Women’s Health Diagnostics Market Trends:
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. according to a new report by MarketsandMarkets™. The 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, increasing adoption of POC diagnostic testing and the growth in the number of diagnostic and imaging centers support the growth of the market.
Key Market Players of Biologics Safety Testing Market:
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)
Hologic, Inc. holds the leading position in the women’s health diagnostics market, owing to its robust portfolio of breast imaging products and related accessories. Hologic has expanded its product portfolio through insight-driven innovation and strategic M&As to establish its position in the market.
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.
Unfavorable changes in regulations and guidelines are hampering the growth of this industry. Major regulatory authorities across the globe (such as CDC, WHO, MHRA, TGA, and EMA) have identified that breast cancer patients are at greater risk of COVID-19 infection than healthy adults. Thus, screening, diagnostic exams, and surgical procedures are being severely restricted or postponed at hospitals and breast centers. This is expected to cause disruption in the breast cancer diagnosis as well as treatment market.
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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:
- 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.
- 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.
- 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.
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.
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