Men’s Reproductive Health Market Size, Share & Trend Analysis - Global - 2025-2031 - Includes: Inflatable and Malleable Erectile Dysfunction Device Markets
Description
Global Men’s Reproductive Health Device Market Report, 2025 Edition
Executive Summary
The global men’s reproductive health device market was valued at over $289 million in 2024 and is forecast to grow at a compound annual growth rate (CAGR) of 2.5 percent to exceed $343 million by 2032. Growth is driven by rising awareness of erectile dysfunction (ED), higher diagnosis rates among younger and middle-aged men, and the increasing prevalence of diabetes and neurological diseases that contribute to ED. At the same time, pricing pressure, limited reimbursement and strong competition from drug therapy and other non-surgical treatments constrain faster expansion.
This report focuses on the market for surgical men’s reproductive health devices, specifically inflatable erectile dysfunction devices and malleable erectile dysfunction devices. It quantifies unit sales, average selling prices (ASPs), market values, growth rates and company shares by device type and region. The analysis also reviews procedure volumes, technology trends and clinical practice patterns that shape demand for penile implants.
Although penile implants are used by a small subset of men with erectile dysfunction, they remain an important segment because they offer a permanent solution for patients whose condition does not respond to pharmacologic treatment or who are not candidates for drug therapy. Satisfaction rates reported in clinical studies are high, and device lifetimes in the range of nine to eleven years create recurring replacement demand as younger patients age.
The market is concentrated, with Boston Scientific and Coloplast accounting for most global revenues through established inflatable and malleable product lines. Newer entrants such as Rigicon are gaining modest share by offering alternative designs and by targeting underpenetrated regions. Future growth will depend on continued education of patients and clinicians, reimbursement support in cost sensitive markets, and product innovation that simplifies implantation while improving reliability and patient comfort.
Market Overview
Men’s reproductive health devices play a specialized role within the broader urology and sexual health landscape. Erectile dysfunction is common worldwide and increases with age, but only a fraction of patients are treated with surgical implants. Most begin with oral drug therapy or non-invasive options, and only those who fail or cannot tolerate these approaches progress to penile prostheses.
Within this context, the global men’s reproductive health device market is relatively small but stable. It is well established in North America and Western Europe, where specialist centers, trained surgeons and structured referral pathways support implant usage. In many emerging markets, adoption remains low due to affordability constraints, cultural factors and limited access to specialized surgery.
Average selling prices have faced pressure in recent years from hospital budget controls and competitive tenders. At the same time, the market must compete with a wide range of non-surgical treatment options, including first-line pharmacologic therapies and vacuum erection devices that are often cheaper and more widely reimbursed. These factors limit rapid expansion in total market value, even as underlying disease prevalence increases.
Despite these headwinds, structural growth drivers are present. Earlier and more open discussion of erectile dysfunction, improved diagnostic workups and broader acceptance of surgical solutions are all contributing to incremental increases in procedure volume. In addition, men are seeking implants at younger ages, which not only raises immediate demand but also increases the likelihood of future replacement procedures within the forecast horizon.
Market Drivers
Increased Awareness
Historically, erectile dysfunction was rarely discussed in public or even in clinical settings. Today, there is greater openness about male sexual health, supported by patient advocacy, direct-to-consumer campaigns and digital health content. This change has improved awareness of available treatment options and reduced stigma around seeking help.
As more men understand that penile implants are a viable option when other treatments fail, interest in surgical solutions is rising. Importantly, patients are also presenting at younger ages, rather than waiting until symptoms are severe. Since device lifetimes are typically nine to eleven years, this shift toward earlier implantation increases the likelihood of at least one replacement over a patient’s lifetime, which in turn supports recurring demand.
Increased Rate of Diabetes and Neurological Diseases
Diabetes and neurological disorders are strongly associated with erectile dysfunction. Elevated blood glucose levels and microvascular changes damage blood vessels and nerves, which can impair penile blood flow and erectile function. The global prevalence of diabetes continues to grow, especially in aging and increasingly sedentary populations, which raises the number of men at risk of moderate to severe ED.
