Description
The molecular diagnostics market, a driving force within the global in vitro diagnostics (IVD) industry, continues to thrive several years post-pandemic, offering significant growth opportunities across infectious diseases, cancer, and transplant diagnostics. Kalorama Information’s latest report, The World Market for Molecular Diagnostics, 13th Edition, provides an unparalleled deep dive into this dynamic sector, revealing key trends, applications, and innovations shaping the market from 2024 to 2029.
Why This Report is a Must-Have:
- Comprehensive Market Insights: Analyze global and regional molecular diagnostics markets, segmented by application areas such as infectious diseases, blood screening, cancer, and histology.
- Cutting-Edge Trends: Understand how technologies like Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), and ISH are transforming healthcare.
- Competitive Intelligence: Gain strategic insights into major players, including Roche Diagnostics, Thermo Fisher Scientific, and Illumina, along with emerging competitors.
- Strategic Guidance: Navigate complex markets with detailed forecasts and actionable data to identify high-growth areas and untapped opportunities.
Key Market Highlights:
- Molecular diagnostics plays a vital role in precise disease detection and treatment, from identifying antimicrobial-resistant infections to supporting personalized cancer therapies.
- The demand for molecular diagnostics is surging in both developed and emerging markets, with North America and Europe leading adoption.
- Segments like molecular infectious disease diagnostics, cancer diagnostics, and transplant diagnostics are driving innovation and growth.
With the integration of advanced molecular techniques into clinical settings, the market is poised to redefine healthcare standards globally.
Table of Contents
Chapter One: Executive Summary
Size of Molecular Diagnostics Market
- Table 1-1: Molecular Diagnostics Global Market (COVID-19 and without COVID-19), 2023 vs 2024 ($ million)
- Figure 1-1: Molecular Diagnostics Global Market (COVID-19 and without COVID-19), 2023 vs 2024 ($ million)
- Figure 1-2: Molecular Diagnostics Global Market (COVID-19 and without COVID-19), 2024 ($ million)
- Figure 1-3: Overall Molecular Diagnostics Global Market, 2023, 2024, 2029 ($ million)
Growth Areas in Molecular Diagnostics
- Table 1-2: Growth Applications, by Segment Revenue Growth, 2024-2029 (%) (Cancer Assays, Circulating Tumor Cells, HAIs/Sepsis, Hepatitis, Histology [ISH, FISH], HIV, Inherited/Genetic, Molecular HPV, NIPT, Respiratory, STIs, Transplantation, Tuberculosis [TB])
- Figure 1-4: Growth Applications, by Revenue Growth, 2024-2029 (%) (Cancer Assays, Circulating Tumor Cells, HAIs/Sepsis, Hepatitis, Histology [ISH, FISH], HIV, Inherited/Genetic, Molecular HPV, NIPT, Respiratory, STIs, Transplantation, Tuberculosis [TB])
Recent Developments
Emerging Trends
- Avian Flu
- Monkeypox
- Automation
- Molecular Point of Care
- Table 1-3: Selected Molecular POC Diagnostic Platforms, 2024
- Next-Generation Sequencing
Other Developments in Molecular Diagnostics, 2023-2024
Chapter Two: Molecular Diagnostics Market
Recent Brisk Activity
Recent Product Introductions and Regulatory Approvals
- Table 2-1: Recent Product Introductions, 2018-2024
- Table 2-2: Regulatory Approvals and Announcements, 2019-2024
Market Size and Forecast by Segments
- Table 2-3: Molecular Diagnostic Market, by Segment, 2024 and 2029 ($ million) (Circulating Tumor Cells; Genetic [Inherited/Genetic, NIPT]; Infectious: [COVID, HAIs/Sepsis, Hepatitis, HIV, Respiratory, STIs, TB, Other]; NAT Blood Screening; Oncology [Cancer Assays, Histology [ISH/FISH], Molecular HPV]; Transplantation)
- Figure 2-1: Molecular Diagnostic Market, by Segment, 2024 and 2029 ($ million) (Circulating Tumor Cells, Genetic; Infectious, NAT Blood Screening, Oncology, Transplantation)
- Figure 2-2: Infectious Molecular Diagnostic Market, Sales by Segment, 2024 and 2029 ($ million) (COVID, HAIs/Sepsis, Hepatitis, HIV, Respiratory, STIs, TB, Other)
- Figure 2-3: Infectious Molecular Diagnostic Market, by Segment Share, 2024 (%) (COVID, HAIs/Sepsis, Hepatitis, HIV, Respiratory, STIs, TB, Other)
