United States Women Health Laboratory Testing Market By Hereditary Cancer (Cervical Cancer, Ovarian Cancer, Breast Cancer), By Reproductive Health and Infectious Diseases (CT/NG Testing, Preimplantation Genetic Testing (PGT), Herpes Simplex Virus (HSV), Hepatitis, Sexually Transmitted Infections, Vaginal Infections, PAP Smear Testing, HIV Testing, Pregnancy and Ovulation Testing, HPV Testing), By Prenatal Screening and Diagnostic Testing (Non-Invasive Prenatal Testing (NIPT), Maternal Serum Screening (MSS), Prenatal Diagnostic Testing), By Region, Competition Forecast & Opportunities, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 17.14 Billion
CAGR (2026-2031)	8.24%
Fastest Growing Segment	Cervical Cancer
Largest Market	West
Market Size (2031)	USD 27.56 Billion

Market Overview

The United States Women Health Laboratory Testing Market will grow from USD 17.14 Billion in 2025 to USD 27.56 Billion by 2031 at a 8.24% CAGR. The United States Women Health Laboratory Testing Market encompasses diagnostic services and assays specifically designed to detect, monitor, and manage health conditions unique to or disproportionately affecting women, such as gynecological cancers, reproductive health disorders, and hormonal imbalances. The market is fundamentally driven by the rising prevalence of chronic and lifestyle-related diseases among the female population, coupled with increasing public awareness regarding the importance of early detection and preventive healthcare. Furthermore, favorable government initiatives aimed at improving access to screening programs and the expansion of reimbursement coverage for essential diagnostic tests are actively supporting market development.

The substantial volume of disease cases requiring diagnostic intervention further illustrates the critical nature of this sector. According to the American Cancer Society, in 2025, an estimated 316,950 women in the United States will be diagnosed with invasive breast cancer. Despite this sustained demand, the market encounters a significant impediment regarding the high cost associated with specialized molecular and genetic testing, which creates financial barriers for underinsured patients and restricts broader market expansion.

Key Market Drivers

The Rising Prevalence of Women-Centric Chronic and Infectious Diseases serves as a critical engine for market expansion, necessitating frequent and accurate diagnostic interventions. This driver encompasses the dual burden of sexually transmitted infections and gynecological malignancies, which require robust screening protocols to mitigate long-term health complications. For instance, the resurgence of infectious conditions has intensified the need for prenatal and reproductive health screening. According to the Centers for Disease Control and Prevention, September 2025, in the 'Sexually Transmitted Infections Surveillance, 2024 (Provisional)' report, reported cases of congenital syphilis increased for the 12th consecutive year, reaching nearly 4,000 cases. Simultaneously, the persistent threat of chronic conditions sustains demand for pathology and oncology testing. According to the American Cancer Society, January 2025, in 'Cancer Facts & Figures 2025', approximately 13,360 new cases of invasive cervical cancer are projected to be diagnosed in the United States, underscoring the continuous necessity for early diagnostic screening programs.

Technological Advancements in Molecular Diagnostics and Genetic Testing are significantly reshaping the market by enhancing test sensitivity, turnaround times, and accessibility. Innovations in polymerase chain reaction platforms and next-generation sequencing are empowering laboratories to deliver precise results for complex women's health panels, including those for high-risk HPV and reproductive genetics. These advancements not only improve clinical outcomes but also drive substantial commercial growth for diagnostic providers. Illustrating this trend, according to Hologic, Inc., February 2025, in its 'First Quarter Fiscal 2025 Financial Results', the company's diagnostics segment revenue increased 5.1% to $470.6 million, primarily fueled by the adoption of its molecular diagnostic assays. As these sophisticated technologies become more integrated into clinical workflows, they reduce the reliance on invasive procedures and facilitate the broader adoption of personalized medicine in women's healthcare.

