HIV Testing Market (Immunoassay, Molecular, Point-of-Care [POC])

 
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Published Oct 25, 2017 | 157 Pages | Pub ID: KLI15515800

HIV Testing Market (Immunoassay, Molecular, Point-of-Care [POC])

Visit our 'Immunoassays' curated page for complete industry coverage.

Human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) are primary acquired immunodeficiency disorders resulting in defective immune functioning. HIV Testing Market examines the three distinct categories that comprise the global HIV testing market:

  • Lab-based immunoassay HIV testing
  • Molecular HIV testing
  • Point-of-care (POC) HIV testing
Market analyses in this report cover world markets for HIV testing, including immunoassays on large, high-throughput instruments in centralized core laboratories down to manual lateral flow and other manual immunoassays used in the point-of-care setting. In addition, this report covers line immunoassay testing, combination testing and nucleic acid testing.

Types of HIV Testing

HIV Testing Market reviews the types of HIV testing. To diagnose HIV infection, laboratory tests such as the enzyme-linked immunosorbent assay (ELISA) and the Western blot are used to detect the presence of HIV antibodies, which, in infected individuals, are found in measurable quantities. When the ELISA test result is positive, a second test, the Western blot, is used to confirm the presence of HIV antibodies. The nucleic acid test (NAT) or nucleic acid amplification test (NAAT) is a molecular test can detect the HIV virus in blood, or other body tissues. The report provides data on these and other test types:
  • Selected EIA HIV Assays
  • Selected Western Blot HIV Assays
  • Selected Indirect Fluorescent Antibody HIV Assays
  • Selected Combination HIV Assays
  • Selected Nucleic Acid HIV Assays
  • Selected HIV Assays Used for Screening

Global Market Size and Growth

The report provides market size and growth of the global HIV testing market, including:
  • Global HIV Testing Market, 2015-2022 (in millions at manufacturer level)
  • Global HIV Testing Market Share Percent by Test Category, 2017 (%; Lab-based, Molecular, POC)
  • Global HIV Testing Market Share Percent by Test Category, 2022 (%; Lab-based, Molecular, POC)

Lab-based Immunoassay HIV Testing Market

Lab-based immunoassay HIV tests have entered a mature growth phase. Immunoassays for high volume infectious diseases are commonly found on core lab instruments. All of the major IVD companies market tests for HIV. Data on the lab-based market include:
  • Market Size and Growth for Lab-based HIV Testing Market, 2017-2022
  • Selected Companies Marketing Central Lab-Based HIV Immunoassays Worldwide

Molecular HIV Testing Market

Molecular HIV testing is fairly mature with most innovation and growth relating to antiviral therapy including testing for viral load, viral tropism, and drug resistance. Outside of developed markets, HIV screening and diagnosis remains an ongoing challenge. Clinical approaches to HIV in the United States, Europe and other developed countries emphasize molecular testing as a tool for the management of chronic infection and achieving viral suppression. The report provides the following information on the molecular market:
  • Market Size and Growth for Molecular HIV Testing Market, 2017-2022
  • Market-Available HIV Molecular Diagnostic Platforms

Point-of-Care (Rapid) HIV Testing Market

Most point-of-care (POC) HIV tests have used PCR and were designed to improve HIV testing in developing countries. Molecular tests designed specifically for use at the POC, by non-lab trained personnel, have always been a goal for patient care sites in rural areas of developed countries and for developing countries. Data provided on the POC HIV testing market include:
  • Market Size and Growth for POC HIV Testing Market, 2017-2022
  • Market Size and Growth for Professional POC HIV Testing Market, 2017-2022
  • Market Size and Growth for Self-Testing HIV Testing Market, 2017-2022
  • Selected Rapid HIV Professional and Home Tests

