Molecular Diagnostics for Infectious Disease By Syndrome, Plex, Place and by Country. With Analysis and Executive Guides 2024 - 2028

1.1 Strategic Situation Analysis
1.2 Guide for Executives and Business Development Staff
1.3 Guide for Management Consultants and Investment Advisors

2.1 What are Molecular Diagnostics?
2.2 The Diagnostics Revolution
2.3 Market Definition
2.3.1 Revenues
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

3.1 HIV - Human Immunodeficiency Virus (AIDS)
3.1.1 Virology
3.1.1.1 Classification
3.1.1.2 Structure and genome
3.1.1.3 Tropism
3.1.1.4 Replication cycle
3.1.1.5 Genetic variability
3.1.2 Diagnosis
3.1.3 Testing
3.1.3.1 Antibody tests
3.1.3.2 Point of Care Tests (POCT)
3.1.3.3 Antigen Tests
3.1.3.4 Nucleic acid-based tests (NAT)
3.1.3.5 Other tests used in HIV treatment
3.1.4 Market Opportunity Analysis
3.2 HBV - Hepatitis B
3.2.1 Virology
3.2.1.1 Genome
3.2.1.2 Pathogenesis
3.2.1.3 Hepatitis B virus replication
3.2.1.4 Serotypes and genotypes
3.2.2 Mechanisms
3.2.3 Diagnosis
3.2.4 Market Opportunity Analysis
3.3 HCV - Hepatitis C
3.3.1 Taxonomy
3.3.2 Structure
3.3.2.1 Genome
3.3.3 Molecular biology
3.3.4 Replication
3.3.5 Genotypes
3.3.5.1 Clinical importance
3.3.6 Market Opportunity Analysis
3.4 HPV - Human papillomavirus
3.4.1 Virology
3.4.1.1 E6/E7 proteins
3.4.1.2 Role in Cancer
3.4.1.3 E2 research
3.4.1.4 Latency period
3.4.1.5 Clearance
3.4.2 Diagnosis
3.4.2.1 Cervical testing
3.4.2.2 Oral testing
3.4.2.3 Testing men
3.4.2.4 Other testing
3.4.3 Market Opportunity Analysis
3.5 Influenza
3.5.1 Virology
3.5.1.1 Types of virus
3.5.1.2 Influenzavirus A
3.5.1.3 Influenzavirus B
3.5.1.4 Influenzavirus C
3.5.1.5 Structure, properties, and subtype nomenclature
3.5.1.6 Replication
3.5.2 Testing
3.5.2.1 Advantages/Disadvantages of Molecular Assays
3.5.3 Market Opportunity Analysis
3.6 CTGC - Chlamydia/Gonorhea
3.6.1 Gonorrhea
3.6.1.1 Diagnosis
3.6.1.2 Screening
3.6.2 Chlamydia
3.6.2.1 Diagnosis
3.6.2.2 Screening
3.6.3 Testing
3.6.3.1 Nucleic acid amplification tests (NAATs).
3.6.3.2 Performance of NAAT Tests
3.6.4 Market Opportunity Analysis
3.7 Tuberculosis
3.7.1 Mycobacteria
3.7.2 Diagnosis
3.7.2.1 Active tuberculosis
3.7.2.2 Latent tuberculosis
3.7.3 Epidemiology
3.7.4 Molecular Diagnostic Tests
3.7.5 Market Opportunity Analysis
3.8 MRSA - Methicillin-resistant Staphylococcus aureus
3.8.1 Diagnosis
3.8.2 FDA Approved Molecular Tests
3.8.3 Market Opportunity Analysis
3.9 VRE - Vancomycin-resistant Enterococcus
3.9.1 FDA-Approved MDx Tests for VRE
3.9.2 Market Opportunity Analysis
3.10 Blood Screening
3.10.1 Collection and Testing
3.10.2 FDA Approved Multiplex Assays
3.10.3 Market Opportunity Analysis
3.11 COVID-19
3.11.1 Signs and symptoms
3.11.2 Transmission
3.11.3 Diagnosis
3.11.4 Prevention
3.11.5 Management
3.11.6 Prognosis
3.12 Pandemic Diagnostics
3.12.1 Risk Management - Spark and Spread
3.12.2 Dx Technology - Nucleic Acid-Based
3.12.3 Dx Technology - Immunoassay & Serology
3.12.4 Time to Market and Preparedness Issues
3.12.5 Unrecognized Role of Multiplex in Pandemic Management

