The global cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market size was estimated at USD 8,437.04 million in 2024 and is projected to grow at a CAGR of 5.90% from 2025 to 2035, driven by advancements in technology, artificial intelligence (AI), and patient-centric screening programs. Efforts to enhance early detection and streamline diagnostic workflows are playing a pivotal role in reducing the global burden of cervical cancer.
According to a 2021 National Cancer Institute study, approximately 70-80% of eligible women (ages 21-65) in the U.S. are up to date with their screening recommendations. These guidelines include Pap tests and for women over 30, HPV testing or co-testing at extended intervals as advised by the U.S. Preventive Services Task Force (USPSTF). Similarly, Canada’s provincial programs report high participation rates in cervical cancer screening. However, despite strong participation, traditional screening methods-including Pap tests, liquid-based cytology (LBC), visual inspection with acetic acid (VIA), and HPV DNA testing-often require colposcopy for confirmation, which can be resource-intensive and prone to human error.
AI is revolutionizing cervical cancer screening by improving accuracy, speed, and scalability. AI-powered algorithms, particularly those based on deep learning, are now being integrated into screening workflows to detect early-stage cellular abnormalities with greater precision automatically. By analyzing large datasets of Pap smear images, these systems can consistently flag potential pre-cancerous lesions, reducing the likelihood of missed early-stage abnormalities and improving patient outcomes.
A notable advancement in AI-driven diagnostics is CerviCARE AI, a system introduced in a Scientific Reports study in January 2024. Developed to enhance colposcopy efficiency, CerviCARE AI automatically analyzes Tele-cervicography images and differentiates between low-grade and high-grade cervical lesions. In a multicenter retrospective study, the system achieved an impressive 98% sensitivity for high-risk groups (including P2, P3, HSIL, and CIN2 or higher) and a specificity of 95.5%. These findings suggest that AI-powered diagnostic tools like CerviCARE AI could significantly enhance early detection efforts, streamline cervical cancer screening workflows, and reduce diagnostic errors. Although further prospective studies are needed to validate its clinical effectiveness, the integration of AI in cervical cancer diagnostics and pre-cancerous lesion detection marks a major advancement in the market.
A groundbreaking shift in cervical cancer screening is the rise of self-screening programs, improving accessibility for individuals who may face barriers to traditional testing methods. In British Columbia, starting January 29, 2024, a province-wide cervix self-screening program was launched, becoming the first at-home self-screening option in Canada. This initiative allows individuals aged 25 to 69 to order a self-collection kit for HPV testing or opt for sample collection by a healthcare provider. Given that HPV is the primary cause of cervical cancer, this innovative screening approach aims to facilitate early detection and intervention, significantly reducing cervical cancer incidence. Premier David Eby highlighted the program’s potential in achieving the goal of eliminating cervical cancer in the province.
Similarly, in May 2024, the Alaska Native Tribal Health Consortium introduced an initiative focused on in-house HPV testing aimed at improving early detection and timely treatment. With 95% of cervical cancers linked to untreated HPV infections, this program is designed to streamline the screening process, minimize delays, and improve patient outcomes through efficient, localized diagnostics. Both of these innovative screening initiatives underscore the market’s shift toward more accessible, efficient, and patient-centric solutions.
Technology |
Description |
Application |
Thermal ablation |
Utilizes heat beams to eradicate precancerous cervical lesions. |
Significant potential for cervical cancer prevention. |
Liquid-based cytology and automation |
Enhances case adequacy and lab productivity, facilitates HPV testing, and is compatible with automated analysis. |
Enhanced screening efficiency. |
Point-of-care HPV molecular test |
Plays a crucial role in allowing the clinical research team to offer post-test counseling to women who tested positive for HPV. |
Self-sampling and high-resolution microendoscopy technologies. |
Molecular testing advancements |
Genomic techniques analyze oncogene and tumor suppressor gene profiles at the DNA level, focusing on clinically relevant biomarkers associated with HPV infections. |
Integration of high-risk HPV DNA detection into prevention efforts, potential for improved risk assessment and triage. |
Artificial intelligence (AI) |
Enhances accuracy and efficiency in interpretation, aids non-invasive differentiation of cervical cancer, and supports triaging of HPV-positive individuals. |
Real-time and reliable diagnosis, automated recognition of cervical precancer and cancer. |
Biomarkers |
Involves HPV DNA testing, miRNAs, proteins, HPV E6/E7 oncogene transcripts, p16INKa/ki-67, M-CSF, VEGF, DNA methylation, PD-L1 status, mismatch repair status, and tumor mutational burden status. |
Potential in enhancing early detection and prognosis; further research needed for clinical applicability. |
Leading companies are introducing cutting-edge products that enhance early detection, diagnostics, and treatment of pre-cancerous dysplasia lesions. In May 2024, Roche achieved a significant milestone with FDA approval for its HPV self-collection solution, one of the first self-sampling options available in the U.S. This innovative tool allows individuals to collect their own vaginal samples in a healthcare setting, which are then analyzed using Roche’s cobas molecular instrument in a specialized laboratory. By simplifying the screening process and enabling prompt HPV detection, this technology ensures faster diagnosis and early intervention, reducing the progression to pre-cancerous lesions or cervical cancer.
