Market Research Logo

The Market and Potential for Molecular Point of Care Diagnostic Tests

The Market and Potential for Molecular Point of Care Diagnostic Tests

Molecular diagnostics performed at the point of care or near the patient is regarded as a leading expansion segment in the global in vitro diagnostics (IVD) market. Molecular point-of-care (POC) diagnostics are able to improve the sensitivity and specificity of existing near-patient and rapid tests and also expand the diagnostic capabilities at points of care such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world. The Market and Potential for Molecular Point of Care Diagnostic Tests provides consensus market views and realistic estimates for this novel field, including:

  • Market Analysis, Molecular Point of Care – 2018-2023 ($ millions)
  • Molecular Point of Care Market by Geography, 2018 (%; US, EU, ROW)
  • Market for Molecular POC by Test, 2018-2023 (Influenza, Strep A, RSV, Other Respiratory, CT/NG, GBS, HPV, HSV, Vaginitis, HIV, GI Pathogens, Hepatitis, Malaria, Tropical/Other, HAIs, Other Molecular POC) ($ millions)
  • Molecular POC Market by Category, 2018 (%; Flu/Resp. Vs. All Other)
Further, the report examines the major developments in molecular POC diagnostics, providing the following market information:
  • Molecular POC Systems on the Market
  • Molecular POC Systems in Development
  • Advantages and Disadvantages of Molecular POC
  • Selected Isothermal Amplification Methods and Platform Examples
  • Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Image Sensor Detectors (CCD, CMOS)
  • Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Photodiode Detectors
  • Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Electrochemical Detectors
  • Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Immunochromatographic Detection
  • Selected Next-Generation Sequencing (NGS) Platforms for Decentralized and POC Sequencing
  • Market-Available Molecular POC Diagnostic Platforms (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles)
  • Market-Available Hospital Molecular Diagnostic Platforms (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles)
  • Hospital and POC Molecular Diagnostic Platforms in Development (Vendor, Assay Menu, Procedure Integration, Test Principles)
  • Menu Expansions for Hospital and POC Molecular Platforms (Vendor, Platform, Menu Addition, Time to Results, CLIA-waiver, US/EU Availability)
  • Market-Available Molecular Diagnostic Platforms for Emerging Markets and the Developing World (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles)
  • Molecular Diagnostic Platforms in Development for Emerging Markets and the Developing World (Vendor, Assay Menu, Procedure Integration, Test Principles)
  • Line Probe Assays and Other Molecular Lateral Flow Test Strips (Vendor, Assay Menu, Planned Assays, Regulatory Status)
  • Potential Entrants into Molecular POC Diagnostics (Vendor, Current Platform[s], Primary Market for Platform, Assay Menu, Applicable Tech)
  • Selected Developmental Molecular POC-Enabling Technologies and Platforms by Vendor
Profiled companies in The Market and Potential for Molecular Point of Care Diagnostic Tests include those with clinical molecular diagnostic systems applicable to POC testing markets; molecular diagnostic systems applicable to hospital lab molecular testing; development-stage molecular diagnostic systems for decentralized testing; molecular diagnostic products for use primarily in emerging markets of the developing world and for field testing; companies with original equipment manufacturer (OEM) platforms and component technologies that could be featured in the molecular POC diagnostics market; and other companies that have been involved in molecular POC diagnostics through investment, collaborative research or technology development that could allow them to enter the market. Companies profiled include:
  • Abacus Diagnostica Oy
  • Abbott Laboratories
  • Akonni Biosystems
  • Becton, Dickinson & Co.
  • binx health, inc. (formerly Atlas Genetics)
  • Biocartis NV
  • bioMérieux SA
  • Cepheid
  • Curetis NV
  • DiAssess, Inc.
  • DNA Electronics Ltd
  • DxNA, LLC
  • genedrive plc
  • GenePOC, Inc.
  • GeneReach Biotechnology
  • Greiner Bio-One GmbH
  • Hain Lifescience GmbH
  • HiberGene Diagnostics
  • iCubate, Inc.
  • Illumina, Inc.
  • Immunexpress, Inc.
  • MBio Diagnostics, Inc.
  • Meridian Bioscience, Inc.
  • Mesa Biotech, Inc.
  • Molbio Diagnostics Pvt. Ltd.
  • Nanōmix, Inc.
  • Orion Diagnostica Oy
  • QIAGEN NV
  • QuantuMDx Group
  • Quidel Corporation
  • Roche
  • Seegene, Inc.
  • STAT-Dx
  • T2 Biosystems
  • Veredus Laboratories Pte. Ltd.
For the purposes of this report, Kalorama describes molecular point-of care systems as:
  • Systems that are CLIA-waived or will soon have the capability for running CLIA-waived tests
  • Mod-complex or high-complex tests used in a decentralized area such as a non-laboratory area of a hospital or a physician office/clinic visit
  • Tests with a short waiting period for result, which make such systems practical for point-of-care
The report incorporates primary and secondary research, feedback from end users, and reports from vendors. It also factors in tests already being used by laboratories at this time.


