101 Companies in

Immunoassays

Immunoassays are versatile tests, used in detection of many conditions, from allergies to cancer.

They are tests that are based on the binding of antibodies to antigens to identify the presence of a

substance (an analyte). Immunoassays have been used in clinical laboratory medicine since the

1960s, and are indispensable tools in clinical diagnostics. A wide range of types of

immunoassays is used to measure proteins (including antibodies),

hormones, drugs, and other analytes. Kalorama Information has

found that the market for immunoassays, or tests that bind

antibodies to antigens to detect the presence of a substance (an

analyte) in a patient, is over $20 billion. Fully automated

immunoassay systems are now found in clinical laboratories.

Even though the field of immunoassays is now mature,

companies have continued to develop new immunoassays and

immunoassay instrument platforms to improve the sensitivity of

the assays. New developments are designed to make multiplexing

possible, to miniaturize the platforms for point-of­care, and to

identify and develop assays for novel biomarkers; thus, further expanding the potential of

immunoassays for the future.

The immunoassay market consists of three major segments:

The central lab-based immunoassays market is by far the largest segment of the total

immunoassay market with 70.6% of this market in 2016. Centralized laboratories include

reference laboratories (such as Laboratory Corporation of America or LabCorp, Quest

Diagnostics, and others), hospital laboratories, laboratories operated by health

maintenance organizations (HMOs), and other centralized laboratories. These

laboratories range from very high volume labs down to smaller labs, but they typically

use the fully automated immunoassay and chemistry/immunoassay analyzers discussed in

Chapter 3 for their high volume immunoassay tests. They may also have other platforms

Based on Kalorama

Information’s

IMMUNOASSAY

MARKETS

for tests that are not as high volume, and therefore are not on the fully automated

platforms. While the central laboratory segment of the immunoassay market is expected

to continue to dominate this market, the market share of this segment is gradually

shrinking due to the more rapid growth seen in the point-of-care (POC) or rapid test

segment of the market.

The market for point-of-care (POC) testing consists of two segments, self-testing (also

referred to as the over-the-counter or OTC segment), and professional POC testing.

However, there are many locations where POC testing can occur within these segments,

especially the professional POC market. Professional POC testing is performed in a

number of different settings including in hospitals, physicians office laboratories (POLs)

and clinics, retail clinics, and many other locations. While the POC/rapid test segment

represented only 25.9% of total world immunoassay sales in 2016, this is the fastest

growing segment of the immunoassay market. POC/rapid testing is expected to grow to

27% of the total immunoassay market by 2021.

The smallest growing segment of the immunoassay market is the blood testing (or blood

screening) market, which represents only 3.5% of the total immunoassay market. In

developed countries, all units of blood and blood products are already screened for

several infectious agents. Growth of the blood testing market in these countries is

primarily driven by changes in the numbers of units donated and being screened. An

exception and potentially significant step increase in the size of this market could occur if

it is mandated that a new (additional) immunoassay be used to screen blood for an

additional disease. In some developing countries, not all units of blood and blood

products are screened for every recommended infectious agent. Additional growth could

occur in these markets as more of the blood supply is screened. However, Kalorama

expects that the overall, worldwide market for immunoassays used to screen blood will

continue to grow slowly.

Below is a list of 101 Companies that participate in the immunoassay market. Further profiles

are found in the report, Immunoassay Markets.

Table 4-1: Selected Companies Marketing Central Lab-Based Immunoassays Worldwide

Company Product

Abbott ARCHITECT family of analyzers; Alinity i

Atlas Link Lateral flow, ELISA

Audit Dx Lateral flow, ELISA

Autobio Diagnostics Lateral flow; ELISA; CLIA

Awareness Technology ELISA; CLIA

Avioq ELISA

AXA Diagnostics ELISA, IFA, immunoblot, immunodot, and Immunoquick technologies

Beckman Coulter/Danaher DxC 600i, DxC 660i, DxC680i, DxC 860i, and DxC880i Immunoassay analyzers: DxC 600i, DxC 660i, DxC680i, DxC 860i, and DxC880i

Beijing Chemclin Biotech Chemiluminescence assays

Beijing Wantai Biological Pharmacy ELISA, Dot-ELISA Rapid Tests and Colloidal Gold Rapid Tests

