Clinical Laboratory Molecular Diagnostics for Infectious Disease Markets. Strategies and Trends. Forecasts by Application (Transplant, Respiratory, etc.) by Country. With Market Analysis & Executive Guides. 2023 to 2027

The Molecular Diagnostics - Infectious Disease sector of the clinical diagnostics industry is poised for further growth. A market that just keeps on growing but is becoming more complex and segmented. Find out what's happening in this informative report. And find out about the impact of multiplex assays which threaten to change diagnosis and treatment forever.

Infectious disease testing directly benefits from the explosion in biotechnology, especially genomics. Learn all about it in this new report. 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

1 Market Guides

1.1 Situation Analysis
1.2 Market Shares of Leading Companies - Table and Chart

2 Introduction and Market Definition

2.1 Market Definition
- 2.1.1 Market Size
- 2.1.2 Currency
- 2.1.3 Years
2.2 Methodology
- 2.2.1 Methodology
- 2.2.2 Sources
- 2.2.3 Authors
2.3 Perspective: Healthcare and the IVD Industry
- 2.3.1 Global Healthcare Spending
- 2.3.2 Spending on Diagnostics
- 2.3.3 Important Role of Insurance for Diagnostics

3 The Infectious Diseases - Guide to the Pathogens

3.1 Infectious Disease Pathogens - The Big Picture
- 3.1.1 Viruses
- 3.1.2 Bacteria
- 3.1.3 Fungi
- 3.1.4 Parasites
- 3.1.5 Prions
- 3.1.6 Virulence
- 3.1.7 Transmission
3.2 The Coronavirus
- 3.2.1 Severe acute respiratory syndrome (SARS)
- 3.2.2 Middle East respiratory syndrome (MERS)
- 3.2.3 COVID-19. The SARS CoV 2 Virus.
  - 3.2.3.1 Signs and symptoms
  - 3.2.3.2 Transmission
  - 3.2.3.3 Diagnosis
  - 3.2.3.4 Prevention
  - 3.2.3.5 Management
  - 3.2.3.6 Prognosis
3.4 HIV - Human Immunodeficiency Virus (AIDS)
- 3.4.1 Virology
  - 3.4.1.1 Classification
  - 3.4.1.2 Structure and genome
  - 3.4.1.3 Tropism
  - 3.4.1.4 Replication cycle
  - 3.4.1.5 Genetic variability
- 3.4.2 Diagnosis
- 3.4.3 Testing
  - 3.4.3.1 Antibody tests
  - 3.4.3.2 Point of Care Tests (POCT)
  - 3.4.3.3 Antigen Tests
  - 3.4.3.4 Nucleic acid-based tests (NAT)
  - 3.4.3.5 Other tests used in HIV treatment
3.5 HBV - Hepatitis B
- 3.5.1 Virology
  - 3.5.1.1 Genome
  - 3.5.1.2 Pathogenesis
  - 3.5.1.3 Hepatitis B virus replication
  - 3.5.1.4 Serotypes and genotypes
- 3.5.2 Mechanisms
- 3.5.3 Diagnosis
- 3.5.4 Market Opportunity Analysis
3.6 HCV - Hepatitis C
- 3.6.1 Taxonomy
  - 3.6.1.1 Structure
  - 3.6.1.2 Genome
- 3.6.2 Molecular biology
- 3.6.3 Replication
- 3.6.4 Genotypes
  - 3.6.4.1 Clinical importance
- 3.6.5 Market Opportunity Analysis
3.7 HPV - Human papillomavirus
- 3.7.1 Virology
  - 3.7.1.1 E6/E7 proteins
  - 3.7.1.2 Role in cancer
  - 3.7.1.3 E2 research
  - 3.7.1.4 Latency period
  - 3.7.1.5 Clearance
- 3.7.2 Diagnosis
  - 3.7.2.1 Cervical testing
  - 3.7.2.2 Oral testing
  - 3.7.2.3 Testing men
  - 3.7.2.4 Other testing
- 3.7.3 Market Opportunity Analysis
3.8 Influenza
- 3.8.1 Virology
  - 3.8.1.1 Types of virus
  - 3.8.1.2 Influenzavirus A
  - 3.8.1.3 Influenzavirus B
  - 3.8.1.4 Influenzavirus C
  - 3.8.1.5 Structure, properties, and subtype nomenclature
  - 3.8.1.6 Replication
- 3.8.2 Testing
  - 3.8.2.1 Advantages/Disadvantages of Molecular Assays
- 3.8.3 Market Opportunity Analysis
3.9 CTGC - Chlamydia/Gonorhea
- 3.9.1 Gonorrhea
  - 3.9.1.1 Diagnosis
  - 3.9.1.2 Screening
- 3.9.2 Chlamydia
  - 3.9.2.1 Diagnosis
  - 3.9.2.2 Screening
- 3.9.3 Testing
  - 3.9.3.1 Nucleic acid amplification tests (NAATs).
  - 3.9.3.2 Performance of NAAT Tests
- 3.9.4 Market Opportunity Analysis
3.10 Tuberculosis
- 3.10.1 Mycobacteria
- 3.10.2 Diagnosis
  - 3.10.2.1 Active tuberculosis
  - 3.10.2.2 Latent tuberculosis
- 3.10.3 Epidemiology
- 3.10.4 Molecular Diagnostic Tests
- 3.10.5 Market Opportunity Analysis
3.11 MRSA - Methicillin-resistant Staphylococcus aureus
- 3.11.1 Diagnosis
- 3.11.2 FDA Approved Molecular Tests
- 3.11.3 Market Opportunity Analysis
3.12 VRE - Vancomycin-resistant Enterococcus
- 3.12.1 FDA Approved MDx Tests for VRE
- 3.12.2 Market Opportunity Analysis
3.13 VRE - Vancomycin-resistant Enterococcus
- 3.13.1 FDA Approved MDx Tests for VRE
- 3.13.2 Market Opportunity Analysis

