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World Market for Molecular Diagnostics, 14th Edition
Publication Date: December 31, 2025
Tags: Blood Banking, COVID-19, Diagnostics, Diagnostics Market Research, Genetic Diseases, Hepatitis, In Vitro Diagnostics (IVD), Infectious Diseases, Molecular, Molecular Diagnostics, Molecular Testing, Oncology and Cancer, Respiratory Diseases
Pages: 306
SKU: 25-053KA
The molecular diagnostics market remains a powerful growth engine within the global in vitro diagnostics (IVD) industry. Several years after the pandemic, demand continues to expand across infectious disease testing, cancer diagnostics, and transplant applications. Kalorama Information’s World Market for Molecular Diagnostics, 14th Edition delivers a comprehensive, data-driven analysis of this fast-evolving sector, examining the technologies, applications, and competitive dynamics shaping the market from 2025 to 2030.
As molecular techniques become increasingly integrated into routine clinical practice, this report provides essential insight into how innovations in diagnostics are enabling more precise disease detection, supporting personalized treatment strategies, and driving continued market expansion in both developed and emerging regions.
Report Features
Comprehensive Market Insights
Analyze global and regional molecular diagnostics markets at the manufacturer level, segmented by key application areas including infectious diseases, blood screening, cancer diagnostics, and histology. Market size estimates for 2025 and detailed forecasts through 2030 are provided, along with compound annual growth rates (CAGRs) for each segment.
Technology-Driven Market Evolution
Explore how core molecular technologies—including polymerase chain reaction (PCR), next-generation sequencing (NGS), and in situ hybridization (ISH)—are transforming diagnostic capabilities and expanding the role of molecular diagnostics in clinical settings worldwide.
Competitive Intelligence and Market Structure
Gain insight into the competitive landscape through profiles of major market participants such as Roche Diagnostics, Thermo Fisher Scientific, and Illumina, alongside emerging competitors. The report examines company performance, new product developments, partnerships, mergers and acquisitions, and evolving competitive strategies.
Research Parameters
World Market for Molecular Diagnostics, 14th Edition covers global and regional markets for molecular diagnostics IVD products, including systems, kits, and consumables. Market data reflect manufacturer revenues, with 2025 as the base year and forecasts extending through 2030.
The analysis is supported by extensive primary and secondary research, including interviews with IVD manufacturers, clinical laboratory professionals, and industry experts, in addition to information from government and trade publications, industry reports, company annual reports, and public filings.
Chapter One: Executive Summary
Scope and Methodology
Overview
Size of Molecular Diagnostics Market
- Table 1-1: Global Molecular Diagnostics Market, w/ and w/out COVID-19, 2025 ($ million)
- Figure 1-1: Global Molecular Diagnostics Market, w/ and w/out COVID-19, 2025 ($ million)
Growth Areas in Molecular Diagnostics
- Table 1-2: Molecular Diagnostics Growth Applications, by Revenue Growth, 2025-2030 (%) [Cancer Assays, Circulating tumor cells, HAIs/sepsis, Hepatitis, Histology (ISH, FISH), HIV, Inherited/genetic, Molecular HPV, NIPT, Respiratory, STIs, TB, Transplantation]
- Figure 1-2: Molecular Diagnostics Growth Applications, by Revenue Growth, 2025-2030 (%) [Cancer Assays, Circulating tumor cells, HAIs/sepsis, Hepatitis, Histology (ISH, FISH), HIV, Inherited/genetic, Molecular HPV, NIPT, Respiratory, STIs, TB, Transplantation]
Recent Trends and Developments
Automation
Molecular Point of Care
- Table 1-3: Selected Molecular POC Diagnostic Platforms
Next-Generation Sequencing
Avian Flu
Monkeypox
Other Developments in Molecular Diagnostics, 2024-2025
Chapter Two: Molecular Diagnostics Market
Recent Product Introductions and Regulatory Approvals
- Table 2-1: Regulatory Approvals and Announcements, January 2020-December 2025