Many of these patients will initially try oral medications, but a subset will not respond adequately or will experience contraindications related to cardiovascular disease or nitrate therapy. For this group, surgical devices become an important treatment option. As the number of men with diabetes and neurological conditions such as spinal cord injury or neurodegenerative disease increases, the pool of candidates for penile implants also expands.
Clinical Advantages of Penile Implants
Although penile implantation is invasive and requires specialized surgical skill, clinical outcomes are generally strong. Penile implants offer a permanent solution that is independent of ongoing drug intake and can provide reliable function for many years. Studies have reported satisfaction rates in the range of 80 to 90 percent, both for patients and their partners, which is higher than for many non-surgical treatments.
Inflatable devices allow a more natural appearance and function when deflated, while malleable devices provide a simpler mechanical solution that can be preferable in certain clinical situations. Once implanted, devices typically require minimal day-to-day maintenance from the patient. For men seeking a definitive and predictable solution after long periods of frustration with other therapies, these clinical advantages are compelling and support steady procedure demand.
Market Limiters
Reimbursement
In many health systems, reimbursement for men’s reproductive health devices is limited or inconsistent. In low cost markets and in some public payer systems, budgets for erectile dysfunction surgery are constrained, which restricts access to inflatable implants in particular. Where patients must pay a large portion of costs out of pocket, many choose to continue with drug therapy or non-surgical options rather than pursue surgery.
Even in higher income countries, hospital budgets and payer policies may favor less costly treatments. This creates regional variability in implant uptake and caps overall market penetration, despite high satisfaction among treated patients.
Alternative Treatment Options
Drug therapy for erectile dysfunction is usually the recommended first-line treatment, since it is non-invasive and widely available. For the majority of patients, oral medications provide adequate function. Success rates of around 70 to 80 percent significantly reduce the pool of men who proceed to surgical implants.
When drug therapy fails, vacuum erection devices and other non-surgical options can still provide benefit for some patients. These devices are generally cheaper and do not require permanent implantation. As long as they remain acceptable and effective for a share of the population, they limit the size of the addressable market for penile prostheses.
Price Pressure
The men’s reproductive health device market is highly concentrated, with two major manufacturers competing for most global share. In recent years, competitive tenders, contract negotiations and value analysis processes have increased pressure on pricing. Hospitals and procurement groups often compare device systems side by side and negotiate discounts, which has led to gradual declines in ASPs.
At the same time, payers are sensitive to overall episode cost for ED treatment. As more providers seek to demonstrate value and reduce per-procedure spend, manufacturers have limited room to raise prices, even when offering product improvements. This pricing environment slows revenue growth in mature regions and encourages providers to scrutinize case selection more closely.
Market Coverage and Data Scope
This report provides quantitative and qualitative coverage of the global men’s reproductive health device market, with historical data from 2022 to 2024, a 2024 base year and forecasts through 2032. The analysis measures unit sales, ASPs, market values, market shares and growth rates by device type and region.
Quantitative coverage includes:
Market size and growth by year
Market shares for leading competitors
Forecasts to 2032 based on procedure volumes and pricing trends
Units sold by device type
Average selling prices by region and segment
Qualitative coverage includes:
Market growth trends and demand drivers
Market limiters and reimbursement constraints
Competitive analysis and SWOT profiles for top companies
Mergers and acquisitions affecting the segment
Company profiles and product portfolios for key players
Technology developments, device recalls and regulatory updates
Disease overviews for erectile dysfunction and related comorbidities
Data sources include primary interviews with surgeons, urologists and industry executives, government and physician datasets, regulatory filings, hospital purchasing data, import and export statistics and the iData Research internal database. Triangulation of units, ASPs and procedure data is used to validate market estimates and forecasts.
Care settings covered include hospitals, specialized urology and andrology centers and private clinics that perform penile implant surgery.
Markets Covered and Segmentation
The scope of this report is limited to device based treatments for erectile dysfunction in the form of surgical implants. It does not quantify revenues from oral drug therapy, vacuum erection devices or other non-surgical products.
