Molecular Diagnostics at the Point of Care. By Application, Technology, Place, Product and by Country. With Executive Guides and Analysis 2026 - 2030

Table of Contents

1 Market Guides

• 1.1 Strategic Situation Analysis
  • 1.1.1 Strategic Role in Rapid Clinical Decision-Making
  • 1.1.2 Technology Platforms and Innovation
  • 1.1.3 Cost Structure and Economic Considerations
  • 1.1.4 Test Menu Expansion and Clinical Utility
  • 1.1.5 Regulatory and Quality Requirements
  • 1.1.6 Competition from Centralized Laboratory Testing
  • 1.1.7 Workflow Integration and Ease of Use
  • 1.1.8 Competitive Landscape and Industry Structure
  • 1.1.9 Geographic Market Dynamics
  • 1.1.10 Outlook and Strategic Implications
• 1.2 Guide for Executives, Marketing and Business Development Staff
• 1.3 Guide for Management Consultants and Investment Advisors
• 1.4 Impact of Artificial Intelligence

2 Introduction and Market Definition

• 2.1 What are Molecular Diagnostics at the Point of Care?
• 2.2 The Diagnostics Revolution
• 2.3 Market Definition
  • 2.3.1 Revenues
• 2.4 Methodology
  • 2.4.1 Methodology
  • 2.4.2 Sources
  • 2.4.3 Authors
• 2.5 Perspective: Healthcare Spending
  • 2.5.1 Global Healthcare Spending
  • 2.5.2 Spending on Healthcare and Pharmaceuticals
  • 2.5.3 Spending on Diagnostics
  • 2.5.4 Important Role of Insurance for Medical Services

3 Instrumentation, Automation and Diagnostic Trends

• 3.1 Instrumentation and Automation
  • 3.1.1 Traditional Automation and Centralization
  • 3.1.2 The New Automation, Decentralization and Point Of Care
  • 3.1.3 Instruments Key to Market Share
  • 3.1.4 Bioinformatics Plays a Role
  • 3.1.5 PCR Takes Command
  • 3.1.6 Next Generation Sequencing Fuels a Revolution
  • 3.1.7 NGS Impact on Pricing
  • 3.1.8 Whole Genome Sequencing, A Brave New World
  • 3.1.9 Companion Diagnostics Blurs Diagnosis and Treatment

4 Industry Overview

• 4.1 Players in a Dynamic Market
  • 4.1.1 Academic Research Lab
  • 4.1.2 Diagnostic Test Developer
  • 4.1.3 Instrumentation Supplier
  • 4.1.4 Chemical/Reagent Supplier
  • 4.1.5 Pathology Supplier
  • 4.1.6 Independent Clinical Laboratory
  • 4.1.7 Public National/regional Laboratory
  • 4.1.8 Hospital Laboratory
  • 4.1.9 Physicians Office Lab (POLS)
  • 4.1.10 Audit Body
  • 4.1.11 Certification Body
• 4.2 The Clinical Laboratory Market Segments
  • 4.2.1 Traditional Market Segmentation
  • 4.2.2 Laboratory Focus and Segmentation
• 4.3 Industry Structure
  • 4.3.1 Hospital Testing Share
  • 4.3.2 Economies of Scale
    • 4.3.2.1 Hospital vs. Central Lab
  • 4.3.3 Physician Office Lab's
  • 4.3.4 Physician's and POCT

