Table of Contents
ONE: EXECUTIVE SUMMARY
Overview
Scope and Methodology
Market Overview
Prognosis for Growth
TWO: INTRODUCTION
Diagnosis and Treatment of Cancer
Point of View
THREE: TECHNOLOGIES USED IN CANCER DIAGNOSTICS
Chromosome Analysis (Karyotyping)
Cytology/Histology Stains
Tests for Fecal Occult Blood
Immunoassays
Overview – Immunoassays
Immunoassay Instrument Platforms
Immunohistochemistry (IHC)
Flow Cytometry
Fluorescence in situ Hybridization (FISH) and Chromogenic in situ Hybridization(CISH)
Nucleic Acid Amplification Technologies
Analysis of Gene Expression Patterns (Gene Signatures)
Microarrays
Protein Microarrays
DNA Microarrays
Chromosomal Microarrays
Tissue Microarrays
Sequencing Technologies
Sanger Sequencing
Early Next Generation Sequencing Technologies
Sequencing by Synthesis (SBS)
Supported Oligonucleotide Ligation and Detection (SOLiD)
Ion Torrent Sequencing
True Single Molecule Sequencing (tSMS)
Single Molecule Real Time (SMRT) Sequencing
DNA Nanoball Sequencing
Nanopore Sequencing
Other Sequencing Technologies
Mass Spectrometry
Mass Spectrometry Technology
Research and Clinical Applications of Mass Spectrometry
Circulating Tumor DNA (Cell Free DNA)
Circulating Tumor Cells (CTCs)
Cell-Based Assays (Live Cell Cancer Tests)
Digital Pathology and Image Cytometry
Information Technology
FOUR: CANCER DIAGNOSTICS – APPLICATIONS
Assess Risk of Developing Cancer
Cancer Screening
Cancer Screening – Pap Smear and Human Papillomavirus (HPV) Testing
Colorectal Cancer Screening
Prostate Cancer Screening
Screening for Other Cancers
Diagnosis/Prognosis/Monitoring of Cancer
Personalized Medicine/Companion Diagnostics/Precision Testing
Drug Metabolism
Predicting Response to Therapy
FIVE: CANCER DIAGNOSTIC MARKETS
In Vitro Diagnostic Kits Marketed to Clinical Laboratories
Point-of-Care Tests for Cancer
Clinical Laboratory Test Services
SIX: DEALS – CANCER DIAGNOSTICS
Investments and Financing Agreements for Cancer Diagnostic Companies
Agreements with Other Companies
Acquisitions of Cancer Diagnostic Companies
Selected Other Agreements
SEVEN: CANCER DIAGNOSTICS – MARKET DRIVERS AND CHALLENGES
Cancer Diagnostic Market Drivers
Advances in Technology Changing the Future of Cancer Diagnostics
Impact of Companion Diagnostic Tests
Limited Tissue from Biopsies for Growing Number of Cancer Tests
Laboratory Developed Tests and the FDA
Cost and Reimbursement Issues
Physician Education, Acceptance, and Use of New Cancer Tests
Competition
Future Prospects
EIGHT: IN VITRO CANCER DIAGNOSTICS MARKET ANALYSIS
In Vitro Cancer Diagnostics Market by Geographical Distribution
Clinical Laboratory Testing Market – Cancer Diagnostics
In Vitro Cancer Diagnostics Market Segments
Histology/Cytology
Immunoassays
Rapid Tests
Molecular (Nucleic Acid-Based) Assays
NINE: COMPANY PROFILES: CANCER DIAGNOSTIC COMPANIES
M Genomics Ltd.
20/20 GeneSystems, Inc.
AB SCIEX
Abbott Laboratories
Abcodia Ltd.
Abingdon Health Ltd
Abnova Corporation
ACT Genomics Co., Ltd.
Adaptive Biotechnologies Corporation
Admera Health (a GENEWIZ company)
Advanced Cell Diagnostics
Affymetrix, Inc.
Agena Bioscience Inc.
Agendia NV
Agilent Technologies Inc.
Alere Inc.
Ambry Genetics Corp.
Amoy Diagnostics Co., Ltd.
