HPV 검사 및 자궁경부암 검사 시장 평가 : 검사 유형, 용도, 기술(PCR, 액체 검체 세포진단, 하이브리드 캡처), 최종사용자, 지역별 기회와 예측(2017-2031년)

Global HPV testing and pap test market is projected to witness a CAGR of 11.9% during the forecast period 2024-2031F, growing from USD 5.05 billion in 2023 to USD 12.41 billion in 2031F. The market has experienced significant growth in recent years and is expected to maintain a strong pace of expansion in the coming years.

Human Papillomavirus (HPV) is one of the leading causes of vaginal and cervical cancer in women today. The market is seeing an evident increase in demand for pap smears and HPV tests due to increased preventive care knowledge, better healthcare infrastructure, and increased consumer awareness. Developments in diagnostic technology, like the use of HPV DNA testing and liquid-based cytology for pap smears, are important drivers influencing this industry. These advancements reduce false negative results and potentially save countless lives by improving sensitivity and accuracy in detecting cervical abnormalities. The industry is also growing due to increased healthcare spending and government campaigns that are being conducted to encourage women's health checkups. Furthermore, point-of-care testing is becoming more popular in the market, increasing accessibility and convenience of screening. The rising incidences of cervical cancer, improvements in product technology, and government initiatives to lessen the burden of cancer cases are propelling the market's expansion. For instance, the National Cervical Screening Programme (NCSP) of Australia revised its recommendations in May 2024 to prevent cervical cancer by screening more women between the ages of 25 and 74.

Likewise, in March 2023, the International Agency for Research on Cancer (IARC) launched the IARC atlas, an internet-based manual designed to instruct and guide medical practitioners in using HPV tests for illness detection and treatment.

Advancements in Diagnostic Techniques Fuel the Market Growth

This industry is primarily driven by the ongoing developments in diagnostic technology. Despite their effectiveness, traditional pap smears have some drawbacks, such as a higher likelihood of false negative results and lesser sensitivity. In response, more advanced technologies have surfaced, like liquid-based cytology for pap smears and HPV DNA testing. By offering increased sensitivity and precision, these advancements lessen the possibility of overlooking precancerous or cancerous lesions. The adoption of these cutting-edge diagnostic instruments has greatly boosted market expansion. Human Papillomavirus (HPV) DNA testing is one of the most notable developments. Early identification of high-risk HPV strains known to cause cervical cancer is now possible due to HPV DNA testing, which is more sensitive and specific than conventional techniques. These tests have increased screening accuracy while lowering the false negative rate, resulting in a more accurate evaluation of a patient's possible symptoms. Another important development in pap smear technology is liquid-based cytology. By collecting a wider variety of cervical cells, liquid-based cytology offers an alternative to traditional pap tests that require the analysis of a fixed cellular sample. This lowers the possibility of missing precancerous lesions while simultaneously improving the test's sensitivity and making it easier to identify aberrant cells.

The development of computer-assisted detection (CAD) software and automated screening devices further streamlines the interpretation of pap smear and HPV test findings. These technologies help medical personnel detect aberrant cells more quickly and precisely, lowering the possibility of human error and guaranteeing prompt intervention when needed.

Karkinos Healthcare Private Limited, a company in the oncology healthcare industry, launched CerviRaksha in June 2022. It is a clinically validated HPV test that has been pre-qualified and approved by the Food and Drug Administration (FDA) and the World Health Organization (WHO). It carries the Conformite Europeenne (CE) certification, and the results are emailed to the patient after the samples are taken from their homes. Separate genotypes for HPV-16 and HPV-18 are identified, and false positives are filtered.

Impact of Education and Rising Awareness to Positively Impact Market Growth

The public's knowledge of cervical cancer, its risk factors, and the significance of routine screening has significantly increased over time. Governments, advocacy groups, and healthcare organizations have made crucial efforts to educate women about the importance of pap screenings and HPV testing. Due to this, more women are proactively requesting these tests, which is fueling the expansion of the industry. Medical professionals, advocacy groups, government agencies, and healthcare organizations have all made substantial contributions to the informational landscape of cervical cancer prevention. Expanding the reach of public awareness initiatives has been made possible through the use of both offline and internet marketing. These programs disseminate information regarding symptoms, risk factors, and the critical role that pap smears and HPV tests play in early detection and prevention. Additionally, during normal check-ups, healthcare professionals are increasingly discussing about cervical cancer screening. Women are encouraged to take control of their own health by making appointments for Pap smears and HPV tests.