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
4.3 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 Physicians and POCT

5.1 1928 Diagnostics
5.2 Abacus Diagnostica
5.3 Abbott Laboratories
5.4 Accelerate Diagnostics
5.5 Access Bio
5.6 Ador Diagnostics
5.7 ADT Biotech
5.8 Akonni Biosystems
5.9 Altona Diagnostics
5.10 Alveo Technologies
5.11 Anatolia Geneworks
5.12 Anitoa
5.13 Antelope Dx
5.14 Applied BioCode
5.15 Assurance Scientific Laboratories
5.16 Aureum Diagnostics
5.17 Aus Diagnostics
5.18 Beckman Coulter Diagnostics
5.19 Becton, Dickinson, and Company
5.20 Binx Health
5.21 Biocartis
5.22 BioFire Diagnostics (bioMérieux)
5.23 bioMérieux Diagnostics
5.24 Bio-Rad Laboratories, Inc
5.25 Bosch Healthcare Solutions GmbH
5.26 Celemics
5.27 Cepheid (Danaher)
5.28 Chembio
5.29 Co-Diagnostics
5.30 Credo Diagnostics Biomedical
5.31 Cue Health
5.32 Curetis N.V. / Curetis GmbH
5.33 Detect
5.34 Diagenode Diagnostics
5.35 Diascopic
5.36 Diasorin S.p.A.
5.37 Domus Diagnostics
5.38 Eiken Chemical
5.39 Element Biosciences
5.40 Enzo Biochem
5.41 Eurofins Scientific
5.42 Fluxergy
5.43 Fulgent Genetics
5.44 Fusion Genomics.
5.45 Genedrive
5.46 Genetic Signatures
5.47 GenMark Dx (Roche)
5.48 Genomadix
5.49 Grifols
5.50 Grip Molecular Technologies
5.51 Hibergene Diagnostics
5.52 Hologic
5.53 Illumina
5.54 Immunexpress
5.55 Inflammatix
5.56 Invetech
5.57 Janssen Diagnostics
5.58 Karius
5.59 Lexagene
5.60 LightDeck Diagnostics
5.61 Lucira Health
5.62 Luminex Corp (DiaSorin)
5.63 LumiraDx
5.64 Lumos Diagnostics
5.65 Mammoth Biosciences
5.66 Maxim Biomedical
5.67 Meridian Bioscience
5.68 Mesa Biotech (Thermo Fisher)
5.69 MicroGem
5.70 Millipore Sigma
5.71 Mindray
5.72 Minute Molecular
5.73 Mobidiag (Hologic)
5.74 Molbio Diagnostics
5.75 NanoDx
5.76 Nanomix
5.77 Novacyt
5.78 Novel Microdevices
5.79 OnsiteGene
5.80 Operon
5.81 Oxford Nanopore Technologies
5.82 Panagene
5.83 Pathogenomix
5.84 Perkin Elmer
5.85 Prenetics
5.86 Primerdesign (Novacyt)
5.87 Promises
5.88 Proof Diagnostics
5.89 Qiagen
5.90 QuantuMDx
5.91 Quest Diagnostics
5.92 QuidelOrtho
5.93 Randox Toxicology
5.94 Roche Molecular Diagnostics
5.95 Saw Diagnostics
5.96 Scope Fluidics
5.97 SD Biosensor
5.98 Seegene
5.99 Siemens Healthineers
5.100 Singular Genomics
5.101 SomaLogic
5.102 Sona Nanotech
5.103 SpeeDx
5.104 T2 Biosystems
5.105 Talis Biomedical
5.106 Thermo Fisher Scientific Inc.
5.107 Ultima Genomics
5.108 Vela Diagnostics
5.109 Veramarx
5.110 Veredus Laboratories
5.111 Vir
5.112 Vircell
5.113 Visby Medical
5.114 XCR Diagnostics
5.115 YD Diagnostics
5.116 Zhejiang Orient Gene Biotech

