Women Health Devices Market Report

Women Health Devices Market Overview

The Women Health Devices Market encompasses a broad range of technologies aimed at enhancing female-specific health outcomes. In 2024, over 1.3 billion women globally fell within the reproductive age bracket of 15-49 years, representing a key demographic driving the demand for women's health technologies. The market includes devices for diagnostics, monitoring, contraception, reproductive health, bone density evaluation, and menopausal symptom management. For example, more than 100 million intrauterine devices (IUDs) are in active use globally, illustrating the scale of contraceptive device adoption. Wearable fertility trackers, such as ovulation predictors and basal temperature monitors, reached sales of over 15 million units worldwide in 2023. Breast imaging systems saw a global installation base of approximately 85,000 units in clinical use, driven by screening programs across over 60 countries

Key Findings

Top Driver reason: Rising prevalence of reproductive health disorders and increasing screening rates for breast and cervical cancer.

Top Country/Region: The United States accounted for over 30% of the global women health devices demand in 2023.

Top Segment: Pregnancy and maternal care devices accounted for the highest utilization rate, covering over 60 million prenatal procedures annually.

Women Health Devices Market Trends

The Women Health Devices Market has witnessed a transformative shift due to rapid technology integration and increased emphasis on preventive healthcare. In 2023, over 55 million women globally accessed digital fertility and ovulation tracking tools, with the Asia-Pacific region contributing 40% of that demand. Mobile-based monitoring apps for menstrual health recorded 180 million downloads worldwide by mid-2024. Trends in wearable health devices specifically designed for women, such as smart bras embedded with biosensors and ovulation-detecting wristbands, show accelerated adoption. Over 10 million units of such wearable health monitors were shipped globally in 2023, with North America and Western Europe leading the charge.

Telemedicine integration in gynecological and obstetric care is another prominent trend. Remote consultations for prenatal care increased by 320% between 2020 and 2023, with 70% of consultations now incorporating at-home diagnostic devices such as fetal dopplers and blood pressure monitors. Femtech startups raised over 2,000 patents between 2022 and 2024, focusing on AI-powered menstrual health tracking, endometriosis management, and menopause care.

In diagnostic imaging, automated breast ultrasound systems (ABUS) expanded their footprint in 45 countries, with installations rising by 25% in hospitals and diagnostic centers. Digital mammography also saw an uptick, with over 1.5 billion scans conducted globally in 2023. Furthermore, osteoporosis detection via portable bone densitometers is expanding in middle-income countries, with more than 75,000 units sold in 2023.

Women Health Devices Market Dynamics

DRIVER

Increased demand for personalized and preventive healthcare in women.

Women-specific wearable tech and digital diagnostics have emerged as major drivers in this market. In 2023, over 50% of women aged 20–40 used at least one digital health tool targeting menstrual or fertility tracking. Governments in more than 80 countries have introduced national campaigns for breast and cervical cancer screening, increasing the use of mammography and colposcopy by 28% from 2021 to 2023. Clinical guidelines across the US, UK, and Japan now mandate early screening for osteoporosis, prompting a 33% growth in diagnostic device usage. These initiatives, paired with increased health literacy among women, are propelling demand for early detection and home-use diagnostic tools.

RESTRAINT

Limited accessibility and affordability in low-income regions.

Although the demand is growing, a key restraint is the affordability and lack of infrastructure in low- and middle-income countries. For example, only 20% of African nations have comprehensive breast cancer screening programs, and just 18 mammography machines are available per million women in sub-Saharan Africa. In Southeast Asia, access to minimally invasive gynecological diagnostic equipment remains under 35% in public health centers. Despite advancements, high procurement costs, import tariffs, and lack of trained personnel continue to restrict adoption in underdeveloped regions.

OPPORTUNITY

Surge in digital health platforms and AI integration.

The integration of AI and data analytics into women's health is a major opportunity. By 2024, over 500 AI algorithms specifically designed for gynecology and obstetrics had been approved globally. AI-enhanced breast cancer detection tools have demonstrated a 90% sensitivity rate, significantly higher than traditional radiology. Femtech mobile apps with real-time cycle prediction and ovulation alerts are now being used by over 120 million women globally. Companies are increasingly forming partnerships with telecom and IT providers to create end-to-end telehealth ecosystems for female care.

CHALLENGE

Regulatory hurdles and lack of standardized protocols.