Analysis by Geographic Region

HIV Testing Market (Immunoassay, Molecular, Point-of-Care [POC]) features analysis by geographic region, including the United States, Europe, and the rest of world. The United States HIV testing market is the largest; Europe has made a concerted effort to develop novel POC technologies for HIV testing including developing models for strategic, evidence-based decision making on adoption of novel approaches to testing; and the rise in incidence of HIV in developing countries continues to push the market revenues upward. Market data provided include:
  • Market Size and Growth for United States HIV Testing Market, 2017-2022
  • Market Size and Growth for Europe HIV Testing Market, 2017-2022
  • European Regional Market Share by Country, % 2017 (Germany, France, UK, Italy, Spain, Turkey, Other)
  • Market Size and Growth for Japan HIV Testing Market, 2017-2022
  • Market Size and Growth for Rest of World HIV Testing Market, 2017-2022
  • ROW Regional Market Share by Country, % 2017 (China, India, Brazil, Russia, Canada, SE Asia, ROW)

Competitive Analysis

Competition in the HIV testing market is intense and it is expected to increase as more innovative HIV tests enter the marketplace. Some established immunoassay IVD companies have even found it necessary to move into other areas of HIV testing such as molecular and POC. The report provides global HIV testing market analysis by competitor revenues and market share for 2017.

Market leaders in HIV testing profiled in the report include:
  • Abbott Laboratories
  • AccuBioTech Co. Ltd.
  • Akers Biosciences, Inc.
  • Alere Inc.
  • ARKRAY, Inc.
  • Artron Laboratories, Inc.
  • Atlas Link Biotech, Co., LTD.
  • Autobio Diagnostics, Co., LTD.
  • Avioq, Inc.
  • Beckman Coulter, Inc.
  • Becton Dickinson
  • Beijing Wantai Biological Pharmacy Enterprise Co., LTD.
  • Bhat Bio-Tech India Private LTD. (BBI)
  • Biokit S.A.
  • bioLytical Laboratories
  • bioMerieux S.A.
  • Bio-Rad Laboratories, Inc.
  • Calypte Biomedical Corporation
  • Cavidi
  • Cepheid
  • Chembio Diagnostic Systems, Inc.
  • CTK Biotech, Inc.
  • Danaher Corporation
  • Diagnostics for the Real World LTD.
  • DIALAB GmbH
  • ERBA Molecular
  • EY Laboratories
  • GlysBy Snc
  • Grifols International S.A.
  • Hema Diagnostics Systems, LLC
  • Hologic, Inc.
  • Mbio Diagnostics, Inc.
  • MedMira, Inc.
  • Molbio Diagnostics PVT. LTD.
  • Nanobiosym, Inc.
  • Northwestern Global Health Foundation (NWGHF)
  • Omega Diagnostics Group Plc
  • OraSure Technologies, Inc.
  • Ortho Clinical Diagnostics
  • Princeton Biomeditech Corporation
  • Quidel Corporation
  • Roche Diagnostic Corporation
  • Sacace Biotechnologies S.r.l.
  • Savyon Diagnostics LTD.
  • Siemens Healthineers
  • Standard Diagnostics, Inc.
  • Trinity Biotech Plc
  • WAMA Diagnostica
  • Wave 80 Biosciences