- Table 2-2: Recent Product Introductions, January 2020-December 2024
Market Size and Forecast by Segments
- Table 2-3: Worldwide Molecular Diagnostic Market, by Segment, 2025 and 2030 ($ million) [Infectious (Respiratory, HAIs/Sepsis, Hepatitis, HIV, STIs, TB, Organism ID, Other); Oncology (Cancer Assays, Histology {SH, FISH}, Molecular HPV, Circulating Tumor Cells); NAT Blood Screening; Genetic (NIPT, Inherited/Genetic); Transplantation)]
- Table 2-4: Worldwide Molecular Diagnostic Market, by Region, 2025 ($ million) [APAC, Europe, North America, Rest of World]
- Figure 2-1: Molecular Diagnostics Market, by Region, 2025 ($ million) [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
Liquid Biopsy
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)
NIPT and Research Areas
Inherited Disease Tests
Molecular Diagnostics Market Deals, Collaborations, Acquisitions
- Table 2-8: Molecular Diagnostics Market Deals, Collaborations, Acquisitions, 2020-2025
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
- Figure 3-1: Share of the Molecular Diagnostics Market Revenues, by Test Technique, 2025 (%) [ISH, Microarrays, NGS, PCR]
Evolving Informatics Solutions in Clinical Sequencing
Sample Preparation and Quality Control
Lab Automation and Molecular Diagnostics
- Table 3-2: Selected Automated/ Integrated Molecular Test Instrument Platforms
Gene Editing Applications in Molecular Diagnostics
CRISPR and Diagnostic Applications
- Table 3-3: Selected Gene Editing / CRISPR Innovations
Chapter Four: Company Profiles
Abbott Diagnostics
Company Overview
Financial Review
- Table 4-1: Abbott Diagnostics Revenue History, by Segment, 2022-2024 ($ million)
- Figure 4-1: Abbott Diagnostics Molecular Diagnostic Revenue History, 2016-Q3 2025 ($ million)
- Figure 4-2: Abbott Rapid Diagnostics Revenue History, Q4 2017-Q3 2025 ($ million)
Corporate Background
FDA Approval of Alinity m STI Assay and High‑Risk HPV Assay
FDA Approval of ALK Break Apart FISH Probe Kit
WHO Prequalification for Viral Load Test
Products in Molecular Diagnostics
Advanced Cell Diagnostics (Bio-Techne)
Company Overview
Products and Technologies
Expansion Into Clinical Diagnostics
Industry Collaborations and Automation Partnerships
Product Enhancements and Automation Advances
Agena Bioscience
Company Overview
Agendia BV
Company Overview
Partnerships and Business Expansion
Recent Developments
Regulatory Recognition and Clinical Validation
Details on MammaPrint and BluePrint
ColoPrint
Digital Pathology and AI Collaborations
Agilent Technologies (incl. Dako)
Company Overview
Financial Review
Company Overview
- Figure 4-3: Agilent Diagnostics and Genomics Segment Revenues, Fiscal 2016-Q3 2025 ($ million)
Genomics
Cytogenetic Analysis
Sequencing
Altona Diagnostics
Company Overview
Selected EUA and IVD Launches
Amoy Diagnostics
Company Overview
Product Portfolio and Regulatory Status
Key Partnerships and Collaborations
Ongoing Expansion and Newer Collaborations
Applied Spectral Imaging
Company Overview
Molecular Clinical Diagnostics Applications
Karyotyping
ISH and FISH Applications
Digital Pathology (HiPath)
Key Partnerships and Technology Developments
ARUP Laboratories
Company Overview
COVID‑19 Response
Key Collaborations and Innovation Initiatives
Oncology and Genetic Testing Developments
Additional Partnerships and Assay Launches
Recent Launches
Asuragen Inc. (Bio-Techne)
Company Overview
Quantidex and NGS‑Related Technologies
RNA Stabilization and Sample‑Handling Technology
NGS Panel Development and Collaborations
Additional Test and Technology Releases
Acquisition
Becton, Dickinson & Co. (BD)
Company Overview
Business Segments
BD Medical
BD Life Sciences
BD Interventional
Acquisitions
Divestitures
Leading Position in Flow Cytometry
Cytology
Revenue and Growth
- Figure 4-4: BD Diagnostic Solutions Quarterly Revenues, Fiscal 2024- 2025 ($ million)
Molecular Diagnostics Focus
BD MAX System
BD Affirm and ProbeTec Platforms
BD Viper System
COVID‑19, Respiratory Panels, and Other Recent Developments
Beijing Genomics Institute (BGI)
Company Overview
PCR and Fluorescent Diagnostics
MGI Tech Co., Ltd.
