Women’s Health Diagnostics Market Size, Share, Growth, Trends, and Global Industry Analysis: By Type (Diagnostic Device, Diagnostic Tests), By Application (Breast Cancer, Infectious Disease, Osteoporosis, STD, Other) and Region Forecast 2020-2031

Women’s Health Diagnostics Market size was valued at US$ 26,712.3 million in 2024 and is projected to reach US$ 44,434.5 million by 2031, at 7.35% CAGR from 2025-2031. the increased prevalence of infectious disorders among women, such as hepatitis and urinary tract infections, is expected to fuel growth over the projection period. Advances in medical science provide lucrative chances to combat women-specific problems such as infectious illnesses, osteoporosis, and breast cancer.

Key Developments

• In Oct 2024: Roche has gotten CE Mark clearance for VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* to identify patients with metastatic breast cancer whose HER2 is low expressing for consideration as a targeted treatment with ENHERTU® (trastuzumab deruxtecan). The test, branded PATHWAY in the US, received US Food and Drug Administration (FDA) clearance in October 2022.
• In Aug 2024: GE HealthCare collaborated with the University of California San Diego School of Medicine to explore some innovative MRI protocols and techniques that could prove useful in diagnosing diseases and disorders unique to female-specific pelvic disease and conditions. It also developed comprehensive educational products for clinicians. Such a research program bridges a significant gap in medical studies and treatments and seems to promise much in providing better healthcare for women's pelvic health. The results of this study should enable clinicians to make more informed decisions and diagnose conditions with speed and relative ease while giving easier access to quality care for the pelvic needs of women.
• In May 2024: Lumos Diagnostics said it has completed the first phase of a Development Agreement to develop a novel fetal fibronectin (fFN) test for leading women's health company, Hologic, Inc. The focus of the Development Agreement is a next generation version of Hologic’s on- market fFN diagnostic product for pre-term birth.
• In May 2024: BD (Becton, Dickinson and Company) formed a strategic alliance with Healthians, India's leading diagnostics service provider, in an effort to promote cervical cancer screening through innovative self-collection as an option for women in India to collect a sample in the comfort of their own homes.
• In Jan 2024: BD (Becton, Dickinson & Company) the world's largest distributor of syringes, needles and surgical instruments, has partnered with the Kenyan Government through the National Cancer Institute-Kenya, to advance access to critical cancer diagnostics for women in Kenya. This is further advancing its commitment toward making progress in advancing health equity to underserved communities around the world.
• In Jan 2024: Lumos said it entered into two new agreements with US-based women's health company, Hologic. One is an Intellectual Property agreement worth US$10.0 million, and the other is a Development Agreement worth US$4.7 million. The Agreements are regarding the development of a next-generation version of Hologic's on-market fFN diagnostic product for pre-term birth-a women's health product for which Hologic is the only manufacturer globally. Make the test compatible for use on the Lumos proprietary reader platform and enhance how it connects with other users' devices.
• In Sep 2023: Hologic Inc and Bayer announced a collaboration that they will be using to deliver contrast-enhanced mammography solutions in order to enhance the detection of breast cancer for women in several countries located in Europe, Canada and the Asia Pacific region.
• In March 2023, The US FDA has authorized Visby Medical's sexual health test. It is a second-generation PCR test that employs self-collected vaginal swabs to diagnose STIs such as trichomoniasis, chlamydia, and gonorrhoea.
• In February 2023, Genetic Technologies Limited, a global leader in genomic-based diagnostics for health, wellness, and serious disease, has launched the 'World First' complete risk assessment test. This novel test assesses a woman's chance of acquiring breast and/or ovarian cancer due to either an inherited genetic mutation or the more frequent familial or sporadic malignancy.