The cervical cancer screening industry is experiencing rapid innovation, driven by AI-powered diagnostics, self-sampling kits, and molecular testing advancements. Technologies like CerviCARE AI and Roche’s HPV self-collection solution enhance accuracy and accessibility. AI-driven automation, digital pathology, and deep-learning algorithms are transforming early detection, reducing errors, and streamlining clinical workflows for efficient pre-cancerous lesion identification.
The market has witnessed increased mergers and acquisitions (M&A), with major diagnostic firms acquiring biotech startups to enhance their cervical cancer screening portfolios. Companies are focusing on integrating AI, liquid biopsy, and molecular diagnostics into their offerings. Strategic collaborations and acquisitions are accelerating product innovation, global market penetration, and cost-effective screening solutions for low-resource settings.
Regulatory frameworks shape product approvals and market adoption. Stringent guidelines from the FDA, CE Mark, and WHO ensure screening tests meet safety and efficacy standards. Policies promoting self-screening and AI integration are driving adoption, while data privacy regulations and reimbursement policies influence market dynamics, ensuring compliance and widespread acceptance of new diagnostic technologies.
Companies are expanding product lines by integrating AI-driven colposcopy, digital cytology, and molecular HPV testing. Innovations include non-invasive self-collection kits, next-generation sequencing (NGS), and telemedicine-compatible screening solutions. With growing emphasis on early detection and precision diagnostics, firms are developing cost-effective, portable, and scalable screening solutions for global healthcare markets.
The market is expanding into emerging economies with high cervical cancer prevalence. Governments and global health organizations are supporting affordable screening programs in Africa, Asia, and Latin America. Companies are establishing local manufacturing units, distribution partnerships, and regulatory approvals to enhance access. This expansion bridges healthcare gaps, improving screening rates and patient outcomes worldwide.
Based on type, the cervical cancer screening segment led the market with the largest revenue share of 48.29% in 2024 and is anticipated to grow at the fastest CAGR during the forecast period. Cervical cancer screening is essential for early detection and prevention, utilizing a variety of devices and technologies to enhance accuracy, accessibility, and patient outcomes. Traditional Pap smear collection tools remain a cornerstone of screening, particularly in areas lacking advanced diagnostic infrastructure. However, HPV testing platforms have emerged as the preferred screening method due to their high sensitivity in detecting high-risk HPV strains, which are the leading cause of cervical cancer. Leading products in this category include Roche’s Cobas HPV test and Abbott’s Alinity m HR HPV Assay. Cytology sample collection devices, such as cytobrushes, improve sample quality, while colposcopes aid in detecting abnormal lesions during follow-up examinations. In addition, cervical biopsy devices are critical for histopathological analysis when high-grade lesions are suspected. The rise of self-collection kits, such as Roche’s HPV Self-Collection Solution and Teal Health’s Teal Wand, has significantly increased screening participation, particularly among underserved populations. Advanced technologies like High-Resolution Microendoscopy (HRME) and AI-driven screening tools are further revolutionizing the segment by improving diagnostic accuracy and efficiency.
Several competitive developments are propelling growth in the cervical cancer screening industry. In May 2024, the FDA approved Roche’s HPV Self-Collection Solution for use with the cobas HPV test, allowing private, at-home sample collection and addressing screening barriers. That same month, Teal Health’s Teal Wand received Breakthrough Device Designation from the FDA, reflecting the rising demand for accessible screening options. In November 2023, Abbott’s Alinity m HR HPV Assay was approved, providing genotyping for 14 high-risk HPV strains and strengthening HPV-based screening. The HPV Self-Sampling Initiatives launched in November 2024 under the NHS Cervical Screening Program validated the accuracy and user satisfaction of Aptima Multitest, FLOQswabs, and Evalyn Brush for self-sampling. The YouScreen Trial, conducted by King’s College London in July 2024, demonstrated that HPV self-sampling kits could potentially screen over one million additional women within three years, addressing disparities among ethnic minorities and underserved groups. In January 2024, the UK Government and NHS England integrated digital pathology into screening programs, enhancing diagnostic speed and efficiency through remote slide reviews. In February 2025, BD and Camtech Health launched Singapore’s first at-home HPV testing initiative, combining Camtech’s self-collection test with the BD Onclarity HPV Assay to improve early detection of high-risk HPV genotypes.
