발기부전 디바이스 시장의 평가 : 디바이스 유형별, 연령층별, 원인별, 지역별 기회 및 예측(2017-2031년)

Global erectile dysfunction device market is projected to witness a CAGR of 9.28% during the forecast period 2024-2031, growing from USD 1.65 billion in 2023 to USD 3.19 billion in 2031. With the increasing prevalence of erectile dysfunction, lifestyle disorders, and technological advancements, the global erectile dysfunction device market is expected to expand at a fast pace in the forecast period.

Erectile dysfunction (ED) can be treated with various devices when medications are not effective. ED devices are used to help men achieve and maintain an erection sufficient for sexual intercourse. The most common type is the vacuum erection device, which consists of a plastic cylinder placed over the penis, a pump to create suction, and a constriction ring to maintain the erection. For men who dislike the lack of spontaneity with vacuum devices, penile prostheses are an option. These are mechanical implants surgically placed in the penis to create an erect state on demand. Malleable implants contain semi-rigid rods that are always firm, while inflatable implants use a pump in the scrotum to fill cylinders in the penis with fluid. Newer technologies include focused shockwave therapy, which uses acoustic pulses to break down plaques in blood vessels and stimulate new vessel growth to improve blood flow to the penis. In younger men under 40 who have had a traumatic pelvic injury affecting penile blood vessels, microsurgical penile revascularization can be performed. This procedure surgically bypasses blocked penile arteries to restore adequate blood flow needed to sustain an erection.

The increasing efforts of various medical device manufacturing companies to launch upgraded versions of their existing products and technologies to optimize results is also supporting the growth of the global erectile dysfunction device market. For instance, Ohh-Med Medical Ltd., an Israel-based men's health company, released a new application to accompany its ED wearable gadget in June 2024. Vertica, the app-assisted ED gadget, uses radiofrequency technology to gently warm and stimulate the collagen and elastin fibers in the penis. Ohh-Med has created VerticaPlus, an app that works in tandem with the gadget and offers feedback on how much the user's performance has improved.

Increasing Prevalence of Erectile Dysfunction

The increasing prevalence of ED is significantly driving the demand for ED devices. As the global population ages and lifestyle-related factors such as obesity, sedentary behavior, and chronic health conditions become more common, the incidences of ED are on the rise. Growing awareness of ED as a serious medical condition encourages more men to seek help, leading to an uptake in the utilization of devices designed to assist with achieving and maintaining erections. As per John Hopkins University, in 1995, more than 152 million men worldwide had ED. By 2025, more than 322 million male patients are expected to be suffering from ED.

Furthermore, the rising cases of ED can also be attributed to the increasing incidences of prostate cancer in various regions across the globe, as neurovascular bundle injury caused by radical prostatectomy and hormonal therapy to block testosterone bolster the frequency of ED. According to the estimates of the American Cancer Society, approximately 99,010 new cases of prostate cancer and 35,250 deaths from prostate cancer are expected to occur in the United States in 2024.

Lifestyle Disorders are Leading to Increasing Incidences of ED

Lifestyle disorders are significantly contributing to the growing prevalence of ED worldwide. Sedentary behavior, poor dietary habits, smoking, and excessive alcohol consumption are major risk factors for ED. Obesity, which is often linked to an unhealthy lifestyle, is strongly associated with ED. Studies from National Center for Biotechnology Information (NCBI) conducted in January 2024 show that up to 50% of men with ED also have obesity. Diabetes, another lifestyle-related condition, is a major cause of ED, with up to 66% of men with type 2 diabetes experiencing some degree of ED. Cardiovascular diseases, which are exacerbated by an unhealthy lifestyle, are closely tied to ED, as they can impair blood flow to the penis. As the global population becomes more sedentary and adopts an unhealthy lifestyle, the incidences of ED are expected to rise, underscoring the need for lifestyle modifications to prevent and manage this condition.

Penile Implants Dominate the Global Erectile Dysfunction Device Market

Due to the different advantages associated with penile implants, they have become a safe and effective vessel for surgically managing ED, with significant developments in technology over the last 50 years allowing for improved outcomes, functionality, and cosmesis. Studies from the National Center for Biotechnology Information (NCBI) conducted in January 2024 show patient satisfaction ratings for the latest penile implant models consistently at or above 75%. Given the aging population and increasing prevalence of ED risk factors, penile implant surgeries are expected to continue to grow in popularity as a treatment option for men with ED who have failed to receive promising results from other therapies.

