Description
Infectious diseases are among the most challenging issues facing health care delivery systems around the world today. The World Health Organisation estimates that more than 17 million people die of an infectious disease each year, with many of these acquired in hospitals. This Kalorama Information report, The World Market for Infectious Disease Diagnostic Tests, takes a comprehensive look at the markets for companies of testing products that can combat infectious disease threats.
One of the Most Dynamic Areas of the IVD Market, Comprehensively Covered
The art of microorganism identification and therapy decisions is becoming increasingly more important and more complex. This provides both challenges and opportunities for infectious disease testing. The world is getting smaller and smaller – people and products are moving over country boundaries as never before. Immigrants and visitors to countries bring with them different species of microorganisms that may require identification. Therefore highly sophisticated and versatile methodologies are required to respond for the need to identify a larger and more diversified list of pathogens. The report provides a review of trends and technological advancements in infectious disease testing in the next 5 years.
Market Size and Sales Forecasts to 2017 by Type of Test
Sales and forecasts of infectious disease reagents are made through to 2017. Emerging products and markets are described; key players and strategies discussed and competitive trends are analyzed. Specific market details are provided for the following:
- HIV Testing, Molecular and Immunoassays
- Respiratory Infecton Testing
- Immunoassays for STDs
- Immunoassays for Hepatitis
- TORCH testing
- Rapid Influenza Testing
- Rapid Malaria Testing
- Rapid HIV
- Rapid Strep A
- Rapid Hepatitis,
- Rapid STD Testing
- C. diff Testing
- E. coli Testing
- H. pylori Testing
- OTC – Home Use Testing For Infectious Disease
- Molecular HIV Testing
- Molecular Hepatitis Testing
- Molecular GC/Chlamydia Testing
- Molecular Hospital Acquired Infection Testing
- Molecular Respiratory Testing
- Organism ID Testing
- Blood Bank, Immunoassays
- Blood Bank, Molecular
- ID/AST Panels
- ID/AST Chromogenetic Media
- Parasitology
- Sepsis Testing
- Others
Market analysis in this report covers world markets for infectious disease tests, however the reader will find a bias toward the developed areas of the globe — North America, Japan and Western Europe. The BRIC set of countries (Brazil, Russia, India and China) have drawn a lot of attention in the economic media in the past 2 -3 years. Thus there is more discussion of the mix of economics and diagnostics that may evolve in these countries. Nevertheless, infectious diseases are a growing global problem and where possible the report covers IVD products related to the globalization of diseases.
All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the in vitro diagnostic market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible. The dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.
The Threat of Emerging Infectious Disease
Globalization has made the world a smaller place in a very short time. There are numerous reports of the spread of imported diseases such a lyme, chagas and malaria to regions where they were not usually present. Global travel and trade, along with climate change, are expanding the habitats of the mosquitoes that carry many of the vector-borne infectious disease far and wide.
Thus not only is it imperative to have rapid and efficient tests for countries in the developing world, healthcare providers in developed countries can also benefit. The situation in developed countries is probably less urgent for the tropical diseases, but it is equally important to have better rapid tests for hepatitis, HIV, tuberculosis and sexually transmissible diseases worldwide. The following diseases are covered in the report in detail.
- Chagas Disease
- Chikungunya
- Dengue
- HIV
- HPV/ cervical cancer
- Respiratory
- Hepatitis
- HAIs
- Diarrheal Diseases
- Leishmaniasis
- Leptospirosis
- Malaria
- Onchocerciasis
- STDs
- TB
For each of these diseases, the report provides statistics, and an estimate of the opportunity for IVD companies.
The report discusses tests and technologies that are currently available and those that are expected to take their place. Generally, current products and technologies establish the standard of care and its value to payers. Many of the assays and techniques presented in the report are expected to replace the standard of care in 2012, but with healthcare systems’ emphasis on cost/benefit analysis for new technologies adoption, the market value and thus penetration capabilities of newer approaches may be limited.
Exhaustive Company Profiling
The information contained in this report has been assembled from primary and secondary data. Secondary date was collected from peer review journals and industry generated press releases. Primary research was conducted via telephone conversation with selected diagnostic marketers of in vitro diagnostics to assess the current market and trends in laboratory medicine.
