Sexually Transmitted Diseases (STDs) spread primarily through person-to-person sexual contacts. Varied testing technologies used for the identification and analysis of the STD contracted comprise the definition of ‘diagnostic testing of STDs’. The location where diagnostic tests are delivered i.e. in the laboratories or at the point-of-care (POC) also encompasses the definition for ‘diagnostic testing of STDs’. The Medicines and Healthcare Products Regulatory Agency (MHRA) defines POC testing as ‘any analytical test performed for a patient by a healthcare professional outside the conventional laboratory setting’.
Undiagnosed (that often results in untreated cases) STDs can have critical implications for reproductive, maternal and newborn health. For instance, 10% - 15% of women with untreated Chlamydia infection may develop symptomatic pelvic inflammatory disease (PID); progression of ~10% - 15% of PID cases lead to tubal factor infertility. Human Papilloma Virus (HPV) is the causative agent for ~99% of cervical cancers in women. Globally, HPV infection results in ~500,000 cases of cervical cancer and ~300,000 cervical cancer deaths per year. Undiagnosed and untreated STDs such as Syphilis lead to Congenital Syphilis - that results in preterm labor with associated risks of pre-term birth, low birth weight, blindness and death of the neonate. Globally, over 1 million cases of Syphilis occur among pregnant women and a majority proportion of these were untreated or inadequately treated. Unless testing and treatment of Syphilis in pregnancy are readily available, over 50% of the pregnancies in women with Syphilis will result in adverse outcomes as stated above.
Prenatal transmission of Herpes Simplex Virus (HSV) infection is associated with a high risk of neurological problems and death. Undiagnosed and untreated STDs also increase the risk of both acquisition and transmission of Human Immunodeficiency Virus (HIV), by a factor of up to two- to three-fold. Timely diagnosis of STDs is thus imperative for prevention of transmission, control and reducing the risk of incurable and fatal STD infections.
STDs can broadly be categorized as STDs of the developed regions and STDs of the poor/developing regions. As STDs namely Chlamydia, Gonorrhea and P&S Syphilis are more prevalent in North America and Europe, these developed regions have a higher market share in terms of testing volume. While Chancroid is non-existent in these developed region, for instance, there are only about 8 - 10 cases in North America. Moreover occurrence of these Chancroid cases in North America or Europe is solely a result of acquiring this infection i.e. travelling to the Rest of the World regions. As many of the viral STDs trace origin in the poor/developing regions such as the RoW; these regions have garnered a higher market share in terms of testing volume of STDs such as HIV, HSV and Chancroid.
Laboratory testing is of high significance for diagnostic testing of STDs; as although many Point-Of-Care (POC) tests are available for all STDs, some STDs cannot be diagnosed by POC methods and devices. For example, HSV, Low-risk HPV and Chancroid that clinically manifest as warts, require physical examination by laboratory experts. Also many of the POC methods and devices are not approved by the regulatory authorities such as the U.S. FDA; many of these fail to qualify the specificity and sensitivity norms prescribed by the regulatory authorities. Hence laboratory testing for diagnosis of STDs is considered reliable and the universally accepted diagnostic testing method.
