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Syndromic Multiplex Diagnostic Markets - Strategies and Trends, Forecasts by Syndrome (Respiratory, Sepsis, GI etc.) & by Country - With Market Analysis, Executive Guides & Customization 2020 to 2024

  • ID: 4850695
  • Report
  • Region: Global
  • 402 Pages
  • Howe Sound Research
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Syndromic Testing Displacing Physician Based Diagnostics

FEATURED COMPANIES

  • Accelerate Diagnostics
  • Biocartis
  • Fast Track Diagnostics
  • Janssen Diagnostics
  • Nanomix
  • Saw Diagnostics
  • MORE

Are targeted tests for specific pathogens going to be obsolete? Will diagnostics replace physicians? 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 2024. 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.

This research makes you the expert in your organization.

All report data is available in Excel format on request.

Make investment decisions and valuations with confidence using the latest data.

Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Accelerate Diagnostics
  • Biocartis
  • Fast Track Diagnostics
  • Janssen Diagnostics
  • Nanomix
  • Saw Diagnostics
  • MORE

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
2.1.1.1 Classification
2.1.1.2 Structure and genome
2.1.1.3 Tropism
2.1.1.4 Replication cycle
2.1.1.5 Genetic variability
2.1.2 Diagnosis
2.1.3 Testing
2.1.3.1 Antibody tests
2.1.3.2 Point of Care Tests (POCT)
2.1.3.4 Antigen Tests
2.1.3.5 Nucleic acid-based tests (NAT)
2.1.3.6 Other tests used in HIV treatment
2.2 HBV – Hepatitis B
2.2.1 Virology
2.2.1.1 Genome
2.2.1.2 Pathogenesis
2.2.1.3 Hepatitis B virus replication
2.2.1.4 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
2.3.2.1 Structure
2.3.2.2 Genome
2.3.3 Molecular biology
2.3.4 Replication
2.3.5 Genotypes
2.3.1.1 Clinical importance
2.3.6 Market Opportunity Analysis
2.4 HPV - Human papillomavirus
2.4.1 Virology
2.4.1.1 E6/E7 proteins
2.4.1.2 Role in cancer
2.4.1.3 E2 research
2.4.1.4 Latency period
2.4.1.5 Clearance
2.4.2 Diagnosis
2.4.2.1 Cervical testing
2.4.2.2 Oral testing
2.4.2.3 Testing men
2.4.2.4 Other testing
2.4.3 Market Opportunity Analysis
2.5 Influenza
2.5.1 Virology
2.5.1.1 Types of virus
2.5.1.2 Influenzavirus A
2.5.1.3 Influenzavirus B
2.5.1.4 Influenzavirus C
2.5.1.5 Structure, properties, and subtype nomenclature
2.5.1.6 Replication
2.5.2 Testing
2.5.2.1 Advantages/Disadvantages of Molecular Assays
2.5.3 Market Opportunity Analysis
2.6 CTGC - Chlamydia/Gonorhea
2.6.1 Gonorrhea
2.6.1.1 Diagnosis
2.6.1.2 Screening
2.6.2 Chlamydia
2.6.2.1 Diagnosis
2.6.2.2 Screening
2.6.3 Testing
2.6.3.1 Nucleic acid amplification tests (NAATs).
2.6.3.2 Performance of NAAT Tests
2.6.4 Market Opportunity Analysis
2.7 Tuberculosis
2.7.1 Mycobacteria
2.7.2 Diagnosis
2.7.2.1 Active tuberculosis
2.7.2.2 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
3.3.2.1 Hospital vs. Central Lab
3.3.3 Physician Office Lab’s
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 Administration/reimbursement
4.2.3 Infectious Disease is Declining But…
4.2.4 Wellness Hurts
4.2.5 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
  • Applied BioCode Submits FDA Application for Syndromic BioCode® Respiratory Pathogen Panel
  • Expedeon AG and Sona Nanotech to Collaborate on Multiplex POC
  • QIAGEN’s New GI Panel Performance Assessed
  • McKesson to Distribute QIAstat-Dx Syndromic Testing Solution in USA
  • Applied BioCode Obtains FDA Clearance
  • Meridian Bioscience to Acquire GenePOC Inc
  • Curetis Introduces Rapid DNA Testing for Antibiotic Resistance
  • Qiagen gets FDA clearance for syndromic testing system
  • Entasis Therapeutics Signs Rapid Diagnostic Agreement with bioMérieux
  • 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
  • bioMérieux 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
  • bioMérieux seeksr 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
  • bioMérieux
  • Bio-Rad Laboratories
  • Bosch Healthcare Solutions GmbH
  • Cepheid
  • Cue Health
  • Curetis
  • Diagenode Diagnostics
  • Diasorin
  • Expedeon
  • Fusion Genomics.
  • GenePOC Diagnostics
  • Genetic Signatures
  • GenMark Dx
  • Hologic
  • Immunexpress
  • Inflammatix
  • Invetech
  • Janssen Diagnostics
  • Karius
  • Lexigene
  • Luminex
  • Mbio Diagnostics
  • Meridian Bioscience
  • Mesa Biotech
  • Mobidiag
  • Nanomix
  • Oxford Nanopore
  • Panagene
  • Primerdesign
  • Prominex
  • Qiagen (Statdx)
  • Quantumdx
  • Quidel
  • Roche Molecular Diagnostics
  • Saw Diagnostics
  • Seegene
  • Sensovation
  • Siemens Healthineers (Fast Track Diagnostics)
  • SkylineDx
  • Sona Nanotech
  • 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

