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The World Market for Molecular Diagnostics Tests, 10th Edition
Publication Date: June 18, 2021
Tags: Coagulation, COVID-19, Diagnostic Instruments, Genetic Diseases, Hematology, Histology and Cytology, In Vitro Diagnostics (IVD), Infectious Diseases, Molecular Diagnostics, Next-Generation Sequencing (NGS), Next-Generation Sequencing (NGS) Systems, PCR, Sequencing, Sequencing Technologies
Pages: 335
SKU: 21-028
Molecular diagnostics is a rapidly evolving and dynamic field, representing the fastest-growing segment within the in vitro diagnostics (IVD) market. It has become an indispensable tool in clinical medicine, influencing various aspects of healthcare such as early identification of antimicrobial resistant (AMR) infections, companion diagnostics for cancer treatment, pharmacokinetics for HIV, psychiatric conditions, and blood thinners, as well as cancer prognosis, organ matching, blood safety, and diagnosis of latent and neonatal conditions. Kalorama Information’s The World Market for Molecular Diagnostics Tests, 10th Edition (NGS, PCR, NAAT, ISH, TMA, Other) provides a comprehensive analysis of the global market, segmented by application and region.
Key Features of the Report:
- Global Market Segmentation: Detailed analysis of molecular diagnostics by application segments from 2021 to 2026.
- Infectious Diseases
- Blood Screening
- Histology
- Cancer Assays
- Transplant
- Inherited Diseases
- Regional Market Breakdown: Market data for molecular diagnostics segmented by major regions.
- North America (2021-2026)
- Europe (2021-2026)
- Asia Pacific (2021-2026)
- Rest of World (2021-2026)
In-Depth Analysis by Subsegments:
- Molecular Infectious Disease Diagnostics:
- Hepatitis
- HIV
- Healthcare-Associated Infections (HAIs)/Sepsis
- Human Papillomavirus (HPV)
- Chlamydia/Gonorrhea (CT/NG)
- Respiratory Diseases
- Mycobacteria/Tuberculosis (TB)
- Molecular Blood Screening Diagnostics:
- Geographic analysis of blood screening diagnostics markets.
- Molecular Histology and Cytology Diagnostics:
- Cancer
- Inherited Diseases
- Infectious/Other
- Molecular Cancer Diagnostics:
- Tissue-based tests
- Companion assays
- Prognosis and diagnosis of specific cancer types
- Molecular Transplant Diagnostics:
- HLA gene screening
- PCR-based and bead-array-based test kits
- Growing demand for NGS technologies
- Molecular Inherited Diseases Diagnostics:
- Thrombophilia (SNP tests) & Coagulation Markers
- Non-Invasive Prenatal Testing (NIPT)
- Other inherited diseases
Key Trends and Developments:
- Technological Advancements: Introduction of new technologies and products in molecular diagnostics.
- Market Growth Drivers: Factors contributing to the growth of the molecular diagnostics market, including increased demand for high sensitivity and specificity in infectious disease testing.
- Competitive Landscape: Analysis of leading industry players and their strategies, including expansions, acquisitions, and product launches.
Table: Molecular Diagnostic Market, by Category, 2021-2026 ($ millions)
| Segment | 2021 | 2026 | CAGR (%) |
| Infectious: | |||
| HAIs/ sepsis | $XX Millions | $XX Millions | XX% |
| Hepatitis | $XX Millions | $XX Millions | XX% |
| HIV | $XX Millions | $XX Millions | XX% |
| STIs | $XX Millions | $XX Millions | XX% |
| Respiratory | $XX Millions | $XX Millions | XX% |
| TB | $XX Millions | $XX Millions | XX% |
| Total Infectious, non COVID | $XX Millions | $XX Millions | XX% |
| Oncology: | |||
| Cancer Assays* | $XX Millions | $XX Millions | XX% |
| Histology (ISH, FISH) | $XX Millions | $XX Millions | XX% |
| Molecular HPV | $XX Millions | $XX Millions | XX% |
| Total Oncology | $XX Millions | $XX Millions | XX% |
| NAT Blood Screening | $XX Millions | $XX Millions | XX% |
| Genetic: | |||
| NIPT | $XX Millions | $XX Millions | XX% |
| Thrombophilia/SNPs | $XX Millions | $XX Millions | XX% |
| Pharmacogenomics | $XX Millions | $XX Millions | XX% |
| Inherited/Rare | $XX Millions | $XX Millions | XX% |
| Total Genetic | $XX Millions | $XX Millions | XX% |
| Transplantation | $XX Millions | $XX Millions | XX% |
| TOTAL | $XX Millions | $XX Millions | XX% |
| COVID | $XX Millions | $XX Millions | XX% |
| Total Market w COVID | $XX Millions | $XX Millions | XX% |
Source: Kalorama Information
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Table of Contents
Chapter One: Executive Summary
- Emerging Trends Influencing the Market Landscape
- Democratization of Molecular Testing with Sample-to-Result and POC Systems
- Impact of Molecular Diagnostics on Conventional IVD Segments
- Reimbursement Environment for Molecular Diagnostics
- Reimbursement Environment in the US
- Reimbursement Environment in Europe
- Reimbursement Environment in Canada
- Reimbursement Environment in Japan
- Reimbursement Environment in China
- Reimbursement Environment in India
- Examples of Molecular Tests that Received Positive Reimbursement Decisions
- Clinical Utility of Molecular Diagnostics
- Regulatory Status of Laboratory Developed Tests (LDTs)
- Influence of Advanced Bioinformatics and other IT platforms
