The Market and Potential for Molecular Point of Care Diagnostic Tests

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Published Jan 25, 2018 | 280 Pages | Pub ID: KLI15582179

Detailed Look at a Novel Trend in IVD - Revised and Updated for the 2018 Market! 

Among the various technologies and products of the global in vitro diagnostics (IVD) market, molecular diagnostics performed at the point of care or near the patient are regarded as a leading expansion 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. Existing POC diagnostics range from urinalysis dipsticks performed in physician office laboratories (POLs) through rapid infectious disease tests used to quickly diagnose admitted patients. 

Real-World Estimates and Reliable Forecasts

There have been many projections made about molecular point care.  This report provides consensus market views and realistic estimates for this novel field, incorporating 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 and how molecular POC has fared in displacing those markets.    

Kalorama Information, with two decades of experience in IVD markets – the publishers of The Worldwide Market for In Vitro Diagnostics in ten editions -  produced two definitive market studies of this market in 2013, prior to significant product development, and 2016 as the first products - Alere i, BioFire Film Array, Gene Expert Omni and cobas Liat appeared on the scene.  Now, with more market track records and approvals, mPOC products competing with traditional systems, Kalorama has updated its findings with the latest information.  Who is leading?  Where is investment in mPOC systems?  Who has products in development?  What companies are lagging?   What can we expect in the future.  This report answers these questions and more.  

The Market and Potential for Molecular Point of Care Diagnostic Tests examines the major segments of molecular POC diagnostics, exploring in-depth current sales and market opportunity and providing the following market information:

Molecular POC Systems on the Market 
Molecular POC Systems in Development
Advantages and Disadvantages of Molecular POC
Molecular POC Market for Influenza Testing (2017-2023)
Molecular POC Market for Strep A Testing (2017-2023)
Molecular POC Market for RSV and Other Respiratory
Molecular POC Market for STD Testing [CT/NG, GBS, HSV, Others] (2017-2023)
Molecular POC Market for HIV (2017-2023)
Molecular POC Market for GI Pathogens (2017-2023)
Molecular POC Market for HAIs (2017-2023)
Other Molecular POC (2017-2023)
Investments in Decentralized Molecular Diagnostics Companies (2014-2017)
Potential Entrants, Platforms, Menus and Other Industry Trends
Retail Clinics and Other Walk-ins: Game Changers in Healthcare
Extensive Company Profiling

 Profiled companies 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:

The market introduction of POC diagnostics or tests (POCTs) often follows a period of technological maturation or refinement of an existing laboratory diagnostic modality or platform. One of the major enabling technologies for POC testing with molecular diagnostics is real-time polymerase chain reaction (qPCR) testing that eliminated the need for post-amplification electrophoresis and integrated detection within the same instrument that performed amplification. Advances and innovations in microfluidics; isothermal and other alternative amplification chemistries; test automation; primers and probes; and next-generation sequencing (NGS) methods have been the most significant to the development of decentralized molecular diagnostics. In many cases, these technologies work together to facilitate clinical molecular testing in an automated manner within a smaller device.

Who is Who in Molecular POC? - Company Coverage

Companies profiled in this report include:

Ahram Biosystems  
Akonni Biosystems  
Alere (Abbott)  
Analytik Jena  
Atlas Genetics  
Becton, Dickinson And Company  
Canon Biomedical  
Destina Genomics  
Diagnostics For All  
Diagnostics For The Real World  
Eiken Chemical  
Erba Molecular  
Genedrive  (Formerly Epistem)  
Genereach Biotechnology  
Greiner Bio-One  
Hai Kang Life  
Hain Lifescience  
Mast Group  
Mbio Diagnostics  
Meridian Bioscience  
Mesa Biotech  
Metaara Medical Technologies  
Micronics (Sony) 
MP Biomedicals  
Nanoivd 235
Nanodetection Technology  
Nanosphere (Luminex)  
Orion Diagnostica  
Positive Id  
Roche Diagnostics  
Spartan Bioscience  
T2 Biosystems  
Thermal Gradient  
Ustar Biotechnologies  
Veredus Laboratories  
Wave 80 Bioscience 