Moreover, people may now educate themselves about cervical cancer and screening alternatives due to proliferation of trustworthy online information. Women can make well-informed decisions regarding their health due to the abundance of information available on trustworthy websites and online tools. For instance, in June 2022, F. Hoffmann-La Roche Ltd confirmed that a human papillomavirus (HPV) self-sampling solution would be available in nations that are CE certified. With the help of this novel approach, a patient can discreetly gather a sample for HPV testing. Using the Roche molecular equipment, the clinically validated vaginal sample is subjected to analysis using the Roche Cobas HPV test. Those who confirm the test may later consult with a doctor. Such developments hugely push and encourage women to take self-care steps, such as testing for HPV from the comfort of their homes.

Increasing Dominance of Cervical Cancer Screening Drives the Market

An integral component of a woman's well-being and health is their cervical health. Regular healthcare check-ups now include screening for cervical cancer or any other related disorder, which is a great step. An HPV test is advised for women who are 25 years of age and older in order to detect the virus. Screening helps to identify precancerous lesions caused by HPV and stop invasive malignancies from growing, if done beforehand. Cervical cancer screening and such procedures were discovered to have been suspended in 2020 due to the growing COVID-19 burden; only urgent procedures were being carried out, which affected the market's total growth. However, things are anticipated to improve following the pandemic as the services are restored, leading to positive growth. The increasing global incidence of cervical cancer is the main factor propelling the segment's rise. In March 2024, the World Health Organisation reported that in the world, cervical cancer ranks fourth in terms of frequency among women, and in 2022, there were about 660,000 new cases and 350,000 fatal cases.

According to the American Society of Clinical Oncology, 13,960 women in the United States were expected to have an invasive cervical cancer diagnosis in 2023. In 2020, 604,127 women worldwide were expected to receive a cervical cancer diagnosis. Most of the time, abnormal cell changes in the cervix that occur before cervical cancer develops can be treated early to prevent cervical cancer. Thus, the market is anticipated to increase favorably during the projection due to the growing usage of early diagnosis. Due to growing government funding for cervical cancer management and growing awareness of the advantages of early cancer detection, the cervical cancer screening tests sector is currently leading the market. Therefore, the market is anticipated to increase because of all these factors.

North America to Dominate the HPV Testing and Pap Test Market

The rising number of screening procedures and instances of cervical cancer have led to the market's dominance in North America. Cervical cancer screening has seen a significant uptick. As health systems plan to reopen primary care appointments and preventive care visits, there may be a steady increase in clinic-based cervical cancer screening procedures. One of the leading causes of death for women in the United States is discovered to be cervical cancer. According to projections made by the American Cancer Society, 4,360 women will lose their lives to cervical cancer in the United States in 2024, and 13,820 new instances of invasive cervical cancer will be identified. Compared to aggressive cervical cancer, cervical pre-cancers are more frequently diagnosed. With an average age of 50, women are diagnosed with cervical cancer often between the ages of 35 and 44. It seldom manifests in women under the age of twenty. The fact that cervical cancer can still strike older women is something that many are unaware of. In women over 65, cervical malignancies account for more than 20% of cases. Nonetheless, women before they were 65, who have already undergone routine testing to check for cervical cancer, are rarely the victims of such cancers.

Currently, the only HPV tests approved by the FDA are those to detect HPV in a woman's cervix; there is no HPV test approved for men. The market for diagnostic HPV and pap tests has experienced growth due to the increase in cervical cancer occurrences. A pap test is recommended for women with specific findings from the cobas test, which is the only HPV test that has recently been approved for use as the primary screening tool for cervical cancer in women 25 years of age and older. Additionally, a plethora of novel assays are being developed to enhance the assessment of women who test positive for HPV. Thus, the market is anticipated to expand due to the rising demand for pap, HPV, and other tests for cancer screening. Furthermore, during the forecast period, the market is anticipated to be driven by advantageous government policies in North America. The National Breast and Cervical Cancer Early Detection Programme (NBCCEDP) in the United States has contributed to the overall expansion of the breast and cervical cancer screening market.

