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The Market and Potential for Molecular Point of Care Diagnostics: Revenue Forecasts to 2020


Attention: There is an updated edition available for this report.

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

  • Molecular POC Market for Respiratory Tract Infections (2015-2020)
  • Molecular POC Market for Women’s Health and Sexual Health (2015-2020)
  • Molecular POC Market for High-Burden Diseases (2015-2020)
  • Molecular POC Market for GI Pathogens, HAIs and Bloodstream Infections (2015-2020)
  • Molecular POC Market for Non-Infectious Diseases (2015-2020)
  • Investments in Decentralized Molecular Diagnostics Companies (2014-2015)
  • Potential Entrants into Molecular POC Diagnostics (Vendor, Current Platform[s], Primary Market for Platform, Assay Menu, Applicable Tech)

Clinical molecular diagnostics has steadily progressed from research-emergent, highly complex tests performed in few labs to analyzer-integrated and -automated steps from sample preparation through results analysis.  The Market and Potential for Molecular Point of Care Diagnostics probes molecular point of care diagnostics developments and applications, including:

  • 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 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)
  • 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 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:

  • Oxford Nanopore Technologies
  • Xagenic
  • T2 Biosystems
  • Rheonix
  • Nanosphere
  • Great Basin Scientific
  • DNA Electronics
  • Enigma Diagnostics
  • Curetis
  • Biocartis
  • Atlas Genetics


