Women’s Health Diagnostics Market Size, Share, Growth, Trends, and Global Industry Analysis: By Type (Diagnostic Devices, and Diagnostic Tests), By Applications (Breast Cancer, Infectious Disease Testing, Osteoporosis Testing, Pregnancy and Fertility Testing, Sexually Transmitted Disease Testing, and Others), By End User (Hospital, Clinics, Home Care Settings, and Others) and Region Forecast 2020-2031

Women’s Health Diagnostics Market size was valued at US$ 6,480 million in 2024 and is expected to reach US$ 9,120 million by 2031, growing at a significant CAGR of 5.2% from 2025-2031. Moreover, the U.S. Women’s Health Diagnostics Market is projected to grow significantly, reaching an estimated value of US$ 2,940 million by 2031, driven by rising awareness of preventive care, growing access to diagnostic services, and technological advancements in women-specific testing.

The space of women's health diagnosis is no longer medicine's quiet corner it is changing fast as the wellspring of policy focus, consumer-driven demand, and innovation. Past beneficiaries of broad diagnostic umbrellas and largely ignored in the past, women's health has become a vertical market in its own right, driven by increasing appreciation for gender-specific pathophysiology and desire for integrated care. From initial diagnosis of cervical cancers and reproductive disease through to sophisticated screening technology for osteoporosis and PCOS, the market indicates a shift towards precision diagnosis. The merging of biomarker science, digital health integration, and direct-to-consumer testing has transformed how, when, and where women interact with diagnostics.

This change is not only scientific; it is profoundly socio-economic. Growing healthcare awareness, shifting reproductive patterns, and rising maternal age in high-growth areas have generated new demands for steady, affordable, and timely diagnosis in women. Additionally, infusion of AI into imaging, fertility-tracking platforms, and rising regulatory interest in female-centered clinical trials are all evidentiary of a technology-disruptive market change precipitated by an ethically required change. As healthcare systems move towards preventive, not merely reactive, measures, the women's health diagnostics market is to reap from sustained demand and policy actions across geographies such as breast health, prenatal screening, and management of chronic disease throughout the woman's lifecycle.

Facts & Figures

• More than 230 million girls and women have been cut in 30 countries in Africa, Asia, and the Middle East where FGM continues to be practiced.
• FGM is most often performed on young girls between infancy and age 15 and is considered a severe abuse of human rights. The overall annual worldwide cost of FGM complications is estimated at US$ 1.4 billion, and this is also likely to grow unabated unless immediate action is taken.
• In 2023, the world adolescent birth rate among girls aged 10-14 years was estimated at 1.5 per 1,000 girls, much higher in sub-Saharan Africa at 4.4 and Latin America & the Caribbean at 2.3.
• Control of teen pregnancy and mother health is one of the most important pathways toward better women's health results and achieving the most urgent Sustainable Development Goals (SDGs).
• There will be approximately 69,120 U.S. uterine cancer women by 2025, demonstrating the need for more early and precise diagnostics.
• The breast cancer fatality rate in the United States has decreased from 31.9 (1950) to 18.7 per 100,000 in 2022, reflecting increased early detection and treatment

Key Developments:

• In May 2025, India's first women's preventive healthcare-specific diagnostic platform, Femcliffe, was launched by Redcliffe Labs of India. The effort is helping to tackle diagnosis delays, indicated by 50% of women, for caregiving duties. Femcliffe offers lifecycle-directed packages of diagnostics for hormonal, reproductive, and bone health with home sample collection and digital assistance for online bookings available through Redcliffe's PAN-India network.
• In May 2025, Wisp (U.S.), a leading telehealth women's health company, launched its At-Home Testing & Follow-Up Care vertical in May 2025, expanding to include diagnostic services. This delivers greater than 1.5 million users access to self-collection test kits and care delivered remotely, lowering barriers to sexual and reproductive health diagnostics for women.
• In April 2025, Covera Health (U.S.) introduced Protect Her in April 2025, an AI-powered radiology platform for early detection of women's health diseases like breast cancer, cardiovascular disease, and osteoporosis. Integrated into routine scans (e.g., mammograms, CTs), the system enables asymptomatic detection, making timely intervention and proactive woman-centered care possible.

Women’s Health Diagnostics Market Segmentation:

Based on the type:

• Diagnostic Devices
• Biopsy Device
• Imaging and Monitoring Devices
• Accessories and Consumables
• Diagnostic Tests
• Breast Cancer Testing
• PAP Smear and HPV Test
• Pregnancy Testing and Ovulation Testing
• Others

Amongst the diagnostic modalities, breast cancer testing is still the clinically and commercially biggest in the women's health space. Leadership is based on global burden of disease, since breast cancer is the most common cancer in women worldwide. Routine mammography, testing for the BRCA gene, and the development of molecular assays have evolved from detection to risk stratification and customized treatment avenues. The widespread institutionalization of screening programs in developed and emerging economies—along with growing awareness campaigns and workplace screening programs—has taken this test out of the clinic and into the mainstream of public health. With innovation marching toward minimally invasive testing and artificial intelligence-based diagnostics, breast cancer testing is still the standard of the pace and trajectory of the broader diagnostics market.

Based on the Application:

• Breast Cancer
• Infectious Disease Testing
• Osteoporosis Testing
• Pregnancy and Fertility Testing
• Sexually Transmitted Disease Testing
• Others

Pregnancy and fertility testing is a high-interactive, high-volume market with both clinical significance as well as consumer-generated vitality. With increasing women delaying childbearing for career and lifestyle factors, fertility monitoring technologies like ovulation predictor kits, AMH tests, and luteinizing hormone detection have come into the core of individual health planning. Concurrently, at-home early pregnancy testing with rapid test kits is still the queen of clinical testing due to its convenience, affordability, and emotionally unmediated path. Together with mobile applications tracking cycle and hormone patterns, the diagnostic experience has also become more personalized. The app space is built on repeated use, emotional engagement, and technological support, hence becoming a commercially and socially responsible place to be.

Based on the end user:

• Hospitals & Clinics
• Diagnostic and Imaging Centers
• Home Care Settings
• Others

Clinics and hospitals continue to be the cornerstone of women's health diagnostic services, particularly for intricate, high-risk, or multi-stage diagnostic procedures. These are facilities with an integrated environment where specialist services, imaging capabilities, and laboratory space can come together to deliver comprehensive care. From the management of abnormal PAP smears, breast cancer staging, or biopsies, hospitals possess the clinical infrastructure and capabilities required for quality diagnostics. The availability of multidisciplinary team presentations also makes possible shortened diagnosis-to-treatment times—necessary in diseases such as cervical or ovarian cancer. Second, hospitals have reimbursement policies and governmental program affiliations that make them the choice of most women who undergo diagnostic tests in urban and semi-urban areas.