The cervical cancer diagnostics industry is witnessing substantial growth, driven by advancements in biopsy devices and colposcopes, alongside increasing adoption and demand for these technologies. In December 2024, the Federal Capital Territory Administration introduced a colposcopy machine designed to enhance early detection and treatment of cervical cancer among women. This groundbreaking initiative is expected to revolutionize healthcare delivery in the region. By incorporating advanced colposcopic technology, healthcare providers can swiftly detect cervical abnormalities and implement timely interventions. The improved diagnostic precision offered by these tools not only enhances patient outcomes but also contributes to broader efforts to lower cervical cancer mortality rates.
Biopsy tools have also undergone significant advancements in recent years. These instruments play a crucial role in obtaining precise tissue samples from suspicious areas in the cervix, enabling accurate histopathological analysis. Modern biopsy devices are designed to be minimally invasive, prioritizing patient comfort while providing clinicians with high-quality specimens for diagnosis. The synergy between advancements in colposcopy and biopsy technology is instrumental in reducing cervical cancer mortality rates by enabling early detection, accurate diagnosis, and prompt intervention. These innovations are reshaping the landscape of cervical cancer management and prevention.
North America dominated the cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market with the largest revenue share of 41.17% in 2024. North America has made remarkable progress in reducing cervical cancer incidence and mortality over the past several decades, primarily through extensive cervical cancer screening programs. These initiatives rely heavily on Pap smears (cytology) and, increasingly, human papillomavirus (HPV) testing. However, despite high overall screening rates in many regions, disparities persist in screening participation and follow-up care, particularly among underserved populations.
To address these gaps, healthcare systems across North America are adopting innovative solutions. Recent FDA approvals for HPV self-collection tests, such as the cobas HPV and BD Onclarity HPV assays, present a promising alternative for women who may avoid traditional pelvic exams due to discomfort, cultural sensitivities, or past trauma. These advancements aim to broaden screening accessibility and enhance early detection efforts, ensuring more women receive timely diagnosis and treatment.
The cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market in the U.S. is growing significantly. Projections for 2025 indicate that the American Cancer Society estimates 13,360 new invasive cervical cancer cases and 4,320 deaths in the United States. Cervical cancer primarily affects women aged 35-44, with the average age at diagnosis being around 50. Notably, over 20% of cases are diagnosed in women over 65, particularly among those who were unscreened earlier in life.
In the realm of treatment innovations, several key clinical trials are shaping the future of cervical cancer management. The INTERLACE Trial (2023) evaluated induction chemotherapy followed by chemoradiotherapy (CRT) versus CRT alone in patients with locally advanced cervical cancer, demonstrating improved progression-free survival (HR: 0.65; p=0.013) and overall survival (HR: 0.61; p=0.04). Similarly, the BEATcc Trial (2023) focused on first-line treatment for recurrent or metastatic cervical cancer, comparing a regimen of paclitaxel, carboplatin, and bevacizumab with or without atezolizumab. This trial reported enhanced progression-free survival (HR: 0.62; p<0.0001) and overall survival (HR: 0.68; p=0.0046) with the inclusion of atezolizumab.
The cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market in Europe holds the second-largest share, propelled by robust government initiatives. According to the WHO, more than 66,000 women in the WHO European Region are diagnosed with cervical cancer annually, with over 30,000 succumbing to the disease.
In August 2020, the World Health Assembly adopted the Global Strategy to eliminate cervical cancer as a public health problem, marking the first global commitment to eradicating cancer. Building on this momentum, the WHO European Region introduced the Roadmap to Accelerate Elimination of Cervical Cancer (2022-2030), which aims to secure universal access to HPV vaccination, screening, and treatment services.
Achieving the 90-70-90 global targets by 2030 will require coordinated, cross-country efforts to ensure equitable prevention and care. These ambitious initiatives are driving substantial demand for HPV vaccines, advanced screening technologies, diagnostic tools, and innovative treatment solutions, thereby broadening healthcare infrastructure and expanding market opportunities across the region.
