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The World Market for Cancer Diagnostics, 2014-2019, 6th Edition (Histology [ISH, IHC, HPV, Pap], Flow Cytometry, PSA, CEA, Liquid Biopsy, FOB and Other Rapid, Image Cytometry, Sequencing, Digital Pathology, Molecular Assays)

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Description

The World Market for Cancer Diagnostics, 2014-2019, 6th Edition (Histology [ISH, IHC, HPV, Pap], Flow Cytometry, PSA, CEA, Liquid Biopsy, FOB and Other Rapid, Image Cytometry, Sequencing, Digital Pathology, Molecular Assays)

Cancer testing is maturing from personalized medicine to precision medicine, where protein and molecular biomarkers are essential for precise diagnosis, therapy selection, therapy monitoring and early detection of cancer recurrence.  The World Market for Cancer Diagnostics, 6th Edition., as well as relevant industry merger data provided by Kalorama Information, provides authoritative and complete analysis of the cancer testing industry, with expert market sizing and opportunity assessment.  
 
Segment markets for cancer testing are comprehensively covered in Kalorama Information’s World Market for Cancer Diagnostics, 6th. Edition.  The report contains detailed market data on the following IVD segments for their use in cancer diagnostics:
  • IVD Market for Cancer Tests
  • Service Test Market
  • in situ hybridization (ISH)
  • Immunohistochemistry (IHC)
  • FOB and Other Rapid Tests
  • PSA, CEA and Other Markers
  • Flow Cytometry
  • Pap and HPV Testing
  • Molecular Oncology Assays
  • Tissue Microrrays
  • Methylated DNA
  • Circulating Tumor Cells
  • Next-Generation Sequencing Technologies
  • Tissue Function Tests
  • Companion Testing, CDX Products and Deals
 
The Race for Prevention Supports a Market for Innovative Diagnostic Tools 
 
Given the unfortunate statistics of cancer in the developed world, innovation is a must. Growth rates in cancer testing tends to be higher than in other IVD fields. Diagnostic tests for effective cancer screening are obviously needed more than ever. As this report goes to print a number of significant developments are taking place in cancer follow up. New imaging tools, bioinformatics, sequencing technologies, improved histological tests are among the trends discussed in this multifaceted report.  The importance of this industry is seen in the flurry of investments and financing arrangements made and the number of partnerships and purchases/mergers where one or both companies are involved in cancer diagnostics.  This report contains
 
  • Investments and Financing Agreements For Cancer Diagnostics Companies
  • Selected Agreements Between Cancer Diagnostic Companies
  • Selected Agreements Between Cancer Diagnostic Companies and Other Diagnostic Companies 
  • Selected Agreements Between Cancer Diagnostic Companies and Pharmaceutical or Biopharmaceutical Companies
  • Selected Cancer Diagnostic Company Agreements with Academic or Other Non-Profit Organizations
  • Selected Acquisitions of Cancer Diagnostic Companies
 
Complete Market and Trend Analysis 
 
In five previous editions. Kalorama has defined the oncology testing market, based on primary research of the market with particular attention to important market trends.  These trends are more important to understand than today’s numbers.  Market analysis in this report covers world markets for in vitro cancer diagnostics, however the reader will find a bias toward the developed areas of the globe — N. America, Japan and Western Europe. However cancer is a growing global problem and where possible the report covers cancer testing in the more industrialized developing countries of Latin America and Asia Pacific. 
 
The phenomenon of test personalization comes under many guises as pharmacogenomic, pharmacogenetic, companion tests, and represents one of the fastest growing segments of the market for cancer tests. It has emerged fully from research into clinical practice. Instrumentation now automates many of the sample preparation and assay steps that were formerly labor intensive. New tests are being launched all the time. Some personalized cancer tests are CE Marked and FDA-cleared and many more are in development. More and more laboratories offer complex panels of tests that help physicians evaluate disease risk and make therapeutic decisions. Government and private healthcare payers have recognized the value of new molecular tools and are agreeing to pay for them. 
 
Unparalleled Review of Cancer Testing Competitors: Top Tier IVD Companies And Specialist Companies 
 
This report is written from the point of view of diagnostic modalities for the detection and management of cancer and in particular solid tumors. The technology to detect cancers of the blood – lymphomas, myelomas and leukemia – is mature and well established. The routine complete blood count screens for blood cell abnormalities and is followed by bone marrow analysis and flow cytometric studies of the blood cell surface markers. These to arrive at a more specific diagnosis. As such this report does not discuss area of hematological cancer diagnosis in great detail. 
 
The emphasis is on in vitro diagnostic tests, however a discussion of the role of diagnostics in cancer management, must include in vitro and in vivo tests. The two are inextricably linked. The same cell markers used in flow cytometry and antibodies used for immunoassays to detect elements of the immunity process are used as vectors for imaging agents to detect tumors and to monitor the extent of cancer metastasis. 
 
In addition to extensive reviews of products on the market and in development in each segment, the report provides detailed company profiles in several sections, including the following 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.,

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)

    Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 12th Edition
    May 13, 2025
    In Vitro Diagnostic (IVD) Trends and Market Update, 2025
    April 7, 2025
    In Vitro Diagnostics Business Outlook, 2025 (6 Issues)
    April 3, 2025
    Molecular Diagnostics Quarterly Datastream, 2025
    April 2, 2025

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