The Worldwide Market for Cancer Diagnostics, 4th Edition
Since Kalorama Information last updated our comprehensive market report on cancer testing, changes in the industry abound. Developments that were novel two years ago such as the commercialization of service products , PGx testing and tissue microarrays are showing an increased presence. Some companies who promised much in the past have not produced results. And new entrants have entered the field.
These changes and more are addressed in Kalorama Information's Worldwide Market for Cancer Diagnostics, 4th. Edition. This report authored by Kalorama Diagnostic Analyst Shara Rosen, contains detailed market data on the following IVD segments for their use in cancer diagnostics:
Kalorama Information's Worldwide Market for Cancer Diagnostics, 4th Edition represents the fourth time Kalorama has engaged in an exhaustive study on the status of this important diagnostic market. Among the market data provided in this report, readers will find:
As well as tests for specific cancers:
In addition to extensive reviews of products on the market and in development in each segment, the report provides detailed company profiles.
Top Tier Companies Abbott Diagnostics Beckman Coulter Inc. Becton, Dickinson and Company (BD) bioMerieux Inc. Bio-Rad Laboratories Inc. Dako A/S Fujirebio Diagnostics, Inc. Gen-Probe Inc. Hologic, Inc. Inverness Medical Innovations Ortho Clinical Diagnostics QIAGEN N.V. Roche Diagnostics Siemens Medical Solutions Diagnostics Sysmex Corporation Status Quo Leader Companies
All market data is based on factory sales to the end user and not retail pricing or reimbursement payments. For cancer testing, this means that the actual dollar market - that is what manufacturers earn from the sale of their products is undervalued. This is because many of the new tests are offered as test services either by the companies that have developed the tests and/or their partners.
Market data is presented in dollar market size for categories of tests, and for specific analytes where possible. Here the dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.
The report discusses tests and technologies that are currently available and those that are expected to take their place. Generally, current products and technologies establish the standard of care and its value to payers. Many of the assays and imaging techniques presented in the report are expected to replace the standard of care in 2010, but with healthcare systems' emphasis on cost/benefit analysis for new technologies adoption, the market value and thus penetration capabilities of newer approaches may be limited.
The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of in vitro diagnostics, imaging industries and cancer specialists.
These changes and more are addressed in Kalorama Information's Worldwide Market for Cancer Diagnostics, 4th. Edition. This report authored by Kalorama Diagnostic Analyst Shara Rosen, contains detailed market data on the following IVD segments for their use in cancer diagnostics:
- Histology/Cytology
- Immunoassays
- Flow Cytometry
- Rapid Tests
- Molecular Assays
- Tissue Arrays
- Circulating Tumor Cells
- Pharmacodiagnostics
Kalorama Information's Worldwide Market for Cancer Diagnostics, 4th Edition represents the fourth time Kalorama has engaged in an exhaustive study on the status of this important diagnostic market. Among the market data provided in this report, readers will find:
- Immunoassay Lab Based Cancer Test Sales
- Pap Smear Testing Volumes
- World Cancer Statistics
- POC Tests
- DNA Reagents for Cancer Testing
- CTC Testing Markets
- Biochip Innovations
- New Companies with Novel Approaches
- "Laggard" Companies Who Have Not Met Expectations
- Major Protein and Molecular Markers Used in Tissue Staining
- Biomarkers Under Investigation
- Acquisitions and Mergers
- Status of PGx Testing
- Microarray Markets in Clinical Labs
- Lists of Vendors and Major Products
- Unmet Needs of the Marketplace
As well as tests for specific cancers:
- Bladder Cancer
- Breast Cancer
- Cervical Cancer
- Colon Cancer
- Lung Cancer
- Ovarian Cancer
- Prostate Cancer
- Tests for specific cancers, and
- Cancer tests in specific IVD segments
In addition to extensive reviews of products on the market and in development in each segment, the report provides detailed company profiles.
Top Tier Companies
- AdnaGen AG
- Agendia BV
- AMDL Diagnostics, Inc. (ADI)
- American Diagnostica Inc.
