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Syndromic Multiplex Diagnostic Markets. Strategies and Trends. Forecasts by Syndrome (respiratory, Sepsis, Gi Etc.) by Country. with Market Analysis, Executive Guides and Customization. 2019 to 2023 - Global Version
Author:sino    Source:Sino-report    Number of clicks :     Update time:2018-08-22 19:29
Are targeted tests for specific pathogens going to be obsolete? Will Infectious Disease testing move into the Physician's Office or even the Home
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REPORT OVERVIEW:

Are targeted tests for specific pathogens going to be obsolete? Will Infectious Disease testing move into the Physician's Office or even the Home?

Our facts and support = Your success.

Syndromic testing is proving itself in the market. Players are reporting double digit growth. Lowering costs, improving outcomes and even helping in the battle against Anti Microbial Resistance. Learn about this market including the issues and outlooks. The two key trends of Point of Care Testing and Molecular Diagnostics are merging with spectacular success. It could possibly displace most frontline test protocols AND save money at the same time. The report forecasts the market size out to 2023. In a special section the report looks at the numbers on how syndromic molecular diagnostics is replacing traditional panel based ordering of infectious disease tests.

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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

Table of Contents

i. Market Guides

  • iA. Situation Analysis
  • iB. Guide for Executives and Marketing Staff
  • iC. Guide for Investment Analysts and Management Consultants

1. Introduction and Market Definition

  • 1.1. What are Syndromic Multiplex Tests?
  • 1.2. Syndromic Testing - the quiet revolution in diagnostics
    • 1.2.1. Syndromic Testing - more than Panels.
  • 1.3. Market Definition
    • 1.3.1. Multiplex Market Size
    • 1.3.2. Panel Market Size
    • 1.3.2. Currency
    • 1.3.3. Years
  • 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 - Guide to the Pathogens

  • 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
  • 2.2. 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

3. Industry Overview

  • 3.1. Industry Participants
    • 3.1.1. IVD Supplier
    • 3.1.2. Independent lab specialized/esoteric
    • 3.1.3. Independent lab national/regional
    • 3.1.4. Independent lab analytical
    • 3.1.5. Public National/regional lab
    • 3.1.6. Hospital lab
    • 3.1.7. Physician lab
    • 3.1.8. Audit body
  • 3.2. The Clinical Laboratory Market Segments
    • 3.2.1. Traditional Market Segmentation
    • 3.2.2. Laboratory Focus and Segmentation
    • 3.2.3. Segmenting the Syndromic Testing Market
  • 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

4. Market Trends

  • 4.1. Factors Driving Growth
    • 4.1.1. Speed of Diagnosis
    • 4.1.2. Effect of Syndromic Testing on Costs.
    • 4.1.3. Point of Care Advantage
    • 4.1.4. Syndrome Testing, Accuracy and Diagnostic Risk
    • 4.1.5. Single Visits
    • 4.1.6. Improvement in Outcomes.
  • 4.2. Factors Limiting Growth
    • 4.2.1. Lower Prices
    • 4.2.2. Infectious Disease is Declining But...
    • 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.
    • 4.3.3. Syndrome Testing Moving to Big Instruments?
  • 4.4. Diagnostic Technology Development
    • 4.4.1. Comparing Syndrome and Targeted Testing
    • 4.4.2. The Multiplex Paradigm Shift
    • 4.4.2. The Sepsis Testing Market - Bellwether for Syndromics
    • 4.4.3. The Single Visit and AntiMicrobial Resistance
    • 4.4.4. Syndromics drives POCT adoption
    • 4.4.5. A Big Future for PCR?

