Table of Contents
ONE: EXECUTIVE SUMMARY
Introduction
The Globalization of Infectious Diseases
Mounting Threat of Microbial Antibiotic Resistance
Near-Patient Testing
The Global Market for Infectious Disease Tests
ID/AST Market
Infectious Disease Immunoassay Market
Blood Screening Assay Market
Major Conclusions
TWO: INTRODUCTION TO INFECTIOUS DISEASES IN HEALTHCARE
Introduction to the Evolving World of Infectious Disease Testing
Public Health Response
Funding Sources
Leading Disease Threats
Leading Infetious Disease Testing Technologies
Point of View
THREE: TRENDS IN CLINICAL INFECTIOUS DISEASES
Background
The Globalization of Infectious Diseases
Globalization Through Trade and Travel
Disease Burdens in Developing World
Vaccines
Mounting Threat of Microbial Antibiotic Resistance
Near-Patient Testing
New Technology Platforms in Infectious Disease Testing
Real-Time PCR
Alternative Nucleic Acid Amplification Methods
Loop-mediated isothermal amplification (LAMP)
Nicking Enzyme Amplification Reaction (NEAR)
Strand Displacement Amplification (SDA)
Helicase Dependent Amplification (HDA)
Nucleic Acid Sequence-Based Amplification (NASBA
Transcription-mediated amplification (TMA)
Sequencing
Mass Spectrometry
Flow Cytometry
Conclusions
FOUR: OVERVIEW OF THE INFECTIOUS DISEASE TEST MARKET
Background
The World Market for Infectious disease Tests
Infectious Disease Test Markets – ID/AST, Immunoassays, Molecular Assays
Major Competitors in the Global Infectious Disease Test Market
Market-Leading Infectious Diseases
FIVE: THE MARKET FOR MICROBIOLOGY ID/AST TESTING
Background
Liquid Microbiology and ID/AST Automation
Market Analysis
Regional Breakout
Market Share
Rapid Tests
Microbial Identification and Antimicrobial Susceptibility Systems
Chromogenic Media
Blood Culture
Vendor Developments in Blood Culture ID Testing
Market Outlook for ID/AST Testing
SIX: THE MARKET FOR IMMUNOASSAYS
Background
Sepsis Serology
Hepatitis
HIV
Mycology
Parasitology
Respiratory
ToRCH
Sexually Transmitted Diseases (STDs)
Regional Breakout
Market Outlook for Immunoassay Infectious Disease Testing
SEVEN: THE MARKET FOR MOLECULAR ASSAYS
Background
Market Analysis
HAI Market
HIV Market
Hepatitis Market
Chlamydia/Gonorrhea (CT/NG)
HPV
Respiratory
Mycobacteria/TB
Other
CT/NG, HPV and Sexual Health / Women’s Health
Healthcare-Acquired Infections (HAIs) / Antimicrobial Resistance (AMR)
HIV
Respiratory
Market Outlook for Molecular Infectious Disease Testing
EIGHT: THE INFECTIOUS DISEASE BLOOD SCREENING MARKET
Commonly Tested Pathogens in Blood Screening
Market Analysis by Type
Vendor Market Share
Immunoassays
Nucleic Acid Tests (NATs)
Nucleic Acid Test Introductions and Innovations
NINE: COMPANY PROFILES
Abbott Diagnostics
Alere
Beckman Coulter (Danaher)
Becton, Dickinson & Co. (BD)
bioMérieux
Bio-Rad Laboratories
Cepheid
Chembio Diagnostic Systems
Copan Diagnostics
DiaSorin
Molecular
Blood Banking
Grifols
Blood Screening (Molecular PROCLEIX Tests)
Hologic
Molecular Cytology / Histology (HPV)
Other Molecular (STIs, HIV, HCV, TB, Respiratory)
Microbiology (AccuProbe Molecular Culture ID Tests)
Blood Screening (Molecular PROCLEIX Tests)
Meridian Bioscience
OraSure Technologies
Ortho-Clinical Diagnostics
QIAGEN
Molecular Diagnostics
Immunoassays
Quidel Corporation
Roche Diagnostics
Siemens Healthcare Diagnostics
Thermo Fisher Scientific
Trinity Biotech
LIST OF EXHIBITS
ONE: EXECUTIVE SUMMARY
Figure 1-1: European Antimicrobial Resistance (AMR) Heat Map By Country/Year(30 EEA Member Countries/2004-2013) – Methicillin Resistant S. aureus (MRSA)
Figure 1-2: Worldwide Infectious Disease Test Market by Region
