Companion Diagnostic Markets - The Future of Diagnostics by Application, Technology and Funding with Customized Forecasting/Analysis, and Executive and Consultant Guides

Table of Contents

1 Market Guides 
1.1 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 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 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 Chemical/Reagent Supplier 
3.1.5 Pathology Supplier 
3.1.6 Independent Clinical Laboratory 
3.1.7 Public National/regional Laboratory 
3.1.8 Hospital Laboratory 
3.1.9 Physicians Office Lab (POLS) 
3.1.10 Audit Body 
3.1.11 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 The Aging World 
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, Automation and Diagnostic Trends 
4.3.1 Traditional Automation and Centralization 
4.3.2 The New Automation, Decentralization and Point Of Care 
4.3.3 Instruments Key to Market Share 
4.3.4 Bioinformatics Plays a Role 
4.3.5 PCR Takes Command 
4.3.6 Next Generation Sequencing Fuels a Revolution 
4.3.7 NGS Impact on Pricing 
4.3.8 Whole Genome Sequencing, A Brave New World 
4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment 
4.3.10 Shifting Role of Diagnostics 

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 JaxBio to Create Array-Based Cancer Tests 
5.3 Agilent, Qiagen Win FDA Approvals Companion Diagnostics 
5.4 Navignostics Using Single-Cell Spatial Proteomics 
5.5 HMNC Brain Health to Develop Companion Diagnostics 
5.6 Propath UK, Nucleai Partner on Spatial Proteomics 
5.7 Becton Dickinson, Labcorp Collaborate for Flow Cytometry-Based Companion Diagnostics 
5.8 Almac, AstraZeneca Strike CDx Development Pact 
5.9 Avalon GloboCare, Lu Daopei Hematology Institute to Develop Cell Therapy CDx 
5.10 Burning Rock Secures Lung Cancer NGS Test Approval in China 
5.11 TenSixteen Bio Developing Drugs, Companion NGS Tests 
5.12 Guardant Health Plans New Comprehensive Assay 
5.13 Thermo Fisher, Oncocyte Ink Comarketing Deal for Cancer IVDs 
5.14 Qiagen, Denovo Biopharma to Develop Liquid Biopsy CDx Test 
5.15 Japanese Approves Thermo Fisher Scientific Oncomine Assay as CDx 
5.16 Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug 
5.17 Natera Aims to Lead Market in Solid Tumor Adjuvant CDx 
5.18 Oncocyte Details Expansions Plans 
5.19 Agilent Acquires Resolution Biosciences 
5.20 Qiagen, Inovio Expand CDx Partnership 
5.21 AmoyDx, AstraZeneca Strike Ovarian Cancer CDx Alliance 
5.22 NeoGenomics to Grow Through CDx Agreements, Acquisitions 
5.23 Personalis Neoantigen Platform Driving Improved Immunotherapy Prediction 
5.24 Biocartis Collaborating with Endpoint Health on CDx Tests for Idylla Platform 
5.25 FDA Approves Foundation Medicine Test as CDx for Three Targeted Therapies 
5.26 Promega to Develop MSI Assay as CDx 
5.27 Guardant Health to Develop CDx for Janssen 
5.28 Burning Rock Bio, CStone Pharmaceuticals to Codevelop CDx 
5.29 FDA Approval for FoundationOne®CDx 
5.30 FDA finalizes CDx Guidance
5.31 QIAGEN Launches CDx Therascreen BRAF Test 