BG Medicine ELISA

Bhat Bio-Tech India Lateral flow, ELISA

Binding Site Assays on SPAplus® Special Protein Analyzer, and also on analyzers marketed by Siemens, Roche, and Beckman Coulter

Biocare Diagnostics Lateral flow, ELISA

BioCheck ELISA

BIOCLIN ELISA, Lateral flow

Biokit BIO-FLASH, BIO-ELISA

Biomerica Lateral flow, ELISA

bioMérieux VIDAS immunoassay analyzers

BioPorto Diagnostics ELISA

Bio-Rad Labs BioPlex 2200 Multiplexing Platform; EVOLIS system

Bioscience (Tianjin) Dx Technology CLIA

Biotech Atlantic Lateral flow, ELISA, CLIA

Biotron Dx Lateral flow, ELISA

Company Product

Boditech Med Lateral flow, ELISA

Boson Biotech Lateral flow, CLIA

Calypte Biomedical ELISA

Cellmid ELISA

Cisbio Bioassays ELISA, RIA

Corgenix Medical Lateral flow; ELISA; immunoturbidimetry (IT)

Critical Diagnostics Lateral flow; ELISA

CTK Biotech Lateral flow; ELISA

Denka Seiken Latex-enhanced turbidimetric immunoassays for use on clinical chemistry analyzers

diaDexus ELISA

Diagenics Lateral flow, ELISA

DIALAB Lateral flow, ELISA

Diametra ELISA

DiaSorin LIAISON and LIAISON XL automated platforms for immunoassays

DIAsource Immunoassays Lateral flow, ELISA

Diaxonhit Lateral flow, ELISA

DIESSE Diagnostica ELISA

Dr Fooke Lateral flow, ELISA

DRG Lateral flow, ELISA

D-Tek ELISA

Erba Diagnostics Mago (Fully automated ELISA and IFA processor), Erba Lisa Scan (Automated ELISA 7 Microbiology Reader)

EUROIMMUN Blot techniques: Western blot, EUROASSAY, EUROLINE, EUROLINE-WB ELISA assays; BIOCHIPs; EUROASSAY

Eurospital Lateral flow, ELISA, IFA

Fujirebio RIA; EIA; Lumipulse instrument systems for automated CLEIA (Chemiluminescence Enzyme Immunoassay)

Company Product

GenBio Lateral flow; ImmunoWELL and in an immunofluorescence format called ImmunoFA

Grifols Triturus automated (ELISA analyzer)

Hema Diagnostic Lateral flow; ELISA

Hipro Biotechnology CLIA

HYCOR Biomedical HYTEC 288 immunoassay analyzer and Ultra-Sensitive EIA System quantitative determination of specific IgE

Immunetics ELISA

Immunodiagnostic Systems IDS-iSYS Fully Automated Immunoassay System

Immuno-Mycologics Lateral flow; ELISA

InBios Lateral flow; ELISA

Inova Dx BIO-FLASH (fully automated, random access chemiluminescent analyzer) plus microtiter plate processor

InTec ELISA

j.Mitra ELISA

Labor Diagnostika Lateral flow, ELISA, RIA

MagnaBioSciences Magnetic Immuno-Chromatographic Test (MICT

Medipan ELISA, RIA

Mercodia ELISA

Monobind ELISA, CLIA

Novatec Immunodiagnostika ELISA

Oasis Dx ELISA

Omega Dx VISITECT two-site sandwich immunoassays for POC testing; ELISA

Operon Lateral flow, ELISA

Orgentec Diagnostika ELISA; Alegria fully automated instrument

Ortho Clinical Dx VITROS line of automated chemistry analyzers and immunoassay analyzers, plus one integrated system

Point Scientific ELISA

Company Product

PreCheck Bio Lateral flow, ELISA

Prestige Dx Lateral flow, latex serology tests, ELISA

Pro-Lab Dx ProlisaTM line of immunoassay tests (EIA)

Radiometer Medical/Danaher AQT90 FLEX immunoassay analyzer

Randox Labs Biochip Array Technology (BAT) and three BAT analyzers: Evidence MultiStat, Evidence Investigator, and Evidence Evolution

