OVERVIEW:
COVID-19 Drives a surge in demand but what is the long term impact? The microbiology lab my disappear while multiplex takes center stage.
The Molecular Diagnostics - Infectious Disease sector of the clinical diagnostics industry is poised for record growth. A market that just keeps on growing but is spiking as an enormous C19Dx demand sweeps over the globe. Find out what the numbers are in this informative report. And find out about the exciting developments in multiplex assays which threaten to change diagnosis and treatment while limiting the threat of anti microbial drug resistance.
Infectious disease testing directly benefits from the explosion in biotechnology, especially genomics. Learn all about it in this new report from Howe Sound Research. A range of dynamic trends are pushing market growth and company valuations.
Trends like ......
- Multiplex testing
- pathogen evolution and pandemics
- biotechnology advances in genetics
- climate change
- globalization
- the rise of rapid testing
Exciting technical developments especially in the seesaw between nucleic acid testing and immunoassay, hold the promise of a dynamic, growing and evolving world market that holds the promise of diagnostics taking the lead in infectious disease eradication.
All report data is available in Excel format on request.
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. Molecular Diagnostics of Infectious Disease - Strategic Situation Analysis and Impact of COVID-19.
ii. Guide for Executives, Marketing, Sales and Business Development Staff
iii. Guide for Management Consultants and Investment Advisors
1. Introduction and Market Definition
- 1.1 What is Molecular Diagnostics
- 1.2 The Diagnostics Revolution
- 1.3 Market Definition
- 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 - Market Analysis by Disease
- 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
- 2.1.4 Market Opportunity Analysis
- 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 Structure
- 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 Blood Screening
- 2.10.1 Collection and Testing
- 2.10.2 FDA Approved Multiplex Assays
- 2.10.3 Market Opportunity Analysis
- 2.11 COVID-19
- 2.11.1 Signs and symptoms
- 2.11.2 Transmission
- 2.11.3 Diagnosis
- 2.11.4 Prevention
- 2.11.5 Management
- 2.11.6 Prognosis
- 2.12 Pandemic Diagnostics
- 2.12.1 Risk Management - Spark and Spread
- 2.12.2 Dx Technology - Nucleic Acid Based
- 2.12.3 Dx Technology - Immunoassay & Serology
- 2.12.4 Time to Market and Preparedness Issues
- 2.12.5 Unrecognized Role of Multiplex in Pandemic Mangement
3. Industry Overview
- 3.1 Players in a Dynamic Market
- 3.1.1 Academic Research Lab
- 3.1.2 Diagnostic Test Developer
- 3.1.3 Instrumentation Supplier
- 3.1.4 Distributor and Reagent Supplier
- 3.1.5 Independent Testing Lab
- 3.1.6 Public National/regional lab
- 3.1.7 Hospital lab
- 3.1.8 Physician Office Labs
- 3.1.9 Audit Body
- 3.1.10 Certification Body
- 3.2 The Clinical Laboratory Market Segments
- 3.2.1 Traditional Market Segmentation
- 3.2.2 Laboratory Focus and Segmentation
- 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
- 3.4 Profiles of Key MDx Companies
- Abbott Diagnostics
- Accelerate Diagnostics
- Ador Diagnostics
- Akonni Biosystems
- Alveo Technologies
- Applied BioCode
- Atlas Genetics
- Aus Diagnostics
- BD Diagnostics
- Beckman Coulter
- Biocartis
- bioMérieux
- Bio-Rad Laboratories
- Bosch Healthcare Solutions GmbH
- Cepheid
- Chembio
- Curetis
- Diagenode Diagnostics
- DiaSorin
- Eiken Chemical
- Fusion Genomics.
- Genedrive
- GenePOC Diagnostics
- GenMark Dx
- Grifols
- Hologic
- Illumina
- Inflammatix
- Janssen Diagnostics
- Karius
- Lexagene
- Luminex
- Mbio Diagnostics
- Meridian Bioscience
- Mesa Biotech
- Mobidiag
- Nanomix
- Oxford Nanopore Technologies
- Panagene
- Primerdesign
- Prominex
- Qiagen
- Quantumdx
- Quidel
- Roche Molecular Diagnostics
- Seegene
- Siemens Healthineers
- T2 Biosystems
- Thermo Fisher
- Veramarx
- XCR Diagnostics
4. Market Trends
- 4.1 Factors Driving Growth
- 4.1.1 New Genotypes Creating New Markets
- 4.1.2 Aging Population a Boon for All Diagnostics
- 4.1.3 Developing World Driving ID Dx Growth
- 4.1.4 Point of Care - Why Centralization is Losing Steam
- 4.1.5 Self Testing
- 4.1.6 The Need for Speed
- 4.2 Factors Limiting Growth
- 4.2.1 Lower Costs
- 4.2.2 Infectious Disease is Declining
- 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.
- 4.3.2 Multiplex, Point of Care and The Speed Factor
- 4.4 Diagnostic Technology Development
- 4.4.1 The Sepsis Testing Market - A New Direction?
- 4.4.2 POCT/Self Testing as a Disruptive Force
- 4.4.3 The Genetics Play - One Test for All Known Infections
- 4.4.4 Antibiotic Resistance Genes - Simplifying Diagnostics
5. Molecular Dx - Infectious Disease Recent Developments
- Recent Developments - Importance and How to Use This Section
- Importance of These Developments
- How to Use This Section
- FDA Provides Self Testing SARS-CoV-2 EAU Guidance
- Mammoth Biosciences Announces Rapid, CRISPR-Based COVID-19 Diagnostic
- Genetic Signatures Gets CE Mark for Coronavirus Molecular Test
- Qiagen Respiratory Panel with Coronavirus Receives CE Mark
- Lumos Diagnostics Closes $15M Series A Funding
- Fusion Genomics to Assess NGS-Based Respiratory Tract Infection Assay
- New Genomic Tests Diagnose Deadly Infections Faster
- Biotia Raises $2.4M Seed Round
- STDs resurge in US
- Ares Genetics signs R&D agreement with leading global IVD corporation
- Cell-Free DNA Used for Infectious Disease Testing
- One BioMed Raises $5M
- FDA grants Qiagen clearance for syndromic testing system
- iCubate, Wondfo Biotech Form Chinese JV to Develop MDx Assays
- Researchers Launch CRISPR Dx Firm Sherlock Biosciences
- Israel's BATM to Invest up to $30M in Ador Diagnostics
- Superbug Test from Mobidiag Gets CE Mark
- Akonni Biosystems Submits Multiplex Diagnostics System to FDA
- Mesa Biotech RSV Test Wins CE Mark
- Karius Test to Be Available in Brazil
- Panagene's STD kit gains Approval
- Startup Prominex Raises $4M in Series A1
- GenePOC's Investment Validated by Medicare Decision
- GenePOC® launches its GenePOC® CDiff test in Canada
- NYU researchers adapt HIV test to Zika virus
- GA-EMS receives diagnostic device contract
- Biocartis & Immunexpress Sign Partnership for Sepsis
- PerkinElmer to Acquire Euroimmun for $1.3B
- Alveo Closes Financing to Create Accessible Diagnostics Devices
- Siemens Healthineers completes takeover of Fast Track Diagnostics
- Sekisui Diagnostics Enters Strategic Alliance with Mesa Biotech Inc
- Chembio and FIND to Develop Point-of-Care Multiplex Test
- Locus Biosciences and IDbyDNA Partner to Develop Companion Diagnostic Test
- Alere bags FDA nod for rapid flu diagnostic
- FDA approves tests of tick-borne disease to protect blood supply
- Qiagen Trichomonas Assay Gets CE Mark
- Vela Diagnostics HSV Test Gets FDA Clearance
- QIAGEN enters into agreement to acquire STAT-Dx
- Bruker to Acquire Majority Stake in Infectious Disease MDx Firm Hain
- Applied BioCode's Syndromic Gastrointestinal Pathogen Panel Approved by the FDA
- Ares Genetics to develop AI diagnostic test for infectious diseases
- FDA Considers Guidelines for NGS-Based Infectious Disease Diagnostics
6. The Global Market for Molecular Diagnostics Infectious Disease
- 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 Plex - Overview
- 6.3.1 Table - Global Market by Plex
- 6.3.2 Chart - Global Market by Plex - Base/Final Year Comparison
- 6.3.3 Chart - Global Market by Plex - Base Year
- 6.3.4 Chart - Global Market by Plex - End Year
- 6.3.5 Chart - Global Market by Plex - Share by Year
- 6.3.6 Chart - Global Market by Plex - Segments Growth
- 6.4 Global Market by Place - Overview
- 6.4.1 Table - Global Market by Place
- 6.4.2 Chart - Global Market by Place - Base/Final Year Comparison
- 6.4.3 Chart - Global Market by Place - Base Year
- 6.4.4 Chart - Global Market by Place - End Year
- 6.4.5 Chart - Global Market by Place - Share by Year
- 6.4.6 Chart - Global Market by Place - Segments Growth
7. Global MDx Infectious Disease 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 Markets for Infectious Disease - by Plex
- 8.1 Single Plex
- 8.1.1 Table Single Plex - by Country
- 8.1.2 Chart - Single Plex Growth
- 8.2 Duplex
- 8.2.1 Table Duplex - by Country
- 8.2.2 Chart - Duplex Growth
- 8.3 Triplex
- 8.3.1 Table Triplex - by Country
- 8.3.2 Chart - Triplex Growth
- 8.4 Multiplex Technology
- 8.4.1 Table Multiplex - by Country
- 8.4.2 Chart - Multiplex Growth
9. Global MDx Infectious Disease Markets - by Place
- 9.1 Hospital Lab
- 9.1.1 Table Hospital Lab - by Country
- 9.1.2 Chart - Hospital Lab Growth
- 9.2 Outpatient Lab
- 9.2.1 Table Outpatient Lab - by Country
- 9.2.2 Chart - Outpatient Lab Growth
- 9.3 POC
- 9.3.1 Table POC - by Country
- 9.3.2 Chart - POC Growth
- 9.4 Other Technology
- 9.4.1 Table Other - by Country
- 9.4.2 Chart - Other Growth
Appendices
- I. United States Medicare System: 2020 Clinical Laboratory Fees Schedule
- II. COVID-19 Approved Assays