- Abbott Diagnostics
- Beckman Coulter Inc./Danaher
- Becton, Dickinson and Company (BD)
- BD GeneOhm
- bioMérieux Inc. Marcy L’etoile, France Www.Biomerieux.Com
- Bio-Rad Laboratories Inc.
- Gen-Probe Inc.
- Hologic, Inc.
- Ortho Clinical Diagnostics
- QIAGEN N.V.
- Roche Diagnostics
- Siemens Healthcare Diagnostics
- Thermo Fisher Scientific Inc.
- Bruker BioSciences Corporation
- CHROMagar
- Copan Diagnostics Inc.
- Hardy Diagnostics
- Laboratorios CONDA
- Lab M
- Liofilchem S.R.L.
- Mindray Bio-Medical Electronics Co., Ltd
- Oxoid
- Serosep Limited
- Astra Biotech GmbH
- Cavidi AB
- Cellestis Ltd
- Corgenix Medical Corporation
- Diagnostic HYBRIDS, Inc. (DHI)
- DiaSorin S.p.A
- Diaxonhit
- Euroimmun AG
- Fujirebio Diagnostics, Inc.
- Gold Standard Diagnostics
- Immunetics Inc.
- Immuno-Mycologics (IMMY)
- InBios International, Inc.
- Luminex Corporation
- MBio Diagnostics, Inc.
- Meridian Bioscience, Inc.
- illumigene Molecular
- Meridian Life Science
- J.Mitra & Co. Pvt Ltd
- MP Biomedicals LLC
- Nova Biomedical
- OncoHealth Corporation
- Orgentec Diagnostika
- Oxford Immunotec Ltd.
- Pro-Lab Diagnostics
- Quanterix Corporation
- Quidel Corporation
- Sekisui Diagnostics (formerly Genzyme Diagnostics)
- TECHLAB Inc.
- Trinity Biotech plc
- The Tulip Group
- Vircell, SL
And Many Other Companies in Infectious Disease Diagnostic Testing…
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
Introduction
Scope and Methodology
Market Trends
Immunoassays
ID/AST
Molecular Tests
Blood Banking
The Commercial Outlook for Infectious Disease Testing
CHAPTER TWO: INTRODUCTION
Introduction To The Evolving World of Infectious Disease Testing
Public Health Response
Funding Sources
Cost of Disease
WHO Campaign
Programs and Initiatives
George Institute Report
WHO Programs
Point of View
CHAPTER THREE: TRENDS IN INFECTIOUS DISEASE TESTING
Background
The Globalization of Emerging Infectious Diseases
Drivers of Disease
Leptospirosis Threat
Measles Threat
Lyme Disease
WHO Surveillance
The Role of Vaccines
IVD Market Effect of Vaccines
Lyme Vaccine
Advance Market Commitment
New Era of Vaccine Discovery?
Antibiotic Resistant Tests
Trends For Nearer The Patient Testing
The Role Of Pathogens In Chronic Diseases
New Testing Opportunities
Real-time PCR
Sequencing
Mass Spectrometry
Flow Cytometry
CHAPTER FOUR: MARKET ANALYSIS OVERVIEW
Background
Regional Market Breakout
Market in Developed Countries
Market in Developing Countries
Infectious Disease Testing Trends In The Developed World
Infectious Disease Testing Trends In The Developing World
No Region Untouched
Diseases And Growth Opportunities, Worldwide
Disease Burden
Influenza
Hospital Acquired Infections
Hepatitis
HIV
Human Papilloma Virus (HPV)
Respiratory Infections
Sexually Transmissible Diseases (STDs)
Diarrheal Diseases
Tuberculosis
Malaria
Dengue Fever
Chagas Disease
Chikungunya virus (CHIKV)
Lyme Disease
West Nile
Babesiosis
Middle Eastern Respiratory Syndrome (MERS)
Emerging Pathogens
Top Suppliers and Niche players
biomérieux
BD
Roche
Thermo Fisher
Abbott
Siemens
Hologic
Bio-Rad
Alere
Qiagen
Cepheid
Others
CHAPTER FIVE: THE MARKET FOR MICROBIOLOGY ID/AST TESTING
