OVERVIEW:
Cancer Molecular Diagnostics is back on the growth path. And growth is accelerating in every segment. We include a special segment Cancer Companion Diagnostics, a new segment of the market that is reshaping the industry. Over 140 companies are profiled. A range of dynamic trends are pushing market growth and company valuations.
Trends like:
- personalized medicine
- pharmacogenomics
- liquid biopsy
- minimal residual disease testing
- emergence of new economies with large markets
- physician diagnostics being displaced by new intelligent diagnostic tests
Exciting technical developments especially in companion diagnostics, hold the promise of a dynamic, growing and evolving world market where single laboratories serve a global patient base.
The report includes detailed breakouts for 18 Countries and 4 Regions. A detailed breakout for any country 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 Cancer MDx - Strategic Situation Analysis
- 1.2 Guide for Executives, Marketing, and Business Development Staff
- 1.3 Guide for Management Consultants and Investment Advisors
2 Introduction and Market Definition
- 2.1 What are Molecular Diagnostics?
- 2.2 The Diagnostics 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 Market Segments
- 3.1.1 Traditional Market Segmentation
- 3.1.2 Laboratory Focus and Segmentation
- 3.2 Industry Structure
- 3.2.1 Hospital Testing Share
- 3.2.2 Economies of Scale
- 3.2.3 Physician Office Lab's
- 3.2.4 Physician's and POCT
4 Market Trends
- 4.1 Factors Driving Growth
- 4.1.1 New Diagnostics Create New Markets
- 4.1.2 New Roles for Diagnostics
- 4.1.3 Aging Effect
- 4.1.4 Expanding the Pharmaceutical Toolbox
- 4.1.5 Regulatory Retreat
- 4.2 Factors Limiting Growth
- 4.2.1 Falling Prices
- 4.2.2 Lower Costs
- 4.2.3 Wellness has a Downside
- 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
- 4.3.11 Multiplexing and Foundation One
- 4.3.12 Pharmacogenomics Technology
- 4.3.13 Gene Editing and Gene Therapy
5 Molecular 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 Therapeutics to Develop CDx
- 5.3 NHS Declines to Accelerate Grail Galleri Implementation
- 5.4 GeneDx Sees Growing Demand for Testing
- 5.5 Thermo Fisher and Bayer to Develop CDx for Cancer Therapies
- 5.6 ClearNote Health Expands Into Immunotherapy Monitoring
- 5.7 Foundation Medicine to Collaborate on CDx for Lung Cancer
- 5.8 Qiagen and Myriad Genetics Partner to Develop Cancer CDx
- 5.9 Lung Cancer Data Heralds Shift for Hummingbird Dx
- 5.10 PamGene Awarded Euro-7.5M for Immunotherapy Test
- 5.11 Grail Cancer Test Faces New Clinical Questions
- 5.12 Freenome Acquires Cancer Dx Firm Oncimmune
- 5.13 Quest Diagnostics to Acquire Liquid Biopsy Firm Haystack Oncology
- 5.14 Ultima Genomics, Genome Insight Partner on WGS for Cancer Patients
- 5.15 Digital Pathology Meets Cancer Sequencing
- 5.16 Exact Sciences Preps Expanded Oncology Portfolio
- 5.17 Qiagen Details Oncology Plans for Digital PCR Platform
- 5.18 Sema4 Exiting Reproductive Health Screening
- 5.19 Thermo Fisher Introduces Cancer Profiling Assay
- 5.20 Genomic Test IDs Cysts Likely to Progress to Cancer
- 5.21 Naveris to Commercialize Virus-Related Cancer Tests
- 5.22 Larger Liquid Biopsy Panels Loom
- 5.23 Halo Diagnostics to Offer Genomic Profiling Tests
- 5.24 BillionToOne Raises $125M
- 5.25 Local Cancer Genomic Profiling Options Grow
- 5.26 German MDx Firm Mainz Biomed Raises $10M in IPO
- 5.27 Guardant Health Q3 Revenues Up 27 Percent
- 5.28 BforCure Raises $2.3M to Adapt Rapid PCR Platform for Cancer Detection
- 5.29 Nucleix to Invest in Early-Stage Lung Cancer Dx
- 5.30 Labcorp, GeneCentric Partnering on Development of RNA-Based Cancer Diagnostics
- 5.31 Grail Gets Approval for Galleri Multicancer Test
- 5.32 Finnish Firms to Form Point-of-Care Testing Firm
- 5.33 Datar Cancer Genetics Expands to Dx and Screening
- 5.34 HTG Molecular Diagnostics: HTG Transcriptome Panel
- 5.35 PacBio's Omniome Acquisition Shortens Path to Clinical
- 5.36 Invitae to Acquire Genosity for $200M
- 5.37 Bio-Techne Obtains CE Mark for Exosomal Liquid Biopsy Prostate Test
- 5.38 Agilent Technologies to Acquire Liquid Biopsy Firm Resolution Bioscience
- 5.39 Natera Revenues Grow 35 Percent
- 5.40 AnchorDx Closes $40M Financing Round
- 5.41 Exact Sciences Strategy for End-to-End Cancer Testing
- 5.42 Genomics England: Whole Genome Sequencing for Cancer Patients to Launch
6 Profiles of Key MDx Companies
- 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 ARUP Laboratories
- 6.13 AVIVA Systems Biology
- 6.14 Baylor Miraca Genetics Laboratories
- 6.15 Beckman Coulter Diagnostics (Danaher)
- 6.16 Becton, Dickinson and Company
- 6.17 BGI Genomics Co. Ltd
- 6.18 BillionToOne
- 6.19 Bioarray Genetics
- 6.20 Biocartis
- 6.21 Biocept, Inc.