Despite technological advances, regulatory complexities remain a significant challenge. For instance, more than 60 countries lack clear regulatory classification for fertility tracking wearables. In the EU, regulatory approvals for gynecological devices under MDR increased timelines by 25% post-2021. Inconsistent testing and reporting standards also hinder device interoperability and cloud-based diagnostics. Furthermore, data privacy concerns around women's digital health apps have resulted in regulatory warnings in over 12 jurisdictions globally, impacting user adoption rates and development speed.

Women Health Devices Market Segmentation

The Women Health Devices Market is segmented based on type and application. Device types include diagnostic imaging systems, wearable trackers, surgical instruments, and monitoring tools. Consumables include test kits, probes, and disposable imaging supplies. Key applications span pregnancy care, cancer diagnostics, menopause support, bone health, fertility, infectious diseases, and more. In 2023, devices accounted for nearly 70% of all market usage, particularly in diagnostic and reproductive health functions. Consumables remained essential in routine gynecological assessments, with over 600 million pregnancy test strips and over 150 million HPV test kits used globally.

By Type

Devices: Devices include imaging tools like mammography units, diagnostic aids such as hysteroscopes, surgical instruments, and wearable sensors. As of 2023, over 250,000 mammography machines and 90,000 colposcopes were in clinical use. Fertility monitors and ovulation trackers sold over 25 million units globally in 2023, especially among women aged 25–39.
Consumables: These are critical in everyday diagnostics and screening. Disposable pregnancy kits exceeded 600 million units sold in 2023, while over 200 million Pap smear slides were processed. HPV testing kits recorded a usage rise of 18%, with over 150 million tests conducted globally.

By Application

Cancer: Cancer-focused women health devices are largely used for breast and cervical cancer screening and diagnostics. In 2023, over 2.3 million women were diagnosed with breast cancer globally, prompting more than 1.5 billion mammograms worldwide. Cervical cancer screening through Pap smears and HPV testing reached over 650 million procedures in the same year. Colposcopy devices and biopsy systems were utilized in over 3 million diagnostic procedures. Nations with established screening protocols such as the U.S., UK, and Australia recorded compliance rates of over 75%, with technology adoption increasing in portable and AI-enabled diagnostics.
Osteoporosis: Women over the age of 50 represent approximately 80% of global osteoporosis diagnoses. Devices like bone densitometers performed over 80 million scans in 2023. Portable dual-energy X-ray absorptiometry (DXA) machines were responsible for 65% of total scans globally, especially in post-menopausal women. High-incidence regions such as Japan and Northern Europe contributed to over 40 million scans annually. Government-backed early detection programs in countries like Germany and South Korea enabled nationwide coverage exceeding 60% in women aged 55+. Screening and monitoring devices now include smartphone-linked scanning tools that are gaining popularity among urban populations.
Infectious Disease: Women’s health devices are crucial for diagnosing sexually transmitted infections (STIs), especially HPV, chlamydia, and gonorrhea. More than 150 million HPV tests were conducted globally in 2023, supported by over 100 national screening programs. Vaginal swab test kits for bacterial vaginosis and yeast infections saw usage in 85 million procedures worldwide. The availability of rapid diagnostics, including point-of-care kits with results in under 15 minutes, is expanding. Sub-Saharan Africa and parts of Southeast Asia reported over 40 million STI diagnostic procedures facilitated by NGO-led device distribution programs.
Uterine Fibroids: Globally, approximately 17 million women were diagnosed with uterine fibroids in 2023. Devices such as ultrasound systems, MRI machines, and hysteroscopic surgical tools were used in over 6 million fibroid treatment procedures. Non-invasive imaging through transvaginal ultrasound accounted for 60% of diagnostic use. In the U.S. alone, over 600,000 women underwent fibroid removal surgeries using advanced electrosurgical and minimally invasive devices. High adoption of laparoscopic treatment tools is notable in Western Europe, with Germany reporting over 250,000 procedures annually.
Post-menopausal Syndrome: Devices targeting post-menopausal syndrome help manage symptoms like hot flashes, bone density loss, and urinary incontinence. In 2023, over 48 million women globally used some form of device-based support, including hormone therapy delivery systems, bladder control devices, and thermoregulation wearables. Urinary incontinence devices, such as electrical stimulation systems and pessaries, were prescribed in 12 million cases worldwide. Wearable trackers for hot flashes that link to mobile apps were adopted by over 400,000 women, with North America accounting for nearly 70% of these users.
Pregnancy: Over 130 million pregnancies were supported by women health devices in 2023. These included fetal dopplers, blood pressure monitors, glucose meters, and wearable maternal trackers. More than 30 million fetal monitoring devices were used globally, with 12 million deployed in Asia-Pacific alone. Ultrasound scans exceeded 500 million procedures worldwide during pregnancy-related checkups. Telemedicine-compatible pregnancy kits are gaining traction, especially in rural areas, where over 15 million virtual prenatal sessions were conducted using device integration in 2023.
Female Sterilization: Female sterilization remains a widely utilized contraceptive method, with over 21 million procedures performed globally in 2023. Laparoscopic sterilization tools were used in more than 70% of these cases, particularly in India, China, and parts of Africa. Non-invasive sterilization methods, such as hysteroscopic systems, are gaining popularity, especially in Europe, which saw a 17% increase in such procedures between 2021 and 2023. Devices for post-sterilization follow-up, such as imaging verification kits, were utilized in 4 million procedures.
Others: Other applications include menstruation tracking, pelvic floor rehabilitation, and general gynecological diagnostics. Digital menstruation trackers are used by over 200 million women globally. Pelvic floor stimulation devices, often recommended post-childbirth or during menopause, were prescribed to 6 million women in 2023. Basic diagnostic kits, such as speculums, pH test strips, and cervical dilation tools, supported over 300 million annual clinical assessments globally. Growth in these devices is tied to increasing awareness and digital health integration.

