Table of Content

1 Market Guides 
1.1 Companion Diagnostic Market - Strategic Situation Analysis  
1.2 Guide for Executives, Marketing, Sales and Business Development Staff 
1.3 Guide for Management Consultants and Investment Advisors 

2 Introduction and Market Definition 
2.1 What are Companion Diagnostics?
2.2 The Personalized Medicine Revolution
2.3 Market Definition  
2.3.1 Revenue Market Size
2.4 Methodology 
2.4.1 Authors 
2.4.2 Sources 
2.5 A Spending Perspective on Clinical Laboratory Testing  
2.5.1 U.S. Medicare Expenditures for Laboratory Testing  

3 Market Overview
3.1 Players in a Dynamic Market
3.1.1 Academic Research Lab 
3.1.2 Diagnostic Test Developer
3.1.3 Instrumentation Supplier 
3.1.4 Distributor and Reagent Supplier 
3.1.5 Independent Testing Lab 
3.1.6 Public National/regional lab  
3.1.7 Hospital lab 
3.1.8 Physician Office Labs  
3.1.9 Audit Body 
3.1.10 Certification Body 
3.2 Personalized Medicine and Companion Diagnostics  
3.2.1 Basics 
3.2.2 Method
3.2.3 Disease risk assessment  
3.2.4 Applications  
3.2.5 Diagnosis and intervention  
3.2.5.1 Companion Diagnostics 
3.2.6 Drug development and usage 
3.2.7 Respiratory proteomics  
3.2.8 Cancer genomics 
3.2.9 Population screening  
3.2.10 Challenges
3.2.11 Regulatory oversight 
3.2.12 Intellectual property rights 
3.2.13 Reimbursement policies
3.2.14 Patient privacy and confidentiality 
3.3 Chromosomes, Genes and Epigenetics 
3.3.1 Chromosomes 
3.3.2 Genes 
3.3.3 Epigenetics 
3.4 Cancer Genes
3.4.1 Germline vs Somatic 
3.4.2 Changing Clinical Role  
3.5 Structure of Industry Plays a Part
3.5.1 New Pharmaceutical Funding Market 
3.5.2 Economies of Scale 
3.5.2.1 Hospital vs. Central Lab
3.5.3 Physician Office Labs  
3.5.4 Physicians and POCT

4 Market Trends 
4.1 Factors Driving Growth 
4.1.1 Level of Care.  
4.1.2 Immuno-oncology
4.1.3 Liability 
4.1.4 Aging Population
4.2 Factors Limiting Growth 
4.2.1 State of knowledge 
4.2.2 Genetic Blizzard
4.2.3 Protocol Resistance 
4.2.4 Regulation and coverage
4.3 Instrumentation and Automation  
4.3.1 Instruments Key to Market Share 
4.3.2 Bioinformatics Plays a Role  
4.4 Diagnostic Technology Development 
4.4.1 Next Generation Sequencing Fuels a Revolution 
4.4.2 Single Cell Genomics Changes the Picture
4.4.3 Pharmacogenomics Blurs Diagnosis and Treatment
4.4.4 CGES Testing, A Brave New World
4.4.5 Biochips/Giant magneto resistance based assay

5 Companion Diagnostics Recent Developments
5.1 Recent Developments - Importance and How to Use This Section 
5.1.1 Importance of These Developments 
5.1.2 How to Use This Section 
5.2 HTG Molecular Diagnostics 2020 Revenues Fall 56 Percent  
5.3 Oncocyte Details Expansions Plans  
5.4 Agilent Acquires Resolution Biosciences 
5.5 Qiagen, Inovio Expand CDx Partnership
5.6 AmoyDx, AstraZeneca Strike Ovarian Cancer CDx Alliance 
5.7 NeoGenomics to Grow Through CDx Agreements, Acquisitions
5.8 Personalis Neoantigen Platform Driving Improved Immunotherapy Prediction 
5.9 Biocartis Collaborating with Endpoint Health on CDx Tests for Idylla Platform 
5.10 FDA Approves Foundation Medicine Test as CDx for Three Targeted Therapies 
5.11 Promega to Develop MSI Assay as CDx 
5.12 HTG Molecular Q2 Revenues Drop 66 Percent 
5.13 Guardant Health to Develop CDx for Janssen  
5.14 Burning Rock Bio, CStone Pharmaceuticals to Codevelop CDx .
5.15 FDA Approval for FoundationOne®CDx 
5.16 FDA finalizes CDx Guidance 
5.17 QIAGEN Launches CDx Therascreen BRAF Test
5.18 Myriad Genetics Seeks Approval for Companion Diagnostic 
5.19 ARUP Labs Seek PMA for Hemophilia Gene Therapy CDx 
5.20 QIAGEN Builds on Global Collaboration with Amgen  
5.21 Foundation Medicine nabs 19th companion Dx 
5.22 Maze Therapeutics Uses CRISPR for Precision Medicine Companion Diagnostics  
5.23 Myriad Wins Japanese Approval for BRACAnalysis
5.24 Fujitsu Improves Efficiency in Cancer Genomic Medicine 
5.25 Thermo Fisher's automated sequencer to offer same-day, pan-cancer test results 
5.26 Takeda, Prometheus Enter IBD Drug-Companion Diagnostic Partnership 
5.27 Thermo Fisher, Eli Lilly Ink CDx Collaboration in NSCLC, Thyroid Cancer 
5.28 Roche VENTANA PD-L1 (SP142) Assay approved as companion diagnostic 
5.29 Universal Genetic Testing for All Breast Cancer Patients 
5.30 Exact Sciences buys Genomic Health 
5.31 Biodesix Highlights Pipeline and Companion Diagnostic Development 

