The "United States Human Papilloma Virus Testing Market Report by Application, Product, Technology, End Use, States and Company Analysis, 2025-2033" report has been added to ResearchAndMarkets.com's offering.



United States Human Papilloma Virus Testing Market is expected to reach US$ 1.01 billion by 2033 from US$ 457.52 million in 2024, with a CAGR of 9.24% from 2025 to 2033.

The U.S. HPV testing market shows regional variation, with strong adoption in California, Texas, New York, and Florida, driven by healthcare infrastructure, awareness programs, and government-backed initiatives promoting preventive testing across diverse demographics. Rising awareness of cervical cancer prevention, more screening programs, technical advancements, and the expanding use of sophisticated diagnostic technologies in healthcare settings are all likely to contribute to the steady growth of the US HPV testing market.



United States Human Papilloma Virus Testing Industry Overview



The American Cancer Society (ACS) and the U.S. Preventive Services Task Force (USPSTF) encourage women aged 30 to 65 to get primary HPV testing or co-testing, which increases uptake. FDA approvals have increased the number of high-sensitivity, genotype-specific choices, including Abbott's Alinity m HR HPV assay (November 2023) and Roche's cobas Human Papilloma Virus (HPV) Test. Access to screening is being improved for underserved people through an increase in self-sampling pilots, spearheaded by Kaiser Permanente and other organizations. In line with governmental objectives to lower the incidence of cervical cancer, demand is further fueled by growing awareness initiatives from the CDC and American Sexual Health Association.



Updated clinical guidelines, historic regulatory approvals, and a move toward patient-centered screening approaches are driving the rapid evolution of the U.S. HPV testing market. The American Cancer Society (ACS) revised their guidelines in July 2020, stating that primary HPV testing every five years is the recommended course of action for anyone between the ages of 25 and 65. The ACS cited improved accuracy, longer screening intervals, and fewer needless procedures when compared to Pap smears. This action reflects mounting evidence that HPV testing avoids the overdiagnosis associated with cytology and more accurately detects high-grade precancerous lesions.



According to proposed guidelines published in December 2024 by the U.S. Preventive Services Task Force (USPSTF), women aged 30 to 65 should get tested for HPV every five years. Pap testing or HPV/Pap co-testing are acceptable substitutes. Importantly, the USPSTF recognized research demonstrating similar accuracy to clinician-collected specimens and noticeably higher uptake among historically under screened groups by include self-collected HPV samples obtained in healthcare settings for the first time.



Together, these programs have the potential to eliminate important screening gaps, as there are 13,000 new cervical cancer diagnoses and 4,000 related deaths in the United States each year, with over half occurring in under screened populations. In order to increase reach, update screening procedures, and guarantee equitable access, public-private partnerships - like the National Cancer Institute's Cervical Cancer "Last Mile" Initiative - are in line with WHO's 2030 eradication approach. The U.S. HPV testing market is anticipated to grow rapidly as self-collection and guideline-driven HPV testing become more popular. This growth will be fueled by rising demand for high-sensitivity molecular assays, wider participation, and increased reimbursement coverage.



Key Factors Driving the United States Human Papilloma Virus Testing Market Growth

Rising Awareness and Preventive Healthcare Initiatives



Public health campaigns, educational programs, and awareness drives are increasing the adoption of HPV testing across the U.S. Government agencies and non-profit organizations actively promote cervical cancer prevention through regular screening. Initiatives highlighting the importance of early detection are encouraging women to undergo HPV testing as part of routine healthcare. These efforts are particularly effective in urban centers where access to healthcare is stronger, but outreach to underserved populations is also expanding.

The integration of HPV testing into national cervical cancer prevention guidelines has further reinforced its role as a primary diagnostic tool. This rising awareness ensures higher participation rates, strengthening the market and positioning HPV testing as an essential part of preventive healthcare strategies.



