Description
Molecular diagnostics is a fast evolving and dynamic field and is the fastest growing segment within the in vitro diagnostics (IVD) market. It has become an indispensable tool in clinical medicine that touches all aspects of healthcare including treatment decisions in terms of identifying antimicrobial resistant (AMR) infections at the earliest, companion diagnostics assisting in the evaluation of suitability of various cancer treatment options, pharmacokinetics or patient metabolism of drugs for HIV, psychiatric conditions or blood thinners; cancer prognosis and therapy, organ matching, blood safety, and the diagnosis of latent and neonatal conditions. Kalorama’s The World Molecular Diagnostics Market, 8th Edition, examines the global market as well as markets by region, including:
- Global Markets for Molecular Diagnostics by Application Segments (2019-2024) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($, Million)
- Global Markets for Molecular Diagnostics by Technology Segments (2019-2024) (PCR, iNAAT, Microarrays, ISH, NGS, Other, Total) ($, Million)
- North American Markets for Molecular Diagnostics (2019-2024) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($, Million)
- European Markets for Molecular Diagnostics (2019-2024) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($, Million)
- Asia Pacific Markets for Molecular Diagnostics (2019-2024) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant , Inherited Diseases, Total) ($, Million)
Detection of active and latent patient infections by targeting genetic sequences specific to pathogens is the approach used in molecular infectious disease tests. Clinical molecular tests available for infectious disease testing offer a combination of high sensitivity, specificity and low turnaround time advantages. This has powered this segment for high market growth over other major diagnostic platforms commonly used for infectious disease testing such as immunoassay and ID/AST. Molecular detection platforms are increasingly being recognized for the improved sensitivity and specificity they can offer, even though they are more expensive. The report offers global analysis of the molecular infectious disease diagnostics segment, as well as analysis of subsegments that include CT/NG, HPV, hepatitis, HIV, HAIs, respiratory diseases, and tuberculosis:
- Global Molecular Infectious Disease Diagnostics Markets (2019-2024), By Infection (Hepatitis, HIV, HAIs/Sepsis, HPV, CT/NG, Respiratory diseases, Mycobacteria/TB, Other, Total) ($, Million)
- Global Molecular Infectious Disease Diagnostics Markets, by Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
- Global Molecular HPV Testing Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
- Global Molecular CT/NG Testing Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
- Global Molecular Hepatitis Testing Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
- Global Molecular HIV Testing Markets, By Region (North America, Europe, APAC, RoW, Total) (2019-2024) ($, Million)
- Global Molecular HAIs/Sepsis Testing Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
- Global Molecular Respiratory Diseases Testing Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
- Global Molecular Mycobacteria/TB Testing Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
As a result of concerted efforts to make blood product transfusions safer, there is an increase in antigen testing by nucleic acid test (NAT) screening to test for common pathogens. Developing countries are replacing immunoassays by molecular tests, especially for HIV, hepatitis, etc. World Molecular Diagnostics Market covers the markets for molecular blood screening diagnostics, outlining the blood testing market by geography:
- Global Molecular Blood Screening Diagnostics Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
Molecular histology, which predominantly consists of ISH tests, captures several different areas of testing including molecular cytogenetics or study of chromosomes, related techniques for the detection of pre- and post-natal genetic disorders, cancer testing, and the detection of pathogens or pathogenic activity from tissues and blood cultures. Various sub-segments within the ISH segment of molecular histology market include FISH, CISH, Rapid ISH (RISH), etc. CISH for RNA markers is increasingly used in drug development and companion diagnostics. The report analyzes key molecular histology segments:
- Global Molecular Histology and Cytology Diagnostics Markets by Application (2019-2024) (Cancer, Inherited diseases, Infectious/Other, Total) ($, Million)
- Global Molecular Histology and Cytology Diagnostics Markets, by Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