The UK cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market is experiencing growth. Government initiatives, enhanced screening programs, and technological advancements in diagnostic tools are driving increased adoption. Innovations in HPV testing and therapeutic treatments further bolster market expansion, improving early detection and patient outcomes. As public health priorities align with industry developments, the market is poised for continued progress, fostering improved care, and lowering cervical cancer mortality rates.
The cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market in France is expanding in response to the disease’s incidence. Among the 27.9 million at-risk women, there are 3,379 new cases and 1,452 deaths annually. Cervical cancer ranks 12th among female cancers and 4th for ages 15-44, with HPV-16/18 responsible for 75.6% of cases and a 4.7% HPV prevalence in women with normal cytology. Since introducing HPV vaccination in 2007-with 46% receiving the first dose and 37% full-dose by 2021-France has also implemented a national screening program in 2020, targeting women aged 25-65 through cytology (every three years for ages 25-29) and HPV tests (every five years for ages 30-65), achieving a 76% participation rate over the past five years.
The cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market in Asia Pacific is expanding, driven by both the disease burden and technological advancements. Cervical cancer remains a major public health concern across Asia, with significant variations in prevention efforts and healthcare infrastructure among subregions. This form of cancer disproportionately affects women in low- and middle-income countries, where access to vaccination, screening, and treatment is limited. A study published in the Asian Pacific Journal of Cancer Prevention in July 2023 emphasized the critical need for effective screening methods, especially in developing nations. The review highlighted innovative solutions such as HPV-DNA self-tests, portable colposcopes, and smartphone-based tools, which have the potential to improve accessibility and clinical efficiency. These advancements are set to play a pivotal role in enhancing early detection and treatment, thereby propelling market growth across the region.
The Japan cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market is witnessing significant growth driven by innovation. In February 2025, the National Cancer Center Japan launched the A-TRAIN study under the ATLAS project, which focuses on personalized treatments for advanced cancers, including cervical cancer, through the use of liquid biopsy. This pioneering study is conducted in collaboration with industry leaders such as Guardant Health, Thermo Fisher, and Roche, highlighting the country's commitment to advancing cancer care.
The cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market in India is experiencing significant growth driven by robust awareness programs. In February 2025, Roche Diagnostics India signed an MoU with CAPED to combat cervical cancer through comprehensive early detection and awareness initiatives, which include conducting 100 workshops and distributing HPV DNA self-sampling kits.
The Australia cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market is experiencing robust growth fueled by significant investments. In November 2023, the Albanese Labor Government announced a USD 48.2 million investment over four years to implement the National Strategy for the Elimination of Cervical Cancer by 2035, along with an additional USD 12.5 million dedicated to supporting cervical cancer elimination efforts in the Indo-Pacific region. Continuing its proactive approach, in September 2024, the government launched the "Own It" campaign, a USD 10 million initiative designed to promote cervical cancer screening among women aged 25-74. This campaign emphasizes self-collection testing and specifically targets priority groups, including Aboriginal and Torres Strait Islander women.
The cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market in Latin America is expanding due to the high prevalence of the disease. Despite advancements in screening and prevention, cervical cancer remains a major public health challenge in the region, with high incidence and mortality rates. Human papillomavirus (HPV) infection, the leading cause of cervical cancer, is widespread and further exacerbated by limited healthcare access, socioeconomic disparities, and varying awareness levels regarding preventive measures. Argentina and Brazil, two of Latin America’s largest countries, continue to face a substantial cervical cancer burden, though their epidemiological profiles and prevention strategies vary.
The Brazil cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market is growing, driven by strong government support and strategic initiatives. In 2023, the Brazilian Federation of Gynecology and Obstetrics Associations (FEBRASGO) introduced targeted measures to combat cervical cancer. These include expanding HPV vaccination campaigns, enhancing screening programs for early detection, ensuring equitable access to treatment nationwide, and launching public awareness campaigns to educate communities on prevention, vaccination, and regular screenings.
The cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market in the Middle East & Africa region, including South Africa, Saudi Arabia, and the UAE, is experiencing growth due to the high prevalence of the disease. In the Middle East and North Africa region, cervical cancer remains a leading cause of female mortality. According to the ICO/IARC HPV Information Centre (2023), deaths are projected to rise from 8,964 in 2012 to 16,241 by 2030, averaging 44 fatalities per day without intervention. HPV vaccination, particularly for girls aged 9-13, offers up to 99% efficacy with minimal side effects. However, the financial burden of treating advanced cervical cancer remains a significant challenge for many families, underscoring the need for increased preventive measures and accessible healthcare solutions.