- Aperio Technologies, Inc.
- Asuragen, Inc.
- AviaraDx
- Binding Site (The) Ltd.
- BioCurex Inc.
- BioGenex Laboratories, Inc.
- BioImagene
- Bio-Reference Laboratories, Inc.
- Biotage AB
- bioTheranostics
- BioView Ltd.
- Celera Diagnostics
- China Medical Technologies, Inc.
- Cisbio Bioassays
- Clarient Inc. (formerly ChromaVision)
- Clinical Data, Inc.
- CytoCore, Inc.
- DxS Ltd.
- Epigenomics AG
- Genetix Applied Imaging
- Genomic Health, Inc.
- Genzyme Genetics
- Health Discovery Corporation
- HistoRx, Inc.
- Ikonisys, Inc.
- Ipsogen SA
- Lab21 Healthcare
- Laboratory Corporation of America Holdings (LabCorp)
- Life Technologies
- Monogram Biosciences, Inc.
- mtm laboratories AG
- Myriad Genetics, Inc.
- Nanosphere, Inc.
- OncoVista Innovative Therapies, Inc.
- Pathwork Diagnostics
- Precision Therapeutics
- Prometheus Laboratories Inc.
- Quest Diagnostics
- Response Genetics, Inc.
- Rosetta Genomics Ltd.
- Sequenom
- Transgenomic Inc.
- Veridex, LLC
- Vermillion Inc.
- Zila, Inc.
- 20/20 GeneSystems, Inc.
- 454 Life Sciences Corporation
- Acrometrix Corporation (Life Tech.)
- Acupath Laboratories, Inc.
- Advalytix
- Affymetrix, Inc.
- Allegro Diagnostics
- Althea Technologies, Inc.
- Amorfix Life Sciences Ltd.
- Arbor Vita Corporation
- ArcticDx Inc.
- Arrayit Diagnostics Inc.
- AVEO Pharmaceuticals, Inc.
- Axela, Inc.
- Baypoint Biosystems, Inc.
- Biodesix, Inc.
- Biologix Diagnostics, LLC
- BioMarker Strategies, LLC
- Biomoda
- BioMosaics
- BioProspecting NB, Inc. (BPNBI)
- BioServe
- Biosystems International SAS (BSI)
- BioTrove, Inc.
- Cambridge Research & Instrumentation, Inc. (CRi)
- Cangen Biotechnologies, Inc.
- Caris Diagnostics
- Castle Biosciences Inc.
- Celerus Diagnostics
- Cell Biosciences
- CeMines, Inc.
- Cepheid
- ChromoCure Inc.
- Chronix Biomedical Inc.
- Clinical Genomics Pty Ltd.
- CombiMatrix Molecular Diagnostics (CMDX)
- Comprehensive Cancer Cell (CCC) Diagnostics Inc.
- Compugen Ltd.
- Correlogic Systems, Inc.
- CS-Keys, Inc.
- deCode Genetics Inc.
- DiaGenic ASA
- DiagnoCure --
- Diagnoplex
- Diagnostic Biosystems Company
- DNA Direct, Inc.
- DexTerity Diagnostics
- EDP Biotech Corporation
- Epistem Plc
- Exact Sciences Corp.
- Exiqon A/S
- ExonHit Therapeutics
- Exosome Diagnostics Inc.
- Expression Pathology Inc.
- Falcon Genomics, Inc.
- FASgen Diagnostics, LLC
- Fluxion Biosciences
- Foligo Therapeutics, Inc.
- Gastrocor
- Genelex Corporation
- GeneNews Limited
- Genoptix
- iKaryos Diagnostics
- Illumina
- Inostics GmbH
- InteRNA Technologies B.V.
- Intrinsic Bioprobes Inc.
- Invirion Diagnostics, LLC
- InVivoScribe Technologies
- Iris BioTechnologies Inc.
- IRIS International, Inc.
- MabCure Inc.
- MacroArray Technologies, LLC
- MagArray Inc.
- Martell Biosystems, Inc.