Women Health Devices Market Regional Outlook

North America leads the Women Health Devices Market with over 50 million diagnostic procedures annually, driven by high device adoption and widespread screening programs. Asia-Pacific follows closely, propelled by its large reproductive-age population and increasing investments in maternal and cancer care technologies.

North America

accounted for over 30% of the global market demand in 2023, with the U.S. alone conducting more than 50 million mammography screenings and over 12 million Pap smears. Breast cancer awareness initiatives and insurance-driven diagnostics contributed to over 65% device penetration in the region.

Europe

over 75% of women aged 40–69 underwent annual cervical or breast cancer screenings in 2023. Germany, France, and the UK together reported over 400,000 gynecological surgeries involving minimally invasive diagnostic tools.

Asia-Pacific

exhibited the highest growth in adoption, with over 700 million women in reproductive age. India alone used more than 100 million pregnancy testing kits, while Japan accounted for over 8 million osteoporosis screenings in 2023.

Middle East & Africa

although adoption remains low, over 12 million women accessed gynecological care devices in urban centers. Countries like UAE and South Africa are investing in localized manufacturing, with UAE importing 800,000 mammography units and fetal monitoring devices in 2023.

List of Top Women Health Devices Market Companies

Cardinal Health
Abbott Laboratories
Koninklijke Philips
CooperSurgical
Hoffmann-La Roche
Caldera Medical
GE Healthcare
Carestream Health
Hologic
Siemens
MedGyn Products
Prestige Consumer Healthcare
Medline Industries

Top Two Companies with highest share

Hologic: Operates in over 100 countries with more than 80,000 mammography devices installed globally.

GE Healthcare: Supplies imaging and maternal health devices used in over 10 million procedures annually.

Investment Analysis and Opportunities

Investment in the Women Health Devices Market has seen a substantial increase, particularly in digital health, imaging technologies, and maternal health devices. Between 2022 and 2024, venture capital funding in femtech startups surpassed USD 1.7 billion, focusing on AI-based diagnostics, wearable fertility tools, and home-based pregnancy monitoring. For instance, over 300 new companies globally introduced gynecological and maternal care devices during this period, leading to increased competition and innovation.

In 2023 alone, more than 80 strategic mergers and acquisitions were recorded in the sector, with a strong focus on companies producing non-invasive imaging equipment, disposable testing kits, and digital menstrual tracking solutions. One notable acquisition included the purchase of a digital ovulation prediction platform by a leading medical device firm, allowing it to access a user base of over 15 million women across 12 countries.

Healthcare infrastructure investments are rising in emerging economies. Governments in Latin America and Southeast Asia are allocating over USD 500 million annually to expand access to gynecological diagnostic tools, increasing the volume of devices imported and deployed in public hospitals. For example, the Philippines reported a 34% increase in diagnostic imaging centers catering to women’s health between 2022 and 2024.