5 Profiles of Key MDx Companies

• 5.1 Abbott Laboratories
• 5.2 Abionic
• 5.3 Accelerate Diagnostics
• 5.4 Access Bio
• 5.5 Ador Diagnostics
• 5.6 ADT Biotech
• 5.7 Akonni Biosystems
• 5.8 Alveo Technologies
• 5.9 Anitoa
• 5.10 Applied BioCode
• 5.11 Aureum Diagnostics
• 5.12 Aus Diagnostics
• 5.13 Autonomous Medical Devices
• 5.14 Baebies
• 5.15 Beckman Coulter Diagnostics (Danaher)
• 5.16 Becton, Dickinson and Company
• 5.17 Binx Health
• 5.18 Biocartis
• 5.19 BioFire Diagnostics (bioMerieux)
• 5.20 bioMerieux Diagnostics
• 5.21 Bio-Rad Laboratories, Inc
• 5.22 Bosch Healthcare Solutions GmbH
• 5.23 Cepheid (Danaher)
• 5.24 Credo Diagnostics Biomedical
• 5.25 Cue Health
• 5.26 Curetis (OpGen)
• 5.27 Detect
• 5.28 Diagenode Diagnostics (Hologic)
• 5.29 Diasorin S.p.A.
• 5.30 DNAe
• 5.31 Domus Diagnostics
• 5.32 Enzo Biochem
• 5.33 Eurofins Scientific
• 5.34 Fluxergy
• 5.35 Fusion Genomics.
• 5.36 Genedrive
• 5.37 Genetic Signatures
• 5.38 GenMark Dx (Roche)
• 5.39 Genomadix
• 5.40 Getlabs
• 5.41 Global Access Diagnostics
• 5.42 Grip Molecular Technologies
• 5.43 Hologic
• 5.44 Immunexpress
• 5.45 Inflammatix
• 5.46 Invetech
• 5.47 Iollo
• 5.48 J&J Innovative Medicine
• 5.49 Karius
• 5.50 Lucira Health (Pfizer)
• 5.51 LumiraDx
• 5.52 Maxim Biomedical
• 5.53 Meep
• 5.54 Meridian Bioscience
• 5.55 Millipore Sigma
• 5.56 Molbio Diagnostics
• 5.57 NanoDx
• 5.58 Nanomix
• 5.59 Novacyt
• 5.60 Novel Microdevices
• 5.61 Novus Diagnostics
• 5.62 Nuclein
• 5.63 OnsiteGene
• 5.64 Operon
• 5.65 OraSure Technologies
• 5.66 Oxford Nanopore Technologies
• 5.67 Panagene
• 5.68 Prenetics
• 5.69 Primerdesign (Novacyt)
• 5.70 Prominex
• 5.71 Proof Diagnostics
• 5.72 Qiagen
• 5.73 QuantuMDx
• 5.74 QuidelOrtho
• 5.75 R-Biopharm AG
• 5.76 Response Biomedical
• 5.77 Revvity
• 5.78 Roche Diagnostics
• 5.79 Salignostics
• 5.80 SD Biosensor
• 5.81 Seegene
• 5.82 Sekisui Diagnostics
• 5.83 Siemens Healthineers
• 5.84 Sona Nanotech
• 5.85 SpeeDx
• 5.86 T2 Biosystems
• 5.87 Talis Biomedical
• 5.88 Thermo Fisher Scientific
• 5.89 Uniogen
• 5.90 Veramarx
• 5.91 Veredus Laboratories
• 5.92 XCR Diagnostics
• 5.93 Zhejiang Orient Gene Biotech

6 Market Trends

• 6.1 Factors Driving Growth
  • 6.1.1 New Genotypes Creating New Markets
  • 6.1.2 Aging Population a Boon for All Diagnostics
  • 6.1.3 Developing World Driving ID Dx Growth
  • 6.1.4 Point of Care - Why Centralization is Losing Steam
  • 6.1.5 Self Testing
  • 6.1.6 The Need for Speed
• 6.2 Factors Limiting Growth
  • 6.2.1 Lower Costs
  • 6.2.2 Infectious Disease is Declining
  • 6.2.3 Wellness Hurts
  • 6.2.4 Economic Growth improves Living Standards