The South Africa cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market is growing due to the high prevalence of the disease. Among the 22.2 million women at risk, an estimated 10,702 new cases and 5,870 deaths occur annually. Cervical cancer is the second most common cancer among women and the leading cause of cancer-related deaths in those aged 15-44. HPV-16 and HPV-18 are responsible for 64.2% of cases.
South Africa introduced HPV vaccination in 2014, achieving a 34% coverage rate for the final dose by 2021. Screening for cervical cancer is recommended for women aged 25-55, with cytology performed every five years or HPV testing every ten years. Current screening coverage stands at 44% for women aged 25-65 and 52% for those aged 30-49. In addition, the country faces a high HIV prevalence of 25.8%, which further impacts cervical cancer risk and screening efforts.
Some major players catering to the cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment industry are F. Hoffmann-La Roche; BD; Abbott; QIAGEN; Hologic, Inc.; CooperSurgical Inc.; MedGyn Products, Inc.; WISAP Medical Technology GmbH; Liger Medical; Utah Medical Products, Inc; among others. These companies focus on capturing the market by increasing their presence using various business initiatives, such as collaborations and partnerships with the government. Their well-established product portfolios help them capture major market share.
SD Biosensor, Inc., Wantai BioPharm., and Lionex GmbH are among the emerging market participants. These companies' prevalent operating strategies include developing and launching improved and new diagnostic tools that offer higher accuracy, faster results, and easier usability.
The following are the leading companies in the cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market. These companies collectively hold the largest market share and dictate industry trends.
In May 2024, BD, in collaboration with the National Cancer Institute, launched the Cervical Cancer "Last Mile" Initiative to address disparities in cervical cancer screening, focusing on underserved communities
In February 2024, BD partnered with Camtech Health to introduce self-collection cervical cancer screening options in Singapore, enabling women to collect samples in the privacy of their homes.
In February 2024, Hologic, Inc. announced that its Genius Diagnostics System, featuring the Cervical AI algorithm, received clearance from the FDA. It is a digital cytology system that integrates AI with advanced volumetric imaging technology for the detection of pre-cancerous lesions and cervical cancer
Report Attribute |
Details |
Market size value in 2025 |
USD 8,833.83 million |
Revenue forecast in 2035 |
USD 15,675.04 million |
Growth rate |
CAGR of 5.90% from 2025 to 2035 |
Base year for estimation |
2024 |
Historical data |
2018 - 2023 |
Forecast period |
2025 - 2035 |
Quantitative units |
Revenue in USD million/billion and CAGR from 2025 to 2035 |
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
Segments covered |
Type, region |
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
Country scope |
U.S.; Canada; Mexico; UK; Germany; Spain; France; Italy; Spain; Denmark; Sweden; Norway; China; Japan; India; Australia; South Korea; Thailand; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
Key companies profiled |
Hoffmann-La Roche; BD; Abbott; QIAGEN; Hologic, Inc.; CooperSurgical Inc.; MedGyn Products, Inc; WISAP Medical Technology GmbH; Liger Medical; Utah Medical Products, Inc |
Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
This report forecasts revenue growth and provides at global, regional, and country levels an analysis of the latest trends in each of the sub-segments from 2018 to 2035. For this report, Grand View Research has segmented the global cervical cancer screening, diagnostics, and pre-cancerous dysplasia lesion treatment market report based on type and region:
Type Outlook (Revenue, USD Million, 2018 - 2035)
Cervical Cancer Screening
Pap Smear Collection Devices
HPV Testing Platforms
Cytobrush
Self-collection kits
Others
Cervical Cancer Diagnostics
Colposcopes
Cervical Biopsy Devices
Colposcopes with AI Imaging (Digital)
Others
Pre-cancerous Lesion Treatment
LEEP (loop electrosurgical excision procedure) Machine
Cryotherapy
Thermal Ablation
Others
Regional Outlook (Revenue, USD Million, 2018 - 2035)
North America
U.S.
Canada
Mexico
Europe
UK
Germany
France
Italy
Spain
Denmark
Sweden
Norway
Asia Pacific
Japan
China
India
Australia
South Korea
Thailand
Latin America
Brazil
Argentina
Middle East & Africa
South Africa
Saudi Arabia
UAE
Kuwait
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