The global men’s reproductive health device market is segmented as follows:
Men’s reproductive health devices
Inflatable erectile dysfunction devices
Malleable erectile dysfunction devices
Within these two categories, the report analyzes unit sales and market value by:
Device type and configuration
Primary indication (for example, vasculogenic ED, neurogenic ED, diabetes related ED) where data is available
Replacement versus first-time implantation
Major geographic regions
This segmentation structure allows readers to distinguish between the higher value inflatable segment and the simpler malleable segment, and to understand how procedure patterns and reimbursement environments influence device mix over time.
Competitive Analysis
Boston Scientific was the leading competitor in the men’s reproductive health device market in 2024. The company offers a broad line of penile implant devices, including the AMS 700 MS series of three piece inflatable systems and the AMS Ambicor two piece inflatable system, along with other configurations tailored to different patient needs. Boston Scientific’s strong position reflects its acquisition of American Medical Systems (AMS) in 2018, which brought a long history of product design, clinical data and surgeon familiarity into its portfolio.
Coloplast was the second leading competitor in 2024. The company markets the Titan line of inflatable penile prostheses and a range of malleable implants. Coloplast’s products are recognized for robust mechanical performance and a strong service and training infrastructure that supports implanting surgeons. The company competes directly with Boston Scientific for tenders and hospital contracts in many major markets.
Rigicon has emerged as a newer entrant and gained a modest share of the total market with its Rigi10 malleable and Infla10 inflatable prosthesis lines. By focusing on specific geographic niches and partnering with local distributors, Rigicon is positioning itself as an alternative supplier in regions where market penetration of the two main incumbents has room to grow.
Together, these companies shape pricing, innovation and training in the segment. The high level of technical and clinical expertise required to develop and support penile implants creates a barrier to entry, which helps maintain a concentrated competitive environment while still leaving limited space for emerging players that can differentiate on service, training or regional focus.
Technology and Practice Trends
Several technology and practice trends are influencing the men’s reproductive health device market. On the device side, manufacturers continue to refine materials, coatings and mechanical designs to reduce complications such as infection, mechanical failure and patient discomfort. Improvements in pump design, reservoir placement options and cylinder geometry aim to provide more natural function and appearance while simplifying surgical implantation.
Infection prevention remains a key focus, since revision procedures due to infection are costly and distressing for patients. Antimicrobial coatings, refined surgical protocols and standardized perioperative care pathways are helping to lower infection rates and improve implant longevity.
From a practice perspective, there is a gradual shift toward streamlined patient pathways that integrate counseling, shared decision making and realistic expectation setting before surgery. As digital health tools and telemedicine become more common, preoperative and postoperative follow up can sometimes be managed remotely, which improves access for men who live far from specialist centers.
Training programs and proctoring are also important trends. Because penile implant surgery is highly specialized, manufacturers provide education and hands on training courses to help new surgeons enter the field and to keep experienced surgeons updated on technique refinements. These programs support safe adoption of newer device generations and can influence brand loyalty and product selection.
Geography
This report provides global coverage across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.
Why This Report
Use this report to answer key strategic questions such as:
What is the current global market size for men’s reproductive health devices and which regions and device types are expected to grow fastest through 2032?
How do trends in diabetes, neurological disease and aging populations translate into long term demand for penile implants?
How much of the erectile dysfunction treatment pathway is captured by surgical devices versus drug therapy and non-surgical options, and how might this mix change over time?
Which competitors hold the largest shares of the inflatable and malleable segments and how are new entrants positioning themselves?
What technology and practice trends, including infection prevention measures, design improvements and training programs, are shaping clinician and patient preferences?
How do reimbursement constraints, price pressure and alternative treatment options limit market penetration, and where are the best opportunities to expand access?
In which regions is there the greatest gap between ED prevalence and implant procedure volumes, indicating potential for targeted marketing, education and partnership strategies?
Commercial, marketing, strategy and investment teams can use these insights to size opportunities, refine product roadmaps, tailor training and education programs and build evidence based value propositions for payers and providers.
About iData Research
iData Research is a premium market intelligence firm headquartered in Canada with offices across North America and Europe.
Over the last 20 years, the company has specialized in device-level sizing, procedure models, pricing trends, and competitive share across MedTech.
Since 2005, iData has supported global OEMs, mid-market innovators, and investors with triangulated data based on units and ASPs, with country-level forecasts and analyst access across Europe, North America, Latin America, the Middle East, Africa, and APAC.