Prenatal Testing
Test Services
Notable Research and Partnerships
Whole Genome Sequencing (WGS) Initiatives
Regulatory Approvals
NGS Sequencing and Metagenomics
Collaborations
Berry Genomics
Company Overview
NIPT and Genetic Disease Testing
Strategic Partnerships and Technology Development
Expansion of Sequencing Capabilities
binx health
Company Overview
The io Platform
Pipeline and Additional Tests
Regulatory and Commercial Milestones
Partnerships
Bio-Rad Laboratories, Inc.
Key Comment
Company Overview
Recent Revenue History
- Table 4-2: Bio-Rad Diagnostics Revenue History, 2020-2024 ($ million)
Acquisitions and Partnerships
Key Product Launches and Regulatory Approvals
QX One ddPCR System
Liquid Biopsy and Oncology Diagnostics
QC and Control Products
Liquid Biopsy and CTC Technologies
Digital PCR Leadership
Sequencing Collaboration with Illumina
Biocartis
Company Overview
Strategic Partnerships and Collaborations
Immuno‑Oncology and CDx Partnerships
Assay Development and Commercialization Agreements
Financial Review
- Table 4-3: Biocartis’ Revenue History, 2017-2023 ($ million)
Products and Technologies
Menu Expansion and Assay Development
Additional Commercial and Regulatory Milestones
Biodesix
Company Overview
VeriStrat® Proteomic Test
GeneStrat® Liquid Biopsy Test
Research Partnerships and Collaborations
Technology Platforms
bioMérieux
Company Overview
- Figure 4-5: bioMérieux’s Revenue History by Quarter, Molecular Biology and Microbiology Segments, 2016-Q3 2025 (€ million)
BIOFIRE Business
Molecular Diagnostics
Centralized Lab Molecular Portfolio
Isothermal Testing (NASBA)
FilmArray – Impact on Molecular Diagnostics
NGS‑Based Epidemiology
CareDx, Inc.
Company Overview
- Figure 4-6: CareDx Revenue, 2017-Q3 2025 ($ million)
2022–2025 Developments
Testing Services Offered by CareDx
AlloMap®
AlloSure®
Products Gained Through Allenex Acquisition
Regulatory and Legal Updates
Danaher
Company Overview
Revenue Performance
Revenue by Segment
- Figure 4-7: Danaher Major Segment Revenues, by Quarter, Q1 2018-Q3 2025 ($ million)
Life Sciences Business
Diagnostics Business
Cepheid
GeneXpert / Xpress Line
Tuberculosis
Microbiology
Point‑of‑Care STI Testing
Cancer
Leica Biosystems
Digital Pathology (Aperio)
Strategic Partnerships and Collaborations
Recent Organizational and Technology Milestones
DiaSorin
Company Overview
Expansion into Molecular Diagnostics
Regulatory Milestones and Product Approvals
Growth Strategy
LIAISON IAM and LIAISON IXT Platforms
Corporate Transactions
Molecular Diagnostics Portfolio
Key Regulatory Milestones
Molecular Oncology
Expansion Activities
Eiken Chemical
Company Overview
LAMP Technology and Molecular Platform
Global Impact and Licensing
Product News
Fecal Occult Blood and Microbiology Products
Strategic Partnerships and NGS Development
Greiner Bio-One GmbH
Company Overview
Genspeed R2 Analyzer and Molecular Diagnostics
System Features
Available CE‑IVD Assays
oCheck Diagnostic Product Line
PapilloCheck®
Corporate Updates and Strategic Moves
Grifols, S. A
Company Overview
Expansion Through Acquisitions and Investments
Molecular Immunohematology and Specialty Testing (Progenika)
Procleix NAT Blood Screening
Platforms
Procleix Assays
Recent Approvals
Additional Corporate Developments
Hologic, Inc.
Company Overview
- Figure 4-8: Hologic Diagnostics Revenues, Calendar Q4 2019 -Q3 2025 ($ million)
- Table 4-4: Hologic’s Diagnostics Revenue History, Fiscal 2019-2025 ($ million)
Acquisitions
Panther Molecular System
Panther Assay Menu (U.S.)
