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The World Molecular Diagnostics Market - 7th Edition (HIV Testing, Hepatitis Testing, Molecular Cancer Tests, Blood Screening, Hospital-Acquired Tests, RSV, CT/NG, HPV, Inherited Diseases, ISH)

World Molecular Diagnostics Market

This Kalorama Information report, The World Molecular Diagnostics Market, examines the current state for molecular assays, including cancer tests, NAT blood screening, transplantation testing, histology testing and inherited disease testing. Market size and forecasts are provided to 2021 for major segments and several subsegments. Profiles of operators and market share is provided.


As part of its coverage, the following market estimates are included in this report:

  Microbiology Market, 2016-2021
  Oncology Testing Market 2016-2021
  Blood Screening Market 2016-2012
  Infectious Disease Molecular Diagnostics Markets:
     Hepatitis Test Market
     HIV Diagnostics Market, 2016 to 2021
     HAIs/Sepsis Market, 2016 to 2021
     CT/NG Diagnostics Market, 2016 to 2021
     HPV Diagnostics Market, 2016 to 2021
     RSV Diagnostics Market, 2016 to 2021
     Mycobacteria/TB Molecular Diagnostics Market, 2016 to 2021
     Other Infectious Disease Molecular Diagnostics Market, 2016 to 2021
  ISH Market by Application: Genetic, Cancer, Other, 2016 to 2021
  Other Histology Molecular Diagnostics Market, 2016 to 2021
  Inherited Diseases Molecular Diagnostics Market, 2016 to 2021
  Transplant Diagnostics Market, 2016 to 2021
 

The major applications of clinical molecular diagnostics include the following:

Infectious disease diagnostics - molecular microbiology and virology, including the detection, identification, quantification and nucleic-acid based resistance or susceptibility profiling of pathogens
Blood transfusion diagnostics - nucleic acid screening (NAT) of donated blood, often pooled samples, for the detection of active infections responsible for transfusion transmitted infections (TTIs); ancillary market for molecular immunohematology or blood typing
Histology / cytology diagnostics - largely synonymous with in situ hybridization (ISH) methods that use direct hybridization of chromogenic (CISH) or fluorescent (FISH) nucleic acid probes within slided tissue or suspended cell samples viewed under microscopy; ISH applications primarily include cancer testing and cytogenetics or chromosomal study
Cancer diagnostics - tissue, blood and urine samples can be assayed using nucleic acid amplification tests (NAATs) or sequencing to diagnose, prognose and identify key mutations for targeted therapies; future additional capabilities are premised on liquid biopsy sampling (non-invasive fluid samples such as venous blood or urine) and next-generation sequencing (NGS) and include early cancer detection (including recurrence), therapy monitoring (remission)
Transplant diagnostics - various PCR-based methodologies, Sanger sequencing and NGS used to type HLA alleles in low to high resolution in order to match donors and recipients for solid organ and hematopoietic stem cell (HSCT) or bone marrow transplants; post-transplant monitoring including for transplant rejection is an ancillary testing area
Inherited disease diagnostics - diagnosis of rare genetic diseases and other inherited traits including pharmacodiagnostic (pharmacokinetic) traits; major area of application is thrombophilia markers and anticoagulant response markers


All of these areas are covered in Kalorama Information's 7th Edition report.   

Advantages of Kalorama Information's report include:

- Market Share Analysis - This report contains market share analysis for each segment of molecular diagnostics.  (inherited diseases contains a great number of tests, and thus key players in disease areas are discussed rather than market share computation).
- Company Profiles - the report fully functions as a benchmarking tool, providing recent revenue performance, product launches, acquisitions for every significant competitor in the market. 
-Forecasts for each category of the market.   
-Industry Focus - Kalorama reports are industry-focused, they are based on events in the industry and not on academic configurations or economic models. 
-Expert Analyst - Kalorama reports are written by an expert group of analysts with combined decades of experience in IVD, biotech and medical device markets.  These analysts are able to read between the lines, triangulate hard to discover data and sort through company hype.  
-Healthcare only focus - Kalorama publishes only in healthcare.  We track these markets on a regular basis and have sources in the industry that other competitors are too scattered in focus to maintain.  Our brand as a top IVD, biotech and medical device market research publisher enables us to have unbiased conversations with industry and to provide independent analysis that in-house company research cannot produce.  