6 Profiles of Key Players 
6.1 10x Genomics, Inc
6.2 Abbott Laboratories 
6.3 AccuraGen Inc
6.4 Adaptive Biotechnologies 
6.5 Aethlon Medical 
6.6 Agilent/Dako 
6.7 Anchor Dx 
6.8 ANGLE plc 
6.9 ARUP Laboratories 
6.10 AVIVA Systems Biology 
6.11 Baylor Miraca Genetics Laboratories 
6.12 Beckman Coulter Diagnostics 
6.13 Becton, Dickinson and Company 
6.14 BGI Genomics Co. Ltd 
6.15 Bioarray Genetics 
6.16 Biocartis 
6.17 Biocept, Inc
6.18 Biodesix Inc
6.19 BioFluidica 
6.20 BioGenex 
6.21 BioIVT 
6.22 Biolidics Ltd 
6.23 bioMérieux Diagnostics 
6.24 Bioneer Corporation 
6.25 Bio-Rad Laboratories, Inc
6.26 Bio-Reference Laboratories 
6.27 Bio-Techne 
6.28 Bioview 
6.29 Bolidics 
6.30 Boreal Genomics 
6.31 Bristol-Myers Squibb 
6.32 Burning Rock 
6.33 Cardiff Oncology 
6.34 Caris Molecular Diagnostics 
6.35 Castle Biosciences, Inc
6.36 CellCarta 
6.37 CellMax Life 
6.38 Cepheid (Danaher) 
6.39 Charles River Laboratories 
6.40 Circulogene 
6.41 Cizzle Biotech 
6.42 Clinical Genomics 
6.43 Cytolumina Technologies Corp
6.44 Datar Cancer Genetics Limited 
6.45 Diagnologix LLC
6.46 Diasorin S.p.A
6.47 Dxcover 
6.48 Element Biosciences 
6.49 Enzo Biochem 
6.50 Epic Sciences 
6.51 Epigenomics AG
6.52 Eurofins Scientific 
6.53 Fabric Genomics 
6.54 Fluxion Biosciences 
6.55 Freenome 
6.56 FUJIFILM Wako Diagnostics 
6.57 Fyr Diagnostics 
6.58 GeneFirst Ltd
6.59 Genetron Holdings 
6.60 GenomOncology 
6.61 GILUPI Nanomedizin 
6.62 Guardant Health 
6.63 HansaBiomed 
6.64 HeiScreen 
6.65 Helomics 
6.66 HTG Molecular Diagnostics 
6.67 iCellate 
6.68 Illumina 
6.69 Incell Dx 
6.70 Inivata 
6.71 INOVIQ 
6.72 Integrated Diagnostics 
6.73 Invitae Corporation 
6.74 Invivogen 
6.75 Invivoscribe 
6.76 Janssen Diagnostics 
6.77 Lunglife AI Inc 
6.78 MDNA Life SCIENCES, Inc
6.79 MDx Health 
6.80 Menarini Silicon Biosystems 
6.81 Mesa Laboratories, Inc
6.82 Millipore Sigma 
6.83 Miltenyi Biotec 
6.84 miR Scientific 
6.85 Myriad Genetics/Myriad RBM 
6.86 NantHealth, Inc
6.87 Natera 
6.88 NeoGenomics 
6.89 NGeneBio
6.90 Novogene Bioinformatics Technology Co., Ltd
6.91 Oncocyte
6.92 OncoDNA 
6.93 Ortho Clinical Diagnostics 
6.94 Oxford Nanopore Technologies 
6.95 PamGene 
6.96 Panagene 
6.97 Perkin Elmer 
6.98 Personal Genome Diagnostics 
6.99 Personalis
6.100 Precipio 
6.101 Precision Medicine Group 
6.102 PrecisionMed 
6.103 Predicine 
6.104 Promega 
6.105 Qiagen 
6.106 Rarecells SAS 
6.107 RareCyte 
6.108 Roche Molecular Diagnostics 
6.109 Screencell 
6.110 Sema4 Holdings 
6.111 Sense Biodetection 
6.112 Siemens Healthineers 
6.113 simfo GmbH 
6.114 Singlera Genomics Inc
6.115 Singular Genomics 
6.116 Singulomics 
6.117 SkylineDx 
6.118 Standard BioTools 
6.119 Stilla Technologies 
6.120 Sysmex Inostics
6.121 Tempus Labs, Inc
6.122 Thermo Fisher Scientific Inc
6.123 Todos Medical 
6.124 Ultima Genomics 
6.125 Veracyte 
6.126 Volition 
6.127 Vortex Biosciences 
6.128 Vyant Bio 

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 
7.4 Global Market Technology - Overview 
7.4.1 Table - Global Market by Technology 
7.4.2 Chart - Global Market Technology - Base/Final Year Comparison
7.4.3 Chart - Global Market Technology - Base Year 
7.4.4 Chart - Global Market Technology - Final Year 
7.4.5 Chart - Global Market Technology - Share by Year 

8 Global
8.1 Table Oncology - by Country 
8.1.1 Chart - Oncology Growth 
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
9.1 Table Pharmaceutical - by Country 
9.1.1 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 Global
10.1 Table Next Generation Sequencing - by Country 
10.1.1 Chart - Next Generation Sequencing Growth 
10.2 Global Market PCR 
10.2.1 Table PCR - by Country 
10.2.2 Chart - PCR Growth 
10.3 Global Market IHC/ISH 
10.3.1 Table IHC/ISH - by Country 
10.3.2 Chart - IHC/ISH Growth 
10.4 Global Market Other Technology 
10.4.1 Table Other Technology - by Country
10.4.2 Chart - Other Technology Growth 

11 Appendices 
11.1 United States Medicare System: Clinical Laboratory Fees Schedule 
11.2 The Most Used IVD Assays 
11.3 The Highest Grossing Assays 
11.4 Pharmacogenomic Biomarkers in Drug Labeling

List of Tables
Table 1 FDA Approved Companion Dx 
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 Seven Key Diagnostic Laboratory Technology Trends 
Table 7 Global Companion Diagnostic Market by Region 
Table 8 Global Market by Application 
Table 9 Global Market by Funding Source 
Table 10 Global Market by Technology 
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 Next Generation Sequencing by Country 
Table 20 PCR by Country 
Table 21 IHC/ISH by Country 
Table 22 Other Technology by Country 
Table 23 Clinical Laboratory Fee Schedule 
Table 24 The Most Common Assays 
Table 25 Largest Revenue Assays 
Table 26 Pharmacogenomic Biomarkers