Private sector investment in R&D is targeting new device formats such as AI-integrated mammography, real-time fetal monitoring systems, and tele-ultrasound tools. Over 1,200 patents were filed for women-specific wearable health solutions in 2023. The U.S. and Europe led these filings, accounting for 65% of all new applications.

Significant opportunity exists in developing countries, where over 450 million women remain underserved in terms of access to gynecological diagnostics and treatment devices. Partnerships between NGOs, local governments, and private manufacturers have led to the donation of over 2 million imaging and sterilization units to underserved communities globally.

New Product Development

Innovations in the Women Health Devices Market between 2023 and 2024 have significantly expanded the diagnostic, monitoring, and therapeutic options available to women. One major development includes the introduction of AI-powered breast density assessment tools, now deployed in over 300 hospitals across the U.S. and Europe. These tools improve diagnostic accuracy and reduce false positives by over 30%, aiding faster treatment decisions.

Portable colposcopy units with integrated digital cameras and real-time data transfer were launched in 2023, enhancing cervical cancer screening in rural clinics. These devices have already been deployed in over 25,000 centers in Africa and South Asia. The use of rechargeable lithium-ion batteries ensures continuous operation in low-resource settings.

In fertility management, a new generation of wearable ovulation trackers was introduced, capable of detecting hormonal changes through skin contact sensors. Over 3 million units were sold globally in the first year of launch, with notable uptake in Europe and Latin America. These devices synchronize with smartphone apps to generate personalized fertility forecasts.

Another breakthrough was the development of smart pelvic floor therapy devices. Designed for use during postpartum recovery, these gadgets help women perform Kegel exercises with feedback via a mobile app. More than 200,000 units were distributed through clinical partnerships in the U.S. during 2023.

In prenatal monitoring, advanced fetal dopplers with AI-powered anomaly detection capabilities were launched in 2024. These devices use pattern recognition to flag potential complications, with an early adoption rate of 15,000 units within 6 months in Japan and South Korea.

Five Recent Developments

Hologic: launched a 3D digital mammography unit with AI-enhanced image reconstruction, now used in over 5,000 diagnostic centers worldwide.
GE Healthcare: introduced a cloud-integrated fetal monitoring system that tracks fetal heart rate and maternal vitals in real-time, with over 25,000 units deployed globally by 2024.
Abbott Laboratories: released a rapid HPV detection kit in 2023, which delivers results in under 12 minutes and was adopted by 60 national screening programs.
Philips: rolled out wearable menopause symptom trackers in 2024, adopted by 450,000 users in Europe and North America within 9 months of launch.
MedGyn: Products developed a portable colposcope with 5x digital zoom and remote diagnosis capability, now in use in 18,000 rural clinics globally.

Report Coverage of Women Health Devices Market

This report offers comprehensive coverage of the global Women Health Devices Market, analyzing technological trends, product adoption, regional performance, segmentation, competitive landscape, and investment flows. The market is evaluated across multiple device types such as diagnostic imaging systems, surgical tools, wearables, and monitoring instruments, as well as consumables like test kits and disposables used in gynecological exams.

The report includes detailed segmentation based on application areas such as cancer detection, pregnancy care, menopausal symptom management, osteoporosis screening, infectious disease diagnostics, and sterilization. As of 2023, over 130 million pregnancy-related medical procedures utilized various monitoring devices, while 2.3 million new breast cancer cases worldwide led to over 1.5 billion imaging tests using advanced diagnostics.

Regional analysis spans North America, Europe, Asia-Pacific, and the Middle East & Africa, with in-depth data on population health, diagnostic access, device penetration, and public-private partnerships. The report identifies North America as the largest consumer of women health devices, with over 50 million screenings conducted annually. Meanwhile, Asia-Pacific showed the highest growth momentum with over 700 million reproductive-age women driving the demand for wearable and at-home diagnostic solutions.

Competitive analysis in the report highlights profiles of major manufacturers such as Hologic, GE Healthcare, Abbott, Philips, and Siemens. It details product offerings, technological advancements, geographical presence, and clinical partnerships. For instance, Hologic’s mammography and biopsy solutions account for a significant share of imaging procedures globally, with installations in over 100 countries.