Molecular Diagnostics for Infectious Disease By Syndrome, Plex, Place and by Country. With COVID-19 Impact & Forecasting/Analysis, and Executive Guides and Customization 2021 - 2025
Report 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.
The report has hundreds of pages of information including a complete list of Current 2020 United States Medicare Fee Payment Schedules to help sharpen your pricing. Again, assistance in using the information is normally provided without additional charges. The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report.
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- 1. Introduction and Market Definition
- 1.1 What is Molecular Diagnostics
- 1.2 The Diagnostics Revolution
- 1.3 Market Definition
- 1.3.1 Revenues
- 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
- 2.3.2.2 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 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
- SpeeDx
- 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
- 4.1.7 The COVID Pandemic
- 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
- Scanogen Developing 90 Minute Infection Test
- Malaria Assays Use CRISPR for Point-of-Care Multispecies Detection
- 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
- 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
- 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
- Table of Tables
- Table 1 Medicare Clinical Lab Expenditures Actual & Forecast 2014 to 2024 ($Billion)
- Table 2 Classification of HIV Species
- Table 3 HIV Tests - CMS Codes & Prices
- Table 4 Current HIV Molecular Tests and Instruments Used
- Table 5 HBV Tests - CMS Codes & Prices
- Table 6 HCV Tests - CMS Codes & Prices
- Table 7 HPV Clearance Rates
- Table 8 HPV Tests - CMS Codes & Prices
- Table 9 HPV Tests, Technology, Types
- Table 10 Types of Influenza Tests
- Table 11 Influenza Tests - CMS Codes & Prices
- Table 12 FDA Cleared Molecular Assays for Influenza
- Table 13 FDA Cleared NAAT CTGC Tests
- Table 14 CTGC NAAT Target Sequences and Possible False Reactions
- Table 15 CTGC Tests - CMS Codes & Prices
- Table 16 FDA Approved MDx Tests for Tuberculosis
- Table 17 Tuberculosis Tests - CMS Codes & Prices
- Table 18 FDA Approved Tests for MRSA
- Table 19 MRSA Tests - CMS Codes & Prices
- Table 20 FDA Approved Tests for VRE
- Table 21 VRE Tests - CMS Codes & Prices
- Table 22 FDA Approved Multiplex Assays
- Table 23 Characteristics of Coronavirus Pandemic Infections
- Table 24 COVID-19 Symptoms
- Table 25 Market Players by Type
- Table 26 Clinical Laboratory Departments and Segments
- Table 27 Laboratory Management Focus – Different Approaches
- Table 28 Key Segmentation Variables Going Forward
- Table 29 Five Factors Driving Growth
- Table 30 Four Factors Limiting Growth
- Table 31 Key Diagnostic Laboratory Technology Trends
- Table 32 - Global Market by Region
- Table 33 Global Market by Syndrome
- Table 34 Global Market by Plex
- Table 35 Global Market by Place
- Table 36 Respiratory by Country
- Table 37 Gastrointestinal by Country
- Table 38 Blood by Country
- Table 39 Meningitis/Encephalitis by Country
- Table 40 Sexually Transmitted Disease by Country
- Table 41 Other by Country
- Table 42 Single Plex by Country
- Table 43 Duplex by Country
- Table 44 Triplex by Country
- Table 45 Multiplex by Country
- Table 46 Hospital Lab by Country
- Table 47 Outpatient Lab by Country
- Table 48 POC by Country
- Table 49 Other by Country
- Table 50 2020 Clinical Lab Fee Schedule
- Table 51 COVID -19 Approved Assays
- Table of Figures
- Figure 1 Medicare Clinical Lab Expenditures 2014 to 2024 ($Million)
- Figure 2 HIV Virion
- Figure 3 Diagram of the HIV Replication Cycle
- Figure 4 The Structure of the HBV Virus
- Figure 5 Hepatitis B Replication
- Figure 6 Structure of the HCV Virus
- Figure 7 HCV Replication Cycle
- Figure 8 Structure of the Influenza Virion
- Figure 9 Influenza Replication
- Figure 10 Scanning Electronmicrograph of Tuberculosis
- Figure 11 Percentage of World Population Over 65
- Figure 12 Chart Infectious Disease Decline
- Figure 13 Global Market Shares Chart
- Figure 14 Global Market by Syndrome - Base vs. Final
- Figure 15 Global Market by Syndrome Base Year
- Figure 16 Global Market by Syndrome End Year
- Figure 17 Syndrome Share by Year
- Figure 18 Syndrome Segments Growth
- Figure 19 Global Market by Plex - Base vs. Final
- Figure 20 Global Market by Plex Base Year
- Figure 21 Global Market by Plex End Year
- Figure 22 Plex Share by Year
- Figure 23 Plex Segments Growth
- Figure 24 Global Market by Place - Base vs. Final
- Figure 25 Global Market by Place Base Year
- Figure 26 Global Market by Place End Year
- Figure 27 Place Share by Year
- Figure 28 Place Segments Growth
- Figure 29 Respiratory Growth
- Figure 30 Gastrointestinal Diagnostics Growth
- Figure 31 Blood Growth
- Figure 32 Meningitis/Encephalitis Growth
- Figure 33 Sexually Transmitted Disease Growth
- Figure 34 Other Growth
- Figure 35 Single Plex Growth
- Figure 36 Duplex Growth
- Figure 37 Triplex Growth
- Figure 38 Multiplex Growth
- Figure 39 Hospital Lab Growth
- Figure 40 Outpatient Lab Growth
- Figure 41 POC Growth
- Figure 42 Other Growth