成本效益評估。美國泌尿系統協會 (AUA) 2025 年的一項研究顯示，首次植入後兩年內再次手術的機率高達 29%，凸顯了該治療方法持續存在的耐用性問題，阻礙了其廣泛應用。

市場趨勢

人工尿道括約肌 (AUS) 市場正受到兩大趨勢的影響：智慧電子 AUS 系統的整合以及可調節壓力調節機制的發展。智慧電子系統正在取代傳統的機械泵，其採用針對患者最佳化的自動控制功能，利用感測器和演算法動態調節袖帶壓力。這項創新技術最大限度地減少了尿道損傷，同時預防了尿失禁，其有效性得到了行業大量投資的支持，例如 UroMems 公司在 2024 年 6 月成功完成 4700 萬美元的資金籌措，用於其 UroActive 系統的臨床試驗。同時，流體動力學的進步正在推動可調節壓力調節機制的開發，該機制能夠動態適應腹內壓的變化。這避免了持續的高靜壓，並防止了組織萎縮。這些設計改進已被證明具有很高的可靠性，Rigicon 公司的 ContiReflex 系統的早期研究顯示，其 18 個月的設備存活率高達 98%，為傳統設計提供了更優的替代方案。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：男性人工尿道括約肌的全球市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 按類型（帶氣囊儲氣囊的AUS（3個組件），帶彈簧的AUS（2個組件））
    • 依最終使用者（醫院、診所和其他醫療機構、學術和研究機構）分類
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美男性人工尿道括約肌市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲男性人工尿道括約肌市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區男性人工尿道括約肌市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲男性人工尿道括約肌市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美男性人工尿道括約肌市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章：全球男性人工尿道括約肌市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • Boston Scientific Corporation
  • Zephyr Surgical Implants
  • Affluent Medical
  • UroMems（URO MEMS）
  • Rigicon
  • ProMinent GmbH
  • Coloplast A/S
  • Medtronic plc
  • Stryker Corporation
  • Silimed

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 16618

The global market for male artificial urinary sphincters is projected to expand from USD 511.77 million in 2025 to USD 672.99 million by 2031, exhibiting a CAGR of 4.67%. This market encompasses implantable medical devices designed to address moderate to severe stress urinary incontinence by replicating the natural function of a healthy urinary sphincter. Key growth drivers include the increasing incidence of post-prostatectomy incontinence following prostate cancer surgeries and the growing geriatric population susceptible to urological issues, highlighting a strong demand for lasting continence solutions. However, challenges persist, notably the high cost of these devices and the associated risks of surgical revision, mechanical failure, and urethral erosion. These concerns can hinder patient adoption and broader market penetration, despite the significant clinical need underscored by statistics like the 14% to 25% of post-prostatectomy men experiencing bothersome leakage, as reported by the American Urological Association in 2024.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 511.77 Million
Market Size 2031USD 672.99 Million
CAGR 2026-20314.67%
Fastest Growing SegmentHospitals
Largest MarketNorth America

Market Driver

The primary driver for the Male Artificial Urinary Sphincter Market is the rising incidence of prostate cancer, which directly increases the patient population requiring continence restoration after radical prostatectomy. The American Cancer Society projected 313,780 new prostate cancer cases in the US for 2025, with an annual incidence rate increase of 3% from 2014-2021, underscoring a persistent need for post-surgical incontinence management. Complementing this, technological advancements are significantly boosting market expansion by improving device reliability and minimizing surgical revision risks. Next-generation artificial sphincters feature enhanced materials and user-friendly components, reducing complications like urethral atrophy and device failure, which in turn promotes greater adoption among clinicians and patients. This innovation is reflected in strong financial outcomes, such as Boston Scientific's MedSurg segment reporting 16.4% sales growth in Q3 2025, validating the market's positive response to sophisticated, reliable incontinence solutions.

Market Challenge

A significant challenge for the Male Artificial Urinary Sphincter Market stems from the devices' vulnerability to mechanical failure and the resulting necessity for surgical revision. The inherent risks of device malfunction, urethral erosion, and infection cause considerable apprehension among both patients and healthcare providers. This concern about repeat invasive procedures often leads eligible patients to choose less invasive management options, thereby diminishing patient confidence and restricting the overall market potential due to reliability uncertainties. Additionally, the high re-operation rate imposes a substantial economic and clinical burden, straining healthcare budgets and reducing the therapy's perceived cost-effectiveness. A 2025 study by the American Urological Association revealed a 29% probability of surgical reintervention within two years of initial implantation, highlighting the ongoing durability issues that discourage widespread adoption of this therapeutic solution.