- 6.22 Biodesix Inc.
- 6.23 BioFluidica
- 6.24 BioGenex
- 6.25 BioIVT
- 6.26 Biolidics Ltd
- 6.27 bioMerieux Diagnostics
- 6.28 Bioneer Corporation
- 6.29 Bio-Rad Laboratories, Inc
- 6.30 Bio-Reference Laboratories
- 6.31 Bio-Techne
- 6.32 Bioview
- 6.33 Bristol-Myers Squibb
- 6.34 Burning Rock
- 6.35 C2i Genomics
- 6.36 Cardiff Oncology
- 6.37 Caris Molecular Diagnostics
- 6.38 Castle Biosciences, Inc.
- 6.39 Celemics
- 6.40 CellCarta
- 6.41 CellMax Life
- 6.42 Cepheid (Danaher)
- 6.43 Charles River Laboratories
- 6.44 Circulogene
- 6.45 Cizzle Biotech
- 6.46 Clearbridge Biomedics
- 6.47 Clinical Genomics
- 6.48 Cytolumina Technologies Corp.
- 6.49 Datar Cancer Genetics Limited
- 6.50 Diagnologix LLC
- 6.51 Diasorin S.p.A.
- 6.52 Dxcover
- 6.53 Element Biosciences
- 6.54 Enzo Biochem
- 6.55 Epic Sciences
- 6.56 Epigenomics AG
- 6.57 Erythra
- 6.58 Eurofins Scientific
- 6.59 Exact Sciences
- 6.60 Fabric Genomics
- 6.61 Fluxion Biosciences (Cell Microsystems)
- 6.62 Freenome
- 6.63 FUJIFILM Wako Diagnostics
- 6.64 Fujirebio
- 6.65 Fulgent Genetics
- 6.66 Fyr Diagnostics
- 6.67 GeneDx Holdings
- 6.68 GeneFirst Ltd.
- 6.69 Genetron Holdings
- 6.70 GenomOncology
- 6.71 GILUPI Nanomedizin
- 6.72 Guardant Health
- 6.73 HansaBiomed
- 6.74 HTG Molecular Diagnostics
- 6.75 iCellate
- 6.76 ICON PLC
- 6.77 Illumina
- 6.78 Incell Dx
- 6.79 Inivata
- 6.80 INOVIQ
- 6.81 Invitae Corporation
- 6.82 Invivogen
- 6.83 Invivoscribe
- 6.84 J&J Innovative Medicine
- 6.85 Lucence Health
- 6.86 Lunglife AI Inc
- 6.87 MDNA Life SCIENCES, Inc.
- 6.88 MDx Health
- 6.89 Menarini Silicon Biosystems
- 6.90 Mesa Laboratories, Inc.
- 6.91 Metabiomics Corp
- 6.92 Millipore Sigma
- 6.93 Miltenyi Biotec
- 6.94 miR Scientific
- 6.95 Myriad Genetics
- 6.96 Nanostring
- 6.97 NantHealth, Inc.
- 6.98 Natera
- 6.99 NeoGenomics
- 6.100 NGeneBio
- 6.101 Novogene
- 6.102 Oncimmune
- 6.103 Oncocyte
- 6.104 OncoDNA
- 6.105 Oncohost
- 6.106 OraLiva
- 6.107 Oxford Nanopore Technologies
- 6.108 PamGene
- 6.109 Panagene
- 6.110 Personalis
- 6.111 Perthera
- 6.112 PGDx (Labcorp)
- 6.113 Precipio
- 6.114 PrecisionMed
- 6.115 Predicine
- 6.116 Predictive Oncology
- 6.117 Prenetics
- 6.118 Promega
- 6.119 Qiagen
- 6.120 QuidelOrtho
- 6.121 Rarecells SAS
- 6.122 RareCyte
- 6.123 Revvity
- 6.124 Roche Diagnostics
- 6.125 Screencell
- 6.126 Sherlock Biosciences
- 6.127 Siemens Healthineers
- 6.128 simfo GmbH
- 6.129 Singlera Genomics Inc.
