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Clinical Laboratory Molecular Diagnostics for Infectious Disease Market: Forecasts by Application by Place and by Country, with Market Analysis & Executive Guides

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    Report

  • 362 Pages
  • July 2024
  • Region: Global
  • Howe Sound Research
  • ID: 5834849

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. 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.

The report has hundreds of pages of information including a complete list of Current United States Medicare Fee Payment Schedules to help sharpen your pricing along with the most frequently used and billed tests. 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.

This research makes you the expert in your organization. 

The report includes five year market forecasts.

 

Table of Contents

1 Market Guides
1.1 Situation Analysis

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
2.4 The Nature of the IVD Product
2.4.1 Features Overview
2.4.2 The Misunderstood Feature
2.4.3 Regulation
2.4.4 The Newest Feature
2.4.5 The Oldest Feature
2.4.6 All About Scope
2.4.7 Why Turnaround is Becoming More Important
2.4.8 The Role of Trust
2.5 The IVD Product of the Future

3 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

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 The Nucleic Acid Impact
5.1.2 Population Dynamics
5.1.3 The Developing World
5.1.4 Decentralization
5.1.5 Self Testing
5.1.6 The Need for Speed
5.2 Factors Limiting Growth
5.2.1 Costs and Experience Curve Effects
5.2.2 The Role of ID Prevalence
5.2.3 Wellness
5.2.4 The Impact of 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 Roche Respiratory Panel Receives FDA EUA
6.3 Genetic Signatures Gets Approval for GI Parasite Panel
6.4 Diasorin Expands Respiratory Panel
6.5 BioMérieux Outlines MDx-Driven Growth
6.6 T2 Biosystems Gets Extended T2Bacteria Panel
6.7 Diasorin Aims to Deliver Updated Instruments, New Assays
6.8 Oxford Nanopore Nabs Investment From BioMérieux
6.9 Day Zero Diagnostics Closes Financing Round
6.10 Spindiag Seeks Investors for Rapid PCR System
6.11 Sorrento Therapeutics Nabs Contract for Dx Platform
6.12 Kephera Planning Menu of Infectious Disease Tests
6.13 Oxford Nanopore and BioMérieux to Develop IDDx
6.14 SD Biosensor Eyes Global Expansion
6.15 Selux Dx Next Gen Phenotyping Gets FDA Clearance
6.16 Takara Developing High-Throughput Multiplex Panels
6.17 BioGX Debuts New Point-of-Care Molecular Testing System
6.18 Nanopath MDx Platform Providing 15-Minute Results
6.19 ProtonDx Commercializing Rapid MDx Instrument
6.20 Siemens Healthineers to Develop Next-Gen, High-Throughput MDx Platform
6.21 Hologic Obtains CE Mark for MDx Epstein-Barr, BK Virus Assays
6.22 Pathogenomix Infectious Disease Platform Uses Cloud-Based Analytics, NGS
6.23 Accelerate Diagnostics Anticipates Growth
6.24 Growth of Decentralized Testing Expected to Continue
6.25 Lumos Diagnostics Expanding Test Portfolio
6.26 Study Validates Karius Cell-Free DNA to Detect Hundreds of Pathogens
6.27 CareDx, IDbyDNA Develop Infectious Disease Dx for Transplant Patients

7 Key Companies
7.1 Abbott Laboratories
7.2 Agilent
7.3 Altona Diagnostics
7.4 Anitoa
7.5 Autonomous Medical Devices
7.6 Beckman Coulter Diagnostics (Danaher)
7.7 Becton, Dickinson and Company
7.8 BioGX
7.9 Biomatik
7.10 bioMérieux Diagnostics
7.11 Bio-Rad Laboratories, Inc
7.12 Cepheid (Danaher)
7.13 Diasorin S.p.A.
7.14 DNAe
7.15 Flow Health
7.16 Global Access Diagnostics
7.17 Great Basin Scientific, Inc
7.18 Hologic
7.19 Novacyt
7.20 Novus Diagnostics
7.21 Oncimmune
7.22 One Codex
7.23 OraSure Technologies
7.24 Proof Diagnostics
7.25 Qiagen
7.26 QuidelOrtho
7.27 R-Biopharm AG
7.28 Response Biomedical
7.29 Revvity
7.30 Roche Diagnostics
7.31 Siemens Healthineers
7.32 Thermo Fisher Scientific
7.33 Vela Diagnostics
7.34 Veredus Laboratories
7.35 YD Diagnostics
7.36 Zhejiang Orient Gene Biotech

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
8.3 Global Market by Place - Overview
8.3.1 Table - Global Market by Place
8.3.2 Chart - Global Market by Place - Base/Final Year Comparison
8.3.3 Chart - Global Market by Place - Base Year
8.3.4 Chart - Global Market by Place - End Year
8.3.5 Chart - Global Market by Place - Share by Year
8.3.6 Chart - Global Market by Place - 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 Meningitis
9.7.1 Table Meningitis - by Country
9.7.2 Chart - Meningitis Growth
9.8 Gastrointestinal
9.8.1 Table Gastrointestinal - by Country
9.8.2 Chart - Gastrointestinal Growth
9.9 Tropical
9.9.1 Table Tropical - by Country
9.9.2 Chart - Tropical Growth

