1 Market Guides
1.1 Situation Analysis
1.2 Guide for Executives and Marketing Staff
1.3 Guide for Investment Analysts and Management Consultants
2 Introduction and Market Definition
2.1 What are Syndromic Multiplex Tests?
2.2 Syndromic Testing - the quiet revolution in diagnostics
2.2.1 Syndromic Testing - more than Panels.
2.3 Market Definition
2.3.1 Multiplex Market Size.
2.3.2 Currency.
2.3.3 Years.
2.4 Methodology
2.4.1 Methodology
2.4.2 Sources
2.4.3 Authors
2.5 Perspective: Healthcare and the IVD Industry
2.5.1 Global Healthcare Spending
2.5.2 Spending on Diagnostics
2.5.3 Important Role of Insurance for Diagnostics
3 Infectious Disease
3.1 Infections - The Big Picture
3.2 The Pathogens
3.2.1 Bacteria
3.2.2 Fungi and Protozoa
3.2.3 Viruses
3.2.4 Prions
3.3 Symptoms and Syndromes
3.3.1 Bacterial or viral
3.3.2 Typical Viral Symptoms
3.3.3 Typical Bacterial Symptoms
3.4 Disease
3.5 Transmission
3.6 Infectious Disease Diagnostics
3.6.1 Microbial culture
3.6.2 Microscopy
3.6.3 Biochemical tests
3.6.4 PCR-based diagnostics
3.6.5 Metagenomic sequencing
3.7 Defining Infections
3.8 Syndromic Infection
4 Industry Overview
4.1 Players in a Dynamic Market
4.1.1 Academic Research Lab
4.1.2 Diagnostic Test Developer
4.1.3 Instrumentation Supplier
4.1.4 Chemical/Reagent Supplier
4.1.5 Pathology Supplier
4.1.6 Independent Clinical Laboratory
4.1.7 Public National/regional Laboratory
4.1.8 Hospital Laboratory
4.1.9 Physicians Office Lab (POLS)
4.1.10 Audit Body
4.1.11 Certification Body
4.2 The Clinical Laboratory Market Segments
4.2.1 Traditional Market Segmentation
4.2.2 Laboratory Focus and Segmentation
4.2.3 Segmenting the Syndromic Testing Market
4.3 Industry Structure
4.3.1 Hospital Testing Share
4.3.2 Economies of Scale
4.3.2.1 Hospital vs. Central Lab
4.3.3 Physician Office Lab’s
4.3.4 Physician’s and POCT
5 Market Trends
5.1 Factors Driving Growth
5.1.1 Speed of Diagnosis.
5.1.2 Effect of Syndromic Testing on Costs.
5.1.3 Point of Care Advantage.
5.1.4 Accuracy and Diagnostic Risk.
5.1.5 Single Visits.
5.1.6 Improvement in Outcomes.
5.1.7 Impact of the Pandemic.
5.2 Factors Limiting Growth
5.2.1 Lower Prices.
5.2.2 Administration/reimbursement.
5.2.3 Infectious Disease is Declining But….
5.2.4 Wellness Hurts.
5.2.5 Economic Growth improves Living Standards.
5.2.6 Impact of the Pandemic
5.3 Instrumentation, Automation and Diagnostic Trends
5.3.1 Traditional Automation and Centralization
5.3.2 The New Automation, Decentralization and Point of Care
5.3.3 Instruments Key to Market Share
5.3.4 Bioinformatics Plays a Role
5.3.5 PCR Takes Command
5.3.6 Next Generation Sequencing Fuels a Revolution
5.3.7 NGS Impact on Pricing
5.3.8 Whole Genome Sequencing, A Brave New World
5.3.9 Companion Diagnostics Blurs Diagnosis and Treatment
5.3.10 Comparing Syndrome and Targeted Testing
5.3.11 The Multiplex Paradigm Shift
5.3.12 The Sepsis Testing Market - Bellwether for Syndromics
5.3.13 The Single Visit and AntiMicrobial Resistance
5.3.14 Syndromics drives POCT adoption.
6 Syndromic Testing Recent Developments
6.1 Recent Developments - Importance and How to Use This Section
6.1.1 Importance of These Developments
6.1.2 How to Use This Section
6.2 BioMérieux Submits Application for Respiratory, Sore Throat Panel