6.1 Factors Driving Growth
6.1.1 New Genotypes Creating New Markets
6.1.2 The Aging Effect
6.1.3 Developing World Driving ID Dx Growth
6.1.4 Point of Care - Why Centralization is Losing Steam
6.1.5 Self Testing
6.1.6 The Need for Speed
6.1.7 The COVID Pandemic
6.2 Factors Limiting Growth
6.2.1 Lower Costs
6.2.2 Infectious Disease is Declining
6.2.3 Wellness Hurts
6.2.4 Economic Growth improves Living Standards
6.3 Instrumentation and Automation
6.3.1 Instruments Key to Market Share
6.3.2 The Shrinking Machine
6.3.3 Multiplex, Point of Care, and The Speed Factor
6.4 Diagnostic Technology Development
6.4.1 The Sepsis Testing Market - A New Direction?
6.4.2 POCT/Self Testing as a Disruptive Force
6.4.3 The Genetics Play - One Test for All Known Infections
6.4.4 Antibiotic Resistance Genes - Simplifying Diagnostics

7.1 Recent Developments - Importance and How to Use This Section
7.1.1 Importance of These Developments
7.1.2 How to Use This Section
7.2 Binx Health Refocuses on POC STD Testing
7.3 LetsGetChecked Authorized for STD Test
7.4 Genetic Signatures Applies for GI Parasite Detection Kit
7.5 Sensible Diagnostics Nabs Award for Respiratory Panel
7.6 Post-Pandemic Changes Landscape of ID Dx
7.7 Multiplex Meningitis/Encephalitis Panel Market Expanding
7.8 Sensible Diagnostics to Launch 10-Minute POC PCR System
7.9 ReadyGo Dx Emerges From Stealth With MDx Plan
7.10 BioMérieux, Oxford Nanopore Form ID Dx Pact
7.11 SD Biosensor Eyes Global Expansion for Rapid MDx System
7.12 Compact POCT Platform Unlocks Multiplexing Potential of Real-Time PCR
7.13 Takara Bio and BioExcel Partner on ID Panels
7.14 BioGX introduces pixl real-time PCR platform
7.15 Sherlock Biosciences Improves ID Dx Toolkit
7.16 Climate change is making hundreds of diseases much worse
7.17 BioMérieux Invests in Sepsis Dx Startup Weezion
7.18 Domus Diagnostics to Launch POC MDx Test System
7.19 Proof Dx Plans Infectious Disease, Oncology Tests for CRISPR-Based POC
7.20 Oxford Nanopore Diagnostics to Develop Clinical Tools
7.21 Pathogenomix Developing Infectious Disease Platform Using NGS
7.22 COVID-19 Accelerating Trend Toward Pharmacy-Based Testing
7.23 Co-Diagnostics Seeks FDA EUA for At-Home PCR Diagnostic
7.24 Sense Biodetection to Debut Instrument-Free Point-of-Care MDx
7.25 Home Test Company Prenetics to go Public
7.26 Roche to Acquire TIB Molbiol to Expand Infectious Disease Portfolio
7.27 Lucira Health Posts Revenue Growth on OTC C19 Test
7.28 BforCure Preparing Multiple Panels for Point-of-Care qPCR Platform
7.29 Talis Biomedical Discusses Point-of-Care
7.30 Roche to Acquire GenMark Diagnostics for $1.8B
7.31 Pandemic Pushes Handheld qPCR Devices Closer to Commercialization
7.32 Hologic to Acquire Mobidiag
7.33 Lucira Health Focuses on User Friendly Approach to Home Testing
7.34 Infectious Disease Dx Firm Talis Biomedical Raises $254M in IPO
7.35 Fluidigm Plans 'Durable' Diagnostics, Clinical Business
7.36 Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M
7.37 Mammoth Biosciences Developing Pathogen Detection Tech
7.38 Illumina, IDbyDNA Developing Sequencing-Based Respiratory Tests
7.39 Scanogen Developing 90 Minute Infection Test
7.40 Malaria Assays Use CRISPR for Point-of-Care Multispecies Detection
7.41 FDA Provides Self Testing SARS-CoV-2 EAU Guidance
7.42 Mammoth Biosciences Announces Rapid, CRISPR-Based COVID-19 Diagnostic
7.43 Genetic Signatures Gets CE Mark for Coronavirus Molecular Test
7.44 Qiagen Respiratory Panel with Coronavirus Receives CE Mark
7.45 Lumos Diagnostics Closes $15M Series A Funding
7.46 Fusion Genomics to Assess NGS-Based Respiratory Tract Infection Assay

