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HIV-AIDS Testing Markets - Product Image

HIV-AIDS Testing Markets

  • Published: October 2012
  • Region: Global
  • 151 Pages
  • TriMark Publications

FEATURED COMPANIES

  • Abbott Diagnostics
  • Avioq, Inc.
  • Bio-Rad Laboratories
  • Green Cross
  • Maxim Biomedical
  • Qualpro Diagnostics
  • MORE

There are an estimated 33.3 million people living with HIV (the virus which causes AIDS) worldwide and approximately 2.6 million people are newly-infected each year. While the Asian and African regions account for more than 90% of the HIV-infected population (with the highest number in Sub-Saharan Africa), the U.S. and European regions make up greater than 60% of the HIV testing market.

This report provides a comprehensive examination of the HIV/AIDS testing market, a specific segment of the in vitro diagnostics (IVD) market as it relates to infectious diseases. It examines the available and emerging technologies being utilized by the HIV testing field, defines the dollar volume of sales—both in the U.S. and worldwide—and analyzes the factors that influence the size and growth of the market. The chief HIV testing assays, i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic, are covered thoroughly, as are high-growth applications in different clinical diagnostic areas and expanding markets, such as employee screening, emergency medicine and satellite clinic testing.

Additionally, this analysis covers the following areas in details: READ MORE >

1. Overview
1.1 Statement of Report
1.2 About This Report
1.3 Scope of the Report
1.4 Objectives
1.5 Methodology
1.6 Executive Summary

2. Overview of HIV and AIDS
2.1 HIV Virus
2.1.1 Structure
2.1.2 Genetic Code
2.1.3 Subtypes
2.1.3.1 HIV-1
2.1.3.2 HIV-2
2.2 Viral Mechanism of Action (HIV Life Cycle)
2.2.1 Entry into the Cell
2.2.2 Replication and Transcription
2.2.3 Assembly and Release
2.3 HIV Transmission
2.4 Symptoms of HIV and AIDS
2.4.1 Acute (Primary) Infection
2.4.2 Clinically Asymptomatic Infection
2.4.3 Symptomatic HIV Infection
2.4.4 AIDS
2.5 Diagnosis of HIV and AIDS
2.6 Brief Summary of Current Therapies

3. Profile of HIV/AIDS: Statistics and Epidemiology
3.1 Worldwide HIV/AIDS Incidence
3.1.1 Sub-Saharan Africa
3.1.2 Asia
3.1.3 Eastern Europe and Central Asia
3.1.4 Caribbean
3.1.5 Central and South America
3.1.6 Middle East and North Africa
3.1.7 North America and Western and Central Europe
3.1.8 Oceania
3.2 HIV/AIDS in the U.S.
3.3 Economic Impact of HIV/AIDS

4. Overview of HIV Testing
4.1 Main Objectives of HIV Testing
4.2 HIV Screening Tests
4.3 HIV Confirmation Tests
4.4 HIV Monitoring Tests
4.4.1 Measuring Viral Loads
4.4.2 Genotyping Assays
4.4.3 Phenotyping Assays
4.5 Proposed Changes to the HIV Testing Algorithm
4.6 U.S. Recommendations for HIV Testing
4.7 U.S. HIV Testing Statistics

5. Technological Platforms Used in HIV Testing
5.1 Enzyme-Linked Immunosorbent Assay (ELISA)
5.1.1 Rapid HIV Tests
5.1.1.1 Immunoconcentration (Flow Through Assay)
5.1.1.2 Immunochromatography (Lateral Flow Assay)
5.1.1.3 Particle Agglutination
5.1.1.4 Solid Phase (Dipstick Assay)
5.2 Antibody/p24 Antigen Test (Fourth-Generation Test)
5.3 Western Blot Assay
5.4 Line Immunoassays
5.5 Indirect Fluorescent Antibody (IFA) Assay
5.6 Nucleic Acid Tests
5.7 Emerging Technologies

6. Issues Affecting HIV Testing
6.1 Overview of Specimens Used in HIV Testing
6.1.1 Blood Samples
6.1.1.1 Dried Blood Spot Samples
6.1.2 Oral Fluid Samples
6.1.3 Urine Samples
6.2 Limitations of Existing HIV Testing Products
6.2.1 Sensitivity and Specificity
6.2.1.1 False Negative Rates
6.2.1.2 False Positive Rates
6.2.1.3 Positive Predictive Values
6.2.2 Indeterminate Results
6.2.3 Window Period (Delayed Detection of HIV Infection)
6.3 Quality Control Criteria
6.4 Challenges Associated with HIV Testing
6.5 Potential Areas of Improvement in HIV Testing and Assay Performance
6.6 Factors Influencing Selection and Use of HIV Tests
6.7 Barriers and Facilitators to Routine HIV Testing
6.7.1 Routine HIV Testing in Emergency Departments
6.7.2 Compatibility of State Laws with CDC HIV Testing Recommendations
6.8 Clinical Laboratory Improvement Amendments (CLIA)

