HPV Testing and Pap Test Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented Test Type (HPV Test, Pap Test, Co-testing), By Application (Cervical Cancer Screening Test, Head and Neck Cancer Screening Test, Other Applications), By End User (Hospitals/Clinics, Diagnostic Centers, Point-of-Care/Self-sampling), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 4.77 Billion
CAGR (2026-2031)	11.53%
Fastest Growing Segment	Diagnostic Centers
Largest Market	North America
Market Size (2031)	USD 9.18 Billion

Market Overview

The Global HPV Testing and Pap Test Market is projected to grow from USD 4.77 Billion in 2025 to USD 9.18 Billion by 2031 at a 11.53% CAGR. The Global HPV Testing and Pap Test Market comprises diagnostic technologies and laboratory services designed to detect human papillomavirus infections and identify cervical cytological abnormalities. The primary drivers fueling market expansion include the rising prevalence of cervical malignancies and the widespread implementation of government-mandated screening initiatives. According to the American Cancer Society, in 2025, approximately 13,360 new cases of invasive cervical cancer were projected to be diagnosed in the United States. This consistent disease burden necessitates rigorous diagnostic monitoring and sustains the demand for both molecular assays and cytological testing consumables.

However, the market faces a significant impediment regarding the high cost of implementation in developing economies. Limited healthcare infrastructure and a scarcity of trained cytopathologists in low-resource regions create substantial barriers to the adoption of advanced molecular diagnostic platforms. These financial and logistical constraints hinder the establishment of universal screening programs and restrict the potential for broader market scalability in emerging nations.

Key Market Drivers

Technological Innovations in HPV Diagnostics and Liquid-Based Cytology are fundamentally reshaping the market by enhancing accessibility and diagnostic accuracy. The recent regulatory approval of self-collection devices represents a structural shift, allowing patients to perform vaginal sampling at home, thereby overcoming barriers related to clinical visits and patient discomfort. This innovation not only expands the addressable market to under-screened populations but also integrates seamlessly with high-throughput molecular platforms used in central laboratories, maintaining clinical rigor while improving compliance. According to Teal Health, May 2025, in the 'FDA Approves Teal Wand' press announcement, the company's newly authorized self-collection device demonstrated a 96% sensitivity for detecting cervical precancer in clinical studies, a performance comparable to clinician-collected samples. Such advancements are critical in driving the adoption of primary HPV testing, as they significantly reduce logistical burdens on healthcare systems.

Implementation of Government-Led Cervical Cancer Screening Initiatives acts as a robust catalyst for sustained market growth by establishing large-scale, recurring demand for diagnostic consumables and laboratory services. National health services are increasingly transitioning towards organized screening programs that mandate specific testing intervals and technologies, securing long-term contracts for diagnostic manufacturers. According to NHS England, January 2025, in the 'Cervical Screening Programme Statistics' report, the national programme successfully tested 3.25 million individuals during the 2023-24 period, maintaining a coverage rate of 68.8% across the eligible population. These government-backed volumes provide stability and incentivize further industrial investment in diagnostic capacity to meet national elimination targets. Reflecting the financial scale of this demand, According to Hologic, in 2025, the company's Diagnostics segment generated $1.82 billion in revenue, driven largely by the global adoption of its molecular cervical health solutions.

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Key Market Challenges

The high cost of implementing advanced diagnostic infrastructure presents a primary obstacle to the expansion of the Global HPV Testing and Pap Test Market, particularly within developing economies. While developed nations maintain established screening protocols, low-resource regions struggle with the significant financial investment required for molecular diagnostic platforms and the recruitment of specialized personnel. This economic disparity creates a fragmented market landscape where growth is heavily concentrated in wealthy nations, leaving vast potential markets stagnant due to an inability to fund necessary laboratory networks and consumable supply chains. Consequently, the lack of affordable testing options directly limits the total addressable volume for manufacturers.

This infrastructure gap is statistically evident in the stark disparities regarding testing accessibility. According to the World Economic Forum, in 2024, less than 20% of women in lower-middle-income and low-income countries had been screened for cervical cancer in their lifetime, compared to 84% in high-income nations. This sharp contrast demonstrates how financial and logistical barriers effectively lock out a majority of the global population from participating in the testing market, thereby capping revenue potential for diagnostic providers in these regions.

Key Market Trends

The Integration of Artificial Intelligence in Cervical Cytology is fundamentally altering laboratory operations by automating the review of cellular samples to address workforce shortages. These AI-driven systems analyze digital images of Pap smears, prioritizing slides with potential abnormalities for pathologist review, thereby increasing screening throughput and standardizing diagnostic quality. By filtering out clearly negative cases, laboratories can significantly reduce manual workload and focus expert attention on complex diagnostics. According to Hologic, November 2025, in the 'Hologic Introduces Digital Pathology Capabilities With Expanded CE Marking' press announcement, the company's Genius Digital Diagnostics System received expanded regulatory clearance in the European Union to image and review both cell and tissue specimens, facilitating a unified digital workflow for disease diagnosis.