6 Profiles of Key Players 
6.1 10x Genomics, Inc
6.2 Abbott Diagnostics  
6.3 AccuraGen Inc
6.4 Adaptive Biotechnologies
6.5 Aethlon Medical 
6.6 Agena Bioscience, Inc. 
6.7 Agilent 
6.8 Anchor Dx  
6.9 ANGLE plc 
6.10 ApoCell, Inc. 
6.11 ArcherDx, Inc
6.12 ARUP Laboratories
6.13 Asuragen
6.14 AVIVA Biosciences  
6.15 Baylor Miraca Genetics Laboratories  
6.16 Beckman Coulter Diagnostics 
6.17 Becton, Dickinson and Company 
6.18 BGI Genomics Co. Ltd  
6.19 Bioarray Genetics
6.20 Biocartis  
6.21 Biocept, Inc 
6.22 Biodesix Inc
6.23 BioFluidica 
6.24 BioGenex  
6.25 BioIVT 
6.26 Biolidics Ltd
6.27 bioMérieux Diagnostics
6.28 Bioneer Corporation  
6.29 Bio-Rad Laboratories, Inc
6.30 Bio-Reference Laboratories. 1
6.31 Bio-Techne 
6.32 Bioview 
6.33 Bolidics 
6.34 Boreal Genomics 
6.35 Bristol-Myers Squibb
6.36 Cancer Genetics 
6.37 Caris Molecular Diagnostics  
6.38 Castle Biosciences, Inc. 
6.39 CellMax Life 
6.40 Cepheid (now Danaher)
6.41 Charles River Laboratories  
6.42 Chronix Biomedical 
6.43 Circulogene
6.44 Clinical Genomics 
6.45 Cynvenio
6.46 Cytolumina Technologies Corp
6.47 CytoTrack 
6.48 Datar Cancer Genetics Limited 
6.49 Diagnologix LLC
6.50 Diasorin S.p.A
6.51 Enzo Life Sciences, Inc
6.52 Epic Sciences 
6.53 Epigenomics AG
6.54 Eurofins Scientific  2
6.55 Exosome Diagnostics 
6.56 Exosome Sciences
6.57 Fabric Genomics  
6.58 Fluidigm Corp 
6.59 Fluxion Biosciences 
6.60 Foundation Medicine 
6.61 Freenome 
6.62 GeneFirst Ltd.  
6.63 Genetron Health (Beijing) Co., Ltd.  
6.64 Genomic Health
6.65 GenomOncology
6.66 GILUPI Nanomedizin
6.67 Grail, Inc. 
6.68 Guardant Health  
6.69 HalioDx 
6.70 HansaBiomed 
6.71 HeiScreen 
6.72 Helomics
6.73 Horizon Discovery 
6.74 HTG Molecular Diagnostics 
6.75 iCellate
6.76 Illumina 
6.77 Incell Dx 
6.78 Inivata 2
6.79 Integrated Diagnostics 
6.80 Invivogen  
6.81 Invivoscribe  
6.82 Janssen Diagnostics 
6.83 MDNA Life SCIENCES, Inc
6.84 MDx Health  
6.85 Menarini Silicon Biosystems 
6.86 Millipore Sigma  
6.87 Miltenyi Biotec 
6.88 MIODx 
6.89 miR Scientific
6.90 Molecular MD 
6.91 MyCartis 
6.92 Myriad Genetics/Myriad RBM  
6.93 NantHealth, Inc. 
6.94 Natera 
6.95 NeoGenomics 
6.96 New Oncology  
6.97 Novogene Bioinformatics Technology Co., Ltd. 
6.98 Oncocyte 
6.99 OncoDNA 
6.100 Ortho Clinical Diagnostics  
6.101 Oxford Nanopore Technologies 
6.102 Panagene2
6.103 Perkin Elmer 
6.104 Personal Genome Diagnostics
6.105 Personalis
6.106 Precipio  
6.107 PrecisionMed  
6.108 Promega 
6.109 Qiagen Gmbh 
6.110 Rarecells SAS
6.111 RareCyte
6.112 Roche Molecular Diagnostics  
6.113 Screencell 
6.114 Sense Biodetection. 
6.115 Serametrix 
6.116 Siemens Healthineers 
6.117 Silicon Biosystems 
6.118 simfo GmbH 
6.119 Singlera Genomics Inc
6.120 Singulomics  
6.121 SkylineDx 
6.122 Stratos Genomics 
6.123 Sysmex Inostics
6.124 Tempus Labs, Inc
6.125 Thermo Fisher Scientific Inc
6.126 Thrive Earlier Detection 2
6.127 Todos Medical 
6.128 Trovagene
6.129 Volition 
6.130 Vortex Biosciences  

