HPV Testing And Pap Test Market (2023 - 2030)

HPV Testing And Pap Test Market Summary

Cervical cancer is one of the most common cancers among women above the age of 40. For instance, according to the WHO, around 604,000 women were diagnosed with cervical cancer and 342,000 women died from the disease in 2020. Moreover, around 13,000 new cervical cancer cases are diagnosed every year in the U.S. As most of these cases are associated with the human papillomavirus infection, it is expected to increase the demand for HPV testing over the forecast period.

The prevalence of HPV infection in women across the world is around 11%-12%. It is more prevalent in women aged below 25 years. Moreover, the high risk of developing cervical cancer in infected women is expected to increase the demand for testing to detect infections at an early stage. It represents more than 6.0% of all female malignancies, with 90% of disease-related deaths occurring in middle-income and low-income economies. Moreover, according to data from World Cancer Research Fund (WCRF), cervical cancer is the seventh most commonly occurring cancer globally. The increase in disease prevalence has boosted the demand for diagnostic products, thereby enabling market growth.

Favorable initiatives undertaken by governments for cervical cancer screening of women in the average-to-high-risk group are further anticipated to drive the market. Some of the guideline committees are ACS, the United States Preventive Services Task Force (USPSTF), the American Society for Colposcopy and Cervical Pathology (ASCCP), the American College of Obstetricians and Gynecologists (ACOG), and the Society of Gynecologic Oncology (SGO) is continuously increasing awareness about the disease among people. Moreover, in May 2023, the National Cervical Screening Program (NCSP) of Australia updated guidelines to prevent cervical cancer by increasing screening of women aged between 25 to 74 years.

An increase in awareness programs for screening by organizations including National Cervical Cancer Coalition (NCCC), WHO, CDC, and USPSTF is one of the major factors expected to boost market growth during the forecast period. For instance, in January 2023, the WHO launched the Cervical Cancer Elimination Strategy for the Eastern Mediterranean region and announced January as a Cervical Cancer Awareness month. Under this program, the WHO set the target to screen 70% of women aged 35 to 45 years. In addition, major market players are undertaking initiatives to increase awareness about cervical and vaginal cancer screening to detect diseases at an early stage.

The introduction of technologically advanced testing products and guidelines to use novel tests are further anticipated to increase the market growth over the forecast period. Market players are increasing R&D activities to introduce novel and effective HPV tests to diagnose infection. For instance, in September 2022, Mylab Discovery Solutions introduced the PathoDetect HPV detection test, an RT-PCR test to detect high-risk strains, which can lead to cervical cancer development. Similarly, in March 2023, the International Agency for Research on Cancer launched the IARC atlas, an online guide to direct healthcare professionals to use HPV tests for screening and management of the disease.

Test Type Insights

The Pap test segment held the largest market share of 63.24% in 2022 owing to the widespread implementation of screening programs. Pap test is used to screen abnormalities in normal or precancerous cells that may eventually turn into cervical cancer. The test is recommended for women above 21 years. This test is valid for both low-risk (minor) and high-risk (major) HPVs.

Furthermore, the cost-effective nature of these tests resulted in their higher penetration in low- and middle-income countries. Women aged between 21 to 29 should be screened with a Pap test every three years and women aged between 30 to 65 should be screened with either HPV alone or combination test, every five years. This is now a grade-A recommendation from the U.S. Preventive Services Task Force and the cost of testing will be covered by most service providers in the U.S.

HPV testing is expected to witness the fastest growth during the forecast period, due to the increasing introduction of various HPV tests and adoption of the more efficient HPV screenings. HPV-DNA testing detects high-risk strains of HPV which is the major cause of cervical cancer.

Increasing adoption of these tests as primary tests, global availability, and increasing adoption due to higher sensitivity are expected to drive the HPV testing industry during the forecast period. WHO recommends that self-retrieved samples can be used for HPV DNA testing. Ongoing studies support the notion that women often feel more comfortable collecting their samples rather than visiting a testing laboratory for the same. However, women require confidence in their ability and appropriate support to carry out the sample collection.

Application Insights

The cervical cancer screening segment held the largest revenue share of 76.49% in 2022. This segment is anticipated to grow at the fastest CAGR over the forecast period. This is due to the increasing investments by market players in the field and higher incidences of cervical cancer as compared to vaginal cancer. WHO’s global strategic initiatives for the elimination of cervical cancer that is also endorsed by the World Health Assembly in 2020 require that 70% of women need to be screened regularly under high-performance testing, and at least 90% of those needing it should receive appropriate treatment.

Moreover, new approvals and launches of products due to investments by players are likely to boost the market. In February 2020, the U.S. FDA approved the Cobas HPV Test for primary cervical cancer screening for women aged 25 or older. The test detects DNA from 14 high-risk HPV types in cervical cell samples which means that a positive test for HPV type 16 or 18 is considered an indication of a need to conduct the colposcopy test and a positive test for any of the 12 other high-risk HPV types is considered an indication of a need to conduct Papanicolaou (Pap) test.

Vaginal screening tests are conducted when a person is at high risk of developing cancer but shows no symptoms. The disease can be treated effectively when detected at an early stage. There are no reliable or simple tests for screening vaginal cancers. In addition, Pap tests can fail early detection of vaginal cancer as it is a comparatively rare form of cancer.

