HPV Testing & Pap Test Market

HPV Testing & Pap Test Market by Test Type (HPV Testing (Follow-Up, Co-Testing, Primary)), by Application (Pap Test (Cervical Cancer, Vaginal Cancer)), by End User (Laboratories, Hospitals, Physicians’ Offices & Clinics) - Global Forecast to 2020

Report Code: MD 4083 Feb, 2016, by marketsandmarkets.com

The global HPV testing and Pap test market is projected to reach USD 4.52 billion by 2020 from USD 3.29 billion in 2015, at a CAGR of 6.6% from 2015 to 2020. Cervical cancer is the second most common type of cancer in women, preceded by breast cancer. HPV, a sexually transmitted virus, has been clinically proven to be the primary cause of cervical cancer. HPV contributes to around 90% of all anal and cervical cancers and 70% of vaginal and vulvar cancers. Pap tests are the most preferred tests to detect cervical cancer. These tests include microscopic observation of specimens. However, these tests are unable to detect all the genotypes causing HPV infections and might also lead to a significant number of false negative results. Owing to these challenges posed by Pap tests, HPV diagnostic tests were introduced as effective molecular diagnostic tests.

Market Dynamics

Drivers

  • Increasing number of cervical cancer cases and growing aging population
  • Increasing awareness of cervical cancer screening programs
  • Government initiatives and funding.

Restraints

  • Changes in regulatory guidelines for cervical cancer screening
  • HPV vaccination

Opportunities

  • Introduction of HPV primary screening tests

Challenges

  • Uncertain reimbursement scenario

Increasing number of cervical cancer cases and growing aging population

Cervical cancer is considered to be the fourth most prevalent forms of cancer globally, and is the most common cause of death among women (Source: Global Cancer Facts and figures). It has been estimated that 527,624 new cases of cervical cancer have emerged worldwide, while 265,653 women died due to cervical cancer in 2012. This figure is expected to reach to 609,270 new cases and 315,727 deaths by 2020. (Source: Globocan 2012). Approximately 26,000 new cancers attributable to HPV occur each year, 18,000 among females and 8,000 among males (Source: CDC). The growing number of cervical cancer cases results in the need for new, technically advanced, and less expensive screening programs. This in turn is expected to drive the HPV testing and Pap test market in the coming years.

Objectives Of The Study

  • To define, describe, and segment the global HPV testing and Pap test market on the basis of test types, application, end user, and region
  • To provide detailed information regarding the major factors influencing the growth of the market (drivers, restraints, opportunities, and industry-specific challenges)
  • To analyze micromarkets with respect to individual growth trends, prospects, and contributions to the global HPV testing and Pap test market
  • To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market players
  • To forecast the size of the market segments with respect to four major regional segments, namely, North America, Europe, Asia Pacific, and the Rest of the World (RoW)
  • To profile the key players in the market and comprehensively analyze their market positions and core competencies
  • To track and analyze competitive developments such as acquisitions, product launches, expansions, agreements, partnership and collaborations in the HPV testing and Pap test market

Research Methodology

Both, top-down and bottom-up approaches were used to validate the size of the global HPV testing and Pap test market and estimate the size of various other dependent submarkets. Major players in the market were identified through secondary research and their market presence was studied through primary and secondary research. Secondary research included the study of the annual and financial reports of top market players, presentations, websites, and press releases of top players, news articles, journals; and paid databases ,white papers, medical journals, certified publications, articles from recognized authors, directories, and databases such as American Cancer Society (ACS), American Society for Colposcopy and Cervical Pathology (ASCCP), Centers for Disease Control and Prevention (CDC), National Breast and Cervical Cancer Early Detection Program (NBCCEDP), National Cervical Cancer Coalition (NCCC), Ontario Cervical Screening Program (OCSP). Whereas, primary research included extensive interviews with key opinion leaders such as CEOs, vice presidents, directors, marketing executives, and related key executives from various companies. The percentage splits, shares, and breakdowns of the segments were determined using secondary sources and verified through primary sources. This data is consolidated and added to detailed inputs and analysis from MarketsandMarkets and presented in this report.

