United States Human Papilloma Virus (HPV) Testing Market Size & Forecast 2025–2033

The United States Human Papilloma Virus (HPV) Testing Market is experiencing a major transformation driven by updated clinical guidelines, strong public health campaigns, and an accelerating shift toward high-sensitivity molecular diagnostics. According to Renub Research, the market is projected to reach US$ 1,013.55 million by 2033, up from US$ 457.52 million in 2024, reflecting a 9.24% CAGR during 2025–2033.

Growing awareness of cervical cancer prevention, increased adoption of self-collection technologies, and rapid advancements in HPV genotype testing position this market for robust, long-term expansion across hospitals, clinics, laboratories, and public health channels.

A Market Transforming Through Innovation & Updated Screening Guidelines

Over the past decade, HPV testing has shifted from a supportive test to a leading diagnostic tool in the U.S.—a result of compelling clinical evidence and evolving national guidelines. Today, HPV testing is recognized as more sensitive, more predictive, and more reliable than traditional cytology (Pap smears), especially for early detection of high-grade cervical lesions.

ACS & USPSTF Guidelines Fuel Market Adoption

The American Cancer Society (ACS) updated its guidelines in 2020, recommending:

Primary HPV screening every 5 years

For all individuals aged 25–65 years

The U.S. Preventive Services Task Force (USPSTF) followed in December 2024 with a historic recommendation supporting:

HPV testing every 5 years for ages 30–65

Allowing self-collected HPV samples in clinical settings for the first time

These updates have sparked national momentum, promoting HPV tests as the gold standard for cervical cancer screening.

Major Impact on Underserved Communities

With nearly 13,000 cervical cancer cases and 4,000 deaths annually, and half occurring in under-screened populations, expanded guideline-driven testing aims to close critical care gaps. National and state programs—often in partnership with the CDC, ASHA, Kaiser Permanente, and the NCI—are working to boost access and improve health equity.

Self-collection technologies, mobile clinics, and federally supported outreach programs are enabling screening for populations historically left behind.

Market Drivers: What’s Fueling Growth?

1. Rising Awareness & Preventive Healthcare Initiatives

Public health agencies and non-profit organizations are aggressively promoting HPV testing as essential preventive care. Awareness campaigns are especially effective in:

Urban centers with strong healthcare networks

Minority communities with historically lower screening rates

Younger women transitioning from Pap-based to HPV-based testing

The integration of HPV screening into national cervical cancer elimination strategies—aligned with WHO’s 2030 framework—is expected to sustain growth throughout the forecast period.

2. Technological Advancements in Molecular Diagnostics

The U.S. market is benefiting from next-generation diagnostic tools, including:

PCR-based assays

Liquid-based cytology platforms

Genotype-specific HPV tests

Next-generation sequencing (NGS)

AI-assisted diagnostic interpretation

FDA-approved self-sampling kits

These technologies offer improved accuracy, speed, and convenience. They also reduce false negatives, enhance sensitivity for high-risk strains, and support mass screening initiatives by increasing laboratory throughput.

Notable FDA approvals include:

Abbott’s Alinity m HR HPV Assay – Approved in November 2023

Roche cobas HPV Test – Widely adopted, including for the FDA-approved self-collection pathway (May 2024)

3. Growing Investments, Insurance Coverage & Screening Programs

Rising healthcare spending and insurance expansion are making HPV testing more affordable for millions. Public and private investments are accelerating:

Workforce training

Lab modernization

Infrastructure upgrades

Mobile screening services

Digital health integration

Government-funded screening programs for low-income groups also significantly boost the market.

Market Challenges

1. Socioeconomic Inequalities & Accessibility Gaps

Despite progress, several barriers persist:

Limited access in rural regions

Lower screening rates among low-income women

Cultural stigmas surrounding HPV

Language and educational barriers

Gaps in insurance literacy

Addressing these disparities is essential for national cancer prevention goals.

2. High Costs & Implementation Barriers

Advanced molecular platforms require:

Costly equipment

Specialized personnel

Compliance with strict laboratory standards

Smaller clinics and community health centers often struggle with adoption, limiting nationwide standardization. While reimbursement has improved, gaps remain for certain tests and patient categories.

Regional Market Outlook: Leading States in HPV Testing Adoption

California

California accounts for one of the largest HPV testing markets due to:

Statewide screening programs

High public health spending

Strong urban healthcare presence

Leading diagnostic innovations from Silicon Valley and major medical centers

Continuous outreach to low-income and rural populations enhances its statewide testing footprint.

