OVERVIEW:
Companion Diagnostics are poised to revolutionize the diagnostics industry. The market is finally moving out of the lab and into the clinic. Oncology, especially immune-oncology is leading the way. And the FDA is holding the door open for this diagnostic technology of the future. But COVID-19 is impacting healthcare treatment everywhere and lowering demand for specialized cancer testing. Find out the latest outlook for this important market.
Will Personalized Companion Diagnostics become the norm for diagnostics?
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 of molecular diagnostics continues to fall.
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
i. Companion Diagnostic Market - Strategic Situation Analysis
ii. Guide for Executives, Marketing, Sales and Business Development Staff
iii. Guide for Management Consultants and Investment Advisors
1. Introduction and Market Definition
- 1.1 What are Companion Diagnostics?
- 1.2 The Personalized Medicine Revolution
- 1.3 Market Definition
- 1.3.1 Revenue Market Size
- 1.4 Methodology
- 1.4.1 Authors
- 1.4.2 Sources
- 1.5 A Spending Perspective on Clinical Laboratory Testing
- 1.5.1 U.S. Medicare Expenditures for Laboratory Testing
2. Market Overview
- 2.1 Players in a Dynamic Market
- 2.1.1 Academic Research Lab
- 2.1.2 Diagnostic Test Developer
- 2.1.3 Instrumentation Supplier
- 2.1.4 Distributor and Reagent Supplier
- 2.1.5 Independent Testing Lab
- 2.1.6 Public National/regional lab
- 2.1.7 Hospital lab
- 2.1.8 Physician Office Labs
- 2.1.9 Audit Body
- 2.1.10 Certification Body
- 2.2 Personalized Medicine and Companion Diagnostics
- 2.2.1 Basics
- 2.2.2 Method
- 2.2.3 Disease risk assessment
- 2.2.4 Applications
- 2.2.5 Diagnosis and intervention
- 2.2.5.1 Companion Diagnostics
- 2.2.6 Drug development and usage
- 2.2.7 Respiratory proteomics
- 2.2.8 Cancer genomics
- 2.2.9 Population screening
- 2.2.10 Challenges
- 2.2.11 Regulatory oversight
- 2.2.12 Intellectual property rights
- 2.2.13 Reimbursement policies
- 2.2.14 Patient privacy and confidentiality
- 2.3 Chromosomes, Genes and Epigenetics
- 2.3.1 Chromosomes
- 2.3.2 Genes
- 2.3.3 Epigenetics
- 2.4 Cancer Genes
- 2.4.1 Germline vs Somatic
- 2.4.2 Changing Clinical Role
- 2.5 Structure of Industry Plays a Part
- 2.5.1 New Pharmaceutical Funding Market
- 2.5.2 Economies of Scale
- 2.5.2.1 Hospital vs. Central Lab
- 2.5.3 Physician Office Labs
- 2.5.4 Physicians and POCT
3. Market Trends
- 3.1 Factors Driving Growth
- 3.1.1 Level of Care
- 3.1.2 Immuno-oncology
- 3.1.3 Liability
- 3.1.4 Aging Population
- 3.2 Factors Limiting Growth
- 3.2.1 State of knowledge
- 3.2.2 Genetic Blizzard.
- 3.2.3 Protocol Resistance
- 3.2.4 Regulation and coverage
- 3.3 Instrumentation and Automation
- 3.3.1 Instruments Key to Market Share
- 3.3.2 Bioinformatics Plays a Role
- 3.4 Diagnostic Technology Development
- 3.4.1 Next Generation Sequencing Fuels a Revolution.
- 3.4.2 Single Cell Genomics Changes the Picture
- 3.4.3 Pharmacogenomics Blurs Diagnosis and Treatment
- 3.4.4 CGES Testing, A Brave New World
- 3.4.5 Biochips/Giant magneto resistance based assay
4. Companion Diagnostics Recent Developments
- 4.1 Recent Developments - Importance and How to Use This Section
- 4.1.1 Importance of These Developments
- 4.1.2 How to Use This Section
- FDA Approval for FoundationOne®CDx
- FDA finalizes CDx Guidance
- QIAGEN Launches CDx Therascreen BRAF Test
- Myriad Genetics Seeks Approval for Companion Diagnostic
- ARUP Labs Seek PMA for Hemophilia Gene Therapy CDx
- QIAGEN Builds on Global Collaboration with Amgen
- Foundation Medicine nabs 19th companion Dx
- Maze Therapeutics Uses CRISPR for Precision Medicine Companion Diagnostics
- Myriad Wins Japanese Approval for BRACAnalysis
- Fujitsu Improves Efficiency in Cancer Genomic Medicine
- Thermo Fisher's automated sequencer to offer same-day, pan-cancer test results
- Takeda, Prometheus Enter IBD Drug-Companion Diagnostic Partnership
- Thermo Fisher, Eli Lilly Ink CDx Collaboration in NSCLC, Thyroid Cancer
- Roche VENTANA PD-L1 (SP142) Assay approved as companion diagnostic
- Universal Genetic Testing for All Breast Cancer Patients
- Exact Sciences buys Genomic Health
- Biodesix Highlights Pipeline and Companion Diagnostic Development
- Multi-Gene Liquid Biopsy Breast Cancer Panel
- New Gene Panel Identifies High Risk Prostate Cancer
- Guardant Health Liquid Biopsy Test to be Covered by EviCore
- Inivata Completes £39.8M Series B Funding Round
- Bio-Rad Clinical ddPCR Test, Diagnostic System Get FDA Clearance
- CellMax, Medigen Biotech Partner in Colorectal Cancer Clinical Trials
5. Profiles of Key Players
- 10x Genomics, Inc.