Panther Assay Menu (Europe)
Panther Trax (2021)
Panther Fusion
Open Access (LDT Capability)
HIV Testing
Sexually Transmitted Infections
Infectious Diseases
Illumina, Inc.
Company Overview
- Table 4-5: Illumina’s Revenue History, 2016-2024 ($ million)
- Figure 4-9: Illumina’s Revenue History, 2017-Q3 2024 ($ million)
Sequencing Systems and Clinical Expansion
Systems and Products
MiSeq
MiSeqDx
iSeq 100
NovaSeq Series
Long‑Read Technology
Recent International Approvals
COVIDSeq
Companion Diagnostics, cfDNA, and Liquid Biopsy
TruSight Oncology 500 (TSO 500)
VeriSeq NIPT Solution v2
TruSight Oncology 500 ctDNA
TruSight Tumor 170
Pan‑Cancer CDx (2022)
Strategic Collaborations and Deals
Roche Partnership (January 2020)
PierianDx Collaboration (January 2019)
Frederick National Lab / NCI Studies (2019)
QIAGEN Partnership (October 2019)
Imagia AI Collaboration (June 2020)
BlueBee Acquisition (June 2020)
Pacific Biosciences Merger Termination (January 2020)
GRAIL Acquisition and Divestiture (2020–2024)
Precision Oncology Partnerships (2021–2023)
Pillar Biosciences Partnership (August 2023)
Single‑Cell Sequencing Partnership with Bio‑Rad
CareDx Licensing Agreement
Illumina in China
Key Developments
Meridian Bioscience Inc
Company Overview
- Figure 4-10: Meridian Bioscience Pre-Merger Revenues, Calendar Q1 2015-Q4 2022 ($ million)
Life Science Business
Clinical Diagnostics Portfolio
Diagnostic Platforms
FDA‑Cleared Alethia Assays
Gastrointestinal and Pediatric Strength
Regulatory and Product Milestones (2018–2025)
Merger
NanoString Technologies, Inc.
Company Overview
Technology and Core Platforms
nCounter System Features
Specialized Assays
Spatial Biology Portfolio
GeoMx Digital Spatial Profiler (DSP) – Launched March 2019
CosMx SMI Platform
Additional Product and Research Milestones
Corporate Partnerships and Licensing
Transplant Diagnostics (2020)
Cloud and Data Analysis
High‑Throughput SARS‑CoV‑2 Testing
Diagnostic Platform Licensing
Illumina Accelerator Partnership (March 2021)
New Oncology and Immune Panels
New Platforms and Data‑Integration Tools
Acquisition by Bruker
Oxford Nanopore Technologies Ltd
Company Overview
Promega Corporation
Company Overview
Companion Diagnostics and MSI Portfolio
Strategic Partnerships and Technology Licensing
Research Tools and Product Portfolio
Molecular Diagnostics and Infectious Disease
OncoMate MSI Dx System
Qiagen
Company Overview
- Table 4-6: QIAGEN’s Revenue History, 2018-2024 ($ million)
Molecular Expansion Strategy
QIAstat‑Dx System Features
Regulatory and Portfolio Expansion
Next‑Generation Syndromic Testing Systems
NeuMoDx System Discontinuation
Precision Medicine / Companion Diagnostics
Key Regulatory and Partnership Milestones (2019–2023)
Molecular Microbiology
New artus and Molecular Assays
QIAstat‑Dx Menu Expansion
Prenatal Testing
PartoSure
Next‑Generation Sequencing Portfolio
NGS Product Development Timeline
Sample Prep and Informatics
Digital PCR
Liquid Biopsy
Cervical Cancer Portfolio
Expansion and Additional Developments
Antimicrobial Resistance (AMR) Informatics
Apis Assay Technologies Partnership
China Market Strategy
Immuno‑Oncology Assets
Key Regulatory Events
Digital PCR Clinical Expansion
Recent Product Introductions
IVDR Milestone
Thermo Fisher Acquisition Attempt (2020)
Other Industry Partnerships
QuidelOrtho
Company Overview
Lyra Platform
Solana Molecular Platform
Key Solana Features
Solana Assay Menu
Regulatory Milestones
Revvity
Company Overview
Prenatal and Maternal Health Solutions
Key Acquisitions Supporting Screening and Genomics
