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 TriMark Publications 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: enzyme-linked immunosorbent assay (ELISA), antibody/p24 antigen test (fourth-generation test), Western blot assay, line immunoassays, indirect fluorescent antibody (IFA) assay, nucleic acid tests for infectious diseases, and the emerging technologies related to HIV and AIDS diagnosis. Moreover, this study also provides a thorough analysis of the companies known to be marketing, manufacturing or developing HIV testing products, as well as provides detailed tables and figures covering HIV testing markets around the globe.

Table of Contents

1. Overview 7
1.1 Statement of Report 7
1.2 About This Report 8
1.3 Scope of the Report 8
1.4 Objectives 9
1.5 Methodology 9
1.6 Executive Summary 10
2. Overview of HIV and AIDS 13
2.1 HIV Virus 13
2.1.1 Structure 13
2.1.2 Genetic Code 14
2.1.3 Subtypes 14
2.1.3.1 HIV-1 14
2.1.3.2 HIV-2 15
2.2 Viral Mechanism of Action (HIV Life Cycle) 15
2.2.1 Entry into the Cell 16
2.2.2 Replication and Transcription 16
2.2.3 Assembly and Release 16
2.3 HIV Transmission 16
2.4 Symptoms of HIV and AIDS 17
2.4.1 Acute (Primary) Infection 17
2.4.2 Clinically Asymptomatic Infection 17
2.4.3 Symptomatic HIV Infection 17
2.4.4 AIDS 18
2.5 Diagnosis of HIV and AIDS 18
2.6 Brief Summary of Current Therapies 21
3. Profile of HIV/AIDS: Statistics and Epidemiology 24
3.1 Worldwide HIV/AIDS Incidence 24
3.1.1 Sub-Saharan Africa 25
3.1.2 Asia 26
3.1.3 Eastern Europe and Central Asia 26
3.1.4 Caribbean 26
3.1.5 Central and South America 27
3.1.6 Middle East and North Africa 27
3.1.7 North America and Western and Central Europe 27
3.1.8 Oceania 27
3.2 HIV/AIDS in the U.S. 28
3.3 Economic Impact of HIV/AIDS 32
4. Overview of HIV Testing 33
4.1 Main Objectives of HIV Testing 33
4.2 HIV Screening Tests 33
4.3 HIV Confirmation Tests 34
4.4 HIV Monitoring Tests 34
4.4.1 Measuring Viral Loads 34
4.4.2 Genotyping Assays 35
4.4.3 Phenotyping Assays 35
4.5 Proposed Changes to the HIV Testing Algorithm 35
4.6 U.S. Recommendations for HIV Testing 37
4.7 U.S. HIV Testing Statistics 40
5. Technological Platforms Used in HIV Testing 42
5.1 Enzyme-Linked Immunosorbent Assay (ELISA) 42
5.1.1 Rapid HIV Tests 44
5.1.1.1 Immunoconcentration (Flow Through Assay) 47
5.1.1.2 Immunochromatography (Lateral Flow Assay) 47
5.1.1.3 Particle Agglutination 49
5.1.1.4 Solid Phase (Dipstick Assay) 49
5.2 Antibody/p24 Antigen Test (Fourth-Generation Test) 50
5.3 Western Blot Assay 51
5.4 Line Immunoassays 52
5.5 Indirect Fluorescent Antibody (IFA) Assay 53
5.6 Nucleic Acid Tests 53
5.7 Emerging Technologies 56
6. Issues Affecting HIV Testing 57
6.1 Overview of Specimens Used in HIV Testing 57
6.1.1 Blood Samples 57
6.1.1.1 Dried Blood Spot Samples 57
6.1.2 Oral Fluid Samples 58
6.1.3 Urine Samples 58
6.2 Limitations of Existing HIV Testing Products 58
6.2.1 Sensitivity and Specificity 59
6.2.1.1 False Negative Rates 59
6.2.1.2 False Positive Rates 60
6.2.1.3 Positive Predictive Values 60
6.2.2 Indeterminate Results 61
6.2.3 Window Period (Delayed Detection of HIV Infection) 61
6.3 Quality Control Criteria 62
6.4 Challenges Associated with HIV Testing 63
6.5 Potential Areas of Improvement in HIV Testing and Assay Performance 64
6.6 Factors Influencing Selection and Use of HIV Tests 65
6.7 Barriers and Facilitators to Routine HIV Testing 65
6.7.1 Routine HIV Testing in Emergency Departments 66
6.7.2 Compatibility of State Laws with CDC HIV Testing Recommendations 66
6.8 Clinical Laboratory Improvement Amendments (CLIA) 68
7. HIV Tests on the Market 71
7.1 Overview of the Types of HIV Tests on the Market 71
7.2 Anti-HIV Antibody Screening Tests 72
7.2.1 Whole Blood, Serum, or Plasma-based HIV Tests 72
7.2.1.1 Abbott Diagnostics 73
7.2.1.2 Ani Labsystems 73
7.2.1.3 Avioq, Inc. 73
7.2.1.4 Bio-Rad Laboratories 74