Table 1-2: Worldwide Infectious Disease Test Market by Region/Country North America, Western Europe (EU), Japan, China, India, Latin America,Rest of the World (ROW) (2015-2020)
Table 1-3: Worldwide Infectious Disease Test Market by Test Segment – LaboratoryImmunoassays, Rapid Professional POC Immunoassays, Rapid Home / OTC Immunoassays, ID/AST, Infectious Disease Molecular Assays, Blood Screening Immunoassays, Blood Screening Nucleic Acid Tests (2015-2020)
THREE: TRENDS IN CLINICAL INFECTIOUS DISEASES
Table 3-1: Infectious Diseases of Globalization and Their Drivers
Table 3-2: Disease Preventable Vaccines in 2015
Table 3-3: Preventive Vaccines in Development for Infectious Diseases (2015)
Figure 3-1: European Antimicrobial Resistance (AMR) Heat Map By Country/Year (30 EEA Member Countries/2004-2013) – E. coli Resistance to Third-Generation Cephalosporins
Figure 3-2: European Antimicrobial Resistance (AMR) Heat Map By Country/Year (30 EEA Member Countries/2004-2013) – K. pneumoniae Multidrug Resistance to Third-Generation Cephalosporins, Fluoroquinolones and Aminoglycosides
Figure 3-3: European Antimicrobial Resistance (AMR) Heat Map By Country/Year (30 EEA Member Countries/2004-2013) – Methicillin Resistant S. aureus (MRSA)
Table 3-4: Selected Advanced Antibiotic Resistance Tests
Table 3-5: Selected Antibiotic Resistance Facts (CDC)
Table 3-6: Selected Advanced Near-Patient Infectious Disease Testing Platforms
Table 3-7: Selected Microorganisms and Their Associated Diseases
Table 3-8: Selected Isothermal Amplification Methods and Platform Examples
Table 3-9: Selected Next Generation Sequencers for Infectious Disease Applications
Table 3-10: Selected Infectious Disease Sequencing Innovations
Table 3-11: Selected Mass Spectrometry Microbiology Platforms
Table 3-12: Selected Flow Cytometry Infectious Disease Applications
FOUR: OVERVIEW OF THE INFECTIOUS DISEASE TEST MARKET
Table 4-1: Worldwide Infectious Disease Test Market by Region/Country – North America, Western Europe (EU), Japan, China, India, Latin America, Rest of the World (ROW) (2015-2020)
Table 4-2: Worldwide Infectious Disease Test Market by Test Segment – Laboratory Immunoassays, Rapid Professional POC Immunoassays, Rapid Home / OTC Immunoassays, ID/AST, Infectious Disease Molecular Assays, Blood Screening Immunoassays, Blood Screening Nucleic Acid Tests (2015-2020) ($ millions)
Table 4-3: Global Infectious Disease Test Market Shares – Abbott Diagnostics, Alere, Beckman Coulter, BD, bioMérieux, Bio-Rad Labs, Cepheid, DiaSorin, Grifols, Hologic, Meridian Bioscience, Ortho-Clinical Diagnostics, Quidel, Roche Diagnostics, Siemens Healthcare Diagnostics, Thermo Fisher Scientific, Others (%)
Table 4-4: Worldwide Infectious Disease Test Market by Major Diseases – HAI / AMR, Hepatitis, HIV, Respiratory, STDs / Women’s Health, Other Infectious Diseases (2015) ($ millions)
FIVE: THE MARKET FOR MICROBIOLOGY ID/AST TESTING
Table 5-1: Microbiology Sample/Specimen Types Ranked by Average Volume
Table 5-2: Worldwide ID/AST Sales by Segment – Panels and Reagents, Blood Culture, Chromogenic Media, Rapid Micro (2015-2020) ($ millions)
Table 5-3: Worldwide ID/AST Sales by Region – North America, Western Europe, Japan, China, India, Latin America, ROW (2015-2020) ($ millions)
Table 5-4: ID/AST Leader Market Shares – BD, Beckman Coulter, bioMérieux, Thermo Fisher Scientific, Others
Table 5-5: Selected ID/AST System Innovations
Table 5-6: Selected Chromogenic Media Innovations and Launches
Table 5-7: Selected Blood Culture Innovations and Launches
