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
1.4 Impact of Artificial Intelligence
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 Agilent Technologies Expands Certification for PD-L1 CDx
5.3 Foundation Medicine, Sumitomo Pharma to Develop CDx
5.4 Tempus xT CDx
5.5 Caris Life Sciences Expands CDx Through Deal With Lumea
5.6 FDA Approves Illumina Cancer Genomic Profiling Assay as CDx
5.7 Foundation Medicine, Repare to Partner on CDx for Lunresertib
5.8 Burning Rock, Bayer to Develop NGS Companion Diagnostic
5.9 PathAI, Roche to Develop AI-Enabled Companion Diagnostics
5.10 ARUP and Medicover Expand Companion Diagnostic in EU
5.11 Thermo Fisher Signs Companion Diagnostic Agreement
5.12 Agilent CDx Assay IVDR Certified
5.13 ARUP Laboratories Gets Approval for Gene Therapy CDx
5.14 Guardant Health Gets Medicare Coverage for Liquid Biopsy Test
5.15 Amoy Dx PLC Panel Gets Approval in Japan as CDx
5.16 UnitedHealthcare Expands Precision Oncology Dx Coverage
5.17 JaxBio to Create Array-Based Cancer Tests
5.18 Agilent, Qiagen Win FDA Approvals Companion Diagnostics
5.19 Navignostics Using Single-Cell Spatial Proteomics
5.20 HMNC Brain Health to Develop Companion Diagnostics
5.21 Propath UK, Nucleai Partner on Spatial Proteomics
5.22 Becton Dickinson, Labcorp Develop Flow Cytometry Companion Diagnostics
5.23 Almac, AstraZeneca Strike CDx Development Pact
5.24 Avalon GloboCare to Develop Cell Therapy CDx
5.25 Burning Rock Secures Lung Cancer NGS Test Approval in China
5.26 TenSixteen Bio Developing Drugs, Companion NGS Tests
5.27 Guardant Health Plans New Comprehensive Assay
5.28 Thermo Fisher, Oncocyte Ink Comarketing Deal for Cancer IVDs
5.29 Qiagen, Denovo Biopharma to Develop Liquid Biopsy CDx Test
5.30 Japanese Approves Thermo Fisher Scientific Oncomine Assay as CDx
5.31 Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug
5.32 Natera Aims to Lead Market in Solid Tumor Adjuvant CDx
5.33 Oncocyte Details Expansions Plans
5.34 Agilent Acquires Resolution Biosciences
5.35 Qiagen, Inovio Expand CDx Partnership
5.36 AmoyDx, AstraZeneca Strike Ovarian Cancer CDx Alliance
5.37 NeoGenomics to Grow Through CDx Agreements, Acquisitions
5.38 Personalis Neoantigen Platform Driving Improved Immunotherapy Prediction
5.39 Biocartis Collaborating with Endpoint Health on CDx Tests for Idylla Platform
5.40 FDA Approves Foundation Medicine Test as CDx for Three Targeted Therapies
5.41 Resolution Bio Launches Lung Cancer Liquid Biopsy
5.42 Promega to Develop MSI Assay as CDx
5.43 Guardant Health to Develop CDx for Janssen
5.44 Burning Rock Bio, CStone Pharmaceuticals to Codevelop CDx
5.45 FDA Approval for FoundationOne®CDx
5.46 FDA finalizes CDx Guidance
5.47 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 Acuamark Diagnostics
6.5 Adaptive Biotechnologies
6.6 Admera Health, LLC
6.7 Aethlon Medical
6.8 Agilent
6.9 Amoy Diagnostics Co., Ltd.
6.10 Anchor Dx
6.11 ANGLE plc
6.12 Applied DNA Sciences
6.13 ARUP Laboratories
6.14 AVIVA Systems Biology
6.15 Baylor Miraca Genetics Laboratories
