United States Human Papilloma Virus Testing Market Report by Application, Product, Technology, End Use, States and Company Analysis, 2025-2033

United States Human Papilloma Virus Testing Market Size and Forecast
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. 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 Papillomavirus (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.

United States Human Papilloma Virus Testing Market Overview by States

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. The following provides a market overview by States:

California Human Papilloma Virus Testing Market

California represents one of the largest markets for HPV testing in the United States, supported by its extensive healthcare infrastructure and diverse population. The state has actively promoted cervical cancer screening through government-led programs and community health initiatives. High awareness levels, coupled with urban healthcare accessibility, ensure widespread adoption of HPV testing. Additionally, the integration of advanced molecular diagnostic technologies into leading hospitals and clinics has reinforced California’s role as a hub for innovation in preventive healthcare. Private and public healthcare providers are working collaboratively to expand coverage among underserved communities, particularly in rural and low-income areas. With its focus on education, technology adoption, and accessibility, California continues to play a pivotal role in driving growth within the national HPV testing market.

Texas Human Papilloma Virus Testing Market

Texas holds a significant share of the HPV testing market, driven by its large population base and diverse healthcare ecosystem. The state has prioritized cervical cancer prevention through expanded screening programs and partnerships between public health agencies and private providers. Urban centers such as Houston, Dallas, and Austin exhibit strong adoption rates due to advanced medical infrastructure, while rural areas continue to face accessibility challenges. Efforts to address these disparities include mobile screening units and state-supported initiatives targeting underserved populations. Healthcare providers in Texas are increasingly integrating molecular diagnostic technologies, improving the accuracy and efficiency of testing. As preventive healthcare becomes a greater focus, Texas remains a critical market with opportunities for both technology providers and healthcare stakeholders.

New York Human Papilloma Virus Testing Market

New York is a leading state in HPV testing adoption, supported by its strong healthcare infrastructure, research institutions, and robust public health programs. The state actively promotes awareness about cervical cancer prevention, particularly in urban centers like New York City, where access to healthcare is extensive. Advanced diagnostic technologies are widely integrated into hospitals and laboratories, ensuring accurate and efficient testing. Efforts to expand coverage include outreach programs for minority communities and underserved populations, addressing cultural and socioeconomic barriers. Insurance coverage for HPV testing further supports its widespread utilization across the state. With its combination of policy support, healthcare innovation, and awareness campaigns, New York remains at the forefront of HPV testing adoption, significantly contributing to the overall U.S. market growth.

Florida Human Papilloma Virus Testing Market

Florida plays a vital role in the U.S. HPV testing market, with its healthcare system emphasizing preventive care and cervical cancer screening. The state’s large and diverse population, coupled with high demand for healthcare services, supports strong market adoption. Urban areas like Miami, Orlando, and Tampa showcase advanced diagnostic infrastructure, while rural regions face challenges in accessibility and awareness. Public health initiatives and partnerships with non-profits are helping to expand testing among underserved communities. Healthcare providers in Florida are also adopting molecular testing technologies, improving detection rates and reducing diagnostic errors. With growing awareness campaigns and insurance coverage expansion, Florida continues to drive growth in HPV testing, positioning itself as an important regional contributor to the national market landscape.

Recent Developments in U.S. Human Papilloma Virus Testing Market

• A new project to increase access to human papillomavirus (HPV) screening for women at risk of cervical cancer was announced by Quest Diagnostics in April 2025. In a clinical or other healthcare setting, doctors can now give patients the option to self-collect specimens for HPV screening as part of this program. At its 2,000 patient service locations around the country, Quest will also start offering the self-collection option with a doctor's order early next month. This program expands on Quest's successful self-collection services for vaginitis and other genital tract illnesses, such as trichomoniasis, gonorrhea, chlamydia, and Mycoplasma genitalium, which were launched in October 2024 and have experienced high patient adoption. Utilizing Roche's FDA-approved HPV self-collection method, which was authorized in May 2024 for use with the Cobas HPV test, the new product makes sample collection easy and discrete while preserving clinical accuracy.

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

All the Key players have been covered

• Overviews
• Key Person
• Recent Developments
• SWOT Analysis
• Revenue Analysis

Company 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.