ANGLE plc
ApoCell, Inc.
Applied Proteomics, Inc.
Applied Spectral Imaging, Inc.
Arbor Vita Corporation
ARKRAY, Inc.
ARUP Laboratories
Astra Biotech GmbH
Asuragen, Inc.
AsymmetRx Medical, Inc.
Atossa Genetics Inc.
AutoGenomics, Inc
Avant Diagnostics, Inc. (formerly Arrayit Diagnostics Inc.)
Axela, Inc
AXO Science
Beckman Coulter, Inc. (subsidiary of Danaher Corporation)
Becton, Dickinson and Company (BD)
BGI-Shenzhen
The Binding Site Group Ltd.
Biocare Medical, LLC
Biocartis SA
Biocept, Inc.
Biodesix, Inc.
BioFluidica
BioGenex
Biological Dynamics Inc.
BioMarker Strategies
bioMérieux SA
BioMosaics
Bio-Rad Laboratories, Inc.
Bio-Reference Laboratories, Inc. (BRLI)
BioSystems
bioTheranostics (a bioMérieux company)
Biotype Diagnostic GmbH
BioView Ltd
Boditech Med Inc.
Cancer Genetics, Inc.
Canopus Bioscience Ltd.
Caprion, Inc.
Caris Life Sciences
Castle Biosciences, Inc.
CDx Diagnostics
Celerus Diagnostics, Inc.
Cellmid Ltd.
Centogene AG
Cepheid
Cernostics
Cirdan Imaging Ltd
Clarient Diagnostic Services, Inc. (a GE Healthcare company)
Clearbridge BioMedics Pte Ltd
Color Genomics, Inc.
Counsyl, Inc.
Cube Dx GmbH
Cynvenio Biosystems, Inc.
CytoTest Inc.
Dako A/S (an Agilent company)
Danaher Corporation
DermTech, Inc.
DiaCarta, Inc.
DiaSorin S.p.A.
DiaTech Oncology
EDP Biotech Corporation
Eiken Chemical Co., Ltd.
EntroGen, Inc.
Enzo Biochem, Inc
Enzo Life Sciences, Inc.
Enzo Clinical Labs, Inc.
Epic Sciences, Inc.
Epigenomics AG
Eutropics Pharmaceuticals
Exact Sciences Corporation
Exosome Diagnostics, Inc.
Fluxion Biosciences, Inc.
Foundation Medicine, Inc.
Fujirebio Inc.
Fujirebio Diagnositics, Inc.
GE Healthcare
Genalyte, Inc.
GeneCentric Diagnostics, Inc.
Genection, Inc. (an Invivoscribe company)
GeneDx
GeneNews Limited
Genetic Technologies Limited / Phenogen Sciences, Inc. (U.S. division)
GenomeDx Biosciences
Genomica S.A.U.
Genomic Health, Inc.
Genomic Vision
Genoptix (a Novartis company)
GenPath / GenPath Women’s Health and GenPath Oncology
Guardant Health, Inc.
HalioDx
Healgen Scientific LLC
Helomics Corporation
Hologic, Inc.
HTG Molecular Diagnostics, Inc.
Human Longevity, Inc.
Icellate AB
Ikonisys, Inc.
Illumina, Inc.
ImCare BioTech
Immunovia AB
IncellDx, Inc.
Inform Genomics, Inc.
Financings
Other Agreements
Inivata Ltd.
Innovations Exchange Pte Ltd (INEX)
Insight Genetics, Inc.
IntegraGen SA
Integrated Diagnostics, Inc.
Invitae Corporation
Invivoscribe Technologies, Inc.
Iris BioTechnologies Inc.
Janssen Diagnostics / Janssen Diagnostics BVBA
Janssen Diagnostics, LLC
Laboratory Corporation of America (LabCorp) / Integrated Genetics
Leica Biosystems Inc. (a Danaher company)
Leica Microsystems (a Danaher company)
Lifecode, Inc.
MagArray, Inc.
Martell Diagnostic Laboratories, Inc.
Matrix-Bio, Inc.
