Erectile Dysfunction Treatment Devices Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Vacuum Constriction Devices, Penile Implants, Shockwave Therapy, Others), By Cause (Vascular Disorders and Diabetes, Neurologic disorder, Others), By End-user (Hospital & Clinics, Ambulatory Surgery Center, Others), by region, and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.52 Billion
CAGR (2026-2031)	7.83%
Fastest Growing Segment	Penile Implants
Largest Market	North America
Market Size (2031)	USD 2.39 Billion

Market Overview

The Global Erectile Dysfunction Treatment Devices Market will grow from USD 1.52 Billion in 2025 to USD 2.39 Billion by 2031 at a 7.83% CAGR. The Global Erectile Dysfunction Treatment Devices Market comprises vacuum erection systems, penile prostheses and shock wave therapy equipment designed to manage impotence. Market growth is primarily driven by the rising incidence of diabetes and cardiovascular diseases which necessitate physiological interventions alongside an aging population seeking durable mechanical solutions. According to the 'American Urological Association', in '2024', '86% of surveyed urologists utilized penile rehabilitation therapies that frequently employ devices such as vacuum pumps for patient recovery'. This strong clinical reliance underscores the vital role of these apparatuses in managing complex urological conditions.

Despite these positive drivers the market encounters a significant challenge regarding the high expense and invasiveness of surgical implants. Procedures for penile prostheses involve medical risks including infection and mechanical malfunction which often deter potential candidates. Furthermore limited insurance coverage for these premium devices in many regions restricts affordability and hampers broader market accessibility.

Key Market Drivers

The increasing incidence of lifestyle-associated chronic conditions, particularly diabetes and cardiovascular diseases, acts as a primary catalyst for the Global Erectile Dysfunction Treatment Devices Market. As these systemic pathologies progress, they frequently cause severe vascular and neural damage that renders first-line oral pharmacotherapies ineffective, thereby compelling patients to seek mechanical interventions such as vacuum erection systems or penile prostheses. This correlation between chronic metabolic disorders and sexual dysfunction significantly expands the addressable patient pool for device manufacturers. According to News-Medical, October 2024, in the 'New study reveals two-thirds of diabetic men suffer from erectile dysfunction' article, a comprehensive review determined the global prevalence of erectile dysfunction in diabetic patients to be approximately 65.8%, highlighting the substantial scale of this comorbidity. Consequently, the consistent rise in metabolic health crises ensures a steady demand for non-pharmacological management options.

Technological advancements in inflatable and malleable penile implants have further propelled market expansion by enhancing device durability and patient satisfaction rates. Manufacturers are developing advanced, infection-resistant, and user-friendly prosthetic solutions that encourage uptake among men seeking long-term curative measures over temporary fixes. This innovation-led demand is reflected in the financial performance of major industry players who continue to report strong divisional gains. According to Boston Scientific, October 2024, in the 'Q3 2024 Financial and Operational Highlights', the company achieved a 10.3% reported increase in global Urology sales, driven largely by their prostate and prosthetic portfolios. This positive momentum is echoed across the sector, reinforcing the commercial viability of interventional urology solutions. According to Coloplast, in 2024, their Interventional Urology business area delivered an organic growth rate of 5% for the financial year, confirming sustained investment and clinical utilization of these critical therapeutic devices.

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Key Market Challenges

The high expense and invasiveness associated with surgical implants, particularly penile prostheses, present a substantial barrier to the expansion of the Global Erectile Dysfunction Treatment Devices Market. These procedures are inherently complex and carry significant medical risks, such as infection and mechanical failure, which deter a large segment of the eligible patient population. Consequently, the reluctance to undergo invasive surgery restricts the addressable market for these durable solutions, forcing many patients to rely on less effective or temporary alternatives despite the availability of long-term options.

This hesitation is further compounded by clinical data highlighting the functional challenges and dissatisfaction that can arise post-surgery. According to the 'Sexual Medicine Society of North America', in '2024', '36.7% of patients receiving penile prosthesis implants reported difficulties reaching orgasm and 31.6% experienced issues with prosthesis deflation at the 12-month mark'. Such statistics regarding mechanical reliability and post-operative functionality validate patient concerns about the risks of these premium devices. This direct correlation between potential device malfunction and patient dissatisfaction significantly hampers market adoption rates, limiting revenue growth in the implantable device segment.

Key Market Trends

Accelerating Adoption of Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) is reshaping the market landscape by shifting clinical focus from symptomatic management to restorative cures. Unlike mechanical implants or pumps that bypass physiological deficits, Li-ESWT promotes neovascularization to rehabilitate underlying erectile tissue, making it an increasingly attractive option for patients seeking non-invasive and durable improvements. This transition is substantiated by emerging long-term efficacy data that builds provider confidence in the therapy's restorative potential. According to Storz Medical, February 2025, in the 'Is low-intensity shockwave therapy for erectile dysfunction a durable treatment option?' article, a randomized controlled trial demonstrated that patients receiving Li-ESWT achieved a sustained increase in Sexual Health Inventory for Men (SHIM) scores, rising from a baseline of 10.8 to 15.6 at the 12-month assessment. Such clinical validation is pivotal for broader insurance adoption and patient uptake, positioning regenerative therapies as a viable competitor to traditional surgical interventions.