- The Global Molecular Diagnostics Market
- Table 1-1: Global Markets for Molecular Diagnostics by Application Segments (2021-2026) ($, Million) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total)
Growth by Technology: The Promise of NGS, Strength of Incumbent Segments
Molecular Diagnostics Markets by Region
- North American Markets for Molecular Diagnostics
- Table 1-3: North American Markets for Molecular Diagnostics (2021-2026) ($, Million) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total)
European Markets for Molecular Diagnostics
-
- Table 1-4: European Markets for Molecular Diagnostics (2021-2026) ($, 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 (2021-2026) ($, 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 (2017-2021)
- Fast Growing NGS Demand in China
- NGS Market Outlook for APAC
Chapter Three: Markets for Molecular Infectious Disease Diagnostics
-
- Table 3-1: Selected Integrated Clinical Molecular Systems in the Market for Infectious Disease Diagnostics
- Prospects for Molecular POC Testing for Infectious Diseases Diagnostics
- Table 3-2: Selected Molecular POC Platforms in the Market for Infectious Disease Testing
- Market Analysis – Global
- Table 3-3: Global Molecular Infectious Disease Diagnostics Markets (2021-2026), By Infection ($, Million) (Hepatitis, HIV, HAIs/Sepsis, HPV, CT/NG, Respiratory diseases, Mycobacteria/TB, Other, Total)
Table 3-4: Global Molecular Infectious Disease Diagnostics Markets, by Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
CT/NG, HPV and Womenís Health
-
- Table 3-5: Global Molecular HPV Testing Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
- Table 3-6: Global Molecular CT/NG Testing Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
Hepatitis
-
- Table 3-7: Global Molecular Hepatitis Testing Markets, By Region (2021-2026) ($, 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 (2021-2026) (North America, Europe, APAC, RoW, Total)
Hospital-Acquired Infections (HAIs)
-
- Table 3-10: Global Molecular HAIs/Sepsis Testing Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total)
Respiratory Diseases
-
- Table 3-11: Global Molecular Respiratory Diseases Testing Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
Mycobacteria/Tuberculosis
-
- Table 3-12: Global Molecular Mycobacteria/TB Testing Markets, By Region (2021-2026) ($, 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 (2021-2026) (North America, Europe, APAC, RoW, Total)
Chapter Five: Markets for Molecular Histology and Cytology Diagnostics
- Market Trends in Molecular Histology Segment
- Innovation in CISH, Signal Detection and Reagent Chemistries
- Histology Automation
- Table 5-1: Global Molecular Histology and Cytology Diagnostics Markets by Application (2021-2026) ($, Million) (Cancer, Inherited diseases, Infectious/Other, Total)
- Table 5-2: Global Molecular Histology and Cytology Diagnostics Markets, by Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
- Table 5-3: Global Molecular Histology Diagnostics Markets, by Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
Chapter Six: Markets for Molecular Cancer Diagnostics
- Market Trends in Molecular Cancer Diagnostics
- Massively Parallel Sequencing in Cancer Diagnostics
- Role of Molecular Diagnostics in Hereditary Cancer Diagnosis
- Predictive Biomarker Tests for Identifying Drug-Gene Match
- Liquid Biopsy-based Non-Invasive Cancer Molecular Diagnostics
- Table 6-1: Companies Offering Liquid Biopsy-based Molecular Cancer Assays
- Molecular Diagnosis of Cancers of Unknown Primary Site (CUP)
- Evolution of Molecular Cancer Diagnostics and Current Status
- Table 6-2: Selected Molecular Companion and Complementary Assays for Cancer
- Cancer Molecular Diagnostics Markets, Global
- Table 6-3: Global Molecular Cancer Diagnostics Markets, By Region (2021-2026) ($, 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
- Table 7-1: Selected Innovations in the Field of Molecular Transplant Diagnostics
- Molecular Transplant Diagnostics, Global
- Table 7-2: Global Molecular Transplant Diagnostics Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
Chapter Eight: Markets for Molecular Inherited Diseases Diagnostics
- Thrombophilia and Coagulation Markers
- Non-Invasive Prenatal Testing (NIPT)
- Autism
- Alzheimerís Disease
- Cardiovascular Disease
- Psychiatric Disorders
- Table 8-1: Global Molecular Inherited Diseases Diagnostics Markets, By Disease Segments (2021-2026) ($, Million) (Thrombophilia [SNP tests] & Coagulation Markers, NIPT, Others, Total)
- Table 8-2: Global Molecular Inherited Diseases Diagnostics Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
Chapter Nine: Company Profiles
Abbott Diagnostics
Advanced Cell Diagnostics (Biotechne)
Agilent Technologies
Amoy Diagnostics
Applied Spectral Imaging
Becton, Dickinson & Co. (BD)
Beijing Genomics Institute (BGI)
Berry Genomics
bioMe¥rieux
Bio-Rad Laboratories
CareDx, Inc.
Danaher (Cepheid and Leica Biosystems)
Cepheid
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
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