U.S. Women Health Laboratory Testing Market – Analysis and Forecast (2026-2035)

Industry Overview

The U.S. Women Health Laboratory Testing Market size is expected to reach USD 110.5 billion by 2035 from USD 70.2 billion in 2025, registering a CAGR of 4.5% during the forecast period. The term "U.S. women's health laboratory testing market" refers to the market for testing women's samples in laboratories for conditions like breast cancer, birth control, gynecology disorders, ovarian cancer, and sexually transmitted diseases (STDs) like chlamydia that affect women. The tests that take place throughout prenatal development and those connected to pregnancy are also included. There is an increased number of tests for screening and detection of various diseases so as to avoid complications and enhance the quality of life. Thus, health tests are crucial to improve health and prevent and treat chronic diseases.

U.S. Women Health Laboratory Testing Market Segmentation

Insight by Cancer

Based on Cancer, the U.S. Women Health Laboratory Testing Market is segmented into Cervical Cancer, Breast Cancer, and Ovarian Cancer. Breast Cancer is anticipated to grow at a high CAGR during the forecast period owing to rising incidences of breast cancer and increased awareness regarding developed breast cancer diagnostic techniques like ABUS.

Insight by Prenatal Screening and Diagnostic Testing

Based on Prenatal Screening and Diagnostic Testing, the U.S. Women Health Laboratory Testing Market is segregated into Non-Invasive Prenatal Testing (NIPT), Maternal Serum Screening (MSS), Prenatal Diagnostic Testing. Non-Invasive Prenatal Testing (NIPT) dominates the market as it reduces the chances of miscarriage. Owing to increased prominence of trisomy-related genetic conditions, NIPT is expected to grow significantly during the forecasted timeframe.

Insight by Reproductive Health and Infectious Diseases

Based on Reproductive Health and Infectious Diseases, the U.S. Women Health Laboratory Testing Market is divided into Pregnancy and Ovulation Testing, HPV Testing, PAP Smear Testing, HIV Testing, CT/NG Testing, Preimplantation Genetic Testing (PGT), Sexually Transmitted Infections (Syphilis, Gonorrhea, Chlamydia), Herpes Simplex Virus (HSV), Hepatitis, and Vaginal Infections. HIV Testing contributes the largest share in the market owing to the rising number of blood transfusions and blood donations, advantages provided by POC instruments and kits, and rising initiatives by the government that will propel the market development.

U.S. Women Health Laboratory Testing Market Report Coverage

Industry Dynamics

U.S. Women Health Laboratory Testing Market Growth Drivers

Factors attributing to the market growth of U.S. women laboratory testing include mounting prominence of chronic and lifestyle disorders, rising incidences of infectious diseases like HIV, hepatitis, etc., increased awareness among women about health-related tests, increasing average maternal age that has led to high risk of fetal chromosomal aneuploidies. There is also a rise in reproductive health problems, thereby leading to increased market demand for laboratory testing in women. Moreover, the rising geriatric women population, surge in healthcare expenditure, rising incidences of lifestyle diseases in women, established healthcare industry, the surge in demand for fertility tests in women, rising number of private diagnostic and imaging centers, rising population of women in the workforce, and increased public-private partnership will improve infrastructure, thereby bolstering the market growth in the industry.

U.S. Women Health Laboratory Testing Market Challenges

The stringent regulatory guidelines regarding laboratory testing, high cost of diagnostic imaging devices and procedures, shortage of skilled laboratory technicians, and lack of awareness regarding pregnancy and fertility issues in several regions of US will hamper the market development of U.S. women health laboratory testing industry. Moreover, insufficient reimbursements for diagnostic tests will stymie market expansion.