- Figure 2-4: Genetic Molecular Diagnostic Market, Sales by Segment, 2024 and 2029 ($ million) (Inherited/Genetic, NIPT)
- Figure 2-5: Genetic Molecular Diagnostic Market, by Segment Share, 2024 (%) (Inherited/Genetic, NIPT)
- Figure 2-6: Oncology Molecular Diagnostic Market, Sales by Segment, 2024 and 2029 ($ million) (Cancer Assays, Histology [ISH/FISH], Molecular HPV)
- Figure 2-7: Oncology Molecular Diagnostic Market, by Segment Share, 2024 (%) (Cancer Assays, Histology [ISH/FISH], Molecular HPV)
- Table 2-4: Molecular Diagnostic Market, by Region, 2024 ($ million) (APAC, Europe, North America, Rest of World)
- Figure 2-8: Molecular Diagnostic Market, by Region, 2024 ($ million) (APAC, Europe, North America, Rest of World)
- Figure 2-9: Molecular Diagnostics Market Share, by Region, 2024 (%) (APAC, Europe, North America, Rest of World)
Infectious Diseases
- Table 2-5: Selected Molecular Hepatitis Tests
HIV Market and COVID-19 Impact
- Table 2-6: Selected Molecular Test Products for HIV
NAT Blood Screening
COVID-19 Impact
- Other Trends
- Declining Blood Transfusions in Developed Markets
Molecular Histology and Cytology Diagnostics
HPV
Product Developments
Markets for Molecular Cancer Diagnostics
Molecular Transplant Diagnostics
- Table 2-7: Selected Innovations in the Field of Molecular Transplant Diagnostics
Molecular Inherited Diseases Diagnostics
Thrombophilia and Coagulation Markers
Non-Invasive Prenatal Testing (NIPT)
Inherited Disease Tests
Molecular Diagnostics Market Deals, Collaborations, Acquisitions
- Table 2-8: Molecular Diagnostics Market Deals, Collaborations, Acquisitions, 2018-2024
Chapter Three: Trends to Watch – Sequencing, CRISPR, Automation
Sequencing
NGS and Companion Diagnostics
- Table 3-1: Selected Clinical NGS Platforms
Outlook for NGS in Molecular Diagnostics
- Table 3-2: Percent of the MDX Market Revenues, by Test Technique, 2024 (%) (ISH, Microarrays, NGS, PCR)
- Figure 3-1: Percent of the MDX Market Revenues, by Test Technique, 2024 (%) (ISH, Microarrays, NGS, PCR)
Evolving Informatics Solutions in Clinical Sequencing
Sample Preparation and Quality Control
Lab Automation and Molecular Diagnostics
- Table 3-3: Selected Automated/ Integrated Molecular Test Instrument Platforms
Gene Editing Applications in Molecular Diagnostics
CRISPR and Diagnostic Applications
- Table 3-4: Selected Gene Editing / CRISPR Innovations
Chapter Four: Company Profiles
Abbott Diagnostics
Company Overview
Financial Review
- Table 4-1: Abbott Diagnostics’ Revenue History, 2017-2023 ($ billion)
- Figure 4-1: Abbott Diagnostics’ Molecular Diagnostic Revenue History, 2016-Q3 2024 ($ million)
- Figure 4-2: Abbott Rapid Diagnostics Revenue History, Q4 2017-Q3 2024 ($ million)
FDA approval of Alinity m STI assay and High Risk HPV Assay
FDA approval of ALK Break Apart FISH Probe Kit
Alinity s System
WHO prequalification (PQ) approval of viral load test
Advanced Cell Diagnostics (Bio-Techne)
Company Overview
Agena Bioscience
Company Overview
Agendia BV
Company Overview
Agilent Technologies (incl. Dako)
Company Overview
Financial Review
- Figure 4-3: Agilent Diagnostics and Genomics Segment Revenues, Fiscal 2016- Q3 2024 ($ million)
Genomics
Cytogenetic Analysis
Sequencing
Altona Diagnostics
Company Overview
Amoy Diagnostics
Company Overview
Applied Spectral Imaging
Company Overview
ARUP Laboratories
Company Overview
Asuragen Inc. (Bio-Techne)
Company Overview
Becton, Dickinson & Co. (BD)
Company Overview
Business Segments
- BD Medical
- BD Life Sciences
- BD Interventional
Acquisitions
- TVA Medical, Inc.
- R. Bard, Inc.
- CareFusion Corporation
Divestitures
- Advanced Bio-processing
- Respiratory Solutions and Vyaire Medical
Leading Position in the Flow Cytometry Market
Cytology
Revenue and Growth
- Figure 4-4: BD Life Sciences Unit Quarterly Revenues, Fiscal 2018-Q4 2024 ($ million)
Molecular Diagnostics Focus
Beijing Genomics Institute (BGI)
Company Overview
PCR and Fluorescence
MGI Tech Co., Ltd.
Prenatal Testing
Test Services
Whole Genome Sequencing (WGS)
NGS Sequencing
Collaborations
Berry Genomics
Company Overview
binx health
Company Overview
Bio-Rad Laboratories, Inc.