HPV Testing & Pap Test Market

To know about the assumptions considered for the study, download the pdf brochure

Key players in the HPV testing and Pap test market include Hologic Inc. (U.S.), Qiagen N.V. (Netherlands), F. Hoffmann-La Roche Ltd. (Switzerland), Quest Diagnostics (U.S.), OncoHealth Corporation (U.S.), and Becton, Dickinson and Company (U.S.).

Major Market Developments

  • In April 2014, Roche received the U.S. FDA approval for its cobas HPV (Human Papillomavirus) Test, which is used as a first-line primary screening test for cervical cancer in women.
  • In February 2014, BD Diagnostics received the CE/IVD marking for the BD Onclarity HPV Assay that can be used on the new BD Viper LT System
  • In September 2015, QIAGEN introduced careHPV Test and digene HC2 Collection Device for the HPV screening process in women.
  • IN February 2014, QIAGEN expanded commercial launch of careHPV test in India, a molecular diagnostic test for high risk human papillomavirus (HPV), a primary cause of cervical cancer in woman.

Target Audience:

  • Molecular Diagnostic Instruments & Assays Manufacturers And distributors
  • In vitro Diagnostic (IVD) Companies
  • Hospital Laboratories
  • Reference Laboratories
  • Pharmaceutical and Biotechnology Companies
  • Research and Consulting Firms
  • Health Insurance Players
  • Physicians

Scope of the Report

The research report categorizes the global HPV testing and Pap test market into the following segments and subsegments:

HPV testing and Pap test market, by test type

  • HPV Testing
      • Follow-up HPV Testing
      • Co-testing
      • HPV Primary testing
  • Pap Test

HPV testing and Pap test market, by application

  • Pap Test
      • Cervical Cancer Screening
      • Vaginal Cancer Screening

HPV testing and Pap test Market, by end user

  • Laboratories
  • Hospitals
  • Physician’s Offices & Clinics

Global HPV testing and Pap test Market, by Region

  • North America
      • US
      • Canada
  • Europe
  • Asia Pacific
      • Japan
      • India
      • China
      • Rest of Asia (RoAPAC)
  • Rest of the World (RoW)

Available customizations

With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to 5)

Geographic Analysis

  • Detailed analysis of HPV testing and Pap test market in European countries such as the UK, Germany, France, Italy, Spain, and others

The global HPV testing and Pap test market is projected to reach USD 4.52 billion by 2020 from USD 3.29 billion in 2015, at a CAGR of 6.6% from 2015 to 2020. The Papanicolaou test (Pap test) is a screening test used to detect pre-cancerous cells in the endocervical canal of the female reproductive system. Pre-cancerous cells might change into cancerous cells, if they are not diagnosed at an early stage. Pap tests are usually used to screen for cervical cancer, but sometimes vaginal cancer cells can also be detected on a Pap test. The HPV test is used to diagnose the infection caused by HPV that mutates a normal cell into a cancerous cell and further leads to the development of genital warts, abnormal cervical cells, or cervical cancer. The growth of the HPV testing and Pap test market is mainly attributed to the increasing number of cervical cancer cases, growing aging population, increasing awareness of cervical cancer screening programs, and government initiatives and funding.

In this report, the global HPV testing and Pap test market is broadly segmented by test type, application, end user, and region.

The HPV testing and Pap test market is broadly segmented into HPV testing and Pap test market. Among HPV testing and Pap test, HPV testing is preferred due to its broad application in cervical cancer screening and increasing awareness of this screening procedure. The HPV testing market is further segmented into follow-up HPV testing, co-testing, and HPV primary testing. The HPV primary testing segment is expected to grow at the highest CAGR during the forecast period. Growing incidences of cervical cancer, higher consistency and effectiveness of HPV primary tests, and approval for Roche’s HPV test as a primary screening method are factors driving the growth of the HPV primary testing market.

Based on the application, the Pap test market is segmented into cervical cancer screening and vaginal cancer screening. The cervical cancer screening segment is expected to grow at the highest CAGR during the forecast period, owing to growing incidences of cervical cancer.

On the basis of end user, the HPV testing and Pap test market is categorized into hospitals, laboratories, physician’s offices and clinics. The hospitals segment is projected to grow at the highest CAGR from 2015 to 2020. This growth is attributed to the increasing patient volumes in hospitals, as most diagnostic tests are carried out in-house with advanced technologies and more accessibility.

