OVERVIEW:
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
Table of Contents
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