U.S. Women Health Laboratory Testing Market Opportunities

The industry players offer tremendous market opportunities in the U.S. Health Laboratory testing Industry which includes

• Development in diagnostic technologies like genetic testing and digital and mobile mammography like breast MRI, bone density testing, and ultrasound will propel growth.
• Increased number of Regulatory Approvals for Immunoassay diagnostic techniques
• Healthcare Disparities in Rural Counties in the United States
• Healthcare Gap for Reproductive Age in Women with Psychological Distress
• Significant Mergers and Acquisitions by Companies to Increase Market Share

U.S. Women Health Laboratory Testing Market Geographic Overview

South region contributes the largest share in the U.S. women health laboratory testing market owing to increased incidences of lifestyle disorders. The rising implementation of POC and rapid diagnostic testing and an upsurge in the number of diagnostic and imaging centers will support the market advancement of U.S. women health laboratory testing industry.

U.S. Women Health Laboratory Testing Market Competitive Insight

The market for women's health laboratory testing in the United States is in its advanced stages. Partnerships, business expansion, collaborations, product launch, and M&A, as well as increased regulatory, legal, and funding activities, are some of the key strategies adopted by industry players in the U.S. Women Health Laboratory Testing market. Also, New entrants can emphasize in developing early detection tests for hereditary cancer, prenatal screening and diagnostic testing.

Roche Diagnostics offers medical tests and digital tools that provide information to help healthcare professionals find the best treatment for patients and provide the best patient care in order to improve, prolong, and save lives. Roche Diagnostics currently leads the industry in the development of diagnostic products for cancer, cardiovascular health, infectious diseases, women's health, and diabetes management. Roche Diagnostics is the trusted diagnostic partner that healthcare providers can rely on for everything and includes cervical cancer screening, fertility support, prenatal testing, pregnancy care, breast cancer, ovarian cancer diagnosis, and bone health management.

DIASORIN is a prominent leader in laboratory diagnostics, specializing in immunodiagnostics and molecular diagnostics. The Group has been developing, manufacturing, and commercializing diagnostic tests for over 50 years: supports clinical laboratory needs and activities by providing solutions that are reliant, innovative, fully automated, and standardized. DiaSorin strives to invest in Research and development, enhancing its distinct Immunodiagnostics expertise to deliver high-quality assays and increase laboratory efficiency.

Recent Development by Key Players

Roche has entered into a definitive merger agreement to acquire 89bio, Inc. that is a publicly listed clinical-stage biopharmaceutical company pioneering the development of innovative therapies for the treatment of liver and cardiometabolic diseases.

Quest has partnered with Epic Systems to integrate its diagnostic enterprise technologies across Quest’s operations through Project Nova which is designed to improve patient and provider lab testing experiences across healthcare systems.

The U.S. Women Health Laboratory Testing Market report offers a comprehensive market segmentation analysis along with an estimation for the forecast period 2025–2030.

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1.    Research Overview

        1.1.    The Report Offers
        1.2.    Market Coverage
                  1.2.1.    By Cancer 
                  1.2.2.    By Prenatal Screening and Diagnostic Testing 
                  1.2.3.    By Reproductive Health and Infectious Diseases 
        1.3.    Research Phases
        1.4.    Limitations
        1.5.    Market Methodology
                  1.5.1.  Data Sources
                             1.5.1.1. Primary Research
                             1.5.1.2. Secondary Research
                  1.5.2.  Methodology
                             1.5.2.1. Data Exploration
                             1.5.2.2. Forecast Parameters
                             1.5.2.3. Data Validation
                             1.5.2.4. Assumptions
                  1.5.3.  Study Period & Data Reporting Unit

2.    Executive Summary

3.    Industry Overview

       3.1.    Industry Dynamics
                 3.1.1.    Market Growth Drivers
                 3.1.2.    Market Restraints
                 3.1.3.    Key Market Trends
                 3.1.4.    Major Opportunities
       3.2.    Industry Ecosystem
                 3.2.1.    Porter’s Five Forces Analysis
                 3.2.2.    Recent Development Analysis
                 3.2.3.    Value Chain Analysis
       3.3.    Competitive Insight
                 3.3.1.    Competitive Position of Industry Players
                 3.3.2.    Market Attractive Analysis
                 3.3.3.    Market Share Analysis