Company Overview
Recent Revenue History
- Table 4-2: Bio-Rad Diagnostics Revenue History, 2017-2023 ($ million)
Liquid Biopsy
Droplet Digital PCR
Sequencing
Biocartis
Company Overview
Financial Review
- Table 4-3: Biocartis’ Revenue History, 2017-2023 ($ million)
Products and Technologies
Biodesix
Company Overview
bioMérieux
Company Overview
- Figure 4-5: bioMérieux’s Revenue History, Molecular Biology and Microbiology Segments, 2016-Q1 2024 (€ million)
BIOFIRE Business
Molecular Diagnostics
CareDx, Inc.
Company Overview
- Figure 4-6: CareDx Revenue, 2017-Q3 2024 ($ million)
Testing Services Offered by CareDx
- AlloMap Tests
- AlloSure Tests
- Products Offered by CareDx
Danaher
Company Overview
Danaher’s 2023 Performance
- Figure 4-7: Danaher Major Segment Revenues by Quarter, Q1 2018-Q3 2024 ($ million)
Life Sciences Business
Diagnostics Business
Cepheid
GeneXpert / Xpress Line
Tuberculosis
Microbiology
POC STI Testing
Cancer
Leica Biosystems
DiaSorin
Company Overview
Molecular Diagnostics
Molecular Oncology
Expansion
Eiken Chemical
Company Overview
Product News
Exact Sciences Corp.
Company Overview
Recent Revenues and Developments
Greiner Bio-One GmbH
Company Overview
Grifols, S. A
Company Overview
Molecular Immunohematology and Specialty Testing Products
NAT Blood Screening
Hologic, Inc.
Company Overview
- Figure 4-8: Hologic Diagnostics Revenues, Calendar Q4 2019-Q3 2024 ($ million)
- Table 4-4: Hologic’s Diagnostics Revenue History, by Segment, Fiscal 2017-2023 ($ million)
Acquisitions
PANTHER Molecular System
HIV Testing
Sexually Transmitted Infections
Infectious Diseases
Panther Fusion
Illumina, Inc.
- Table 4-5: Illumina’s Revenue History, 2015-2023 ($ million)
- Figure 4-9: Illumina’s Revenue History, 2017-Q3 2024 ($ million)
China
Meridian Bioscience Inc
Company Overview
- Figure 4-10: Meridian Bioscience Pre-Merger Revenues, Calendar Q1 2015-Q4 2022 ($ million)
Myriad Genetics, Inc.
Company Overview
- Table 4-6: Myriad Genetics Revenue History, 2017-2023 ($ million)
NanoString Technologies, Inc.
Company Overview
Oxford Nanopore Technologies Ltd
Company Overview
Promega Corporation
Company Overview
Qiagen
Company Overview
- Table 4-7: QIAGEN’s Revenue History, 2017-2023 ($ million)
Molecular Expansion
Precision Medicine / Companion Diagnostics
Molecular Microbiology
Prenatal Testing
Next Generation Sequencing
Sample Prep, Informatics
Digital PCR
Liquid Biopsy
Cervical Cancer
Expansion and Other Developments
QuantuMDx Group
Company Overview
QuidelOrtho
Company Overview
The Solana Business
Molecular – Savanna
Revvity
Company Overview
Diagnostics
Sequencing /Genomics
Liquid Biopsy
Histology
Prenatal Business
Lab Services
Rheonix, Inc.
Company Overview
Roche Diagnostics
Company Overview
Financial Review
- Figure 4-11: Roche Quarterly Molecular Diagnostics Revenues, Q1 2016-Q2 2024 ($ million)
- Table 4-8: Roche Diagnostics’ Revenue History, 2016-2023 ($ million)
Molecular Expansion
Core Molecular
Digital PCR
HPV
HIV
Coagulation
cobas Liat System – POC
Blood Bank
Transplant Medicine
Cancer Companion Testing
IT in Anatomical Pathology
Information Technology
Other Recent Developments
Seegene
Company Overview
Sekisui Diagnostics LLC
Company Overview
Sherlock Biosciences
Company Overview
Standard BioTools
Company Overview
T2 Biosystems
Company Overview
Thermo Fisher Scientific Inc.
Company Overview
- Table 4-9: Thermo Fisher Scientific Estimated Clinical Diag. and NGS Revenues, 2017-2023 ($ million)
- Table 4-10: Thermo Fisher Scientific Estimated Revenues by IVD Test Segment, 2017-2023 ($ million)
Microbiology
Molecular Test Business
Next Generation Sequencing
qPCR
Oncology Companion Diagnostics
Transplant Medicine
Microbiome
Other Collaborations and Acquisitions
Gene Editing and Cell Therapy
China
Vela Diagnostics
Company Overview
Veracyte, Inc.
Company Overview