- Global Molecular Histology Diagnostics Markets, by Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
This report reviews the current makeup of the molecular diagnostics market in cancer, including its notable products and geographical segmentation. The report also reviews expected developments, such as technology and product introduction. The current market is largely composed of tissue-based tests, companion assays, and tests for the prognosis and diagnosis of specific cancer types. Some of the most significant developments in this field may have an impact in shaping cancer diagnostics and treatment management. The report examines the markets for molecular cancer diagnostics, outlining the global market by geography:
- Global Molecular Cancer Diagnostics Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
The molecular transplant diagnostics space is a competitive market with many companies offering PCR-based and bead-array-based test kits based on the HLA genes that have been characterized. The demand for NGS has been growing in the segment. An HLA test requires that some six genes are screened in parallel, with each displaying about 100 important (known) local variants. This requirement lends itself to technologies such as microarrays and sequencing that can screen for many targets. The report outlines the markets for molecular transplant diagnostics by geography:
- Global Molecular Transplant Diagnostics Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
The detection of single nucleotide polymorphisms (SNPs) or gene variants from tissue, blood, urine and saliva samples can be used to diagnose inherited diseases and genetic disorders as well as determine the risk of disease manifestation or progression. One of the major challenges facing molecular tests for gene based inherited diseases is getting stakeholders including payers, physicians, researchers and regulators to work together to close the gap between research and clinical applicability. World Molecular Diagnostics Market analyzes the developments in most significant markets within molecular inherited disease diagnostics and provides the following market data:
- Global Molecular Inherited Diseases Diagnostics Markets, By Disease Segments (2019-2024) (Thrombophilia [SNP tests] & Coagulation Markers, NIPT, Others, Total) ($, Million)
- Global Molecular Inherited Diseases Diagnostics Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total) ($, Million)
In addition to reviewing recent industry and market developments, as well as examining key market trends that are influencing the market landscape, the report looks at the molecular diagnostics industry players. The following companies are profiled:
- Abbott Diagnostics
- Advanced Cell Diagnostics (Biotechne)
- Agilent Technologies
- Amoy Diagnostics
- Applied Spectral Imaging
- Becton, Dickinson & Co. (BD)
- Beijing Genomics Institute (BGI)
- Berry Genomics
- bioMérieux
- Bio-Rad Laboratories
- CareDx, Inc.
- Danaher (Cepheid and Leica Biosystems)
- Eiken Chemical
- GenMark Diagnostics
- Genotypic Technology Pvt. Ltd.
- Grifols, S. A
- Illumina
- Immucor, Inc.
- Meridian Bioscience Inc
- Molbio Diagnostics Pvt. Ltd.
- PerkinElmer Inc.
- QIAGEN N.V.
- Quidel Corporation
- Roche Diagnostics
- Thermo Fisher Scientific Inc.
- Vela Diagnostics
Table of Contents
Chapter One: Executive Summary
Emerging Trends Influencing the Market Landscape
Democratization of Molecular Testing with Sample-to-Result and POC Systems
Impact of Molecular Diagnostics on Conventional IVD Segments
- Reimbursement Environment for Molecular Diagnostics
- Reimbursement Environment in the US
- Reimbursement Environment in Europe
- Reimbursement Environment in Canada
- Reimbursement Environment in Japan
- Reimbursement Environment in China
- Reimbursement Environment in India
- Examples of Molecular Tests that Received Positive Reimbursement Decisions
Clinical Utility of Molecular Diagnostics
Regulatory Status of Laboratory Developed Tests (LDTs)
Influence of Advanced Bioinformatics and other IT platforms
The Global Molecular Diagnostics Market
- Table 1-1: Global Markets for Molecular Diagnostics by Application Segments (2019-2024) ($, Million) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total)
- Growth by Technology: The Promise of NGS, Strength of Incumbent Segments
- Table 1-2: Global Markets for Molecular Diagnostics by Technology Segments (2019-2024) ($, Million) (PCR, iNAAT, Microarrays, ISH, NGS, Other, Total)
- Molecular Diagnostics Markets by Region
- North American Markets for Molecular Diagnostics