Geographically, the HPV testing and Pap test market is segmented into North America, Europe, Asia Pacific, and the Rest of the World (RoW). North America is expected to grow at the highest CAGR in the forecast period. Increased government funding & grants and introduction of HPV primary tests are major factors fueling the growth of the HPV testing and Pap test market in North America.

HPV Testing & Pap Test Market

However, changes in regulatory guidelines for cervical cancer screening and HPV vaccination are major restraints impacting the growth of the HPV testing and Pap test market

Key players in the HPV testing and Pap test market include Hologic Inc. (U.S.), Qiagen N.V. (Netherlands), F. Hoffmann-La Roche Ltd. (Switzerland), Quest Diagnostics (U.S.), OncoHealth Corporation (U.S.), and Becton, Dickinson and Company (U.S.). These players focus on inorganic and organic strategies such as product approvals & licenses, agreements, collaborations, and partnerships, expansions, acquisitions to sustain their growth in the HPV testing and Pap test market.

To speak to our analyst for a discussion on the above findings, click Speak to Analyst

Table of Contents

1 Introduction (Page No. - 13)
    1.1 Objectives of the Study
    1.2 Market Definition
    1.3 Study Scope
           1.3.1 Markets Covered
           1.3.2 Years Considered for the Study
    1.4 Currency
    1.5 Limitations
    1.6 Stakeholders

2 Research Methodology (Page No. - 16)
    2.1 HPV testing Market Size Estimation
    2.2 HPV testing Market Breakdown and Data Triangulation
           2.2.1 Key Data From Secondary Sources
           2.2.2 Key Data From Primary Sources
                    2.2.2.1 Key Industry Insights
           2.2.3 Assumptions

3 Executive Summary (Page No. - 23)

4 Premium Insights (Page No. - 26)
    4.1 Market Overview
    4.2 Market, By Test Type
    4.3 Market, By Test Type and End User
    4.4 Market, By Region

5 Market Overview (Page No. - 28)
    5.1 Introduction
    5.2 Market Segmentation
    5.3 Market Dynamics
           5.3.1 Drivers
                    5.3.1.1 Increasing Number of Cervical Cancer Cases and Growing Aging Population
                    5.3.1.2 Increasing Awareness of Cervical Cancer Screening Programs
                    5.3.1.3 Government Initiatives and Funding
           5.3.2 Restraints
                    5.3.2.1 Changes in Regulatory Guidelines for Cervical Cancer Screening
                    5.3.2.2 HPV Vaccination
           5.3.3 Opportunity
                    5.3.3.1 Introduction of HPV Primary Screening Tests
           5.3.4 Challenge
                    5.3.4.1 Uncertain Reimbursement Scenario

6 HPV Testing and PAP Test Market, By Test Type (Page No. - 37)
    6.1 Introduction
    6.2 HPV Testing
    6.3 Follow-Up HPV Testing
    6.4 Co-Testing
    6.5 Primary HPV Testing
    6.6 PAP Test

7 PAP Test Market, By Application (Page No. - 47)
    7.1 Introduction
           7.1.1 Cervical Cancer Screening
           7.1.2 Vaginal Cancer Screening

8 HPV Testing and PAP Test Market, By End User (Page No. - 53)
    8.1 Introduction
    8.2 Laboratories
    8.3 Hospitals
    8.4 Physicians’ Offices and Clinics

9 HPV Testing and PAP Test Market, By Region (Page No. - 61)
    9.1 Introduction
    9.2 North America
           9.2.1 U.S.
           9.2.2 Canada
    9.3 Europe
    9.4 Asia-Pacific
           9.4.1 Japan
           9.4.2 China
           9.4.3 India
           9.4.4 Rest of Asia-Pacific
    9.5 Rest of the World

10 Competitive Landscape (Page No. - 92)
     10.1 Overview
     10.2 Market Share Analysis, Global HPV testing Market
             10.2.1 Product Approvals and Licenses
             10.2.2 New Product Launches
             10.2.3 Agreements, Collaborations, and Partnerships
             10.2.4 Acquisitions
             10.2.5 Expansions

11 Company Profile (Page No. - 100)
(Overview, Products and Services, Financials, Strategy & Development)*
     11.1 Introduction
     11.2 Abbott Laboratories
     11.3 Qiagen N.V.
     11.4 Roche Diagnostics
     11.5 Hologic, Inc.
     11.6 Becton, Dickinson and Company
     11.7 Quest Diagnostics
     11.8 Onco Health Corporation
     11.9 Seegene, Inc.
     11.10 Femasys Inc.
     11.11 Arbor Vita Corporation

*Details on Overview, Products and Services, Financials, Strategy & Development Might Not Be Captured in Case of Unlisted Companies.