4 Industry Overview

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
- 4.2.3 Segmenting the Syndromic Testing Market
4.3 Industry Structure
- 4.3.1 Hospital Testing Share
- 4.3.2 Economies of Scale
- 4.3.3 Hospital vs. Central Lab
- 4.3.4 Physician Office Lab's
- 4.3.5 Physician's and POCT

5 Market Trends

5.1 Factors Driving Growth
- 5.1.1 New Genotypes Creating New Markets
- 5.1.2 Aging Population a Boon for All Diagnostics
- 5.1.3 Developing World Driving ID Dx Growth
- 5.1.4 Point of Care - Why Centralization is Losing Steam
- 5.1.5 Self Testing
- 5.1.6 The Need for Speed
- 5.1.7 The COVID Pandemic
5.2 Factors Limiting Growth
- 5.2.1 Lower Costs
- 5.2.2 Infectious Disease is Declining
- 5.2.3 Wellness Hurts
- 5.2.4 Economic Growth improves Living Standards
5.3 Instrumentation, Automation and Diagnostic Trends
- 5.3.1 Traditional Automation and Centralization
- 5.3.2 The New Automation, Decentralization and Point Of Care
- 5.3.3 Instruments Key to Market Share
- 5.3.4 Bioinformatics Plays a Role
- 5.3.5 PCR Takes Command
- 5.3.6 Next Generation Sequencing Fuels a Revolution
- 5.3.7 NGS Impact on Pricing
- 5.3.8 Whole Genome Sequencing, A Brave New World
- 5.3.9 Companion Diagnostics Blurs Diagnosis and Treatment

6 Clinical Laboratory MDx Infectious Disease Recent Developments

6.1 Recent Developments - Importance and How to Use This Section
- 6.1.1 Importance of These Developments
- 6.1.2 How to Use This Section
6.2 Spindiag Seeks Investors for Rapid PCR System
6.3 Sorrento Therapeutics Nabs Contract for Dx Platform
6.4 Kephera Planning Menu of Infectious Disease Tests
6.5 Oxford Nanopore and BioMérieux to Develop IDDx
6.6 SD Biosensor Eyes Global Expansion
6.7 Selux Dx Next Gen Phenotyping Gets FDA Clearance
6.8 Takara Developing High-Throughput Multiplex Panels
6.9 BioGX Debuts New Point-of-Care Molecular Testing System
6.10 Nanopath MDx Platform Providing 15-Minute Results
6.11 ProtonDx Commercializing Rapid MDx Instrument
6.12 Siemens Healthineers to Develop Next-Gen, High-Throughput MDx Platform
6.13 Hologic Obtains CE Mark for MDx Epstein-Barr, BK Virus Assays
6.14 Pathogenomix Infectious Disease Platform Uses Cloud-Based Analytics, NGS
6.15 Accelerate Diagnostics Anticipates Growth
6.16 Growth of Decentralized Testing Expected to Continue
6.17 Lumos Diagnostics Expanding Test Portfolio
6.18 Study Validates Karius Cell-Free DNA to Detect Hundreds of Pathogens
6.19 CareDx, IDbyDNA Develop Infectious Disease Dx for Transplant Patients
6.20 Accelerated Development of CRISPR as a Diagnostic Platform
6.21 Lab-on-a-Chip Infection Test Threatens Clinical Laboratory Role

7 Key Companies and Competitive Analysis

7.1 Abbott Laboratories
7.2 Beckman Coulter Diagnostics
7.3 Becton, Dickinson and Company
7.4 bioMérieux Diagnostics
7.5 Bio-Rad Laboratories, Inc.
7.6 Cepheid (Danaher)
7.7 Hologic
7.8 Ortho Clinical Diagnostics
7.9 Perkin Elmer
7.10 Qiagen
7.11 Roche Molecular Diagnostics
7.12 Siemens Healthineers
7.13 Thermo Fisher Scientific Inc.

