U.S. Cervical Cancer Laboratory Testing Market: Focus on Test Type, and Region-Level Analysis - Analysis and Forecast, 2025-2035

Introduction to U.S. Cervical Cancer Laboratory Testing Market

Cervical cancer laboratory testing refers to diagnostic procedures used to detect abnormalities in the cervix that may lead to cervical cancer. The tests typically include PAP smears to identify cell changes and HPV DNA testing to detect the presence of high-risk human papillomavirus strains. These tests help in early detection, allowing for timely intervention and prevention.

Various factors such as the increasing prevalence of cervical cancer in the U.S., advancement in testing technologies, increasing government initiatives and screening programs, and shifting trends towards precision medicine are driving the market of cervical cancer laboratory testing. According to the American Cancer Society, approximately 14,100 women are diagnosed with cervical cancer in the U.S. each year. This rising number of cases drives the demand for early screening and diagnostic tests, particularly through Pap smears and HPV (Human Papillomavirus) testing, which are crucial for detecting the disease at early stages.

Moreover, continuous advancements in cervical cancer testing technologies have expanded the testing market. The development of molecular diagnostics, such as HPV DNA testing, has significantly improved the accuracy of screening tests. For instance, Qiagen’s digene HPV test, approved by the FDA, is used to detect high-risk HPV types associated with cervical cancer, offering enhanced diagnostic precision compared to traditional Pap smears.

Also, government-led initiatives to reduce cervical cancer rates are driving market growth. The U.S. Preventive Services Task Force (USPSTF) recommends regular screening for cervical cancer through Pap tests and HPV testing for women aged 21 to 65. Federal and state health agencies have also launched awareness programs, increasing public knowledge about cervical cancer prevention and boosting the adoption of diagnostic tests. In addition, the American Cancer Society's (ACS) guidelines encourage women to begin screening at age 21 and continue with regular tests until age 65. This has led to the widespread adoption of HPV and Pap testing as standard healthcare practice in the U.S. Various states in the U.S. also have local initiatives, such as California's Cervical Cancer Control Program (C4P), which helps women in underserved communities access free or low-cost Pap smears and HPV testing.

However, the high costs associated with advanced diagnostic tests, such as HPV DNA testing and molecular screening, can be a barrier to widespread adoption. For instance, tests like the HPV DNA test by Abbott Laboratories or Qiagen can be more expensive than routine Pap smears, making them less accessible to certain populations, especially those without insurance or in underserved areas.

Furthermore, despite government efforts, there remains a gap in awareness and access to cervical cancer screening, particularly in rural and low-income areas. Women in these regions may have limited access to healthcare facilities that offer laboratory testing or may lack awareness about the importance of regular screening, thus restricting the market growth.

Market players are actively introducing new technologies, expanding testing options, and collaborating with healthcare organizations to increase accessibility and awareness. For instance, Qiagen’s Cervista HPV HR test is an FDA-approved test used to detect high-risk HPV types that are known to be associated with cervical cancer. The company is expanding its HPV testing portfolio by combining HPV DNA testing with other diagnostic solutions, such as its Digene HC2 High-Risk HPV DNA Test. Qiagen has also been involved in raising awareness through educational campaigns in various regions, including the U.S. to increase the adoption of HPV testing. Similarly, Abbott’s Alinity m HPV Assay is another advanced HPV test that aids in detecting high-risk strains of HPV. In 2023, Abbott entered a collaboration with various public health organizations in the U.S. to enhance awareness about HPV testing and encourage women to undergo regular screening.

Key players in the market are Abbott Laboratories, Inc., Becton, Dickinson and Company, F. Hoffmann-La Roche, QIAGEN N.V., and Laboratory Corporation of America Holdings, Hologic, Inc., among others.

Market Segmentation:

Segmentation 1: by Test Type
• PAP Smear • HPV Testing

HPV Testing to Lead the U.S. Cervical Cancer Laboratory Testing Market (by Test Type)

In the U.S. cervical cancer laboratory testing market, HPV testing is currently dominating the market over Pap smear tests. The shift toward HPV testing as the primary screening method is driven by its higher accuracy and ability to detect the root cause of cervical cancer high-risk HPV infections before abnormal cell changes occur. HPV testing is more sensitive than the Pap smear test in detecting cervical cancer risk. It identifies the presence of high-risk HPV strains, which are the primary cause of cervical cancer, even before abnormal cell changes appear. For instance, the FDA-approved Cobas HPV Test by Roche is one of the leading HPV tests used in the U.S. It can detect high-risk HPV types 16 and 18, which are responsible for the majority of cervical cancer cases, offering earlier and more accurate detection. Moreover, health organizations such as the U.S. Preventive Services Task Force (USPSTF) and the American Cancer Society now recommend HPV testing as the preferred method for cervical cancer screening for women over 30. The guidelines suggest co-testing with both Pap smear and HPV tests for women aged 30 to 65, but HPV testing is often considered more reliable for primary screening, especially for women over 30. For instance, Quest Diagnostics offers co-testing for both Pap and HPV, which is now the standard of care for cervical cancer screening.

Segmentation 2: by Region

Northeast Region (by State)
Midwest Region (by State)
South Region (by State)
West Region (by State)

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