  • Executive Summary
    • Introduction
    • Molecular Diagnostic Technologies
    • Molecular Diagnostics in Healthcare
    • Global Molecular Diagnostics Market
      • Table Global Molecular Diagnostics Market (2016-2021) –Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases ($ millions)
      • Table Global Molecular Diagnostics Market (2016) –Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases ($ millions)
      • Table Global Molecular Diagnostics Market (2016-2021) –Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases ($ millions)
      • Table Global Molecular Diagnostics Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Diagnostics Market (2016) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Diagnostics Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
    • Major Conclusions
  • Introduction to Clinical Molecular Diagnostics
    • Introduction
    • Nucleic Acid Amplification Test (NAAT) Technologies
      • Real-Time PCR (qPCR)
      • Isothermal Amplification
        • Table Selected Isothermal Amplification Methods and Platform Examples Amplification Method Examples (pathogen detected)
      • Trends in Nucleic Acid Amplification Testing and Emerging Technologies
    • Microarrays
      • Table Selected Clinical Array Component and Microarray Systems
      • Trends in Microarray Testing
    • In Situ Hybridization (ISH)
      • Table Selected Commercial In Situ Hybridization (ISH) Tests
      • Trends in In Situ Hybridization Testing
    • Sequencing
      • Table Selected Clinical Next-Generation Sequencing Platforms
      • Trends in Clinical Sequencing
    • Conclusions
  • Molecular Diagnostics in Healthcare
    • Introduction
    • Reimbursement Environment for Molecular Diagnostics
    • Molecular Diagnostics and the Clinical Utility Standard
    • Laboratory-Developed Tests Are Here to Stay
    • Conclusions
  • Market for Molecular Infectious Disease Diagnostics
    • Table Market-Available Molecular Diagnostic Platforms - POC, Hospital and Developing World (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles)
    • Market Analysis
      • Table Global Molecular Infectious Disease Diagnostics Market (2016-2021) –Hepatitis, HIV, HAIs/Sepsis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other ($ millions)
      • Table Global Molecular Infectious Disease Diagnostics Market (2016) - Hepatitis, HIV, HAIs/Sepsis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other ($ millions)
      • Table Global Molecular Infectious Disease Diagnostics Market (2016-2021) –Hepatitis, HIV, HAIs/Sepsis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other ($ millions)
      • Table Global Molecular Infectious Disease Diagnostics Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Infectious Disease Diagnostics Market (2016) - United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Infectious Disease Diagnostics Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Infectious Disease Diagnostics Market Share - Abbott Diagnostics, BD, bioMérieux, Cepheid, Hologic, Qiagen, Roche Diagnostics, Siemens Healthcare Diagnostics, Others (%)
    • CT/NG, HPV and Women's Health
    • Hepatitis
    • HIV
    • Hospital-Acquired Infections (HAIs) and Sepsis
    • Respiratory
    • Tuberculosis
    • Conclusions
  • Market for Molecular Blood Transfusion Diagnostics
    • Introduction
    • Market Analysis
      • Table NAT Blood Screening Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global NAT Blood Screening Market (2016) - United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global NAT Blood Screening Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Commonly Tested Pathogens in Blood Screening
      • Table Global NAT Blood Screening Share - Grifols, Roche Diagnostics, Others (%)
    • New Infectious Disease Threats and Assay Introduction
    • Conclusions
  • Market for Molecular Histology and Cytology Diagnostics
    • Introduction
    • Market Analysis
      • Table Global Molecular Histology Diagnostics Market (ISH, Other Direct Hybridization) by Application (2016- 2021) –Genetic Disorders, Cancer, Other/Infectious ($ millions)