- Med BioGene, Inc. (MBI)
- Medical Prognosis Institute
- Metabolon, Inc.
- Miraculins Inc.
- MolecularMD Corp.
- Neogenix Oncology, Inc.
- NextGen Sciences
- Nuvera Biosciences
- Olink AB
- Oncimmune LLC
- OncoMethylome Sciences S.A.
- On-Q-ity
- Orion Genomics
- Oxford BioTherapeutics
- Pacific Edge Biotechnology Ltd. (PEB)
- Photocure ASA
- Power3 Medical Products, Inc.
- Prediction Sciences
- Predictive Biosciences
- PrognosDx Health, Inc.
- Provista Life Sciences LLC
- Rubicon Genomics, Inc.
- Rules-Based Medicine, Inc. (RBM)
- Saladax Biomedical, Inc. (SBI)
- SensiGen LLC
- Sienna Cancer Diagnostics
- Signature Genomic Laboratories, LLC
- Singulex Inc.
- Skyline Diagnostics B.V.
- Source MDx
- Soar BioDynamics, Ltd.
- Strategic Diagnostics Inc.
- Synergenz Bioscience Ltd.
- Targeted Molecular Diagnostics (TMD)
- Theranostics Health (TH)
- TrimGen Corporation
- TrovaGene, Inc.
- Vitatex Inc.
- WaferGen Biosystems, Inc.
- Xceed Molecular (formerly MetriGenix Corporation)
- Zetiq Technologies Ltd.
All market data is based on factory sales to the end user and not retail pricing or reimbursement payments. For cancer testing, this means that the actual dollar market - that is what manufacturers earn from the sale of their products is undervalued. This is because many of the new tests are offered as test services either by the companies that have developed the tests and/or their partners.
Market data is presented in dollar market size for categories of tests, and for specific analytes where possible. Here the dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.
The report discusses tests and technologies that are currently available and those that are expected to take their place. Generally, current products and technologies establish the standard of care and its value to payers. Many of the assays and imaging techniques presented in the report are expected to replace the standard of care in 2010, but with healthcare systems' emphasis on cost/benefit analysis for new technologies adoption, the market value and thus penetration capabilities of newer approaches may be limited.
The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of in vitro diagnostics, imaging industries and cancer specialists.
- CHAPTER ONE: Executive Summary
- Introduction
- Scope and Methodology
- Size and Growth of the Market
- Test Segments
- Geographic Distribution
- Market Trends
- Death Rates
- Revolutionary Therapeutics
- Physician Factor
- Consumer Lobby
- Price
- CHAPTER TWO: Introduction
- Background
- Pharmacogenomics
- Test Service Commercialization
- Cancer - Diagnosis and Therapy Management
- Point of View
- CHAPTER THREE: Market Trends In The Commercialization Of Cancer Diagnostics
- Background
- Demographics of Cancer, a Global Phenomenon
- Cancer Testing in the World:
- Screening and Government Supported Programs
- United States of America
- International
- Europe
- Mexico
- China
- India
- Reimbursement and Commercialization of Novel Tests
- Test Services - Route for Cancer Innovation
- Table 3-3
- Regulatory requirements of new products
- Strategic Alliances and Partnerships
- Personalized Medicine Advances
- Gene Patents and Test Commercialization
- CHAPTER FOUR: Technological Trends
- Background
- Biomarker Revolution
- The promise of Personalized Medicine
- Miniaturization and Multiplexed Biological Assays
- The emergence of non-invasive tools
- New Technologies Applied To Cancer Diagnostics
- Overview
- New Platforms
- Mass Spectrometry
- Chromosome Analysis
- Next-Generation Sequencing
- RNA - Ribonucleic Acid
- The In Vitro/In Vivo Mix
- CHAPTER FIVE: Market Analysis
- Background
- World Regional Segments of the Market for Cancer Diagnostics
- Companies and Products
- Has Screening Lost its Allure?
