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 Agilent CDx Assay IVDR Certified
5.3 ARUP Laboratories Gets Approval for Gene Therapy CDx
5.4 Guardant Health Gets Medicare Coverage for Liquid Biopsy Test
5.5 Amoy Dx PLC Panel Gets Approval in Japan as CDx
5.6 UnitedHealthcare Expands Precision Oncology Dx Coverage
5.7 JaxBio to Create Array-Based Cancer Tests
5.8 Agilent, Qiagen Win FDA Approvals Companion Diagnostics
5.9 Navignostics Using Single-Cell Spatial Proteomics
5.10 HMNC Brain Health to Develop Companion Diagnostics
5.11 Propath UK, Nucleai Partner on Spatial Proteomics
5.12 Becton Dickinson, Labcorp Collaborate for Flow Cytometry-Based CompanionDiagnostics
5.13 Almac, AstraZeneca Strike CDx Development Pact
5.14 Avalon GloboCare, Lu Daopei Hematology Institute to Develop Cell Therapy CDx
5.15 Burning Rock Secures Lung Cancer NGS Test Approval in China
5.16 TenSixteen Bio Developing Drugs, Companion NGS Tests
5.17 Guardant Health Plans New Comprehensive Assay
5.18 Thermo Fisher, Oncocyte Ink Comarketing Deal for Cancer IVDs
5.19 Qiagen, Denovo Biopharma to Develop Liquid Biopsy CDx Test
5.20 Japanese Approves Thermo Fisher Scientific Oncomine Assay as CDx
5.21 Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug
5.22 Natera Aims to Lead Market in Solid Tumor Adjuvant CDx
5.23 Oncocyte Details Expansions Plans
5.24 Agilent Acquires Resolution Biosciences
5.25 Qiagen, Inovio Expand CDx Partnership
5.26 AmoyDx, AstraZeneca Strike Ovarian Cancer CDx Alliance
5.27 NeoGenomics to Grow Through CDx Agreements, Acquisitions
5.28 Personalis Neoantigen Platform Driving Improved Immunotherapy Prediction
5.29 Biocartis Collaborating with Endpoint Health on CDx Tests for Idylla Platform
5.30 FDA Approves Foundation Medicine Test as CDx for Three Targeted Therapies
5.31 Promega to Develop MSI Assay as CDx
5.32 Guardant Health to Develop CDx for Janssen
5.33 Burning Rock Bio, CStone Pharmaceuticals to Codevelop CDx
5.34 FDA Approval for FoundationOne®CDx
5.35 FDA finalizes CDx Guidance
5.36 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 (Revvity)
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 Companion Diagnostic Markets - By Application
8.1 Oncology
8.1.1 Table Oncology - by Country
8.1.2 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 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
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
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 Growth
Figure 31 Neurology Growth
Figure 32 Cardiology Growth
Figure 33 Other Application Growth
Figure 34 Pharmaceutical Growth
Figure 35 Venture Growth
Figure 36 Clinical Growth
Figure 37 Other Funding Growth
Figure 38 Next Generation Sequencing Growth
Figure 39 PCR Growth
Figure 40 IHC/ISH Growth
Figure 41 Other Technology Growth