Table of Contents
Chapter 1 Preface
1.1 Report Description
1.2 Market Segmentation
1.3 Research Methodology
1.4 Assumptions
Chapter 2 Executive Summary
Chapter 3 Introduction: Diagnostic Testing of STDs
3.1 Definition - Diagnostic Testing of STDs
3.2 Significance of STDs, STDs control and prevention
3.3 Types of Diagnostic Tests of STDs
Chapter 4 Global Diagnostic Testing of STDs Market Overview
4.1 Overview
4.2 Drivers
4.2.1 Increasing prevalence and incidence rates of STDs
4.2.2 National Screening Programs implemented
4.2.3 Favourable reimbursement for STDs testing
4.3 Restraints
4.3.1 Stigma associated with voluntary/CICT STD testing
4.3.2 Large proportion of STD infected patients in out-of-reach geographic areas
4.3.3 Stringent regulatory compliance requirements for market participants
4.4 Opportunities
4.4.1 National screening programs across regions - an opportunity for laboratory tests and POC tests / technologies providers
4.4.2 Declining visits to specialized STD and GUM clinics - an opportunity for public / private labs
4.4.3 RoW and Asia-Pacific markets - niche opportunity for POC tests/ technologies providers
4.5 Market Attractiveness Analysis: Global Diagnostic Testing of STDs Market, by Geography
Chapter 5 Global Diagnostic Testing of STDs Market, by STD Type, 2013 - 2019 (USD Million)
5.1 Chlamydia testing
5.1.1 Global Chlamydia Diagnostic Testing Market, Volume (in Millions)
5.1.2 Global Chlamydia Diagnostic Testing Market, Value (USD Million)
5.2 Gonorrhea testing
5.2.1 Global Gonorrhea Diagnostic Testing Market, Volume (in Millions)
5.2.2 Global Gonorrhea Diagnostic Testing Market, Value (USD Million)
5.3 P&S Syphilis testing
5.3.1 Global P&S Syphilis Diagnostic Testing Market, Volume (in Millions)
5.3.2 Global P&S Syphilis Diagnostic Testing Market, Value (USD Million)
5.4 HPV testing
5.4.1 Global HPV Diagnostic Testing Market, Volume (in Millions)
5.4.2 Global HPV Diagnostic Testing Market, Value (USD Million)
5.5 HSV testing
5.5.1 Global HSV Diagnostic Testing Market, Volume (in Millions)
5.5.2 Global HSV Diagnostic Testing Market, Value (USD Million)
5.6 HIV testing
5.6.1 Global HIV Diagnostic Testing Market, Volume (in Millions)
5.6.2 Global HIV Diagnostic Testing Market, Value (USD Million)
5.7 Chancroid testing
5.7.1 Global Chancroid Diagnostic Testing Market, Volume (in Millions)
5.7.2 Global Chancroid Diagnostic Testing Market, Value (USD Million)
5.8 Laboratory Equipment and Supplies Market
Chapter 6 Global Diagnostic Testing of STDs Market, by Location, 2013 - 2019 (USD Million)
6.1 Laboratory Testing
6.2 POC Testing
Chapter 7 Global Diagnostic Testing of STDs Market, by Geography, 2013 - 2019 (USD Million)
7.1 Introduction
7.1.1 Global Diagnostic Testing of STDs Market, by Geography, 2013 - 2019 (USD Million)
7.2 Chlamydia Diagnostic Testing: Regional (North America, Europe, Asia-Pacific & RoW) Market Size, 2013 and 2019 (USD Million)
7.3 Gonorrhea Diagnostic Testing: Regional (North America, Europe, Asia-Pacific & RoW) Market Size, 2013 and 2019 (USD Million)
7.4 P&S Syphilis Diagnostic Testing: Regional (North America, Europe, Asia-Pacific & RoW) Market Size, 2013 and 2019 (USD Million)
7.5 HPV Diagnostic Testing: Regional (North America, Europe, Asia-Pacific & RoW) Market Size, 2013 and 2019 (USD Million)
7.6 HSV Diagnostic Testing: Regional (North America, Europe, Asia-Pacific & RoW) Market Size, 2013 and 2019 (USD Million)
7.7 HIV Diagnostic Testing: Regional (North America, Europe, Asia-Pacific & RoW) Market Size, 2013 and 2019 (USD Million)
7.8 Chancroid Diagnostic Testing : Regional (North America, Europe, Asia-Pacific & RoW) Market Size, 2013 and 2019 (USD Million)