Advancements in Infection-Resistant and Hydrophilic Implant Coatings are critically addressing the primary medical risks associated with penile prostheses, thereby expanding the addressable patient pool. Manufacturers are integrating novel surface modifications that enhance lubricity and facilitate antibiotic absorption, directly mitigating the infection concerns that historically deterred both surgeons and patients from opting for implantation. These technological improvements are yielding tangible safety outcomes in real-world applications, significantly reducing revision rates. According to the National Institutes of Health, January 2025, in the 'Patient satisfaction study for the new Rigicon Infla10 inflatable penile prosthesis' article, a clinical evaluation of patients implanted with the hydrophilic-coated Infla10 device revealed an exceptionally low infection-related explant rate of just 1.7% over a median follow-up of 19 months. This demonstrated reduction in post-operative adverse events enhances the commercial appeal of next-generation implants and supports their increased utilization in complex urological cases.

Segmental Insights

The penile implants segment is recognized as the fastest growing category within the Global Erectile Dysfunction Treatment Devices Market. This accelerated expansion is primarily driven by the increasing patient population that remains unresponsive to oral medications and requires a reliable long-term solution. The demand is further supported by improvements in device durability and inflation mechanisms which enhance user satisfaction. Additionally, consistent product clearances by regulatory authorities such as the US Food and Drug Administration have reinforced clinical confidence in these surgical interventions, thereby promoting their wider adoption for managing severe cases.

Regional Insights

North America maintains a leading position in the global erectile dysfunction treatment devices market, driven by a high prevalence of urological disorders and established healthcare infrastructure. The region benefits from favorable reimbursement policies that increase patient access to vacuum constriction devices and penile implants. Additionally, strong regulatory frameworks provided by the U.S. Food and Drug Administration ensure the safety and availability of effective therapeutic options. The presence of major medical device manufacturers within the region further consolidates this dominance, ensuring steady availability and adoption of treatment solutions across the United States and Canada.

Recent Developments

• In January 2025, Comphya SA announced that the U.S. Food and Drug Administration (FDA) had granted Investigational Device Exemption (IDE) approval to initiate a clinical trial for CaverSTIM. This implantable neuromodulator is developed to treat erectile dysfunction in patients who do not respond to standard oral medications. The approval permits the company to evaluate the device's safety and efficacy in the United States, marking a critical milestone in its clinical development. The technology functions by stimulating the cavernous nerve to restore natural erectile function, offering a promising therapeutic alternative for individuals such as those recovering from radical prostatectomy.
• In December 2024, significant research regarding the Rigicon Infla10 inflatable penile prosthesis was published, reporting the first patient satisfaction and safety data for the device. The study, which appeared in a prominent medical journal, analyzed outcomes from a series of patients implanted with the three-piece inflatable device. Results demonstrated high survival rates for the implant and strong patient satisfaction scores over a multi-year follow-up period. The findings confirmed that the device's mechanical reliability and safety profile are comparable to long-established competitors in the market, validating its position as an effective surgical solution for refractory erectile dysfunction.
• In September 2024, Haleon announced the United States launch of Eroxon, a novel treatment for erectile dysfunction that is regulated as a medical device. This product is the first FDA-cleared gel available over-the-counter without a prescription, designed to stimulate nerve endings through a rapid cooling and warming physical action. The company introduced the product to address the demand for accessible, fast-acting, and drug-free options for men. It was made available for pre-order through major online platforms, providing a new first-line alternative for millions of men seeking treatment for erectile dysfunction without the potential side effects of systemic medications.
• In June 2024, Ohh-Med Medical Ltd. introduced VerticaPlus, an upgraded model of its home-use medical device for erectile dysfunction, which now features connectivity with a dedicated mobile application. The device employs radiofrequency energy to stimulate collagen remodeling in penile tissue, aiming to improve the physical mechanism of erection. The newly launched app acts as a digital coach, offering users real-time feedback, guided treatment sessions, and progress tracking to ensure optimal usage. This product launch highlights the company's focus on integrating digital health solutions with non-invasive therapeutic technologies to treat the underlying physiological causes of the condition.

Key Market Players

• Boston Scientific Corporation
• Coloplast Corp.
• Zephyr Surgical Implants
• Owen Mumford Ltd.
• Augusta Medical Systems
• Storz medical AG,
• The Elator AB
• Timm Medical Technologies Ltd.
• Alma Lasers Ltd
• Futura Medical plc

By Type	By Cause	By End-user	By Region
Vacuum Constriction Devices Penile Implants Shockwave Therapy Others	Vascular Disorders and Diabetes Neurologic disorder Others	Hospital & Clinics Ambulatory Surgery Center Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Erectile Dysfunction Treatment Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Erectile Dysfunction Treatment Devices Market , By Type:

• Vacuum Constriction Devices
• Penile Implants
• Shockwave Therapy
• Others

• Erectile Dysfunction Treatment Devices Market , By Cause:

• Vascular Disorders and Diabetes
• Neurologic disorder
• Others

• Erectile Dysfunction Treatment Devices Market , By End-user:

• Hospital & Clinics
• Ambulatory Surgery Center
• Others

• Erectile Dysfunction Treatment Devices 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