Human Papilloma Virus/HPV Test and Pap Smear/Test Market

The HPV testing and Pap test market is valued at an estimated USD 2.44 billion in 2025 and is projected to reach USD 3.94 billion by 2030, at a CAGR of 10.0% during the forecast period. Market growth is primarily driven by the rising number of HPV cases, which is closely linked to an increasing incidence of cervical cancer. This situation has created a strong demand for early detection and preventive testing. Additionally, the growing awareness of cervical cancer screening programs, supported by government initiatives and healthcare organizations, has encouraged more women to undergo routine tests, further boosting market adoption. Furthermore, the increase in research and development funding aimed at cervical cancer prevention has accelerated the creation of advanced and more accurate HPV testing methods, making diagnostics more accessible and reliable. Together, these factors are significantly contributing to market expansion.

In October 2024, Becton, Dickinson and Company (BD) (US) received approval from Health Canada for its BD Onclarity HPV Assay, which is designed for human papillomavirus (HPV) testing using self-collected vaginal specimens at home.

In June 2024, the World Health Organization (WHO) granted prequalification designations to the cobas HPV test, developed by F. Hoffmann-La Roche Ltd. in Switzerland. This approval is applicable for use with the cobas 5800 system and for self-collected samples tested on the cobas 5800, 6800, and 8800 systems.

The key players in the HPV testing and Pap test market are Hologic, Inc. (US), Becton, Dickinson and Company (BD) (US), F. Hoffmann-La Roche Ltd. (Switzerland), QIAGEN (Netherlands), Danaher Corporation (US), Abbott (US), Seegene Inc. (South Korea), SD Biosensor, INC. (South Korea), Sansure Biotech Inc. (China), ACON Laboratories, In. (US), Molbio Diagnostics Limited (India), Tellgen Corporation (China), Daan Gene Co., Ltd. (China), Jiangsu BioPerfectus Technologies Co., Ltd. (China), Anatolia Geneworks (Turkey), AB ANALITICA s.r.l. (Italy), CERTEST BIOTEC (Spain), Atila Biosystems (US), Yaneng BIOscience (Shenzhen) Co., Ltd. (China), Xiamen Zeesan Biotech Co., Ltd. (China), Advanced Molecular Diagnostics (AMD) (UK), Mylab Discovery Solutions Pvt. Ltd. (India), Sacace Biotechnologies Srl (Italy), Jiangsu Mole Bioscience Co., Ltd. (China), HANGZHOU ALLTEST BIOTECH CO., LTD. (China), Hangzhou Tongzhou Biotechnology Co., Ltd. (China), and Nanjing Liming Biological Products Co., Ltd. (China).

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Hologic, Inc. (US) holds a leading position in the HPV testing and Pap test market, leveraging its strong expertise in women’s health diagnostics and a comprehensive range of molecular assays and cytology solutions. The company’s portfolio of FDA-approved HPV tests and Pap screening products is widely integrated into cervical cancer prevention programs, enabling accurate and reliable detection across diverse clinical settings. Hologic’s global reach, backed by continuous innovation and regulatory approvals, has positioned it as a trusted partner for healthcare providers and laboratories. Its focus on improving diagnostic accuracy, advancing laboratory efficiency, and expanding access to high-quality women’s health solutions highlights its leadership in this market. Additionally, the company’s sustained investments in R&D, strategic partnerships, and customer-focused initiatives further reinforce its strong competitive advantage.

Becton, Dickinson and Company (US) maintains a strong foothold in the HPV testing and Pap test market, supported by its wide-ranging diagnostic solutions and commitment to advancing women’s health screening. The company provides molecular diagnostic assays and cytology-based screening products that ensure accuracy, consistency, and reliability in cervical cancer detection. Leveraging its global presence and expertise in sample collection systems, BD emphasizes innovation, regulatory compliance, and laboratory efficiency to meet the stringent needs of clinical settings. Its sustained focus on product development, R&D investment, and customer-driven strategies further strengthens its role as a key partner for laboratories worldwide.

F. Hoffmann-La Roche Ltd. (Switzerland) is a prominent player in the HPV testing and Pap test market, recognized for its advanced molecular diagnostic tests and supporting systems designed for cervical cancer screening. The company provides high-quality, system-specific solutions that deliver precise and standardized results, helping laboratories achieve accuracy and efficiency in women’s health diagnostics. Roche’s strength lies in combining innovation with scalability, supported by its global presence, strong R&D capabilities, and emphasis on automation and digitalization. By continuously enhancing its diagnostic offerings and providing integrated solutions that streamline clinical workflows, Roche reinforces its leadership position in the market. Its reputation for scientific excellence, broad distribution network, and customer-focused approach further solidifies its standing as a trusted partner in HPV and Pap testing.

Market Ranking

The top five players in the HPV testing and Pap test market are Hologic, Inc. (US), Becton, Dickinson and Company (BD) (US), F. Hoffmann-La Roche Ltd. (Switzerland), QIAGEN (Netherlands), and Danaher Corporation (US), each driving market growth through advanced testing solutions, global reach, and comprehensive product portfolios. Hologic leads with its fully integrated cervical cancer screening solutions, combining HPV tests, Pap tests, and cytology platforms for high sensitivity and workflow efficiency. BD contributes through its automated cytology systems and sample collection devices, enhancing accuracy and lab productivity. F. Hoffmann-La Roche Ltd. leverages its molecular diagnostics expertise to deliver high-performance HPV assays with broad genotype coverage and strong global distribution. QIAGEN focuses on innovative nucleic acid-based HPV testing kits, emphasizing precision, automation compatibility, and high-throughput capabilities. Danaher Corporation, through its subsidiaries, strengthens the market with reliable molecular testing platforms, reagents, and quality control solutions.

Related Reports:

Human Papilloma Virus/HPV Test and Pap Smear/Test Market by Product & Service (Consumables, Instruments), Test Type (Follow-up, Co-testing, Primary HPV), Technology (MDx, Cytology), Application (Vaginal, Cervical), Care Setting - Global Forecast to 2030

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