6.3 Sensible Diagnostics Nabs Award for Respiratory Panel
6.4 Aptitude Medical Systems to Develop At-Home STI Test
6.5 Multiplex Meningitis/Encephalitis Panel Market Expanding
6.6 Burst Dx to Deliver Lab-Accurate ELISA-in-a-Cartridge
6.7 OpGen Seeking Approval for UTI Panel
6.8 Altratech to Enter MDx, POC Space by Supplanting PCR
6.9 BIOFIRE Announces New SPOTFIRE® System
6.10 Cambridge Nucleomics to Develop 'Nanobait' Tech
6.11 Takara Bio Developing Multiplex Panels
6.12 Rover Diagnostics Developing Optical Multiplex PCR
6.13 Nanopath Secures Funding to Develop POC Dx
6.14 Genetic Signatures Wins Public Health Wales Contract
6.15 Qiagen Looks to Long-Term Growth
6.16 LexaGene Gets Investment
6.17 Seegene Multiplex COVID-19/Flu/RSV Test Receives Approval
6.18 BforCure to Adapt Rapid PCR Platform for Cancer
6.19 Accelerated Growth for Decentralized Testing
6.20 QuantuMDx Developing Syndromic Panels for European Launch
6.21 Quidel Gains CE Mark for Savanna Analyzer, Respiratory Panel
6.22 QuantumDx Gets CE Mark for Rapid PoC PCR System
6.23 Bio-Rad Laboratories, Seegene Partner for MDx Development
6.24 Baebies to Expand Finder Platform
6.25 With Luminex Acquisition, DiaSorin to Broaden MDx Portfolio
6.26 Binx Health Targeting Clinics, DTC & OTC With STI Tests
6.27 Luminex Lands BARDA Grant to Develop Test for SARS-CoV-2, Flu, RSV
6.28 Molzym, Fraunhofer Developing Rapid Sepsis Diagnostic
6.29 MiRxes Receives Approval for Multiplex SARS-CoV-2, Flu Test
6.30 New Approach Involves Silicon-Based Test for Infectious Disease Screening
6.31 Scanogen’s Portable Battery Operated Instrument for 90 Minute Multiplex Test
6.32 Qiagen sees NeuMoDx as Growth Vehicle
6.33 Torus Biosystems Developing Syndromic Test with 30-Minute Turnaround
6.34 Roche, SpeeDx Partner to Expand Access to Antibiotic Resistance Tests
6.35 BioMérieux's BioFire SARS-CoV-2 Respiratory Panel Wins FDA EAU
6.36 Infectious Disease Testing Firm Curative Acquires KorvaLabs
6.37 ChromaCode Raises Additional $10M
6.38 COVID-19 Patients Need Syndromic Testing
6.39 GenMark Diagnostics - New Respiratory Panel due in June
6.40 Qiagen Respiratory Panel with Coronavirus Targets Receives CE Mark
6.41 Exact Diagnostics launches respiratory panel control
6.42 bioMérieux submits enhanced BIOFIRE® BCID2 Panel to FDA
7 Profiles of Key Syndromic Testing Companies
7.1 Abacus Diagnostica
7.2 Abbott Laboratories
7.3 Accelerate Diagnostics
7.4 Ador Diagnostics
7.5 ADT Biotech
7.6 Akonni Biosystems
7.7 Alveo Technologies
7.8 Antelope Dx
7.9 Applied BioCode
7.10 Aureum Diagnostics
7.11 Aus Diagnostics
7.12 Baebies
7.13 Beckman Coulter Diagnostics
7.14 Becton, Dickinson and Company
7.15 Binx Health
7.16 Biocartis
7.17 BioFire Diagnostics (bioMérieux)
7.18 bioMérieux Diagnostics
7.19 Bio-Rad Laboratories, Inc
7.20 Bosch Healthcare Solutions GmbH
7.21 Cepheid (Danaher)
7.22 Credo Diagnostics Biomedical
7.23 Cue Health
7.24 Curetis N.V./Curetis GmbH
7.25 Detect
7.26 Diagenode Diagnostics
7.27 Diasorin S.p.A.
7.28 Domus Diagnostics
7.29 Enzo Biochem
7.30 Eurofins Scientific
7.31 Fluxergy
7.32 Fusion Genomics.
7.33 Genetic Signatures
7.34 GenMark Dx (Roche)
7.35 Grip Molecular Technologies
7.36 Hibergene Diagnostics