      • Table Global Molecular Histology Diagnostics Market (ISH, Other Direct Hybridization) by Application (2016) - Genetic Disorders, Cancer, Other/Infectious ($ millions)
      • Table Global Molecular Histology Diagnostics Market (ISH, Other Direct Hybridization) by Application (2016- 2021) –Genetic Disorders, Cancer, Other/Infectious ($ millions)
      • Table Global Molecular Histology Diagnostics Market (2016-2021) - United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Histology Diagnostics Market (2016) - United States, Europe, Japan,China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Histology Diagnostics Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
    • RNA in Molecular Histology
    • CISH and Other Reagent Chemistries
    • Prenatal Testing moves to NIPT
    • Conclusions
  • Market for Molecular Cancer Diagnostics
    • Introduction
    • Bringing Molecular Resolution to Cancer Diagnostics
    • Tissue-Based Diagnostics, Companion Assays and the Status Quo in IVD
      • Table Major Molecular Companion and Complementary Assays for Cancer
    • Market Analysis
      • Table Global Molecular Cancer Diagnostics Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Cancer Diagnostics Market (2016) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Cancer Diagnostics Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Cancer Diagnostics Market Share - Roche Diagnostics, Illumina, Qiagen, Others (%)
    • U.S. Market
    • EU Market
    • Chinese Market
    • Rest of the World
    • Conclusions
  • Market for Molecular Transplant Diagnostics
    • Introduction
    • Market Analysis
      • Table Global Molecular Transplant Diagnostics Market (2016-2021) –United States, Europe, Japan, Rest of World ($ millions)
      • Table Global Molecular Transplant Diagnostics Market (2016) –United States, Europe, Japan, Rest of World ($ millions)
      • Table Global Molecular Transplant Diagnostics Market (2016-2021) –United States, Europe, Japan, Rest of World ($ millions)
      • Table Global Molecular Transplant Diagnostics Market Share - Thermo Fisher Scientific, Immucor, CareDx, Others (%)
    • Technological Shift to Next-Generation Sequencing and Real-Time PCR
    • Conclusions
  • Market for Molecular Diagnostics in Inherited Diseases
    • Market Analysis
      • Table Global Molecular Diagnostics Market in Inherited Diseases (2016-2021) - United States, Europe, Rest of World ($ millions)
      • Table Global Molecular Diagnostics Market in Inherited Diseases (2016) –United States, Europe, Rest of World ($ millions)
      • Table Global Molecular Diagnostics Market in Inherited Diseases (2016-2021) –United States, Europe, Rest of World ($ millions)
    • Thrombophilia and Coagulation Markers
    • Autism
    • Alzheimer's Disease
    • Cardiovascular Disease
    • Diabetes
    • Psychiatric Disorders
    • Gastrointestinal Conditions
    • Other Autoimmune Diseases
    • Conclusions
  • Molecular Diagnostics Market Summary and Major Conclusions
    • Market Summary
      • Table Global Molecular Diagnostics Market (2016-2021) –Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases ($ millions)
      • Table Global Molecular Diagnostics Market (2016) –Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases ($ millions)
      • Table Global Molecular Diagnostics Market (2016-2021) –Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases ($ millions)
      • Table Global Molecular Diagnostics Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Diagnostics Market (2016) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
      • Table Global Molecular Diagnostics Market (2016-2021) –United States, Europe, Japan, China, Latin America, Rest of World ($ millions)
    • Major Conclusions
  • Company Profiles
    • Abbott Diagnostics
      • Table Abbott Diagnostics Revenue (2013-2016) ($ millions)
      • Infectious Diseases/qPCR
      • Cytogenetics/Oncology/FISH
      • Molecular ID/AST
    • Advanced Cell Diagnostics