SIX: THE MARKET FOR IMMUNOASSAYS
Table 6-1: Selected Sepsis Serology Innovations
Table 6-2: Worldwide Infectious Disease Immunoassay Sales by Segment – Lab-Based, Rapid / POC (2015-2020) ($ millions)
Table 6-3: Worldwide Infectious Disease Immunoassay Sales by Region – North America, Western Europe, Japan, China, India, Latin America,
ROW (2015-2020) ($ millions)
Table 6-4 Alere, Beckman Coulter, bioMérieux, Bio-Rad Laboratories, DiaSorin, Meridian Bioscience, Ortho-Clinical Diagnostics, Quidel, Roche Diagnostics, Siemens Healthcare Diagnostics, Trinity Biotech, Others
Table 6-5: Laboratory Infectious Disease Immunoassays Sales by Disease or Pathogen – Hepatitis, HIV, Mycology, Parasitology, Respiratory, Sepsis, Sexually Transmitted Diseases (STDs), ToRCH, Others (2015)
Table 6-6: Selected Laboratory Infectious Disease Immunoassay Innovations
Table 6-7: CLIA-Waived Infectious Disease Tests and Analytes
Table 6-8: Rapid Infectious Disease Immunoassays Sales by Disease or Pathogen – C. difficile, E. coli, H. pylori, Hepatitis, HIV, Influenza, Malaria, Strep A, STDs, Others (2015)
Table 6-9: Selected Rapid Infectious Disease Immunoassay Innovations
SEVEN: THE MARKET FOR MOLECULAR ASSAYS
Table 7-1: Selected Moderate and Waived Complexity Molecular Infectious Disease Testing Platforms
Table 7-2: Worldwide Molecular Infectious Disease Assay Sales by Disease Area – CT/NG, HAIs, Hepatitis, HIV, HPV, Mycobacteria/TB,
Respiratory, Others (2015-2020)
Table 7-3 bioMérieux, Cepheid, Hologic, QIAGEN, Roche Diagnostics, Siemens Healthcare Diagnostics, Others
Table 7-4: Selected Molecular Sexual Health and Women’s Health Test Introductions and Innovations
Table 7-5: Selected Molecular Healthcare-Acquired Infection (HAI) / Antimicrobial Resistance (AMR) Test Introductions and Innovations
Table 7-6: Selected Molecular Hepatitis Test Introduction and Innovations
Table 7-7: Selected Molecular HIV Test Introduction and Innovations
Table 7-8: Selected Molecular Respiratory Infection Test Introduction and Innovations 178
EIGHT: THE INFECTIOUS DISEASE BLOOD SCREENING MARKET
Table 8-1: Commonly Tested Pathogens in Blood Screening
Table 8-2: Worldwide Infectious Disease Blood Screening Test Sales – Immunoassays and Nucleic Acid Tests (NATs) (2015-2020) ($ millions)
Table 8-3: Infectious Disease Blood Screening Test Market Shares – Abbott Diagnostics, DiaSorin, Grifols, Hologic, Ortho-Clinical Diagnostics, Roche Diagnostics, Others
Table 8-4: Selected Blood Screening Immunoassay Introductions and Innovations Nucleic Acid Tests (NATs)
Table 8-5: Selected Blood Screening Nucleic Acid Test Introductions and Innovations..
NINE: COMPANY PROFILES
Table 9-2: Alere Revenue (2011-2014)
Table 9-3: Beckman Coulter Revenue (2011-2014)
Table 9-4: Becton, Dickinson & Co. (BD) Revenue (FY 2011-2014)
Table 9-5: bioMérieux Revenue (2011-2014)
Table 9-6: Bio-Rad Laboratories Revenue (2011-2014)
Table 9-7: Cepheid Revenue (2011-2014)
Table 9-8: Chembio Diagnostics Systems Revenue (2011-2014)
Table 9-9: DiaSorin Revenue (2011-2014)
Table 9-10: Grifols Revenue (2011-2014)
Table 9-11: Hologic Revenue (FY 2011-2014)
Table 9-12: Meridian Bioscience Revenue (2011-2014)
Table 9-13: OraSure Technologies Revenue (2011-2014)
Table 9-14: Ortho-Clinical Diagnostics Revenue (2011-2014)
Table 9-15: QIAGEN Revenue (2011-2014)
Table 9-16: Quidel Corporation Revenue (2011-2014)
Table 9-17: Roche Diagnostics Revenue (2011-2014)
Table 9-18: Siemens Healthcare Diagnostics Revenue (FY 2011-2014)
Table 9-19: Thermo Fisher Scientific Revenue (2011-2014)
Table 9-20: Trinity Biotech Revenue (2011-2014)