Male Artificial Urinary Sphincter Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Type (AUS with a balloon reservoir (3-component), AUS with a spring (2-component)), By End-user (Hospitals, Clinics & Other Healthcare Centers, Academic & Research Centers), By Region, By Competition Forecast & Opportunities,

Market Overview

Global Male Artificial Urinary Sphincter Market has valued at USD 226.45 million in 2022 and is anticipated to project impressive growth in the forecast period with a CAGR of 5.39% through 2028. Urinary Incontinence (UI) represents a significant health concern with substantial economic and societal implications. The increase in cases of male urinary incontinence can be attributed to the growing prevalence of urological ailments, such as prostatitis-induced incontinence, nerve and muscle damage resulting from surgical procedures, and infections, among other factors, all of which contribute to disruptions in bladder function. One potential factor is the enlargement of the prostate gland, a condition known as benign prostate hyperplasia, which tends to occur with age. Another potential trigger is prostatitis, characterized by inflammation of the prostate gland. Furthermore, incontinence can also arise as a consequence of nerve and muscle impairment caused by surgical interventions.

Key Market Drivers

Rising Aging Population

The global healthcare landscape is undergoing a transformative shift as the world witnesses an unprecedented increase in the aging population. As longevity becomes the norm, age-related medical conditions are on the rise, one of which is urinary incontinence. The world is witnessing a demographic revolution, with a substantial portion of the global population entering their golden years. According to the United Nations, the number of people aged 60 and over is expected to nearly double by 2050, from 962 million in 2017 to an estimated 2.1 billion. This significant demographic shift is creating an ever-expanding pool of potential patients in need of treatment for age-related health issues, including urinary incontinence. Urinary incontinence, a condition characterized by the involuntary leakage of urine, is more prevalent among older adults. Aging brings about various physiological changes, such as muscle weakening and hormonal imbalances, which can contribute to urinary incontinence. Additionally, age-related medical conditions like benign prostate hyperplasia (BPH) and prostatitis are common culprits. As the aging population grows, so does the prevalence of these conditions, necessitating effective treatment options. The desire for an improved quality of life among the elderly is a significant driving force behind the growth of the male artificial urinary sphincter market. Urinary incontinence can have a profound impact on an individual's daily life, leading to social isolation, embarrassment, and a loss of independence. Recognizing the importance of preserving the dignity and well-being of older adults, healthcare providers are increasingly recommending male artificial urinary sphincters as a solution. In tandem with the aging population, advancements in medical technology have improved the design and effectiveness of male artificial urinary sphincters. Modern devices offer better control over urinary function, fewer complications, and enhanced patient comfort. These innovations have made these devices a more attractive and viable option for older individuals seeking to regain their independence and quality of life. As the aging population grows, so does healthcare spending. Governments and private healthcare providers are allocating more resources to address the unique needs of older adults. This increased investment in healthcare infrastructure and services includes the adoption of advanced medical technologies, such as male artificial urinary sphincters, which are crucial for improving the quality of care and the overall well-being of aging patients.

