Market Research Logo

The World Market for Infectious Disease Diagnostic Tests


Attention: There is an updated edition available for this report.

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…


  • Executive Summary
    • INTRODUCTION
    • SCOPE ANDMETHODOLOGY
      • Table Exchange Rate Fluctuations, 2009-2012
    • MARKET TRENDS
      • Table Worldwide Infectious Disease Test Sales by Type
    • IMMUNOASSAYS
      • ID/AST
      • Molecular Tests
      • Blood Banking
    • THE COMMERCIAL OUTLOOK FOR INFECTIOUS DISEASE TESTING
  • 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
  • Trends In Infectious Disease Testing
    • BACKGROUND
    • THE GLOBALIZATION OF EMERGING INFECTIOUS DISEASES
      • Drivers of Disease
        • Table Factors for the Spread of Infectious Diseases
      • Leptospirosis Threat
      • Measles Threat
      • Lyme Disease
      • WHO Surveillance
      • The Role of Vaccines
        • Table Disease Preventable Vaccines in 2013
        • Table Selected Vaccines in Development for Infectious Diseases
      • IVD Market Effect of Vaccines
      • Lyme Vaccine
      • Advance Market Commitment
      • New Era of Vaccine Discovery?
        • Table Selected Antibiotic Resistance Facts
      • Antibiotic Resistant Tests
        • Table Selected Advanced Antibiotic Resistance Tests
      • Trends For Nearer The Patient Testing
      • The Role Of Pathogens In Chronic Diseases
        • Table Selected Microorganisms And Their Associated Diseases
      • New Testing Opportunities
      • Real-time PCR
      • Sequencing
        • Table Selected Next Generation Sequencing Platforms
        • Table Selected Infectious Disease Sequencing Innovations
      • Mass Spectrometry
        • Table Selected Infectious Disease Mass Spectroscopy Innovations
      • Flow Cytometry
        • Table Selected CD4 Test Innovations
        • Table Selected Flow Cytometry Applications for Infectious Diseases
  • Market Analysis Overview
    • BACKGROUND
      • Table Per Capita Infectious Disease Test Spending, 2012
      • Regional Market Breakout
        • Table Worldwide Infectious Disease Test Sales by Type
        • Table Worldwide Infectious Disease Test Sales By Geography
      • Market in Developed Countries
      • Market in Developing Countries
      • Infectious Disease Testing Trends In The Developed World
      • Infectious Disease Testing Trends In The Developing World
        • Table Required Test Devices for Developing Countries
      • No Region Untouched
        • Table Distribution Of Curable Infectious Diseases, Worldwide
      • Diseases And Growth Opportunities, Worldwide
        • Table Disease opportunities evaluated, 2013
      • Disease Burden
        • Table Selected Disease Statistics, Worldwide, as at July 2012
      • 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
        • Table Selected Emerging Viruses
      • Top Suppliers and Niche players
        • Table Revenues of Major Infectious Disease Companies, 2012
      • biomérieux
      • BD
      • Roche
      • Thermo Fisher
      • Abbott
      • Siemens
      • Hologic
      • Bio-Rad
      • Alere
      • Qiagen
      • Cepheid
      • Others
  • The Market for Microbiology ID/AST Testing
    • BACKGROUND
      • Identification and Antibiotic Sensitivity Testing
      • Identification systems
        • Table Microbiology Sample type breakdown
    • LIQUID MICROBIOLOGY
    • MARKET ANALYSIS
      • Table Worldwide ID/AST Sales, by type
      • Table Worldwide ID/AST Sales, by Region (N. America, Western Europe, Japan, China, India, Latin America, Rest of the World)
      • Table Revenue of Selected MicrobiologyProduct Companies, 2012 (estimated)
      • Microbial Identification and Antimicrobial Sensitivity Tests
      • Chromogenic Media
        • Table Selected Chromogenic Media
      • Blood Culture
        • Table Selected Advanced Techniques For Positive Blood Cultures
      • Rapid Tests