    • Affymetrix (Thermo Fisher Scientific)
      • Table Affymetrix Revenue (2013-2016) ($ millions)
    • Agilent Technologies
      • Table Agilent Technologies Revenue (FY 2013-FY 2016) ($ millions)
    • Alere
      • Table Alere Revenue (2013- 2016) ($ millions)
    • Amoy Diagnostics
    • Applied Spectral Imaging
    • Beckman Coulter (Danaher)
    • Becton, Dickinson & Co. (BD)
      • Table Becton, Dickinson & Co. (BD) Revenue (FY 2013-FY 2016) ($ millions)
      • Molecular
      • Histology/Cytology
      • Flow Cytometry
    • Beijing Genomics Institute (BGI)
    • Berry Genomics
    • Biocartis
      • Table Biocartis Revenue (2013-2016) ($ millions)
    • bioMérieux
      • Table bioMérieux Revenue (2013-2016) ($ millions)
      • Molecular
      • Sequencing
    • Bio-Rad Laboratories
      • Transplant Diagnostics
      • Molecular Diagnostic QC Products
      • Sequencing
    • BioView
      • Table BioView Revenue (2013-2016) ($ millions)
    • CareDx
      • Sequencing
      • Molecular HLA Typing
    • Cepheid (Danaher)
      • Table Cepheid Revenue (2013-2016) ($ millions)
      • Molecular Hospital-Acquired Infection (HAI) Testing
      • Molecular Sexual Health and Women's Health Testing
      • Molecular Critical Infectious Disease Testing
      • Molecular Oncology Testing
    • Covaris
    • Dako (Agilent Technologies)
      • Table Dako Revenue (2013-2016) ($ millions)
    • Eiken Chemical
      • Table Eiken Chemical Revenue (FY 2013-FY 2016) ($ millions)
    • Epigenomics
      • Table Epigenomics Revenue (2013-2016) ($ millions)
    • Exosome Diagnostics
    • GenMark Diagnostics
      • Table GenMark Diagnostics Revenue (2013-2016) ($ millions)
    • Grifols
      • Table Grifols Diagnostic Revenue (2013-2016) ($ millions)
      • Molecular Immunohematology and Specialty Testing Services
      • NAT Blood Screening
    • Hologic
      • Table Hologic Revenue (FY 2013-FY 2016) ($ millions)
      • Molecular Cytology / Histology (HPV)
      • Other Molecular (STIs, HIV, HCV, TB, Respiratory)
      • Microbiology (AccuProbe Molecular Culture ID Tests)
    • Illumina
      • Table Illumina Revenue (2013-2016) ($ millions)
      • Sequencing
      • Translational Research
      • Clinical Assay Development
      • Industry Lab-Developed Tests
      • Arrays
    • Immucor
      • Table Immucor Revenue (FY 2013-FY 2016) ($ millions)
      • Transfusion Diagnostics
      • Transplant Diagnostics
      • Immucor Dx Laboratory Service
    • Janssen Diagnostics (Johnson & Johnson)
    • Leica Biosystems (Danaher)
      • Table Leica Biosystems Revenue (2013-2016) ($ millions)
    • Luminex Corporation
      • Table Luminex Corporation Revenue (2013- 2016) ($ millions)
      • Business Expansion
      • MAGPIX Multiplexing
      • ARIES Molecular System
    • Meridian Bioscience
      • Table Meridian Bioscience Revenue (FY 2013-FY 2016) ($ millions)
    • Nanosphere (Luminex)
      • Table Nanosphere Revenue (2013-2016) ($ millions)
    • NanoString Technologies
      • Table NanoString Technologies Revenue (2013-2016) ($ millions)
      • Clinical Diagnostics
      • Companion Assay Development
      • Research Platforms
      • Sequencing
    • Qiagen
      • Table Qiagen Revenue (2013-2016) ($ millions)
      • Molecular Infectious Disease
      • Cancer Diagnostics
      • Transplant Diagnostics
      • Next-Generation Sequencing
      • Circulating Tumor Cells
    • Quidel
      • Table Quidel Revenue (2013-2016) ($ millions)
    • Roche Diagnostics
      • Table Roche Diagnostics Revenue (2013-2016) ($ millions)
      • Molecular Diagnostics
      • Blood Screening
      • Sequencing
      • Liquid Biopsy
      • Microbiology
    • Siemens Healthcare Diagnostics
    • Thermo Fisher Scientific
      • Table Thermo Fisher Scientific Revenue (2013-2016) ($ millions)
      • Transplant Diagnostics
      • qPCR
      • Sequencing
    • Vela Diagnostics
    • Ventana Medical Systems (Roche)
      • Table Ventana Medical Systems Revenue (2013-2016) ($ millions)

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