Prevalence of Urological Disorders

The global healthcare landscape is witnessing a surge in the prevalence of urological disorders, and this phenomenon is reshaping the landscape of medical technology. One significant beneficiary of this trend is the male artificial urinary sphincter market. Urological disorders encompass a range of conditions affecting the urinary tract and male reproductive organs. These disorders include benign prostate hyperplasia (BPH), prostatitis, and other ailments that can lead to urinary incontinence. The global prevalence of these disorders has been on the rise, primarily due to factors such as aging demographics and changes in lifestyle. As the global population ages, the incidence of urological disorders, particularly those associated with aging, has increased significantly. BPH, a non-cancerous enlargement of the prostate gland, is a prime example. It is estimated that by the age of 60, over 50% of men will experience symptoms of BPH. These conditions often lead to urinary incontinence, which necessitates effective management and treatment options like male artificial urinary sphincters. Urological disorders, when left untreated, can have a profound impact on an individual's quality of life. Frequent urination, discomfort, and urinary incontinence can lead to social isolation, reduced mobility, and emotional distress. As awareness of these quality-of-life issues grows, patients and healthcare providers alike are seeking more advanced and reliable solutions. Male artificial urinary sphincters have emerged as a lifeline for individuals battling urological disorders that result in urinary incontinence. These devices are designed to provide precise control over urinary function, offering patients greater independence and an enhanced quality of life. The rising prevalence of urological disorders has driven increased demand for these innovative solutions. The growth of the male artificial urinary sphincter market is further propelled by continuous advancements in medical technology. Modern devices are more sophisticated, user-friendly, and associated with fewer complications. This encourages both healthcare providers and patients to consider these solutions as a viable option for managing urological disorders. Growing awareness about urological disorders and the found at treatment options is another pivotal factor. Patients are now more informed about their conditions, leading to proactive healthcare-seeking behaviors. Healthcare providers, in turn, are better educated about the benefits of male artificial urinary sphincters and are more inclined to recommend them as part of a comprehensive treatment plan.

Advancements in Medical Technology

In an era characterized by relentless innovation, medical technology has become a driving force behind advancements in healthcare. One area where this is particularly evident is in the growth of the global male artificial urinary sphincter market. Advancements in medical technology have revolutionized the way we diagnose, treat, and manage various health conditions. This holds true for the field of urology and the treatment of male urinary incontinence. Modern medical technology is enabling healthcare professionals to provide more effective, minimally invasive, and patient-centric solutions. One of the key factors driving the growth of the male artificial urinary sphincter market is the increased precision and control offered by advanced technologies. These devices have evolved to provide patients with a high degree of control over urinary function. They are equipped with sensors, microprocessors, and customizable settings, allowing users to adjust the device to their specific needs. This level of precision enhances patient outcomes and comfort. Advancements in medical technology have led to male artificial urinary sphincters with improved safety profiles. Modern devices are designed to minimize complications and side effects, making them a safer and more attractive option for both patients and healthcare providers. As these safety features become more pronounced, the market is likely to experience continued growth. Technological advancements have also led to the development of minimally invasive procedures for implanting male artificial urinary sphincters. These procedures are less traumatic for patients, resulting in reduced recovery times and improved overall patient experiences. Minimally invasive approaches have broadened the appeal of these devices and expanded their potential patient base. Technological advancements have also led to the development of minimally invasive procedures for implanting male artificial urinary sphincters. These procedures are less traumatic for patients, resulting in reduced recovery times and improved overall patient experiences. Minimally invasive approaches have broadened the appeal of these devices and expanded their potential patient base. The rise of telemedicine and remote monitoring has further accelerated the adoption of male artificial urinary sphincters. Patients can now consult with healthcare providers, receive device adjustments, and monitor their progress remotely, reducing the need for frequent in-person visits. This convenience factor is making the devices more accessible to a wider range of patients. Modern male artificial urinary sphincters are often designed with a patient-centered approach. Feedback from patients and healthcare professionals informs the design and functionality of these devices, ensuring that they meet the specific needs and preferences of users. This approach not only enhances patient satisfaction but also contributes to the continued growth of the market.