Future Market Scenario (2024-2031F)

One of the main factors contributing to the anticipated growth of the HPV testing and pap test market is the increasing prevalence of cervical and vaginal cancers in women. Rising population and sedentary lifestyles are also factors that are expected to propel the market growth in future. Given that technology is advancing, we can expect cutting-edge technology in this market. Players in this market are expanding at an unparalleled rate, introducing cost-effective and efficient technologies. For instance, in May 2022, Alercell, Inc., a molecular diagnostics firm and supplier, announced the Meltpro HPV genotype test, an HPV DNA-based test kit. Analysis of DNA sequencing forms its basis. Using a PCR machine reduces the possibility of human error and yields quicker results in less than three hours

.

Key Players Landscape and Outlook

Several companies, such as Quest Diagnostics Incorporated, Hologic, Inc., Roche Diagnostics International Ltd (F. Hoffmann-La Roche Ltd), Abbott Laboratories, Becton, Dickinson and Company, QIAGEN, Seegene, Inc., Mylab Discovery Solutions Pvt. Ltd., Arbor Vita Corporation, Femasys Inc., etc., are expanding business by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launch of newly developed HPV and pap tests to help researchers and increase their market presence. New product launches, agreements based on contracts, acquisitions and mergers, investments, and partnerships are a few ways through which they are trying to achieve the same.

For example, Mylab Discovery Solutions Pvt. Ltd. unveiled the PathoDetect HPV detection test in September 2022. This RT-PCR test identifies high-risk strains of the virus that may cause cervical cancer.

For example, the World Health Organization declared January 2023 Cervical Cancer Awareness Month and unveiled the Cervical Cancer Elimination Strategy for the Eastern Mediterranean region. Under this program, the WHO established the goal of screening 70% of women between the ages of 35 and 45.

Table of Contents

1. Research Methodology

2. Project Scope and Definitions

3. Executive Summary

4. Global HPV Testing and Pap Test Market Outlook, 2017-2031F

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
• 4.2. By Test Type
  • 4.2.1. HPV Test
    • 4.2.1.1. Follow-up HPV Test
    • 4.2.1.2. Co-Test
    • 4.2.1.3. Primary HPV Test
  • 4.2.2. Pap Test
• 4.3. By Application
  • 4.3.1. Cervical Cancer Screening
  • 4.3.2. Vaginal Screening
  • 4.3.3. HPV Screening
  • 4.3.4. Others
• 4.4. By Technology
  • 4.4.1. Polymerase Chain Reaction (PCR)
  • 4.4.2. Liquid-based Cytology
  • 4.4.3. Hybrid Capture
• 4.5. By End-user
  • 4.5.1. Hospitals
  • 4.5.2. Laboratories
  • 4.5.3. Gynecologist Clinics
  • 4.5.4. Physician's Offices
  • 4.5.5. Point-of-Care-Testing Facilities
  • 4.5.6. Others
• 4.6. By Region
  • 4.6.1. North America
  • 4.6.2. Europe
  • 4.6.3. Asia-Pacific
  • 4.6.4. South America
  • 4.6.5. Middle East and Africa
• 4.7. By Company Market Share (%), 2023

5. Global HPV Testing and Pap Test Market Outlook, By Region, 2017-2031F

• 5.1. North America*
  • 5.1.1. Market Size & Forecast
    • 5.1.1.1. By Value
  • 5.1.2. By Test Type
    • 5.1.2.1. HPV Test
      • 5.1.2.1.1. Follow-up HPV Test
      • 5.1.2.1.2. Co-Test
      • 5.1.2.1.3. Primary HPV Test
    • 5.1.2.2. Pap Test
  • 5.1.3. By Application
    • 5.1.3.1. Cervical Cancer Screening
    • 5.1.3.2. Vaginal Screening
    • 5.1.3.3. HPV Screening
    • 5.1.3.4. Others
  • 5.1.4. By Technology
    • 5.1.4.1. Polymerase Chain Reaction (PCR)
    • 5.1.4.2. Liquid-based Cytology
    • 5.1.4.3. Hybrid Capture
  • 5.1.5. By End-user
    • 5.1.5.1. Hospitals
    • 5.1.5.2. Laboratories
    • 5.1.5.3. Gynecologist Clinics
    • 5.1.5.4. Physician's Offices
    • 5.1.5.5. Point-of-Care-Testing Facilities
    • 5.1.5.6. Others
  • 5.1.6. United States*
    • 5.1.6.1. Market Size & Forecast
      • 5.1.6.1.1. By Value
    • 5.1.6.2. By Test Type
      • 5.1.6.2.1. HPV Test
        • 5.1.6.2.1.1. Follow-up HPV Test
        • 5.1.6.2.1.2. Co-Test
        • 5.1.6.2.1.3. Primary HPV Test
      • 5.1.6.2.2. Pap Test
    • 5.1.6.3. By Application
      • 5.1.6.3.1. Cervical Cancer Screening
      • 5.1.6.3.2. Vaginal Screening
      • 5.1.6.3.3. HPV Screening
      • 5.1.6.3.4. Others
    • 5.1.6.4. By Technology
      • 5.1.6.4.1. Polymerase Chain Reaction (PCR)
      • 5.1.6.4.2. Liquid-based Cytology
      • 5.1.6.4.3. Hybrid Capture
    • 5.1.6.5. By End-user
      • 5.1.6.5.1. Hospitals
      • 5.1.6.5.2. Laboratories
      • 5.1.6.5.3. Gynecologist Clinics
      • 5.1.6.5.4. Physician's Offices
      • 5.1.6.5.5. Point-of-Care-Testing Facilities
      • 5.1.6.5.6. Others
  • 5.1.7. Canada
  • 5.1.8. Mexico