12 Appendix (Page No. - 120)
     12.1 Insights of Industry Experts
     12.2 Discussion Guide
     12.3 Introducing RT: Real-Time Market Intelligence
     12.4 Available Customizations
     12.5 Related Reports


List of Tables (80 Tables)

Table 1 Increasing Number of Cervical Cancer Cases and Growing Aging Population Drive the HPV testing Market
Table 2 Changes in Regulatory Guidelines for Cervical Cancer Screening Acts A Restraining Factor Hampering the Market Growth
Table 3 Introduction of HPV Primary Screening Tests Provide Significant Growth Opportunities for the HPV testing Market
Table 4 Uncertain Reimbursement Scenario is Limiting the Growth for the PAP Test Market
Table 5 HPV testing Market Size, By Test Type, 2013–2020 (USD Million)
Table 6 Market Size, By Test Type, 2013–2020 (Million Tests)
Table 7 Market Size, By Test Type, 2013–2020 (USD Million)
Table 8 Market Size, By Region, 2013–2020 (USD Million)
Table 9 Market Size, By Region, 2013–2020 (Million Tests)
Table 10 North America: Market Size, By Country, 2013–2020 (USD Million)
Table 11 Asia-Pacific: Market Size, By Country, 2013–2020 (USD Million)
Table 12 Follow-Up HPV Testing Market Size, By Region, 2013–2020 (USD Million)
Table 13 HPV Co-Testing Market Size, By Region, 2013–2020 (USD Million)
Table 14 Market Size, By Region, 2013–2020 (USD Million)
Table 15 Market Size, By Region, By Volume 2013–2020 (Million Tests)
Table 16 North America: Market Size, By Country, 2013–2020 (USD Million)
Table 17 Asia-Pacific: Market Size, By Country, 2013–2020 (USD Million)
Table 18 Market Size, By Application, 2013–2020 (USD Million)
Table 19 Cervical Cancer Screening Market Size, By Region, 2013–2020 (USD Million)
Table 20 North America: Cervical Cancer Screening Market Size, By Country, 2013–2020 (USD Million)
Table 21 Asia-Pacific: Cervical Cancer Screening Market Size, By Country, 2013–2020 (USD Million)
Table 22 Vaginal Cancer Screening Market Size, By Country, 2013–2020 (USD Million)
Table 23 Asia-Pacific: Vaginal Cancer Screening Market Size, By Country, 2013–2020 (USD Million)
Table 24 Market Size, By End User, 2013–2020 (USD Million)
Table 25 Market Size for Laboratories, By Region, 2013–2020 (USD Million)
Table 26 North America: Market Size for Laboratories, By Country, 2013–2020 (USD Million)
Table 27 Asia-Pacific: Market Size for Laboratories, By Country, 2013–2020 (USD Million)
Table 28 Market Size for Hospitals, By Region, 2013–2020 (USD Million)
Table 29 North America: Market Size for Hospitals, By Country, 2013–2020 (USD Million)
Table 30 Asia-Pacific: Market Size for Hospitals, By Region/Country, 2013–2020 (USD Million)
Table 31 Market Size for Physician’s Offices and Clinics, By Region, 2013–2020 (USD Million)
Table 32 North America: Market Size for Physician’s Offices and Clinics, By Country, 2013–2020 (USD Million)
Table 33 Asia-Pacific: Market Size for Physician’s Offices and Clinics, By Country, 2013–2020 (USD Million)
Table 34 Market Size, By Region, 2013–2020 (USD Million)
Table 35 Market Size, By Region, 2013–2020 (Million Tests)
Table 36 North America: HPV Testing Market Size, By Country, 2013–2020 (USD Million)
