Women's Health Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecast (2022 - 2027)

The Women's Health Diagnostics Market is Segmented by Type (Diagnostic Devices and Diagnostic Tests), Application (Breast Cancer, Infectious Disease Testing, Osteoporosis Testing, Pregnancy and Fertility Testing, Sexually Transmitted Disease Testing, and Other Applications), End User (Hospital and Diagnostics Centers and Home Care), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the abovementioned segments.

Market Snapshot

Women’s Health Diagnostics Market Summary
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia-Pacific
Largest Market: North America
CAGR: 7.88 %
Women’s Health Diagnostics Market Major Players

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Market Overview

The women’s health diagnostics market is expected to register a CAGR of 7.88% over the forecast period, 2022-2027.

During the COVID-19 pandemic, unfavorable changes in guidelines and regulations are impeding the growth of this sector. Major regulatory authorities have identified that breast cancer patients are at greater risk of COVID-19 infection than healthy adults. Thus, screening, surgical procedures, and diagnostic exams are being postponed and severely restricted at hospitals and breast cancer centers. The Radiological Society of North America (RSNA) published an article in March 2021, titled ‘Time to Treatment Initiation for Breast Cancer During the 2020 COVID-19 Pandemic", in 2020, there were 18.8% fewer patients diagnosed with breast cancer and a decrease in the diagnosis rate. Such low screening due to COVID-19 impacts the growth of the women's health diagnostics market. The delay in breast cancer diagnosis also impacted the treatment of the same, which is expected to disrupt the breast cancer treatment and diagnosis market.

The market is expected to show rapid growth due to the rising incidence of chronic and lifestyle-related disorders, the rising number of imaging and diagnostic centers, and the increased adoption of point-of-care and rapid diagnostic tests coupled with collaborations and partnerships by players. The increasing burden of such diseases creates the need for the proper diagnosis devices and tests for the diseases and thus driving the growth of the women’s health diagnostics market over the forecast period.According to the Global Cancer Observatory (Globocan) Statistics, in December 2020 globally, breast cancer is the most common cancer among women, and it represents 1 in 4 cancers diagnosed among women. Additionally, Colorectal, lung, cervical, and thyroid cancers are also common among women. Moreover, the increasing burden of sexually transmitted diseases among women also contributes to the growth of the women's health diagnostics market. For instance, Avert article titled ‘‘Women and Girls, HIV and AIDS’’ updated in April 2020 reported that women account for more than half the number of people living with HIV worldwide. Additionally, it also reports that young women (10-24 years old) are twice as likely to acquire HIV as young men the same age. It also reported that AIDS-related illnesses remain the leading cause of death for women aged between 15 and 49 years. Such a high burden of disease and mortality due to creates the need for diagnostic devices and tests and thus drives the growth of the studied market.

With the increasing awareness among women for their health, rising burden of diseases, there is a constant need for imaging and diagnostics centers in the world. Since most of the diagnostic and imaging tests are performed at centers it is expected to drive the growth of the market. According to the United Nations, Food and Drug Administration (USFDA) article titled ‘’Mammography Quality Standards Act and Program (MQSA) National Statistics’’ updated in November 2021 reported that as of November 1st, 2021, in the United States there are 23,588 accredited units for mammography. Out of 13,125 are accredited Full Field Digital Mammography and Computed Radiography Units and 10,458 are Digital Breast Tomosynthesis units. It also reported that as of October 2020, there are 8,718 certified facilities and the number has reached 8,733 by November 2021. Such a large availability of facilities in the United States is driving the growth of the market.

The various strategies adopted by the key market players expected to boost the market. For instance, in June 2021, OWN (Oprah Winfrey Network) and its health initiative Own Your Health has reported an exclusive partnership with Hologic’s Project Health Equality public health initiative. The collaboration will raise awareness about disparities in healthcare quality received by Black women in the United States for breast, cervical, and uterine fibroids. Similarly, in November 2020, Hologic Inc. and RadNet announced a collaboration to advance the development of artificial intelligence tools for breast health. The collaboration will include data sharing, R&D, and an upgrade of RadNet’s fleet of Hologic mammography systems to state-of-the-art imaging technology.

The surge in demand for the development of miniature diagnostic devices, a rise in healthcare infrastructure, and new marketing initiatives by key vendors in emerging countries are expected to provide lucrative opportunities for market expansion during the forecast period.

