Table of Contents
1: EXECUTIVE SUMMARY
INTRODUCTION
MOLECULAR DIAGNOSTIC TECHNOLOGIES
MOLECULAR DIAGNOSTICS IN HEALTHCARE
GLOBAL MOLECULAR DIAGNOSTICS MARKET
Table 1-1: Global Molecular Diagnostics Market (2016-2021) – Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Disease
Figure 1-1: Global Molecular Diagnostics Market (2016) – Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases
Figure 1-2: Global Molecular Diagnostics Market (2016-2021) – Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases
Table 1-2: Global Molecular Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 1-3: Global Molecular Diagnostics Market (2016) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 1-4: Global Molecular Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
MAJOR CONCLUSIONS
2: INTRODUCTION TO CLINICAL MOLECULAR DIAGNOSTICS
INTRODUCTION
NUCLEIC ACID AMPLIFICATION TEST (NAAT) TECHNOLOGIES
Real-Time PCR (qPCR)
Isothermal Amplification
Table 2-1: Selected Isothermal Amplification Methods and Platform Examples
Trends in Nucleic Acid Amplification Testing and Emerging Technologies
MICROARRAYS
Table 2-2: Selected Clinical Array Component and Microarray Systems
Trends in Microarray Testing
IN SITU HYBRIDIZATION (ISH)
Table 2-3: Selected Commercial In Situ Hybridization (ISH) Tests
Trends in In Situ Hybridization Testing
SEQUENCING
Table 2-4: Selected Clinical Next-Generation Sequencing Platforms
Trends in Clinical Sequencing
CONCLUSIONS
3: 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
4: MARKET FOR MOLECULAR INFECTIOUS DISEASE DIAGNOSTICS
Table 4-1: Market-Available Molecular Diagnostic Platforms – POC, Hospital and Developing World (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles)
MARKET ANALYSIS
By Test Type
Table 4-2: Global Molecular Infectious Disease Diagnostics Market (2016-2021) – Hepatitis, HIV, HAIs/Sepsis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other
Figure 4-1: Global Molecular Infectious Disease Diagnostics Market (2016) – Hepatitis, HIV, HAIs/Sepsis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other
Figure 4-2: Global Molecular Infectious Disease Diagnostics Market (2016-2021) – Hepatitis, HIV, HAIs/Sepsis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other
By Geography
Table 4-3: Global Molecular Infectious Disease Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 4-3: Global Molecular Infectious Disease Diagnostics Market (2016) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 4-4: Global Molecular Infectious Disease Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 4-5: 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
5: MARKET FOR MOLECULAR BLOOD TRANSFUSION DIAGNOSTICS
INTRODUCTION
MARKET ANALYSIS
Table 5-1: Global NAT Blood Screening Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 5-1: Global NAT Blood Screening Market (2016) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 5-2: Global NAT Blood Screening Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
Table 5-2: Commonly Tested Pathogens in Blood Screening
Figure 5-3: Global NAT Blood Screening Share (%)
NEW INFECTIOUS DISEASE THREATS AND ASSAY INTRODUCTION
CONCLUSIONS
6: MARKET FOR MOLECULAR HISTOLOGY AND CYTOLOGY DIAGNOSTICS
INTRODUCTION
MARKET ANALYSIS
Table 6-1: Global Molecular Histology Diagnostics Market (ISH, Other Direct Hybridization) by Application (2016-2021) – Genetic Disorders, Cancer, Other/Infectious