- Cancer Specific Tests
- Bladder Cancer
- Breast Cancer
- Cervical Cancer
- Colon Cancer
- Lung Cancer
- Ovarian Cancer
- Prostate Cancer
- CHAPTER SIX: Cancer Tests in IVD Segments (Segment Analysis)
- Cancer Diagnostics and IVD Markets
- The Market For Cancer Tests In Clinical Chemistry
- The Market For Immunoassay Cancer Tests, Lab & Rapid
- Point-of-care
- The Market for Cancer Tests in Histology / Cytology
- Traditional Tissue Stains
- Pap Smear and HPV Testing
- IHC/ISH
- The Market for Tissue Microarrays
- The Market For Cancer Tests in Flow Cytometry
- The Market for Circulating Tumor Cells in Cancer Diagnostics
- The Market For Cancer Molecular Assays
- The Market For Cancer Tests in Pharmacodiagnostics
- The market for Biochips and Arrays in Cancer Diagnostics
- The Commercial Outlook for Cancer Diagnostics
- CHAPTER SEVEN: Conclusions
- Conclusions and Strategic Implications
- Conclusion 1
- Implication:
- Conclusion 2
- Implication:
- Conclusion 4
- Implication
- Conclusion 5
- Implication:
- Conclusion 6:
- Unmet Market Needs
- Unmet Need #1
- Unmet Need #2
- Unmet Need #3
- CHAPTER EIGHT: The Top Tier of IVD Companies and their investment in cancer diagnostics
- Abbott Diagnostics
- Molecular Histology
- Molecular Diagnostics
- Immunoassays
- Beckman Coulter Inc
- FOB
- Flow Cytometry
- Becton, Dickinson and Company (BD)
- Histology
- bioMerieux Inc
- Bio-Rad Laboratories Inc
- Dako A/S
- Fujirebio Diagnostics, Inc
- Gen-Probe Inc
- Hologic, Inc
- Histology
- HPV
- Inverness Medical Innovations
- Ortho Clinical Diagnostics
- QIAGEN N.V
- Roche Diagnostics Indianapolis, IN www.roche.com Recent Revenue History ($ million)
- Histology
- Immunoassays
- PCR
- Research
- Siemens Medical Solutions Diagnostics
- Molecular
- In Vivo
- Sysmex Corporation
- CHAPTER NINE: The Status Quo in Cancer Diagnostics
- AdnaGen AG
- Agendia BV
- AMDL Diagnostics, Inc. (ADI)
- American Diagnostica Inc
- Aperio Technologies, Inc
- Asuragen, Inc
- AviaraDx
- Binding Site (The) Ltd
- BioCurex Inc
- BioGenex Laboratories, Inc
- BioImagene
- Bio-Reference Laboratories, Inc
- Biotage AB
- bioTheranostics
- BioView Ltd
- Celera Diagnostics
- China Medical Technologies, Inc
- Cisbio Bioassays
- Clarient Inc. (formerly ChromaVision)
- Clinical Data, Inc
- CytoCore, Inc
- DxS Ltd
- Epigenomics AG
- Genetix Applied Imaging
- Genomic Health, Inc
- Genzyme Genetics
- Health Discovery Corporation
- HistoRx, Inc
- Ikonisys, Inc
- InterGenetics Inc
- Ipsogen SA
- Lab21 Healthcare
- Laboratory Corporation of America Holdings (LabCorp)
- Life Technologies
- Monogram Biosciences, Inc
- mtm laboratories AG
- Myriad Genetics, Inc
- Nanosphere, Inc
- OncoVista Innovative Therapies, Inc
- Pathwork Diagnostics
- Precision Therapeutics
- Prometheus Laboratories Inc
- Quest Diagnostics
- Response Genetics, Inc
- Rosetta Genomics Ltd
- Sequenom
- Transgenomic Inc
- Veridex, LLC
- Vermillion Inc
- Zila, Inc
- CHAPTER TEN: New Entrants And Novel Product Developers
- 20/20 GeneSystems, Inc
- 454 Life Sciences Corporation
- Acrometrix Corporation (Life Tech.)