Scope of the Report

As per the scope of the report, women are considered to be more susceptible to certain disorders such as osteoporosis, menstrual disorders, cancer, and autoimmune diseases. The major diseases include menopause, infertility, polycystic ovarian syndrome, and certain cancers, such as breast cancer and cervical cancer, as well as urological disorders. The rise in innovative solutions for women’s health gives physicians the ability to provide the right treatment at the right time. The women's health diagnostics market is segmented by type (diagnostic devices and diagnostic tests), application (breast cancer, infectious disease testing, osteoporosis testing, pregnancy and fertility testing, sexually transmitted disease testing, and other applications), end user (hospital and diagnostics centers and home care), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD million) for the abovementioned segments.

By Type
Diagnostic Devices
Biopsy Devices
Imaging and Monitoring System
Diagnostic Tests
Breast Cancer Testing
PAP Smear (PAP) and HPV Test
Pregnancy Testing and Ovulation Testing
Other Diagnostic Tests
By Application
Breast Cancer
Infectious Disease Testing
Osteoporosis Testing
Pregnancy and Fertility Testing
Sexually Transmitted Disease Testing
Other Applications
By End User
Hospital and Diagnostics Centers
Home Care
North America
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle-East and Africa
South Africa
Rest of Middle-East and Africa
South America
Rest of South America

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Key Market Trends

Breast Cancer Segment Expected to Show Significant Growth During the Forecast Period

Breast cancer can be detected early, which can lead to better results such as a higher survival rate, more treatment options, and a higher quality of life. The rising incidence of breast cancer will aid segment growth over the forecast period. The demand for breast cancer tests is increasing as the need for these tests grows in both developing and developed countries, resulting in segment growth.

Breast cancer is the most commonly occurring cancer in women and the second most common cancer worldwide. A significant increase in the patient pool of breast cancer is expected to further accelerate the demand for breast cancer diagnostics. The Global Cancer Observatory (Globocan) Statistics 2020 reported that in 2020, among females, there is a 2,261,419 estimated new cases of breast cancer around the world. The same source also reports that 865,630 estimated new cases of Colorectum cancer in females. Such a high incidence of cancer among women will generate the need for diagnostic devices and tests and thus drive the growth of the market.

Key companies operating in the women’s health diagnostics market are focusing on organic growth strategies such as product launches, advanced product development, and product approvals. They have adopted various inorganic strategies such as mergers and acquisitions, and collaborations to gain a competitive edge in the market. For instance, to increase its foothold in the women's health diagnostics industry, In January 2021, Hologic Inc. acquired Biotheranostics, a privately held, commercial-stage firm that develops molecular diagnostic tests for metastatic and breast cancers Product launches are another key factor to drive the growth of the market. For instance, in January 2021, Roche launched its CE-IVD-approved automated digital pathology algorithms, uPath HER2 (4B5) image analysis, and uPath HER2 Dual ISH image analysis for breast cancer. These algorithms help determine the best treatment strategy for each patient.

Thus, the abovementioned factors are likely to boost the segmental growth over the forecast period.

Women’s Health Diagnostics Market: Estimated Age-standardized Breast Cancer Incidence Rate per 100,000, by Countries, Female, All Ages, 2020

North America Expected to Record the Largest Share During the Forecast Period

North America is expected to hold a major market share, owing to the high prevalence of cancer among women, rising incidence of lifestyle-related disorders, high adoption of technologically advanced products, product launches, and government initiatives. The growth is attributed to the increasing cases of cancers in women such as breast and ovarian cancer, and other chronic diseases coupled with the presence of key market players in the region. For instance, as per the in July 2022 report of the Breast Cancer Facts and Statistics, in the United States, women are anticipated to receive diagnoses of 287,850 new cases of invasive breast cancer and 51,400 new cases of non-invasive (in situ) breast cancer in 2022. Thus, the growing prevalence of breast cancer is expected to drive the demand for women's health diagnoses thereby boosting the market growth.