6.16 Beckman Coulter Diagnostics (Danaher)
6.17 Becton, Dickinson and Company
6.18 Berkley Lights
6.19 BGI Genomics Co. Ltd
6.20 BillionToOne
6.21 Bioarray Genetics
6.22 Biocartis
6.23 Biocept, Inc.
6.24 Biodesix Inc.
6.25 BioFluidica
6.26 BioGenex
6.27 BioIVT
6.28 Biolidics Ltd
6.29 bioMérieux Diagnostics
6.30 Bioneer Corporation
6.31 Bio-Rad Laboratories, Inc
6.32 Bio-Reference Laboratories
6.33 Bio-Techne
6.34 Bioview
6.35 Bristol-Myers Squibb
6.36 Burning Rock
6.37 C2i Genomics
6.38 Cardiff Oncology
6.39 Caris Molecular Diagnostics
6.40 Castle Biosciences, Inc.
6.41 CellCarta
6.42 CellMax Life
6.43 Cepheid (Danaher)
6.44 Charles River Laboratories
6.45 Circulogene
6.46 Cizzle Biotech
6.47 Clearbridge Biomedics
6.48 Clinical Genomics
6.49 Cytolumina Technologies Corp.
6.50 Datar Cancer Genetics Limited
6.51 Diagnologix LLC
6.52 Diasorin S.p.A.
6.53 Dxcover
6.54 Element Biosciences
6.55 Enzo Biochem
6.56 Epic Sciences
6.57 Epigenomics AG
6.58 Eurofins Scientific
6.59 Fabric Genomics
6.60 Fluxion Biosciences (Cell Microsystems)
6.61 Freenome
6.62 FUJIFILM Wako Diagnostics
6.63 Fujirebio
6.64 Fyr Diagnostics
6.65 GeneDx Holdings
6.66 GeneFirst Ltd.
6.67 Genetron Holdings
6.68 GenomOncology
6.69 GILUPI Nanomedizin
6.70 Guardant Health
6.71 HansaBiomed
6.72 HTG Molecular Diagnostics
6.73 iCellate
6.74 ICON PLC
6.75 Illumina
6.76 Incell Dx
6.77 Inivata
6.78 INOVIQ
6.79 Invitae Corporation
6.80 Invivogen
6.81 Invivoscribe
6.82 J&J Innovative Medicine
6.83 KEW
6.84 Lucence Health
6.85 Lunglife AI Inc
6.86 MDNA Life SCIENCES, Inc.
6.87 MDx Health
6.88 Menarini Silicon Biosystems
6.89 Mesa Laboratories, Inc.
6.90 Millipore Sigma
6.91 Miltenyi Biotec
6.92 miR Scientific
6.93 Myriad Genetics
6.94 Nanostring
6.95 NantHealth, Inc.
6.96 Natera
6.97 NeoGenomics
6.98 NGeneBio
6.99 Novogene
6.100 Oncimmune
6.101 Oncocyte
6.102 OncoDNA
6.103 Oncohost
6.104 Oxford Nanopore Technologies
6.105 PamGene
6.106 Panagene
6.107 Personalis
6.108 Perthera
6.109 PGDx (Labcorp)
6.110 Precipio
6.111 PrecisionMed
6.112 Predicine
6.113 Predictive Oncology
6.114 Prenetics
6.115 Promega
6.116 Qiagen
6.117 QuidelOrtho
6.118 Rarecells SAS
6.119 RareCyte
6.120 Revvity
6.121 Roche Diagnostics
6.122 Screencell
6.123 Sherlock Biosciences
6.124 Siemens Healthineers
6.125 simfo GmbH
6.126 Singlera Genomics Inc.
6.127 Singular Genomics
6.128 Singulomics
6.129 SkylineDx
6.130 Standard BioTools
6.131 Stilla Technologies
6.132 Sysmex Inostics
6.133 Tempus Labs, Inc.
6.134 Thermo Fisher Scientific
6.135 Todos Medical
6.136 Ultima Genomics
6.137 Veracyte
6.138 Vir
6.139 VolitionRX
6.140 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
7.2.6 Chart - Global Market by Application - Segment Growth Rates
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 Companion Diagnostic Markets - By Application
8.1 Oncology Breast
8.1.1 Table Oncology Breast - by Country
8.1.2 Chart - Oncology Breast Growth
8.2 Oncology Lung
8.2.1 Table Oncology Lung - by Country
8.2.2 Chart - Oncology Lung Growth
8.3 Oncology Colorectal