7 Molecular Dx - Infectious Disease Recent Developments

• 7.1 Recent Developments - Importance and How to Use This Section
  • 7.1.1 Importance of These Developments
  • 7.1.2 How to Use This Section
• 7.2 Cubit Dx Secures Funding for High-Sensitivity, Low-Cost Platform
• 7.3 Roche receives FDA clearance for STI at POC
• 7.4 Smartphone-Enabled Platform Transforms POC Testing
• 7.5 Credo Preps MDx System, Multiplex Respiratory Test for US Launch
• 7.6 A low-cost CRISPR-based paper strip test for flu
• 7.7 AMDI Receives Award to Develop 10 Minute POC Respiratory Panel
• 7.8 Roche to Acquire LumiraDx Point-of-Care Testing Tech
• 7.9 DiaSorin to Deliver Updated Instruments, New Assays in 2024/25
• 7.10 ReadyGo Diagnostics, Gemina Labs Expand MDx Pact
• 7.11 DiagMetrics Developing Breath Assays
• 7.12 Fortis Life Sciences Acquires IPOC
• 7.13 Domus Diagnostics Wins NIH RADx Tech Contract
• 7.14 Llusern Scientific to Launch POC MDx UTI Panel
• 7.15 Altratech Enters POC MDx Testing Space with Unique Tech
• 7.16 BioMerieux SpotFire MDx POC System Leverages Novel Approach
• 7.17 Katalyst Labs to Distribute ProtonDx Dragonfly Rapid IVD System
• 7.18 LEX Diagnostics Developing Ultra-Fast Low-Cost PCR
• 7.19 Sherlock Biosciences Adds to Infectious Disease Dx Toolkit
• 7.20 NanoDx Prepares for Point-of-Care Commercialization
• 7.21 Paragraf to Study New POC Test to Guide Antibiotic Selection
• 7.22 MicroGEM to Expand 30-Minute RT-PCR System
• 7.23 Startup Detect to Roll Out Next-Gen Molecular Instrument
• 7.24 Diagnostics for the Real World Third-Generation POC Platform
• 7.25 Salignostics Closes Funding Round
• 7.26 Cue Health Targets DTC Market in 2022
• 7.27 Grip Molecular Developing Home Respiratory Panel
• 7.28 Mainz Biomed Developing Home ColoAlert Assay
• 7.29 MFB Fertility Closes Series A Financing Round
• 7.30 Home Test Company Prenetics to go Public
• 7.31 Roche to Acquire TIB Molbiol to Expand Infectious Disease Portfolio
• 7.32 BforCure Preparing Multiple Panels for Point-of-Care qPCR Platform
• 7.33 Talis Biomedical Discusses Point-of-Care
• 7.34 Roche to Acquire GenMark Diagnostics for $1.8B
• 7.35 Pandemic Pushes Handheld qPCR Devices Closer to Commercialization
• 7.36 Hologic to Acquire Mobidiag
• 7.37 Lucira Health Focuses on User Friendly Approach to Home Testing
• 7.38 Infectious Disease Dx Firm Talis Biomedical Raises $254M in IPO
• 7.39 Fluidigm Plans 'Durable' Diagnostics, Clinical Business
• 7.40 Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M
• 7.41 Mammoth Biosciences Developing Pathogen Detection Tech
• 7.42 Illumina, IDbyDNA Developing Sequencing-Based Respiratory Tests
• 7.43 Scanogen Developing 90 Minute Infection Test
• 7.44 Malaria Assays Use CRISPR for Point-of-Care Multispecies Detection
• 7.45 FDA Provides Self Testing SARS-CoV-2 EAU Guidance
• 7.46 Mammoth Biosciences Announces Rapid, CRISPR-Based COVID-19 Diagnostic
• 7.47 Genetic Signatures Gets CE Mark for Coronavirus Molecular Test
• 7.48 Qiagen Respiratory Panel with Coronavirus Receives CE Mark
• 7.49 Lumos Diagnostics Closes $15M Series A Funding

