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The Market and Future Potential for Molecular Point of Care

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SKU: 20-025 Categories: Diagnostics Market Research, Point-of-Care Diagnostics Tags: molecular point-of-care market, mPOC Flu, mPOC RSV, mPOC Strep, Near Patient Molecular IVD Market, Respiratory Segment Breakout, Small-Footprint Molecular Point of Care Market Pages: 127
  • Description
  • Table of Contents
  • Latest reports

Description

THIS REPORT HAS A NEWER VERSION AVAILABLE: https://kaloramainformation.com/product/2021-molecular-point-of-care/

 

This report provides market sizing, forecasting, trend mapping and competitive analysis for point of care tests using PCR or other molecular technology with fast turnaround times and usability in near-patient settings. Major IVD companies such as Abbott and Roche compete in this segment, influenza competitors Sekisui and Quidel also operate, as do specialty concerns such as Curetis, Biocartis, and a host of small but innovative players.

Molecular point of care or mPOC systems are designed to be faster than lab-based tests while more accurate than existing point of care systems. Development of new systems and menu expansion on existing lines is constant. Kalorama Information defines molecular point of care or mPOC as consisting of devices marketed to customers outside the reference lab that run PCR or other DNA and RNA testing on a device with a small footprint. mPOC systems tend to have a result time fast enough for an office visit or bedside consultation. These systems feature cartridges or reduced preparation steps and limited interpretation of test results.

Less than 10 years from the launch of products this remains a novel test instrument area though with increasing market definition and participation by IVD majors. The market is by no means stable; there is still heavy competition and a need to justify purchases to providers. Kalorama’s report provides the current status of this market, including estimates of current sales of near patient molecular systems, forecasts for their future use, and the segments that they are best participating in. Though a global report in scope, regional market share is also provided.

The data in The Market and Future Potential for Molecular Point of Care includes information on systems and competitor analysis, as well as data on the size and growth of the market:

  • Current Molecular POC Systems
  • Molecular Point of Care Market: 2019-2024
  • Molecular Point of Care Market Share by Vendor, 2019 ($M, %)
  • Small-Footprint Molecular Point of Care Market, 2019 (%)
  • Geographic Breakout of the Molecular Point of Care Market, 2019 (N. America, Europe, APAC, RoW)
  • Segment Breakout of Molecular Point of Care Market, 2019 (Respiratory vs. Other)
  • Breakout of Molecular Point of Care Market, 2019 (%; Respiratory, Other)
  • Respiratory Segment Breakout, 2019 (Flu, RSV, Strep, Other)
  • Breakout of mPOC Respiratory, 2019 (%; Flu, Strep, RSV, Other)
  • Near Patient Molecular IVD Market: 2019-2024
  • Near Patient Molecular Market Share by Vendor, 2019
  • Company Profiles

Many trends are covered in the report, including menu expansion, disease statistics, the COVID-19 crisis, immunoassay competition and enhancement of those competitive POC systems, emerging markets, new journal studies about the efficacy of mPOC and other trends.

Companies profiled include:

  • Abbott Laboratories
  • Aidian Oy
  • Akonni Biosystems
  • binx health, inc.
  • Biocartis NV
  • bioMérieux SA
  • Cepheid
  • Credo Bioscience
  • Curetis NV
  • DiaSorin S.p.A
  • GenMark Diagnostics
  • Greiner Bio-One GmbH
  • Meridian Bioscience, Inc.
  • Mesa Biotech, Inc.
  • QIAGEN NV
  • QuantuMDx Group
  • Quidel Corporation
  • Roche
  • Sekisui Diagnostics LLC
  • T2 Biosystems

Table of Contents

Chapter One: Executive Summary
Where is Molecular Point of Care in 2020?
Molecular Point of Care Market Analysis

    • Table 1-1: Molecular Point of Care Market: 2019-2024
    • Figure 1-1: mPOC Market by Disease Indication, 2019 (%; Respiratory, Other)
  • Market Observations
  • ìNear-Patientî Molecular Systems Market
    • Table 1-2: Near Patient Molecular Systems Market: 2019-2024

Current Trends

  • CLIA Waivers and New Standard
  • PAMA Hurts Point of Care Most
  • Immunoassay Are Competitive and Not Going Away
  • Thermo Buys Qiagen

Molecular Point-of-Care Diagnostics Defined
Usage of Molecular Point of Care
Leading mPOC Platforms

    • Table 1-3: Market-Available Molecular POC Diagnostic Platforms

Trends
Scope and Methodology

Chapter Two: Molecular Point-of-Care Market Development and Trends
Advantages and Disadvantages of Molecular Point of Care

    • Table 2-1: Disadvantages of Molecular Point of Care, by Setting

Justification: The Sensitivity/Specificity Argument
New Systems and Menu Expansion

  • Molecular POC Enters STI with Binx Approval
  • Recent RSV Test Approvals Add Revenue Lines to Respiratory
  • Spartan Bioscience Pushing to Commercialize Personalized Heart Test
  • Ontera Developing Single-Pore Sensor for Sepsis, TB, and Zika Diagnostic Testing
  • QuantuMDx and SpeeDx Collaborate on Battery-Operated SDi Test
    • Table 2-2: Recent Menu Expansions for Hospital and POC Molecular Platforms (Vendor, Platform, Menu Addition, Time to Results, CLIA-waiver, US/EU Availability)

Investment in mPOC Systems

  • EU Researchers Awarded Ä3M to Develop POC Molecular Tests
  • Scope Fluidics AST System Sees Investment
  • Other Recent Investments

Competition from Raman Spectroscopy?
China as a POC Market
Common Tests and Analytes in POC Diagnostics
Thermoís Qiagen Acquisition

    • Table 2-3: Complementary Diagnostic Products Offered by Thermo Fisher, Qiagen

Component Technologies of Molecular Point-of-Care Diagnostics

  • Microfluidics
  • qPCR
  • Microarrays
  • Isothermal Amplification
  • Test Automation
  • Primers and Probes
  • Detection
  • Next-Generation Sequencing

Molecular Diagnostics

  • Real-Time PCR (qPCR)
  • Isothermal Amplification Methods
  • Line Probe Assays
  • Next-Generation Sequencing

Applications and Potential Applications for Molecular Point-of-Care

  • Major Testing Applications for Molecular POC Diagnostics
  • Influenza
  • Hospital-Acquired Infections (HAIs)
  • Strep A
  • Respiratory Syncytial Virus (RSV)

Emerging Applications

  • Zika
  • Other Respiratory Infections
  • Group B Streptococcus
  • Human Papillomavirus
  • Herpes Simplex Virus
  • Vaginitis
  • Tuberculosis
  • Malaria
  • Other Tropical and Neglected Diseases
  • Cancer

European Device Regulations Nearing

Chapter Three: Market Analysis
Molecular Point of Care Market Analysis

    • Table 3-1: Molecular Point of Care Market: 2019-2024
    • Table 3-2: Molecular Point of Care Market Share by Vendor, 2019 ($M, %)
    • Figure 3-1: Small-Footprint Molecular Point of Care Market, 2019 (%)
    • Table 3-3: Geographic Breakout of the Molecular Point of Care Market, 2019 (N. America, Europe, APAC, RoW)
    • Table 3-4: Segment Breakout of Molecular Point of Care Market, 2019 (Respiratory vs. Other)
    • Figure 3-2: Breakout of Molecular Point of Care Market, 2019 (%; Respiratory, Other)
  • Respiratory Molecular Point of Care Segmentation
    • Table 3-5: Respiratory Segment Breakout, 2019 (Flu, RSV, Strep, Other)
    • Figure 3-3: Breakout of mPOC Respiratory, 2019 (%; Flu, Strep, RSV, Other)

Near Patient Molecular Market

    • Table 3-6: Near Patient Molecular IVD Market: 2019-2024
  • Market Share Near Patient
    • Table 3-7: Near Patient Molecular Market Share by Vendor, 2019

Chapter Four: Company Profiles
Abbott Laboratories
Aidian Oy
Akonni Biosystems
binx health, inc.
Biocartis NV
bioMÈrieux SA
Cepheid

  • Molecular Healthcare-Acquired Infection (HAI) Testing
  • Molecular Sexual Health and Womenís Health Testing
  • Molecular Critical Infectious Disease Testing
  • Molecular Oncology/Genetics Testing

Credo Bioscience
Curetis NV
DiaSorin S.p.A
GenMark Diagnostics
Greiner Bio-One GmbH
Meridian Bioscience, Inc.
Mesa Biotech, Inc.
QIAGEN NV
QuantuMDx Group
Quidel Corporation
Roche
Sekisui Diagnostics LLC
T2 Biosystems

Appendix: COVID-19 and Molecular POC
CDC Response Creates Opportunity
COVID-19ís Unique Challenge
mPOC Steps In?
List of mPOC Tests under Development

    • Table A-1: mPOC-based Coronavirus Announced Tests in Development
    In Vitro Diagnostic (IVD) Procedure Volumes (Chemistry, Immunoassays, Hematology, Microbiology, Histology, Point of Care), 2023-2028
    September 22, 2023
    The Worldwide Market for In Vitro Diagnostic Tests, 16th Edition
    August 24, 2023
    30-Country IVD Market Atlas (In Vitro Diagnostic Markets for US, China, Germany, UK, Saudi Arabia, India, UAE, France, Vietnam, Turkey and 20 Other Countries)
    August 21, 2023
    At-Home Diagnostic Testing Markets and Trends (COVID-19, FOB, Glucose, HIV and Other Tests), 2023
    June 6, 2023

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