- 6.130 Singular Genomics
- 6.131 Singulomics
- 6.132 SkylineDx
- 6.133 Standard BioTools
- 6.134 Stilla Technologies
- 6.135 Sysmex Inostics
- 6.136 Tempus Labs, Inc.
- 6.137 Thermo Fisher Scientific
- 6.138 Todos Medical
- 6.139 Ultima Genomics
- 6.140 Variantyx
- 6.141 Vela Diagnostics
- 6.142 Veracyte
- 6.143 VolitionRX
- 6.144 Vortex Biosciences
- 6.145 Zhejiang Orient Gene Biotech
7 The Global Market for MDx Cancer
- 7.1 MDx Cancer - 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 Cancer Type - Overview
- 7.2.1 Table - Global Market by Cancer Type
- 7.2.2 Chart - Global Market by Cancer Type - Base/Final Comparison
- 7.2.3 Chart - Global Market by Cancer Type - Base Year
- 7.2.4 Chart - Global Market by Cancer Type -Final Year
- 7.2.5 Chart - Global Market by Cancer Type - Share by Year
- 7.2.6 Chart - Global Market by Cancer Type - Segment Growth
- 7.3 Global Market by Product Type - Overview
- 7.3.1 Table - Global Market by Product Type
- 7.3.2 Chart - Global Market by Product Type - Base/Final Comparison
- 7.3.3 Chart - Global Market by Product Type - Base Year
- 7.3.4 Chart - Global Market by Product Type -Final Year
- 7.3.5 Chart - Global Market by Product Type - Share by Year
- 7.3.6 Chart - Global Market by Product Type - Segment Growth
- 7.4 Global Market by Place - Overview
- 7.4.1 Table - Global Market by Place
- 7.4.2 Chart - Global Market by Place - Base/Final Comparison
- 7.4.3 Chart - Global Market by Place - Base Year
- 7.4.4 Chart - Global Market by Place -Final Year
- 7.4.5 Chart - Global Market by Place - Share by Year
- 7.4.6 Chart - Global Market by Place - Segment Growth
8 Global Market by Cancer Type
- 8.1 MDx Breast Cancer
- 8.1.1 Table Breast Cancer Testing - by Country
- 8.1.2 Chart - Breast Cancer Testing Growth
- 8.2 MDx Colorectal Cancer
- 8.2.1 Table Colorectal Cancer Testing - by Country
- 8.2.2 Chart - Colorectal Cancer Testing Growth
- 8.3 MDx Cervical Cancer
- 8.3.1 Table Cervical Cancer Testing - by Country
- 8.3.2 Chart - Cervical Cancer Testing Growth
- 8.4 MDx Lung Cancer
- 8.4.1 Table Lung Cancer Testing - by Country
- 8.4.2 Chart - Lung Cancer Testing Growth
- 8.5 MDx Prostate
- 8.5.1 Table Prostate Testing - by Country
- 8.5.2 Chart - Prostate Testing Growth
- 8.6 MDx Melanoma Cancer
- 8.6.1 Table Melanoma Cancer Testing - by Country
- 8.6.2 Chart - Melanoma Cancer Testing Growth
- 8.7 MDx Blood
- 8.7.1 Table Blood Testing - by Country
- 8.7.2 Chart - Blood Testing Growth
- 8.8 MDx Companion Dx Development
- 8.8.1 Table Companion Dx Development - by Country
- 8.8.2 Chart - Companion Dx Development Growth
- 8.9 MDx Other Cancer
- 8.9.1 Table Other Cancer Testing - by Country
- 8.9.2 Chart - Other Cancer Testing Growth
9 Global Market by Product Type
- 9.1 MDx Instruments
- 9.1.1 Table Instruments - by Country
- 9.1.2 Chart - Instruments Growth
- 9.2 MDx Reagents
- 9.2.1 Table Reagents - by Country
- 9.2.2 Chart - Reagents Growth
- 9.3 MDx Software and Services
- 9.3.1 Table Software and Services - by Country
- 9.3.2 Chart - Software and Services Growth
10 Global Market by Place
- 10.1 MDx Clinical Laboratory
- 10.1.1 Table Clinical Laboratory - by Country
- 10.1.2 Chart - Clinical Laboratory Growth
- 10.2 MDx Pharmaceutical
- 10.2.1 Table Pharmaceutical - by Country
- 10.2.2 Chart - Pharmaceutical Growth
- 10.3 MDx Research
- 10.3.1 Table Research - by Country
- 10.3.2 Chart - Research Growth
11 Cancer Treatment and Trials
- 11.1 FDA Approvals by Year and Application
- 11.2 Clinical Trials Starts
- 11.3 Prevalence of Cancer Treatments
12 Appendices
- 12.1 United States Medicare System: Clinical Laboratory Fees Schedule
- 12.2 The Most Used IVD Assays
- 12.3 The Highest Grossing Assays
- 12.4 FDA Approved Human Genetic Tests
- 12.5 FDA Approved Pharmacogenomics Tests