Syndromic Multiplex Diagnostic Markets: Global Insights & Forecasts, 2019-2023 – Syndromic Testing Displacing Physician-based Diagnostics


DUBLIN, March 15, 2019 — The “Global Syndromic Multiplex Diagnostic Markets 2019 to 2023 – Strategies and Trends, Forecasts by Syndrome (Respiratory, Sepsis, GI etc.), by Country, with Market Analysis, Executive Guides and Customization.” report has been added to’s offering.

Are targeted tests for specific pathogens going to be obsolete? Will Infectious Disease testing move into the Physician’s Office or even the Home?

Syndromic testing is proving itself in the market. Players are reporting double-digit growth. Lowering costs, improving outcomes and even helping in the battle against Anti Microbial Resistance.

Learn about this market including the issues and outlooks. The two key trends of Point of Care Testing and Molecular Diagnostics are merging with spectacular success. It could possibly displace most frontline test protocols AND save money at the same time.

The report forecasts the market size out to 2023. In a special section, the report looks at the numbers on how syndromic molecular diagnostics is replacing traditional panel-based ordering of infectious disease tests.

Topics Covered

i. Market Guides

iA. Situation Analysis

iB. Guide for Executives and Marketing Staff

iC. Guide for Investment Analysts and Management Consultants

1. Introduction and Market Definition

1.1 What are Syndromic Multiplex Tests?

1.2 Syndromic Testing – the quiet revolution in diagnostics

1.2.1 Syndromic Testing – more than Panels.

1.3 Market Definition

1.3.1 Multiplex Market Size

1.3.2 Panel Market Size

1.3.2 Currency

1.3.3 Years

1.4 Methodology

1.4.1 Authors

1.4.2 Sources

1.5 U.S. Medical Market and Clinical Laboratory Testing – Perspective

1.5.1 U.S. Medicare Expenditures for Clinical Testing

2. The Infectious Diseases – Guide to the Pathogens

2.1 HIV – Human Immunodeficiency Virus (AIDS)

2.1.1 Virology Classification Structure and genome Tropism Replication cycle Genetic variability

2.1.2 Diagnosis

2.1.3 Testing Antibody tests Point of Care Tests (POCT) Antigen Tests Nucleic acid-based tests (NAT) Other tests used in HIV treatment

2.2 HBV – Hepatitis B

2.2.1 Virology Genome Pathogenesis Hepatitis B virus replication Serotypes and genotypes

2.2.2 Mechanisms

2.2.3 Diagnosis

2.2.4 Market Opportunity Analysis

2.3 HCV – Hepatitis C

2.3.1 Taxonomy Structure Genome

2.3.3 Molecular biology

2.3.4 Replication

2.3.5 Genotypes Clinical importance

2.3.6 Market Opportunity Analysis

2.4 HPV – Human papillomavirus

2.4.1 Virology E6/E7 proteins Role in cancer E2 research Latency period Clearance

2.4.2 Diagnosis Cervical testing Oral testing Testing men Other testing

2.4.3 Market Opportunity Analysis

2.5 Influenza

2.5.1 Virology Types of virus Influenzavirus A Influenzavirus B Influenzavirus C Structure, properties, and subtype nomenclature Replication

