• In February 2023, the U.S. FDA approved BD's Onclarity HPV Assay, which, when used with the ThinPrep PAP test, detects HPV types 16, 18, 45, and additional genotypes including 31, 51, 52, 56/59/66, and 33/58, as well as 35/39/68.

• In June 2022, Roche Diagnostics launched a new HPV self-sampling solution aimed at expanding its cancer screening portfolio. This solution allows patients to privately collect HPV screening samples at healthcare facilities under the supervision of healthcare workers.

In this report, the Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market has been segmented by Test Type, Technology, Application, End User and Geography.

Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market, Segmentation by Test Type

The Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market has been segmented by Test Type into HPV Test, PAP Test, Co-Testing, and Others.

HPV Test

HPV tests lead the global HPV and PAP test market with an estimated share of 40–45%. These tests detect high-risk strains of the human papillomavirus, which are directly linked to the development of cervical cancer. Due to their superior sensitivity and early detection potential, HPV testing is being increasingly adopted in both routine and high-risk screenings.

PAP Test

PAP tests, also known as Pap smears, make up approximately 30–35% of the market. This traditional screening method remains essential for identifying precancerous cervical cell changes. Although newer methods are emerging, PAP tests continue to be a cornerstone of routine cervical screening, especially in countries with established public health protocols.

Co-Testing

Co-testing represents around 15–20% of the market and is becoming a preferred method for women over 30. By combining both the HPV test and PAP test, co-testing improves detection accuracy and minimizes missed diagnoses. It is increasingly included in global screening guidelines for early cervical cancer detection.

Others

The 'Others' category accounts for roughly 5–10% of the market and includes innovative diagnostic approaches such as liquid-based cytology, self-sampling kits, and advanced molecular screening technologies. These alternatives aim to improve screening access, particularly in low-resource or remote areas.

Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market, Segmentation by Technology

The Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market has been segmented by Technology into Polymerase Chain Reaction (PCR), Liquid-Based cytology, Immunodiagnostics, Hybrid Capture and Others.

Polymerase Chain Reaction (PCR)

PCR technology leads the HPV and PAP test market with a share of approximately 35–40%. Renowned for its high sensitivity and specificity, PCR is used to amplify and identify high-risk HPV DNA sequences. Its ability to deliver reliable results quickly makes it a preferred choice for clinical diagnostics and early-stage detection.

Liquid-Based Cytology

Liquid-based cytology represents about 25–30% of the market and is widely used in routine cervical screening. This method enhances sample quality, reduces contamination, and improves cell visualization. It remains a trusted and efficient approach for identifying abnormal cervical cells in a minimally invasive way.

Immunodiagnostics

Immunodiagnostics account for roughly 15–18% of the global market. These tests detect HPV-associated proteins and antigens, offering complementary insights alongside molecular assays. The approach is gaining traction in population-level screening due to its convenience and diagnostic value.

Hybrid Capture

Hybrid capture holds a share of about 10–12%, offering a proven alternative for HPV DNA detection. It utilizes RNA probes and chemiluminescence signals to detect viral presence. FDA-approved and scalable, it remains widely used in high-volume diagnostic labs.

Others

The 'Others' category contributes an estimated 5–7% and includes innovations like next-generation sequencing (NGS), AI-powered screening tools, and self-sampling kits. These technologies are paving the way for personalized diagnostics, remote access, and enhanced automation in HPV and cervical cancer testing.

Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market, Segmentation by Application

The Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market has been segmented by Application into Cervical Cancer Screening Test, Vaginal Cancer Screening Test and Others.

Cervical Cancer Screening Test

Cervical cancer screening dominates the global HPV and PAP test market, accounting for approximately 75–80% of the total application share. Routine use of PAP smears and HPV DNA testing has become a global standard for early cervical cancer detection. Public health initiatives, screening awareness, and government-supported programs continue to drive strong adoption worldwide.

Vaginal Cancer Screening Test

Vaginal cancer screening makes up an estimated 10–12% of the market. Although less prevalent than cervical cancer, the role of HPV-based diagnostics in identifying high-risk patients is gaining ground. As clinical guidelines evolve, there’s a growing push for comprehensive gynecological screening, including tests for vaginal malignancies.

Others

The 'Others' segment contributes around 8–10% and includes testing for anal cancer, head and neck cancers, and other HPV-associated diseases. These applications are seeing increased research and clinical attention, driven by rising awareness of HPV’s role in non-cervical cancers and growing support for multi-site screening.

Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market, Segmentation by End User

The Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market has been segmented by End User into Hospitals/Clinics, Laboratories and Other

Hospitals/Clinics

Hospitals and clinics dominate the end-user segment, accounting for about 45–50% of the global HPV and PAP test market. These healthcare facilities are primary sites for routine cervical cancer screening, where both PAP tests and HPV diagnostics are administered. Their integrated care approach and physician-led testing make them highly reliable access points.

Laboratories

Laboratories represent approximately 35–40% of the market, functioning as centralized hubs for high-throughput diagnostic testing. They specialize in HPV DNA detection, liquid-based cytology, and molecular analysis, ensuring precise and efficient processing for public health and private screening programs.

Others

The 'Others' category contributes around 10–15% and includes independent diagnostic centers, research labs, and mobile screening services. These end users are vital for reaching underserved populations, conducting field testing, and advancing innovation in HPV diagnostics.

Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market, Segmentation by Geography

In this report, the Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa and Latin America.

Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market Share (%), by Geographical Region, 2024

North America

North America dominates the global HPV and PAP test market with an estimated share of 40–45%. The region’s leadership stems from widespread access to preventive healthcare, high awareness of cervical cancer screening, and robust adoption of advanced testing technologies. The United States remains the key market due to its established infrastructure and insurance-backed screening programs.

Europe

Europe holds a strong position with approximately 25–30% market share, supported by national screening policies, well-developed healthcare systems, and strong regulatory frameworks. Adoption of co-testing and liquid-based cytology is increasing across Western Europe, with public-private partnerships enhancing test accessibility.

Asia Pacific

Asia Pacific is growing rapidly with a market share of 15–20%, driven by a rising burden of cervical cancer, expanding healthcare infrastructure, and growing awareness. Governments in China, India, and Japan are promoting HPV vaccination programs and subsidized screening initiatives.

Middle East & Africa

Middle East & Africa accounts for a smaller share of 3–5%, largely limited by insufficient access to routine screening. However, growing awareness in urban areas, international support, and NGO-driven programs are helping to improve screening uptake and infrastructure in key regions.

Latin America

Latin America contributes about 5–7% to the global market. Countries like Brazil, Argentina, and Mexico are focusing on expanding HPV testing, supported by public health campaigns and the rollout of low-cost diagnostics. Increased efforts in cervical cancer prevention are strengthening the region’s presence in the market.

This report provides an in depth analysis of various factors that impact the dynamics of Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Increasing HPV prevalence
• Growing awareness programs
• Technological advancements
• Rising cervical cancer cases

• Government initiatives support - Government initiatives play a pivotal role in supporting the Global Human Papillomavirus (HPV) Test and Papanicolaou (PAP) Test Market. One of the primary ways governments contribute is through public health programs aimed at promoting awareness, prevention, and early detection of cervical cancer, which is closely linked to HPV infection. Many governments allocate significant funding towards vaccination programs targeting HPV, particularly for young girls, as vaccination has proven effective in preventing HPV infection and subsequently reducing the risk of cervical cancer. Additionally, governments often collaborate with healthcare organizations and NGOs to establish screening programs that offer PAP tests to detect abnormal cervical cells early, enabling timely intervention and treatment.

  Government support extends to healthcare infrastructure development, particularly in low- and middle-income countries where access to screening and diagnostic services may be limited. Governments may invest in building and upgrading healthcare facilities, training healthcare professionals in performing PAP tests, and ensuring the availability of necessary equipment and supplies. By prioritizing cervical cancer prevention and screening initiatives, governments not only contribute to improving public health outcomes but also alleviate the burden of cervical cancer on healthcare systems and society as a whole. These concerted efforts underscore the importance of government initiatives in driving growth and accessibility in the Global HPV Test and PAP Test Market.

Restraints

• Limited healthcare access
• Stigma surrounding testing

• Lack of skilled professionals - Lack of skilled professionals is not a driver but rather a significant restraint in the Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market. The effectiveness of cervical cancer screening programs heavily relies on the availability of trained cytotechnologists, pathologists, and lab technicians to perform, analyze, and interpret test results accurately. In many low- and middle-income regions, a shortage of these professionals leads to delayed diagnoses, inconsistent test quality, and limited screening coverage, ultimately impacting patient outcomes.

  This gap in skilled labor also limits the adoption of advanced screening technologies that require specialized training for operation and interpretation. As testing procedures grow more sophisticated with the integration of automated systems and molecular diagnostics, the demand for technically proficient personnel continues to rise. Without adequate training infrastructure and workforce development, the full potential of HPV and PAP testing remains underutilized, especially in areas where cervical cancer incidence is highest.

Opportunities

• Emerging markets expansion
• Development of self-testing kits
• Telemedicine integration
• Focus on preventive healthcare

• Strategic partnerships formation - Strategic partnerships formation, while often viewed as a growth enabler, can also act as a restraint in the Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market when not executed effectively. Collaborative ventures between diagnostic companies, healthcare providers, and government agencies may encounter challenges related to misaligned objectives, regulatory hurdles, or intellectual property concerns. These issues can delay project execution, restrict technology sharing, and limit the scalability of screening initiatives in underserved regions.

  Additionally, over-reliance on partnerships for expanding market access or technology deployment may reduce flexibility and slow decision-making. In some cases, poorly structured agreements can lead to inefficient resource allocation or fragmented service delivery, ultimately impacting test availability and affordability. To mitigate these risks, stakeholders must ensure that collaborations are backed by clear governance, aligned incentives, and long-term sustainability strategies, especially in the context of expanding global cervical cancer screening programs.

Key players in Global Human Papillomavirus (HPV) Test & Papanicolaou (PAP) Test Market include:

• Roche Diagnostics
• Hologic Inc
• Becton Dickinson and Company (BD)
• Abbott Laboratories
• Qiagen NV
• Quest Diagnostics
• Thermo Fisher Scientific Inc
• F Hoffmann-La Roche Ltd
• Siemens Healthineers
• OncoCyte Corporation

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Market Share Analysis
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis