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.