- Acupath Laboratories, Inc
- Advalytix
- Affymetrix, Inc
- Allegro Diagnostics
- Althea Technologies, Inc
- Amorfix Life Sciences Ltd
- Arbor Vita Corporation
- ArcticDx Inc
- Arrayit Diagnostics Inc
- AVEO Pharmaceuticals, Inc
- Axela, Inc
- Baypoint Biosystems, Inc
- Biodesix, Inc
- Biologix Diagnostics, LLC
- BioMarker Strategies, LLC
- Biomoda
- BioMosaics
- BioProspecting NB, Inc. (BPNBI)
- BioServe
- Biosystems International SAS (BSI)
- BioTrove, Inc
- Cambridge Research & Instrumentation, Inc. (CRi)
- Cangen Biotechnologies, Inc
- Caris Diagnostics
- Castle Biosciences Inc
- Celerus Diagnostics
- Cell Biosciences
- CeMines, Inc
- Cepheid
- ChromoCure Inc
- Chronix Biomedical Inc
- Clinical Genomics Pty Ltd
- CombiMatrix Molecular Diagnostics (CMDX)
- Comprehensive Cancer Cell (CCC) Diagnostics Inc
- Compugen Ltd
- Correlogic Systems, Inc
- CS-Keys, Inc
- deCode Genetics Inc. ---
- DiaGenic ASA
- DiagnoCure --
- Diagnoplex
- Diagnostic Biosystems Company
- DNA Direct, Inc
- DexTerity Diagnostics
- EDP Biotech Corporation
- Epistem Plc
- Exact Sciences Corp
- Exiqon A/S
- ExonHit Therapeutics
- Exosome Diagnostics Inc
- Expression Pathology Inc
- Falcon Genomics, Inc
- FASgen Diagnostics, LLC
- Fluxion Biosciences
- Foligo Therapeutics, Inc
- Gastrocor
- Genelex Corporation
- GeneNews Limited
- Genoptix
- iKaryos Diagnostics
- Illumina
- Inostics GmbH
- InteRNA Technologies B.V
- Intrinsic Bioprobes Inc
- Invirion Diagnostics, LLC
- InVivoScribe Technologies
- Iris BioTechnologies Inc
- IRIS International, Inc
- MabCure Inc
- MacroArray Technologies, LLC
- MagArray Inc
- Martell Biosystems, Inc
- Med BioGene, Inc. (MBI)
- Medical Prognosis Institute
- Metabolon, Inc
- Miraculins Inc
- MolecularMD Corp
- Neogenix Oncology, Inc
- NextGen Sciences
- Nuvera Biosciences
- Olink AB
- Oncimmune LLC
- OncoMethylome Sciences S.A
- On-Q-ity
- Orion Genomics
- Oxford BioTherapeutics
- Pacific Edge Biotechnology Ltd. (PEB)
- Photocure ASA
- Power3 Medical Products, Inc
- Prediction Sciences
- Predictive Biosciences
- PrognosDx Health, Inc
- Provista Life Sciences LLC
- Rubicon Genomics, Inc
- Rules-Based Medicine, Inc. (RBM)
- Saladax Biomedical, Inc. (SBI)
- SensiGen LLC
- Sienna Cancer Diagnostics
- Signature Genomic Laboratories, LLC
- Singulex Inc
- Skyline Diagnostics B.V
- Source MDx
- Soar BioDynamics, Ltd
- Strategic Diagnostics Inc
- Synergenz Bioscience Ltd
- Targeted Molecular Diagnostics (TMD)
- Theranostics Health (TH)
- TrimGen Corporation
- TrovaGene, Inc
- Vitatex Inc
- WaferGen Biosystems, Inc
- Xceed Molecular (formerly MetriGenix Corporation)
- Zetiq Technologies Ltd
- LIST OF EXHIBITS
- CHAPTER ONE: EXECUTIVE SUMMARY
- CHAPTER THREE: MARKET TRENDS
- Table 3-1: Participation rates of CRC screening in National Programs and Pilot Studies
- Table 3-2: Selected Lab Service Cancer Tests Launched in 2008 & 2009
- Table 3-4: Selected acquisitions and mergers, 2008-2009
- Table 3-5: Selected Company Alignments for Cancer Diagnostics, 2008-2009
- Table 3-6: Selected collaborations Between IVD and Pharmaceutical Companies, 2008-2009
