HPV Testing And Pap Test Market Size and Share
Market Overview
| Study Period | 2019 - 2030 |
|---|---|
| Market Size (2025) | USD 6.87 Billion |
| Market Size (2030) | USD 11.43 Billion |
| Growth Rate (2025 - 2030) | 10.70% CAGR |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0. |
|
HPV Testing And Pap Test Market Analysis by Mordor Intelligence
The HPV Testing and Pap Test market reached USD 6.87 billion in 2025 and is forecast to attain USD 11.43 billion by 2030, translating into a 10.7% CAGR over the period. Uptake accelerates as primary HPV screening becomes the standard of care, self-collection gains regulatory backing, and governments align with the WHO 90-70-90 elimination targets. Rapid guideline shifts, AI-enabled cytology, and DNA-methylation triage biomarkers improve test accuracy and laboratory throughput while widening access in low-resource settings. HPV vaccination generates future volume headwinds, yet near-term demand remains buoyant because screening coverage in many regions is still below 50%. Consolidation pressure is mounting after the FDA’s 2024 rule on laboratory-developed tests, which favors vendors able to shoulder heavier compliance costs.
Key Report Takeaways
By test type, Pap tests led with 53.45% of HPV Testing and Pap Test market share in 2024, while HPV testing is projected to expand at an 11.25% CAGR through 2030.
By sample collection method, clinician-collected cervical samples dominated with 69.86% share of the HPV Testing and Pap Test market size in 2024; self-collection is advancing at an 11.56% CAGR to 2030.
By product & service, consumables and reagents accounted for 54.38% of the HPV Testing and Pap Test market size in 2024, whereas software and AI platforms record the fastest 11.88% CAGR.
By application, cervical cancer screening captured 80.62% of HPV Testing and Pap Test market share in 2024, yet post-treatment follow-up is rising at a 12.21% CAGR.
By end user, pharma and biotech companies held 53.82% share of the HPV Testing and Pap Test market size in 2024; home-based testing shows the highest 12.54% CAGR.
Global HPV Testing And Pap Test Market Trends and Insights
Driver Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Rising incidence of cervical cancer | +2.1% | Global, with highest impact in Asia-Pacific and Sub-Saharan Africa | Medium term (2-4 years) |
| Shift to primary HPV testing guidelines | +1.8% | North America & EU, expanding to APAC | Short term (≤ 2 years) |
| Growing adoption of self-collection kits | +1.5% | Global, with early gains in Australia, Canada, UK | Short term (≤ 2 years) |
| Government-backed screening programs | +1.4% | National programs in China, India, Australia, NHS England | Medium term (2-4 years) |
| DNA-methylation biomarkers for triage | +0.9% | EU & North America, selective APAC markets | Long term (≥ 4 years) |
| AI-assisted cytology platforms | +0.7% | North America, EU, Japan, South Korea | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
Rising incidence of cervical cancer
WHO's February 1, 2024 press release explicitly states: "In 2022, cervical cancer accounted for 661,044 new cases and 348,186 deaths globally. Screening coverage is still 4% in sub-Saharan Africa, creating a large untreated population base. China’s plan to reach 70% coverage by 2030 could generate 400 million additional tests. India faces 1.5 million DALYs in 2025, spurring federal and state screening initiatives. These dynamics underpin sustained demand for both cytology-based and molecular diagnostics.
Shift to primary HPV testing guidelines
WHO, ASCCP, and many national programs now endorse DNA-based HPV tests as first-line screening because sensitivity exceeds 95% for CIN2+ versus 53% for Pap cytology. Ontario replaced Pap tests with HPV testing in March 2025. British Columbia saw 25,000 self-screens in months after its January 2024 switch. These policy moves accelerate laboratory investment in high-throughput PCR platforms.
Growing adoption of self-collection kits
Roche and BD gained FDA clearance for self-collection solutions in May 2024, confirming diagnostic equivalence with clinician-collected samples. Teal Health’s Teal Wand became the first at-home device approved in May 2025 and showed 96% accuracy alongside 94% user preference. Australia reports self-collection now contributes 27% of all cervical tests. Self-sampling boosts participation from 17% to 41% in controlled NIH trials.
Government-backed screening programs
NHS England targets elimination by 2040 and is adding self-collection options to raise attendance above the current 68.8%. Canada’s modeling shows elimination by 2034 with primary HPV testing versus 2045 under cytology. China and India are scaling nationwide screening subsidization, securing long-run demand visibility.
Restraint Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| HPV vaccination curbing test volumes | -1.6% | North America & EU, expanding globally | Long term (≥ 4 years) |
| Regulatory & reimbursement hurdles | -1.2% | Global, with highest impact in emerging markets | Medium term (2-4 years) |
| Limited molecular-lab capacity (LICs) | -0.8% | Sub-Saharan Africa, South Asia, Latin America | Long term (≥ 4 years) |
| Data-privacy concerns in at-home screening | -0.4% | EU, North America, developed APAC markets | Short term (≤ 2 years) |
| Source: Mordor Intelligence | |||
HPV vaccination curbing test volumes
CDC surveillance shows CIN2-3 lesions plummeted 79% among U.S. women aged 20-24 between 2008 and 2022. England observed an 83.9% cervical-cancer reduction in vaccinated cohorts. Germany reports a 51.1% drop in CIN2+ prevalence post-immunization. These successes shrink long-term screening pools, especially in high-income countries.