  • Executive Summary
    • INTRODUCTION
    • MOLECULAR POINT-OF-CARE DIAGNOSTICS DEFINED
    • STRENGTHS AND WEAKNESS OF MOLECULAR POC TESTING
      • Table Advantages of Point-of-Care Diagnostics by Setting - Hospital POC, POL/Outpatient, Low-Resource and Developing Areas
      • Table Disadvantages of Point-of-Care Diagnostics by Setting - Hospital POC, POL/Outpatient, Low-Resource and Developing Areas
    • COMPONENT TECHNOLOGIES OF MOLECULAR POC 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)
    • INVESTMENT IN DECENTRALIZED MOLECULAR DIAGNOSTICS -VENTURE FINANCING AND PUBLIC OFFERINGS (2009-2015)
    • GLOBALMOLECULAR POC DIAGNOSTICS MARKET (2015-2020)
    • MAJOR CONCLUSIONS
  • Introduction to Molecular Point of Care Diagnostics
    • INTRODUCTION
    • POINT-OF-CARE DIAGNOSTICS IN BRIEF
      • Common Tests and Analytes in POC Diagnostics
      • Market Drivers for POC Diagnostics
        • Table Advantages of Point-of-Care Diagnostics by Setting - Hospital POC, POL/Outpatient, Low-Resource and Developing Areas
      • Market Barriers for POC Diagnostics
        • Table Disadvantages of Point-of-Care Diagnostics by Setting - Hospital POC, POL/Outpatient, Low-Resource and Developing Areas
    • MOLECULAR DIAGNOSTICS
      • Real-Time PCR (qPCR)
      • Isothermal Amplification Methods
        • Table Selected Isothermal Amplification Methods and Platform Examples
      • Microarrays
      • Sequencing
      • Common Tests and Analytes in Molecular Diagnostics
    • ADVANTAGES AND DISADVANTAGES OF MOLECULAR DIAGNOSTICS AT THE POINT OF CARE
    • SUMMARY
  • Molecular Point of Care Diagnostics Development and Applications
    • 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 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
    • MAJOR TESTING APPLICATIONS FOR MOLECULAR POC DIAGNOSTICS
      • Influenza
      • Strep A
      • Respiratory Syncytial Virus (RSV)
      • Other Respiratory Infections
      • Chlamydia and Gonorrhea
      • Group B Streptococcus
      • Human Papillomavirus
      • Herpes Simplex Virus
      • Vaginitis
      • Human Immunodeficiency Virus (HIV)
      • Tuberculosis
      • Hepatitis
      • Malaria
      • Other Tropical and Neglected Diseases
      • Gastrointestinal Infections
      • Hospital-Acquired Infections (HAIs)
      • Bloodstream Infections (BSIs)
      • Pharmacogenetics
      • Hereditary Disease
      • Cancer
    • CONCLUSIONS
  • Markets for Molecular Point-of-Care Diagnostics
    • INTRODUCTION
    • INVESTMENT IN DECENTRALIZED MOLECULAR DIAGNOSTICS -VENTURE FINANCING AND PUBLIC OFFERINGS (2009-2015)
      • Table Investments in Decentralized Molecular Diagnostics Companies (2014-2015) ($ millions)
    • RESPIRATORY TRACT INFECTIONS
      • Table Molecular POC Market for Respiratory Tract Infections - Influenza, Strep A, RSV, Others (2015-2020) ($ millions) - Sales / Market Opportunity
    • WOMEN'S HEALTH AND SEXUAL HEALTH
      • Table Molecular POC Market for Women's Health and Sexual Health - CT/NG, GBS, HPV, HSV, Vaginitis (including TV) (2015-2020) ($ millions) - Sales / Market Opportunity
    • HIGH-BURDEN DISEASES
      • Table Molecular POC Market for High-Burden Diseases - HIV, TB, Hepatitis, Malaria, Other Tropical and Neglected Diseases (2015-2020) ($ millions) - Sales / Market Opportunity
    • GASTROINTESTINAL, HOSPITAL-ACQUIRED AND BLOODSTREAM INFECTIONS
      • Table Molecular POC Market for GI Pathogens, HAIs and Bloodstream Infections (2015-2020) ($ millions) - Sales / Market Opportunity
    • NON-INFECTIOUS DISEASE TESTS - PHARMACOGENETICS, HEREDITARY TRAITS AND CANCER
      • Table Molecular POC Market for Non-Infectious Diseases - Pharmacogenetics / Hereditary Traits and Cancer (2015-2020) ($ millions) - Sales / Market Opportunity
    • CONCLUSIONS
      • Table Molecular POC Test Markets for Respiratory Tract Infections, Women's Health and Sexual Health, High-Burden Diseases, GI Pathogens, HAIs, Bloodstream Infections, Pharmacogenetics, Other Genetics, and Cancer Testing (2015-2020) ($ millions) - Sales / Market Opportunity
  • Company Profiles
    • ABACUS DIAGNOSTICA
    • ADVANCED LIQUID LOGIC (ILLUMINA)
    • AHRAM BIOSYSTEMS
    • AKONNI BIOSYSTEMS
    • ALERE (ABBOTT)
      • Table Alere Revenue (2012-2015)
    • AMPLINO
    • ANALYTIK JENA
      • Table Analytik Jena Revenue (FY 2011-2014)
    • AQUILA DIAGNOSTIC SYSTEMS
    • ATLAS GENETICS
    • AXXIN
    • BECTON, DICKINSON &CO. (BD)
      • Table Becton, Dickinson & Co. (BD) Revenue (FY 2012-2015)
    • BIOCARTIS
      • Table Biocartis NV Revenue (2012-2015)
    • BIOMEME
    • BIOMÉRIEUX
      • Table bioMérieux Revenue (2012-2015)
    • CANON BIOMEDICAL
    • CEPHEID
      • Table Cepheid Revenue (2012-2015)
      • Molecular Healthcare-Acquired Infection (HAI) Testing
      • Molecular Sexual Health and Women's Health Testing
      • Molecular Critical Infectious Disease Testing
      • Molecular Oncology Testing
    • CORIS BIOCONCEPT
    • COYOTE BIOSCIENCE
    • CURETIS
    • DESTINA GENOMICS
    • DIAGNOSTICS FOR ALL
    • DIAGNOSTICS FOR THE REAL WORLD
    • DIASORIN
      • Table DiaSorin Revenue (2012-2015)
    • DIASSESS
    • DNA ELECTRONICS
    • DXNA
    • EIKEN CHEMICAL
      • Table Eiken Chemical Revenue (FY 2012-2015)
    • ENIGMA DIAGNOSTICS
    • ENTOPSIS
    • EPISTEM
      • Table Epistem Revenue (FY 2012-2015)
    • ERBAMOLECULAR (LUMORA)
    • ESPIRA
    • GENAPSYS
    • GENEFLUIDICS
    • GENEPOC
    • GENEREACH BIOTECHNOLOGY
    • GNUBIO (BIO-RAD)
    • GREAT BASIN SCIENTIFIC
      • Table Great Basin Corporation Revenue (2012-2015)
    • GREINER BIO-ONE
    • HAI KANG LIFE
    • HAIN LIFESCIENCE
    • HIBERGENE DIAGNSOTICS
    • ICUBATE
    • IMMUNEXPRESS
    • INSILIXA
    • LUCIGEN
    • MAST GROUP
    • MBIO DIAGNOSTICS
    • MERIDIAN BIOSCIENCE
      • Table Meridian Bioscience Revenue (FY 2012-2015)
    • MESA BIOTECH
    • METAARAMEDICAL TECHNOLOGIES
    • MICRONICS (SONY)
    • MOLBIO DIAGNOSTICS
    • MP BIOMEDICALS
    • MYCROLAB DIAGNOSTICS
    • NANOBIOSYM
    • NANOBIOSYS
    • NANODETECTION TECHNOLOGY
    • NANOIVD
    • NANOMIX
    • NANOSPHERE
      • Table Nanosphere Revenue (2012-2015)
    • OPTIGENE
    • ORION DIAGNOSTICA
      • Table Orion Diagnostica Revenue (2012-2015)
    • OXFORD NANOPORE TECHNOLOGIES
    • POSITIVEID
      • Table PositiveID Revenue (2012-2015)
    • PRETECT
    • QIAGEN
      • Table QIAGEN Revenue (2012-2015)
      • HPV
      • Other Activities (Development, Licensing, Investment)
    • QUANTUMDX
    • QUIDEL
      • Table Quidel Corporation Revenue (2012-2015)
    • RHEONIX
    • ROCHE DIAGNOSTICS
      • Table Roche Diagnostics Revenue (2012-2015)
    • SCANOGEN
    • SEEGENE
      • Table Seegene Revenue (2012-2015)
    • SPARTAN BIOSCIENCE
    • STAT-DIAGNOSTICA
    • T2 BIOSYSTEMS
      • Table T2 Biosystems Revenue (FY 2012-FY 2015)
    • THERMAL GRADIENT
    • UBIQUITOME
    • USTAR BIOTECHNOLOGIES
    • VEREDUS LABORATORIES
    • WAVE 80 BIOSCIENCES
    • XAGENIC

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