7.37 Hologic
7.38 Immunexpress
7.39 Inflammatix
7.40 Invetech
7.41 Janssen Diagnostics
7.42 Karius
7.43 Lexagene
7.44 LightDeck Diagnostics
7.45 Lucira Health
7.46 Luminex Corp (DiaSorin)
7.47 Maxim Biomedical
7.48 Meridian Bioscience
7.49 Mesa Biotech (Thermo Fisher)
7.50 MicroGem
7.51 Millipore Sigma
7.52 Minute Molecular
7.53 Mobidiag (Hologic)
7.54 Molbio Diagnostics
7.55 Nanomix
7.56 Novel Microdevices
7.57 OnsiteGene
7.58 Operon
7.59 Oxford Nanopore Technologies
7.60 Panagene
7.61 Perkin Elmer
7.62 Primerdesign (Novacyt)
7.63 Prominex
7.64 Proof Diagnostics
7.65 Qiagen
7.66 QuantuMDx
7.67 QuidelOrtho
7.68 Roche Molecular Diagnostics
7.69 Saw Diagnostics
7.70 Scope Fluidics
7.71 Seegene
7.72 Siemens Healthineers
7.73 Sona Nanotech
7.74 SpeeDx
7.75 T2 Biosystems
7.76 Talis Biomedical
7.77 Thermo Fisher Scientific Inc.
7.78 Vela Diagnostics
7.79 Veramarx
7.80 Visby Medical
7.81 XCR Diagnostics
8 The Global Market for Syndromic Multiplex Diagnostics
8.1 Global Market Overview by Country
8.1.1 Table - Global Market by Country
8.1.2 Chart - Global Market by Country
8.2 Global Market by Syndrome - Overview
8.2.1 Table - Global Market by Syndrome
8.2.2 Chart - Global Market by Syndrome - Base/Final Year Comparison
8.2.3 Chart - Global Market by Syndrome - Base Year
8.2.4 Chart - Global Market by Syndrome - End Year
8.2.5 Chart - Global Market by Syndrome - Share by Year
8.2.6 Chart - Global Market by Syndrome - Segments Growth
8.3 Global Market by Place - Overview
8.3.1 Table - Global Market by Place
8.3.2 Chart - Global Market by Place - Base/Final Year Comparison
8.3.3 Chart - Global Market by Place - Base Year
8.3.4 Chart - Global Market by Place - End Year
8.3.5 Chart - Global Market by Place - Share by Year
8.3.6 Chart - Global Market by Place - Segments Growth
8.4 Global Market by Product - Overview
8.4.1 Table - Global Market by Product
8.4.2 Chart - Global Market by Product - Base/Final Year Comparison
8.4.3 Chart - Global Market by Product - Base Year
8.4.4 Chart - Global Market by Product - End Year
8.4.5 Chart - Global Market by Product - Share by Year
8.4.6 Chart - Global Market by Product - Segments Growth
9 Global Syndromic Multiplex Markets - By Syndrome
9.1 Respiratory
9.1.1 Table Respiratory - by Country
9.1.2 Chart - Respiratory Growth
9.2 Gastrointestinal
9.2.1 Table Gastrointestinal - by Country
9.2.2 Chart - Gastrointestinal Growth
9.3 Blood
9.3.1 Table Blood - by Country
9.3.2 Chart - Blood Growth
9.4 Meningitis/Encephalitis
9.4.1 Table Meningitis/Encephalitis - by Country
9.4.2 Chart - Meningitis/Encephalitis Growth
9.5 Sexually Transmitted Disease
9.5.1 Table Sexually Transmitted Disease - by Country
9.5.2 Chart - Sexually Transmitted Disease Growth
9.6 Other Syndrome
9.6.1 Table Other - by Country
9.6.2 Chart - Other Growth
10 Global MDx Infectious Disease Markets - by Place
10.1 Hospital Lab
10.1.1 Table Hospital Lab - by Country
10.1.2 Chart - Hospital Lab Growth
10.2 Outpatient Lab
10.2.1 Table Outpatient Lab - by Country
10.2.2 Chart - Outpatient Lab Growth
10.3 Point of Care
10.3.1 Table Point of Care - by Country
10.3.2 Chart - Point of Care Growth
10.4 Other Place
10.4.1 Table Other - by Country
10.4.2 Chart - Other Place Growth