- Table 1-3: North American Markets for Molecular Diagnostics (2019-2024) ($, Million) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total)
- European Markets for Molecular Diagnostics
- Table 1-4: European Markets for Molecular Diagnostics (2019-2024) ($, Million) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total)
- Asia Pacific Markets for Molecular Diagnostics
- Table 1-5: Asia Pacific Markets for Molecular Diagnostics (2019-2024) ($, Million) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant , Inherited Diseases, Total)
Chapter Two: Markets by Technology Segments
Nucleic Acid Amplification Test (NAAT) Technologies
Market Trends in the Clinical NAAT Diagnostics Markets
- Decentralization of molecular tests
- Commoditization of established tests through automation and centralization
- Innovation in NAAT ñ New Biomarkers, Higher Throughput, and digital PCR
- Table 2-1: Commercially Available DNA Methylation Tests for Cancer
Real-Time PCR (qPCR)
Isothermal Nucleic Acid Amplification Technology (iNAAT)
- Table 2-2: Selected iNAAT Methods and Commercially Available Platforms
Microarrays
- Market Trends in Microarray Testing
- Molecular Immunohematology or Molecular Blood Typing
- Suspension Arrays and Others as Alternatives to Microarrays
- Table 2-3: Selected Clinical Arrays Component and Microarray Systems
In Situ Hybridization (ISH)
- Table 2-4: Selected Commercial In Situ Hybridization Tests
Market Trends in ISH
- Digital Pathology Algorithms
- Clinical RNA ISH
- Alternative ISH Probes and Reagents
Sequencing
- Table 2-5: Selected Clinical NGS Platforms in the Market
Market Trends in Clinical Sequencing
- Improvements in Miniaturization, Speed and Cost
- Evolving Informatics Solutions in Clinical Sequencing
- Sample Preparation and Quality Control
- Liquid Biopsy in NGS
- Whole Exome Sequencing (WES)
- Methylation
- Collaborations and Acquisitions: NGS Market Landscape Changing Fast
- Table 2-6: Selected Acquisitions/Collaborations in the NGS Market (2017-2019)
- Fast Growing NGS Demand in China
- NGS Market Outlook for APAC
Chapter Three: Markets for Molecular Infectious Disease Diagnostics
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- Table 3-1: Selected Integrated Clinical Molecular Systems in the Market for Infectious Disease Diagnostics
Prospects for Molecular POC Testing for Infectious Diseases Diagnostics
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- Table 3-2: Selected Molecular POC Platforms in the Market for Infectious Disease Testing
Market Analysis – Global
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- Table 3-3: Global Molecular Infectious Disease Diagnostics Markets (2019-2024), By Infection ($, Million) (Hepatitis, HIV, HAIs/Sepsis, HPV, CT/NG, Respiratory diseases, Mycobacteria/TB, Other, Total)
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- Table 3-4: Global Molecular Infectious Disease Diagnostics Markets, by Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
- CT/NG, HPV and Womenís Health
- Table 3-5: Global Molecular HPV Testing Markets, By Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
- Table 3-6: Global Molecular CT/NG Testing Markets, By Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
- Hepatitis
- Table 3-7: Global Molecular Hepatitis Testing Markets, By Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
- HIV
- Table 3-8: Innovations in Molecular POC Diagnostics for HIV
- Table 3-9: Global Molecular HIV Testing Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total)
- Hospital-Acquired Infections (HAIs)
- Table 3-10: Global Molecular HAIs/Sepsis Testing Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total)
- Respiratory Diseases
- Table 3-11: Global Molecular Respiratory Diseases Testing Markets, By Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
- Mycobacteria/Tuberculosis
- Table 3-12: Global Molecular Mycobacteria/TB Testing Markets, By Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
Chapter Four: Markets for Molecular Blood Screening Diagnostics
Declining Blood Transfusions in Developed Markets
Growing Demand in Developing Nations
New Infectious Disease Threats and Assay Introductions
- Nucleic Acid Testing Markets for Blood Screening
Blood Testing Market by Geography
- Table 4-1: Global Molecular Blood Screening Diagnostics Markets, By Region (2019-2024) (North America, Europe, APAC, RoW, Total)
Chapter Five: Markets for Molecular Histology and Cytology Diagnostics
Market Trends in Molecular Histology Segment
- RNA in Molecular Histology
- Innovation in CISH, Signal Detection and Reagent Chemistries
- Histology Automation
- Prenatal Testing Moving from FISH to NIPT
- Key Molecular Histology Application Segments