Reports are available with flexible licensing to fit commercial, strategy, and investment workflows.
Executive Summary
The global men’s reproductive health device market was valued at over $289 million in 2024 and is forecast to grow at a compound annual growth rate (CAGR) of 2.5 percent to exceed $343 million by 2032. Growth is driven by rising awareness of erectile dysfunction (ED), higher diagnosis rates among younger and middle-aged men, and the increasing prevalence of diabetes and neurological diseases that contribute to ED. At the same time, pricing pressure, limited reimbursement and strong competition from drug therapy and other non-surgical treatments constrain faster expansion.
This report focuses on the market for surgical men’s reproductive health devices, specifically inflatable erectile dysfunction devices and malleable erectile dysfunction devices. It quantifies unit sales, average selling prices (ASPs), market values, growth rates and company shares by device type and region. The analysis also reviews procedure volumes, technology trends and clinical practice patterns that shape demand for penile implants.
Although penile implants are used by a small subset of men with erectile dysfunction, they remain an important segment because they offer a permanent solution for patients whose condition does not respond to pharmacologic treatment or who are not candidates for drug therapy. Satisfaction rates reported in clinical studies are high, and device lifetimes in the range of nine to eleven years create recurring replacement demand as younger patients age.
The market is concentrated, with Boston Scientific and Coloplast accounting for most global revenues through established inflatable and malleable product lines. Newer entrants such as Rigicon are gaining modest share by offering alternative designs and by targeting underpenetrated regions. Future growth will depend on continued education of patients and clinicians, reimbursement support in cost sensitive markets, and product innovation that simplifies implantation while improving reliability and patient comfort.
Market Overview
Men’s reproductive health devices play a specialized role within the broader urology and sexual health landscape. Erectile dysfunction is common worldwide and increases with age, but only a fraction of patients are treated with surgical implants. Most begin with oral drug therapy or non-invasive options, and only those who fail or cannot tolerate these approaches progress to penile prostheses.
Within this context, the global men’s reproductive health device market is relatively small but stable. It is well established in North America and Western Europe, where specialist centers, trained surgeons and structured referral pathways support implant usage. In many emerging markets, adoption remains low due to affordability constraints, cultural factors and limited access to specialized surgery.
Average selling prices have faced pressure in recent years from hospital budget controls and competitive tenders. At the same time, the market must compete with a wide range of non-surgical treatment options, including first-line pharmacologic therapies and vacuum erection devices that are often cheaper and more widely reimbursed. These factors limit rapid expansion in total market value, even as underlying disease prevalence increases.
Despite these headwinds, structural growth drivers are present. Earlier and more open discussion of erectile dysfunction, improved diagnostic workups and broader acceptance of surgical solutions are all contributing to incremental increases in procedure volume. In addition, men are seeking implants at younger ages, which not only raises immediate demand but also increases the likelihood of future replacement procedures within the forecast horizon.
Market Drivers
Increased Awareness
Historically, erectile dysfunction was rarely discussed in public or even in clinical settings. Today, there is greater openness about male sexual health, supported by patient advocacy, direct-to-consumer campaigns and digital health content. This change has improved awareness of available treatment options and reduced stigma around seeking help.
As more men understand that penile implants are a viable option when other treatments fail, interest in surgical solutions is rising. Importantly, patients are also presenting at younger ages, rather than waiting until symptoms are severe. Since device lifetimes are typically nine to eleven years, this shift toward earlier implantation increases the likelihood of at least one replacement over a patient’s lifetime, which in turn supports recurring demand.
Increased Rate of Diabetes and Neurological Diseases
Diabetes and neurological disorders are strongly associated with erectile dysfunction. Elevated blood glucose levels and microvascular changes damage blood vessels and nerves, which can impair penile blood flow and erectile function. The global prevalence of diabetes continues to grow, especially in aging and increasingly sedentary populations, which raises the number of men at risk of moderate to severe ED.
Many of these patients will initially try oral medications, but a subset will not respond adequately or will experience contraindications related to cardiovascular disease or nitrate therapy. For this group, surgical devices become an important treatment option. As the number of men with diabetes and neurological conditions such as spinal cord injury or neurodegenerative disease increases, the pool of candidates for penile implants also expands.