Figure 6-1: Global Molecular Histology Diagnostics Market (ISH, Other Direct Hybridization) by Application (2016) – Genetic Disorders, Cancer, Other/Infectious
Figure 6-2: Global Molecular Histology Diagnostics Market (ISH, Other Direct Hybridization) by Application (2016-2021) – Genetic Disorders, Cancer, Other/Infectious
Table 6-2: Global Molecular Histology Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 6-3: Global Molecular Histology Diagnostics Market (2016) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 6-4: Global Molecular Histology Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
RNA IN MOLECULAR HISTOLOGY
CISH AND OTHER REAGENT CHEMISTRIES
PRENATAL TESTING MOVES TO NIPT
CONCLUSIONS
7: MARKET FOR MOLECULAR CANCER DIAGNOSTICS
INTRODUCTION
BRINGING MOLECULAR RESOLUTION TO CANCER DIAGNOSTICS
TISSUE-BASED DIAGNOSTICS, COMPANION ASSAYS AND THE STATUS QUO IN IVD
Table 7-1: Major Molecular Companion and Complementary Assays for Cancer
MARKET ANALYSIS
Table 7-2: Global Molecular Cancer Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 7-1: Global Molecular Cancer Diagnostics Market (2016) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 7-2: Global Molecular Cancer Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 7-3: Global Molecular Cancer Diagnostics Market Share (%)
U.S. MARKET
EU MARKET
CHINESE MARKET
REST OF THE WORLD
CONCLUSIONS
8: MARKET FOR MOLECULAR TRANSPLANT DIAGNOSTICS
INTRODUCTION
MARKET ANALYSIS
Table 8-1: Global Molecular Transplant Diagnostics Market (2016-2021) – United States, Europe, Japan, Rest of World
Figure 8-1: Global Molecular Transplant Diagnostics Market (2016) – United States, Europe, Japan, Rest of World
Figure 8-2: Global Molecular Transplant Diagnostics Market (2016-2021) – United States, Europe, Japan, Rest of World
Figure 8-3: Global Molecular Transplant Diagnostics Market Share
TECHNOLOGICAL SHIFT TO NEXT-GENERATION SEQUENCING AND REAL-TIME PCR
CONCLUSIONS
9: MARKET FOR MOLECULAR DIAGNOSTICS IN INHERITED DISEASES
MARKET ANALYSIS
Table 9-1: Global Molecular Diagnostics Market in Inherited Diseases (2016-2021) – United States, Europe, Rest of World
Figure 9-1: Global Molecular Diagnostics Market in Inherited Diseases (2016) – United States, Europe, Rest of World
Figure 9-2: Global Molecular Diagnostics Market in Inherited Diseases (2016-2021) – United States, Europe, Rest of World
THROMBOPHILIA AND COAGULATION MARKERS
AUTISM
ALZHEIMER’S DISEASE
CARDIOVASCULAR DISEASE
DIABETES
PSYCHIATRIC DISORDERS
GASTROINTESTINAL CONDITIONS
OTHER AUTOIMMUNE DISEASES
CONCLUSIONS
10: MOLECULAR DIAGNOSTICS MARKET SUMMARY AND MAJOR CONCLUSIONS
MARKET SUMMARY
By Type
Table 10-1: Global Molecular Diagnostics Market (2016-2021) – Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases
Figure 10-1: Global Molecular Diagnostics Market (2016) – Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases
Figure 10-2: Global Molecular Diagnostics Market (2016-2021) – Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases
By Geography
Table 10-2: Global Molecular Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 10-3: Global Molecular Diagnostics Market (2016) – United States, Europe, Japan, China, Latin America, Rest of World