- Table 3-7: U.S. Patents for Selected Molecular Test Platforms
- CHAPTER FOUR: TECHNOLOGY TRENDS
- Table 4-1: Selected Novel Biomarkers Under Investigation
- Table 4-2: Selected biochip test and service innovations, 2008-2009
- Table 4-3: Selected Innovations in Blood-Based Cancer Diagnostics, 2008-2009
- Table 4-4: Selected non-invasive cancer test innovations, 2008-2009
- Table 4-5: Selected test platform innovations, 2008-2009
- Table 4-6: Selected companies involved in chromosomal analysis of cancer cells
- CHAPTER FIVE: MARKET ANALYSIS
- Table 5-1: World Cancer Statistics, new cases per year
- Table 5-2: World Population, Cancer Patients and Percentage of Cancer Market IVD Statistics, 2005
- Table 5-3: World Cancer Test Sales, by Region, 2009-2014
- Table 5-4: Revenues of Selected Cancer Testing Companies($MM)
- Table 5-5: Selected Underperformers in the Cancer Market, 2008-2009
- Table 5-6: Cancer Diagnostics and the Top Tier of IVD Companies
- Table 5-7: Selected new histological breast cancer tests, 2008-2009
- Table 5-8: Selected Breast Cancer Test Innovations, 2008-2009
- Table 5-9: Selected HPV test innovations, 2008-2009
- Table 5-10: Selected colon cancer test innovations, 2008-2009
- Table 5-11: Selected PGx tests for colon cancer, 2008-2009
- Table 5-12: Selected Lung Cancer Innovations, 2008-2009
- Table 5-13: Selected Ovarian Cancer Test Innovations, 2008-2009
- Table 5-14: Selected Prostate Cancer Test Innovations, 2008-2009
- CHAPTER SIX: SEGMENT MARKET ANALYSIS
- Table 6-1: Worldwide Market for Selected Cancer In Vitro Diagnostics (Histology/Cytology, Immunoassays, Flow Cytometry, Rapid Tests, Molecular Assays, Tissue Arrays, CTCs, Pharmacodiagnostics) 2009-2014
- Table 6-2: Selected Tissue Function Clinical Chemistry Tests
- Table 6-3: Major Players For Clinical Chemistry Analyzers And Reagents
- Table 6-4: Selected Innovations in Cancer Immunoassays, 2008-2009
- Table 6-5: Cancer Immunoassay Sales, Lab-based, (PSA, CEA, CA 125, AFP, Others), 2009-2014
- Table 6-6: Rapid Cancer Test Sales by Test Category (Fecal Occult Blood, PSA H Pylori, NMP22, Other), Worldwide 2009-2014
- Table 6-7: Worldwide Histology/Cytology Sales (Traditional Non Pap, Pap, IHC, ISH, Image Cytometry, Tissue Micorarrays) 2009-2014
- Table 6-8: Selected Vendors of Traditional Histology Stains
- Table 6-9: Selected HPV Tests Innovations, 2008-2009
- Table 6-10: Major Protein and Molecular Markers Used in Tissue Staining
- Table 6-11: Selected Chromosome-Based Cancer Tests, 2008-2009
- Table 6-12: Selected Digital Imaging Innovations, 2008-2009
- Table 6-13: Selected Histopathology Innovations, 2008-2009
- Table 6-14: Selected Tissue Microarray Products, 2008-2009
- Table 6-15: Selected molecular Cancer Test Innovations, 2008-2009
- Table 6-16: Selected Cancer PGx Test Innovations, 2008-2009
- Table 6-17: Selected Array-Based Cancer Test Innovations, 2008-2009
- Table 6-18: Technology Penetration Forecast for Cancer IVDs 2005-2025 (Minor Role, Moderate Role, Major Role, Rarely Used)