Background
Identification and Antibiotic Sensitivity Testing
Identification systems
Liquid Microbiology
Market Analysis
Microbial Identification and Antimicrobial Sensitivity Tests
Chromogenic Media
Blood Culture
Rapid Tests
CHAPTER SIX: THE MARKET FOR IMMUNOASSAYS
Background
Sepsis Serology
Immunoassays – lab based
Innovations
Immunoassays – rapid
OTC – Self Testing
The Commercial Outlook for Infectious Disease Immunoassays
CHAPTER SEVEN: THE MARKET FOR MOLECULAR ASSAYS
Background
Market Analysis
HIV
Hepatitis
Sexually Transmitted Diseases (STDs)
Hospital Acquired Infections (HAIs)
Respiratory Tract Infections
Tuberculosis
Fungal Infections
HPV Testing
Service Industry
POC trends
The Commercial Outlook for Molecular Infectious Disease Testing
CHAPTER EIGHT: THE BLOOD SCREENING MARKET FOR INFECTIOUS DISEASES
Background
Market Analysis
Immunoassay Screens
Nucleic Acid Testing (NAT) Continues to Grow
The Commercial Outlook for Blood Screening
CHAPTER NINE: COMPANY PROFILES: TOP TIER IVD COMPANIES’ INFECTIOUS DISEASE TESTING BUSINESSES
Abbott Diagnostics
Infectious Diseases – Immunoassays
Infectious Diseases – Molecular
Molecular HAI
IntelligentMDx Alliance
PLEX-ID
Molecular Sample Prep
Blood Bank
Alere
Microbiology
Immunoassays
Molecular
HIV CD4
Beckman Coulter Inc./Danaher
Immunoassays
Becton, Dickinson and Company (BD)
Initiatives
Traditional Microbiology
Molecular Beginning
Molecular Development
Viper System
BD GeneOhm
The BD MAX Enterprise
Blood Culture
TB
HPV
Veritor System
Mass Spectrometry
bioMérieux Inc. Marcy L’etoile, France Www.Biomerieux.Com
Expansion
Microbiology
Blood Culture
Blood Banks
Immunoassays
Microbial genotyping:
Molecular Microbiology
NucliSENS
Mass Spectroscopy
Point of Care
Bio-Rad Laboratories Inc.
Microbiology
Quality Control
Immunoassays
Blood Bank
Molecular
Research
Gen-Probe Inc.
STDs
Panther System
HPV
Infectious Diseases
Blood Bank
Hologic, Inc.
Ortho Clinical Diagnostics
Immunoassays
Blood Bank
Molecular
Virco BVBA (Mechelen, Belgium)
QIAGEN N.V.
Market Expansion
Infectious diseases
Rotor-Gene
TB
HPV
Automation for the Future
Women’s Health
Point of Care
Sequencing
Roche Diagnostics
The PCR Enterprise
Molecular Infectious Diseases
Viral Load
STDs
HPV
Immunoassays
Blood Bank
Sequencing
Siemens Healthcare Diagnostics
Microbiology
Immunoassays
Molecular
Sequencing
HIV Companion Testing
Thermo Fisher Scientific Inc.
Clinical (Specialty) Diagnostics is comprised of
Sepsis
Microbiology
CHAPTER TEN: COMPANY PROFILES: COMPANIES FOCUSED ON ID/MIC MICROBIOLOGY TESTING
Bruker BioSciences Corporation
CHROMagar
Copan Diagnostics Inc.
Hardy Diagnostics
Laboratorios CONDA
Lab M
Liofilchem s.r.l.
Mindray Bio-Medical Electronics Co., Ltd
Oxoid
Serosep Limited
CHAPTER ELEVEN: COMPANY PROFILES: COMPANIES
FOCUSED ON IMMUNOASSAYS FOR INFECTIOUS
DISEASE TESTING
Astra Biotech GmbH
Cavidi AB
Cellestis Ltd
Corgenix Medical Corporation
Diagnostic HYBRIDS, Inc. (DHI)
DiaSorin S.p.A
Diaxonhit
Euroimmun AG
Fujirebio Diagnostics, Inc.
Gold Standard Diagnostics
Immunetics Inc.
Immuno-Mycologics (IMMY)
InBios International, Inc.
Luminex Corporation
MBio Diagnostics, Inc.
Meridian Bioscience, Inc.