8 The Global Market for Clinical Laboratory MDx Infectious Disease

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 Application - Overview
- 8.2.1 Table - Global Market by Application
- 8.2.2 Chart - Global Market by Application - Base/Final Year Comparison
- 8.2.3 Chart - Global Market by Application - Base Year
- 8.2.4 Chart - Global Market by Application - End Year
- 8.2.5 Chart - Global Market by Application - Share by Year
- 8.2.6 Chart - Global Market by Application - Segments Growth

9 Global Clinical Laboratory MDx Infectious Disease Markets - By Application

9.1 Respiratory
- 9.1.1 Table Respiratory - by Country
- 9.1.2 Chart - Respiratory Growth
9.2 Blood Borne Virus
- 9.2.1 Table Blood Borne Virus - by Country
- 9.2.2 Chart - Blood Borne Virus Growth
9.3 Transplant
- 9.3.1 Table Transplant - by Country
- 9.3.2 Chart - Transplant Growth
9.4 Hospital Acquired Infections
- 9.4.1 Table Hospital Acquired Infections - by Country
- 9.4.2 Chart - Hospital Acquired Infections Growth
9.5 Reproductive Health
- 9.5.1 Table Reproductive Health - by Country
- 9.5.2 Chart - Reproductive Health Growth
9.6 C19 Singleplex
- 9.6.1 Table C19 Singleplex - by Country
- 9.6.2 Chart - C19 Singleplex Growth
9.7 Other
- 9.7.1 Table Other - by Country
- 9.7.2 Chart - Other Growth

10 Appendices

10.1 United States Medicare System: Laboratory Fees Schedule
10.2 The Most Used IVD Assays
10.3 The Highest Grossing Assays

Table of Tables

Table 1 Market Share of Leading Companies
Table 2 Viral Pathogens and Families
Table 3 Characteristics of Coronavirus Pandemic Infections
Table 4 COVID-19 Symptoms
Table 5 Classification of HIV Species
Table 6 HBV Tests - CMS Codes & Prices
Table 7 HCV Tests - CMS Codes & Prices
Table 8 HPV Clearance Rates
Table 9 HPV Tests - CMS Codes & Prices
Table 10 HPV Tests, Technology, Types
Table 11 Types of Influenza Tests
Table 12 Influenza Tests - CMS Codes & Prices
Table 13 FDA Cleared Molecular Assays for Influenza
Table 14 FDA Cleared NAAT CTGC Tests
Table 15 CTGC NAAT Target Sequences and Possible False Reactions
Table 16 Influenza Tests - CMS Codes & Prices
Table 17 FDA Approved MDx Tests for Tuberculosis
Table 18 Tuberculosis Tests - CMS Codes & Prices
Table 19 FDA Approved Tests for MRSA
Table 20 MRSA Tests - CMS Codes & Prices
Table 21 FDA Approved Tests for VRE
Table 22 VRE Tests - CMS Codes & Prices
Table 23 FDA Approved Tests for VRE
Table 24 VRE Tests - CMS Codes & Prices
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 Possible Market Segments of Syndromic Multiplex Market
Table 30 Five Factors Driving Growth
Table 31 Four Factors Limiting Growth
Table 32 Seven Key Diagnostic Laboratory Technology Trends
Table 33 - Global Market by Region
Table 34 Global Market by Application
Table 35 Respiratory by Country
Table 36 Blood Borne Virus by Country
Table 37 Transplant by Country
Table 38 Hospital Acquired Infections by Country
Table 39 Reproductive Health by Country
Table 40 C19 Singleplex by Country
Table 41 Other by Country
Table 42 Clinical Lab Fee Schedule
Table 43 The Most Common Assays
Table 44 Largest Revenue Assays

Table of Figures

Figure 1 Market Share of Leading Companies Chart
Figure 2 Global Health Care Spending
Figure 3 The Lab Test Pie
Figure 4 Structure of a Typical Virus
Figure 5 Mycobacterium Tuberculosis
FIGURE 6 STRUCTURE OF CORONAVIRUSES
Figure 7 HIV Virion
Figure 8 Diagram of the HIV Replication Cycle
Figure 9 The Structure of the HBV Virus
Figure 10 Hepatitis B Replication
Figure 11 Structure of the HCV Virus
Figure 12 HCV Replication Cycle
Figure 13 Structure of the Influenza Virion
Figure 14 Influenza Replication
Figure 15 Scanning Electronmicrograph of Tuberculosis
Figure 16 The Road to Diagnostics
Figure 17 Percentage of World Population Over 65
Figure 18 Chart Infectious Disease Decline
Figure 19 Centralized vs. Decentralized Laboratory Service
Figure 20 A Highly Multiplexed Syndromic Testing Unit
Figure 21 The Real Cost to Sequence the Human Genome
Figure 22 The Codevelopment Process
Figure 23 Global Market Share Chart
Figure 24 Global Market by Application - Base vs. Final
Figure 25 Global Market by Application Base Year
Figure 26 Global Market by Application End Year
Figure 27 Application Share by Year
Figure 28 Application Segments Growth
Figure 29 Respiratory Growth
Figure 30 Blood Borne Virus Diagnostics Growth
Figure 31 Transplant Growth
Figure 32 Hospital Acquired Infections Growth
Figure 33 Reproductive Health Growth
Figure 34 C19 Singleplex Growth
Figure 35 Other Growth