HIV-AIDS Testing Markets

Published by: TriMark Publications

Published: Oct. 1, 2012 - 151 Pages

Table of Contents

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

Figure 2.2: HIV Replication Cycle

Figure 2.3: Ten Best-Selling AIDS Drugs in the U.S., 2009

Figure 3.1: Global Trend of HIV Infection, 1990-2009

Figure 3.2: Number of People Newly Infected with HIV, 1990-2009

Figure 3.3: Number of Deaths Due to AIDS, 1990-2009

Figure 3.4: Top Ten Countries with the Highest Adult HIV Prevalence Rate, 2009

Figure 3.5: Global View of Adult (Ages 15-49) HIV Infection, 2009

Figure 3.6: Ethnic Distribution of AIDS Patients in the U.S., 2009

Figure 3.7: U.S. Rates for New HIV Cases, 2008

Figure 3.8: New HIV Infections by Transmission Category, 2009

Figure 4.1: Proposed HIV Testing Algorithm

Figure 4.2: Percent of Persons (Ages 18-64) Who Reported Being Tested for HIV in

the U.S., 2011

Figure 4.3: Percent of Persons (Ages 18-64) Who Reported Being Tested for HIV in

the U.S. by

Race/Ethnicity, 2011

Figure 5.1: Schematic of ELISA Tests

Figure 5.2: Concentration of Different HIV Markers in Plasma Following Initial

Infection

Figure 5.3: Schematic of a Flow Through Assay

Figure 5.4: Schematic of a Lateral Flow Assay

Figure 5.5: Basic Components of a Lateral Flow Device

Figure 5.6: Schematic of a Dipstick Assay

Figure 5.7: Schematic of an Antibody/p24 Antigen (Fourth-Generation) Test

Figure 5.8: Western Blot Assay Preparation

Figure 5.9: Western Blot Banding Pattern

Figure 6.1: Understanding Positive Predictive Values

Figure 6.2: Window Period for Antibody-based HIV Tests

Figure 6.3: Concentration of Different HIV Markers in Plasma Following Initial

Infection

Figure 6.4: Percentage of Emergency Departments Performing HIV Testing, 2011

Figure 6.5: Legislative Changes in State Laws to Increase Compatibility with CDC

Recommendations, 2011

Figure 8.1: Global POCT Share of HIV Testing Market, 2010

Figure 8.2: HIV Test Kits Procured by WHO in 2009, by Region

Figure 8.3: Distribution of HIV Molecular Diagnostic Testing by Purpose

Figure 8.4: Market Share Viral Load HIV NAT Diagnostic Testing

INDEX OF TABLES

Table 2.1: AIDS-Defining Conditions

Table 2.2: Different Types of HIV Screening and Diagnostic Tests

Table 2.3: Comparison of CDC and WHO Case Definitions

Table 2.4: CDC Case Definition for HIV Infection Among Adults and Adolescents

(Aged =13 years), 2008

Table 2.5: WHO Case Definition for HIV Infection, 2007

Table 2.6: WHO Case Definition for Advanced HIV (Including AIDS), 2007

Table 2.7: WHO Immunological Classification for Established HIV Infection, 2007

Table 2.8: Classes of Antiretroviral HIV Drugs

Table 2.9: New Antiretroviral Drugs

Table 3.1: Global Summary of the HIV/AIDS Epidemic, 2009

Table 3.2: Global HIV Statistics, 2009

Table 3.3: Countries with the Greatest Number of People Living with HIV, 2009

Table 3.4: Top Ten States by Cumulative AIDS Diagnosis, 2009

Table 3.5: Top Ten States by AIDS Diagnosis Rate, 2009

Table 4.1: Tests Used to Detect Acute HIV Infection

Table 4.2: HIV Antiviral Drug Resistance Testing Recommendations

Table 4.3: Common HIV Testing Sites

Table 4.4: Public Health HIV Testing Sites

Table 5.1: Advantages and Disadvantages of ELISA HIV Tests

Table 5.2: Rapid HIV Testing Outlets

Table 5.3: Desirable Characteristics of Rapid Tests

Table 5.4: Advantages of Rapid HIV Tests

Table 5.5: Disadvantages of Rapid HIV Tests

Table 5.6: Advantages and Disadvantages of Fourth-Generation Tests

Table 5.7: Advantages and Disadvantages of Nucleic Acid HIV Assays

Table 6.1: FDA-Approved Assays for Dried Blood Spot Samples

Table 6.2: Challenges Associated with HIV Testing

Table 6.3: Factors Influencing Assay Selection

Table 6.4: Compatibility of Consent and Counseling Laws with 2006 CDC

Recommendations, 2011

Table 6.5: Financial Comparison for Moderate and Waived CLIA Labs

Table 7.1: ELISA Assays Detecting Anti-HIV Antibodies

Table 7.2: HIV Assays Using Oral Fluid Specimens

Table 7.3: Rapid HIV Immunoassay Tests

Table 7.4: FDA-Approved Rapid HIV Antibody Screening Tests

Table 7.5: USAID List of Approved HIV/AIDS Rapid Test Kits, June 2011

Table 7.6: HIV Antibody/p24 Antigen (Fourth-Generation) Tests

Table 7.7: FDA-Approved Confirmation Tests

Table 7.8: Nucleic Acid HIV Tests

Table 7.9: Summary of Assays for HIV Viral Load Testing

Table 7.10: Commercially Available Molecular Diagnostic Products for HIV Assay

Table 7.11: Comparison of HIV Home Sampling and Home Testing Services

Table 8.1: Worldwide HIV Testing Market, 2007-2016

Table 8.2: Worldwide HIV Screening and Confirmatory Testing Market, 2007-2016

Table 8.3: Worldwide POCT Market for HIV, 2007-2016

Table 8.4: Largest POCT Diagnostic Companies Worldwide, 2008

Table 8.5: Worldwide HIV Monitoring (NAT) Market, 2007-2016

Table 8.6: Number of Testing Facilities and Number of People Who Received HIV

Testing

Worldwide, 2010

Table 8.7: U.S. HIV Testing Market, 2007-2016

Table 8.8: U.S. HIV Screening and Confirmatory Testing Market, 2007-2016

Table 8.9: U.S. POCT Market for HIV, 2007-2016

Table 8.10: Estimated U.S. Market Share for CLIA-waived HIV POCT, 2011

Table 8.11: U.S. Market for NAT Testing to Monitor HIV, 2007-2016

Table 8.12: HIV Testing Market for OTC Testing in the U.S., 2007-2016

Table 8.13: Drivers of Demand for HIV Diagnostic Testing

Table 8.14: NAT HIV Monitoring Market: Market Drivers Ranked in Order of Impact

Table 8.15: Drivers of Demand for HIV Diagnostic Testing

Table 8.16: NAT HIV Monitoring Market: Market Restraints Ranked in Order of

Impact

Table 8.17: Competitive Factors Related to HIV Tests

Abstract

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