Appendices
I. United States Medicare System: 2019 Clinical Laboratory Fees Schedule
II. FDA Approved Microbial Tests

Table of Tables
Table 1 Market Share of Leading Companies
Table 2 Medicare Clinical Lab Expenditures Actual & Forecast 2014 to 2024 ($Billion)
Table 3 Classification of HIV Species
Table 4 HBV Tests - CMS Codes & Prices
Table 5 HCV Tests - CMS Codes & Prices
Table 6 HPV Clearance Rates
Table 7 HPV Tests - CMS Codes & Prices
Table 8 HPV Tests, Technology, Types
Table 9 Types of Influenza Tests
Table 10 Influenza Tests - CMS Codes & Prices
Table 11 FDA Cleared Molecular Assays for Influenza
Table 12 FDA Cleared NAAT CTGC Tests
Table 13 CTGC NAAT Target Sequences and Possible False Reactions
Table 14 Influenza Tests - CMS Codes & Prices
Table 15 FDA Approved MDx Tests for Tuberculosis
Table 16 Tuberculosis Tests - CMS Codes & Prices
Table 17 FDA Approved Tests for MRSA
Table 18 MRSA Tests - CMS Codes & Prices
Table 19 FDA Approved Tests for VRE
Table 20 VRE Tests - CMS Codes & Prices
Table 21  Market Players by Type
Table 22 Clinical Laboratory Departments and Segments
Table 23 Laboratory Management Focus – Different Approaches
Table 24 Key Segmentation Variables Going Forward
Table 25 Possible Market Segments of Syndromic Multiplex Market
Table 26 Five Factors Driving Growth
Table 27 How SMT Improves Outcomes
Table 28 Four Factors Limiting Growth
Table 29 Syndromic Global Market by Country/Region
Table 30 Syndromic Global Market by Syndrome
Table 31 Gi-enteric Syndromic Testing market by country
Table 32 Blood-sepsis Syndromic Testing market by country
Table 33 Meningitis Syndromic Testing market by country
Table 34 Sexually Transmitted Disease Syndromic Testing market by country
Table 35 Other Syndromic Testing market by country
Table 36 Respiratory Panel Testing market – North America
Table 37 Respiratory Panel Testing market – Europe
Table 38 Respiratory Panel Testing market – Asia Pacific
Table 39 GI-Enteric Panel Testing market – North America
Table 40 GI-Enteric Panel Testing market – Europe
Table 41 GI-Enteric Panel Testing market – Asia Pacific
Table 42 Blood-Sepsis Panel Testing market – North America
Table 43 Blood-Sepsis Panel Testing market – Europe
Table 44 Blood-Sepsis Panel Testing market – Asia Pacific
Table 45 Meningitis Panel Testing market – North America
Table 46 Meningitis Panel Testing market – Europe
Table 47 Meningitis Panel Testing market – Asia Pacific
Table 48 Sexually Transmitted Disease Panel Testing market – North America
Table 49 Sexually Transmitted Disease Panel Testing market – Europe
Table 50 Sexually Transmitted Disease Panel Testing market – Asia Pacific
Table 51 Other Panel Testing market – North America
Table 52 Other Panel Testing market – Europe
Table 53 Other Panel Testing market – Asia Pacific
Table 54 2019 Clinical Lab Fee Schedule