        • Table Selected ID/AST Rapid Test Innovations
  • The Market for Immunoassays
    • BACKGROUND
    • SEPSIS SEROLOGY
      • Table Worldwide Infectious Diseases Immunoassays, By Type
      • Table Worldwide Infectious Diseases Immunoassays, by Region (N. America, Western Europe, Japan, China, India, Latin America, Rest of the World)
      • Table Company Revenues For Infectious Disease Immunoassays, Estimated 2012
      • Immunoassays - lab based
        • Table Lab-Based Infectious Disease Immunoassays, By Test, 2012, $ Million
        • Table Selected Infectious Disease Immunoassay Platform Innovation
      • Innovations
        • Table Selected Infectious Disease Immunoassay Innovations
      • Immunoassays - rapid
        • Table Worldwide Rapid Infectious Disease Immunoassay Sales, 2012
        • Table Selected Technical Innovations for POC Infectious Disease Tests
        • Table Selected Professional-use POC Tests for Infectious Diseases
      • OTC - Self Testing
        • Table Selected Infectious Diseases OTC Tests Available
        • Table Selected Infectious Diseases OTC Test Innovations
      • The Commercial Outlook for Infectious Disease Immunoassays
  • The Market for Molecular Assays
    • BACKGROUND
      • Table Selected CLIA Moderate Molecular Tests & Instruments
    • MARKET ANALYSIS
      • Table Molecular Test Sales, 2012-2017
      • Table Molecular Infectious Disease Test Revenues of Selected Vendors, 2012
      • Table Selected Molecular Test and Instrument Innovations
      • HIV
        • Table Selected Molecular HIV Test Innovations
      • Hepatitis
        • Table Selected Molecular Hepatitis Test Innovations
      • Sexually Transmitted Diseases (STDs)
        • Table Selected Molecular STD Test Innovations
      • Hospital Acquired Infections (HAIs)
        • Table Top Sources of HAI Bloodstream Infections
        • Table Top Ten HAI-causing Bacteria
        • Table Selected molecular HAI test innovations, 2012
      • Respiratory Tract Infections
        • Table Selected Molecular Tests For Respiratory Tract Infections
      • Tuberculosis
        • Table Selected Molecular Tests for TB
    • FUNGAL INFECTIONS
      • Table Selected Molecular Tests for Fungal Infections
    • HPVTESTING
      • Table Selected HPV Test Innovations
      • Service Industry
        • Table Selected Infectious Disease Test Services
      • POC trends
        • Table Selected Molecular POC Tests in Development
    • THE COMMERCIAL OUTLOOK FOR MOLECULAR INFECTIOUS DISEASE TESTING
      • Table Selected Infectious Disease Molecular Test Innovations
  • The Blood Screening Market for Infectious Diseases
    • BACKGROUND
      • Table Blood Component Usage
    • MARKET ANALYSIS
      • Table Blood Units Screened, worldwide,
      • Table Laboratory screening of blood donations for transfusion-transmissible infections, number of countries
      • Table Testing For Common Blood Pathogens, By Date And Technology
      • Immunoassay Screens
      • Nucleic Acid Testing (NAT) Continues to Grow
    • THE COMMERCIAL OUTLOOK FOR BLOOD SCREENING
  • 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
  • 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
  • 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
    • MPBIOMEDICALS 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
  • 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.
  • Company Profiles: Companies Focused on POC Assays for Infectious Disease Testing
    • ABSADVANCED 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
    • QUANTUMDXGROUP LIMITED
    • QUICKCHECK HEALTH INC.
    • RESPONSE BIOMEDICAL CORP.
    • TWISTDX LTD.
    • XAGENIC INC.
    • ZYOMYX INC
  • 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 H LABCORP)
    • MAXIM BIOMEDICAL, INC.
    • MEDICAL DIAGNOSTIC LABORATORIES L.L.C. (MDL)
    • METABOLISTICS INC.
    • QUEST DIAGNOSTICS
    • UDOTEST

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook

Share this report