7 The Global Market for Companion Diagnostics 
7.1 Global Market Overview by Country 
7.1.1 Table - Global Market by Country
7.1.2 Chart - Global Market by Country 
7.2 Global Market by Application - Overview
7.2.1 Table - Global Market by Application  
7.2.2 Chart - Global Market by Application - Base/Final Year Comparison 
7.2.3 Chart - Global Market by Application - Base Year  
7.2.4 Chart - Global Market by Application - Final Year
7.2.5 Chart - Global Market by Application - Share by Year 
7.3 Global Market Funding Source - Overview  
7.3.1 Table - Global Market by Funding Source  
7.3.2 Chart - Global Market Funding Source - Base/Final Year Comparison 
7.3.3 Chart - Global Market Funding Source - Base Year 
7.3.4 Chart - Global Market Funding Source - Final Year 
7.3.5 Chart - Global Market Funding Source - Share by Year 

8 Global Companion Diagnostic Markets - By Application 
8.1 Oncology
8.1.1 Table Oncology - by Country 
8.1.2 Chart - Oncology Growth 3
8.2 Neurology  
8.2.1 Table Neurology - by Country
8.2.2 Chart - Neurology Growth 
8.3 Cardiology
8.3.1 Table Cardiology - by Country  
8.3.2 Chart - Cardiology Growth
8.4 Other Application 
8.4.1 Table Other Application - by Country
8.4.2 Chart - Other Application Growth 

9 Global Companion Diagnostic Markets - Funding Source 
9.1 Global Market Pharmaceutical 
9.1.1 Table Pharmaceutical - by Country
9.1.2 Chart - Pharmaceutical Growth 
9.2 Global Market Venture 
9.2.1 Table Venture - by Country 
9.2.2 Chart - Venture Growth  
9.3 Global Market Clinical
9.3.1 Table Clinical - by Country
9.3.2 Chart - Clinical Growth 
9.4 Global Market Other Funding 
9.4.1 Table Other Funding - by Country
9.4.2 Chart - Other Funding Growth 

10 Appendices 
10.1 United States Medicare System: January 2021 Clinical Laboratory Fees Schedule
10.2 Pharmacogenomic Biomarkers in Drug Labeling

List of Tables
Table 1 Lab Spending 2014 to 2024 
Table 2 Market Players by Type 
Table 3 The Base Pairs
Table 4 Five Factors Driving Growth 
Table 5 Four Factors Limiting Growth  
Table 6 Key Diagnostic Laboratory Technology Trends  
Table 7 Next Generation Sequencing Technologies - Speed and Cost  
Table 8 Global Companion Diagnostic Market by Region
Table 9 Global Market by Application 
Table 10 Global Market by Funding Source 
Table 11 Oncology by Country 
Table 12 Neurology by Country 
Table 13 Cardiology by Country 
Table 14 Other Application by Country 
Table 15 Pharmaceutical by Country 
Table 16 Venture by Country
Table 17 Clinical by Country
Table 18 Other Funding by Country  
Table 19 2021 Clinical Laboratory Fee Schedule  
Table 20 Pharmacogenomic Biomarkers  4

List of Figures
Figure 1 FDA Approved Companion Diagnostics
Figure 2 Clinical Lab Spending 2014 to 2024  
Figure 3 DNA Strands and Chromosomes 
Figure 4 Karyogram of Human Chromosomes  
Figure 5 Size of Various Genomes 
Figure 6 Germline vs Somatic Mutations
Figure 7 Comparing Genomic Diagnostic and Traditional Testing  
Figure 8 Percentage of World Population Over 65 
Figure 9 Base Year Country Market Share Chart  
Figure 10 CDx Market by Application - Base vs. Final Year 
Figure 11 CDx Market by Application Base Year  
Figure 12 CDx Market by Application Final Year
Figure 13 Application Type Share by Year
Figure 14 Funding Source - Base vs. Final Year  
Figure 15 Funding Source Market Base Year 
Figure 16 Funding Source Market Final Year 
Figure 17 Funding Source Share by Year 
Figure 18 Oncology Growth  
Figure 19 Neurology Growth 
Figure 20 Cardiology Growth 
Figure 21 Other Application Growth 3
Figure 22 Pharmaceutical Growth 
Figure 23 Venture Growth 
Figure 24 Clinical Growth 
Figure 25 Other Funding Growth