  • 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 Point-of-Care Diagnostics by Setting - Hospital POC, POL/Outpatient, Low- Resource and Developing Areas
    • Component Technologies of Molecular Point-of-care Diagnostics
      • Microfluidics
      • qPCR
      • Microarrays
      • Isothermal Amplification
      • Test Automation
      • Primers and Probes
      • Detection
      • Next-Generation Sequencing
        • Table Molecular POC Products on the Market
    • Scope and Methodology
    • Size and Growth of the Market
      • Table Molecular Point of Care Market, 2017-2023 ($ millions)
      • Conclusions
        • Table Growth Areas for Molecular POC and Rapid Tests
  • What is Molecular Point-of-Care Diagnostics?
    • Advantages and Disadvantages of Molecular 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
        • Table Selected POCTs for the diagnosis of illnesses covered by Emergency Use Authorizations (EUAs) currently in effect
    • 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 Molcular 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)
      • 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
    • Urgent Care Clinics
      • Table Urgent Care Centers vs. Retail Clinics and Physician Practices
    • Retail Clinics
  • Market Analysis
    • Size and Growth of the Market
      • Table Market Analysis, Molecular Point of Care - 2017-2023 ($ millions)
      • 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
      • Table Molecular Point of Care Market by Geography
    • Market Estimate and Market Potential by Type of Disease
      • Table Market for Molecular POC by Test (Influenza, Strep A, RSV, Other Resp., CT/NG, GBS, HPV, HSV, TV, TB, HIV, Hep, Malaria, Tropical/Other Neglected, HAIs, Other Molecular POC)
      • Table Molecular POC Market by Category, 2017 (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
    • Ahram Biosystems
    • Akonni Biosystems
    • Alere (Abbott)
      • Table Alere Revenue (2014-H1 2017)
    • Analytik Jena
    • Atlas Genetics
    • Axxin
    • Becton, Dickinson and Company
      • Table Becton, Dickinson & Co. (BD) Revenue (2014-2017)
    • Biocartis
      • Table Biocartis NV Revenue (2014-2017)
    • bioMerieux
      • Table bioMérieux Revenue (2014-2017)
    • Canon Biomedical
    • Cepheid
      • Table Cepheid Revenue (2013-2016)
      • Molecular Healthcare-Acquired Infection (HAI) Testing
      • Molecular Sexual Health and Women's Health Testing
      • Molecular Critical Infectious Disease Testing
      • Molecular Oncology/Genetics Testing
    • Curetis
    • DestiNA Genomics
    • Diagnostics for All
    • Diagnostics for the Real World
    • Diasorin
      • Table DiaSorin Revenue (2014-Q3 2017)
    • Diassess
    • Eiken Chemical
      • Table Eiken Chemical Revenue (FY 2014-2017)
    • Entopsis
    • ERBA Molecular
    • genedrive plc (formerly EPISTEM)
      • Table genedrive Revenue (FY 2014-2017)
    • GeneFluidics
    • GenePOC
    • GeneReach Biotechnology
    • Greiner Bio-One
    • Hai Kang Life
    • Hain Lifescience
    • Illumina
      • Table Illumina Revenue (FY 2014-2017)
    • Immunexpress
    • Insilixa
    • Lucigen
    • Mast Group
    • Mbio Diagnostics
    • Meridian Bioscience
      • Table Meridian Bioscience Revenue (FY 2014-2017)
    • Mesa Biotech
    • Metaara Medical Technologies
    • Micronics (Sony)
    • Molbio
    • MP Biomedicals
    • Nanodetection Technology
    • NanoIVD
    • Nanomix
    • Nanosphere (Luminex)
      • Table Nanosphere Revenue (2013-2016)
    • Optigene
    • Orion Diagnostica
      • Table Orion Diagnostica Revenue (2014-Q3 2017)
    • PositiveID
      • Table PositiveID Revenue (2014-Q3 2017)
    • Pretect
    • Qiagen
      • Table QIAGEN Revenue (2014-Q3 2017)
      • HPV
      • Other Activities (Development, Licensing, Investment)
    • QuantumDX
    • Quidel
      • Table Quidel Corporation Revenue (2013-2016)
    • Rheonix
    • Roche Diagnostics
      • Table Roche Diagnostics Revenue (2014-2017)
    • Scanogen
    • Seegene
      • Table Seegene Revenue (2014-Q3 2017)
    • Spartan Bioscience
    • Stat-DX
    • T2 Biosystems
      • Table T2 Biosystems Revenue (2014-Q3 2017)
    • Thermal Gradient
    • Ubiquitome
    • Ustar Biotechnologies
    • Veredus Laboratories
    • Wave 80 Bioscience

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