Scope & Methodology

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Telephone interviews and email correspondence were the primary methods of gathering information. For the purpose of this study, Kalorama Information conducted interviews with more than 20 key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Additional interviews were completed with relevant company representatives including marketing directors, division managers, and product representatives.
1. EXECUTIVE SUMMARY
OVERVIEW
SCOPE AND METHODOLOGY
SIZE AND GROWTH OF THE MARKET
Table 1-1: Global HIV Testing Market 2015-2022 (in millions $ at manufacturer level)
COMPETITIVE ANALYSIS
2. INTRODUCTION
EPIDEMIOLOGY
History
Types of HIV
Transmission
ETIOLOGY
HIV Structure
HIV Binding and Infection
PATHOGENESIS
HIV Effect on Immune Cells at the Cellular Level
Viral Production and Cell Death
Progression of HIV Infection
CDC HIV Classification
HIV Statistics Worldwide
Figure 2-1: Worldwide Individuals Living with HIV, by Geographic Region, 2016 (in millions) (Africa, Americas, SE Asia, Europe, West Pacific)
Table 2-1: Global HIV Statistics by Selected Countries 2016 (Angola, Botswana, Brazil, Cambodia, Cameroon, China, Republic of Congo, France, India, Italy, Kenya, Namibia, Nigeria, Spain, South Africa, United States, Vietnam, Zimbabwe)
HIV DIAGNOSTIC TESTING DIFFICULTIES
LACK OF PROFESSIONAL TRAINING
HIV AND CANCER
Table 2-2: Current Research Trials (Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies) for HIV and Cancer Synergy as of October 1, 2017 (Lymphoma, Kaposi Sarcoma, Anal Cancer, Colorectal Cancer, Cervical Cancer, Lung Cancer, Liver Cancer, Others, Total)
3. HIV TESTING
CATEGORIES OF HIV TESTS
Lab-based Immunoassay
Molecular
Point-of-Care (Rapid)
TYPES OF HIV TESTING
Antibody Tests
Table 3-1: Selected EIA HIV Assays
Table 3-2: Selected Western Blot HIV Assays
Table 3-3: Selected Indirect Fluorescent Antibody HIV Assays
Line Immunoassay
Combination Tests
Table 3-4: Selected Combination HIV Assays
Nucleic Acid Tests
Table 3-5: Selected Nucleic Acid HIV Assays
Table 3-6: Selected HIV Assays Used for Screening
TYPES OF HIV TESTING SAMPLES
Blood Tests
Oral Fluid Test
Urine-based HIV Tests
4. MARKET SIZE AND GROWTH AND COMPETITIVE ANALYSIS
GLOBAL HIV TESTING MARKET
Table 4-1: Global HIV Testing Market 2015-2022 (in millions at manufacturer level)
Figure 4-1: Global HIV Testing Market Share Percent by Test Category, 2017 (%; Lab-based, Molecular, POC)
Figure 4-2: Global HIV Testing Market Share Percent by Test Category, 2022 (%; Lab-based, Molecular, POC)
ANALYSIS BY HIV TEST CATEGORY
Lab-based Immunoassay HIV Testing Market
Table 4-2: Market Size and Growth for Lab-based HIV Testing Market, 2017-2022 ($millions)
Table 4-3: Selected Companies Marketing Central Lab-Based HIV
Immunoassays Worldwide
Molecular HIV Testing Market
Table 4-4: Market Size and Growth for Molecular HIV Testing Market, 2017-2022 ($millions)
Table 4-5: Market-Available HIV Molecular Diagnostic Platforms
Point-of-Care (Rapid) HIV Testing Market
Table 4-6: Market Size and Growth for POC HIV Testing Market, 2017-2022 ($millions)
Table 4-7: Market Size and Growth for Professional POC HIV Testing Market, 2017-2022 ($millions)
Table 4-8: Market Size and Growth for Self-Testing HIV Testing Market, 2017-2022 ($millions)
Table 4-9: Selected Rapid HIV Professional and Home Tests
Analysis by Geographic Region