List of Figures
Figure 1 Global Healthcare Spending 
Figure 2 The Lab Test Pie - Wholesale & Retail 
Figure 3 The Road to Diagnostics 
Figure 4 DNA Strands and Chromosomes 
Figure 5 Karyogram of Human Chromosomes 
Figure 6 Size of Various Genomes 
Figure 7 Germline vs Somatic Mutations 
Figure 8 Comparing Genomic Diagnostic and Traditional Testing 
Figure 9 The Changing Age of The World’s Population 
Figure 10 Health Care Consumption by Age 
Figure 11 Cancer Incidence by Age 
Figure 12 Centralized vs. Decentralized Laboratory Service 
Figure 13 A Highly Multiplexed Syndromic Testing Unit 
Figure 14 The Real Cost to Sequence the Human Genome 
Figure 15 The Codevelopment Process 
Figure 16 Comparing MDx Diagnostic and Traditional Testing 
Figure 17 Base Year Country Market Share Chart 
Figure 18 CDx Market by Application - Base vs. Final Year 
Figure 19 CDx Market by Application Base Year 
Figure 20 CDx Market by Application Final Year
Figure 21 Application Type Share by Year 

Samples

Companies Mentioned

• 10x Genomics, Inc
• Abbott Laboratories 
• AccuraGen Inc
• Adaptive Biotechnologies 
• Aethlon Medical 
• Agilent/Dako 
• Anchor Dx 
• ANGLE plc 
• ARUP Laboratories 
• AVIVA Systems Biology 
• Baylor Miraca Genetics Laboratories 
• Beckman Coulter Diagnostics 
• Becton, Dickinson and Company 
• BGI Genomics CoLtd 
• Bioarray Genetics 
• Biocartis 
• Biocept, Inc
• Biodesix Inc
• BioFluidica 
• BioGenex 
• BioIVT 
• Biolidics Ltd 
• bioMérieux Diagnostics 
• Bioneer Corporation 
• Bio-Rad Laboratories, Inc
• Bio-Reference Laboratories 
• Bio-Techne 
• Bioview 
• Bolidics 
• Boreal Genomics 
• Bristol-Myers Squibb 
• Burning Rock 
• Cardiff Oncology 
• Caris Molecular Diagnostics 
• Castle Biosciences, Inc
• CellCarta 
• CellMax Life 
• Cepheid (Danaher) 
• Charles River Laboratories 
• Circulogene 
• Cizzle Biotech 
• Clinical Genomics 
• Cytolumina Technologies Corp
• Datar Cancer Genetics Limited 
• Diagnologix LLC
• Diasorin S.p.A
• Dxcover 
• Element Biosciences 
• Enzo Biochem 
• Epic Sciences 
• Epigenomics AG
• Eurofins Scientific 
• Fabric Genomics 
• Fluxion Biosciences 
• Freenome 
• FUJIFILM Wako Diagnostics 
• Fyr Diagnostics 
• GeneFirst Ltd
• Genetron Holdings 
• GenomOncology 
• GILUPI Nanomedizin 
• Guardant Health 
• HansaBiomed 
• HeiScreen 
• Helomics 
• HTG Molecular Diagnostics 
• iCellate 
• Illumina 
• Incell Dx 
• Inivata 
• INOVIQ 
• Integrated Diagnostics 
• Invitae Corporation 
• Invivogen 
• Invivoscribe 
• Janssen Diagnostics 
• Lunglife AI Inc 
• MDNA Life SCIENCES, Inc
• MDx Health 
• Menarini Silicon Biosystems 
• Mesa Laboratories, Inc
• Millipore Sigma 
• Miltenyi Biotec 
• miR Scientific 
• Myriad Genetics/Myriad RBM 
• NantHealth, Inc
• Natera 
• NeoGenomics 
• NGeneBio
• Novogene Bioinformatics Technology Co., Ltd
• Oncocyte
• OncoDNA 
• Ortho Clinical Diagnostics 
• Oxford Nanopore Technologies 
• PamGene 
• Panagene 
• Perkin Elmer 
• Personal Genome Diagnostics 
• Personalis
• Precipio 
• Precision Medicine Group 
• PrecisionMed 
• Predicine 
• Promega 
• Qiagen 
• Rarecells SAS 
• RareCyte 
• Roche Molecular Diagnostics 
• Screencell 
• Sema4 Holdings 
• Sense Biodetection 
• Siemens Healthineers 
• simfo GmbH 
• Singlera Genomics Inc
• Singular Genomics 
• Singulomics 
• SkylineDx 
• Standard BioTools 
• Stilla Technologies 
• Sysmex Inostics
• Tempus Labs, Inc
• Thermo Fisher Scientific Inc
• Todos Medical 
• Ultima Genomics 
• Veracyte 
• Volition 
• Vortex Biosciences 
• Vyant Bio