  • Executive Summary
    • Molecular Point-of-Care Diagnostics Defined
    • Strengths and Weakness of Molecular Point-of-Care Testing
      • Table Advantages of Molecular Point of Care, by Setting
      • Table Disadvantages of Molecular Point of Care, by Setting
    • Component Technologies of Molecular Point-of-Care Diagnostics
      • Microfluidics
      • qPCR
      • Microarrays
      • Isothermal Amplification
      • Test Automation
      • Primers and Probes
      • Detection
      • Next-Generation Sequencing
    • Leading Platforms in Molecular POC Diagnostics
      • Table Market-Available Molecular POC Diagnostic Platforms (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles
    • Scope and Methodology
    • Size and Growth of the Market
    • Conclusions
      • Table Growth Areas for Molecular Point-of-Care and Rapid Tests
  • What Is Molecular Point-of-Care Diagnostics?
    • Introduction
    • Advantages and Disadvantages of Molecular Diagnostics at the Point of Care
    • Common Tests and Analytes in POC Diagnostics
    • Molecular Diagnostics
      • Real-Time PCR (qPCR)
      • Isothermal Amplification Methods
      • Microarrays
      • Sequencing
      • Common Tests and Analytes in Molecular Diagnostics
    • Point-of-Care Diagnostics in Brief
      • Examples of POCT Settings
  • Molecular POC Systems on the Market and in Development
    • Introduction
      • Advances in Molecular Diagnostics
      • Microfluidics
      • Isothermal Amplification
        • Table Selected Isothermal Amplification Methods and Platform Examples
      • Test Automation
      • Primers and Probes
    • Detection
      • Table Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Image Sensor Detectors (CCD, CMOS)
      • Table Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Photodiode Detectors
      • Table Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Electrochemical Detectors
      • Table Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Immunochromatographic Detection
      • Next-Generation Sequencing
        • Table Selected NGS Platforms for Decentralized and POC Sequencing
    • Molecular Platforms and Products for Decentralized Testing
      • Table Market-Available Molecular POC Diagnostic Platforms (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles)
      • Table Market-Available Hospital Molecular Diagnostic Platforms (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles)
      • Table Hospital and POC Molecular Diagnostic Platforms in Development (Vendor, Assay Menu, Procedure Integration, Test Principles)
      • Table Menu Expansions for Hospital and POC Molecular Platforms (Vendor, Platform, Menu Addition, Time to Results, CLIA-waiver, US/EU Availability)
      • Table Market-Available Molecular Diagnostic Platforms for Emerging Markets and the Developing World (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles)
      • Table Molecular Diagnostic Platforms in Development for Emerging Markets and the Developing World (Vendor, Assay Menu, Procedure Integration, Test Principles)
      • Table Line Probe Assays and Other Molecular Lateral Flow Test Strips (Vendor, Assay Menu, Planned Assays, Regulatory Status)
      • Table Potential Entrants into Molecular POC Diagnostics (Vendor, Current Platform[s], Primary Market for Platform, Assay Menu, Applicable Tech)
      • Table Selected Developmental Molecular POC-Enabling Technologies and Platforms by Vendor
    • Applications and Potential Applications for Molecular Point-of-Care
      • Major Testing Applications for Molecular POC Diagnostics
      • Hospital-Acquired Infections (HAIs)
      • Strep A
      • Respiratory Syncytial Virus (RSV)
      • Zika
      • Influenza
      • Other Respiratory Infections
      • Group B Streptococcus
      • Human Papillomavirus
      • Chlamydia and Gonorrhea
      • Herpes Simplex Virus
      • Vaginitis
      • Human Immunodeficiency Virus (HIV)
      • Tuberculosis
      • Hepatitis
