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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 and Customization. 2019 to 2023 - Global Version

SYNDROMIC MULTIPLEX DIAGNOSTIC MARKETS. Strategies and Trends. Forecasts by Syndrome (Respiratory, Sepsis, GI etc.) by Country. With Market Analysis, Executive Guides and Customization. 2019 to 2023 - Global Version

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 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.

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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
Syndromic Multiplex Diagnostic Markets 2019 to 2023 Page | 6
2.3.5.1 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
Syndromic Multiplex Diagnostic Markets 2019 to 2023 Page | 8
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 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
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 185
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 . 203
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
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
Syndromic Multiplex Diagnostic Markets 2019 to 2023 Page | 14
9.5 Sexually Transmitted Disease Panel Market
9.6 Other Panel Market
Appendices
I. United States Medicare System: 2018 Clinical Laboratory Fees Schedule – National Limit
and Midpoint
II. FDA Approved Microbial Tests
Table of Tables
Table 1 Medicare Clinical Lab Expenditures Actual & Forecast 2004 to 2020 ($Billion)
Table 2 Classification of HIV Species
Table 3 HBV Tests - CMS Codes & Prices
Table 4 HCV Tests - CMS Codes & Prices
Table 5 HPV Clearance Rates
Table 6 HPV Tests - CMS Codes & Prices
Table 7 HPV Tests, Technology, Types
Table 8 Types of Influenza Tests
Table 9 Influenza Tests - CMS Codes & Prices
Table 10 FDA Cleared Molecular Assays for Influenza
Table 11 FDA Cleared NAAT CTGC Tests
Table 12 CTGC NAAT Target Sequences and Possible False Reactions
Table 13 Influenza Tests - CMS Codes & Prices
Table 14 FDA Approved MDx Tests for Tuberculosis
Table 15 Tuberculosis Tests - CMS Codes & Prices
Table 16 FDA Approved Tests for MRSA
Table 17 MRSA Tests - CMS Codes & Prices
Table 18 FDA Approved Tests for VRE
Table 19 VRE Tests - CMS Codes & Prices
Table 20 Market Players by Type
Table 21 Clinical Laboratory Departments and Segments
Table 22 Laboratory Management Focus – Different Approaches
Table 23 Key Segmentation Variables Going Forward
Table 24 Possible Market Segments of Syndromic Multiplex Market
Table 25 Five Factors Driving Growth
Table 26 How SMT Improves Outcomes
Table 27 Four Factors Limiting Growth
Table 28 Syndromic Global Market by Country/Region
Table 29 Syndromic Global Market by Syndrome
Table 30 Gi-enteric Syndromic Testing market by country
Table 31 Blood-sepsis Syndromic Testing market by country
Table 32 Meningitis Syndromic Testing market by country
Table 33 Sexually Transmitted Disease Syndromic Testing market by country
Table 34 Other Syndromic Testing market by country
Table 35 Respiratory Panel Testing market – North America
Table 36 Respiratory Panel Testing market – Europe
Table 37 Respiratory Panel Testing market – Asia Pacific
Table 38 GI-Enteric Panel Testing market – North America
Table 39 GI-Enteric Panel Testing market – Europe
Table 40 GI-Enteric Panel Testing market – Asia Pacific
Table 41 Blood-Sepsis Panel Testing market – North America
Table 42 Blood-Sepsis Panel Testing market – Europe
Table 43 Blood-Sepsis Panel Testing market – Asia Pacific
Table 44 Meningitis Panel Testing market – North America
Table 45 Meningitis Panel Testing market – Europe
Table 46 Meningitis Panel Testing market – Asia Pacific
Table 47 Sexually Transmitted Disease Panel Testing market – North America
Table 48 Sexually Transmitted Disease Panel Testing market – Europe
Table 49 Sexually Transmitted Disease Panel Testing market – Asia Pacific
Table 50 Other Panel Testing market – North America
Table 51 Other Panel Testing market – Europe
Table 52 Other Panel Testing market – Asia Pacific
Table 53 2018 Clinical Lab Fee Schedule

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