Regulatory and reimbursement hurdles
The FDA final rule ends enforcement discretion for laboratory-developed tests, phasing in full IVD oversight by 2028. Legal challenges from laboratory associations create uncertainty that can delay capital investment. Emerging technologies face undefined payer coverage pathways that extend commercialization timelines.
Segment Analysis
By Test Type: Molecular Transition Accelerates
HPV testing is forecast to grow at an 11.25% CAGR, overtaking cytology even though Pap tests still held 53.45% HPV Testing and Pap Test market share in 2024. The HPV Testing and Pap Test market size for HPV assays is projected to reach USD 6.1 billion by 2030, supported by policy mandates in Canada, U.K., and Australia. Laboratories retain dual workflows—co-testing and reflex cytology—during the transition.
Liquid-based cytology (LBC) remains integral because LBC slides feed AI algorithms that raise accuracy with minimal staffing increases. Conventional Paps persist in resource-constrained geographies lacking PCR capacity but will gradually decline as donor-funded PCR initiatives expand. Vendors position multiplex HPV genotyping panels to increase clinical value and offset falling Pap volumes.
By Sample Collection Method: Self-Sampling Gains Momentum
Clinician-collected cervical samples captured 69.86% of HPV Testing and Pap Test market size in 2024, but self-collection is growing 11.56% annually and could approach parity by 2030. The HPV Testing and Pap Test market share for self-collection is buoyed by strong patient preference scores and health-equity objectives.
Urine-based sampling shows promise for remote communities though clinical validation remains ongoing. Blood-based serology is still niche, used primarily in epidemiology. Providers are integrating mail-order logistics, telehealth consent, and automated result portals to support self-sampling scale-up.
By Product & Service: AI Platforms Drive Premium Growth
Consumables and reagents supplied 54.38% of revenue in 2024 and grow in lockstep with test volumes. Software and AI platforms, however, post an 11.88% CAGR as laboratories seek workflow automation and triage accuracy. The HPV Testing and Pap Test market size for AI software is expected to cross USD 1.3 billion by 2030.
Instrument upgrades focus on higher-throughput, random-access analyzers that minimize sample batching. Vendors bundle reagent rental contracts with AI licenses, creating hybrid recurring-revenue models that lock in laboratory customers.
By Application: Surveillance Demand Rises
Cervical cancer screening remained 80.62% of 2024 revenue, yet post-treatment monitoring shows the fastest 12.21% CAGR as survivorship improves. The HPV Testing and Pap Test market size tied to surveillance could double by 2030 because persistent HPV integration predicts recurrence.
Clinical trials increasingly embed HPV and methylation assays as endpoints, generating specialty testing demand. Population health programs deploy reflex methylation triage to reduce unnecessary colposcopies, lowering system costs.
Note: Segment shares of all individual segments available upon report purchase
By End User: Home-Based Testing Disrupts
Pharma and biotech companies led revenue with 53.82% in 2024, leveraging large-scale trial screening. Home-based testing, though, is the standout growth story at 12.54% CAGR as devices like the Teal Wand earn FDA clearance. The HPV Testing and Pap Test market share for home users could exceed 10% by 2030.
Hospitals manage complex diagnostics and immediate treatments, whereas physician offices pivot to counseling roles, interpreting mailed-in results and arranging follow-up.
Competitive Landscape
North America wielded 42.23% of 2024 revenue, reflecting comprehensive insurance coverage, early molecular adoption, and robust self-collection pilots. Canada’s switch to HPV primary screening and the U.S. FDA’s pro-innovation stance sustain growth even as vaccination dampens long-run volumes. Mexico’s cross-border laboratory partnerships expand reach but infrastructure gaps persist in rural states.
Asia-Pacific is the fastest-growing region at 12.89% CAGR, fueled by China’s 70% screening mandate and India’s high disease burden. Australia showcases mature self-sampling rollouts, while Japan and South Korea advance AI cytology. Many ASEAN nations secure donor funding for PCR platforms, widening addressable populations.
Europe presents stable single-digit growth: the U.K. races toward 2040 elimination using self-collection. Germany’s vaccination success will moderate future screening demand but opens opportunities in triage biomarkers. Eastern Europe and the Balkans lag in coverage but represent expansion targets. Latin America and Africa face the lowest current penetration; international aid and public-private partnerships are critical to catalyze instrument placements and training programs.
HPV Testing And Pap Test Industry Leaders
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Arbor Vita Corporation
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F. Hoffmann-La Roche Ltd
-
Seegene Inc.