Table 4-10: Market Size and Growth for United States HIV Testing Market, 2017-2022 ($millions)
Table 4-11: Market Size and Growth for Europe HIV Testing Market, 2017-2022 ($millions)
Figure 4-3: European Regional Market Share by Country, % 2017 (Germany, France, UK, Italy, Spain, Turkey, Other)
Table 4-12: Market Size and Growth for Japan HIV Testing Market, 2017-2022 ($millions)
Table 4-13: Market Size and Growth for Rest of World HIV Testing Market, 2017-2022 ($millions)
Figure 4-4: ROW Regional Market Share by Country, % 2017 (China, India, Brazil, Russia, Canada, SE Asia, ROW)
COMPETITIVE ANALYSIS
Table 4-14: Global HIV Testing Market Analysis by Competitor Revenues and Market Share % 2017
Figure 4-5: Global HIV Testing Market Analysis by Competitor Market Share %, 2017
MARKET CONCLUSIONS
5. COMPANY PROFILES
ABBOTT LABORATORIES
Table-5-1: Abbott Corporate Summary
Company Overview
Product
Company Financials
Table 5-2: Abbott Laboratories Revenue (2014-2017) ($ millions)
ACCUBIOTECH CO, LTD.
Table 5-3: AccuBioTech Summary
Company Overview
Products
AKERS BIOSCIENCES, INC.
Table 5-6: Akers Biosciences Corporate Summary
Company Overview
Products
Company Financials
Table 5-7: Akers Biosciences (2014-2017) ($ thousands)
ALERE INC
Table 5-4: Alere Corporate Summary
Company Overview
Product
Company Financials
Table 5-5: Alere Revenue (2014-2017) ($ millions)
ARKRAY, INC
Table 5-8: ARKRAY Corporate Summary
Company Overview
Products
ARTRON LABORATORIES INC.
Table 5-9: Artron Laboratories Corporate Summary
Company Overview
Products
ATLAS LINK BIOTECH CO., LTD
Table 5-10: Atlas Link Biotech Summary
Company Overview
Products
AUTOBIO DIAGNOSTICS CO., LTD
Table 5-11: Autobio Diagnostics Summary
Company Overview
Products
AVIOQ, INC.
Table 5-12: Avioq Corporate Summary
Company Overview
Products
BECKMAN COULTER, INC
Table 5-13: Beckman Coulter Corporate Summary
Company Overview
Products
Company Financials
Table 5-14: Beckman Coulter (part of Danaher) (2014-2017) ($ millions)
BECTON DICKINSON
Table 5-15: Becton Dickinson Corporate Summary
Company Overview
Products
Company Financials
Table 5-16: Becton Dickinson (2014-2017) ($ millions)
BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD.
Table 5-17: Beijing Wantai Biological Pharmacy Enterprise Corporate Summary
Company Overview
Products
BHAT BIO-TECH INDIA PRIVATE LTD. (BBI)
Table 5-18: Bhat Bio-Tech India Private Corporate Summary
Company Overview
Products
BIOKIT S.A.
Table 5-19: Biokit Corporate Summary
Company Overview
Products
BIOLYTICAL LABORATORIES
Table 5-20: bioLytical Laboratories Summary
Company Overview
Products
BIOMERIEUX SA
Table 5-21: bioMerieux SA Corporate Summary
Company Overview
Products
Company Financials
Table 5-22: bioMerieux Revenues (2014-2017) ($ millions)
BIO-RAD LABORATORIES INC
Table 5-23: Bio-Rad Labs Corporate Summary
Company Overview
Products
Company Financials
Table 5-24: Bio-Rad Labs (2014-2017) ($ millions)
CALYPTE BIOMEDICAL CORPORATION
Table 5-25: Calypte Biomedical Summary
Company Overview
Products
CAVIDI
Table 5-26: Cavidi Corporate Summary
Company Overview
Products
CEPHEID
Table 5-27: Cepheid Corporate Summary
Company Overview
Products
Company Financials
Table 5-28: Cepheid Revenues (2014-2017) ($ millions)
CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Table 5-29: Chembio Diagnostic Corporate Summary
Company Overview
Products
Company Financials
Table 5-30: Chembio Diagnostics Revenues (2014-2017) ($ millions)