Clinical Advantages of Penile Implants
Although penile implantation is invasive and requires specialized surgical skill, clinical outcomes are generally strong. Penile implants offer a permanent solution that is independent of ongoing drug intake and can provide reliable function for many years. Studies have reported satisfaction rates in the range of 80 to 90 percent, both for patients and their partners, which is higher than for many non-surgical treatments.
Inflatable devices allow a more natural appearance and function when deflated, while malleable devices provide a simpler mechanical solution that can be preferable in certain clinical situations. Once implanted, devices typically require minimal day-to-day maintenance from the patient. For men seeking a definitive and predictable solution after long periods of frustration with other therapies, these clinical advantages are compelling and support steady procedure demand.
Market Limiters
Reimbursement
In many health systems, reimbursement for men’s reproductive health devices is limited or inconsistent. In low cost markets and in some public payer systems, budgets for erectile dysfunction surgery are constrained, which restricts access to inflatable implants in particular. Where patients must pay a large portion of costs out of pocket, many choose to continue with drug therapy or non-surgical options rather than pursue surgery.
Even in higher income countries, hospital budgets and payer policies may favor less costly treatments. This creates regional variability in implant uptake and caps overall market penetration, despite high satisfaction among treated patients.
Alternative Treatment Options
Drug therapy for erectile dysfunction is usually the recommended first-line treatment, since it is non-invasive and widely available. For the majority of patients, oral medications provide adequate function. Success rates of around 70 to 80 percent significantly reduce the pool of men who proceed to surgical implants.
When drug therapy fails, vacuum erection devices and other non-surgical options can still provide benefit for some patients. These devices are generally cheaper and do not require permanent implantation. As long as they remain acceptable and effective for a share of the population, they limit the size of the addressable market for penile prostheses.
Price Pressure
The men’s reproductive health device market is highly concentrated, with two major manufacturers competing for most global share. In recent years, competitive tenders, contract negotiations and value analysis processes have increased pressure on pricing. Hospitals and procurement groups often compare device systems side by side and negotiate discounts, which has led to gradual declines in ASPs.
At the same time, payers are sensitive to overall episode cost for ED treatment. As more providers seek to demonstrate value and reduce per-procedure spend, manufacturers have limited room to raise prices, even when offering product improvements. This pricing environment slows revenue growth in mature regions and encourages providers to scrutinize case selection more closely.
Market Coverage and Data Scope
This report provides quantitative and qualitative coverage of the global men’s reproductive health device market, with historical data from 2022 to 2024, a 2024 base year and forecasts through 2032. The analysis measures unit sales, ASPs, market values, market shares and growth rates by device type and region.
Quantitative coverage includes:
Market size and growth by year
Market shares for leading competitors
Forecasts to 2032 based on procedure volumes and pricing trends
Units sold by device type
Average selling prices by region and segment
Qualitative coverage includes:
Market growth trends and demand drivers
Market limiters and reimbursement constraints
Competitive analysis and SWOT profiles for top companies
Mergers and acquisitions affecting the segment
Company profiles and product portfolios for key players
Technology developments, device recalls and regulatory updates
Disease overviews for erectile dysfunction and related comorbidities
Data sources include primary interviews with surgeons, urologists and industry executives, government and physician datasets, regulatory filings, hospital purchasing data, import and export statistics and the iData Research internal database. Triangulation of units, ASPs and procedure data is used to validate market estimates and forecasts.
Care settings covered include hospitals, specialized urology and andrology centers and private clinics that perform penile implant surgery.
Markets Covered and Segmentation
The scope of this report is limited to device based treatments for erectile dysfunction in the form of surgical implants. It does not quantify revenues from oral drug therapy, vacuum erection devices or other non-surgical products.
The global men’s reproductive health device market is segmented as follows:
Men’s reproductive health devices
Inflatable erectile dysfunction devices
Malleable erectile dysfunction devices
Within these two categories, the report analyzes unit sales and market value by:
Device type and configuration
Primary indication (for example, vasculogenic ED, neurogenic ED, diabetes related ED) where data is available
Replacement versus first-time implantation
Major geographic regions
This segmentation structure allows readers to distinguish between the higher value inflatable segment and the simpler malleable segment, and to understand how procedure patterns and reimbursement environments influence device mix over time.