7. HIV Tests on the Market
7.1 Overview of the Types of HIV Tests on the Market
7.2 Anti-HIV Antibody Screening Tests
7.2.1 Whole Blood, Serum, or Plasma-based HIV Tests
7.2.1.1 Abbott Diagnostics
7.2.1.2 Ani Labsystems
7.2.1.3 Avioq, Inc.
7.2.1.4 Bio-Rad Laboratories
7.2.1.5 Green Cross
7.2.1.6 Maxim Biomedical
7.2.1.7 Ortho-Clinical Diagnostics
7.2.1.8 Shanghai Kehua
7.2.1.9 Siemens Healthcare Diagnostics
7.2.1.10 Span Diagnostics
7.2.1.11 Biomedical, Inc.
7.2.2 Oral HIV Tests
7.2.2.1 Avioq, Inc.
7.2.2.2 Chembio Diagnostic Systems
7.2.2.3 Immunoscience, Inc.
7.2.2.4 Maxim Biomedical
7.2.2.5 OraSure Technologies
7.2.2.6 Oral Collection Devices
7.2.3 Urine-based HIV Tests
7.2.3.1 Maxim Biomedical
7.2.4 Rapid HIV Tests
7.2.4.1 Alere
7.2.4.2 bioLytical Laboratories, Inc.
7.2.4.3 Bio-Rad Laboratories
7.2.4.4 MedMira Laboratories, Inc.
7.2.4.5 OraSure Technologies
7.2.4.6 Trinity Biotech
7.2.4.7 Alere
7.2.4.8 bioMérieux
7.2.4.9 Bioner
7.2.4.10 Chembio Diagnostics
7.2.4.11 Core Diagnostics
7.2.4.12 EY Laboratories
7.2.4.13 Green Cross
7.2.4.14 InTec Products
7.2.4.15 J Mitra & Co.
7.2.4.16 Orgenics, Ltd.
7.2.4.17 Premier Medical Corporation
7.2.4.18 Qualpro Diagnostics
7.2.4.19 Savyon Diagnostics
7.2.4.20 Shanghai Kehua
7.2.4.21 Span Diagnostics
7.2.4.22 Standard Diagnostics, Inc.
7.2.4.23 Additional Companies Selling Non-FDA-Approved Rapid HIV Assays Outside of the U.S.
7.3 HIV Antibody/p24 Antigen Tests (Fourth-Generation Tests)
7.3.1 FDA-Approved Fourth-Generation HIV Assays
7.3.1.1 ARCHITECT HIV Ag/Ab Combo Assay (Abbott Laboratories)
7.3.1.2 GS HIV Ag/Ab Combo EIA (Bio-Rad Laboratories)
7.3.2 Fourth-Generation HIV Assays Commercially Available Outside of the U.S.
7.3.2.1 ABBOTT AxSYM HIV Ab/Ag Combo (Abbott Laboratories)
7.3.2.2 Determine? HIV 1/2 Ag/Ab Combo (Alere)
7.3.2.3 Vironostika® HIV Uni-Form II Ag/Ab (bioMérieux)
7.3.2.4 GENEDIA® HIV Ag-Ab ELISA (Green Cross)
7.3.2.5 HIV TRI-DOT + Ag (J Mitra & Co.)
7.3.2.6 Fourth-Generation Microlisa HIV Ag and Ab (J Mitra & Co.)
7.3.2.7 Immunocomb® II HIV 1&2 TriSpot Ag-Ab (Orgenics)
7.3.2.8 Enzygnost HIV Integral II (Siemens Healthcare Diagnostics)
7.3.2.9 Enzaids Duet (Span Diagnostics)
7.4 Anti-HIV Antibody Confirmation Tests
7.4.1 Western Blot
7.4.1.1 Cambridge Biotech HIV-1 Western Blot Kit (Maxim Biomedical)
7.4.1.2 GS HIV-1 Western Blot (Bio-Rad Laboratories)
7.4.1.3 OraSure HIV-1 Western Blot Kit (OraSure Technologies)
7.4.1.4 HIV Blot 2.2 (MP Diagnostics)
7.4.2 Line Immunoassays
7.4.3 Indirect Fluorescent Antibody
7.5 Nucleic Acid Tests
7.5.1 Measuring Viral Loads and Resistance Testing
7.5.2 Instruments and Reagents
7.5.2.1 Abbott Molecular
7.5.2.2 Gen-Probe, Inc.
7.5.2.3 Roche Molecular Systems
7.5.2.4 Siemens Healthcare Diagnostics
7.5.2.5 bioMérieux
7.5.2.6 Qiagen
7.5.3 Diagnostic Testing Services
7.5.4 Comparisons of HIV Nucleic Acid Testing Platforms
7.5.5 HIV Molecular Diagnostic and NAT HIV Monitoring Market History
7.6 Home HIV Testing
7.6.1 Home HIV Testing Kits
7.6.1.1 Direct Access Diagnostics
7.6.1.2 Home Access Health Corp.
7.6.2 Competitive Situation for Home HIV Testing Kits
7.6.3 Advantages and Disadvantages of Home HIV Testing
7.7 Emerging Technologies and Products