Immunoassays
illumigene Molecular
Meridian Life Science
J.Mitra & Co. Pvt Ltd
MP Biomedicals LLC
Nova Biomedical
OncoHealth Corporation
Orgentec Diagnostika
Oxford Immunotec Ltd.
Pro-Lab Diagnostics
Immunoassays
Rapid Tests
Quanterix Corporation
Quidel Corporation
Immunoassays
Molecular
R-Biopharm AG
Molecular
Sekisui Diagnostics (formerly Genzyme Diagnostics)
TECHLAB Inc.
Trinity Biotech plc
Point of Care
The Tulip Group
Vircell, SL
CHAPTER TWELVE: COMPANY PROFILES: COMPANIES FOCUSED ON MOLECULAR TESTS FOR INFECTIOUS DISEASES
Abacus Diagnostica Oy
Accelerate Diagnostics, Inc. (Accelr8 Technology Corporation)
AdvanDx, Inc.
Akonni Biosystems Inc.
Anagnostics Bioanalysis GmbH
Analytik Jena AG
bcs BIOTECH S.p.A.
BGI-Shenzhen (Beijing Genome Institute)
Biocartis SA
BioFire Diagnostics, Inc
Blood Culture
BioHelix Corporation
CapitalBio Corporation
Cepheid
Market Expansion
HAI
TB
Infectious Diseases
Co-Diagnostics HBDC
Cooperative Diagnostics, LLC
Curetis AG
Distribution
DiagCor Bioscience Ltd.
DxNA, LLC
Eiken Chemical Co., Ltd
ELITech Group
Enigma Diagnostics Limited
Enzo Biochem Inc.
Alliances
IP Protection
EraGen Biosciences Inc.
Focus Diagnostics, Inc.
Test development
GenoID Ltd.
GenMark Diagnostics Inc.
Genomica S.A.U.
Great Basin Corporation
Hain Lifescience GmbH
HiberGene Diagnostics Ltd
Ibis Biosciences
iCubate Incorporated
Immunexpress Group
IncellDx, Inc.
Market Expansion
Intelligent Medical Devices, Inc. (IMDx)
IQuum Inc.
CHAPTER THIRTEEN: COMPANY PROFILES: COMPANIES FOCUSED ON POC ASSAYS FOR INFECTIOUS DISEASE TESTING
ABS Advanced Biomedical Systems (ABS)
bioLytical Laboratories
Calypte Biomedical Corporation
Chembio Diagnostic Systems, Inc.
Common Sense Ltd.
DiAssess Inc
Epistem
GenePOC Inc.
General Electric Global Research
Global BioDiagnostics Corp.
Home Access Health Corporation
MedMira Inc.
NanoMal Project (The)
NetBio
OJ-Bio
OPKO Diagnostics
OraSure Technologies, Inc.
Pixie Scientific
Preventx Limited
QuantuMDx Group Limited
QuickCheck Health Inc.
Response Biomedical Corp.
TwistDx Ltd.
Xagenic Inc.
Zyomyx Inc
CHAPTER FOURTEEN: COMPANY PROFILES: SERVICE PROVIDERS FOR INFECTIOUS DISEASE TESTING
Analyte Health Inc.
Bio-Reference Laboratories, Inc. (BRLI)
Boulder Diagnostics Inc.
DermaGenoma, Inc.
Diatherix Laboratories Inc.
Lab21 Limited
Services
Products Division
Microgen Bioproducts Ltd
Expansion
Laboratory Corporation of America Holdings (LabCorp)
Maxim Biomedical, Inc.
Medical Diagnostic Laboratories L.L.C. (MDL)
Metabolistics Inc.
