OVERVIEW:
Companion Diagnostics are changing the diagnostics industry. Whole new markets are emerging. Diagnostic and Therapeutic partnerships. Find out the latest outlook for this important market.
Will Companion Diagnostics become the norm?
Learn all about how diagnostic players are jockeying for position with their pharmaceutical counterparts and creating new and significant business opportunities. And some players are already taking the lead. It is a dynamic market situation with enormous opportunity. Diagnostic companies are trying to back the right horse. The science is racing forward. And the cost picture is changing.
The report includes detailed breakouts for 18 Countries and 4 Regions. A detailed breakout for any country or specific area in the world is available to purchasers of the report.
ABOUT THE LEAD AUTHOR:
Mr. Greg Powell, B.SC., M.B.A is the President of Howe Sound Research. He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years. Mr. Powell's education includes:
- B.Sc. (Chemistry) University of BC
- M.B.A. (Finance and Policy) University of BC
- Market Research Seminar - Burke Institute
- Finance for Senior Executives - Harvard Business School
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 Foundation Medicine, Repare to Partner on CDx for Lunresertib
- 5.3 Burning Rock, Bayer to Develop NGS Companion Diagnostic
- 5.4 PathAI, Roche to Develop AI-Enabled Companion Diagnostics
- 5.5 ARUP and Medicover Expand Companion Diagnostic in EU
- 5.6 Thermo Fisher Signs Companion Diagnostic Agreement
- 5.7 Agilent CDx Assay IVDR Certified
- 5.8 ARUP Laboratories Gets Approval for Gene Therapy CDx
- 5.9 Guardant Health Gets Medicare Coverage for Liquid Biopsy Test
- 5.10 Amoy Dx PLC Panel Gets Approval in Japan as CDx
- 5.11 UnitedHealthcare Expands Precision Oncology Dx Coverage
- 5.12 JaxBio to Create Array-Based Cancer Tests
- 5.13 Agilent, Qiagen Win FDA Approvals Companion Diagnostics
- 5.14 Navignostics Using Single-Cell Spatial Proteomics
- 5.15 HMNC Brain Health to Develop Companion Diagnostics
- 5.16 Propath UK, Nucleai Partner on Spatial Proteomics
- 5.17 Becton Dickinson, Labcorp Develop Flow Cytometry Companion Diagnostics
- 5.18 Almac, AstraZeneca Strike CDx Development Pact
- 5.19 Avalon GloboCare to Develop Cell Therapy CDx
- 5.20 Burning Rock Secures Lung Cancer NGS Test Approval in China
- 5.21 TenSixteen Bio Developing Drugs, Companion NGS Tests
- 5.22 Guardant Health Plans New Comprehensive Assay
- 5.23 Thermo Fisher, Oncocyte Ink Comarketing Deal for Cancer IVDs
- 5.24 Qiagen, Denovo Biopharma to Develop Liquid Biopsy CDx Test
- 5.25 Japanese Approves Thermo Fisher Scientific Oncomine Assay as CDx
- 5.26 Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug
- 5.27 Natera Aims to Lead Market in Solid Tumor Adjuvant CDx
- 5.28 Oncocyte Details Expansions Plans
- 5.29 Agilent Acquires Resolution Biosciences
- 5.30 Qiagen, Inovio Expand CDx Partnership
- 5.31 AmoyDx, AstraZeneca Strike Ovarian Cancer CDx Alliance
- 5.32 NeoGenomics to Grow Through CDx Agreements, Acquisitions
- 5.33 Personalis Neoantigen Platform Driving Improved Immunotherapy Prediction
- 5.34 Biocartis Collaborating with Endpoint Health on CDx Tests for Idylla Platform
- 5.35 FDA Approves Foundation Medicine Test as CDx for Three Targeted Therapies
- 5.36 Promega to Develop MSI Assay as CDx
- 5.37 Guardant Health to Develop CDx for Janssen
- 5.38 Burning Rock Bio, CStone Pharmaceuticals to Codevelop CDx
- 5.39 FDA Approval for FoundationOne-RCDx
- 5.40 FDA finalizes CDx Guidance
- 5.41 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 bioMerieux 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 Singlera Genomics Inc.
- 6.126 Singular Genomics
- 6.127 Singulomics
- 6.128 SkylineDx
- 6.129 Standard BioTools
- 6.130 Stilla Technologies
- 6.131 Sysmex Inostics
- 6.132 Tempus Labs, Inc.
- 6.133 Thermo Fisher Scientific
- 6.134 Todos Medical
- 6.135 Ultima Genomics
- 6.136 Veracyte
- 6.137 Vir
- 6.138 VolitionRX
- 6.139 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