All segments will be provided for all regions and countries covered

• 5.2. Europe
  • 5.2.1. Germany
  • 5.2.2. France
  • 5.2.3. Italy
  • 5.2.4. United Kingdom
  • 5.2.5. Russia
  • 5.2.6. Netherlands
  • 5.2.7. Spain
  • 5.2.8. Turkey
  • 5.2.9. Poland
• 5.3. Asia-Pacific
  • 5.3.1. India
  • 5.3.2. China
  • 5.3.3. Japan
  • 5.3.4. Australia
  • 5.3.5. Vietnam
  • 5.3.6. South Korea
  • 5.3.7. Indonesia
  • 5.3.8. Philippines
• 5.4. South America
  • 5.4.1. Brazil
  • 5.4.2. Argentina
• 5.5. Middle East and Africa
  • 5.5.1. Saudi Arabia
  • 5.5.2. UAE
  • 5.5.3. South Africa

6. Market Mapping, 2023

• 6.1. By Test Type
• 6.2. By Application
• 6.3. By Technology
• 6.4. By End-user
• 6.5. By Region

7. Macro Environment and Industry Structure

• 7.1. Demand Supply Analysis
• 7.2. Import Export Analysis
• 7.3. Value Chain Analysis
• 7.4. PESTEL Analysis
  • 7.4.1. Political Factors
  • 7.4.2. Economic System
  • 7.4.3. Social Implications
  • 7.4.4. Technological Advancements
  • 7.4.5. Environmental Impacts
  • 7.4.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5. Porter's Five Forces Analysis
  • 7.5.1. Supplier Power
  • 7.5.2. Buyer Power
  • 7.5.3. Substitution Threat
  • 7.5.4. Threat From New Entrant
  • 7.5.5. Competitive Rivalry

8. Market Dynamics

• 8.1. Growth Drivers
• 8.2. Growth Inhibitors (Challenges and Restraints)

9. Regulatory Framework and Innovation

• 9.1. Clinical Trials
• 9.2. Regulatory Approvals
• 9.3. Innovations/Emerging Technologies

10. Key Players Landscape

• 10.1. Competition Matrix of Top Five Market Leaders
• 10.2. Market Revenue Analysis of Top Five Market Leaders (By Value, 2023)
• 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4. SWOT Analysis (For Five Market Players)
• 10.5. Patent Analysis (If Applicable)

11. Pricing Analysis

12. Case Studies

13. Key Players Outlook

• 13.1. Quest Diagnostics Incorporated
  • 13.1.1. Company Details
  • 13.1.2. Key Management Personnel
  • 13.1.3. Products and Services
  • 13.1.4. Financials (As Reported)
  • 13.1.5. Key Market Focus and Geographical Presence
  • 13.1.6. Recent Developments
• 13.2. Hologic, Inc.
• 13.3. Roche Diagnostics International Ltd (F. Hoffmann-La Roche Ltd)
• 13.4. Abbott Laboratories
• 13.5. Becton, Dickinson and Company
• 13.6. QIAGEN
• 13.7. Seegene, Inc.
• 13.8. Mylab Discovery Solutions Pvt. Ltd.
• 13.9. Arbor Vita Corporation
• 13.10. Femasys Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

14. Strategic Recommendations

15. About Us & Disclaimer