Chapter 8 Recommendations
8.1 Gain accreditation to ensure qualification to participate in National Screening Programs across regions
8.2 Investment In Laboratory Infrastructure In Developed Regions
8.3 Investing in Asia-Pacific and RoW markets
Chapter 9 Company Profiles
9.1 Roche Holdings AG
9.1.1 Company Overview
9.1.2 Financial Overview
9.1.3 Product Portfolio
9.1.4 Business Strategies
9.2 Alere, Inc.
9.2.1 Company Overview
9.2.2 Financial Overview
9.2.3 Product Portfolio
9.2.4 Business Strategies
9.3 Becton Dickinson & Company
9.3.1 Company Overview
9.3.2 Financial Overview
9.3.3 Product Portfolio
9.3.4 Business Strategies
9.3.5 Recent Developments
9.4 bioMerieux
9.4.1 Company Overview
9.4.2 Financial Overview
9.4.3 Product Portfolio
9.4.4 Business Strategies
9.4.5 Recent Developments
9.5 Danaher Corporation (Beckman Coulter)
9.5.1 Company Overview
9.5.2 Financial Overview
9.5.3 Product Portfolio
9.5.4 Business Strategies
9.6 Hologic, Inc. (Gen-Probe)
9.6.1 Company Overview
9.6.2 Financial Overview
9.6.3 Product Portfolio
9.6.4 Business Strategies
Chapter 10 Appendix
List of Tables
TABLE 1 Market Snapshot: Global Diagnostic Testing of STDs Market
TABLE 2 Global Chlamydia Diagnostic Testing Market, Value, 2011 - 2019 (USD Million)
TABLE 3 Number of Cases of Gonorrhea Resistance (%)
TABLE 4 Global Gonorrhea Diagnostic Testing Market, Value, 2011 - 2019 (USD Million)
TABLE 5 Global P&S Syphilis Diagnostic Testing Market, Value, 2011 - 2019 (USD Million)
TABLE 6 Global HPV Diagnostic Testing Market, Value, 2011 - 2019 (USD Million)
TABLE 7 Global HSV Diagnostic Testing Market, Value, 2011 - 2019 (USD Million)
TABLE 8 Global HIV Diagnostic Testing Market, Value, 2011 - 2019 (USD Million)
TABLE 9 Global Chancroid Diagnostic Testing Market, Value, 2011 - 2019 (USD Million)
List of Figures
FIG. 1 Diagnostic Testing of STDs: Market Segmentation
FIG. 2 Global Diagnostic Testing of STDs Market, by STD type, 2012, Volume (in Millions)
FIG. 3 Algorithm for P&S Syphilis testing utilized in screening programs
FIG. 4 Algorithm for HIV testing
FIG. 5 Declining visits to specialized STD clinics
FIG. 6 Market Attractiveness Analysis: Global Diagnostic Testing of STDs Market, by Geography
FIG. 7 Global Chlamydia Diagnostic Testing Market, Volume (in Millions), 2011 - 2019
FIG. 8 Global Gonorrhea Diagnostic Testing Market, Volume (in Millions), 2011 - 2019
FIG. 9 Global P&S Syphilis Diagnostic Testing Market, Volume (in Millions), 2011 - 2019
FIG. 10 Low-risk and High-risk HPV types
FIG. 11 Global HPV Diagnostic Testing Market, Volume (in Millions), 2011 - 2019
FIG. 12 Global HSV Diagnostic Testing Market, Volume (in Millions), 2011 - 2019
FIG. 13 Global HIV Diagnostic Testing Market, Volume (in Millions), 2011 - 2019
FIG. 14 Global Chancroid Diagnostic Testing Market, Volume (in Millions), 2011 - 2019
FIG. 15 Global Diagnostic Testing of STDs Market, by Geography, 2013 - 2019 (USD Million)
FIG. 16 Comparative Analysis : Global Market for Chlamydia Diagnostic Testing, by Geography, 2013 and 2019 (USD million)
FIG. 17 Comparative Analysis : Global Market for Gonorrhea Diagnostic Testing, by Geography, 2013 and 2019 (USD million)
FIG. 18 Comparative Analysis : Global Market for P&S Syphilis Diagnostic Testing, by Geography, 2013 and 2019 (USD million)
FIG. 19 Comparative Analysis : Global Market for HPV Diagnostic Testing, by Geography, 2013 and 2019 (USD million)
FIG. 20 Comparative Analysis : Global Market for HSV Diagnostic Testing, by Geography, 2013 and 2019 (USD million)
FIG. 21 Comparative Analysis : Global Market for HIV Diagnostic Testing, by Geography, 2013 and 2019 (USD million)
FIG. 22 Comparative Analysis : Global Market for Chancroid Diagnostic Testing, by Geography, 2013 and 2019 (USD million)
FIG. 23 Roche Holdings AG: Annual Sales Revenue, USD million, 2010 – 2012
FIG. 24 Alere: Annual Sales Revenue, USD million, 2010 – 2012
FIG. 25 Becton Dickinson: Annual Sales Revenue, USD million, 2010 – 2012
FIG. 26 bioMerieux: Annual Sales Revenue, USD million, 2010 – 2012
FIG. 27 Danaher Corporation: Annual Sales Revenue, USD million, 2010 – 2012
FIG. 28 Hologic: Annual Sales Revenue, USD million, 2010 – 2012
FIG. 29 Healthy People 2020 (HP 2020) Sexually Transmitted Diseases Objectives