Competitive Analysis
Boston Scientific was the leading competitor in the men’s reproductive health device market in 2024. The company offers a broad line of penile implant devices, including the AMS 700 MS series of three piece inflatable systems and the AMS Ambicor two piece inflatable system, along with other configurations tailored to different patient needs. Boston Scientific’s strong position reflects its acquisition of American Medical Systems (AMS) in 2018, which brought a long history of product design, clinical data and surgeon familiarity into its portfolio.
Coloplast was the second leading competitor in 2024. The company markets the Titan line of inflatable penile prostheses and a range of malleable implants. Coloplast’s products are recognized for robust mechanical performance and a strong service and training infrastructure that supports implanting surgeons. The company competes directly with Boston Scientific for tenders and hospital contracts in many major markets.
Rigicon has emerged as a newer entrant and gained a modest share of the total market with its Rigi10 malleable and Infla10 inflatable prosthesis lines. By focusing on specific geographic niches and partnering with local distributors, Rigicon is positioning itself as an alternative supplier in regions where market penetration of the two main incumbents has room to grow.
Together, these companies shape pricing, innovation and training in the segment. The high level of technical and clinical expertise required to develop and support penile implants creates a barrier to entry, which helps maintain a concentrated competitive environment while still leaving limited space for emerging players that can differentiate on service, training or regional focus.
Technology and Practice Trends
Several technology and practice trends are influencing the men’s reproductive health device market. On the device side, manufacturers continue to refine materials, coatings and mechanical designs to reduce complications such as infection, mechanical failure and patient discomfort. Improvements in pump design, reservoir placement options and cylinder geometry aim to provide more natural function and appearance while simplifying surgical implantation.
Infection prevention remains a key focus, since revision procedures due to infection are costly and distressing for patients. Antimicrobial coatings, refined surgical protocols and standardized perioperative care pathways are helping to lower infection rates and improve implant longevity.
From a practice perspective, there is a gradual shift toward streamlined patient pathways that integrate counseling, shared decision making and realistic expectation setting before surgery. As digital health tools and telemedicine become more common, preoperative and postoperative follow up can sometimes be managed remotely, which improves access for men who live far from specialist centers.
Training programs and proctoring are also important trends. Because penile implant surgery is highly specialized, manufacturers provide education and hands on training courses to help new surgeons enter the field and to keep experienced surgeons updated on technique refinements. These programs support safe adoption of newer device generations and can influence brand loyalty and product selection.
Geography
This report provides global coverage across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.
Why This Report
Use this report to answer key strategic questions such as:
What is the current global market size for men’s reproductive health devices and which regions and device types are expected to grow fastest through 2032?
How do trends in diabetes, neurological disease and aging populations translate into long term demand for penile implants?
How much of the erectile dysfunction treatment pathway is captured by surgical devices versus drug therapy and non-surgical options, and how might this mix change over time?
Which competitors hold the largest shares of the inflatable and malleable segments and how are new entrants positioning themselves?
What technology and practice trends, including infection prevention measures, design improvements and training programs, are shaping clinician and patient preferences?
How do reimbursement constraints, price pressure and alternative treatment options limit market penetration, and where are the best opportunities to expand access?
In which regions is there the greatest gap between ED prevalence and implant procedure volumes, indicating potential for targeted marketing, education and partnership strategies?
Commercial, marketing, strategy and investment teams can use these insights to size opportunities, refine product roadmaps, tailor training and education programs and build evidence based value propositions for payers and providers.
About iData Research
iData Research is a premium market intelligence firm headquartered in Canada with offices across North America and Europe.
Over the last 20 years, the company has specialized in device-level sizing, procedure models, pricing trends, and competitive share across MedTech.
Since 2005, iData has supported global OEMs, mid-market innovators, and investors with triangulated data based on units and ASPs, with country-level forecasts and analyst access across Europe, North America, Latin America, the Middle East, Africa, and APAC.
Reports are available with flexible licensing to fit commercial, strategy, and investment workflows.
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