+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

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

  • ID: 4896020
  • Report
  • February 2022
  • Region: Global
  • 157 Pages
  • Mordor Intelligence
The women’s health diagnostics market was valued at USD 23,667.18 million and is expected to register a CAGR of 7.88% over the forecast period.

During the COVID-19 pandemic, limited transportation options and travel restrictions created impediments to international trade and transportation, which disrupted the supply chain for the women’s health diagnostics market, temporarily leading to a decline in demand due to uncertainty in the capital market and the global economy. The 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. According to an article in the JAMA Network in August 2020, there was a significant decline in breast cancer diagnoses (by as much as 51.8%) in the US from March 1, 2020, to April 18, 2020. 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. For instance, in June 2021, OWN Your Health entered an exclusive agreement with Hologic's Project Health Equality public health program. The collaboration will raise awareness about disparities in healthcare quality received by Black women in the US 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 women’s health diagnostics market is growing due to the increasing prevalence of osteoarthritis, ovarian cancer, breast cancer, and cervical cancer. Breast cancer is the most commonly occurring cancer in women and the second most common cancer worldwide. According to Globocan 2020, there were around 2,261,419 new breast cancer cases in 2020. The increasing cases resulted in increased sales of test kits for home usage, which is also expected to drive the market’s revenue growth over the forecast period. The rise in the adoption of point-of-care diagnostic testing and an increase in the number of diagnostic and imaging devices worldwide are expected to fuel the market growth.

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.

Key Market Trends

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

People with underlying diseases and conditions like breast cancer are at a higher risk of acquiring the COVID-19 infection. Thus, many organizations have taken definite measures to manage these diseases. According to a research article by Dafina Petrova et al., published in Medicina Clínica Journal in September 2020, the Spanish Society of Medical Oncology (SEOM), the European Society for Medical Oncology (ESMO), and the Spanish Society of Radiation Oncology (SEOR) published recommendations on how to modify treatment protocols to reduce risks in cancer patients. Such instances are expected to support the growth of breast cancer diagnosis in this market.

Certain factors expected to drive the segmental growth are the growing burden of breast cancer, increasing investments in research and development, and advancements in cancer diagnosis. According to Globocan, in 2020, around 2.26 million new breast cancer cases were reported across the world in females, accounting for around 11.7% of the total cancer cases. A significant increase in the patient pool of breast cancer is expected to further accelerate the demand for breast cancer diagnostics. 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.

Additionally, the growth in breast cancer diagnostics reimbursement and insurance coverage is expected to drive the segment’s growth. For instance, in June 2019, Genomic Health’s Oncotype DX Breast Recurrence Score test was approved by the German Federal Joint Committee for nationwide reimbursement. Thus, the abovementioned factors are likely to boost the segmental growth over the forecast period.

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. 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 July 2019, Paragon Biosciences LLC launched Qlarity Imaging LLC, which was founded to harness the value of artificial intelligence (AI) to improve medical outcomes. Qlarity Imaging will develop QuantX, one of the first computer-aided breast cancer diagnosis systems in radiology to be approved by the US Food and Drug Administration. Such approvals for technologically advanced products to improve diagnosis are driving the market’s growth. Additionally, 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.

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.

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

This product will be delivered within 2 business days.

Table of Contents

1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Incidence of Chronic and Lifestyle-related Disorders
4.2.2 Rising Number of Imaging and Diagnostic Centers
4.2.3 Increased Adoption of Point-of-Care and Rapid Diagnostic Tests
4.3 Market Restraints
4.3.1 High Cost of Diagnostic Imaging Systems
4.3.2 Stringent Regulatory Guidelines
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (Market Size by Value - USD million)
5.1 By Type
5.1.1 Diagnostic Devices Biopsy Devices Imaging and Monitoring System
5.1.2 Diagnostic Tests Breast Cancer Testing PAP Smear (PAP) and HPV Test Pregnancy Testing and Ovulation Testing Other Diagnostic Tests
5.2 By Application
5.2.1 Breast Cancer
5.2.2 Infectious Disease Testing
5.2.3 Osteoporosis Testing
5.2.4 Pregnancy and Fertility Testing
5.2.5 Sexually Transmitted Disease Testing
5.2.6 Other Applications
5.3 By End User
5.3.1 Hospital and Diagnostics Centers
5.3.2 Home Care
5.4 Geography
5.4.1 North America US Canada Mexico
5.4.2 Europe Germany UK France Italy Spain Rest of Europe
5.4.3 Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific
5.4.4 Middle-East and Africa GCC South Africa Rest of Middle-East and Africa
5.4.5 South America Brazil Argentina Rest of South America
6.1 Company Profiles
6.1.1 Abbott Laboratories
6.1.2 Becton, Dickinson and Company
6.1.3 Biomerieux SA
6.1.4 Carestream Health
6.1.5 F. Hoffmann-La Roche AG
6.1.6 GE Healthcare
6.1.7 Hologic Inc.
6.1.8 Koninklijke Philips NV
6.1.9 Mankind Pharma
6.1.10 Myriad Genetics
6.1.11 Perkinelmer Inc.
6.1.12 Procter & Gamble Co.
6.1.13 Quest Diagnostics Inc.
6.1.14 Siemens AG

Companies Mentioned

A selection of companies mentioned in this report includes:

  • Abbott Laboratories
  • Becton, Dickinson and Company
  • Biomerieux SA
  • Carestream Health
  • F. Hoffmann-La Roche AG
  • GE Healthcare
  • Hologic Inc.
  • Koninklijke Philips NV
  • Mankind Pharma
  • Myriad Genetics
  • Perkinelmer Inc.
  • Procter & Gamble Co.
  • Quest Diagnostics Inc.
  • Siemens AG