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 Plex - Overview
8.3.1 Table - Global Market by Plex
8.3.2 Chart - Global Market by Plex - Base/Final Year Comparison
8.3.3 Chart - Global Market by Plex - Base Year
8.3.4 Chart - Global Market by Plex - End Year
8.3.5 Chart - Global Market by Plex - Share by Year
8.3.6 Chart - Global Market by Plex - Segments Growth
8.4 Global Market by Place - Overview
8.4.1 Table - Global Market by Place
8.4.2 Chart - Global Market by Place - Base/Final Year Comparison
8.4.3 Chart - Global Market by Place - Base Year
8.4.4 Chart - Global Market by Place - End Year
8.4.5 Chart - Global Market by Place - Share by Year
8.4.6 Chart - Global Market by Place - Segments Growth

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
9.6.1 Table Other - by Country
9.6.2 Chart - Other Growth

10.1 Single Plex
10.1.1 Table Single Plex - by Country
10.1.2 Chart - Single Plex Growth
10.2 Duplex
10.2.1 Table Duplex - by Country
10.2.2 Chart - Duplex Growth
10.3 Triplex
10.3.1 Table Triplex - by Country
10.3.2 Chart - Triplex Growth
10.4 Multiplex Technology
10.4.1 Table Multiplex - by Country
10.4.2 Chart - Multiplex Growth

11.1 Hospital Lab
11.1.1 Table Hospital Lab - by Country
11.1.2 Chart - Hospital Lab Growth
11.2 Outpatient Lab
11.2.1 Table Outpatient Lab - by Country
11.2.2 Chart - Outpatient Lab Growth
11.3 POC
11.3.1 Table POC - by Country
11.3.2 Chart - POC Growth
11.4 Other Place
11.4.1 Table Other Place- by Country
11.4.2 Chart - Other Place Growth

12.1 United States Medicare System: Clinical Laboratory Fees Schedule
12.2 The Most Used IVD Assays
12.3 The Highest Grossing Assays