2.5.2 Testing Advantages/Disadvantages of Molecular Assays

2.5.3 Market Opportunity Analysis

2.6 CTGC – Chlamydia/Gonorhea

2.6.1 Gonorrhea Diagnosis Screening

2.6.2 Chlamydia Diagnosis Screening

2.6.3 Testing Nucleic acid amplification tests (NAATs). Performance of NAAT Tests

2.6.4 Market Opportunity Analysis

2.7 Tuberculosis

2.7.1 Mycobacteria

2.7.2 Diagnosis Active tuberculosis Latent tuberculosis

2.7.3 Epidemiology

2.7.4 Molecular Diagnostic Tests

2.7.5 Market Opportunity Analysis

2.8 MRSA – Methicillin-resistant Staphylococcus aureus

2.8.1 Diagnosis

2.8.2 FDA Approved Molecular Tests.

2.8.3 Market Opportunity Analysis

2.9 VRE – Vancomycin-resistant Enterococcus

2.9.1 FDA Approved MDx Tests for VRE

2.9.2 Market Opportunity Analysis

3. Industry Overview

3.1 Industry Participants

3.1.1 IVD Supplier

3.1.2 Independent lab specialized/esoteric

3.1.3 Independent lab national/regional

3.1.4 Independent lab analytical

3.1.5 Public National/regional lab

3.1.6 Hospital lab

3.1.7 Physician lab

3.1.8 Audit body

3.2 The Clinical Laboratory Market Segments

3.2.1 Traditional Market Segmentation

3.2.2 Laboratory Focus and Segmentation

3.2.3 Segmenting the Syndromic Testing Market

3.3 Industry Structure

3.3.1 Hospital Testing Share

3.3.2 Economies of Scale Hospital vs. Central Lab

3.3.3 Physician Office Labs

3.3.4 Physician’s and POCT

4. Market Trends

4.1 Factors Driving Growth

4.1.1 Speed of Diagnosis

4.1.2 Effect of Syndromic Testing on Costs

4.1.3 Point of Care Advantage

4.1.4 Syndrome Testing, Accuracy and Diagnostic Risk

4.1.5 Single Visits

4.1.6 Improvement in Outcomes

4.2 Factors Limiting Growth

4.2.1 Lower Prices

4.2.2 Infectious Disease is Declining But

4.2.3 Wellness Hurts.

4.2.4 Economic Growth improves Living Standards

4.3 Instrumentation and Automation

4.3.1 Instruments Key to Market Share

4.3.2 The Shrinking Machine

4.3.3 Syndrome Testing Moving to Big Instruments?

4.4 Diagnostic Technology Development

4.4.1 Comparing Syndrome and Targeted Testing

4.4.2 The Multiplex Paradigm Shift

4.4.2 The Sepsis Testing Market – Bellwether for Syndromics

4.4.3 The Single Visit and AntiMicrobial Resistance

4.4.4 Syndromics drives POCT adoption

4.4.5 A Big Future for PCR?

5. Syndromic Testing Recent Developments

Recent Developments – Importance and How to Use This Section

Importance of These Developments

How to Use This Section

  • Akonni Biosystems Submits Multiplex Diagnostics System to FDA
  • Ador Diagnostic to receive $30M in Funding for 100-Plex PoC
  • SAW Diagnostics Receives Funding for Commercialisation of PoC Platform
  • QuantuMDx and Molbio announce MoU
  • Immunexpress Wins $745K Contract for Rapid Sepsis Assay
  • Mobidiag Inks European, Middle Eastern Distribution Deals
  • BIOFIRE FILMARRAY System chosen for Phase 3 clinical trial
  • bioMerieux launches the BIOFIRE FILMARRAY Pneumonia Panels
  • XCR Diagnostics and Luminex Enter into License Agreement
  • Palmetto Final LCD Denies Coverage to Large Respiratory Panels
  • Karius Test to Be Available in Brazil
  • Inflammatix HostDx Fever Test able to Rapidly Distinguish Bacterial from Viral Infections
  • Panagene’s STD kit gains Approval
  • GenePOC’s Investment Validated by Medicare Decision
  • Startup Prominex Raises $4M in Series A1
  • Alveo Closes Financing to Create Accessible Diagnostics Devices
  • MBio Diagnostics, Inc. Funding Supports Scaling of PoC Testing Platform
  • GenePOC launches its GenePOC CDiff test in Canada
  • Siemens Healthineers completes takeover of Fast Track Diagnostics
  • Chembio and FIND to Develop Point-of-Care Multiplex Test
  • Applied BioCode Receives CE Mark for 18-plex Gastrointestinal Pathogen Panel
  • Rapid Molecular Flu Tests Gain Ground
  • Cepheid Receives FDA Clearance and CLIA Waiver for Xpert Xpress Flu Test
  • bioMerieux seeks FDA Clearance of Pneumonia Panel
  • Mobidiag Announces Release of a Multiplex qPCR Test for Detection of Antibiotic Resistant Bacteria
  • Fast Track Diagnostics Gets CE Mark for Real-Time PCR Detection of High-Risk HPV
  • SEEGENE develops Multiplex PCR tests in 4 days
  • Seegene enters the U.S. diagnostic market in collaboration with Thermo Fisher Scientific
  • Fusion Genomics Developing All Pathogens Diagnostic.
  • Anapa Biotech Announces MeltPlex Technology
  • First multiplex test for tick-borne diseases
  • ArcherDx, MGH Suing Qiagen Over Anchored Multiplex PCR Technology
  • Akonni Biosystems Forms Chinese Commercialization Partnership with Righton
  • Vela Buys Great Basin Scientific
  • BARDA Awards up to $30M to Cue Health for Influenza, Respiratory Pathogen Test
  • QIAGEN enters into agreement to acquire STAT-Dx
  • GA-EMS receives diagnostic device contract
  • Biocartis & Immunexpress Sign Partnership for Sepsis