Quest Diagnostics
UDoTest
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: Exchange Rate Fluctuations, 2009–2012
Figure 1-1: Infectious Disease IVD Market
Table 1-2: Worldwide Infectious Disease Test Sales by Type
Figure 1-1: IVD Market Growth by Segment, 2012–2017
CHAPTER THREE: TRENDS IN INFECTIOUS DISEASE TESTING
Table 3-1: Factors for the Spread of Infectious Diseases
Table 3-2: Disease Preventable Vaccines in 2013
Table 3-3: Selected Vaccines in Development for Infectious Diseases
Table 3-4: Selected Antibiotic Resistance Facts
Table 3-5: Selected Advanced Antibiotic Resistance Tests
Table 3-6: Selected Microorganisms And Their Associated Diseases
Table 3-7: Selected Next Generation Sequencing Platforms
Table 3-8: Selected Infectious Disease Sequencing Innovations
Table 3-9: Selected Infectious Disease Mass Spectroscopy Innovations
Table 3-10: Selected CD4 Test Innovations
Table 3-11: Selected Flow Cytometry Applications for Infectious Diseases
CHAPTER FOUR: MARKET ANALYSIS OVERVIEW
Table 4-1: Per Capita Infectious Disease Test Spending, 2012
Table 4-2: Worldwide Infectious Disease Test Sales by Type
Table 4-3: Worldwide Infectious Disease Test Sales By Geography
Table 4-4: Required Test Devices for Developing Countries
Table 4-5: Distribution Of Curable Infectious Diseases, Worldwide
Table 4-6: Disease opportunities evaluated, 2013
Table 4-7: Selected Disease Statistics, Worldwide, as at July 2012
Table 4-8: Selected Emerging Viruses
Table 4-9: Revenues of Major Infectious Disease Companies, 2012
CHAPTER FIVE: THE MARKET FOR MICROBIOLOGY ID/AST TESTING
Table 5-1: Microbiology Sample Type Breakdown
Table 5-2: Worldwide ID/AST Sales, by Type
Table 5-3: Worldwide ID/AST Sales, by Region (N. America, Western Europe,
Japan, China, India, Latin America, Rest of the World)
Table 5-4: Revenue of Selected MicrobiologyProduct Companies, 2012 (estimated)126
Table 5-5: Selected Chromogenic Media
Table 5-6: Selected Advanced Techniques For Positive Blood Cultures
Table 5-7: Selected ID/AST Rapid Test Innovations
CHAPTER SIX: THE MARKET FOR IMMUNOASSAYS
Table 6-2: Worldwide Infectious Diseases Immunoassays, By Type
Table 6-3: Worldwide Infectious Diseases Immunoassays, by Region (N. America,
Western Europe, Japan, China, India, Latin America, Rest of the World)
Table 6-4: Lab-Based Infectious Disease Immunoassays, By Test, 2012, $ Million .. 145
Table 6-5: Selected Infectious Disease Immunoassay Platform Innovation
Table 6-6: Selected Infectious Disease Immunoassay Innovations
Table 6-7: Worldwide Rapid Infectious Disease Immunoassay Sales, 2012
Table 6-8: Selected Technical Innovations for POC Infectious Disease Tests
Table 6-9: Selected Professional-use POC Tests for Infectious Diseases
Table 6-10: Selected Infectious Diseases OTC Tests Available
Table 6-10: Selected Infectious Diseases OTC Test Innovations
CHAPTER SEVEN: THE MARKET FOR MOLECULAR ASSAYS
Table 7-1: Selected CLIA Moderate Molecular Tests & Instruments
Table 7-2: Molecular Test Sales, 2012-2017
Table 7-3: Molecular Infectious Disease Test Revenues of Selected Vendors, 2012 . 172
Table 7-4: Selected Molecular Test and Instrument Innovations
Table 7-5: Selected Molecular HIV Test Innovations
Table 7-6: Selected Molecular Hepatitis Test Innovations
Table 7-7: Selected Molecular STD Test Innovations
Table 7-8: Top Sources of HAI Bloodstream Infections
Table 7-9: Top Ten HAI-causing Bacteria
Table 7-10: Selected molecular HAI test innovations, 2012
Table 7-11: Selected Molecular Tests For Respiratory Tract Infections
Table 7-12: Selected Molecular Tests for TB
Table 7-13: Selected Molecular Tests for Fungal Infections
Table 7-14: Selected HPV Test Innovations
Table 7-15: Selected Infectious Disease Test Services
Table 7-16: Selected Molecular POC Tests in Development
Table 7-17: Selected Infectious Disease Molecular Test Innovations
CHAPTER EIGHT: THE BLOOD SCREENING MARKET FOR INFECTIOUS DISEASES
Table 8-1: Blood Component Usage
Table 8-2: Blood Units Screened, worldwide,
Table 8-3: Laboratory Screening Of Blood Donations For Transfusion-Transmissible
Infections, Number Of Countries
Table 8-4: Testing For Common Blood Pathogens, By Date And Technology