Table 1 Classification of HIV Species
Table 2 HIV Tests - CMS Codes & Prices
Table 3 Current HIV Molecular Tests and Instruments Used
Table 4 HBV Tests - CMS Codes & Prices
Table 5 HCV Tests - CMS Codes & Prices
Table 6 HPV Clearance Rates
Table 7 HPV Tests - CMS Codes & Prices
Table 8 HPV Tests, Technology, Types
Table 9 Types of Influenza Tests
Table 10 Influenza Tests - CMS Codes & Prices
Table 11 FDA Cleared Molecular Assays for Influenza
Table 12 FDA Cleared NAAT CTGC Tests
Table 13 CTGC NAAT Target Sequences and Possible False Reactions
Table 14 CTGC Tests - CMS Codes & Prices
Table 15 FDA Approved MDx Tests for Tuberculosis
Table 16 Tuberculosis Tests - CMS Codes & Prices
Table 17 FDA Approved Tests for MRSA
Table 18 MRSA Tests - CMS Codes & Prices
Table 19 FDA Approved Tests for VRE
Table 20 VRE Tests - CMS Codes & Prices
Table 21 FDA Approved Multiplex Assays
Table 22 Characteristics of Coronavirus Pandemic Infections
Table 23 COVID-19 Symptoms
Table 24 Market Players by Type
Table 25 Clinical Laboratory Departments and Segments
Table 26 Laboratory Management Focus - Different Approaches
Table 27 Key Segmentation Variables Going Forward
Table 28 Five Factors Driving Growth
Table 29 Four Factors Limiting Growth
Table 30 Key Diagnostic Laboratory Technology Trends
Table 31 - Global Market by Region
Table 32 Global Market by Syndrome
Table 33 Global Market by Plex
Table 34 Global Market by Place
Table 35 Respiratory by Country
Table 36 Gastrointestinal by Country
Table 37 Blood by Country
Table 38 Meningitis/Encephalitis by Country
Table 39 Sexually Transmitted Disease by Country
Table 40 Other by Country
Table 41 Single Plex by Country
Table 42 Duplex by Country
Table 43 Triplex by Country
Table 44 Multiplex by Country
Table 45 Hospital Lab by Country
Table 46 Outpatient Lab by Country
Table 47 POC by Country
Table 48 Other Place by Country
Table 49 Clinical Lab Fee Schedule
Table 50 The Most Common Assays
Table 51 Largest Revenue Assays

Figure 1 Global Healthcare Spending
Figure 2 The Lab Test Pie
Figure 3 HIV Virion
Figure 4 Diagram of the HIV Replication Cycle
Figure 5 The Structure of the HBV Virus
Figure 6 Hepatitis B Replication
Figure 7 Structure of the HCV Virus
Figure 8 HCV Replication Cycle
Figure 9 Structure of the Influenza Virion
Figure 10 Influenza Replication
Figure 11 Scanning Electron micrograph of Tuberculosis
Figure 12 The Road to Diagnostics
Figure 13 The Changing Age of The World’s Population
Figure 14 Health Care Consumption by Age
Figure 15 Cancer Incidence by Age
Figure 16 Chart Infectious Disease Decline
Figure 17 Global Market Shares Chart
Figure 18 Global Market by Syndrome - Base vs. Final
Figure 19 Global Market by Syndrome Base Year
Figure 20 Global Market by Syndrome End Year
Figure 21 Syndrome Share by Year
Figure 22 Syndrome Segments Growth
Figure 23 Global Market by Plex - Base vs. Final
Figure 24 Global Market by Plex Base Year
Figure 25 Global Market by Plex End Year
Figure 26 Plex Share by Year
Figure 27 Plex Segments Growth
Figure 28 Global Market by Place - Base vs. Final
Figure 29 Global Market by Place Base Year
Figure 30 Global Market by Place End Year
Figure 31 Place Share by Year
Figure 32 Place Segments Growth
Figure 33 Respiratory Growth
Figure 34 Gastrointestinal Diagnostics Growth
Figure 35 Blood Growth
Figure 36 Meningitis/Encephalitis Growth
Figure 37 Sexually Transmitted Disease Growth
Figure 38 Other Growth
Figure 39 Single Plex Growth
Figure 40 Duplex Growth
Figure 41 Triplex Growth
Figure 42 Multiplex Growth
Figure 43 Hospital Lab Growth
Figure 44 Outpatient Lab Growth
Figure 45 POC Growth
Figure 46 Other Place Growth