10 Global Clinical Laboratory MDx Infectious Disease Markets - By Place
10.1 Hospital Lab
10.1.1 Table Hospital Lab - by Country
10.1.2 Chart - Hospital Lab Growth
10.2 Outpatient Lab
10.2.1 Table Outpatient Lab - by Country
10.2.2 Chart - Outpatient Lab Growth
10.3 Point of Care
10.3.1 Table Point of Care - by Country
10.3.2 Chart - Point of Care Growth
10.4 Other Place
10.4.1 Table Other Place - by Country
10.4.2 Chart - Other Place Growth

11 Appendices
11.1 Growth of Approved IVD Test Menu
11.2 Growth of Approved Average IVD Test Fee
11.3 The Most Used IVD Assays
11.4 The Highest Grossing Assays
11.5 Laboratory Fees Schedule

List of Tables
Table 1 Key IVD Features
Table 2 Features in the Future
Table 3 Viral Pathogens and Families
Table 4 Characteristics of Coronavirus Pandemic Infections
Table 5 COVID-19 Symptoms
Table 6 Market Players by Type
Table 7 Clinical Laboratory Departments and Segments
Table 8 Laboratory Management Focus - Different Approaches
Table 9 Key Segmentation Variables Going Forward
Table 10 Possible Market Segments of Syndromic Multiplex Market
Table 11 Five Factors Driving Growth
Table 12 Four Factors Limiting Growth
Table 13 Seven Key Diagnostic Laboratory Technology Trends
Table 14 - Global Market by Region
Table 15 Global Market by Application
Table 16 Global Market by Place
Table 17 Respiratory by Country
Table 18 Blood Borne Virus by Country
Table 19 Transplant by Country
Table 20 Hospital Acquired Infections by Country
Table 21 Reproductive Health by Country
Table 22 C19 Singleplex by Country
Table 23 Meningitis by Country
Table 24 Gastrointestinal by Country
Table 25 Tropical by Country
Table 26 Hospital Lab by Country
Table 27 Outpatient Lab by Country
Table 28 Point of Care by Country
Table 29 Other Place by Country
Table 30 The Most Common Assays
Table 31 Largest Revenue Assays
Table 32 Clinical Lab Fee Schedule

List of Figures
Figure 1 Global Health Care Spending Per Capita
Figure 2 The Lab Test Pie
Figure 3 Structure of a Typical Virus
Figure 4 Mycobacterium Tuberculosis
FIGURE 5 STRUCTURE OF CORONAVIRUSES
Figure 6 The Road to Diagnostics
Figure 7 The Changing Age of The World’s Population
Figure 8 Health Care Consumption by Age
Figure 9 Cancer Incidence - Age at Diagnosis
Figure 10 Percentage of World Population Over 65
Figure 11 Chart Infectious Disease Decline
Figure 12 Centralized vs. Decentralized Laboratory Service
Figure 13 A Highly Multiplexed Syndromic Testing Unit
Figure 14 The Real Cost to Sequence the Human Genome
Figure 15 The Codevelopment Process
Figure 16 Global Market Share Chart
Figure 17 Global Market by Application - Base vs. Final
Figure 18 Global Market by Application Base Year
Figure 19 Global Market by Application End Year
Figure 20 Application Share by Year
Figure 21 Application Segments Growth
Figure 17 Global Market by Place - Base vs. Final
Figure 18 Global Market by Place Base Year
Figure 19 Global Market by Place End Year
Figure 20 Place Share by Year
Figure 21 Place Segments Growth
Figure 22 Respiratory Growth
Figure 23 Blood Borne Virus Diagnostics Growth
Figure 24 Transplant Growth
Figure 25 Hospital Acquired Infections Growth
Figure 26 Reproductive Health Growth
Figure 27 C19 Singleplex Growth
Figure 28 Meningitis Growth
Figure 28 Gastrointestinal Growth
Figure 28 Tropical Growth
Figure 22 Hospital Lab Growth
Figure 23 Outpatient Lab Growth
Figure 24 Point of Care Growth
Figure 25 Other Place Growth
Figure 29 IVD Test Menu Growth
Figure 30 IVD Test Average Fees - A Ten Year View

Companies Mentioned

  • Abbott Laboratories 
  • Accelerate Diagnostics
  • Agilent 
  • Altona Diagnostics 
  • Anitoa 
  • Autonomous Medical Devices 
  • Beckman Coulter Diagnostics (Danaher) 
  • Becton, Dickinson and Company 
  • Bio-Rad Laboratories, Inc
  • BioGX 
  • Biomatik 
  • bioMérieux Diagnostics 
  • CareDx
  • Cepheid (Danaher) 
  • Day Zero Diagnostics
  • Diasorin S.p.A. 
  • DNAe 
  • Flow Health 
  • Genetic Signatures
  • Global Access Diagnostics 
  • Great Basin Scientific, Inc 
  • Hologic
  • IDbyDNA
  • Karius
  • Kephera
  • Lumos Diagnostics
  • Nanopath
  • Novacyt 
  • Novus Diagnostics 
  • Oncimmune 
  • One Codex 
  • OraSure Technologies 
  • Oxford Nanopore
  • Pathogenomix
  • Proof Diagnostics 
  • ProtonDx
  • Qiagen 
  • QuidelOrtho 
  • R-Biopharm AG 
  • Response Biomedical
  • Revvity 
  • Roche
  • Roche Diagnostics 
  • SD Biosensor
  • Selux Dx
  • Siemens Healthineers 
  • Sorrento Therapeutics
  • Spindiag
  • T2 Biosystems
  • Takara
  • Thermo Fisher Scientific 
  • Vela Diagnostics 
  • Veredus Laboratories 
  • YD Diagnostics 
  • Zhejiang Orient Gene Biotech