- Abbott Diagnostics
- AccuraGen Inc
- Adaptive Biotechnologies
- Aethlon Medical
- Agena Bioscience, Inc
- Agilent
- Anchor Dx
- ANGLE plc
- ApoCell, Inc.
- ArcherDx, Inc.
- ARUP Laboratories
- Asuragen
- AVIVA Biosciences
- Baylor Miraca Genetics Laboratories
- Beckman Coulter, Inc.
- Becton, Dickinson and Company
- BGI Genomics Co. Ltd
- Bioarray Genetics
- Biocartis
- Biocept, Inc
- Biodesix Inc.
- BioFluidica
- BioIVT
- Biolidics Ltd
- bioMérieux Diagnostics
- Bioneer Corporation
- Bio-Rad Laboratories, Inc
- Bio-Reference Laboratories
- Bio-Techne
- Bioview
- Bolidics
- Boreal Genomics
- Bristol-Myers Squibb
- Cancer Genetics
- Caris Molecular Diagnostics
- Castle Biosciences, Inc.
- CellMax Life
- Cepheid (now Danaher)
- Charles River Laboratories
- Chronix Biomedical
- Circulogene
- Clinical Genomics
- Cynvenio
- Cytolumina Technologies Corp.
- CytoTrack
- Datar Cancer Genetics Limited
- Diagnologix LLC
- Diasorin S.p.A.
- Enzo Life Sciences, Inc.
- Epic Sciences
- Epigenomics AG
- Eurofins Scientific
- Exosome Diagnostics
- Exosome Sciences
- Fabric Genomics
- Fluidigm Corp
- Fluxion Biosciences
- Foundation Medicine (now Roche)
- Freenome
- FUJIFILM Wako Diagnostics
- GeneFirst Ltd.
- Genetron Health (Beijing) Co., Ltd
- Genomic Health
- GenomOncology
- GILUPI Nanomedizin
- Grail, Inc.
- Guardant Health
- HalioDx
- HansaBiomed
- HeiScreen
- Helomics
- Horizon Discovery
- HTG Molecular Diagnostics
- iCellate
- Illumina
- Incell Dx
- Inivata
- Integrated Diagnostics
- Invivogen
- Invivoscribe
- Janssen Diagnostics
- MDNA Life SCIENCES, Inc
- MDx Health
- Menarini Silicon Biosystems
- Miltenyi Biotec
- MIODx
- miR Scientific
- Molecular MD
- MyCartis
- Myriad Genetics/Myriad RBM
- NantHealth, Inc.
- Natera
- NeoGenomics
- New Oncology
- Novogene Bioinformatics Technology Co., Ltd.
- Oncocyte
- OncoDNA
- Ortho Clinical Diagnostics
- Oxford Nanopore Technologies
- Panagene
- Perkin Elmer
- Personal Genome Diagnostics
- Personalis
- Precipio
- PrecisionMed
- Promega
- Qiagen Gmbh
- Rarecells SAS
- RareCyte
- Roche Molecular Diagnostics
- Screencell
- Sense Biodetection.
- Serametrix
- Siemens Healthineers
- Silicon Biosystems
- simfo GmbH
- Singlera Genomics Inc.
- Singulomics
- SkylineDx
- Stratos Genomics
- Sysmex Inostics
- Tempus Labs, Inc.
- Thermo Fisher Scientific Inc.
- Thrive Earlier Detection
- Todos Medical
- Trovagene
- Volition
- Vortex Biosciences
6. The Global Market for Companion Diagnostics
- 6.1 Global Market Overview by Country
- 6.1.1 Table - Global Market by Country
- 6.1.2 Chart - Global Market by Country
- 6.2 Global Market by Application - Overview
- 6.2.1 Table - Global Market by Application
- 6.2.2 Chart - Global Market by Application - 2019/2024 Comparison
- 6.2.3 Chart - Global Market by Application - 2019
- 6.2.4 Chart - Global Market by Application -2024
- 6.2.5 Chart - Global Market by Application - Share by Year
- 6.3 Global Market Funding Source - Overview
- 6.3.1 Table - Global Market by Funding Source
- 6.3.2 Chart - Global Market Funding Source - 2019/2024 Comparison
- 6.3.3 Chart - Global Market Funding Source - 2019
- 6.3.4 Chart - Global Market Funding Source -2024
- 6.3.5 Chart - Global Market Funding Source - Share by Year
7. Global Companion Diagnostic Markets - By Application
- 7.1 Oncology
- 7.1.1 Table Oncology - by Country
- 7.1.2 Chart - Oncology Growth
- 7.2 Neurology
- 7.2.1 Table Neurology - by Country
- 7.2.2 Chart - Neurology Growth
- 7.3 Cardiology
- 7.3.1 Table Cardiology - by Country
- 7.3.2 Chart - Cardiology Growth
- 7.4 Other Application
- 7.4.1 Table Other Application - by Country
- 7.4.2 Chart - Other Application Growth
8. Global Companion Diagnostic Markets - Funding Source
- 8.1 Global Market Pharmaceutical
- 8.1.1 Table Pharmaceutical - by Country
- 8.1.2 Chart - Pharmaceutical Growth
- 8.2 Global Market Venture
- 8.2.1 Table Venture - by Country
- 8.2.2 Chart - Venture Growth
- 8.3 Global Market Clinical
- 8.3.1 Table Clinical - by Country
- 8.3.2 Chart - Clinical Growth
- 8.4 Global Market Other Funding
- 8.4.1 Table Other Funding - by Country
- 8.4.2 Chart - Other Funding Growth
Appendices
- I. United States Medicare System: January 2020 Clinical Laboratory Fees Schedule
- II. Pharmacogenomic Biomarkers in Drug Labeling
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