Figure 10-4: Global Molecular Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest of World
MAJOR CONCLUSIONS
11: COMPANY PROFILES
ABBOTT DIAGNOSTICS
Table 11-1: Abbott Diagnostics Revenue (2013-2016)
Infectious Diseases/qPCR
Cytogenetics/Oncology/FISH
Molecular ID/AST
ADVANCED CELL DIAGNOSTICS
AFFYMETRIX (THERMO FISHER SCIENTIFIC)
Table 11-2: Affymetrix Revenue (2013-2016)
AGILENT TECHNOLOGIES
Table 11-3: Agilent Technologies Revenue (FY 2013-FY 2016)
ALERE
Table 11-4: Alere Revenue (2013- 2016)
AMOY DIAGNOSTICS
APPLIED SPECTRAL IMAGING
BECKMAN COULTER (DANAHER)
BECTON, DICKINSON & CO. (BD)
Table 11-5: Becton, Dickinson & Co. (BD) Revenue (FY 2013-FY 2016)
Molecular
Histology/Cytology
Flow Cytometry
BEIJING GENOMICS INSTITUTE (BGI)
BERRY GENOMICS
BIOCARTIS
Table 11-6: Biocartis Revenue (2013-2016)
BIOMÉRIEUX
Table 11-7: bioMérieux Revenue (2013-2016)
Molecular
Sequencing
BIO-RAD LABORATORIES
Transplant Diagnostics
Molecular Diagnostic QC Products
Sequencing
BIOVIEW
Table 11-8: BioView Revenue (2013-2016)
CAREDX
Sequencing
Molecular HLA Typing
CEPHEID (DANAHER)
Table 11-9: Cepheid Revenue (2013-2016)
Hospital-Acquired Infection (HAI) Testing
Sexual Health and Women’s Health Testing
Molecular Critical Infectious Disease Testing
Molecular Oncology Testing
COVARIS
DAKO (AGILENT TECHNOLOGIES)
Table 11-10: Dako Revenue (2013-2016)
EIKEN CHEMICAL
Table 11-11: Eiken Chemical Revenue (FY 2013-FY 2016)
EPIGENOMICS
Table 11-12: Epigenomics Revenue (2013-2016)
EXOSOME DIAGNOSTICS
GENMARK DIAGNOSTICS
Table 11-13: GenMark Diagnostics Revenue (2013-2016)
GRIFOLS
Table 11-14: Grifols Diagnostic Revenue (2013-2016)
Molecular Immunohematology and Specialty Testing Services
NAT Blood Screening
HOLOGIC
Table 11-15: Hologic Revenue (FY 2013-FY 2016)
Molecular Cytology / Histology (HPV)
Other Molecular (STIs, HIV, HCV, TB, Respiratory)
Microbiology (AccuProbe Molecular Culture ID Tests)
ILLUMINA
Table 11-16: Illumina Revenue (2013-2016)
Sequencing
Translational Research
Clinical Assay Development
Industry Lab-Developed Tests
Arrays
IMMUCOR
Table 11-17: Leica Biosystems Revenue (FY 2013-FY 2016)
Transfusion Diagnostics
Transplant Diagnostics
Immucor Dx Laboratory Service
JANSSEN DIAGNOSTICS (JOHNSON & JOHNSON)
LEICA BIOSYSTEMS (DANAHER)
Table 11-18: Leica Biosystems Revenue (2013-2016)
LUMINEX CORPORATION
Table 11-19: Luminex Corporation Revenue (2013- 2016)
Business Expansion
MAGPIX Multiplexing
ARIES Molecular System
MERIDIAN BIOSCIENCE
Table 11-20: Meridian Bioscience Revenue (FY 2013-FY 2016)
NANOSPHERE (LUMINEX)
Table 11-21: Nanosphere Revenue (2013-2016)
NANOSTRING TECHNOLOGIES
Table 11-22: NanoString Technologies Revenue (2013-2016)
Clinical Diagnostics
Companion Assay Development
Research Platforms
Sequencing
QIAGEN
Table 11-23: Qiagen Revenue (2013-2016)
Molecular Infectious Disease
Cancer Diagnostics
Transplant Diagnostics
Next-Generation Sequencing
Circulating Tumor Cells
QUIDEL
Table 11-24: Quidel Revenue (2013-2016)
ROCHE DIAGNOSTICS
Table 11-25: Roche Diagnostics Revenue (2013-2016)
Molecular Diagnostics
Blood Screening
Sequencing
Liquid Biopsy
Microbiology
SIEMENS HEALTHCARE DIAGNOSTICS
THERMO FISHER SCIENTIFIC
Table 11-26: Thermo Fisher Scientific Revenue (2013-2016)
Transplant Diagnostics
qPCR
Sequencing
VELA DIAGNOSTICS
VENTANA MEDICAL SYSTEMS (ROCHE)
Table 11-27: Ventana Medical Systems Revenue (2013-2016)