4.    Global Market Estimate and Forecast

       4.1.    Global Market Overview
       4.2.    Global Market Estimate and Forecast to 2035

5.    Market Segmentation Estimate and Forecast

       5.1.    By Cancer 
                 5.1.1. Cervical Cancer
                           5.1.1.1. Market Definition
                           5.1.1.2. Market Estimation and Forecast to 2035
                 5.1.2. Breast Cancer
                           5.1.2.1. Market Definition
                           5.1.2.2. Market Estimation and Forecast to 2035
                 5.1.3. Ovarian Cancer.
                           5.1.3.1. Market Definition
                           5.1.3.2. Market Estimation and Forecast to 2035

       5.2.    By Prenatal Screening and Diagnostic Testing 
                 5.2.1. Non-Invasive Prenatal Testing (NIPT)
                           5.2.1.1. Market Definition
                           5.2.1.2. Market Estimation and Forecast to 2035
                 5.2.2. Maternal Serum Screening (MSS)
                           5.2.2.1. Market Definition
                           5.2.2.2. Market Estimation and Forecast to 2035
                 5.2.3. Prenatal Diagnostic Testing
                           5.2.3.1. Market Definition
                           5.2.3.2. Market Estimation and Forecast to 2035

       5.3.    By Reproductive Health and Infectious Diseases 
                 5.3.1. Pregnancy and Ovulation Testing
                           5.3.1.1. Market Definition
                           5.3.1.2. Market Estimation and Forecast to 2035
                 5.3.2. HPV Testing
                           5.3.2.1. Market Definition
                           5.3.2.2. Market Estimation and Forecast to 2035
                 5.3.3. PAP Smear Testing
                           5.3.3.1. Market Definition
                           5.3.3.2. Market Estimation and Forecast to 2035
                 5.3.4. HIV Testing
                           5.3.4.1. Market Definition
                           5.3.4.2. Market Estimation and Forecast to 2035
                 5.3.5. CT/NG Testing
                           5.3.5.1. Market Definition
                           5.3.5.2. Market Estimation and Forecast to 2035
                 5.3.6. Preimplantation Genetic Testing (PGT)
                           5.3.6.1. Market Definition
                           5.3.6.2. Market Estimation and Forecast to 2035
                 5.3.7. Sexually Transmitted Infections (Syphilis
                           5.3.7.1. Market Definition
                           5.3.7.2. Market Estimation and Forecast to 2035
                 5.3.8. Gonorrhea
                           5.3.8.1. Market Definition
                           5.3.8.2. Market Estimation and Forecast to 2035
                 5.3.9. Chlamydia)
                           5.3.9.1. Market Definition
                           5.3.9.2. Market Estimation and Forecast to 2035
                 5.3.10. Herpes Simplex Virus (HSV)
                           5.3.10.1. Market Definition
                           5.3.10.2. Market Estimation and Forecast to 2035
                 5.3.11. Hepatitis
                           5.3.11.1. Market Definition
                           5.3.11.2. Market Estimation and Forecast to 2035
                 5.3.12. Vaginal Infections.
                           5.3.12.1. Market Definition
                           5.3.12.2. Market Estimation and Forecast to 2035

6.   U.S. Market Estimate and Forecast

      6.1.    By Cancer   
      6.2.    By Prenatal Screening and Diagnostic Testing   
      6.3.    By Reproductive Health and Infectious Diseases   

7.   Canada Market Estimate and Forecast

      7.1.    By Cancer   
      7.2.    By Prenatal Screening and Diagnostic Testing   
      7.3.    By Reproductive Health and Infectious Diseases   

8.   Mexico Market Estimate and Forecast

      8.1.    By Cancer   
      8.2.    By Prenatal Screening and Diagnostic Testing   
      8.3.    By Reproductive Health and Infectious Diseases   

10.  Company Profiles

       10.1.   F. Hoffmann-La Roche Ltd
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Myriad Genetics Inc.
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   DiaSorin S.p.A
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Natera Inc.
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Becton, Dickinson and Company
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Hologic Inc.
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Quest Diagnostics Incorporated
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Abbott
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Cardinal Health
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   GE HealthCare
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments

11.    Appendix

         11.1.    Exchange Rates
         11.2.    Abbreviations

Note: Financial insight and recent developments of different companies are subject to the availability of information in the secondary domain.