Product Insights

The consumables segment dominated the HPV testing and Pap test market with a revenue share of 65.83% in 2022, owing to repetitive usage of the product in HPV and cervical screenings. Moreover, continuous development activities by key players operating in the market and the introduction of innovative consumables, such as assays & kits, for more accurate diagnosis of HPV and Pap are anticipated to boost segment growth.

For instance, in September 2020, Becton, Dickinson, and Company submitted a premarket approval application to the FDA to approve the usage of Thin Prep Pap Test PreservCyt Solution vial along with BD Onclarity™ HPV Assay. With this PMA, the company aims to expand the usage of the HPV Assay in the U.S. and improve patient management.

The services segment is expected to witness the fastest CAGR during the forecast period, owing to the introduction of self and at-home HPV screening services to increase the frequency of cervical cancer screening rates in key markets. For instance, according to the Elsevier B.V. article published in June 2020, home-based HPV self-sampling tests were used in a cervical cancer screening campaign conducted in rural Ethiopia.

Technology insights

The other technologies segment which includes colposcopy and cystoscopy dominated the market with a 47.51% revenue share in 2022. This large share can be attributed to the high adoption of colposcopy and cystoscopy techniques in HPV screenings. Moreover, the cost-effectiveness of these tests compared to novel molecular diagnostics and immunoassays has increased the adoption of these tests across the globe.

The PCR segment is expected to witness the fastest CAGR over the forecast period, owing to the implementation of new guidelines to utilize DNA HPV testing methods due to their higher accuracy. Moreover, the use of PCR for HPV testing improves the sensitivity of cervical cancer screening programs by early identification of risky lesions in women aged 30 and older. The sensitivity of PCR tests ranges from 75% to 100%. Moreover, the replacement of conventional tests for HPV screening with DNA tests is further expected to drive segment growth.

End-use Insights

The hospitals & clinics segment dominated the market with 43.95% of the revenue share in 2022. A large number of patient visits, better healthcare infrastructure, and an increasing rise in healthcare expenditure are some of the key factors enhancing diagnostic services in hospitals and clinics. Thus, several hospitals and clinics in key markets are adopting technologically advanced solutions to provide more accurate and efficient results. For instance, in March 2020, India-based Yashoda Hospitals launched an FDA-approved HPV DNA test to improve the early detection and prevention of cervical cancer in women in India.

Increasing adoption of home-based tests for cervical cancer, increasing R&D activities related to disease, and introduction of point-of-care tests are driving the others segment growth over the forecast period. Recent advancements in the POC test kits have resulted in shorter turnaround times and error-free outcomes, which is expected to boost the market for HPV testing and Pap test over the forecast years. Furthermore, the growing adoption of self-sampling for cervical cancer screening is also anticipated to significantly support the growth.

Regional Insights

North America dominated the HPV testing and Pap test market and held the largest revenue share of 40.88% in 2022. It is projected to maintain the lead throughout the forecast period. High awareness about early diagnosis of cervical cancer, well-established screening guidelines, and favorable healthcare reimbursement scenario are the factors driving the growth of the market in the region.

In March 2022, the International Papilloma Virus Society (IPVS) hosted a live panel event International HPV Awareness Day to discuss the criticalities related to the prevention of HPV-related cancers. The event was addressed by key global opinion leaders on HPV vaccination for the realization of elimination goals and to lower the incidences of all types of HPV-related cancer. This campaign aimed at encouraging & inspiring the health community as well as the government to improve public access and raise awareness about screening, early detection, and diagnosis of cervical, oral, & breast cancers among others. Thus, a rise in the number of initiatives undertaken to increase cervical cancer screening is expected to boost market growth during the forecast period.

The introduction of technologically advanced tests, high unmet medical needs, and government initiatives in the Asia Pacific region are anticipated to fuel market growth during the forecast period. In November 2020, WHO introduced the resolution to make cervical cancer a rare disease and officially launched the global elimination strategy to make that happen. Moreover, in February 2021, AyuGen Biosciences launched U.S. FDA-approved DNA-based HPV test for primary cervical cancer screening in India. Therefore, technological advancements in developing assays for cervical cancer diagnosis are expected to boost market growth.

Key Companies & Market Share Insights

Key players are adopting market strategies such as new product launches and geographical expansions to increase their market share. For instance, in June 2022, F. Hoffmann-La Roche Ltd launched HPV self-sampling solutions, which is expected to increase the company’s share in cervical cancer screening. Along with manufacturers, regulatory bodies are also introducing novel testing products to increase HPV screening across the globe. For instance, in January 2023, UNICEF launched Cervical Cancer Toolkit to improve women’s health in low-income countries. Some prominent players in the global HPV testing and Pap test market include:

• Abbott

• QIAGEN

• BD

• Quest Diagnostics Incorporated

• Hologic, Inc.

• F. Hoffmann-La Roche Ltd

• Femasys Inc.

• Arbor Vita Corporation

• NURX Inc.

• Seegene Inc.

• Thermo Fisher Scientific Inc.

• bioMérieux

HPV Testing And Pap Test Market