North America Dominates the Global Erectile Dysfunction Device Market

North America, particularly the United States, has the highest demand for ED devices for several reasons. The condition is widespread in the region due to factors such as an aging population and lifestyle changes like the adoption of sedentary habits and increasing incidences of obesity, creating a large patient pool that drives the demand for treatment options like ED devices. North America's well-established healthcare system, along with accessibility to advanced medical technologies and favorable reimbursement policies, encourages the adoption of these devices. Many leading manufacturers of ED devices, such as Boston Scientific Corporation and Coloplast Group, have a strong presence in North America, allowing for greater availability and accessibility of these solutions. There is also growing awareness and acceptance of ED as a treatable condition in the region, with campaigns like National Impotence Day helping to educate the public and encourage men to seek treatment.

Additionally, the increasing approvals from the Food and Drug Administration (FDA) in the United States for new product launches also provide lucrative growth opportunities to the market. In November 2023, Boston Scientific Corporation received regulatory approval from the FDA for its AMS 700 inflatable penile prosthesis (IPP). The AMS 700 IPP provides a therapeutic alternative for people with ED and consists of three components and two cylinders implanted in the penis, a pump in the scrotum, and a saline reservoir in the lower belly.

Future Market Scenario (2024-2031F)

Smart Penile Implants: The development of smart penile implants that connect to mobile applications for real-time monitoring and feedback is expected to revolutionize treatment options. These devices are anticipated to provide patients with greater control and convenience in managing their condition.

Advanced Shockwave Therapy: Innovative shockwave therapy devices that enhance blood flow and improve erectile function are expected to gain popularity as a non-invasive treatment option.

Increased Awareness and Digitization: Awareness campaigns aimed at destigmatizing ED, particularly among younger men, are expected to drive more men to seek treatment. This trend is also expected to be further supported by the growing prevalence of conditions like diabetes and cardiovascular diseases that contribute to ED.

Integration of Telemedicine and Digital Health: The incorporation of telemedicine and digital health solutions is anticipated to facilitate easier access to consultations and follow-ups, making treatment more accessible for patients. This trend aligns with the increasing adoption of technology in healthcare.

Expansion of the Aging Population: The rapid expansion of the aging population in different regions is expected to bolster the requirement for ED devices in the coming years. According to the estimates from the Population Reference Bureau, the number of individuals aged 65 and over is estimated to increase to 82 million by 2050 in the United States.

Key Player Landscape and Outlook

The market is witnessing the introduction of substantial strategies such as acquisitions, increasing research and development activities, rising regulatory approvals, and novel product launches to expand the market share of the key players. In August 2023, Switzerland-based MedAlliance SA announced that the first patient had been recruited in an ED feasibility trial with their sirolimus drug-eluting balloon at the University of Rome Tor Vergata in Italy. The study's goal is to determine the feasibility and safety of angioplasty with a sirolimus-eluting balloon in patients with erectile dysfunction and distal internal pudendal and/or penile artery stenotic stenosis, with plain old balloon (POB) angioplasty serving as a comparison.

Furthermore, in June 2024, FDA cleared Himplant, a penile enhancement implant, announced its role in preserving the penile health of the patients in cases of severe trauma. The two recent cases highlighting the protective potential of the implant include an NYPD officer involved in a car accident and a man from Virginia involved in a serious motorcycle accident. Bost cases exemplified the protective qualities and robustness of the Himplant and showcased the role of the device in preserving the penile integrity in cases of extreme stress. Such introductions are expected to boost the confidence of users in the devices, providing lucrative growth opportunities to the market.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Erectile Dysfunction Device Market Outlook, 2017-2031F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Device Type
    • 4.2.1.1. Non-Surgical Devices
      • 4.2.1.1.1. Vacuum Construction Devices
      • 4.2.1.1.2. Erectile Dysfunction Shockwave Generators
      • 4.2.1.1.3. External Penile Rigidity Devices
    • 4.2.1.2. Surgical Device
    • 4.2.1.3. Penile Implant
      • 4.2.1.3.1. Inflatable Implants
      • 4.2.1.3.2. Malleable Implants
  • 4.2.2. By Age Group
    • 4.2.2.1. Less Than 40 Years
    • 4.2.2.2. 40-60 Years
    • 4.2.2.3. More Than 60 Years
  • 4.2.3. By Cause
    • 4.2.3.1. Diabetes
    • 4.2.3.2. Neurological Disorders
    • 4.2.3.3. Hypertension
    • 4.2.3.4. Others
  • 4.2.4. By Region
    • 4.2.4.1. North America
    • 4.2.4.2. Europe
    • 4.2.4.3. Asia-Pacific
    • 4.2.4.4. South America
    • 4.2.4.5. Middle East and Africa
  • 4.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2023)
• 4.3. Market Map Analysis, 2023
  • 4.3.1. By Device Type
  • 4.3.2. By Age Group
  • 4.3.3. By Cause
  • 4.3.4. By Region