Mayo Medical Laboratories and Mayo Clinic
Medical & Biological Laboratories Co., Ltd. (MBL)
MBL International Corporation
MDxHealth SA
Metamark Genetics, Inc.
MetaStat, Inc.
MolecularMD Corporation
Multiplicom NV
Myriad Genetics, Inc.
Myriad RBM, Inc.
NanoIVD, Inc.
NanoString Technologies, Inc.
NeoGenomics, Inc. / NeoGenomics Laboratories
NewGene Ltd.
New Oncology AG
Nuclea Biotechnologies, Inc.
Ohmx Corporation
Omnyx
Oncimmune Ltd.
Oncimmune (USA) LLC (acquired by HDL Inc.)
Health Diagnostic Laboratory, Inc.
OncoCyte Corporation
OncoDNA SA
OncoHealth Corp.
Oncolab, Inc.
Oncolys BioPharma Inc.
Oncompass GmbH
Onconome, Inc.
OncoPlex Diagnostics (OncoPlexDx)
Oncospire Genomics
OPKO Health, Inc. / OPKO Diagnostics
Orion Genomics
Ortho-Clinical Diagnostics
OvaGene Oncology Inc.
Oxford Cancer Biomarkers Ltd.
Oxford Gene Technology
Pacific Edge Limited
Pathway Genomics Corporation
Personal Genome Diagnostics, Inc.
PGXL Laboratories
Phenomenome Discoveries Inc.
Polymedco, Inc.
PreTect AS
PrognosDx Health, Inc.
Provista Diagnostics, Inc.
QIAGEN N.V.
QuanDx
Quanterix Corporation
QuantuMDx Group
Quest Diagnostics
RainDance Technologies, Inc.
Randox Laboratories Ltd
Rarecells SAS
Response Genetics, Inc.
Rheonix, Inc.
RiboMed Biotechnologies, Inc.
Roche
Rosetta Genomics Ltd.
ScheBo-Biotech AG
ScreenCell
Sequenom, Inc.
Siemens Healthcare Diagnostics
Symbiodx
Sysmex Corporation
TeloVISION, LLC
Theranostics Health Inc.
Thermo Fisher Scientific, Inc.
Tosoh Corporation
Tosoh Bioscience, Inc.
Transgenomic, Inc.
TrimGen Corporation
TrovaGene, Inc.
Vela Diagnostics
Ventana Medical Systems, Inc. (member of the Roche Group)
Veracyte, Inc.
Wako Diagnostics
Wako Pure Chemical Industries, Ltd.,
,
LIST OF EXHIBITS
ONE: EXECUTIVE SUMMARY
Table 1-1: Worldwide Cancer Diagnostic Market, 2014 and 2019 (Global Cancer IVD Market, Clinical Laboratory Services) (in millions USD)
TWO: INTRODUCTION
Table 2-1: Estimated Global Incidence and Mortality due to Cancer, 2012
THREE: TECHNOLOGIES USED IN CANCER DIAGNOSTICS
Table 3-1: Selected Examples of Companies Marketing Fecal Occult Blood Tests
Table 3-2: Selected Companies with Immunoassays and/or Automated Immunoassay Platforms on the Market or In Development for Cancer Diagnostics
Table 3-3: Selected Examples of Companies Marketing Rapid Lateral Flow Tests for Tumor Antigens
Table 3-4: Selected Companies with Immunohistochemistry Tests on the Market or In Development for Cancer Diagnostics
Table 3-5: Selected Companies Marketing Flow Cytometry Platforms or Consumables
Table 3-6: Selected Companies with in situ hybridization tests on the Market or In Development for Cancer Diagnostics (Company, Comment, Market Status)
Table 3-7: Selected Companies with PCR or Other Nucleic Acid Amplification Based Tests for Cancer Diagnostics
Table 3-8: Selected Examples of Companies Analyzing Gene Expression Patterns (“Gene Signatures”) in Tissues
Table 3-9: Selected Companies Developing/Marketing Cancer Diagnostic Products Based on Microarray Technologies
Table 3-10: Selected Sequencing Technologies and Platforms
Table 3-11: Selected Diagnostic Companies and Clinical Laboratories with Sequencing-Based Cancer Tests
Table 3-12: Selected Companies Developing/Marketing Mass Spectrometry- Based Oncology Diagnostic Tests