Texas

Texas stands out due to its sizable population and rapidly expanding diagnostic ecosystem. Key factors:

High adoption in metropolitan areas: Houston, Dallas, Austin

Ongoing public-private initiatives

Mobile clinics supporting rural regions

Increasing integration of molecular diagnostic technologies

Texas remains a high-potential growth driver with significant opportunities for new entrants.

New York

New York is a frontrunner in HPV test adoption, powered by:

World-class medical research institutions

Strong Medicaid and private payer coverage

Diverse demographic outreach

Robust state-funded screening programs

Minority and immigrant communities benefit from focused education and access initiatives.

Florida

Florida’s demand is growing rapidly due to:

A large, aging population

Strong provider networks in cities like Miami, Tampa, Orlando

Adoption of advanced molecular diagnostics

Community partnerships improving rural screening rates

Florida remains one of the most dynamic HPV testing markets in the Southeast.

Recent Market Development

In April 2025, Quest Diagnostics announced a groundbreaking national program allowing self-collected HPV specimens in clinical settings—leveraging Roche’s FDA-approved cobas HPV self-collection method.

This marks a major step toward:

Expanding screening accessibility

Reducing patient hesitation

Improving uptake among under-screened populations

Quest will deploy self-collection across 2,000 service centers beginning next month.

Market Segmentation

By Application

Cervical Cancer Screening

Vaginal Cancer Screening

By Product

Consumables

Instruments

Services

By Technology / Distribution Channel

Polymerase Chain Reaction (PCR)

Liquid-Based Cytology

Immunodiagnostics

Hybrid Capture

Others

By End Use

Hospitals & Clinics

Laboratories

Others

By States

Includes major and emerging markets such as:

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, and the Rest of United States.

Competitive Landscape & Company Profiles

Below are condensed SWOT-style insights for major players shaping the U.S. HPV Testing Market.

Abbott Laboratories

Overview: Leading developer of molecular assays, including the Alinity m HR HPV test.

Strength: Strong automation and global diagnostics footprint

Weakness: High platform costs

Opportunity: Rising shift to high-throughput molecular testing

Threat: Competition from Hologic and Roche

BioMérieux SA

Overview: Known for infectious disease diagnostics; expanding into HPV via molecular platforms.

Strength: Advanced microbiology networks

Weakness: Smaller HPV test portfolio relative to peers

Opportunity: Growth in PCR demand

Threat: Pressure from U.S.-based diagnostic giants

Bio-Rad Laboratories, Inc.

Overview: Supplies reagents, PCR tools, and molecular diagnostic solutions.

Strength: Strong research-focused ecosystem

Weakness: Limited FDA-approved HPV assays

Opportunity: Expansion into clinical HPV testing

Threat: Regulatory hurdles

Epigenomics AG

Overview: Focus on epigenetic testing and cancer biomarkers.

Strength: Innovation in early cancer detection

Weakness: Small U.S. market presence

Opportunity: Rising demand for precision oncology

Threat: Larger competitors with deeper pipelines

Siemens Healthineers AG

Overview: Global diagnostics leader with automation and imaging tools.

Strength: Extensive hospital partnerships

Weakness: Indirect presence in specialized HPV testing

Opportunity: Integration of HPV testing into automated platforms

Threat: Rapidly evolving molecular landscape

Hologic Inc.

Overview: Dominant U.S. women’s health diagnostics company; strong HPV pipeline.

Strength: Market-leading technologies and wide clinical adoption

Weakness: High pricing vs smaller competitors

Opportunity: Rising adoption of co-testing

Threat: Increasing reliance on molecular-only strategies

Qiagen NV

Overview: Known for the digene HC2 HPV test and sample-preparation tools.

Strength: Deep molecular diagnostics expertise

Weakness: Competition from PCR-based tests

Opportunity: Renewed demand for hybrid capture technologies

Threat: Market shift toward automation-heavy platforms

F. Hoffmann-La Roche Ltd

Overview: Major innovator behind the cobas HPV test; the leader in self-collection approvals.

Strength: Strong FDA-approved pipeline

Weakness: Higher equipment investment

Opportunity: Growing adoption of self-collection

Threat: Pressure to lower costs for community clinics

Final Thoughts

The United States HPV Testing Market stands at a pivotal moment. With the shift toward molecular-based primary screening, rising awareness, and transformational self-collection technologies, the sector is set for sustained double-digit growth. Guideline updates, public health investments, and technological breakthroughs empower millions of women to access reliable, early detection tools—ultimately driving down cervical cancer rates nationwide.

Backed by a strong forecast through 2033, this rapidly maturing market offers substantial opportunities for diagnostic innovators, labs, healthcare providers, and patient-centered organizations committed to expanding equitable screening access.