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Key Market Challenges

The primary impediment hindering the growth of the United States Women Health Laboratory Testing Market is the prohibitive cost associated with specialized molecular and genetic diagnostic assays. These advanced testing methodologies, while clinically superior for detecting conditions such as gynecological cancers and hormonal disorders, often carry high price points that exceed standard insurance reimbursement limits. Consequently, a significant portion of the financial burden shifts to patients in the form of high out-of-pocket expenses. This economic friction discourages underinsured women from pursuing recommended screenings, leading to a substantial reduction in test volumes and stalling the widespread adoption of high-value diagnostic tools within the industry.

The impact of these financial barriers is evident in the persistence of adverse health outcomes that could be mitigated through timely, affordable diagnostics. According to the American Cancer Society, in 2025, it was projected that approximately 42,170 women in the United States would die from breast cancer. Industry experts attribute a portion of this mortality rate to delayed diagnoses, where cost concerns prevent patients from accessing early detection services. This dynamic constricts the market's addressable user base, as the inability to pay for essential testing prevents the conversion of clinical need into realized laboratory revenue.

Key Market Trends

The Proliferation of Direct-to-Consumer At-Home Fertility and Hormone Testing Kits is altering the market by democratizing access to reproductive health insights. Women are increasingly utilizing online platforms to autonomously order diagnostics for ovulation tracking and hormonal monitoring, bypassing traditional clinical gatekeepers. Laboratories are responding with digital infrastructures that facilitate direct-to-patient result delivery, effectively expanding their addressable market. This commercial pivot is evident in the strategic expansion of major providers; according to Quest Diagnostics, January 2025, in the 'Fourth Quarter and Full Year 2024 Financial Results', the company expanded its consumer-initiated test platform to include approximately 135 tests, driven by demand for personalized health solutions.

Simultaneously, the Mainstream Integration of Non-Invasive Prenatal Testing (NIPT) into Routine Antenatal Care is driving volume growth, transitioning assays from high-risk niches to standard screening. Clinicians are prioritizing cell-free DNA analysis over serum screening due to its higher sensitivity for detecting chromosomal aneuploidies, reducing unnecessary invasive procedures. This widespread adoption is reflected in the operational metrics of industry leaders. According to Natera, Inc., May 2025, in the 'First Quarter 2025 Financial Results', the company processed approximately 855,100 tests, an increase of 16.2% compared to the same period in the previous year, underscoring the rapid consolidation of NIPT as a primary tool.

Segmental Insights

In the United States Women Health Laboratory Testing Market, the cervical cancer segment represents the fastest-growing area driven by updated clinical guidelines and increased screening compliance. The U.S. Preventive Services Task Force has strengthened recommendations for regular screening, favoring primary human papillomavirus testing and co-testing strategies to improve detection rates. This shift in regulatory guidance, combined with a growing focus on preventive healthcare, mandates frequent and accurate testing. Therefore, clinical laboratories are experiencing a surge in demand for cervical cancer diagnostics to align with these established national health standards.

Regional Insights

The West region dominates the United States Women Health Laboratory Testing Market, primarily driven by a high concentration of biotechnology and diagnostic manufacturing companies, particularly in California. This region benefits from the early adoption of advanced genomic and molecular screening technologies, such as Non-Invasive Prenatal Testing (NIPT). Furthermore, robust healthcare infrastructure and proactive state-level public health initiatives significantly enhance the accessibility of reproductive and preventive care services. The presence of major industry innovators in the Western states fosters a dynamic environment that supports the continuous expansion of specialized diagnostic testing.