- Table 5-1: Global Molecular Histology and Cytology Diagnostics Markets by Application (2019-2024) ($, Million) (Cancer, Inherited diseases, Infectious/Other, Total)
- Table 5-2: Global Molecular Histology and Cytology Diagnostics Markets, by Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
- Table 5-3: Global Molecular Histology Diagnostics Markets, by Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
Chapter Six: Markets for Molecular Cancer Diagnostics
Market Trends in Molecular Cancer Diagnostics
- Massively Parallel Sequencing in Cancer Diagnostics
- Role of Molecular Diagnostics in Hereditary Cancer Diagnosis
- Predictive Biomarker Tests for Identifying Drug-Gene Match
- Liquid Biopsy-based Non-Invasive Cancer Molecular Diagnostics
- Table 6-1: Companies Offering Liquid Biopsy-based Molecular Cancer Assays
- Molecular Diagnosis of Cancers of Unknown Primary Site (CUP)
Evolution of Molecular Cancer Diagnostics and Current Status
- Table 6-2: Selected Molecular Companion and Complementary Assays for Cancer
Cancer Molecular Diagnostics Markets, Global
- Table 6-3: Global Molecular Cancer Diagnostics Markets, By Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
Cancer Molecular Diagnostics Markets, North America
Cancer Molecular Diagnostics Markets, Europe
Cancer Molecular Diagnostics Markets, APAC
- Japan
- China
- Table 6-4: Recent Partnerships Established between Illumina and Diagnostics Companies in China
- India
- ASEAN
Chapter Seven: Markets for Molecular Transplant Diagnostics
Technological Shift to Advanced DNA Testing Platforms
Rising Investments, Innovation, Market Consolidation, and Other Trends
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- Table 7-1: Selected Innovations in the Field of Molecular Transplant Diagnostics
Molecular Transplant Diagnostics, Global
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- Table 7-2: Global Molecular Transplant Diagnostics Markets, By Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
Chapter Eight: Markets for Molecular Inherited Diseases Diagnostics
Thrombophilia and Coagulation Markers
Non-Invasive Prenatal Testing (NIPT)
Autism
Alzheimerís Disease
Cardiovascular Disease
Psychiatric Disorders
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- Table 8-1: Global Molecular Inherited Diseases Diagnostics Markets, By Disease Segments (2019-2024) ($, Million) (Thrombophilia [SNP tests] & Coagulation Markers, NIPT, Others, Total)
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- Table 8-2: Global Molecular Inherited Diseases Diagnostics Markets, By Region (2019-2024) ($, Million) (North America, Europe, APAC, RoW, Total)
Chapter Nine: Company Profiles
Abbott Diagnostics
- The Molecular Diagnostics Business Post-Acquisition of Alere
Advanced Cell Diagnostics (Biotechne)
Agilent Technologies
Amoy Diagnostics
Applied Spectral Imaging
Becton, Dickinson & Co. (BD)
- Business Segments
- Recent Acquisitions
- Recent Divestitures
- Leading Position in the Flow Cytometry Market
- Revenue and Growth
- Molecular Diagnostics Focus
Beijing Genomics Institute (BGI)
- Complete Genomics
- Sanger Sequencing
Berry Genomics
bioMe¥rieux
Bio-Rad Laboratories
CareDx, Inc.
- Testing Services Offered by CareDx
- Products Offered by CareDx
Danaher (Cepheid and Leica Biosystems)
- Life Sciences Business
- Diagnostics Business
- Cepheid
- Leica Biosystems
- Danaherís 2018 Performance and 2019 Expectations
- Acquisitions and Divestments in 2018 / 2019
Eiken Chemical
GenMark Diagnostics
Genotypic Technology Pvt. Ltd.
Grifols, S. A
- Molecular Immunohematology and Specialty Testing Products
- NAT Blood Screening
Illumina
- Principal Products and Technologies
- Table 9-1: Illuminaís Technology Platforms and Targeted Applications
- Sequencing
- Translational Research
- Clinical Assay Development
- Lab-Developed Tests
- Arrays
Immucor, Inc.
- Transfusion Diagnostics
- Transplant Diagnostics
- Immucor Dx Laboratory Service
Meridian Bioscience Inc
Molbio Diagnostics Pvt. Ltd.
PerkinElmer Inc.
QIAGEN N.V.
- Consumables and Related Revenues
- Automation Platform and Instrumentation
- Molecular Diagnostics Applications
- Applied Testing
- Pharma and Academia
- New Developments (in 2018 until mid-2019)
- Developments in Automation Systems
- Bioinformatics Solutions
- Liquid Biopsy and Other Differentiated Sample Technologies
Quidel Corporation
Roche Diagnostics
- Global Access Program for HIV
- Core Molecular
- Coagulation
- Cobas Liat System – POC
- Blood Bank
- Transplant Medicine
- Cancer Companion Testing
- Prenatal
- Liquid Biopsy
- Partnering with Information Technology
- Product Launches in 2018
Thermo Fisher Scientific Inc.
- Transplant Diagnostics
- qPCR
- Sequencing
Vela Diagnostics