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Becton, Dickinson and Company
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Qiagen NV
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- May 2025: Teal Health won FDA approval for the Teal Wand, the first at-home cervical cancer screening device, with 96% accuracy and 94% patient preference
- March 2025: Ontario replaced Pap with HPV testing in its provincial program
Global HPV Testing And Pap Test Market Report Scope
As per the scope of the report, the human papillomavirus (HPV) test is used to detect the presence of the human papillomavirus, which leads to the development of genital warts, abnormal cervical cells, or cervical cancer. A Pap smear, also called Pap test or smear test, is a procedure doctors use to find cell changes or abnormal cells in the cervix. A Pap smear removes a microscopic sample of cells from the cervix to test for cancer and precancer. Pap tests are the most preferred tests to detect cervical cancer. These tests include microscopic observation of specimens.
The HPV testing and Pap test market is segmented by test type, application, end user, and geography. By test type, the market is segmented into HPV test, Pap test, and co-testing. The market is segmented by application into cervical cancer screening tests, head and neck cancer screening tests, and other applications. By end user, the market is segmented into hospitals/clinics, diagnostic centers, and point-of-care/self-sampling. Geographically, the market is segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and South America. The report offers the value (USD) for the above segments.
| HPV Testing | Primary HPV Screening |
| Follow-up HPV Testing | |
| Co-testing (HPV + Pap) | |
| Pap Test | Liquid-based Cytology (LBC) |
| Conventional Pap Smear |
| Clinician-Collected Cervical Sample |
| Self-Collected Vaginal Swab |
| Urine-based Sampling |
| Blood / Serum-based (Serology) |
| Instruments & Analyzers |
| Consumables & Reagents |
| Software & AI Platforms |
| Testing Services |
| Cervical Cancer Screening |
| Post-treatment Follow-up |
| Clinical Trials & Epidemiology |
| Others |
| Hospitals & Surgical Clinics |
| Diagnostic Laboratories |
| Physician Offices |
| Home Care / Direct-to-Consumer |
| North America | United States |
| Canada | |
| Mexico | |
| Europe | Germany |
| United Kingdom | |
| France | |
| Italy | |
| Spain | |
| Rest of Europe | |
| Asia-Pacific | China |
| India | |
| Japan | |
| South Korea | |
| Australia | |
| Rest of Asia-Pacific | |
| South America | Brazil |
| Argentina | |
| Rest of South America | |
| Middle East and Africa | GCC |
| South Africa | |
| Rest of Middle East and Africa |
| By Test Type | HPV Testing | Primary HPV Screening |
| Follow-up HPV Testing | ||
| Co-testing (HPV + Pap) | ||
| Pap Test | Liquid-based Cytology (LBC) | |
| Conventional Pap Smear | ||
| By Sample Collection Method | Clinician-Collected Cervical Sample | |
| Self-Collected Vaginal Swab | ||
| Urine-based Sampling | ||
| Blood / Serum-based (Serology) | ||
| By Product & Service | Instruments & Analyzers | |
| Consumables & Reagents | ||
| Software & AI Platforms | ||
| Testing Services | ||
| By Application | Cervical Cancer Screening | |
| Post-treatment Follow-up | ||
| Clinical Trials & Epidemiology | ||
| Others | ||
| By End User | Hospitals & Surgical Clinics | |
| Diagnostic Laboratories | ||
| Physician Offices | ||
| Home Care / Direct-to-Consumer | ||
| By Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Europe | Germany | |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Asia-Pacific | China | |
| India | ||
| Japan | ||
| South Korea | ||
| Australia | ||
| Rest of Asia-Pacific | ||
| South America | Brazil | |
| Argentina | ||
| Rest of South America | ||
| Middle East and Africa | GCC | |
| South Africa | ||
| Rest of Middle East and Africa | ||
Key Questions Answered in the Report
How big is the HPV Testing And Pap Test Market?
The HPV Testing And Pap Test Market size is expected to reach USD 6.87 billion in 2025 and grow at a CAGR of 10.70% to reach USD 11.43 billion by 2030.
What is the current HPV Testing And Pap Test Market size?
In 2025, the HPV Testing And Pap Test Market size is expected to reach USD 6.87 billion.
Who are the key players in HPV Testing And Pap Test Market?
Arbor Vita Corporation, F. Hoffmann-La Roche Ltd, Seegene Inc., Becton, Dickinson and Company and Qiagen NV are the major companies operating in the HPV Testing And Pap Test Market.
Which is the fastest growing region in HPV Testing And Pap Test Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in HPV Testing And Pap Test Market?
In 2025, the North America accounts for the largest market share in HPV Testing And Pap Test Market.
What years does this HPV Testing And Pap Test Market cover, and what was the market size in 2024?
In 2024, the HPV Testing And Pap Test Market size was estimated at USD 6.13 billion. The report covers the HPV Testing And Pap Test Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the HPV Testing And Pap Test Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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