HPV Testing and Pap Test Market

Market Overview

The global HPV testing and Pap test market size was valued at USD 5.3 billion in 2022. It is estimated to reach USD 9.5 billion by 2031, growing at a CAGR of 6.7% during the forecast period (2023–2031). Factors such as High Incidence of Cervical Cancer in Middle-Aged Women and Technological Advancements, significantly drives the HPV testing and Pap test market demand by 2031.

The HPV and Pap test can aid in cervical cancer prevention and early detection. The HPV test examines for the virus (human papillomavirus) that can cause abnormalities in the cervix's cells. The Pap test, also called Pap smear, checks for pre-cancers, which are cervix-related cell abnormalities that, if left untreated, could progress into cervical cancer. The Pap test evaluates the appearance of the cells, while the HPV test only examines the virus.

Both tests can be carried out in a clinic or doctor's clinic office. The doctor will examine the vagina during the Pap test using a speculum, a plastic or metal device. This aids in examining the cervix and vagina and collecting a few cells and mucus from the cervix and its surrounding region the doctor. The cells are taken to a laboratory to undergo additional testing. The majority of women between the age of 21 to 65 require Pap tests or Pap and HPV testing together.

Highlights

• The Pap test dominates the test type segment
• Consumables dominate the product segment
• Academic research dominates the end-user segment
• North America is the highest shareholder in the global market

Market Dynamics

Global HPV Testing and Pap Test Market Drivers:

High Incidence of Cervical Cancer in Middle-Aged Women

According to WHO estimates, cervical cancer is the fourth most common cancer, with over 311,000 deaths and 570,000 new cases reported in 2018. According to estimates, HPV infections cause 99% or more of cases of cervical cancer. The average age at diagnosis for cervical cancer is 50 years, with the majority of cases occurring in women between the ages of 35 and 44.

According to the American Cancer Society, pre-cancer in the cervix is identified far more commonly than invasive forms of cervical cancer. The data from the same source also indicates that cervical cancer was the most common cancer-causing death among American women. A significant drop in these rates was witnessed with an increase in Pap test screenings. Similarly, according to the American Society of Clinical Oncology (ASCO), the incidence of cervical cancer decreased by more than 50% between 1975 and 2015 owing to an increase in screening measures, which facilitate early diagnosis. Various favorable guidelines for cervical cancer screening in average-risk and high-risk women are further anticipated to drive the market.

Increasing Number of Awareness Programs for Cervical Cancer Screening

Various initiatives undertaken by regulatory bodies in regions with high rates of cervical cancer are also anticipated to fuel HPV testing and Pap test market growth. For instance, the Go Further partnership to end AIDS and cervical cancer is an initiative aimed at providing cervical cancer screening in African countries wherein high rates of HIV are witnessed. Women with HIV are 5x more likely to develop cervical cancer than other women. The initiative is a collaborative effort by UNAIDS (Joint United Nations Programme on HIV/AIDS), the Bush Institute, Merck, and PEPFAR (U.S. President's Emergency Plan for AIDS Relief). Such factors drive market growth over the forecast period.

Global HPV Testing and Pap Test Market Restraint:

Changes in Regulatory Guidelines for Cervical Cancer Screening

The constant change in regulatory guidelines regarding screening procedures for cervical cancer is one of the key factors anticipated to hinder market growth. The reduction in Pap smear tests and various stringent guidelines by ACS, ASCCP, and the American Society for Clinical Pathology (ASCP) are some of the factors anticipated to constrain the market growth in the coming years.

Global HPV Testing and Pap Test Market Opportunities:

Technological Advancements

One of the primary factors predicted to propel the market over the forecast period is the growing demand for technologically advanced diagnostic techniques for screening cervical and vaginal cancers. The World Cancer Research Fund estimates that 500,000 brand-new cervical cancer cases were found in 2018. In addition, market growth is predicted to be fueled by technological developments such as creating HPV-type 16 E7-specific human immunologic assays used in non-HLA2 types, cobas system approvals, and various molecular markers in screening procedures.