Technological Advancements in Diagnostic Tools



Advances in diagnostic technology are significantly enhancing the performance of HPV testing. The adoption of molecular assays, PCR-based technologies, and automation has improved accuracy, reduced turnaround time, and increased scalability of testing. Next-generation sequencing (NGS) and AI-supported diagnostic platforms are enabling more precise identification of high-risk HPV strains, offering clinicians deeper insights into patient risk profiles.

These innovations also support the integration of HPV testing with broader diagnostic panels, improving efficiency for laboratories and healthcare providers. Technological progress is not only increasing reliability but also lowering operational complexities, making HPV testing more widely accessible. As innovation continues, these advancements will remain key drivers for market growth by expanding adoption across clinical and non-clinical healthcare settings.



Growing Healthcare Investments and Screening Programs



Rising healthcare expenditure and expanding insurance coverage in the U.S. are driving increased access to HPV testing. Government-led screening programs and private initiatives are ensuring broader adoption of preventive testing across demographics. Funding support for cervical cancer screening initiatives, particularly for low-income and rural populations, is helping to bridge healthcare access gaps.

Insurance providers are increasingly covering HPV testing as a standard diagnostic service, reducing out-of-pocket costs for patients and promoting higher uptake. Additionally, healthcare systems are investing in infrastructure and workforce training to support advanced testing capabilities. The focus on preventive medicine, combined with strong financial backing, ensures that HPV testing continues to be prioritized as an essential service within the national healthcare framework.



Challenges in the United States Human Papilloma Virus Testing Market

Socioeconomic and Accessibility Barriers



Despite advancements, disparities in healthcare access remain a major challenge for the U.S. HPV testing market. Underserved populations, particularly in rural areas and among low-income groups, often lack access to affordable diagnostic services. Cultural stigmas and lack of awareness about HPV and its link to cervical cancer further reduce participation in screening programs.

Language barriers, limited healthcare infrastructure, and insufficient outreach in certain communities exacerbate the issue. This uneven access prevents the full potential of HPV testing from being realized, ultimately affecting national cervical cancer prevention goals. Addressing these barriers requires targeted awareness campaigns, mobile testing units, community-based programs, and policy reforms to ensure equitable access for all demographic groups across the country.



High Costs and Implementation Challenges



The high costs associated with advanced HPV testing technologies present another challenge. Molecular assays, DNA sequencing methods, and automated platforms often come with significant expenses, making them less accessible to smaller clinics or uninsured patients. While large hospitals and diagnostic centers can absorb these costs, community-based facilities often struggle. Implementation hurdles, including the need for specialized equipment, trained professionals, and regulatory compliance, further limit widespread adoption.

Although insurance coverage is expanding, reimbursement gaps persist, creating financial challenges for both providers and patients. Balancing cost-efficiency with technological advancement is critical. Without broader affordability and streamlined implementation strategies, the adoption of HPV testing may face limitations in achieving nationwide coverage and consistent utilization.

Key Attributes:

Company Analysis: Overview, Key Persons, Recent Developments, SWOT Analysis, Revenue Analysis

• Abbott Laboratories
• BioMerieux SA
• Bio-Rad Laboratories, Inc.
• Epigenomics AG
• Siemens Healthineers AG
• Hologic Inc
• Qiagen NV
• F. Hoffmann-La Roche Ltd
• Bruker Corp
• FUJIFILM Holdings Corp
• Cubresa Inc.

Market Segmentations

Application

• Cervical Cancer Screening
• Vaginal Cancer Screening

Product

• Consumables
• Instruments
• Services

Distribution Channels

• Polymerase chain reaction (PCR)
• Liquid-based cytology
• Immunodiagnostics
• Hybrid Capture
• Others

End Use

• Hospitals & Clinics
• Laboratories
• Others

States

• California
• Texas
• New York
• Florida
• Illinois
• Pennsylvania
• Ohio
• Georgia
• New Jersey
• Washington
• North Carolina
• Massachusetts
• Virginia
• Michigan
• Maryland
• Colorado
• Tennessee
• Indiana
• Arizona
• Minnesota
• Wisconsin
• Missouri
• Connecticut
• South Carolina
• Oregon
• Louisiana
• Alabama
• Kentucky
• Rest of United States

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