8. Market Analysis: Size, Growth, Share and Competitors
8.1 Worldwide HIV/AIDS Testing Market
8.1.1 U.S. Market
8.1.2 European Market
8.1.3 Asian Market
8.1.4 ROW Market
8.2 Market Drivers and Restraints
8.2.1 Market Drivers
8.2.2 Market Restraints
8.3 Market and Technology Trends
8.3.1 Market Trends
8.3.2 Technology Trends
8.4 Competitive Situation
8.5 HIV Market Challenges and Strategic Recommendations
8.6 Insurance Coverage and Reimbursement
8.7 Policies Affecting HIV Testing
8.8 Recent Industry Activity

INDEX OF FIGURES

Figure 2.1: Diagram of HIV 13
Figure 2.2: HIV Replication Cycle 15
Figure 2.3: Ten Best-Selling AIDS Drugs in the U.S., 2009 22
Figure 3.1: Global Trend of HIV Infection, 1990-2009 24
Figure 3.2: Number of People Newly Infected with HIV, 1990-2009 25
Figure 3.3: Number of Deaths Due to AIDS, 1990-2009 25
Figure 3.4: Top Ten Countries with the Highest Adult HIV Prevalence Rate, 2009 26
Figure 3.5: Global View of Adult (Ages 15-49) HIV Infection, 2009 28
Figure 3.6: Ethnic Distribution of AIDS Patients in the U.S., 2009 29
Figure 3.7: U.S. Rates for New HIV Cases, 2008 30
Figure 3.8: New HIV Infections by Transmission Category, 2009 31
Figure 4.1: Proposed HIV Testing Algorithm 36
Figure 4.2: Percent of Persons (Ages 18-64) Who Reported Being Tested for HIV in the U.S., 2011 40
Figure 4.3: Percent of Persons (Ages 18-64) Who Reported Being Tested for HIV in the U.S. by Race/Ethnicity, 2011 41
Figure 5.1: Schematic of ELISA Tests 42
Figure 5.2: Concentration of Different HIV Markers in Plasma Following Initial Infection 44
Figure 5.3: Schematic of a Flow Through Assay 47
Figure 5.4: Schematic of a Lateral Flow Assay 48
Figure 5.5: Basic Components of a Lateral Flow Device 48
Figure 5.6: Schematic of a Dipstick Assay 50
Figure 5.7: Schematic of an Antibody/p24 Antigen (Fourth-Generation) Test 50
Figure 5.8: Western Blot Assay Preparation 51
Figure 5.9: Western Blot Banding Pattern 52
Figure 6.1: Understanding Positive Predictive Values 60
Figure 6.2: Window Period for Antibody-based HIV Tests 61
Figure 6.3: Concentration of Different HIV Markers in Plasma Following Initial Infection 62
Figure 6.4: Percentage of Emergency Departments Performing HIV Testing, 2011 66
Figure 6.5: Legislative Changes in State Laws to Increase Compatibility with CDC
Recommendations, 2011 68
Figure 8.1: Global POCT Share of HIV Testing Market, 2010 113
Figure 8.2: HIV Test Kits Procured by WHO in 2009, by Region 115
Figure 8.3: Distribution of HIV Molecular Diagnostic Testing by Purpose 118
Figure 8.4: Market Share Viral Load HIV NAT Diagnostic Testing 119

