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The World Market for Cancer Diagnostics, 2021

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    Report

  • 347 Pages
  • December 2021
  • Region: Global
  • Kalorama Information
  • ID: 5513623

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, 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. The report contains detailed market data on the following IVD segments for their use in cancer diagnostics:


  • Immunoassay - tumor markers
  • Molecular - cancer assays
  • Molecular - histology
  • Molecular - HPV
  • CTCs

Critical Need 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.


 


Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY
  • SCOPE AND METHODOLOGY
  • Terminology
    • Table 1-1: Industry Recognized Terms for Companion Diagnostics and Personalized Medicine



CHAPTER 2: INTRODUCTION AND OVERVIEW
  • HISTOLOGY AND CYTOLOGY IN SITU HYBRIDIZATION (ISH)
  • IMMUNOASSAYS
  • POLYMERASE CHAIN REACTION (PCR)
  • COMPANION DIAGNOSTICS
    • Table 2-1: FDA Approved or Cleared Companion Diagnostic (CDx) Tests and Corresponding Therapies, Oncology
    • Table 2-2: Selected Major Biomarkers in Oncology Personalized Medicine Tests

  • PREDICTIVE BIOMARKER TESTS FOR DRUG-GENE MATCH
  • DNA AND RNA VARIANTS
    • Table 2-3: Human Genome and Cancer Gene Identification
    • Table 2-4: Relevant DNA/RNA Variants for Top Six Cancer Types
    • Table 2-5: Relevant DNA/RNA Variants for High Incidence Cancer Types (excl. top six)

  • MOLECULAR DIAGNOSTICS IN HEREDITARY CANCER DIAGNOSIS
    • Table 2-6: Select Innovations in Molecular Cancer Risk Detection and Prevention

  • CANCER MARKERS IN WIDESPREAD USAGE


CHAPTER 3: MARKET TRENDS
  • GROWTH IN PRECISION MEDICINE, COMPANION DIAGNOSTICS, RELATED APPLICATIONS
    • Table 3-1: Selected Molecular Companion and Complementary Assays for Cancer
    • Table 3-2: Pharmacogenomic Biomarkers in Drug Labeling, FDA
    • Table 3-3: Selected FDA Cleared/Approved Companion Diagnostic Tests and Therapeutic Application, 2020

  • PHARMACODIAGNOSTIC TESTS
    • Table 3-4: Selected Liquid Biopsy Innovations

  • COMPANIES OFFERING LIQUID BIOPSY-BASED MOLECULAR CANCER ASSAYS
  • Liquid Biopsy-based Non-Invasive Cancer Molecular Diagnostics
  • CIRCULATING TUMOR CELL (CTC) TESTS
  • SAMPLE COLLECTION PRODUCTS
  • EXOSOME SEQUENCING
  • NEXT-GENERATION SEQUENCING TESTS
  • WHOLE-GENOME SEQUENCING
  • EXOME SEQUENCING
  • RNA SEQUENCING
  • REGULATORY INFLUENCES
  • COMPANIES
  • ADVANCED HISTOLOGY TECHNIQUES
    • Table 3-5: Selected Advanced Histology Techniques

  • AUTOMATION OF HISTOLOGY
    • Table 3-6: Selected Histology Lab Automation
    • Table 3-7: Histology Information Technology Tools

  • ARTIFICIAL INTELLIGENCE
  • MASS SPECTROMETRY
    • Table 3-8: Selected Mass Spectrometry-Based Oncology Tests

  • REGULATORY AND REIMBURSEMENT TRENDS
  • Reimbursement Breakthroughs and Challenges
  • NEXT GENERATION SEQUENCING COVERAGE
  • COMPANION DIAGNOSTICS SEEING DEVELOPMENT IN REGULATIONS
    • Table 3-9: FDA Approved Companion Diagnostics Labeled for Identifying Patients with NSCLC whose

  • Tumors have EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations and the
  • Associated Therapeutic Products
  • LDTS
  • Food and Drug Administration
  • Directive 98/79/EC
  • HEALTH CANADA CHANGES AND FORECASTED ACTION
  • INTERNATIONAL GROWTH OPPORTUNITIES


CHAPTER 4: MARKET REVENUES AND FORECAST
  • Table 4-1: Cancer IVD Market Revenues, 2021-2026
  • MOLECULAR CANCER TEST REGIONAL DISTRIBUTION
    • Table 4-2: Global Molecular Cancer Test Sales Distribution by Region, 2021
    • Figure 4-1: Global Molecular Cancer Test Sales Distribution by Region, 2021

  • HISTOLOGY AND CYTOLOGY
  • HISTOLOGY REGIONAL DISTRIBUTION
    • Table 4-3: Global Histology/Cytology Sales Distribution by Region, 2021
    • Figure 4-2: Global Histology/Cytology Sales Distribution by Region, 2021

  • MOLECULAR CANCER DIAGNOSTICS SEGMENT BY TECHNOLOGY/METHOD
  • Table 4-4: Techniques Used in Molecular Cancer Diagnostics
  • HPV REGIONAL DISTRIBUTION
    • Table 4-5: Global HPV Test Sales Distribution by Region, 2021
    • Figure 4-3: Global HPV Test Sales Distribution by Region, 2021

  • DRIVERS AND CHALLENGES
  • Clinical Utility of Molecular Diagnostics
  • Technological Advancements Including NGS Adopted Incrementally


