Women's Health Diagnostics Market Size, Share & Trends Analysis Report By Type (Diagnostic Devices, Diagnostic Tests), By Application (Infectious Disease Testing, Sexually Transmitted Disease Testing, Osteoporosis Testing, Pregnancy and Fertility Testing, Breast Cancer, Other Applications), By End-User (Home Care, Hospital and Diagnostics Centres) and By Region (North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2025-2033

Women's Health Diagnostics Market Growth Factors

High Frequency of Infectious Illnesses among Females

POC tests and other diagnostic procedures are frequently utilized during routine HIV testing on patients. With a quick point-of-care HIV test, medical professionals can offer patients results and an HIV status assessment within the same visit. Patients do not need to be counselled before and after the test like they often are during conventional laboratory analysis because it is not required. Women have a greater risk of developing HIV and other sexually transmitted illnesses (STDs) and the long-term problems associated with these infections. More than half of the cases of infertility that could have been prevented are attributable to sexually transmitted diseases (STDs) in the United States. The vast majority of sexually transmitted diseases are capable of being passed on to the developing foetus or newborn, which can sometimes have deadly results. Rapid point-of-care testing can enhance the management of infectious diseases such as HIV, urinary tract infections (UTIs), and tuberculosis, particularly in developing nations where obtaining prompt medical care can be difficult and where the healthcare infrastructure is ageing.

Rising Cases of Breast Cancer among Women

Certain diseases, such as osteoporosis, menstrual disorders, cancer, and autoimmune diseases, are more common in women. Menopause, infertility, polycystic ovarian syndrome, and some malignancies, such as breast cancer and cervical cancer, as well as urological issues, are among the primary ailments. Physicians can now provide the proper treatment at the right time, thanks to the rise in innovative solutions for Women's health. Diagnostics are essential in the industry, from cervical cancer screening to infertility support, prenatal testing, pregnancy care, breast and ovarian cancer diagnosis, and bone health management.

The Women's health diagnostics market is expanding as the prevalence of osteoarthritis, ovarian, breast, and cervical cancer rises. Breast cancer is the most frequent disease in women and the second most common cancer in the world. Globocan 2020 estimates that 2,261,419 new breast cancer cases will be diagnosed in 2020. Increased sales of test kits for home use have resulted from the rising number of instances, likely to fuel the market's revenue growth over the forecast period. Increased use of point-of-care diagnostic testing and the wide availability of diagnostic imaging equipment is expected to drive market growth.

Market Opportunity

Increasing Numbers of Government Approval for Immunoassay Diagnostic Techniques

When it comes to detecting a variety of illnesses that affect women, immunoassays are a prevalent sort of technology and platform. Recently, numerous new immunoassays have been approved for use by the FDA or the CE Mark. The following is a list of several examples:

• The United States Food and Drug Administration (FDA) approved in September 2019 for Roche Diagnostics Ltd. (Switzerland) to utilize its Cobas 6800 and Cobas 8800 Systems to conduct the viral load tests for cobas HBV and cobas HCV.
• Alere, Inc. (the US) was awarded the IVD CE Mark for its Alere q HIV-1/2 Detect assay in March of 2018. This assay is part of a revolutionary molecular diagnostic platform that provides point-of-care access for the sensitive detection of HIV in mothers and infants.
• POC testing can identify the HIV p24 antigen and antibodies to HIV-1 and/or HIV-2 if Alere's Determine HIV-1/2 Ag/Ab Combo has been used. This approval came from the FDA in July 2018 and was given to Alere.

Market Restraining Factors

Excessive Costs Associated with Diagnostic Imaging Technologies and Procedures

Most hospitals in developing nations do not have the financial means to purchase expensive diagnostic imaging technology. The price of an MRI machine can range anywhere from around 1.5 million to 2.0 million US dollars. In contrast, the price of a CT machine can range anywhere from approximately 1 million to 1.5 million US dollars. Healthcare facilities such as hospitals and diagnostic centres are hesitant to invest in sophisticated equipment due to the high cost of these systems and the limited financial resources of hospitals. Healthcare institutions that purchase these pricey systems frequently rely on reimbursements from third-party payers (such as Medicare, Medicaid, or commercial health insurance plans) to cover the expenses of diagnostic and screening operations that are carried out using these devices.

Regional Insights

North America: Dominates the Global Market

Because of the increasing prevalence of cancer among women, increased incidence of lifestyle-related illnesses, high adoption of technologically sophisticated devices, new launches, and government initiatives, North America is likely to hold a significant market share. Key market players with technologically improved Women's health diagnostics products are expected to help drive regional expansion. Lia, for example, introduced the world's first flushable and biodegradable pregnancy test in March 2021. Lia's pregnancy tests are constructed entirely of plant fibres and contain no plastic, allowing them to biodegrade in just ten weeks.

Asia Pacific: Fastest Growing Region

Better healthcare infrastructure, increasing knowledge of Women's health conditions, and female engagement in the workforce are expected to boost the regional market's growth. The regulatory authority's clearance is also encouraging the market's expansion in the region. For example, Paragon Biosciences LLC formed Qlarity Imaging LLC in July 2019, intending to use artificial intelligence (AI) to improve medical results. Qlarity Imaging will create QuantX, one of the first FDA-approved computer-aided breast cancer diagnosis systems in radiography. The market is growing due to such approvals for technologically improved diagnostics products.

Segmentation Analysis

By Type

Further, the segments are divided into sub-segments. The market is broken down into diagnostic devices and diagnostic tests based on types. Diagnostic devices are further classified into Biopsy Devices and Imaging & Monitoring systems. Diagnostic tests are divided into Breast Cancer Testing, PAP Smear (PAP) and HPV Test, Pregnancy Testing and Ovulation Testing and Other Diagnostic Tests.

In 2020, the diagnostic testing segment contributed the most to the market. The Women's health diagnostics market for tests is driven by an increase in the prevalence of various health-related disorders among women, such as cancer and infertility, as well as increased awareness about Women's health-related tests, high demand for point-of-care diagnostic testing, and the development of numerous diagnostic & imaging centres.

By Applications

Based on applications, the market is split into Infectious Disease Testing, Sexually Transmitted Disease Testing, Osteoporosis Testing, Pregnancy and Fertility Testing, Breast Cancer and Other Applications.

By End-Users

According to end-users, the market is divided into Home Care and Hospital & Diagnostics Centres. The segment that contributes the most to the market is hospitals and diagnostic centres. The growth in breast and ovarian cancer incidence has resulted in a significant increase in hospitalizations.