Rapid Pathogen Screening Direct Sampling Micro-Filtration (DSMF) and Direct Multi-Planar Chromafiltography (DMC) technology

R-Biopharm Lateral flow; immunofluorescence assay (IFA)

Reagena Group Lateral flow with hand-held refractometer ReaScan and ReaMobile software; ELISA

Roche Dx cobas line of analyzers (clinical chemistry analyzers, immunoassay analyzers, and cobas 8000 modular analyzer series; Elecsys series

Savyon Dx Lateral flow, ELISA

ScheBo-Biotech ELISA

Shanghai Kehua Bio-engineering Lateral flow, ELISA

Siemens Healthineers Dimension EXL integrated chemistry systems, Immulite 2000 XPi Immunoassay System; Immulite 1000 Immunoassay System

Snibe

Automated Chemiluminescence Immunoassay (CLIA) System – Maglumi 1000, Maglumi 2000, Maglumi 2000 PLUS analyzers -Semi-automated Chemiluminescence Immunoassay (CLIA) System -Maglumi semi-auto chemiluminescence analyzers -Magnetic enzyme immunoassay analyzer

Syntron Bioresearch Lateral flow, ELISA

TECHLAB ELISA

Teco Dx Lateral flow, ELISA

Theradig ELISA, FIDIS multiplex platform, Immunofluorescence

Thermo Fisher Scientific ImmunoCAP Lab Tests, Phadia line of laboratory instrument systems, ImmunoCAP ISAC

Tianjin Bio-Enoche Engineering ELISA

Tosoh Corp AIA Automated Immunoassay systems

Transasia Bio-Medicals ELISA, IFA

Company Product

Trinity Biotech Lateral flow; ELISA (lab instruments include TrinLab D2, TrinLab DX, TrinBlot System, plus plates and readers)

Tulip Group One-step membrane, ELISA

Vital Dx PATHFAST CLEIA Analyzer (Chemiluminescence Immunoassay Analyzer)

Wako Dx µTASWako® i30 microfluidic-based clinical immunoanalyzer

WAMA Dx Lateral flow, ELISA

Wiener Labs ELISA

ZEUS Scientific Immunofluorescence assays (IFA), ELISA and multiplex (AtheNA Multi-Lyte®) immunoassays

IMMUNOASSAY MARKETS https://www.kaloramainformation.com/Immunoassay-Infectious-Disease-Tumor-Markers-Thyroid-Allergy-Drugs-Abuse-Therapetutic-Drug-Monitoring-11116430/

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Superior Coverage of Today’s Immunoassay Market and a Look at What’s Next This Kalorama report represents an expert comprehensive market review of the current state of the important market for immunoassays from Kalorama Information. The immunoassay market is a large, well-established market with billions in sales. Fully automated immunoassay systems are now found in clinical laboratories. Even though the field of immunoassays is now mature, companies have continued to develop new immunoassays and immunoassay instrument platforms to improve the sensitivity of the assays. New developments

are designed to make multiplexing possible, to miniaturize the platforms for point-ofcare, and to identify and develop assays for novel biomarkers, thus further expanding the potential of immunoassays for the future. This report, from Kalorama Information, the premier market research publisher in in vitro diagnostics, features the following market data:

Global Market Size and Forecast, 2017-2021

Regional Segmentation (US, Germany, Brazil, China,

Turkey, UK, Spain, France, Saudi Arabia, India)

Infectious Disease Immunoassays: Market Analysis by Type (Hepatitis, HIV, STD,

TORCH, Respiratory, HAIs, Other Infectious Disease), 2017-2021

Tumor Marker Immunoassays by Type, 2017-2021

Thyroid, 2017-2021

Metabolic and Other Hormone Immunoassays, 2017-2021

Therapeutic Drug Monitoring Immunoassays, 2017-2021

Drugs of Abuse Immunoassays, 2017-2021

Transplant Medicine, IBD, Alzheimer's and Other Areas of Disease Innovation

Historical Immunoassay Market Data - 2014-2016

ELISA Market Size

Radioimmunoassay Market Size

Lab-based Immuonassay Markets

POC Immumonassay Market

476

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Blood Screening Immunoassay Market

Instrument Platforms

International and Emerging Markets

Company Profiles