5. Syndromic Testing Recent Developments

  • 5.1. Recent Developments - Importance and How to Use This Section
    • 5.1.1. Importance of These Developments
    • 5.1.2. How to Use This Section
  • 5.3. QIAGEN enters into agreement to acquire STAT-Dx
  • 5.4. GA-EMS receives diagnostic device contract
  • 5.5. Biocartis & Immunexpress Sign Partnership for Sepsis
  • 5.6. Alveo Closes Financing to Create Accessible Diagnostics Devices
  • 5.7. Siemens Healthineers completes takeover of Fast Track Diagnostics
  • 5.8. Chembio and FIND to Develop Point-of-Care Multiplex Test
  • 5.9. Applied BioCode Receives CE Mark for 18-plex Gastrointestinal Pathogen Panel
  • 5.10. Rapid Molecular Flu Tests Gain Ground
  • 5.11. Cepheid Receives FDA Clearance and CLIA Waiver for Xpert® Xpress Flu Test
  • 5.12. bioMérieux seeksr FDA Clearance of Pneumonia Panel
  • 5.13. Mobidiag Announces Release of a Multiplex qPCR Test for Detection of Antibiotic Resistant Bacteria
  • 5.14. Fast Track Diagnostics Gets CE Mark for Real-Time PCR Detection of High-Risk HPV
  • 5.15. SEEGENE develops Multiplex PCR tests in 4 days
  • 5.16. Seegene enters the U.S. diagnostic market in collaboration with Thermo Fisher Scientific
  • 5.17. Fusion Genomics Developing All Pathogens Diagnostic.
  • 5.18. Anapa Biotech Announces MeltPlex® Technology
  • 5.19. First multiplex test for tick-borne diseases
  • 5.20. ArcherDx, MGH Suing Qiagen Over Anchored Multiplex PCR Technology
  • 5.21. Akonni Biosystems Forms Chinese Commercialization Partnership with Righton
  • 5.22. Vela Buys Great Basin Scientific
  • 5.23. BARDA Awards up to $30M to Cue Health for Influenza, Respiratory Pathogen Test

6. Profiles of Key Syndromic Testing Companies

  • 6.1. Abbott Diagnostics (Alere)
  • 6.2. Accelerate Diagnostics
  • 6.3. Alveo Technologies
  • 6.4. Applied BioCode
  • 6.5. Atlas Genetics
  • 6.6. Aus Diagnostics
  • 6.7. BD Diagnostics
  • 6.8. Biocartis
  • 6.9. BioFire Diagnostics
  • 6.10. bioMérieux
  • 6.11. Bio-Rad Laboratories
  • 6.12. Bosch Healthcare Solutions GmbH
  • 6.13. Cepheid
  • 6.14. Curetis
  • 6.15. Diagenode Diagnostics
  • 6.16. Diasorin
  • 6.17. Fusion Genomics.
  • 6.18. GenMark Dx
  • 6.19. Hologic
  • 6.20. Janssen Diagnostics
  • 6.21. Lexigene
  • 6.22. Luminex
  • 6.23. Mesa Biotech
  • 6.24. Mobidiag
  • 6.25. Nanomix
  • 6.26. Primerdesign
  • 6.27. Qiagen (Statdx)
  • 6.28. Quantumdx
  • 6.29. Roche Molecular Diagnostics
  • 6.30. Seegene
  • 6.31. Siemens Healthineers (Fast Track Diagnostics)
  • 6.32. T2 Biosystems
  • 6.33. Thermo Fisher
  • 6.34. Veramarx

7. Global Market Size

  • 7.1. Syndromic Global Market Size by Country with Charts
  • 7.2. Syndromic Global Market Size by Syndrome with Charts

8. Global Market by Syndrome

  • 8.1. Respiratory Syndrome Market
    • 8.1.1. Respiratory Syndrome Market by Country
  • 8.2. GI-Enteric Syndrome Market
    • 8.2.1. GI-Enteric Market by Country with Chart
  • 8.3. Blood-Sepsis Syndrome Market
    • 8.3.1. Blood-Sepsis Market by Country with Chart
  • 8.4. Meningitis Syndrome Market
    • 8.4.1. Meningitis Market by Country with Chart
  • 8.5. Sexually Transmitted Disease Syndrome Market
    • 8.5.1. Sexually Transmitted Disease Market by Country with Chart
  • 8.6. Other Syndrome Market
    • 8.6.1. Other Market by Country with Chart

9. Panel Testing Market - Volumes and Price Forecast with MDx Share

  • 9.1. Respiratory Panel Market
  • 9.2. GI-Enteric Panel Market
  • 9.3. Blood-Sepsis Panel Market
  • 9.4. Meningitis Panel Market
  • 9.5. Sexually Transmitted Disease Panel Market
  • 9.6. Other Panel Market

Appendices

  • I. United States Medicare System: 2018 Clinical Laboratory Fees Schedule - National Limit and Midpoint
  • II. FDA Approved Microbial Tests