      • Malaria
      • Other Tropical and Neglected Diseases
      • Gastrointestinal Infections
      • Bloodstream Infections (BSIs)
      • Pharmacogenetics
      • Hereditary Disease
      • Cancer
  • Market Analysis
    • Size and Growth of the Market
      • Challenges for Molecular POC
    • Market Leaders
      • Abbott / Alere i
      • Biocartis: An Ascendant Player
      • Cepheid Gene Xpert and, Xpert Xpress and Xpert Omni
      • Roche cobas Liat
      • Biomerieux BioFire Film Array
    • Market by Geography
    • Market Estimate and Market Potential by Type of Disease
      • Table Market for Molecular POC by Test, 2018-2023 (Influenza, Strep A, RSV, Other Respiratory, CT/NG, GBS, HPV, HSV, Vaginitis, HIV, GI Pathogens, Hepatitis, Malaria, Tropical/Other, HAIs, Other Molecular POC) ($millions)
      • Table Molecular POC Market by Category, 2018 (%; Flu/Resp. Vs. All Other)
      • Influenza
      • Strep A, RSV and Other Respiratory
      • CT/NG
      • HPV
      • HSV
      • HIV
      • Hepatitis
      • Malaria
      • Other Molecular POC Testing
  • Company Profiles
    • Abacus Diagnostica Oy
      • Table Abacus Diagnostica Oy Corporate Summary
    • Abbott Laboratories
      • Table Abbott Laboratories Corporate Summary
    • Akonni Biosystems
      • Table Akonni Biosystems Corporate Summary
    • Becton, Dickinson & Co.
      • Table Becton, Dickinson & Co. Corporate Summary
    • binx health, inc. (formerly Atlas Genetics)
      • Table binx health, inc. (formerly Atlas Genetics) Corporate Summary
    • Biocartis NV
      • Table Biocartis NV Corporate Summary
    • bioMérieux SA
      • Table bioMérieux SA Corporate Summary
    • Cepheid
      • Table Cepheid Corporate Summary
      • Molecular Healthcare-Acquired Infection (HAI) Testing
      • Molecular Sexual Health and Women's Health Testing
      • Molecular Critical Infectious Disease Testing
      • Molecular Oncology/Genetics Testing
    • Curetis NV
      • Table Curetis NV Corporate Summary
    • DiAssess, Inc.
      • Table DiAssess Corporate Summary
    • DNA Electronics Ltd
      • Table DNA Electronics Ltd Corporate Summary
    • DxNA, LLC
      • Table DxNA, LLC Corporate Summary
    • genedrive plc
      • Table genedriveplc Corporate Summary
    • GenePOC, Inc.
      • Table GenePOC Corporate Summary
    • GeneReach Biotechnology
      • Table GeneReach Biotechnology Corporate Summary
    • Greiner Bio-One GmbH
      • Table Greiner Bio-One GmbH Corporate Summary
    • Hain Lifescience GmbH
      • Table Hain Lifescience GmbH Corporate Summary
    • HiberGene Diagnostics
      • Table HiberGene Diagnostics Corporate Summary
    • iCubate, Inc.
      • Table iCubate Corporate Summary
    • Illumina, Inc.
      • Table Illumina Corporate Summary
    • Immunexpress, Inc.
      • Table Immunexpress Corporate Summary
    • MBio Diagnostics, Inc.
      • Table MBio Diagnostics Corporate Summary
    • Meridian Bioscience, Inc.
      • Table Meridian Bioscience Corporate Summary
    • Mesa Biotech, Inc.
      • Table Mesa Biotech Corporate Summary
    • Molbio Diagnostics Pvt. Ltd.
      • Table Molbio Diagnostics Pvt. Ltd. Corporate Summary
    • Nanomix, Inc.
      • Table Nanomix Corporate Summary
    • Orion Diagnostica Oy
      • Table Orion Diagnostica Oy Corporate Summary
    • QIAGEN NV
      • Table QIAGEN NV Corporate Summary
      • HPV
      • Other Activities (Development, Licensing, Investment)
    • QuantuMDx Group
      • Table QuantuMDx Group Corporate Summary
    • Quidel Corporation
      • Table Quidel Corporate Summary
    • Roche
      • Table Roche Corporate Summary
    • Seegene, Inc.
      • Table Seegene Corporate Summary
    • STAT-Dx
      • Table STAT-Dx Corporate Summary
    • T2 Biosystems
      • Table T2 Biosystems Corporate Summary
    • Veredus Laboratories Pte. Ltd.
      • Table Veredus Laboratories Pte. Ltd. Corporate Summary

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook

Share this report