Table 3-13: Selected Examples of Companies Developing/Commercializing Cancer Diagnostic Assays Based on ctDNA
Table 3-14: Selected Companies Working with Circulating Tumor Cells (CTCs)
Table 3-15: Selected Companies Developing or Commercializing Cell-Based Assays for Cancer Diagnostics
Table 3-16: Selected Digital Pathology Companies
FOUR: CANCER DIAGNOSTICS – APPLICATIONS
Table 4-1: Selected Companies Developing/Marketing Assays to Determine Risk of Cancer
Table 4-2: Selected Companies Developing/Marketing Diagnostic Tests for HPV
Table 4-3: Selected Companies Developing/Marketing Cancer IVD Tests for Colorectal Cancer Screening
Table 4-4: Selected Companies Developing/Marketing Screening Tests for Prostate Specific Antigen
Table 4-5: Selected Companies Developing/Marketing Other Tests for Prostate Cancer
Table 4-6: Selected Companies Developing/Marketing Screening Tests for Other Cancers
Table 4-7: Selected Widely Used Tumor Markers
Table 4-8: Selected Companies Developing/Marketing Tests for Diagnosis/Prognosis/Monitoring of Cancer
Table 4-9: Selected Companies Developing/Marketing Tests for Drug Metabolism – To Personalize Treatment of Cancer
Table 4-10: Selected Companies Developing/Marketing Tests to Predict Response to Therapy; Precision Medicine
Table 4-11: Selected FDA Cleared/Approved Companion Diagnostic Tests
FIVE: CANCER DIAGNOSTIC MARKETS
Table 5-1: Selected Examples – Companies Developing and Marketing Cancer Diagnostics Tests and Platforms to Clinical Laboratories
Table 5-2: Selected Examples – Companies Developing and/or Marketing Pointof-Care and/or Rapid Platforms and Tests for Cancer – Moving Beyond Lateral Flow
Table 5-3: Selected Examples – Companies Developing and/or Offering Cancer Diagnostic Tests as Laboratory Developed Tests
SIX: DEALS – CANCER DIAGNOSTICS
Table 6-1: Selected Investments and Other Financing Agreements for CancerDiagnostic Companies
Table 6-2: Selected Agreements Between Cancer Diagnostic Companies and Other Diagnostic Companies or Clinical Laboratories
Table 6-3: Selected Agreements Between Cancer Diagnostic Companies and Pharmaceutical or Biopharmaceutical Companies
Table 6-4: Selected Agreements Between Two Cancer Diagnostic Companies
Table 6-5: Selected Other Cancer Diagnostic Company Agreements
Table 6-6: Selected Acquisitions of Cancer Diagnostic Companies
Table 6-7: Selected Cancer Diagnostic Company Agreements with Academic or Other Non-Profit Organizations
EIGHT: IN VITRO CANCER DIAGNOSTICS MARKET ANALYSIS
Table 8-1: World Cancer Test Market (In Vitro Diagnostic Kits) by Region (North America, EU, Japan, ROW), 2014 and 2019 ($ millions)
Table 8-2: World Cancer Test Market (Clinical Laboratory Test Services), 2014 and 2019 ($ millions)
Table 8-3: Worldwide Market for Selected Cancer IVD Tests (Sold to ClinicalLabs) (Histology/Cytology, Immunoassays, Flow Cytometry, Rapid Tests, Molecular Assays, CTCs), 2014 and 2019 ($ millions)
Figure 8-1: Geographical Distribution of Pap Smear Testing, 2013
Table 8-4: Worldwide Histology/Cytology Sales (Pap Smears, Other [non-Pap] Stains, HPV, Immunohistochemistry, and In Situ Hybridization), 2014 and 2019($ millions)
Table 8-5: Cancer Immunoassay Sales, Lab-Based (PSA, CEA, CA 125, AFP,Others), 2014 and 2019 ($ millions)
Table 8-6: Rapid Cancer Test Sales by Test Category (FOB, PSA, NMP22, Other)Worldwide, 2014 and 2019 ($ millions)