OVERVIEW:
How will COVID-19 affect Syndromic and Infectious Disease Diagnostics? The COVID pandemic is ushering in a new world of infectious disease diagnostics. Infectious disease Dx is changing and will change more in the future. Can a rapidly growing market expand even faster? Find out all about it in this comprehensive report on Syndromic Multiplex Diagnostics.
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.
All report data is available in Excel format on request.
Make investment decisions and valuations with confidence using the latest data.
ABOUT THE LEAD AUTHOR:
Mr. Greg Powell, B.SC., M.B.A is the President of Howe Sound Research. He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years. Mr. Powell's education includes:
- B.Sc. (Chemistry) University of BC
- M.B.A. (Finance and Policy) University of BC
- Market Research Seminar - Burke Institute
- Finance for Senior Executives - Harvard Business School
Table of Contents
i. Market Guides
- iA. Situation Analysis & COVID Impact Overview
- iB. Guide for Executives and Marketing Staff
- iC. Guide for Investment Analysts and Management Consultants
- iD. Market Shares of Leading Companies - Table and Chart
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 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
- 2.0 The Coronavirus
- 2.0.1 Severe acute respiratory syndrome (SARS)
- 2.0.2 Middle East respiratory syndrome (MERS)
- 2.0.3 COVID-19. The SARS CoV 2 Virus
- 2.0.3.1 Signs and symptoms
- 2.0.3.2 Transmission
- 2.0.3.3 Diagnosis
- 2.0.3.4 Prevention
- 2.0.3.5 Management
- 2.0.3.6 Prognosis
- 2.0.3.7 New Strains and Subsequent Mutations
- 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
- 2.3.5.1 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
- 2.10 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.
- 4.1.7 Impact of the COVID-19 Pandemic.
- 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
- 4.2.6 Impact of the Pandemic Recession
- 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
- Luminex Lands BARDA Grant to Develop Test for SARS-CoV-2, Flu, RSV
- Molzym, Fraunhofer Developing Rapid Sepsis Diagnostic
- MiRxes Receives Approval for Multiplex SARS-CoV-2, Flu Test
- New Approach Involves Silicon-Based Test for Infectious Disease Screening
- Scanogen's Portable Battery Operated Instrument for 90 Minute Multiplex Test
- Qiagen sees NeuMoDx as Growth Vehicle
- Torus Biosystems Developing Syndromic Test with 30-Minute Turnaround
- Roche, SpeeDx Partner to Expand Access to Antibiotic Resistance Tests
- BioMérieux's BioFire SARS-CoV-2 Respiratory Panel Wins FDA EAU
- Infectious Disease Testing Firm Curative Acquires KorvaLabs
- ChromaCode Raises Additional $10M
- COVID-19 Patients Need Syndromic Testing
- GenMark Diagnostics - New Respiratory Panel due in June
- Qiagen Respiratory Panel with Coronavirus Targets Receives CE Mark
- Exact Diagnostics launches respiratory panel control
- bioMérieux submits enhanced BIOFIRE® BCID2 Panel to FDA
- Nanomix Receives CE Mark for Diagnostic
- Applied BioCode Applies to FDA for Syndromic Respiratory 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
- 5.1 Profiles of Key Syndromic Testing Companies
- Abacus Diagnostica
- Abbott Diagnostics
- Accelerate Diagnostics
- Ador Diagnostics
- Akonni Biosystems
- Alveo Technologies
- Applied BioCode
- Aus Diagnostics
- Beckman Coulter Diagnostics
- Becton, Dickinson and Company
- Binx Health
- Biocartis
- bioMérieux Diagnostics
- Bio-Rad Laboratories, Inc.
- Bosch Healthcare Solutions GmbH
- Cepheid (now Danaher)
- Credo Diagnostics Biomedical
- Cue Health
- Curetis N.V. / Curetis GmbH
- Diagenode Diagnostics
- Diasorin S.p.A.
- Enzo Life Sciences, Inc.
- Eurofins Scientific
- Fluxergy
- Fusion Genomics
- Genetic Signatures
- GenMark Dx
- Hibergene Diagnostics
- Hologic
- Immunexpress
- Inflammatix
- Invetech
- Janssen Diagnostics
- Karius
- Lexagene
- LightDeck Diagnostics
- Luminex Corp
- Maxim Biomedical
- Meridian Bioscience
- Mesa Biotech
- Millipore Sigma
- Mobidiag
- Nanomix
- Operon
- Oxford Nanopore Technologies
- Panagene
- Perkin Elmer
- Primerdesign
- Prominex
- Qiagen Gmbh
- Quantumdx
- Quidel
- Roche Molecular Diagnostics
- Saw Diagnostics
- Seegene
- Siemens Healthineers
- Sona Nanotech
- SpeeDx
- T2 Biosystems
- Thermo Fisher Scientific Inc
- Veramarx
- XCR Diagnostics
6. The Global Market for Syndromic Multiplex Diagnostics
- 6.1 Global Market Overview by Country
- 6.1.1 Table - Global Market by Country
- 6.1.2 Chart - Global Market by Country
- 6.2 Global Market by Syndrome - Overview
- 6.2.1 Table - Global Market by Syndrome
- 6.2.2 Chart - Global Market by Syndrome - Base/Final Year Comparison
- 6.2.3 Chart - Global Market by Syndrome - Base Year
- 6.2.4 Chart - Global Market by Syndrome - End Year
- 6.2.5 Chart - Global Market by Syndrome - Share by Year
- 6.2.6 Chart - Global Market by Syndrome - Segments Growth
- 6.3 Global Market by Place - Overview
- 6.3.1 Table - Global Market by Place
- 6.3.2 Chart - Global Market by Place - Base/Final Year Comparison
- 6.3.3 Chart - Global Market by Place - Base Year
- 6.3.4 Chart - Global Market by Place - End Year
- 6.3.5 Chart - Global Market by Place - Share by Year
- 6.3.6 Chart - Global Market by Place - Segments Growth
7. Global Syndromic Multiplex Markets - By Syndrome
- 7.1 Respiratory
- 7.1.1 Table Respiratory - by Country
- 7.1.2 Chart - Respiratory Growth
- 7.2 Gastrointestinal
- 7.2.1 Table Gastrointestinal - by Country
- 7.2.2 Chart - Gastrointestinal Growth
- 7.3 Blood
- 7.3.1 Table Blood - by Country
- 7.3.2 Chart - Blood Growth
- 7.4 Meningitis/Encephalitis
- 7.4.1 Table Meningitis/Encephalitis - by Country
- 7.4.2 Chart - Meningitis/Encephalitis Growth
- 7.5 Sexually Transmitted Disease
- 7.5.1 Table Sexually Transmitted Disease - by Country
- 7.5.2 Chart - Sexually Transmitted Disease Growth
- 7.6 Other
- 7.6.1 Table Other - by Country
- 7.6.2 Chart - Other Growth
8. Global MDx Infectious Disease Markets - by Place
- 8.1 Hospital Lab
- 8.1.1 Table Hospital Lab - by Country
- 8.1.2 Chart - Hospital Lab Growth
- 8.2 Outpatient Lab
- 8.2.1 Table Outpatient Lab - by Country
- 8.2.2 Chart - Outpatient Lab Growth
- 8.3 POC
- 8.3.1 Table POC - by Country
- 8.3.2 Chart - POC Growth
- 8.4 Other Technology
- 8.4.1 Table Other - by Country
- 8.4.2 Chart - Other Growth
Appendices
- I. United States Medicare System: 2021 Clinical Laboratory Fees Schedule