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 and the IVD Industry
2.5.1 Global Healthcare Spending
2.5.2 Spending on Diagnostics
2.5.3 Important Role of Insurance for Diagnostics
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 Physicians 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 (bioMérieux)
5.20 bioMérieux 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 Siemens Healthineers
5.83 Sona Nanotech
5.84 SpeeDx
5.85 T2 Biosystems
5.86 Talis Biomedical
5.87 Thermo Fisher Scientific
5.88 Uniogen
5.89 Veramarx
5.90 Veredus Laboratories
5.91 XCR Diagnostics
5.92 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 Roche to Acquire LumiraDx Point-of-Care Testing Tech
7.3 DiaSorin to Deliver Updated Instruments, New Assays in 2024/25
7.4 ReadyGo Diagnostics, Gemina Labs Expand MDx Pact
7.5 DiagMetrics Developing Breath Assays
7.6 Fortis Life Sciences Acquires IPOC
7.7 Domus Diagnostics Wins NIH RADx Tech Contract
7.8 Llusern Scientific to Launch POC MDx UTI Panel
7.9 Altratech Enters POC MDx Testing Space with Unique Tech
7.10 BioMérieux SpotFire MDx POC System Leverages Novel Approach
7.11 Katalyst Labs to Distribute ProtonDx Dragonfly Rapid IVD System
7.12 LEX Diagnostics Developing Ultra-Fast Low-Cost PCR
7.13 Sherlock Biosciences Adds to Infectious Disease Dx Toolkit
7.14 NanoDx Prepares for Point-of-Care Commercialization
7.15 Paragraf to Study New POC Test to Guide Antibiotic Selection
7.16 MicroGEM to Expand 30-Minute RT-PCR System
7.17 Startup Detect to Roll Out Next-Gen Molecular Instrument
7.18 Diagnostics for the Real World Third-Generation POC Platform
7.19 Salignostics Closes Funding Round
7.20 Cue Health Targets DTC Market in 2022
7.21 Grip Molecular Developing Home Respiratory Panel
7.22 Mainz Biomed Developing Home ColoAlert Assay
7.23 MFB Fertility Closes Series A Financing Round
7.24 Home Test Company Prenetics to go Public
7.25 Roche to Acquire TIB Molbiol to Expand Infectious Disease Portfolio
7.26 BforCure Preparing Multiple Panels for Point-of-Care qPCR Platform
7.27 Talis Biomedical Discusses Point-of-Care
7.28 Roche to Acquire GenMark Diagnostics for $1.8B
7.29 Pandemic Pushes Handheld qPCR Devices Closer to Commercialization
7.30 Hologic to Acquire Mobidiag
7.31 Lucira Health Focuses on User Friendly Approach to Home Testing
7.32 Infectious Disease Dx Firm Talis Biomedical Raises $254M in IPO
7.33 Fluidigm Plans 'Durable' Diagnostics, Clinical Business
7.34 Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M
7.35 Mammoth Biosciences Developing Pathogen Detection Tech
7.36 Illumina, IDbyDNA Developing Sequencing-Based Respiratory Tests
7.37 Scanogen Developing 90 Minute Infection Test
7.38 Malaria Assays Use CRISPR for Point-of-Care Multispecies Detection
7.39 FDA Provides Self Testing SARS-CoV-2 EAU Guidance
7.40 Mammoth Biosciences Announces Rapid, CRISPR-Based COVID-19 Diagnostic
7.41 Genetic Signatures Gets CE Mark for Coronavirus Molecular Test
7.42 Qiagen Respiratory Panel with Coronavirus Receives CE Mark
7.43 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
List 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 Senior Facility by Country
Table 23 Other Place by Country
Table 24 Instrument by Country
Table 25 Cartridge by Country
Table 26 Other Products by Country
Table 27 The Most Common Assays
Table 28 Largest Revenue Assays
Table 29 Clinical Lab Fee Schedule
List of Figures
Figure 1 Global Health Spending
Figure 2 The Lab Test Pie
Figure 3 Centralized vs. Decentralized Laboratory Service
Figure 4 A Highly Multiplexed Syndromic Testing Unit
Figure 5 The Real Cost to Sequence the Human Genome
Figure 6 The Codevelopment Process
Figure 7 The Road to Diagnostics
Figure 8 Percentage of World Population Over 65
Figure 9 Chart Infectious Disease Decline
Figure 10 Global Market Shares Chart
Figure 11 Global Market by Application - Base vs. Final
Figure 12 Global Market by Application Base Year
Figure 13 Global Market by Application End Year
Figure 14 Application Share by Year
Figure 15 Application Segments Growth
Figure 16 Global Market by Technology - Base vs. Final
Figure 17 Global Market by Technology Base Year
Figure 18 Global Market by Technology End Year
Figure 19 Technology Share by Year
Figure 20 Technology Segments Growth
Figure 21 Global Market by Place - Base vs. Final
Figure 22 Global Market by Place Base Year
Figure 23 Global Market by Place End Year
Figure 24 Place Share by Year
Figure 25 Place Segments Growth
Figure 26 Global Market by Product - Base vs. Final
Figure 27 Global Market by Product Base Year
Figure 28 Global Market by Product End Year
Figure 29 Product Share by Year
Figure 30 Product Segments Growth
Figure 31 Respiratory Infectious Disease Diagnostics Growth
Figure 32 Gastrointestinal Infectious Disease Growth
Figure 33 Sexually Transmitted Disease Growth
Figure 34 Other Application Growth
Figure 35 PCR Growth
Figure 36 NGS/Probe Growth
Figure 37 Other Technology Growth
Figure 38 Hospital Point of Care Growth
Figure 39 Clinic or Physician Office Lab Growth
Figure 40 Seniors Facility Growth
Figure 41 Other Place Growth
Figure 42 Instrument Growth
Figure 43 Cartridge Growth
Figure 44 Other Product Growth
Figure 45 IVD Test Menu Growth
Figure 46 IVD Test Average Fees - A Ten Year View