Quality of Life Considerations

Quality of life is a fundamental aspect of well-being, and advancements in healthcare technologies are increasingly focused on improving the lives of individuals affected by various medical conditions. In the realm of urology, male urinary incontinence can significantly compromise one's quality of life. Urinary incontinence is a condition characterized by the involuntary loss of urine, and it can have profound effects on an individual's daily life. Beyond the physical discomfort, the emotional and psychological toll of urinary incontinence can be substantial. Individuals often experience embarrassment, social isolation, a loss of self-esteem, and limitations on their daily activities. Quality of life considerations play a central role in driving the adoption of male artificial urinary sphincters. These devices offer individuals suffering from urinary incontinence a chance to regain their dignity and independence. By providing effective control over urinary function, male artificial urinary sphincters empower users to engage in activities they may have previously avoided, thereby improving their overall quality of life. The psychological well-being of individuals with urinary incontinence is a critical factor in their overall health. Constant worry about accidents, anxiety about social interactions, and the frustration of being unable to engage in once-loved activities can take a toll on mental health. Male artificial urinary sphincters address these concerns by offering a sense of security and control, ultimately contributing to better mental well-being. The social isolation experienced by many individuals with urinary incontinence can lead to feelings of loneliness and depression. Quality of life considerations are driving the use of male artificial urinary sphincters to facilitate social reintegration. These devices enable users to participate in social activities, maintain relationships, and lead more fulfilling lives. Urinary incontinence often disrupts sleep patterns, leading to fatigue and a reduced quality of life. Male artificial urinary sphincters can significantly reduce nighttime awakenings due to urinary urgency, allowing users to enjoy uninterrupted and restful sleep. This improved sleep quality contributes to overall well-being. The restoration of continence through male artificial urinary sphincters can boost self-esteem and confidence levels. When individuals regain control over their bladder, they often experience a sense of accomplishment and empowerment, leading to a more positive self-image and improved quality of life.

Key Market Challenges

High Cost of Treatment

One of the primary challenges facing the male artificial urinary sphincter market is the high cost associated with the treatment. The surgical procedure to implant these devices, along with the device itself, can be expensive. This poses a significant financial burden on patients, especially those without adequate health insurance coverage or access to healthcare resources.

Limited Access to Healthcare

Access to healthcare services varies widely around the world, and not all individuals have equal access to advanced treatments like male artificial urinary sphincters. Rural areas and underserved populations may face challenges in accessing specialized urological care and the necessary surgical procedures.

Inadequate Insurance Coverage

In many regions, insurance coverage for male artificial urinary sphincters may be limited or nonexistent. Patients may be required to bear a substantial portion of the costs themselves, discouraging some from seeking treatment.

Complications and Revision Surgery

While male artificial urinary sphincters are generally safe and effective, complications can occur, such as device malfunction or infection. These complications may necessitate revision surgeries, which can be challenging for patients both in terms of physical recovery and financial costs.

Key Market Trends

Minimally Invasive Procedures

A major trend on the horizon is the increasing adoption of minimally invasive procedures for the implantation of male artificial urinary sphincters. These techniques, often involving smaller incisions and less tissue disruption, offer patients shorter recovery times, reduced post-operative pain, and lower risk of complications. As minimally invasive procedures become more refined and accessible, they are likely to become the preferred approach for implanting these devices.

Enhanced Device Technology

Continual advancements in device technology are expected to drive innovation in the male artificial urinary sphincter market. Manufacturers are focusing on creating devices with improved precision, user-friendliness, and durability. Enhanced sensors, better control mechanisms, and connectivity options for remote monitoring are among the developments on the horizon. These technological enhancements will offer patients more personalized and effective solutions for managing urinary incontinence.

Customization and Personalization

Personalized healthcare is becoming increasingly important, and this trend is extending to the male artificial urinary sphincter market. Devices are being designed with greater flexibility to accommodate individual patient needs. Customization options for pressure settings, fluid volume, and timing of sphincter activation will enable urologists to tailor treatments to the unique requirements of each patient.

Telemedicine Integration

The integration of telemedicine and remote monitoring is expected to become a standard practice in the male artificial urinary sphincter market. Patients will have the ability to consult with healthcare providers, receive device adjustments, and monitor their progress remotely. This trend not only enhances patient convenience but also allows for more proactive and efficient management of urinary incontinence.

Segmental Insights

Type Insights

Based on the category of Type, the segment of Artificial Urinary Sphincters (AUS) featuring a three-component design with a balloon reservoir accounted for the largest market share. This type of AUS, which includes a balloon reservoir, is commonly employed for the treatment of urinary incontinence. The balloon reservoir serves as a storage unit for a fluid (typically saline) used to adjust the cuff surrounding the urethra, controlling the flow of urine.