CHAPTER 5: COMPETITIVE ANALYSIS
  • IMMUNOASSAY COMPETITIVE TRENDS
  • IHC MARKET
  • COMPETITION IN ISH
  • MOLECULAR CANCER DIAGNOSTICS LANDSCAPE
  • HPV
  • LIQUID BIOPSY AND CTCS
  • RECENT DEALS AND COLLABORATIONS
    • Table 5-1: CDx Relevant Partnerships and Collaborations



CHAPTER 6: COVID-19 IMPACT
  • MINIMAL ONGOING SIGNIFICANT DISRUPTIONS


CHAPTER 7: CORPORATE PROFILES
  • ABBOTT DIAGNOSTICS
  • Companion Testing
  • Liquid Biopsy
  • AGENDIA BV
  • AGILENT TECHNOLOGIES
  • Agilent in Genomics
  • Cytogenetic Analysis
  • Sequencing
  • CRISPR
  • Flow Cytometry
  • Companion Diagnostics - Dako
  • ARUP LABORATORIES
  • ASURAGEN INC
  • BECKMAN COULTER (DANAHER)
  • Immunoassays
  • Becton, Dickinson and Company (BD)
  • Cytology
  • Flow Cytometry
  • Licensing
  • BIO-RAD LABORATORIES, INC
  • Immunoassays
  • Liquid Biopsy
  • Droplet Digital PCR
  • BIOCARTIS
  • BIOCEPT, INC.
  • BIODESIX
  • BIOMÉRIEUX INC
  • Immunoassays
  • BIOREFERENCE LABORATORIES
  • BIOTHERANOSTICS, INC. (HOLOGIC)
  • DANAHER CORPORATION
  • Acquisitions
  • DIASORIN S.P.A
  • Immunoassays
  • Molecular Oncology
  • ENZO BIOCHEM INC
  • EPIC SCIENCES
  • EPIGENOMICS AG
  • EXACT SCIENCES CORP.
  • EXOSOME DIAGNOSTICS, INC
  • FOUNDATION MEDICINE, INC
  • GUARDANT HEALTH, INC
  • HELOMICS CORPORATION
  • HOLOGIC, INC
  • ILLUMINA, INC
  • LABCORP, LABORATORY CORPORATION OF AMERICA
  • LEICA BIOSYSTEMS (DANAHER)
  • Digital Pathology
  • Stain Reagents
  • Lab Systems
  • Sample Handling
  • Circulating Tumor Cells (CTCs)
  • Artificial Intelligence
  • LUNGLIFE AI
  • MAYO MEDICAL LABORATORIES
  • MDXHEALTH SA
  • MENARINI-SILICON BIOSYSTEMS
  • MYRIAD GENETICS, INC
  • NATERA
  • NEOGENOMICS
  • OPKO HEALTH, INC
  • PACIFIC BIOSCIENCES (PACBIO)
  • QIAGEN N.V
  • Precision Medicine/Companion Diagnostics
  • Next Generation Sequencing
  • Sample Prep, Informatics
  • Digital PCR
  • Bioinformatics
  • Liquid Biopsy
  • Cervical Cancer
  • QUEST DIAGNOSTICS
  • ROCHE DIAGNOSTICS
  • HPV
  • Cancer Companion Testing
  • Liquid Biopsy
  • IT in Anatomical Pathology
  • Information Technology
  • SYSMEX CORP
  • Hematology
  • Coagulation
  • Urinalysis
  • Immunoassays
  • Lab Information System
  • Information Technology
  • Flow Cytometry
  • Precision Medicine/Companion Test Diagnostics
  • Liquid Biopsy
  • Exosomes
  • Oncology
  • Sysmex Inostics
  • Forging New Markets
  • THERMO FISHER SCIENTIFIC INC
  • Oncology Companion Diagnostics
  • Liquid Biopsy
  • TROVAGENE, INC. (NOW CARDIFF ONCOLOGY)
  • VENTANA MEDICAL SYSTEMS (ROCHE)
  • Immunohistochemistry - IHC
  • Cervical Cancer Screening
  • Companion Diagnostics
  • VERACYTE

Samples

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Companies Mentioned

  • Abbott Diagnostics
  • Agendia BV
  • Agilent Technologies
  • ARUP Laboratories
  • Asuragen Inc.
  • Beckman Coulter (Danaher)
  • Becton, Dickinson and Company (BD)
  • Bio-Rad Laboratories, Inc.
  • Biocartis
  • Biocept, Inc.
  • Biodesix
  • bioMérieux Inc.
  • BioReference Laboratories
  • Biotheranostics, Inc. (Hologic)
  • Danaher Corporation
  • DiaSorin S.p.A
  • Enzo Biochem Inc.
  • Epic Sciences
  • Epigenomics AG
  • Exact Sciences Corp.
  • Exosome Diagnostics, Inc
  • Foundation Medicine, Inc.
  • Guardant Health, Inc.
  • Helomics Corporation
  • Hologic, Inc.
  • Illumina, Inc.
  • LabCorp
  • Leica Biosystems (Danaher)
  • LungLife AI
  • Mayo Medical Laboratories
  • MDxHealth SA
  • Menarini-Silicon Biosystems
  • Myriad Genetics, Inc.
  • Natera
  • NeoGenomics
  • OPKO Health, Inc.
  • Pacific Biosciences
  • Qiagen N.V.
  • Quest Diagnostics
  • Roche Diagnostics
  • Sysmex Corp.
  • Thermo Fisher Scientific Inc.
  • Trovagene, Inc.
  • Ventana Medical Systems (Roche)
  • Veracyte