US Women Health Diagnostic Market 2025 – 2034

Reports Description

The US Women’s Health Diagnostic Market is forecast to grow at a CAGR of 5.92% from 2025 to 2034. The market is expected to reach USD 5.21 Billion by 2034, up from USD 3.02 Billion in 2025.

Overview

The US Women’s Health Diagnostic Market is expected to experience consistent growth due to the increasing prevalence of chronic and reproductive health conditions, progress in diagnostic technologies, more consumer knowledge surrounding the importance of preventive care, and increasing demand for hospital, clinic, and at-home testing products across the country.

Key Trends & Drivers

The US Women’s Health Diagnostic Market Trends have tremendous growth opportunities due to several reasons:

• Increasing Rate of Women-Specific Disorders: The increasing rate of breast cancer, cervical cancer, polycystic ovary syndrome (PCOS), and other reproductive health-related diseases is driving demand for advanced diagnostic techniques. There is demand for greater tools for early detection, since if women receive interventions sooner, there will be increased treatment efficacy, keeping the market growth and adoption going in hospitals, diagnostic centres, and home-test kits.

• Increasing Awareness in Preventive Health: Women are taking a more active role in health management, aided by public health campaigns and by educational tools. Increased uptake of preventive diagnostic screenings for osteoporosis, prenatal health, and other reproductive health issues increases not just the number of diagnostic tests undertaken but also enables innovations across a wider range of diagnostic experiences suited to patients.

• Increasing advancements in diagnostics: AI-supported imaging diagnostics, molecular diagnostics, and next-generation sequencing are changing women’s health diagnostics. They are allowing for increased accuracy, thereby decreasing turnaround time to diagnosis and establishing personalized treatment paths. There is even greater accessibility of diagnostic experiences as a wider range of options are being digitalized and via telehealth. From this, there is an even greater expanse of options and increased adoption of diagnostic experiences for women in both urban and rural populations.

• Proliferation of At-Home Testing Tools: At-home diagnostic kits for women’s health—fertility, hormone testing, and early cancer detection—are becoming increasingly popular. Consumers are drawn to home diagnostic products for their convenience, privacy, and instant results; trends suggest that these products are especially appealing to a younger population. A shift to self-monitoring, primarily through easy-to-use home tests, is changing the landscape for health care and creating a wealth of opportunity for both new entrants and digital health innovators.

• Favorable Regulatory Contexts and Policies: The U.S. government, alongside regulatory agencies, has prioritized initiatives bearing on women’s health by providing grants and approvals for novel diagnostic tools. Legislative policies that support screening for cancer, monitoring for maternal health, and supporting innovations for digital health technologies will encourage other industry players to invest. Favorable context creates an environment for innovation and accelerates market uptake across a number of spaces.

• Investment and Partnerships Year Over Year: Pharmaceutical, diagnostics, and medtech companies are entering partnership agreements to create integrated products and solutions for women’s health. Venture capital investments into female tech start-ups have increased substantially to scale novel diagnostic technologies quickly. Partnerships for diagnostic delivery model development between health care systems and tech companies further bolster the opportunity for a particularly favorable growth potential in the overall market.

Key Threats

The US Women’s Health Diagnostic Market has a number of primary threats that will influence its profitability and future development. Some of the threats are:

• Expensive Diagnostics and Limited Reimbursement: In many cases, expensive advanced diagnostics, coupled with exacerbating reimbursement processes, are the biggest obstruction to market opportunity and acceptance with consumers, particularly in health promotion/harm and early diagnostics.

• Data Privacy and Cybersecurity Issues: The emergence of new digital platforms and home diagnostics has also led to concerns of sensitive health data being in jeopardy of breach, especially regarding privacy and regulatory compliance for diagnostic organisations pushing innovation into the market and for consumers’ trust and security.

• Regulations and Approvals: While regulations and approvals are important to the health of the public, FDA regulations on diagnostics are expensive, time-consuming, and comprehensive and may stifle the commercialisation of new innovative diagnostics. Other new entrants, especially females in femtech, are also likely to be dissuaded from innovation and market growth.

Category Wise Insights

By Type

• Diagnostic Devices: These are imaging devices, mammography systems, and bone densitometers that are fundamental for initial diagnosis and continual evaluation for women’s health issues. Technology continues to drive growth, with specific examples being AI-enabled imaging, which will add efficiencies and improve accuracy to diagnostic practice.

• Diagnostic Tests (Largest Market Share): Diagnostic tests have the largest market share, as they are the most prevalent type of diagnostic, being both the least invasive and the most conventional diagnostic approach for women’s health issues, including breast cancer, fertility, and infectious diseases. There is a wide assortment of diagnostic tests, as they are the most common diagnostic type.

By Application

• Breast Cancer (Dominant Segment): The breast cancer market is dominant because breast cancer is highly prevalent among women, and readily available mammography, MRI, and genetic testing are becoming widely used. Increased awareness campaigns and government-sponsored breast screening programs continue to increase demand for innovative tools to detect breast cancer early.