Additionally, researchers from the Center for Systems Biology at Massachusetts General Hospital and Harvard Medical School in Boston presented a novel screening handheld device that uses artificial intelligence (AI) for HPV detection in 2019. The device was showcased at the Society of Gynecologic Cancers (SGO) annual meeting in 2019. In a turnaround time of two hours, the novel device can detect the presence of HPV strains 16 and 18. Thus, continuing technological advancements are anticipated to increase market demand during the forecast period.

Regional Analysis

Based on region, the global HPV testing and Pap test market share is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global HPV testing and Pap test market shareholder and is predicted to exhibit a CAGR of 15.8% during the forecast period. North America's dominant share can also be attributed to high awareness about early cervical cancer diagnosis, well-established screening guidelines, and favorable healthcare reimbursement. The North American market has expanded due to the high accessibility, adoption, and affordability of technologically advanced goods and services. Leading players' local presence and ongoing strategic initiatives have also significantly supported regional growth. For instance, in September 2020, BD filed a Premarket Approval Application (PMA) to the FDA to approve the ThinPrep Pap Test PreservCyt Solution vial and its Onclarity HPV Assay. The organization hopes to improve patient management through this PMA and increase the use of its Onclarity HPV Assay in the United States. In addition, in January 2019, Nurx, a U.S.-based telemedicine company, launched its Home HPV Screening test, enabling women to easily and conveniently identify their risk for cervical cancer from home.

Europe is predicted to exhibit a CAGR of 15.3% over the forecast period. Europe held a significant market share, attributed to the high incidence of cervical cancer in key countries, including Germany, the UK, France, Italy, and Spain. As per the Globocan estimate for 2020, around 58,169 new cases of cervix uterine cancer were diagnosed in the region, leading to around 25,989 deaths. In addition, a well-established healthcare system, cervical cancer screening guidelines, and favorable reimbursement policies in these key countries have aided further regional growth. Furthermore, easy access to advanced products due to the local presence of leading players has created a conducive environment for growth. For instance, Qiagen N.V. and F. Hoffmann-La Roche are leading Europe-based companies with strong supply chains in European countries. Ongoing initiatives undertaken by these major market players to curb the incidence of cervical cancer by improving diagnosis and screening are also expected to propel the market growth.

Asia-Pacific is predicted to exhibit an exponential CAGR over the forecast period. High rates of human papillomavirus (HPV) and cervical cancer in major economies like Japan, China, and India have contributed to this growth. It is expected that the region of Asia-Pacific will lead the way in technological innovation, accelerating market growth during the forecast period. For instance, Seegene, Inc. used a new AI-based assay development system in January 2018 to detect around eight DNA targets for each sexually transmitted infection and meningitis. Also expected to contribute to expansion over the forecast period are public-private sector efforts to enhance cervical cancer screening programs in this area.

In Latin America, the growth of the HPV and Pap testing market is associated with the surging incidence and mortality rate of cervical cancer in key countries like Brazil, Mexico, and Argentina. Globocan estimated that in 2020, around 41,734 new cases of cervix uterine cancer were diagnosed in the South American region, making it the 7th most common type of cancer in the region. The same source also stated that in 2020, around 22,221 people died of cervix uterine cancer in the South American region.

In the Middle East and Africa, the growth of the HPV and Pap testing market can be attributed to ongoing government initiatives to facilitate early diagnosis and treatment of cervical cancer in the Middle East and Africa region. For instance, in April 2020, the Government of Rwanda, with the support of two U.S. organizations, introduced a comprehensive nationwide cervical cancer prevention program in Kigali. This program facilitates modern molecular HPV diagnostic screening for women between 35 and 45. Similarly, the increased risk of developing cervical cancer due to lasting infection with certain types of HPV in countries such as South Africa is expected to create high demand for HPV and Pap testing products.

