OVERVIEW:
After a pandemic interruption the market for 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 120 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 The 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 Grail Cancer Test Faces New Clinical Questions
- 5.3 Freenome Acquires Cancer Dx Firm Oncimmune
- 5.4 Quest Diagnostics to Acquire Liquid Biopsy Firm Haystack Oncology
- 5.5 Ultima Genomics, Genome Insight Partner on WGS for Cancer Patients
- 5.6 Digital Pathology Meets Cancer Sequencing
- 5.7 Exact Sciences Preps Expanded Oncology Portfolio
- 5.8 Qiagen Details Oncology Plans for Digital PCR Platform
- 5.9 Sema4 Exiting Reproductive Health Screening
- 5.10 Thermo Fisher Introduces Cancer Profiling Assay
- 5.11 Genomic Test IDs Cysts Likely to Progress to Cancer
- 5.12 Naveris to Commercialize Virus-Related Cancer Tests
- 5.13 Larger Liquid Biopsy Panels Loom
- 5.14 Halo Diagnostics to Offer Genomic Profiling Tests
- 5.15 BillionToOne Raises $125M
- 5.16 Local Cancer Genomic Profiling Options Grow
- 5.17 German MDx Firm Mainz Biomed Raises $10M in IPO
- 5.18 Guardant Health Q3 Revenues Up 27 Percent
- 5.19 BforCure Raises $2.3M to Adapt Rapid PCR Platform for Cancer Detection
- 5.20 Nucleix to Invest in Early-Stage Lung Cancer Dx
- 5.21 Labcorp, GeneCentric Partnering on Development of RNA-Based Cancer Diagnostics
- 5.22 Grail Gets Approval for Galleri Multicancer Test
- 5.23 Finnish Firms to Form Point-of-Care Testing Firm
- 5.24 Datar Cancer Genetics Expands to Dx and Screening
- 5.25 HTG Molecular Diagnostics: HTG Transcriptome Panel
- 5.26 PacBio's Omniome Acquisition Shortens Path to Clinical
- 5.27 Invitae to Acquire Genosity for $200M
- 5.28 Bio-Techne Obtains CE Mark for Exosomal Liquid Biopsy Prostate Test
- 5.29 Agilent Technologies to Acquire Liquid Biopsy Firm Resolution Bioscience
- 5.30 Natera Revenues Grow 35 Percent
- 5.31 AnchorDx Closes $40M Financing Round
- 5.32 Exact Sciences Strategy for End-to-End Cancer Testing
- 5.33 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 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 BillionToOne
- 6.16 Bioarray Genetics
- 6.17 Biocartis
- 6.18 Biocept, Inc.
- 6.19 Biodesix Inc.
- 6.20 BioFluidica
- 6.21 BioGenex
- 6.22 BioIVT
- 6.23 Biolidics Ltd
- 6.24 bioMérieux Diagnostics
- 6.25 Bioneer Corporation
- 6.26 Bio-Rad Laboratories, Inc
- 6.27 Bio-Reference Laboratories
- 6.28 Bio-Techne
- 6.29 Bioview
- 6.30 Bolidics
- 6.31 Boreal Genomics
- 6.32 Bristol-Myers Squibb
- 6.33 Burning Rock
- 6.34 Cardiff Oncology
- 6.35 Caris Molecular Diagnostics
- 6.36 Castle Biosciences, Inc.
- 6.37 Celemics
- 6.38 CellCarta
- 6.39 CellMax Life
- 6.40 Cepheid (Danaher)
- 6.41 Charles River Laboratories
- 6.42 Circulogene
- 6.43 Cizzle Biotech
- 6.44 Clinical Genomics
- 6.45 Cytolumina Technologies Corp.
- 6.46 Datar Cancer Genetics Limited
- 6.47 Diagnologix LLC
- 6.48 Diasorin S.p.A.
- 6.49 Dxcover
- 6.50 Enzo Biochem
- 6.51 Epic Sciences
- 6.52 Epigenomics AG
- 6.53 Eurofins Scientific
- 6.54 Exact Sciences
- 6.55 Fabric Genomics
- 6.56 Fluxion Biosciences
- 6.57 Freenome
- 6.58 FUJIFILM Wako Diagnostics
- 6.59 Fulgent Genetics
- 6.60 Fyr Diagnostics
- 6.61 GeneFirst Ltd.
- 6.62 Genetron Holdings
- 6.63 GenomOncology
- 6.64 GILUPI Nanomedizin
- 6.65 Guardant Health
- 6.66 HansaBiomed
- 6.67 HeiScreen
- 6.68 Helomics
- 6.69 HTG Molecular Diagnostics
- 6.70 iCellate
- 6.71 ICON PLC
- 6.72 Illumina
- 6.73 Incell Dx
- 6.74 Inivata
- 6.75 INOVIQ
- 6.76 Integrated Diagnostics
- 6.77 Invitae Corporation
- 6.78 Invivogen
- 6.79 Invivoscribe
- 6.80 Janssen Diagnostics
- 6.81 Lunglife AI Inc
- 6.82 MDNA Life SCIENCES, Inc.
- 6.83 MDx Health
- 6.84 Menarini Silicon Biosystems
- 6.85 Mesa Laboratories, Inc.
- 6.86 Millipore Sigma
- 6.87 Miltenyi Biotec
- 6.88 miR Scientific
- 6.89 Myriad Genetics/Myriad RBM
- 6.90 NantHealth, Inc.
- 6.91 Natera
- 6.92 NeoGenomics
- 6.93 NGeneBio
- 6.94 Novogene Bioinformatics Technology Co., Ltd.
- 6.95 Oncocyte
- 6.96 OncoDNA
- 6.97 Ortho Clinical Diagnostics
- 6.98 Oxford Nanopore Technologies
- 6.99 PamGene
- 6.100 Panagene
- 6.101 Perkin Elmer
- 6.102 Personal Genome Diagnostics
- 6.103 Personalis
- 6.104 Precipio
- 6.105 Precision Medicine Group
- 6.106 PrecisionMed
- 6.107 Predicine
- 6.108 Promega
- 6.109 Qiagen
- 6.110 Rarecells SAS
- 6.111 RareCyte
- 6.112 Roche Molecular Diagnostics
- 6.113 Screencell
- 6.114 Sema4 Holdings
- 6.115 Sense Biodetection
- 6.116 Siemens Healthineers
- 6.117 simfo GmbH
- 6.118 Singlera Genomics Inc.
- 6.119 Singulomics
- 6.120 SkylineDx
- 6.121 Standard BioTools
- 6.122 Sysmex Inostics
- 6.123 Tempus Labs, Inc.
- 6.124 Thermo Fisher Scientific Inc.
- 6.125 Todos Medical
- 6.126 Variantyx
- 6.127 Veracyte
- 6.128 Volition
- 6.129 Vortex Biosciences
- 6.130 Vyant Bio
- 6.131 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