5. North America Erectile Dysfunction Device Market Outlook, 2017-2031F*

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
  • 5.1.2. By Volume
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Device Type
    • 5.2.1.1. Non-Surgical Device
      • 5.2.1.1.1. Vacuum Construction Devices
      • 5.2.1.1.2. Erectile Dysfunction Shockwave Generators
      • 5.2.1.1.3. External Penile Rigidity Devices
    • 5.2.1.2. Surgical Device
    • 5.2.1.3. Penile Implants
      • 5.2.1.3.1. Inflatable Implants
      • 5.2.1.3.2. Malleable Implants
  • 5.2.2. By Age Group
    • 5.2.2.1. Less Than 40 Years
    • 5.2.2.2. 40-60 Years
    • 5.2.2.3. More Than 60 Years
  • 5.2.3. By Cause
    • 5.2.3.1. Diabetes
    • 5.2.3.2. Neurological Disorders
    • 5.2.3.3. Hypertension
    • 5.2.3.4. Others
  • 5.2.4. By Country Share
    • 5.2.4.1. United States
    • 5.2.4.2. Canada
    • 5.2.4.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Erectile Dysfunction Device Market Outlook, 2017-2031F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
      • 5.3.1.1.2. By Volume
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Device Type
        • 5.3.1.2.1.1. Non-Surgical Devices
        • 5.3.1.2.1.1.1. Vacuum Construction Devices
        • 5.3.1.2.1.1.2. Erectile Dysfunction Shockwave Generators
        • 5.3.1.2.1.1.3. External Penile Rigidity Devices
        • 5.3.1.2.1.2. Surgical Devices
        • 5.3.1.2.1.3. Penile Implants
        • 5.3.1.2.1.3.1. Inflatable Implants
        • 5.3.1.2.1.3.2. Malleable Implants
      • 5.3.1.2.2. By Age Group
        • 5.3.1.2.2.1. Less Than 40 Years
        • 5.3.1.2.2.2. 40-60 Years
        • 5.3.1.2.2.3. More Than 60 Years
      • 5.3.1.2.3. By Cause
        • 5.3.1.2.3.1. Diabetes
        • 5.3.1.2.3.2. Neurological Disorders
        • 5.3.1.2.3.3. Hypertension
        • 5.3.1.2.3.4. Others
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Erectile Dysfunction Device Market Outlook, 2017-2031F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Poland

7. Asia-Pacific Erectile Dysfunction Device Market Outlook, 2017-2031F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Erectile Dysfunction Device Market Outlook, 2017-2031F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Erectile Dysfunction Device Market Outlook, 2017-2031F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa
• 9.4. Israel

10. Demand Supply Analysis

11. Import and Export Analysis

12. Value Chain Analysis

13. Porter's Five Forces Analysis

14. PESTLE Analysis

15. Pricing Analysis

16. Market Dynamics

• 16.1. Market Drivers
• 16.2. Market Challenges

17. Market Trends and Developments

18. Regulatory Framework and Innovation

• 18.1. Clinical Trials
• 18.2. Regulatory Approvals

19. Patent Landscape

20. Case Studies

21. Competitive Landscape

• 21.1. Competition Matrix of Top 5 Market Leaders
• 21.2. SWOT Analysis for Top 5 Players
• 21.3. Key Players Landscape for Top 10 Market Players
  • 21.3.1. Boston Scientific Corporation
    • 21.3.1.1. Company Details
    • 21.3.1.2. Key Management Personnel
    • 21.3.1.3. Products and Services
    • 21.3.1.4. Financials (As Reported)
    • 21.3.1.5. Key Market Focus and Geographical Presence
    • 21.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 21.3.2. Coloplast Corporation
  • 21.3.3. Zephyr Surgical Implant Sarl
  • 21.3.4. Owen Mumford Ltd
  • 21.3.5. Augusta Medical Systems LLC
  • 21.3.6. Storz Medical AG
  • 21.3.7. Rigicon Inc
  • 21.3.8. Promedon GmbH
  • 21.3.9. Medispec Ltd
  • 21.3.10. MTS Medical UG

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

22. Strategic Recommendations

23. About Us and Disclaimer