Market Trends

The market for artificial urinary sphincters is being significantly shaped by two key trends: the integration of smart and electronic AUS systems, and the development of adjustable pressure-regulating mechanisms. Smart and electronic systems are replacing traditional mechanical pumps with automated, patient-specific control, using sensors and algorithms to dynamically adjust cuff pressure. This innovation minimizes urethral damage while maintaining continence, a shift validated by substantial industry investment, such as UroMems securing $47 million in June 2024 for its UroActive System clinical trials. Simultaneously, advancements in hydraulic engineering are leading to adjustable pressure-regulating mechanisms that dynamically adapt to intra-abdominal pressure changes, preventing tissue atrophy by avoiding constant high static pressure. These design improvements are proving highly reliable, with early studies for Rigicon's ContiReflex system showing a 98% device survival rate at 18 months, offering enhanced alternatives to older designs.

Key Market Players

  • Boston Scientific Corporation
  • Zephyr Surgical Implants
  • Affluent Medical
  • UroMems (URO MEMS)
  • Rigicon
  • ProMinent GmbH
  • Coloplast A/S
  • Medtronic plc
  • Stryker Corporation
  • Silimed

Report Scope

In this report, the Global Male Artificial Urinary Sphincter Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Male Artificial Urinary Sphincter Market, By Type

  • AUS with a balloon reservoir (3-component)
  • AUS with a spring (2-component)

Male Artificial Urinary Sphincter Market, By End-user

  • Hospitals
  • Clinics & Other Healthcare Centers
  • Academic & Research Centers

Male Artificial Urinary Sphincter Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Male Artificial Urinary Sphincter Market.

Available Customizations:

Global Male Artificial Urinary Sphincter Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Male Artificial Urinary Sphincter Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Type (AUS with a balloon reservoir (3-component), AUS with a spring (2-component))
    • 5.2.2. By End-user (Hospitals, Clinics & Other Healthcare Centers, Academic & Research Centers)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Male Artificial Urinary Sphincter Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Type
    • 6.2.2. By End-user
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Male Artificial Urinary Sphincter Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Type
        • 6.3.1.2.2. By End-user
    • 6.3.2. Canada Male Artificial Urinary Sphincter Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Type
        • 6.3.2.2.2. By End-user
    • 6.3.3. Mexico Male Artificial Urinary Sphincter Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Type
        • 6.3.3.2.2. By End-user

7. Europe Male Artificial Urinary Sphincter Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Type
    • 7.2.2. By End-user
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Male Artificial Urinary Sphincter Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Type
        • 7.3.1.2.2. By End-user
    • 7.3.2. France Male Artificial Urinary Sphincter Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Type
        • 7.3.2.2.2. By End-user
    • 7.3.3. United Kingdom Male Artificial Urinary Sphincter Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Type
        • 7.3.3.2.2. By End-user
    • 7.3.4. Italy Male Artificial Urinary Sphincter Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Type
        • 7.3.4.2.2. By End-user
    • 7.3.5. Spain Male Artificial Urinary Sphincter Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Type
        • 7.3.5.2.2. By End-user

8. Asia Pacific Male Artificial Urinary Sphincter Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Type
    • 8.2.2. By End-user
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Male Artificial Urinary Sphincter Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Type
        • 8.3.1.2.2. By End-user
    • 8.3.2. India Male Artificial Urinary Sphincter Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Type
        • 8.3.2.2.2. By End-user
    • 8.3.3. Japan Male Artificial Urinary Sphincter Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Type
        • 8.3.3.2.2. By End-user
    • 8.3.4. South Korea Male Artificial Urinary Sphincter Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Type
        • 8.3.4.2.2. By End-user
    • 8.3.5. Australia Male Artificial Urinary Sphincter Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Type
        • 8.3.5.2.2. By End-user

9. Middle East & Africa Male Artificial Urinary Sphincter Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Type
    • 9.2.2. By End-user
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Male Artificial Urinary Sphincter Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Type
        • 9.3.1.2.2. By End-user
    • 9.3.2. UAE Male Artificial Urinary Sphincter Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Type
        • 9.3.2.2.2. By End-user
    • 9.3.3. South Africa Male Artificial Urinary Sphincter Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Type
        • 9.3.3.2.2. By End-user

10. South America Male Artificial Urinary Sphincter Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Type
    • 10.2.2. By End-user
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Male Artificial Urinary Sphincter Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Type
        • 10.3.1.2.2. By End-user
    • 10.3.2. Colombia Male Artificial Urinary Sphincter Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Type
        • 10.3.2.2.2. By End-user
    • 10.3.3. Argentina Male Artificial Urinary Sphincter Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Type
        • 10.3.3.2.2. By End-user

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Male Artificial Urinary Sphincter Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Boston Scientific Corporation
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Zephyr Surgical Implants
  • 15.3. Affluent Medical
  • 15.4. UroMems (URO MEMS)
  • 15.5. Rigicon
  • 15.6. ProMinent GmbH
  • 15.7. Coloplast A/S
  • 15.8. Medtronic plc
  • 15.9. Stryker Corporation
  • 15.10. Silimed

16. Strategic Recommendations

17. About Us & Disclaimer