11 Global MDx Infectious Disease Markets - by Product
11.1 Instruments
11.1.1 Table Instruments - by Country
11.1.2 Chart - Instruments Growth
11.2 Cartridges
11.2.1 Table Cartridges - by Country
11.2.2 Chart - Cartridges Growth
11.3 Reagents
11.3.1 Table Reagents - by Country
11.3.2 Chart - Reagents Growth
11.4 Other Product
11.4.1 Table Other Product - by Country
11.4.2 Chart - Other Product Growth
12 Appendices
12.1 United States Medicare System: Clinical Laboratory Fees Schedule
12.2 The Most Used IVD Assays
12.3 The Highest Grossing Assays
List of Tables
Table 1 Market Players by Type
Table 2 Clinical Laboratory Departments and Segments
Table 3 Laboratory Management Focus - Different Approaches
Table 4 Key Segmentation Variables Going Forward
Table 5 Possible Market Segments of Syndromic Multiplex Market
Table 6 Five Factors Driving Growth
Table 7 How SMT Improves Outcomes
Table 8 Four Factors Limiting Growth
Table 9 Seven Key Diagnostic Laboratory Technology Trends
Table 10 - Global Market by Region
Table 11 Global Market by Syndrome
Table 12 Global Market by Place
Table 13 Global Market by Product
Table 14 Respiratory by Country
Table 15 Gastrointestinal by Country
Table 16 Blood by Country
Table 17 Meningitis/Encephalitis by Country
Table 18 Sexually Transmitted Disease by Country
Table 19 Other by Country
Table 20 Hospital Lab by Country
Table 21 Outpatient Lab by Country
Table 22 Point of Care by Country
Table 23 Other by Country
Table 24 Instruments by Country
Table 25 Cartridges by Country
Table 26 Reagents by Country
Table 27 Other Product by Country
Table 28 Clinical Lab Fee Schedule
Table 29 The Most Common Assays
Table 30 Largest Revenue Assays
List of Figures
Figure 1 Global Healthcare Spending
Figure 2 The Lab Test Pie
Figure 3 The Road to Diagnostics
Figure 4 Chart Death Rates and Infectious Disease Decline
Figure 5 Centralized vs. Decentralized Laboratory Service
Figure 6 A Highly Multiplexed Syndromic Testing Unit
Figure 7 The Real Cost to Sequence the Human Genome
Figure 8 The Codevelopment Process
Figure 9 Comparing Syndromic and Targeted Testing
Figure 17 The Multiplex Paradigm Shift
Figure 11 Global Market Share Chart
Figure 12 Global Market by Syndrome - Base vs. Final
Figure 13 Global Market by Syndrome Base Year
Figure 14 Global Market by Syndrome End Year
Figure 15 Syndrome Share by Year
Figure 16 Syndrome Segments Growth
Figure 17 Global Market by Place - Base vs. Final
Figure 18 Global Market by Place Base Year
Figure 19 Global Market by Place End Year
Figure 20 Place Share by Year
Figure 21 Place Segments Growth
Figure 22 Global Market by Product - Base vs. Final
Figure 23 Global Market by Product Base Year
Figure 24 Global Market by Product End Year
Figure 25 Product Share by Year
Figure 26 Product Segments Growth
Figure 27 Respiratory Growth
Figure 28 Gastrointestinal Diagnostics Growth
Figure 29 Blood Growth
Figure 30 Meningitis/Encephalitis Growth
Figure 31 Sexually Transmitted Disease Growth
Figure 32 Other Growth
Figure 33 Hospital Lab Growth
Figure 34 Outpatient Lab Growth
Figure 35 Point of Care Growth
Figure 36 Other Growth
Figure 37 Instruments Growth
Figure 38 Cartridges Growth
Figure 39 Reagents Growth
Figure 40 Other Product Growth