During the forecast period, the AUS segment with a two-component design incorporating a spring is anticipated to experience the most rapid growth. A notable example is the ZSI 375, developed by Zephyr Surgical Implants in 2008, which is widely used. This particular AUS lacks an abdominal component and comes in a ready-to-implant configuration, reducing the time required for implantation. Additionally, it eliminates the need for surgical procedures in the retroperitoneal space due to the absence of an abdominal component. Furthermore, it allows for post-implantation adjustment of device pressure to achieve the desired continence rate. These advantages are expected to drive increased demand in the near future, resulting in a higher market share in terms of sales.

End-user Insights

the hospitals sector held a dominant position in the male artificial urinary sphincter market. This supremacy can be attributed to the increasing number of surgical procedures and a rising incidence of end-stage renal diseases. For instance, according to data from the CDC, in 2021, approximately 786,000 individuals in the United States underwent treatment for end-stage kidney disease, with roughly 71% undergoing dialysis and 29% receiving kidney transplants.

The segment comprising clinics and other healthcare centers is expected to experience significant growth at a considerable CAGR during the projected period. These clinics are well-equipped with the necessary medical instruments and infrastructure. Ambulatory Surgery Centers (ASCs) are specialized surgical facilities primarily focused on providing emergency or same-day surgical procedures and often linked to larger healthcare systems. ASCs offer a wide array of surgical treatments, including procedures for urinary incontinence (UI) such as sling procedures and artificial urinary sphincter (AUS) implantations, among others.

Additional healthcare facilities and centers encompass specialty surgical clinics, urology clinics, hospital-based clinics, and nonprofit healthcare systems. Furthermore, clinics present more cost-effective alternatives compared to hospitals for urological surgeries. As outpatient facilities, these clinics have lower overhead expenses and do not necessitate overnight stays, resulting in reduced overall costs for patients. They also offer shorter waiting times, adopt a patient-centered approach, and frequently employ specialized teams of urologists, nurses, and staff members who possess extensive experience and expertise in urologic surgeries.

Regional Insights

In 2022, Europe emerged as the dominant force in the market. The presence of advanced healthcare systems in Europe has resulted in increased life expectancy, leading to a growing aging population. Approximately one in five individuals in Europe is aged 65 or older, and this demographic group is more susceptible to urinary incontinence (UI). Additionally, the cost of surgical interventions to address UI is considerably higher for individuals. These factors collectively positioned Europe as the primary contributor to revenue in the artificial urinary sphincter market in 2022, and this trend is expected to persist throughout the forecast period.

The North American market for male artificial urinary sphincters is anticipated to experience substantial growth in the forecast period. This can be attributed to the region's well-established healthcare infrastructure, high prevalence of urological disorders, and a strong focus on technological advancements in medical devices. North America is a prominent market for male artificial urinary sphincters, as it is used to diagnose and treat various urological conditions, including kidney stones, enlarged prostates, bladder tumors, and urinary tract strictures, with advanced procedures such as the implantation of male artificial urinary sphincters.

In the United States, AUS has a long history of success among users. Furthermore, the AMS 800, an AUS device developed by Boston Scientific Corporation, has received approval from the U.S. Food and Drug Administration (FDA), ensuring its safety and effectiveness for users. Additionally, it is covered by insurance companies, making it more affordable and accessible to patients in the region.

Recent Developments

• In May 2020, Rigicon, Inc. introduced its Conti AUSportfolio to the worldwide market, featuring two offerings named ColtiClassicand ContiReflex AUS. These products were granted CE Mark Approval and becameaccessible in European markets.

Key Market Players

• Boston Scientific Corporation
• ZephyrSurgical Implants
• AffluentMedical
• UroMems
• Rigicon
• ProMinentGmbH