Recent Developments

• In August 2024, Quest Diagnostics released the findings of a breakthrough study conducted in collaboration with the University of Alabama, which analyzed deidentified laboratory data from over four million pregnancies in the United States. Published in the Journal of Lower Genital Tract Disease, the research revealed that adherence to guideline-based testing for chlamydia and gonorrhea during pregnancy was suboptimal. The study found that one in three women who tested positive for these sexually transmitted infections during pregnancy were not retested before delivery, despite the significant health risks posed to both mothers and newborns. The researchers highlighted that improving adherence to testing protocols and harmonizing guidelines were critical steps needed to address these gaps in maternal healthcare.
• In May 2024, Labcorp announced the launch of a new first-trimester screening test to assess the risk of preeclampsia during pregnancy. This test, the first of its kind available in the United States for this gestational period, was designed to be performed between 11 and 14 weeks of pregnancy to predict the risk of developing the condition before 34 weeks. The screening utilized four specific biomarkers to provide a comprehensive risk assessment, offering higher sensitivity than traditional methods based solely on maternal history or biophysical factors. This launch positioned the company as the only laboratory in the U.S. to offer preeclampsia risk screening across all three trimesters, aiming to improve maternal and fetal health outcomes through earlier detection.
• In May 2024, Roche announced that it obtained approval from the U.S. Food and Drug Administration (FDA) for its human papillomavirus (HPV) self-collection solution, making it one of the first such options available in the United States. The approval allowed individuals to privately collect their own vaginal samples in a healthcare setting, which would then be sent to a laboratory for analysis using the company's molecular instruments. This innovation aimed to reduce barriers to cervical cancer screening, such as access and embarrassment, by providing a more accessible alternative to clinician-collected procedures. The company stated that this solution would help improve access to testing for the large portion of the population that is currently underscreened, supporting global goals to eliminate cervical cancer.
• In February 2024, Hologic, Inc. announced that it received clearance from the U.S. Food and Drug Administration (FDA) for its Genius Digital Diagnostics System, which includes the Genius Cervical AI algorithm. This system became the first FDA-cleared digital cytology platform to combine advanced volumetric imaging with deep-learning artificial intelligence for cervical cancer screening. The technology was designed to help cytologists and pathologists identify pre-cancerous lesions and cervical cancer cells more accurately by digitally imaging glass slides and applying an AI algorithm to pinpoint cells of interest. The system aimed to improve sensitivity in detecting abnormalities without reducing specificity, thereby enhancing the efficiency of laboratory workflows and patient care in the fight against cervical cancer.

Key Market Players

• F.HoffmannLaRocheLtd
• MyriadGeneticsInc
• NateraInc
• BectonDickinsonandCompany
• HologicInc
• QuestDiagnosticsIncorporated
• AbbottLaboratoriesInc
• CardinalHealthInc
• GEHealthCare
• DiaSorinSpA

By Hereditary Cancer	By Reproductive Health and Infectious Diseases	By Prenatal Screening and Diagnostic Testing	By Region
Cervical Cancer Ovarian Cancer Breast Cancer	CT/NG Testing Preimplantation Genetic Testing (PGT) Herpes Simplex Virus (HSV) Hepatitis Sexually Transmitted Infections Vaginal Infections PAP Smear Testing HIV Testing Pregnancy and Ovulation Testing HPV Testing	Non-Invasive Prenatal Testing (NIPT) Maternal Serum Screening (MSS) Prenatal Diagnostic Testing	Northeast Midwest South West

Report Scope:

In this report, the United States Women Health Laboratory Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Women Health Laboratory Testing Market, By Hereditary Cancer:

• Cervical Cancer
• Ovarian Cancer
• Breast Cancer

• United States Women Health Laboratory Testing Market, By Reproductive Health and Infectious Diseases:

• CT/NG Testing
• Preimplantation Genetic Testing (PGT)
• Herpes Simplex Virus (HSV)
• Hepatitis
• Sexually Transmitted Infections
• Vaginal Infections
• PAP Smear Testing
• HIV Testing
• Pregnancy and Ovulation Testing
• HPV Testing

• United States Women Health Laboratory Testing Market, By Prenatal Screening and Diagnostic Testing:

• Non-Invasive Prenatal Testing (NIPT)
• Maternal Serum Screening (MSS)
• Prenatal Diagnostic Testing

• United States Women Health Laboratory Testing Market, By Region:

• Northeast
• Midwest
• South
• West