US Women’s Health Diagnostic Market Size Likely to Grow at a CAGR of 5.92% By 2034

Market Size and Growth

The US Women’s Health Diagnostic Market size 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

An expert from CMI anticipates further gains within the United States Women’s Health Diagnostic space, driven by increased advancement and adoption of digital health technologies, AI-enabled diagnostics, and new at-home testing options. The increase in women’s awareness of preventative healthcare and trends toward personalized medicine encourages women to obtain early and accurate diagnostics, increasing the demand for diagnostics in the key segments, including breast cancer, fertility, osteoporosis, and infectious disease testing.

Strategic alliances between healthcare providers, diagnostic companies, and technology companies are increasing the innovation, accessibility, and affordability of new, advanced solutions. Additionally, regulatory reforms and reimbursement policies are facilitating widespread adoption at a rapid pace. Movement towards addressing women’s health needs overall and advancing connected diagnostics is expected to attract significant institutional investment while driving long-term consultant and consultancy growth across the segments.

Key Trends & Drivers

• Increasing Awareness Campaigns: Government agencies, NGOs, and healthcare providers are raising awareness for women’s health through awareness campaigns related to breast cancer, sexually transmittable diseases (STDs), fertility, and preventive care. This widening awareness is leading to heightened diagnosis and regular health check-ups and providing a significant contribution to market growth.

• Shift to Personalized Medicine: The interest in personalized and precision medicine is increasing with awareness across genomics, biomarkers, and enabled AI, pursued by revolutionizing the accuracy of diagnoses. There is also a desire in women for independent and tailored solutions for reproductive health, cancer, and chronic conditions, creating channels and new ideas for automated diagnostic products for diagnostics.

• Diversity in Insurance Coverage: An expansion in insurance coverage for women’s health diagnostics, especially for preventive screenings and fertility testing for women, with additional items being added in coverage, is reducing financial barriers and will encourage more individuals and more diverse demographics, in particular, to adopt the testing and eventually improve access and affordability.

• Increasing Burden of Lifestyle Diseases: The demographics and lifestyle changes and delaying motherhood contributed to the increase in infertility issues also, changing demographics that are prone to PCOS and even osteoporosis issues are increasing, and the need to have diagnostic monitoring solutions to assist women at the time of illness is increasing for testing solutions whose growing demand leads to advanced and modern testing to follow health and wellbeing.

• AI and Digital Platforms: Innovative tools or AI-driven platforms to offer input more rapidly and resolution of image interpretation, predictive analytics, and remote diagnostics for efficiency and accuracy, which will reduce time and delay in diagnosis in women’s access to timely healthcare scenarios.

Report Scope

SWOT Analysis

• Strengths: The US Women Health Diagnostic market has current and advanced health care infrastructure, strong diagnostic market leaders with long global diagnostic market experience, and a commitment to AI-based platforms that adequately connect diagnostic test providers to evidence of their diagnostic test claims to end-users. Increasing awareness around preventive health care and health awareness as a whole, combined with insurance coverage to access diagnostic testing for women, is allowing smoother and better access to diagnostic testing. Furthermore, the amount of capital invested in R&D is supporting continued innovation in both tests and devices.

• Weaknesses: While there is progress being made in the market, the costs for diagnostics are still too high for uninsured or low-income people to afford. Regionally, there is an ongoing inability to access specialty facilities, and rural areas are facing difficulties accessing the right care at the right time and at the right price. Additionally, the regulatory structure has been quite fragmented, but there has been difficulty expanding to the market for diagnostic testing-related products with no timely approvals from reimbursement stakeholders who may be constrained by payors.

• Opportunities: One primary opportunity is the increased rate of breast cancer, osteoporosis, issues of infertility, sexually transmitted diseases, and the development of new home-testing diagnostics that meet the consumer need for privacy and convenience to get the diagnostics. Generally, there is likely an acceleration of digital health and use of digital devices and telehealth platforms, and the possibility of creating more personalized care based on diagnostic testing, a combination of a diagnostic test with clinical healthcare providers would considerably increase reach and scale.

• Threats: With the self-testing typically on a digital platform, privacy of the data may create a long-term risk to the organization’s continued likelihood of incorrectly interpreting results. The threat of limited players has created competition that will limit margins. Regulatory approval and reimbursement approval take a long time or never happen, which can delay the launch of a new product. A downturn in the economy can reduce discretionary costs for health services and also cause patients to decline the payment of a diagnostic test if it is not deemed a necessity.

List of the prominent players in the US Women’s Health Diagnostic Market:

• 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

The US Women’s 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