The Emergence of Molecular Biomarkers for Risk Stratification is advancing clinical decision-making by enabling more granular classification of HPV infections. Extended genotyping technologies now allow laboratories to identify specific high-risk viral strains beyond types 16 and 18, which carry varying levels of oncogenic potential. This capability permits healthcare providers to tailor follow-up protocols, reducing unnecessary colposcopies for lower-risk infections while ensuring immediate intervention for high-risk patients. According to BD (Becton, Dickinson and Company), November 2025, in the 'BD Onclarity HPV Assay for BD COR and BD Viper LT Systems Receive WHO Prequalification' press announcement, the company's assay became the first to be prequalified by the World Health Organization for individually identifying six high-risk HPV genotypes, underscoring the global shift towards precise molecular profiling.

Segmental Insights

Based on data from leading market research, the Diagnostic Centers segment is identified as the fastest-growing category in the Global HPV Testing and Pap Test Market. This rapid expansion is primarily driven by the increasing tendency of hospitals and clinics to outsource complex molecular testing to specialized facilities equipped with high-throughput automation. Diagnostic Centers offer superior operational efficiency and cost-effectiveness for processing the rising volume of samples generated by national screening initiatives. Furthermore, updated guidelines from regulatory bodies such as the World Health Organization (WHO), which advocate for widespread HPV DNA testing, require the advanced infrastructure typically found in these specialized laboratories, further solidifying their market dominance.

Regional Insights

North America maintains the leading position in the Global HPV Testing and Pap Test Market due to well-established cervical cancer screening programs and comprehensive reimbursement policies. The region benefits significantly from proactive clinical guidelines issued by organizations such as the American Cancer Society, which recommend routine co-testing and primary HPV screening for specific age groups. Additionally, the U.S. FDA plays a critical role by approving validated diagnostic assays, ensuring the availability of reliable testing options. This regulatory support, combined with high patient awareness regarding early disease detection, secures the continuous market expansion within the region.

Recent Developments

• In September 2024, Becton, Dickinson and Company (BD) announced the initial commercial shipments of its FDA-approved HPV self-collection kits to healthcare facilities across the United States. This launch enabled healthcare providers to offer a less invasive and more private screening option for patients, specifically designed for use with the BD Onclarity HPV Assay. The rollout was intended to extend cervical cancer screening access to non-traditional healthcare settings, such as retail pharmacies and mobile clinics. This strategic move supported national efforts to eliminate cervical cancer by providing a validated alternative to traditional Pap smears in the Global HPV Testing and Pap Test Market.
• In July 2024, Seegene Inc. demonstrated its advanced diagnostic solutions at the Asia-Oceania Research Organization in Genital Infection and Neoplasia (AOGIN) conference in Seoul. The company showcased its Allplex HPV HR Detection and Allplex HPV28 Detection assays, which utilize proprietary quantitative PCR technology to identify multiple high-risk and low-risk HPV genotypes. During the event, the company emphasized the clinical importance of genotyping for effective cervical cancer prevention and follow-up management. This showcase highlighted the company's commitment to expanding the adoption of syndromic PCR testing in the Global HPV Testing and Pap Test Market.
• In May 2024, Roche announced the FDA approval of its human papillomavirus (HPV) self-collection solution, marking a significant advancement in the Global HPV Testing and Pap Test Market. This approval allowed individuals to privately collect their own vaginal samples for screening in a healthcare setting, which were then analyzed using the company's cobas molecular instrument. The initiative addressed barriers to routine screening, such as lack of access or discomfort with clinician-collected exams, and aimed to improve detection rates among under-screened populations. The solution was approved for use with the cobas HPV test, which detects high-risk genotypes responsible for cervical cancer.
• In February 2024, Hologic, Inc. announced that its Genius Digital Diagnostics System received clearance from the U.S. Food and Drug Administration (FDA) for cervical cancer screening. This development represented the first FDA-cleared digital cytology platform to utilize deep-learning-based artificial intelligence to detect pre-cancerous lesions and cervical cancer cells. The system was designed to analyze digitally imaged glass slides to assist cytologists and pathologists in identifying abnormalities with greater sensitivity. By combining advanced volumetric imaging with AI algorithms, the company aimed to reduce false negatives and improve the efficiency of laboratory workflows in the Global HPV Testing and Pap Test Market.

Key Market Players

• Arbor Vita Corporation
• Danaher Corporation
• Seegene Inc.
• Becton, Dickinson and Company
• TruScreen Group Limited
• Abbott Laboratories
• Hologic Inc.
• Qiagen N.V.
• F. Hoffmann-La Roche Ltd
• OncoHealth Corporation

By Application	By End User	By Region
Cervical Cancer Screening Test Head and Neck Cancer Screening Test Other Applications	Hospitals/Clinics Diagnostic Centers Point-of-Care/Self-sampling	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global HPV Testing and Pap Test Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• HPV Testing and Pap Test Market, By Application:

• Cervical Cancer Screening Test
• Head and Neck Cancer Screening Test
• Other Applications

• HPV Testing and Pap Test Market, By End User:

• Hospitals/Clinics
• Diagnostic Centers
• Point-of-Care/Self-sampling

• HPV Testing and Pap Test Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE