Life SciencesDiagnosticsIn Vitro DiagnosticsMolecular Diagnostics

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

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from $6,995 445 Pages Howe Sound Research November, 2020 HSR16400430
Lowest Prices Guaranteed
Price from $6,995
Length 445 Pages
Publisher Howe Sound Research
Published Date November, 2020
SKU HSR16400430

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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All report data is available in Excel format on request.


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

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