Diagnostics Division
Sequencing and Genomics
GenePrism: Actionable Insights
Key Genomics Collaborations
Liquid Biopsy
Histology and Spatial Pathology
Prenatal Screening and NIPT Portfolio
Key Products and Milestones
Laboratory Services
U.S. Operations
WGS Expansion via ViaCord
Roche Diagnostics
Company Overview
Financial Review
- Figure 4-11: Roche Quarterly Molecular Diagnostics Revenues, Q1 2016-Q3 2025 (CHF M)
- Table 4-7: Roche Diagnostics’ Revenue History, 2022-2024 ($ million)
Roche Tissue Diagnostics
Molecular Expansion
Core Molecular Systems
December 2025 – cobas 6800/8800 Version 2.0
Respiratory Flex Panel and TAGS Technology
Assay Menu
Regulatory Highlights
Digital PCR
HPV
Additional Milestones
HIV
Coagulation
cobas Liat – Point‑of‑Care PCR
Key Regulatory Milestones
Blood Bank / Donor Screening
Key NAT and Donor‑Screening Tests
Transplant Medicine
Cancer Companion Testing
Foundation Medicine Partnership
Key Timeline of CDx Approvals
IT in Anatomical Pathology
Key Roche Digital Pathology Milestones
Information Technology
Other Recent Developments
Seegene
Company Overview
Syndromic Panels and Global Expansion
Seegene’s Proprietary Diagnostic Systems
CE‑Marked Assays
qTOCE Quantitative Multiplex Assays
Additional CE‑Marked Solutions
Automation and New Product Development
Sekisui Diagnostics LLC
Company Overview
Coagulation Business Transitions
POC and Molecular Testing Portfolio
Silaris Molecular POC System
Acucy Influenza A&B
OSOM Ultra Plus Flu A&B
Recent Partnerships and Product Launches
Aptitude Metrix Platform
Acucy Influenza A&B System Update
Metrix COVID/Flu Test
Sherlock Biosciences
Company Overview
Product Development and Technology
Corporate Growth, Investments, and Acquisitions
Partnerships and Collaborations
CRISPR‑Based COVID‑19 and STI Testing
Licensing and Technology Exchange
Global Health Collaborations
Standard BioTools
Company Overview
Microfluidics and PCR Systems
Key Technology Platforms
C1 and REAP‑Seq
Imaging Mass Cytometry (IMC)
Maxpar Direct Immune Profiling System
Advanta Solid Tumor NGS Assay
IMC Expansion
Acquisitions
Pathology and Sample‑Prep Advances
Global Partnerships
New Microfluidics and PCR Systems
Biomark X
Company Rebranding
X9 Real‑Time PCR System
Imaging Mass Cytometry – Hyperion XTi
Thermo Fisher Scientific Inc.
Company Overview
- Table 4-8: Thermo Fisher Scientific Estimated Clinical Diag. and NGS Revenues, 2018-2024 ($ million)
Geographic Profile and Strategic Expansion
Attempted Acquisition of QIAGEN (2020)
Microbiology
Molecular Test Business
Siemens Partnership (2016–2024)
QuantStudio 5 Dx (2021)
Recent Diagnostic Product Launches
Next Generation Sequencing
Key NGS Collaborations & Milestones
qPCR
Oncology Companion Diagnostics
CDx Timeline
Transplant Medicine
Microbiome
Other Collaborations and Acquisitions
Mesa Biotech Overview (Accula Platform)
Gene Editing and Cell Therapy
China
Vela Diagnostics
Company Overview
Product and Panel Launches
Regulatory Milestones
Technology Licensing and Development
Acquisitions and Global Expansion
Great Basin Scientific Acquisition (June 2018)
Middle East Expansion (November 2018)
Corporate History and Investment
Veracyte, Inc.
Company Overview
Strategic Partnerships, Collaborations & Product Expansions
Lung Cancer Diagnostics
Transplant Diagnostics & nCounter Platform
COVID‑19 and High‑Throughput Sequencing
Regulatory Milestones
Acquisitions and Portfolio Growth
International Reimbursement and Market Expansion
Additional Collaborations
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