7.2.1.5 Green Cross 74
7.2.1.6 Maxim Biomedical 74
7.2.1.7 Ortho-Clinical Diagnostics 75
7.2.1.8 Shanghai Kehua 75
7.2.1.9 Siemens Healthcare Diagnostics 75
7.2.1.10 Span Diagnostics 75
7.2.1.11 Biomedical, Inc. 75
7.2.2 Oral HIV Tests 76
7.2.2.1 Avioq, Inc. 76
7.2.2.2 Chembio Diagnostic Systems 76
7.2.2.3 Immunoscience, Inc. 76
7.2.2.4 Maxim Biomedical 77
7.2.2.5 OraSure Technologies 77
7.2.2.6 Oral Collection Devices 78
7.2.3 Urine-based HIV Tests 79
7.2.3.1 Maxim Biomedical 79
7.2.4 Rapid HIV Tests 79
7.2.4.1 Alere 82
7.2.4.2 bioLytical Laboratories, Inc. 82
7.2.4.3 Bio-Rad Laboratories 83
7.2.4.4 MedMira Laboratories, Inc. 83
7.2.4.5 OraSure Technologies 84
7.2.4.6 Trinity Biotech 85
7.2.4.7 Alere 85
7.2.4.8 bioMérieux 86
7.2.4.9 Bioner 86
7.2.4.10 Chembio Diagnostics 86
7.2.4.11 Core Diagnostics 86
7.2.4.12 EY Laboratories 86
7.2.4.13 Green Cross 87
7.2.4.14 InTec Products 87
7.2.4.15 J Mitra & Co. 87
7.2.4.16 Orgenics, Ltd. 87
7.2.4.17 Premier Medical Corporation 87
7.2.4.18 Qualpro Diagnostics 88
7.2.4.19 Savyon Diagnostics 88
7.2.4.20 Shanghai Kehua 88
7.2.4.21 Span Diagnostics 88
7.2.4.22 Standard Diagnostics, Inc. 89
7.2.4.23 Additional Companies Selling Non-FDA-Approved Rapid HIV Assays Outside of the U.S. 89
7.3 HIV Antibody/p24 Antigen Tests (Fourth-Generation Tests) 90
7.3.1 FDA-Approved Fourth-Generation HIV Assays 91
7.3.1.1 ARCHITECT HIV Ag/Ab Combo Assay (Abbott Laboratories) 91
7.3.1.2 GS HIV Ag/Ab Combo EIA (Bio-Rad Laboratories) 92
7.3.2 Fourth-Generation HIV Assays Commercially Available Outside of the U.S. 92
7.3.2.1 ABBOTT AxSYM HIV Ab/Ag Combo (Abbott Laboratories) 92
7.3.2.2 Determine™ HIV 1/2 Ag/Ab Combo (Alere) 93
7.3.2.3 Vironostika® HIV Uni-Form II Ag/Ab (bioMérieux) 93
7.3.2.4 GENEDIA® HIV Ag-Ab ELISA (Green Cross) 93
7.3.2.5 HIV TRI-DOT + Ag (J Mitra & Co.) 93
7.3.2.6 Fourth-Generation Microlisa HIV Ag and Ab (J Mitra & Co.) 93
7.3.2.7 Immunocomb® II HIV 1&2 TriSpot Ag-Ab (Orgenics) 94
7.3.2.8 Enzygnost HIV Integral II (Siemens Healthcare Diagnostics) 94
7.3.2.9 Enzaids Duet (Span Diagnostics) 94
7.4 Anti-HIV Antibody Confirmation Tests 94
7.4.1 Western Blot 94
7.4.1.1 Cambridge Biotech HIV-1 Western Blot Kit (Maxim Biomedical) 94
7.4.1.2 GS HIV-1 Western Blot (Bio-Rad Laboratories) 95
7.4.1.3 OraSure HIV-1 Western Blot Kit (OraSure Technologies) 95
7.4.1.4 HIV Blot 2.2 (MP Diagnostics) 95
7.4.2 Line Immunoassays 95
7.4.3 Indirect Fluorescent Antibody 95
7.5 Nucleic Acid Tests 96
7.5.1 Measuring Viral Loads and Resistance Testing 97
7.5.2 Instruments and Reagents 97
7.5.2.1 Abbott Molecular 97
7.5.2.2 Gen-Probe, Inc. 98
7.5.2.3 Roche Molecular Systems 99
7.5.2.4 Siemens Healthcare Diagnostics 102
7.5.2.5 bioMérieux 103
7.5.2.6 Qiagen 103
7.5.3 Diagnostic Testing Services 104
7.5.4 Comparisons of HIV Nucleic Acid Testing Platforms 105
7.5.5 HIV Molecular Diagnostic and NAT HIV Monitoring Market History 106
7.6 Home HIV Testing 106
7.6.1 Home HIV Testing Kits 106
7.6.1.1 Direct Access Diagnostics 106
7.6.1.2 Home Access Health Corp. 106
7.6.2 Competitive Situation for Home HIV Testing Kits 107
7.6.3 Advantages and Disadvantages of Home HIV Testing 108
7.7 Emerging Technologies and Products 109
8. Market Analysis: Size, Growth, Share and Competitors 111
8.1 Worldwide HIV/AIDS Testing Market 111
8.1.1 U.S. Market 115
8.1.2 European Market 120
8.1.3 Asian Market 120
8.1.4 ROW Market 122
8.2 Market Drivers and Restraints 122
8.2.1 Market Drivers 122
8.2.2 Market Restraints 124
8.3 Market and Technology Trends 124
8.3.1 Market Trends 124
8.3.2 Technology Trends 126
8.4 Competitive Situation 127
8.5 HIV Market Challenges and Strategic Recommendations 129
8.6 Insurance Coverage and Reimbursement 130
8.7 Policies Affecting HIV Testing 130
8.8 Recent Industry Activity 131

List 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

List 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