The CIN & HR-HPV treatment market size was US$ 11,635.17 million in 2022, and it is projected to reach US$ 17,164.61 million by 2028; the market is estimated to record a CAGR of 6.7% from 2023 to 2028.
The market growth is attributed to an increase in the prevalence of human papillomavirus infections and favorable initiatives for preventing cervical cancer. However, the increased reoccurrence rate and the high cost of CIN & HR-HPV treatment hamper the growth of the market.
High-risk human papillomavirus (HR-HPV) is associated with cervical intraepithelial neoplasia (CIN). Persistent infection with HR-HPV results in invasive cervical cancer. Also, HR-HPV subtypes, particularly HPV 16 and HPV 18, are known to cause cervical cancer. Aberrant cells in cervical intraepithelial neoplasia aren't malignant. However, they can grow into precancer or cancer cases if not monitored or treated in certain circumstances that require therapy. Proper treatment for such disorders helps in timely recovery.
Companies in the healthcare market are undertaking various research and development activities to introduce advanced tests for HPV diagnosis. In May 2021, BD, a leading medical technology company, launched the first CE-marked assay for HPV screening from at-home self-collected vaginal samples. This allows laboratories to process self-collected samples through a BD diluent tube using BD Onclarity HPV assay. The at-home collection of samples helps address the urgent public health challenge of reaching out to women who do not attend routine cervical cancer screening.
In September 2020, F. Hoffmann-La Roche Ltd received the US Food and Drug Administration (FDA) approval for CINtec PLUS Cytology, the first biomarker-based triage test for women whose cervical cancer screening results are positive for HR-HPV. The CINtec PLUS Cytology test identifies the simultaneous presence of the two biomarkers p16 and Ki-67 in a single cell, which is associated with HPV infections that progress to precancer or cancer if not treated on time. Women that are tested positive for these two biomarkers are more significantly at risk of HR-HPV. In June 2022, F. Hoffmann-La Roche Ltd launched HPV self-sampling solution in countries accepting the CE mark. By using this new solution, patients can collect their HPV samples privately at a healthcare facility, following instructions provided by healthcare workers. Roche's cobas HPV test is used to analyze a clinically validated vaginal sample.
In November 2021, Hologic, Inc. launched the Genius Digital Diagnostics System in Europe for cervical cancer screening. This next-generation screening system combines deep learning-based artificial intelligence (AI) with the latest volumetric imaging technology to assess precancerous lesions and cervical cancer cells in women. In November 2021, BD's COR PX/GX System won approval from the FDA for its commercialization in the US. The system has been in use in centralized labs across Europe since 2019 to aid in high-volume processing with increased overall efficiency. The launch of new products is likely to allow companies in the CIN & HR-HPV treatment market to expand their geographic reach and enhance their capacities to cater to a greater than existing customer base.
Based on offering, the CIN & HR-HPV treatment market is categorized into diagnostic method and treatment. In 2022, the treatment segment held a larger share of the market. However, the diagnostic method segment is expected to register a higher CAGR during the forecast period. Further, the diagnostic method segment is categorized into HPV testing, Pap smear test, colposcopy, and biopsy. The HPV testing segment held the largest share of the market for the diagnostic method segment in 2022. HPV is a group of more than 150 related viruses, some of which can cause cancer of the cervix, vagina, vulva, and other parts. HPV infections are of two types: cutaneous and mucosal. Cutaneous HPVs cause warts on the skin of arms, chest, hands, and feet; these don't include genital warts. Mucosal HPV types infect and live in mucosal cells. As they often affect the anal and genital areas, mucosal HPVs are also known as genital (or anogenital) HPVs. This type can also infect mouth and throat linings. Mucosal HPVs generally don't affect the skin or other body parts. They are further classified into low-risk mucosal HPVs that cause warts and rarely lead to cancer and high-risk mucosal HPVs associated with developing certain types of cancer. HPV testing is performed for detecting cervical infection caused by high-risk mucosal HPV types that tend to cause the precancer and cancer of the cervix. The American Cancer Society recommends HPV testing as a preferred primary method to screen for cervical cancers or precancers in individuals aged 25-65. Moreover, HPV testing is gaining preference over the PAP smear as HPV testing techniques offer options such as at-home tests and point-of-care tests.
In March 2023, the International Agency for Research on Cancer (IARC) launched a new IARC atlas, a practical online guide designed to help healthcare professionals to perform HPV tests for screening women for cervical cancer and managing HPV-positive cases. In September 2022, Mylab Discovery Solutions announced the launch of the PathoDetect HPV Detection Test, a real-time PCR-based screening solution to detect HR-HPV in individuals. This test detects the presence of HPV 16 and HPV 18 strains, which cause most cervical cancer cases, along with distinguishing among them.
The World Health Organization (WHO), US Food and Drug Administration (FDA), National Health Insurance Fund (NHIF), and Federation of Obstetricians and Gynaecologists of India (FOGSI) are among the primary and secondary sources referred to while preparing the report on the CIN & HR-HPV treatment market.