Table 37 North America: Market Size, By Test Type, 2013–2020 (USD Million)
Table 38 North America: Market Size, By Test Type, 2013–2020 (Million Tests)
Table 39 North America: Market Size, By Test Type, 2013–2020 (USD Million)
Table 40 North America: PAP Test Market Size, By Application, 2013–2020 (USD Million)
Table 41 North America: Market Size, By End User, 2013–2020 (USD Million)
Table 42 U.S.: Market Size, By Test Type, 2013–2020 (USD Million)
Table 43 U.S.: PAP Test Market Size, By Application, 2013–2020 (USD Million)
Table 44 U.S.: Market Size, By End User, 2013–2020 (USD Million)
Table 45 Canada: Market Size, By Test Type, 2013–2020 (USD Million)
Table 46 Canada: PAP Test Market Size, By Application, 2013–2020 (USD Million)
Table 47 Canada: Market Size, By End User, 2013–2020 (USD Million)
Table 48 Europe: Market Size, By Test Type, 2013–2020 (USD Million)
Table 49 Europe: Market Size, By Test Type, 2013–2020 (Million Tests)
Table 50 Europe: Market Size, By Test Type, 2013–2020 (USD Million)
Table 51 Europe: PAP Test Market Size, By Application, 2013–2020 (USD Million)
Table 52 Europe: PAP Test Market Size, By End User, 2013–2020 (USD Million)
Table 53 Asia-Pacific: PAP Test Market Size, By Country, 2013–2020 (USD Million)
Table 54 Asia-Pacific: PAP Test Market Size, By Test Type, 2013–2020 (USD Million)
Table 55 Asia-Pacific: PAP Test Market Size, By Test Type, 2013–2020 (Million Tests)
Table 56 Asia-Pacific: Market Size, By Test Type, 2013–2020 (USD Million)
Table 57 Asia-Pacific: PAP Test Market Size, By Application, 2013–2020 (USD Million)
Table 58 Asia-Pacific: PAP Test Market Size, By End User, 2013–2020 (USD Million)
Table 59 Japan: PAP Test Market Size, By Test Type, 2013–2020 (USD Million)
Table 60 Japan: PAP Test Market Size, By Application, 2013–2020 (USD Million)
Table 61 Japan: PAP Test Market Size, By End User, 2013–2020 (USD Million)
Table 62 China: PAP Test Market Size, By Test Type, 2013–2020 (USD Million)
Table 63 China: PAP Test Market Size, By Application, 2013–2020 (USD Million)
Table 64 China: Market Size, By End User, 2013–2020 (USD Million)
Table 65 India: Market Size, By Test Type, 2013–2020 (USD Million)
Table 66 India: PAP Test Market Size, By Application, 2013–2020 (USD Million)
Table 67 India: HPV Testing Market Size, By End User, 2013–2020 (USD Million)
Table 68 RoAPAC: HPV Testing Market Size, By Test Type, 2013–2020 (USD Million)
Table 69 RoAPAC: PAP Test Market Size, By Application, 2013–2020 (USD Million)
Table 70 RoAPAC: Market Size, By End User, 2013–2020 (USD Million)
Table 71 RoW: Market Size, By Test Type, 2013–2020 (USD Million)
Table 72 RoW: Market Size, By Test Type, 2013–2020 (Million Tests)
Table 73 RoW: HPV Testing Market Size, By Test Type, 2013–2020 (USD Million)
Table 74 RoW: PAP Test Market Size, By Application, 2013–2020 (USD Million)
Table 75 RoW: Market Size, By End User, 2013–2020 (USD Million)
Table 76 Product Approvals and Licenses 2013-2015
Table 77 New Product Launches, 2012–2015
Table 78 Agreements, Collaborations, and Partnerships, 2012–2015
Table 79 Acquisitions, 2012–2015
Table 80 Expansions, 2012–2015


List of Figures (52 Figures)