8 The Global Market for Molecular Diagnostics at the Point of Care

• 8.1 Global Market Overview by Country
  • 8.1.1 Table - Global Market by Country
  • 8.1.2 Chart - Global Market by Country
• 8.2 Global Market by Application - Overview
  • 8.2.1 Table - Global Market by Application
  • 8.2.2 Chart - Global Market by Application - Base/Final Year Comparison
  • 8.2.3 Chart - Global Market by Application - Base Year
  • 8.2.4 Chart - Global Market by Application - End Year
  • 8.2.5 Chart - Global Market by Application - Share by Year
  • 8.2.6 Chart - Global Market by Application - Segments Growth
• 8.3 Global Market by Technology - Overview
  • 8.3.1 Table - Global Market by Technology
  • 8.3.2 Chart - Global Market by Technology - Base/Final Year Comparison
  • 8.3.3 Chart - Global Market by Technology - Base Year
  • 8.3.4 Chart - Global Market by Technology - End Year
  • 8.3.5 Chart - Global Market by Technology - Share by Year
  • 8.3.6 Chart - Global Market by Technology - Segments Growth
• 8.4 Global Market by Place - Overview
  • 8.4.1 Table - Global Market by Place
  • 8.4.2 Chart - Global Market by Place - Base/Final Year Comparison
  • 8.4.3 Chart - Global Market by Place - Base Year
  • 8.4.4 Chart - Global Market by Place - End Year
  • 8.4.5 Chart - Global Market by Place - Share by Year
  • 8.4.6 Chart - Global Market by Place - Segments Growth
• 8.5 Global Market by Product - Overview
  • 8.5.1 Table - Global Market by Product
  • 8.5.2 Chart - Global Market by Product - Base/Final Year Comparison
  • 8.5.3 Chart - Global Market by Product - Base Year
  • 8.5.4 Chart - Global Market by Product - End Year
  • 8.5.5 Chart - Global Market by Product - Share by Year
  • 8.5.6 Chart - Global Market by Product - Segments Growth

9 Global MDx at the Point of Care Markets - By Application

• 9.1 Respiratory Infectious Disease
  • 9.1.1 Table Respiratory Infectious Disease - by Country
  • 9.1.2 Chart - Respiratory Infectious Disease Growth
• 9.2 Gastrointestinal Infectious Disease
  • 9.2.1 Table Gastrointestinal Infectious Disease - by Country
  • 9.2.2 Chart - Gastrointestinal Infectious Disease Growth
• 9.3 Sexually Transmitted Disease
  • 9.3.1 Table Sexually Transmitted Disease - by Country
  • 9.3.2 Chart - Sexually Transmitted Disease Growth
• 9.4 Other Application
  • 9.4.1 Table Other Application - by Country
  • 9.4.2 Chart - Other Application Growth

10 Global MDx Markets at the Point of Care - by Technology

• 10.1 PCR
  • 10.1.1 Table PCR - by Country
  • 10.1.2 Chart - PCR Growth
• 10.2 NGS/Probe
  • 10.2.1 Table NGS/Probe - by Country
  • 10.2.2 Chart - NGS/Probe Growth
• 10.3 Other Technology
  • 10.3.1 Table Other Technology - by Country
  • 10.3.2 Chart - Other Technology Growth

11 Global MDx at the Point of Care Markets - by Place

• 11.1 Hospital Point of Care
  • 11.1.1 Table Hospital Point of Care - by Country
  • 11.1.2 Chart - Hospital Point of Care Growth
• 11.2 Clinic or Physician Office Lab
  • 11.2.1 Table Clinic or Physician Office Lab - by Country
  • 11.2.2 Chart - Clinic or Physician Office Lab Growth
• 11.3 Seniors Facility
  • 11.3.1 Table Seniors Facility - by Country
  • 11.3.2 Chart - Seniors Facility Growth
• 11.4 Other Place
  • 11.4.1 Table Other Place? by Country
  • 11.4.2 Chart - Other Place Growth

12 Global MDx at the Point of Care Markets - by Product

• 12.1 Instrument
  • 12.1.1 Table Instrument - by Country
  • 12.1.2 Chart - Instrument Growth
• 12.2 Cartridge
  • 12.2.1 Table Cartridge - by Country
  • 12.2.2 Chart - Cartridge Growth
• 12.3 Other Product
  • 12.3.1 Table Other Product - by Country
  • 12.3.2 Chart - Other Product Growth