• Infectious Disease Testing: Women are well known to be highly susceptible to the same infectious diseases seen in men (HPV, HIV, UTIs) as well as several diseases that tend to impact women more significantly than men, resulting in a high need for their testing. Though the pandemic experienced increases in incidence of reversible conditions in women’s health, the demand for improved, rapid, point-of-care tests is increasing as concerns for reproductive health and preventive options rise in hospitals and at home.

• Osteoporosis Testing: As world populations age, it is not surprising that osteoporosis is becoming a point of interest for women’s health societies due to osteoporosis being more prevalent in post-menopausal women. Bone density and imaging tests are needed for early interventions to reduce fracture risk, and therefore, demand for osteoporosis diagnostics is expected to stay consistent.

• Pregnancy & Fertility Testing: Pregnancy and fertility tests represent the fastest growing segment of the women’s health diagnostic marketplace because, with increasing fertility concerns, delayed pregnancies, and relatively low demand for hospital equivalent urine and blood diagnostic tests, women’s adoption of home test kits is developing into a more standardized approach to manage pregnancy/delivery needs as ovulation kits, fertility monitors, and prenatal screenings become available and take their standard positions in women’s health improvement and management comfortability.

• Sexually Transmitted Disease (STD): The presence of STDs like HPV, chlamydia, and gonorrhea emphasizes the importance of this segment. An increase in awareness of conditions, favorable access to testing options, and an increase in the popularity of home STD tests are all driving growth in this market.

• Other: This segment includes diagnostics for gynecological diseases, hormonal disorders, and cardiovascular screening that is specific to women. This segment is expected to gain momentum as personalized medicine and preventative care make headway through health care systems.

Report Scope

Regional Perspective

The US Women Health Diagnostic Market presents a varied regional outlook, shaped by healthcare infrastructure, demographic developments, and policy support. The Northeast region is leading as a result of its high concentration of advanced medical institutions, extensive insurance coverage, and adoption of new diagnostic technologies, including AI-powered imaging and genetic testing. The Midwest market is fueled by its large aging population and high level of need for services such as mammographies and osteoporosis testing due to large rates of osteoporosis and breast cancer. The South has a large amount of potential on its own and is supported by more growing investments in healthcare, along with awareness around fertility and increases in postpartum and infectious disease testing. The South still faces barriers – principally around access to care due to rural populations, which may not benefit as readily from access to early diagnosis by a healthcare professional.

The West, especially parts of California, is emerging as a growth engine more so than anything else, due to the strong uptake of home-based diagnostics, telehealth platforms, and integration of digital health solutions into care. The markets are supported by regulatory approval, with investment in women-centric start-up companies aiding growth as well. Overall, it remains uneven, and while the Northeast and West dominate innovation, the opportunities lie in both the Midwest and, especially, the South and seeing accessible and affordable women’s health diagnostics grow in urban and semi-urban centers where demand is increasingly rising.

Key Developments

• First Ever at-home Cervical Cancer Screening Test Receives FDA Approval – Teal Health (May 9, 2025): Teal Health’s Teal Wand has received FDA approval, making it the first home testing option for cervical cancer screening. The kit allows women aged 25-65 to self-collect vaginal samples to test for HPV, providing women with a private and convenient option if they do not want to/can’t attend an in-clinic Pap smear. The company is reaching out to major insurers to ensure optimal pricing for women. The testing kit is tentatively expected to launch nationally in June 2025.

• New Insurance Backed Longevity Care Program Launches – Midi (May 2025): Midi, a telehealth platform focused on health, launched AgeWell, an insurance-backed longevity care program that provides seniors with access to annual diagnostics, bloodwork, hormone therapy, and screenings without a membership fee. The program aims to expand preventive health access for women across the US as they approach midlife and beyond.

• $10M Federal Grant in Development of Blood Test to Detect Endometriosis – Aspira Women’s Health (Apr 2025): Aspira Women’s Health recently announced they received a $10M ARPA-H Sprint for Women’s Health grant to develop a blood-based, non-invasive test for early detection of endometriosis. Additionally, the test is expected to reduce diagnostic delay and usage of multi-omics and AI to increase the speed at which results can be processed; a delayed diagnosis can affect millions of women each year.

Leading Players

The US Women’s Health Diagnostic Market is highly competitive, with a large number of product providers in Malaysia. Some of the key players in the market include:

• Redcliffe Labs
• Wisp
• Covera Health
• Roche Diagnostics
• Hologic Inc.
• Siemens Healthineers
• Quest Diagnostics
• Abbott Laboratories
• BioMérieux SA
• BD (Becton Dickinson and Company)
• Danaher Corporation
• Thermo Fisher Scientific Inc.
• Fujifilm Holdings Corporation
• Koninklijke Philips N.V.
• Cardinal Health
• Others

These firms apply a sequence of strategies to enter the market, including innovations, mergers, and acquisitions, as well as collaboration.

The US Women Health Diagnostic Market is segmented as follows:

By Type

• Diagnostic Devices
• Diagnostic Tests

By Application

• Breast Cancer
• Infectious Disease Testing
• Osteoporosis Testing
• Pregnancy & Fertility Testing
• Sexually Transmitted Disease (STD) Testing
• Others

By End User

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