INDEX OF TABLES

Table 2.1: AIDS-Defining Conditions 18
Table 2.2: Different Types of HIV Screening and Diagnostic Tests 19
Table 2.3: Comparison of CDC and WHO Case Definitions 20
Table 2.4: CDC Case Definition for HIV Infection Among Adults and Adolescents (Aged ?13 years), 2008 20
Table 2.5: WHO Case Definition for HIV Infection, 2007 20
Table 2.6: WHO Case Definition for Advanced HIV (Including AIDS), 2007 21
Table 2.7: WHO Immunological Classification for Established HIV Infection, 2007 21
Table 2.8: Classes of Antiretroviral HIV Drugs 21
Table 2.9: New Antiretroviral Drugs 23
Table 3.1: Global Summary of the HIV/AIDS Epidemic, 2009 24
Table 3.2: Global HIV Statistics, 2009 27
Table 3.3: Countries with the Greatest Number of People Living with HIV, 2009 28
Table 3.4: Top Ten States by Cumulative AIDS Diagnosis, 2009 32
Table 3.5: Top Ten States by AIDS Diagnosis Rate, 2009 32
Table 4.1: Tests Used to Detect Acute HIV Infection 34
Table 4.2: HIV Antiviral Drug Resistance Testing Recommendations 39
Table 4.3: Common HIV Testing Sites 41
Table 4.4: Public Health HIV Testing Sites 41
Table 5.1: Advantages and Disadvantages of ELISA HIV Tests 43
Table 5.2: Rapid HIV Testing Outlets 45
Table 5.3: Desirable Characteristics of Rapid Tests 46
Table 5.4: Advantages of Rapid HIV Tests 46
Table 5.5: Disadvantages of Rapid HIV Tests 46
Table 5.6: Advantages and Disadvantages of Fourth-Generation Tests 51
Table 5.7: Advantages and Disadvantages of Nucleic Acid HIV Assays 55
Table 6.1: FDA-Approved Assays for Dried Blood Spot Samples 57
Table 6.2: Challenges Associated with HIV Testing 63
Table 6.3: Factors Influencing Assay Selection 65
Table 6.4: Compatibility of Consent and Counseling Laws with 2006 CDC Recommendations, 2011 67
Table 6.5: Financial Comparison for Moderate and Waived CLIA Labs 69
Table 7.1: ELISA Assays Detecting Anti-HIV Antibodies 72
Table 7.2: HIV Assays Using Oral Fluid Specimens 76
Table 7.3: Rapid HIV Immunoassay Tests 79
Table 7.4: FDA-Approved Rapid HIV Antibody Screening Tests 81
Table 7.5: USAID List of Approved HIV/AIDS Rapid Test Kits, June 2011 89
Table 7.6: HIV Antibody/p24 Antigen (Fourth-Generation) Tests 90
Table 7.7: FDA-Approved Confirmation Tests 94
Table 7.8: Nucleic Acid HIV Tests 96
Table 7.9: Summary of Assays for HIV Viral Load Testing 104
Table 7.10: Commercially Available Molecular Diagnostic Products for HIV Assay 104
Table 7.11: Comparison of HIV Home Sampling and Home Testing Services 108
Table 8.1: Worldwide HIV Testing Market, 2007-2016 111
Table 8.2: Worldwide HIV Screening and Confirmatory Testing Market, 2007-2016 111
Table 8.3: Worldwide POCT Market for HIV, 2007-2016 112
Table 8.4: Largest POCT Diagnostic Companies Worldwide, 2008 113
Table 8.5: Worldwide HIV Monitoring (NAT) Market, 2007-2016 114
Table 8.6: Number of Testing Facilities and Number of People Who Received HIV Testing Worldwide, 2010 114
Table 8.7: U.S. HIV Testing Market, 2007-2016 115
Table 8.8: U.S. HIV Screening and Confirmatory Testing Market, 2007-2016 116
Table 8.9: U.S. POCT Market for HIV, 2007-2016 116
Table 8.10: Estimated U.S. Market Share for CLIA-waived HIV POCT, 2011 117
Table 8.11: U.S. Market for NAT Testing to Monitor HIV, 2007-2016 118
Table 8.12: HIV Testing Market for OTC Testing in the U.S., 2007-2016 119
Table 8.13: Drivers of Demand for HIV Diagnostic Testing 123
Table 8.14: NAT HIV Monitoring Market: Market Drivers Ranked in Order of Impact 123
Table 8.15: Drivers of Demand for HIV Diagnostic Testing 124
Table 8.16: NAT HIV Monitoring Market: Market Restraints Ranked in Order of Impact 124
Table 8.17: Competitive Factors Related to HIV Tests 128

- Abbott Diagnostics
- Ani Labsystems
- Avioq, Inc.
- Bio-Rad Laboratories
- Green Cross
- Maxim Biomedical
- Ortho-Clinical Diagnostics
- Shanghai Kehua
- Siemens Healthcare Diagnostics
- Span Diagnostics
- Biomedical, Inc.
- Avioq, Inc.
- Chembio Diagnostic Systems
- Immunoscience, Inc.
- Maxim Biomedical
- OraSure Technologies
- Maxim Biomedical
- Alere
- bioLytical Laboratories, Inc.
- Bio-Rad Laboratories
- MedMira Laboratories, Inc.
- OraSure Technologies
- Trinity Biotech
- Alere
- bioMérieux
- Bioner
- Chembio Diagnostics
- Core Diagnostics
- EY Laboratories
- Green Cross
- InTec Products
- J Mitra & Co.
- Orgenics, Ltd.
- Premier Medical Corporation
- Qualpro Diagnostics
- Savyon Diagnostics
- Shanghai Kehua
- Span Diagnostics
- Standard Diagnostics, Inc.

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