The World Market for Molecular Diagnostics, 7th Edition (Infectious Disease, Cancer, NAT Blood Screening, Transplantation, Histology/Cytology, Inherited Diseases)

Jan 30, 2017
353 Pages - Pub ID: KLI15232978
Share this report
 
Online Download $5,500
Departmental Site License (one location, up to 10 users) $7,995
Global Site License $9,995
Now in Seven Editions: The World Market for Molecular Diagnostics 

Clinical molecular diagnostics has delivered on its promise in healthcare, demonstrating revenue growth at more than twice the rest of the IVD market. Molecular diagnostics now represents more than one-tenth of the global IVD market with a growth trajectory secured through platform innovation in lower-cost nucleic acid amplification tests (NAATs) and clinical next-generation sequencing (NGS). Kalorama Information’s The World Market for Molecular Diagnostics is now in its 7th Edition, providing an independent and authoritative view of this important market segment in clinical testing. Once esoteric, molecular tests have become routine and expanded to all levels of healthcare – from the pathology lab all the way to the doctor’s office and clinics of the developing world. Kalorama Information analyst Emil Salazar details the status of the molecular diagnostics market, as it stands in 2017.

Detailed Market Analysis Provides Needed Business Planning Information 

The market analysis in this report includes molecular diagnostics the relevant test kits, other reagents and instruments that are used for clinical testing are projected to outperform the overall in vitro diagnostics (IVD) market. As part of its coverage, the following market estimates are included in this report:
  • Molecular Diagnostics for Infectious Disease Market, 2016-2021
  • Molecular Diagnostics for Cancer Market 2016-2021
  • Molecular Diagnostics for NAT Blood Screening Market 2016-2012
  • Molecular Diagnostics for Hepatitis Market
  • HIV Molecular Diagnostics Market, 2016 to 2021
  • HAIs/Sepsis Molecular Diagnostics Market, 2016 to 2021
  • CT/NG Molecular Diagnostics Market, 2016 to 2021
  • HPV Molecular Diagnostics Market, 2016 to 2021
  • Respiratory Molecular Diagnostics Market, 2016 to 2021
  • Mycobacteria/TB Molecular Diagnostics Market, 2016 to 2021
  • Other Infectious Disease Molecular Diagnostics Market, 2016 to 2021
  • in situ hybridization (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 Molecular Diagnostics Market, 2016 to 2021
The major applications of clinical molecular diagnostics include: Infectious disease diagnostics such as 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 , which is 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; Molecular Cancer Diagnostics, which are 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; 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, as well as post-transplant monitoring. The report also covers 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

Market Share by Test Segment and Global Market Breakouts 

There are a great number of companies participating in these segments of molecular diagnostics, from molecular specialists to the top-tier IVD companies. This report offers superior detail, identifying market share not only for the overall molecular diagnostics market but for molecular test categories, including:
  • Molecular Blood Testing Market Share Analysis
  • Molecular Cancer Testing Market Share Analysis
  • Molecular Transplantation Market Share Analysis
  • Molecular Infectious Disease Market Share Analysis
  • Inherited Disease Testing Market Share Analysis
The segmented market share allows competitors and interested market-watchers to see not only how a company is performing in the overall molecular diagnostics market, but also in their specialty area. To assist in global business planning efforts, this report contains market sizing and forecasts to 2021 for major world regions including the United States, Europe, Japan, China and Latin America. Data in the report includes:
  • Molecular Blood Screening Geographic Market Segmentation ( United States, Europe, Japan, China, Latin America, Rest of World)
  • Molecular Cancer Testing Market Share ( United States, Europe, Japan, China, Latin America, Rest of World)
  • Molecular Transplantation Market Share ( United States, Europe, Japan, China, Latin America, Rest of World)
  • Molecular Infectious Disease Market Share ( United States, Europe, Japan, China, Latin America, Rest of World)
  • Inherited Disease Testing Market Share ( United States, Europe, Japan, China, Latin America, Rest of World)
Global market numbers allow companies to plan future expansion and find markets for growth.

The future of the molecular diagnostics market lies with nucleic acid amplification tests and sequencing-based tests. Time to results for real-time PCR and isothermal amplification are crucial for several infectious disease testing applications including respiratory testing, hospital-acquired infections, bloodstream infections, and molecular point-of-care tests. These trends are discussed in the report.

Superior Company Profiling 

Kalorama Information reports are designed to be focused on real world industry activities, rather than mere hypothetical business models. This makes company profiles important, as they provide a foundation for understanding what is happening in a market, and what has changed recently. This report contains profiles of major companies competing in molecular diagnostics. For each company, revenues, market share, products on the market and acquisitions and other deals are detailed. The following companies are profiled in the report:
  • Abbott Diagnostics
  • Advanced Cell Diagnostics
  • Affymetrix (Thermo Fisher Scientific)
  • Agilent Technologies
  • Alere
  • Amoy Diagnostics
  • Applied Spectral Imaging
  • Beckman Coulter (Danaher)
  • Becton, Dickinson & Co. (BD)
  • Beijing Genomics Institute (BGI)
  • Berry Genomics
  • Biocartis
  • bioMérieux
  • Bio-Rad Laboratories
  • Cepheid (Danaher)
  • Covaris
  • Dako (Agilent Technologies)
  • Eiken Chemical
  • Epigenomics
  • Exosome Diagnostics
  • Genmark Diagnostics
  • Grifols
  • Hologic
  • Illumina
  • Immucor
  • Janssen Diagnostics (Johnson & Johnson)
  • Leica Biosystems (Danaher)
  • Luminex Corporation
  • Meridian Bioscience
  • Nanosphere (Luminex)
  • Nanostring Technologies
  • Qiagen
  • Quidel
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Thermo Fisher Scientific
  • Vela Diagnostics
  • Ventana Medical Systems (Roche)
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
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
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
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
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)
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 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)

In this report, {{keyword[keywordTextProperty]}} appears {{keyword[keywordCountProperty]}} times. {{searchResults.STATRESULT.SUMMARY.KW[keywordTextProperty]}} appears {{searchResults.STATRESULT.SUMMARY.KW[keywordCountProperty]}} times.

We were unable to search inside this report.

Search for an exact word or phrase by placing the word or phrase in quotation marks ("market trend"). Search for different versions or tenses of a word by placing an asterisk at the end of the word (pharma*).

Please note that your term must be at least three characters long and numbers will be blocked by the # sign.