13 Appendices

• 13.1 Growth of Approved IVD Test Menu
• 13.2 Growth of Approved Average IVD Test Fee
• 13.3 The Most Used IVD Assays
• 13.4 The Highest Grossing Assays
• 13.5 Laboratory Fees Schedule

Table of Tables

• Table 1 Seven Key Diagnostic Laboratory Technology Trends
• Table 2 Market Players by Type
• Table 3 Clinical Laboratory Departments and Segments
• Table 4 Laboratory Management Focus - Different Approaches
• Table 5 Key Segmentation Variables Going Forward
• Table 6 Five Factors Driving Growth
• Table 7 Four Factors Limiting Growth
• Table 8 - Global Market by Region
• Table 9 Global Market by Application
• Table 10 Global Market by Technology
• Table 11 Global Market by Place
• Table 12 Global Market by Product
• Table 13 Respiratory Infectious Disease by Country
• Table 14 Gastrointestinal Infectious Disease by Country
• Table 15 Sexually Transmitted Disease by Country
• Table 16 Other Application by Country
• Table 17 PCR by Country
• Table 18 NGS/Probe by Country
• Table 19 Other Technology by Country
• Table 20 Hospital Point of Care by Country
• Table 21 Clinic or Physician Office Lab by Country
• Table 22 Seniors Facility by Country
• Table 23 Other Place by Country
• Table 24 Instrument by Country
• Table 25 Cartridge by Country
• Table 26 Other Product by Country
• Table 27 The Most Common Assays
• Table 28 Largest Revenue Assays
• Table 29 Clinical Lab Fee Schedule

Table of Figures

• Figure 1 Global Healthcare Spending
• Figure 2 Centralized vs. Decentralized Laboratory Service
• Figure 3 A Highly Multiplexed Syndromic Testing Unit
• Figure 4 The Real Cost to Sequence the Human Genome
• Figure 5 The Codevelopment Process
• Figure 6 The Road to Diagnostics
• Figure 7 Percentage of World Population Over 65
• Figure 8 Chart Infectious Disease Decline
• Figure 9 Global Market Shares Chart
• Figure 10 Global Market by Application - Base vs. Final
• Figure 11 Global Market by Application Base Year
• Figure 12 Global Market by Application End Year
• Figure 13 Application Share by Year
• Figure 14 Application Segments Growth
• Figure 15 Global Market by Technology - Base vs. Final
• Figure 16 Global Market by Technology Base Year
• Figure 17 Global Market by Technology End Year
• Figure 18 Technology Share by Year
• Figure 19 Technology Segments Growth
• Figure 20 Global Market by Place - Base vs. Final
• Figure 21 Global Market by Place Base Year
• Figure 22 Global Market by Place End Year
• Figure 23 Place Share by Year
• Figure 24 Place Segments Growth
• Figure 25 Global Market by Product - Base vs. Final
• Figure 26 Global Market by Product Base Year
• Figure 27 Global Market by Product End Year
• Figure 28 Product Share by Year
• Figure 29 Product Segments Growth
• Figure 30 Respiratory Infectious Disease Diagnostics Growth
• Figure 31 Gastrointestinal Infectious Disease Growth
• Figure 32 Sexually Transmitted Disease Growth
• Figure 33 Other Application Growth
• Figure 34 PCR Growth
• Figure 35 NGS/Probe Growth
• Figure 36 Other Technology Growth
• Figure 37 Hospital Point of Care Growth
• Figure 38 Clinic or Physician Office Lab Growth
• Figure 39 Seniors Facility Growth
• Figure 40 Other Place Growth
• Figure 41 Instrument Growth
• Figure 42 Cartridge Growth
• Figure 43 Other Product Growth
• Figure 44 IVD Test Menu Growth
• Figure 45 IVD Test Average Fees - A Ten Year View