8.3.1 Table Oncology Colorectal - by Country
8.3.2 Chart - Oncology Colorectal Growth
8.4 Oncology Other
8.4.1 Table Oncology Other - by Country
8.4.2 Chart - Oncology Other Growth
8.5 Neurology
8.5.1 Table Neurology - by Country
8.5.2 Chart - Neurology Growth
8.6 Cardiology
8.6.1 Table Cardiology - by Country
8.6.2 Chart - Cardiology Growth
8.7 Other Application
8.7.1 Table Other Application - by Country
8.7.2 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 Global Companion Diagnostic Markets - Technology
10.1 Global Market Next Generation Sequencing
10.1.1 Table Next Generation Sequencing - by Country
10.1.2 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
List of Tables
Table 1 FDA Approved Companion Dx
Table 2 Market Players by Type
Table 3 The Base Pairs
Table 4 Factors Driving Growth
Table 5 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 Breast by Country
Table 12 Oncology Lung by Country
Table 13 Oncology Colorectal by Country
Table 14 Oncology Other by Country
Table 15 Neurology by Country
Table 16 Cardiology by Country
Table 17 Other Application by Country
Table 18 Pharmaceutical by Country
Table 19 Venture by Country
Table 20 Clinical by Country
Table 21 Other Funding by Country
Table 22 Next Generation Sequencing by Country
Table 23 PCR by Country
Table 24 IHC/ISH by Country
Table 25 Other Technology by Country
Table 26 Clinical Laboratory Fee Schedule
Table 27 The Most Common Assays
Table 28 Largest Revenue Assays
List of Figures
Figure 1 Global Healthcare Spending
Figure 2 The Road to Diagnostics
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 The Changing Age of The World’s Population
Figure 9 Health Care Consumption by Age
Figure 10 Cancer Incidence by Age
Figure 11 Centralized vs. Decentralized Laboratory Service
Figure 12 A Highly Multiplexed Syndromic Testing Unit
Figure 13 The Real Cost to Sequence the Human Genome
Figure 14 The Codevelopment Process
Figure 15 Comparing MDx Diagnostic and Traditional Testing
Figure 16 Base Year Country Market Share Chart
Figure 17 CDx Market by Application - Base vs. Final Year
Figure 18 CDx Market by Application Base Year
Figure 19 CDx Market by Application Final Year
Figure 20 Application Type Share by Year
Figure 21 Application Type Segment Growth Rates
Figure 22 Funding Source - Base vs. Final Year
Figure 23 Funding Source Market Base Year
Figure 24 Funding Source Market Final Year
Figure 25 Funding Source Share by Year
Figure 26 Technology - Base vs. Final Year
Figure 27 Technology Market Base Year
Figure 28 Technology Market Final Year
Figure 29 Technology Share by Year
Figure 30 Oncology Breast Growth
Figure 31 Oncology Lung Growth
Figure 32 Oncology Colorectal Growth
Figure 33 Oncology Other Growth
Figure 34 Neurology Growth
Figure 35 Cardiology Growth
Figure 36 Other Application Growth
Figure 37 Pharmaceutical Growth
Figure 38 Venture Growth
Figure 39 Clinical Growth
Figure 40 Other Funding Growth
Figure 41 Next Generation Sequencing Growth
Figure 42 PCR Growth
Figure 43 IHC/ISH Growth
Figure 44 Other Technology Growth