A strong foothold by key market players offering technologically advanced products for women's health diagnostics is likely to boost regional growth. For instance, in March 2021, Lia launched the world’s first flushable and biodegradable pregnancy test. Lia’s pregnancy tests are made from plant fibers and are 100% plastic-free, which means they biodegrade in just ten weeks. The presence of better healthcare infrastructure, growing awareness about women’s health disorders, and increased participation by women in the workforce are poised to positively influence the regional market’s growth. The approval from the regulatory authority is also boosting the growth of the market in the region. For instance, in January 2021, the Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA) granted premarket approval (PMA) to Seno Medical Instruments Inc. for its Imagio Breast Imaging System. It is groundbreaking diagnostic breast cancer imaging technology that will help physicians better differentiate between benign and malignant breast lesions using non-invasive opto-acoustic ultrasound (OA/US) technology to provide information on suspicious breast lesions. Such approvals are fueling the growth of the market. Thus, owing to the abovementioned factors, the women's health diagnostics market in North America is expected to show significant growth over the forecast period.

Women's Health Diagnostics Market - Growth Rate by Region

Competitive Landscape

The market has a large number of companies that are significantly contributing to the market growth. Some major players are Siemens Healthcare Private Limited, Hologic Inc., GE Healthcare, F.Hoffmann-La Roche Ltd, and Koninklijke Philips NV. New product developments, mergers, and acquisitions are some of the strategies being undertaken by these companies to strengthen their market presence.

Recent Developments

  • In June 2022, Mylab Discovery Solutions has forayed into the women’s healthcare segment with the launch of a home pregnancy test kit, PregaScreen. The company plans to launch a range of products in this category in the coming months.
  • In April 2022, Niramai Health Analytix has launched a novel diagnostic test for screening breast cancer in women which is non-touch, radiation-free, and pain free unlike the commonly used mammography method.

Table of Contents


    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Rising Incidence of Chronic and Lifestyle-related Disorders

      2. 4.2.2 Rising Number of Imaging and Diagnostic Centers

      3. 4.2.3 Increased Adoption of Point-of-Care and Rapid Diagnostic Tests

    3. 4.3 Market Restraints

      1. 4.3.1 High Cost of Diagnostic Imaging Systems

      2. 4.3.2 Stringent Regulatory Guidelines

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value – USD million)

    1. 5.1 By Type

      1. 5.1.1 Diagnostic Devices

        1. Biopsy Devices

        2. Imaging and Monitoring System

      2. 5.1.2 Diagnostic Tests

        1. Breast Cancer Testing

        2. PAP Smear (PAP) and HPV Test

        3. Pregnancy Testing and Ovulation Testing

        4. Other Diagnostic Tests

    2. 5.2 By Application

      1. 5.2.1 Breast Cancer

      2. 5.2.2 Infectious Disease Testing

      3. 5.2.3 Osteoporosis Testing

      4. 5.2.4 Pregnancy and Fertility Testing

      5. 5.2.5 Sexually Transmitted Disease Testing

      6. 5.2.6 Other Applications

    3. 5.3 By End User

      1. 5.3.1 Hospital and Diagnostics Centers

      2. 5.3.2 Home Care

    4. 5.4 Geography

      1. 5.4.1 North America

        1. US

        2. Canada

        3. Mexico

      2. 5.4.2 Europe

        1. Germany

        2. UK

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.4.4 Middle-East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle-East and Africa

      5. 5.4.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Abbott Laboratories

      2. 6.1.2 Becton, Dickinson and Company

      3. 6.1.3 Biomerieux SA

      4. 6.1.4 Carestream Health

      5. 6.1.5 F. Hoffmann-La Roche AG

      6. 6.1.6 GE Healthcare

      7. 6.1.7 Hologic Inc.

      8. 6.1.8 Koninklijke Philips NV

      9. 6.1.9 Mankind Pharma

      10. 6.1.10 Myriad Genetics

      11. 6.1.11 Perkinelmer Inc.

      12. 6.1.12 Procter & Gamble Co.

      13. 6.1.13 Quest Diagnostics Inc.

      14. 6.1.14 Siemens AG

    2. *List Not Exhaustive

**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Global Women's Health Diagnostics Market market is studied from 2019 - 2027.

The Global Women's Health Diagnostics Market is growing at a CAGR of 7.88% over the next 5 years.

Asia-Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Siemens AG, Quest Diagnostics Inc., Hologic, Inc., F. Hoffmann-La Roche AG, PerkinElmer Inc. are the major companies operating in Global Women's Health Diagnostics Market.

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