6. Profiles of Key Syndromic Testing Companies

  • Abbott Diagnostics (Alere)
  • Accelerate Diagnostics
  • Ador Diagnostics
  • Akkoni Biosystems
  • Alveo Technologies
  • Applied BioCode
  • Atlas Genetics
  • Aus Diagnostics
  • BD Diagnostics
  • Biocartis
  • BioFire Diagnostics
  • bioMerieux
  • Bio-Rad Laboratories
  • Bosch Healthcare Solutions GmbH
  • Cepheid
  • Curetis
  • Diagenode Diagnostics
  • Diasorin
  • Fusion Genomics
  • GenePOC Diagnostics
  • GenMark Dx
  • Hologic
  • Inflammatix
  • Invetech
  • Janssen Diagnostics
  • Karius
  • Lexigene
  • Luminex
  • Mbio Diagnostics
  • Mesa Biotech
  • Mobidiag
  • Nanomix
  • Oxford Nanopore
  • Panagene
  • Primerdesign
  • Prominex
  • Qiagen (Statdx)
  • Quantumdx
  • Roche Molecular Diagnostics
  • Seegene
  • Sensovation
  • Siemens Healthineers (Fast Track Diagnostics)
  • SkylineDx
  • T2 Biosystems
  • Thermo Fisher
  • Veramarx
  • XCR Diagnostics

7. Global Market Size

7.1 Syndromic Global Market Size by Country with Charts

7.2 Syndromic Global Market Size by Syndrome with Charts

8. Global Market by Syndrome

8.1 Respiratory Syndrome Market

8.1.1 Respiratory Syndrome Market by Country

8.2 GI-Enteric Syndrome Market

8.2.1 GI-Enteric Market by Country with Chart

8.3 Blood-Sepsis Syndrome Market

8.3.1 Blood-Sepsis Market by Country with Chart

8.4 Meningitis Syndrome Market

8.4.1 Meningitis Market by Country with Chart

8.5 Sexually Transmitted Disease Syndrome Market

8.5.1 Sexually Transmitted Disease Market by Country with Chart

8.6 Other Syndrome Market

8.6.1 Other Market by Country with Chart

9. Panel Testing Market – Volumes and Price Forecast with MDx Share

9.1 Respiratory Panel Market

9.2 GI-Enteric Panel Market

9.3 Blood-Sepsis Panel Market

9.4 Meningitis Panel Market

9.5 Sexually Transmitted Disease Panel Market

9.6 Other Panel Market


I. United States Medicare System: 2018 Clinical Laboratory Fees Schedule – National Limit and Midpoint

II. FDA Approved Microbial Tests

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