Molecular Diagnostics at the Point of Care. By Application, Technology, Place, Product and by Country. With Executive Guides and Analysis 2025 - 2029

Table of Contents

1. Market Guides

• 1.1. Strategic Situation Analysis
• 1.2. Guide for Executives, Marketing and Business Development Staff
• 1.3. Guide for Management Consultants and Investment Advisors

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