Women’s Health Diagnostics Market : Rising incidence of various chronic and lifestyle disorders in women

This study involved the extensive use of both primary and secondary sources. The research process involved the study of various factors affecting the industry to identify the segmentation types, industry trends, key players, competitive landscape, key market dynamics, and key player strategies.

Major Growth Drivers:

In the past decade, the demand for various health diagnostic tests has increased significantly across the globe. Currently, the market is mainly driven by growing awareness about various health-related disorders, rising incidence of chronic and lifestyle disorders, and the high prevalence of infectious diseases such as HIV and hepatitis in women across the globe. The increasing adoption of POC diagnostic testing and the growth in the number of diagnostic and imaging centers are also expected to support the growth of this market during the forecast period.

Expected Revenue Growth:

[246 Pages Report] The women’s health diagnostics market is projected to reach USD 36.6 billion by 2025 from USD 25.0 billion in 2020, at a CAGR of 7.9% during the forecast period.

COVID-19 Impact on Global Women’s Health Diagnostics Market

Since the beginning of 2020, more and more countries across the globe shut down their borders and limited transportation and travel to contain the coronavirus (COVID-19) outbreak, thus, creating impediments for international trade and transportation. This had disrupted the supply chains for the women’s health diagnostics market, temporarily leading to fall in demand due to uncertainty in the global economy and capital markets.

Additionally, we are estimating that the major share of the medical devices industry that includes imaging devices, and surgical products among others, which contribute 60-75% of the overall medical devices market will have a stagnant or deep fall in the growth rate in 2020 and couple of quartered from 2021. A new, USD 5-7 billion market opportunity (by 2021) is opening up in the medical devices industry that includes critical care medical devices. Also, the women’s health diagnostics market is witnessing loss of business and the trend is expected to continue till December 2020. 

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Based on application, the women’s health diagnostics market is divided into nine segments—osteoporosis testing, OVC testing, cervical cancer testing, breast cancer testing, pregnancy & fertility testing, prenatal genetic screening & carrier testing, infectious disease testing, STD testing, and ultrasound tests. The breast cancer testing segment accounted for the larger market share in 2019. The large share of this segment can be attributed to the increasing incidence of breast cancer and rising awareness about advanced breast cancer diagnostic techniques, such as ABUS.

Based on end users, the women’s health diagnostics market is segmented into hospitals & clinics, diagnostic & imaging centers, and home care settings. The home care settings segment is expected to witness the highest growth during the forecast period. The increasing advantages of using self-testing kits will continue to drive market growth. Patient self-testing enables patients to better manage their diseases by utilizing home/self-testing kits. Technological advancements have made many self-testing kits available for various conditions, such as pregnancy and ovulation.

North America is expected to account for the largest share of the women’s health diagnostics market in 2019

In 2019, North America accounted for the largest share of the women’s health diagnostics market, followed by Europe, the Asia Pacific, Latin America, and the Middle East & Africa. The large share of this market segment can be attributed to the increasing prevalence of cancer among women, the growing focus of manufacturers of women’s health diagnostic products on expanding their presence in this region, and the increasing demand for fertility testing monitors.

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Key Market Players

The prominent players in this market are Quest Diagnostics Incorporated (US), Hologic, Inc. (US), Abbott Laboratories (US), Siemens AG (Germany), F. Hoffmann-La Roche Ltd. (Switzerland), Cardinal Health, Inc. (US), General Electric Company (US), and Becton, Dickinson and Company (US).

Women’s Health Diagnostics Market Dynamics

Driver:  High prevalence of infectious diseases in women

Diagnostic tests such as POC tests are commonly used to detect HIV among patients. A rapid POC HIV test enables physicians to provide results and the HIV status of patients during the same visit. It does not require pre-test and post-test counseling of patients, as is common during traditional laboratory analysis. In addition to HIV, women are more susceptible to other sexually transmitted diseases (STDs) and their long-term complications. In the US, more than 50% of preventable infertility cases are related to STDs. 

Restraint: High cost of diagnostic imaging systems and procedures

Most hospitals in developing countries cannot afford high-cost diagnostic imaging systems. The average cost of MRI machines is approximately USD 1.5 million to USD 2.0 million, while CT machines cost approximately USD 1.0 million to USD 1.5 million. Due to the high cost of these systems and low financial resources of hospitals, healthcare facilities such as hospitals and diagnostic centers are reluctant to invest in expensive equipment. 

Opportunity: Growing number of regulatory approvals for immunoassay diagnostic techniques

Immunoassays are a commonly used technology/platform for diagnosing various conditions in women. In the past few years, many new immunoassays have received FDA or CE Mark approvals. Some examples are listed below:

• In September 2019, Roche Diagnostics Ltd. (Switzerland) received FDA approval for the cobas HBV and cobas HCV viral load test assays to be used with its cobas 6800 and cobas 8800 Systems.

• In March 2018, Alere, Inc. (US) received the IVD CE Mark for its Alere q HIV-1/2 Detect assay, a new molecular diagnostic platform that offers POC access for acute detection of HIV in mothers and infants.

• In July 2018, Alere’s Determine HIV-1/2 Ag/Ab Combo was approved by the FDA to detect the HIV p24 antigen and antibodies to HIV-1 and/ or HIV-2 through POC testing.

Challenge:  Increasing adoption of refurbished diagnostic imaging systems

Many hospitals in developing countries cannot invest in diagnostic imaging equipment due to their high cost, poor reimbursement rates, and budgetary constraints. However, due to the high demand for diagnostic imaging procedures in these nations, hospitals that cannot afford to invest in new imaging systems opt for refurbished ones. Refurbished systems are priced lower than new systems, costing approximately in the range of 40% to 60% of the original price of the equipment.

Recent Developments

• In 2021, F. Hoffmann-La Roche Ltd. Launched the uPath HER2 (4B5) Image Analysis and uPath Dual ISH Image Analysis.
• In 2021, Hologic, Inc. acquired Biotheranostics, a privately held, commercial-stage company that provides molecular diagnostic tests for breast and metastatic cancers, to strengthen its presence in the women’s health diagnostics market.
• In 2020, Hologic, Inc. launched the 3DQuorum Imaging Technology in Europe.
• In 2019, Carestream Health, Inc. opened a new global business operations center in Mumbai, India, expanding its market presence.

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