Figure 1 Research Design
Figure 2 Market Size Estimation and Data Triangulation
Figure 3 Breakdown of Primary Interviews: By Companies, Designation, and Region
Figure 4 Market Snapshot (2015 vs 2020)
Figure 5 Market, By Test Type, 2015 vs 2020
Figure 6 The Hospitals Segment is Expected to Grow at the Highest CAGR During the Forecast Period
Figure 7 Cervical Cancer Screening Segment Will Continue to Dominate the PAP Test Market During the Forecast Period
Figure 8 New Product Launch is the Most Dominant Strategy Adopted By Market Players
Figure 9 Rising Incidences of Cervical Cancer and Increasing Awareness of Cervical Cancer Screening are Factors Driving Market Growth
Figure 10 HPV Testing Will Be the Fastest-Growing Segment During the Forecast Period
Figure 11 Laboratories Segment Dominates the HPV Testing Market in 2015
Figure 12 The HPV Testing and PAP Test Market in North America is Projected to Grow at the Highest CAGR During the Forecast Period
Figure 13 Market Analysis
Figure 14 Market: Drivers, Restraints, Opportunity, and Challenge
Figure 15 Cervical Cancer Incidences and Mortality: Global Forecast, 2012-2020
Figure 16 HPV Testing Segment to Outgrow PAP Testing During the Forecast Period
Figure 17 Primary HPV Testing Segment is Expected to Grow at the Highest CAGR During Forecast Period
Figure 18 North America is Projected to Dominate the HPV Testing Market During Forecast Period
Figure 19 North America is Expected to Dominate the PAP Test Market During the Forecast Period
Figure 20 Cervical Cancer Screening is A Major Application of the Market
Figure 21 North America is Expected to Dominate the PAP Test Market for Cervical Cancer Screening
Figure 22 North America is Expected to Dominate the Vaginal Cancer Screening Market
Figure 23 Laboratories are the Major End Users of the HPV Testing Market
Figure 24 North America Exhibits Highest Growth Potential in the Laboratories End User Segment
Figure 25 North America is Projected to Dominate the Hospitals Market During the Forecast Period
Figure 26 North America: Highest Growth Potential in the Physicians’ Offices and Clinics End-User Segment
Figure 27 Geographic Snapshot: North America Will Be the Fastest-Growing Region in the HPV Testing Market By 2020
Figure 28 North American Market for HPV Testing Shows Significant Growth Opportunities
Figure 29 The HPV Testing Market in North America is Projected to Grow at the Highest CAGR During the Forecast Period
Figure 30 North America HPV Testing Market Snapshot
Figure 31 The U.S. is Expected to Grow at the Highest CAGR in the North America HPV Testing Market During the Forecast Period
Figure 32 The Follow-Up HPV Testing Segment is Expected to Dominate the North America HPV Testing Market
Figure 33 The Hospitals Segment is Expected to Grow at the Highest CAGR During the Forecast Period
Figure 34 The HPV Testing Segment is Expected to Grow at the Highest CAGR During the Forecast Period
Figure 35 European HPV Testing Market Snapshot
Figure 36 The Hospitals Segment is Expected to Grow at the Highest CAGR During the Forecast Period
Figure 37 Japan is Estimated to Account for the Largest Share in the Asia-Pacific HPV Testing Market
Figure 38 The Laboratories Segment Accounted for the Largest Share in 2015
Figure 39 The Cervical Cancer Screening Segment Accounted for the Largest Share in 2015
Figure 40 The HPV Testing Segment is Expected to Grow at the Highest CAGR During the Forecast Period
Figure 41 The Hospitals Segment is Expected to Grow at the Highest CAGR During the Forecast Period
Figure 42 The Hospitals Segment is Expected to Grow at the Highest CAGR During The Forecast Period
Figure 43 New Product Launches, Product Approvals, Agreements, and Acquisitions Have Been the Key Strategies Adopted in the Last Three Years
Figure 44 Global HPV Testing Market Share, By Key Players, 2014
Figure 45 Battle for Market Share: Product Approvals and Licenses, New Product Launch, Agreements & Acquisitions Have Been the Key Strategies
Figure 46 Geographic Revenue Mix of the Top Five Market Players
Figure 47 Abbott Laboratories: Company Snapshot
Figure 48 Qiagen N.V.: Company Snapshot
Figure 49 Roche Diagnostics: Company Snapshot
Figure 50 Hologic, Inc.: Company Snapshot
Figure 51 Becton, Dickinson and Company: Company Snapshot
Figure 52 Quest Diagnostics: Company Snapshot


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