Table of Figures
Figure 1 Market Share of Leading Companies Chart
Figure 2 Medicare Clinical Lab Expenditures 2014 to 2024 ($Million)
Figure 3 HIV Virion
Figure 4 Diagram of the HIV Replication Cycle
Figure 5 The Structure of the HBV Virus
Figure 6 Hepatitis B Replication
Figure 7 Structure of the HCV Virus
Figure 8 HCV Replication Cycle
Figure 9 Structure of the Influenza Virion
Figure 10 Influenza Replication
Figure 11 Scanning Electronmicrograph of Tuberculosis
Figure 12 Chart Death Rates and Infectious Disease Decline
Figure 13 Comparing Syndromic and Targeted Testing
Figure 14 The Multiplex Paradigm Shift
Figure 15 Market Size by Country - Key Countries
Figure 16 Chart of Global Market by Syndrome
Figure 17 Growth Rates of Syndrome Segments
Figure 18 Segment Share Shift
Figure 19 Chart - Respiratory vs. market Growth
Figure 20 Chart – Gi-enteric vs. market Growth
Figure 21 Chart – Blood-sepsis vs market Growth
Figure 22 Chart - Meningitis vs market Growth
Figure 23 Chart – Sexually Transmitted Disease vs market growth
Figure 24 Chart – Other Syndromic Testing vs market growth

Note: Product cover images may vary from those shown
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  • Abbott Diagnostics (Alere)
  • Accelerate Diagnostics
  • Ador Diagnostic
  • Akkoni Biosystems
  • Alveo
  • Alveo Technologies
  • Anapa Biotech
  • Applied BioCode
  • ArcherDx
  • Atlas Genetics
  • Aus Diagnostics
  • BARDA
  • BD Diagnostics
  • Bio-Rad Laboratories
  • BioFire Diagnostics
  • Biocartis
  • Bosch Healthcare Solutions GmbH
  • Cepheid
  • Chembio
  • Cue Health
  • Curetis
  • Diagenode Diagnostics
  • Diasorin
  • Entasis Therapeutics
  • Expedeon
  • FIND
  • Fast Track Diagnostics
  • Fusion Genomics
  • GA-EMS
  • GenMark Dx
  • GenePOC Inc
  • Genetic Signatures
  • Great Basin Scientific
  • Hologic
  • Immunexpress
  • Inflammatix
  • Invetech
  • Janssen Diagnostics
  • Karius
  • Lexigene
  • Luminex
  • MBio Diagnostics, Inc.
  • MGH
  • Mbio Diagnostics
  • McKesson
  • Meridian Bioscience
  • Mesa Biotech
  • Mobidiag
  • Molbio
  • Nanomix
  • Oxford Nanopore
  • Palmetto Final LCD
  • Panagene
  • Primerdesign
  • Prominex
  • Qiagen
  • Qiagen (Statdx)
  • QuantuMDx
  • Quantumdx
  • Quidel
  • Righton
  • Roche Molecular Diagnostics
  • SAW Diagnostics
  • SEEGENE
  • Saw Diagnostics
  • Seegene
  • Sensovation
  • Siemens Healthineers (Fast Track Diagnostics)
  • SkylineDx
  • Sona Nanotech
  • T2 Biosystems
  • Thermo Fisher Scientific
  • Vela
  • Veramarx
  • XCR Diagnostics
  • bioMérieux
Note: Product cover images may vary from those shown
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