Table of Tables

  • Table 1: Medicare Clinical Lab Expenditures Actual & Forecast 2004 to 2020 ($Billion)
  • Table 2: Classification of HIV Species
  • Table 3: HBV Tests - CMS Codes & Prices
  • Table 4: HCV Tests - CMS Codes & Prices
  • Table 5: HPV Clearance Rates
  • Table 6: HPV Tests - CMS Codes & Prices
  • Table 7: HPV Tests, Technology, Types
  • Table 8: Types of Influenza Tests
  • Table 9: Influenza Tests - CMS Codes & Prices
  • Table 10: FDA Cleared Molecular Assays for Influenza
  • Table 11: FDA Cleared NAAT CTGC Tests
  • Table 12: CTGC NAAT Target Sequences and Possible False Reactions
  • Table 13: Influenza Tests - CMS Codes & Prices
  • Table 14: FDA Approved MDx Tests for Tuberculosis
  • Table 15: Tuberculosis Tests - CMS Codes & Prices
  • Table 16: FDA Approved Tests for MRSA
  • Table 17: MRSA Tests - CMS Codes & Prices
  • Table 18: FDA Approved Tests for VRE
  • Table 19: VRE Tests - CMS Codes & Prices
  • Table 20: Market Players by Type
  • Table 21: Clinical Laboratory Departments and Segments
  • Table 22: Laboratory Management Focus - Different Approaches
  • Table 23: Key Segmentation Variables Going Forward
  • Table 24: Possible Market Segments of Syndromic Multiplex Market
  • Table 25: Five Factors Driving Growth
  • Table 26: How SMT Improves Outcomes
  • Table 27: Four Factors Limiting Growth
  • Table 28: Syndromic Global Market by Country/Region
  • Table 29: Syndromic Global Market by Syndrome
  • Table 30: Gi-enteric Syndromic Testing market by country
  • Table 31: Blood-sepsis Syndromic Testing market by country
  • Table 32: Meningitis Syndromic Testing market by country
  • Table 33: Sexually Transmitted Disease Syndromic Testing market by country
  • Table 34: Other Syndromic Testing market by country
  • Table 35: Respiratory Panel Testing market - North America
  • Table 36: Respiratory Panel Testing market - Europe
  • Table 37: Respiratory Panel Testing market - Asia Pacific
  • Table 38: GI-Enteric Panel Testing market - North America
  • Table 39: GI-Enteric Panel Testing market - Europe
  • Table 40: GI-Enteric Panel Testing market - Asia Pacific
  • Table 41: Blood-Sepsis Panel Testing market - North America
  • Table 42: Blood-Sepsis Panel Testing market - Europe
  • Table 43: Blood-Sepsis Panel Testing market - Asia Pacific
  • Table 44: Meningitis Panel Testing market - North America
  • Table 45: Meningitis Panel Testing market - Europe
  • Table 46: Meningitis Panel Testing market - Asia Pacific
  • Table 47: Sexually Transmitted Disease Panel Testing market - North America
  • Table 48: Sexually Transmitted Disease Panel Testing market - Europe
  • Table 49: Sexually Transmitted Disease Panel Testing market - Asia Pacific
  • Table 50: Other Panel Testing market - North America
  • Table 51: Other Panel Testing market - Europe
  • Table 52: Other Panel Testing market - Asia Pacific
  • Table 53: 2018 Clinical Lab Fee Schedule

Table of Figures

  • Figure 1: Medicare Clinical Lab Expenditures 2004 to 2020 ($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: Chart Death Rates and Infectious Disease Decline
  • Figure 12: Comparing Syndromic and Targeted Testing
  • Figure 13: The Multiplex Paradigm Shift
  • Figure 14: Market Size by Country - Key Countries
  • Figure 15: Global Market by Country
  • Figure 16: Chart of Global Market by Syndrome
  • Figure 17: Growth Rates of Syndrome Segments
  • Figure 18: Chart - Respiratory market by country
  • Figure 19: Chart - Gi-enteric market by country
  • Figure 20: Chart - Blood-sepsis market by country
  • Figure 21: Chart - Meningitis market by country
  • Figure 22: Chart - Sexually Transmitted Disease market by country
  • Figure 23: Chart - Other Syndromic Testing market by country

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