Segmental Analysis

The global HPV testing and Pap test market is segmented by test type, applications, product, technology, and end-user.

Based on test type, the global market is divided into HPV and Pap tests. 

The Pap test segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 15.4% over the forecast period. Pap tests screen abnormalities in normal or precancerous cells that may eventually turn into cervical cancer. The abnormality is generally caused by Human Papillomavirus (HPV). This test validates low-risk (minor) and high-risk (major) HPVs. The Pap test segment dominated the market due to the widespread implementation of screening programs.

Similarly, the cost-effective nature of these tests resulted in their higher penetration in low- and middle-income countries. According to the guidelines by the American Society of Obstetricians and Gynecologists in 2017, women should undergo a Pap test every two years after age 21. Therefore, such initiative factors are expected to fuel market growth during the forecast period.

Based on applications, the global market is divided into cervical cancer screening and vaginal cancer screening. 

The cervical cancer screening segment dominates the global market and is predicted to exhibit a CAGR of 16.7% over the forecast period. The cervical cancer screening segment dominated the market because of the high incidence of cervical cancer and the increasing adoption of screening tests. These tests are used to detect abnormal cells in the cervical lining. Screening the cervix includes its cytology (Pap test) and screening for high-risk HPVs (HPV test). The latter has greater scope in cervical cancer screening as most patients test positive for HPV.

Based on product, the global market is bifurcated into instruments, consumables, and services. 

The consumables segment owns the largest market share and is anticipated to exhibit a CAGR of 16.2% over the forecast period. The consumables segment includes assays, kits, tests, reagents, collection devices, and accessories widely used in HPV and Pap testing. The huge share of the consumables segment is due to the repetitive use of these consumables in HPV and Pap testing procedures in hospitals, clinics, and diagnostic laboratories. Moreover, the increasing prevalence of HPV and cervical cancer and growing awareness about early diagnosis have significantly supported segment growth.

Based on technology, the global market is segmented into PCR, immunodiagnostics, and others. 

The other technologies segment is the largest revenue contributor to the market and is projected to exhibit a CAGR of 15.7% over the forecast period. The other segment includes techniques such as colposcopy and cystoscopy. A colposcopy is performed when the Pap test results show abnormalities in the cervical cells. It is a diagnostic procedure that facilitates more detailed monitoring of the cervical region in case of abnormalities. On the other hand, a cystoscopy is done if the patient's biopsy shows the presence of cancer. It helps determine the spread of the cancer. Cystoscopy test comprises a slender tube attached to a lens and a light source inserted in the bladder through the urethra. This helps check the spread of cancer to the bladder and the urethra.

Based on end-user, the global HPV testing and Pap test market is bifurcated into hospitals and clinics, laboratories, and others. 

The hospitals and clinics segment owns the largest market share and is estimated to exhibit a CAGR of 15.5% over the forecast period. Hospitals and clinics are primary care settings for diagnosing and treating most medical conditions, including HPV infection and cervical cancer. Most of the population, in both developed and developing economies, relies on these facilities to diagnose, treat, and manage diseases. Hospitals and clinics are long-term care facilities that usually have patients who report specific symptoms and need further diagnosis. Prompt detection typically allows physicians to plan a proper patient treatment regimen in such settings. Favorable reimbursement policies have led to further segment growth, resulting in many HPV and Pap tests in hospital settings.

Recent Developments

• June 2023- Roche's cobas HPV test for use on the completely automated cobas 6800/8 Systems was prequalified by the World Health Organization (WHO). The prequalification expands access to screening instruments for cervical cancer in low- and lower-middle-income nations.

• February 2023- BD (Becton, Dickinson and Company), a global leader in medical technology, announced that the U.S. Food and Drug Administration (FDA) had approved the BD OnclarityTM HPV Assay for use with the ThinPrep® Pap Test.