CTK BIOTECH, INC.
Table 5-31: CTK Biotech Corporate Summary
Company Overview
Products
DANAHER CORPORATION
Table 5-32: Danaher Summary
Company Overview
Products
Company Financials
Table 5-33: Danaher Revenues (2014-2017) ($ millions)
DIAGNOSTICS FOR THE REAL WORLD LTD
Table 5-35: Diagnostics for the Real World Summary
Company Overview
Products
DIALAB GMBH
Table 5-34: DIALAB Summary
Company Overview
Products
ERBA MOLECULAR
Table 5-36: ERBA Molecular Summary
Company Overview
Products
EY LABORATORIES
Table 5-37: EY Laboratories Summary
Company Overview
Products
GLYSBY SNC
Table 5-38: GlysBy Corporate Summary
Company Overview
Products
GRIFOLS INTERNATIONAL S.A.
Table 5-39: Grifols International S.A. Corporate Summary
Company Overview
Products
Company Financials
Table 5-40: Grifols (2014-2017) ($ millions)
HEMA DIAGNOSTIC SYSTEMS, LLC
Table 5-41: Hema Diagnostics Systems Corporate Summary
Company Overview
Products
HOLOGIC, INC.
Table 5-42: Hologic Corporate Summary
Company Overview
Products
Company Financials
Table 5-43: Hologic (2014-2017) ($ millions)
MBIO DIAGNOSTICS, INC
Table 5-44: Mbio Diagnostics Summary
Company Overview
Products
MEDMIRA, INC
Table 5-45: MedMira Corporate Summary
Company Overview
Products
Company Financials
Table 5-46: MedMira (2014-2017) ($ millions)
MOLBIO DIAGNOSTICS PVT. LTD
Table 5-47: Molbio Diagnostics Corporate Summary
Company Overview
Products
NANOBIOSYM, INC
Table 5-48: Nanobiosym Corporate Summary
Company Overview
Products
NORTHWESTERN GLOBAL HEALTH FOUNDATION (NWGHF)
Table 5-49: Northwestern Global Health Foundation Summary
Company Overview
Products
OMEGA DIAGNOSTICS GROUP PLC
Table 5-50: Omega Diagnostics Corporate Summary
Company Overview
Products
ORASURE TECHNOLOGIES, INC.
Table 5-51: OraSure Technologies Corporate Summary
Company Overview
Products
Company Financials
Table 5-52: OraSure Revenue (2014-2017) ($ millions)
ORTHO CLINICAL DIAGNOSTICS
Table 5-53: Ortho Clinical Diagnostics Corporate Summary
Company Overview
Products
Company Financials
Table 5-54: Ortho Clinical Diagnostics Revenue (2014-2017) ($ millions)
PRINCETON BIOMEDITECH CORPORATION
Table 5-55: Princeton Biomeditech Corporate Summary
Company Overview
Products
QUIDEL CORPORATION
Table 5-56: Quidel Corporate Summary
Company Overview
Products
Company Financials
Table 5-57: Quidel Revenue (2014-2017) ($ millions)
ROCHE DIAGNOSTIC CORPORATION
Table 5-58: Roche Corporate Summary
Company Overview
Products
Company Financials
Table 5-59: Roche Revenue (2014-2017) ($ millions)
SACACE BIOTECHNOLOGIES S.R.L.
Table 5-60: Sacace Corporate Summary
Company Overview
Products
SAVYON DIAGNOSTICS LTD.
Table 5-61: Savyon Diagnostics Summary
Company Overview
Products
SIEMENS HEALTHINEERS
Table 5-62: Siemens Healthineers Corporate Summary
Company Overview
Products
Company Financials
Table 5-63: Siemens Healthineers Revenue (2014-2017) ($ millions)
STANDARD DIAGNOSTICS, INC.
Table 5-64: Standard Diagnostics Corporate Summary
Company Overview
Products
TRINITY BIOTECH PLC
Table 5-65: Trinity Biotech Corporate Summary
Company Overview
Products
Company Financials
Table 5-66: Trinity Biotech Revenue (2014-2017) ($ thousands)
WAMA DIAGNOSTICA
Table 5-67: WAMA Diagnostica Corporate Summary
Company Overview
Products
WAVE 80 BIOSCIENCES
Table 5-68: Wave 80 Biosciences Corporate Summary
Company Overview
Products

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