Description
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:
- Histology/Cytology
- Immunoassays
- Flow Cytometry
- Rapid Tests
- Molecular Assays
- Tissue Arrays
- Circulating Tumor Cells
- Pharmacodiagnostics
Cancer Testing: A Dynamic FieldGiven 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 cancer becomes more treatable, diagnostics are finding multiple expanded roles, including
pharmacodiagnostics for matching the targeted treatment to the patient and ongoing
disease monitoring as treatable cancer enters the realm of the chronic disease. Often these tests are commercialized as
test services, a trend explored in the report.
Cogent Analysis of Trends in the IndustryKalorama Information reports are always based on primary research of the market with particular attention to important market trends that are more important to understand than today’s numbers. Shara Rosen not only defines the marketplace and provides market numbers, but her report also examines trends that are driving cancer testing now and determining where it will go in the future. Some of the trends examined in this report include:
- Biomarkers and Their Use in Cancer Testing
- The Promise, and Reality of Personalized Medicine
- Miniaturization and Multiplexed Biological Assays
- The Emergence of Non-invasive tools
- The Use of New Platforms:
-
Mass Spectrometry Chromosome Analysis,
-
Next-Generation Sequencing and RNA-based Tests
- The In Vitro/In Vivo Mix
- Global Screening Efforts and Their Impact on Testing Sales
- Mergers and Partnerships in 2008 and 2009
- Reimbursement for Cancer Tests
Based on an analysis of these trends, the report includes a ‘Technology Forecast’ to 2025 that takes each particular technology used now in solid tumor testing and predicts its future role.
Helpful Data Points for Business PlanningKalorama 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. The report contains scores of tables with data points that can be useful for marketing strategy, product development or business forecasting. Here are a sampling of the data points readers could find in this report:
- Sales of Immunoassay Lab-Based Tests (PSA, CEA, CA 125, AFP, Others) in 2009
- The Number of Pap Smear Tests Conducted in the US.
- World Incidence and Prevalence of Cancer Statistics
- Point of Care Tests for Cancer
- DNA Reagents for Cancer Testing
- The Projections and Actual Results of CTC Test Products
- The Needs of the Marketplace Not Met by Any Vendor
- Innovative Biochip Products
- A List of “Laggard” Companies Who Have Not Met Expectations
- The Major Protein and Molecular Markers Used in Tissue Staining
- Biomarkers Currently Under Investigation
- Microarray Markets in Clinical Labs
- Lists of Vendors and Major Products
Dualistic Market AnalysisThis latest edition of Kalorama Information’s study takes a fresh look at all of these developments both qualitatively and quantitatively. The report provides revenue and growth forecasts through 2014 and, as in the previous edition, analyzes the market in two ways:
- Tests for specific cancers,
- Cancer tests in specific IVD segments
This allows the reader to match his or her own situation to the market at large.
Unparalleled Review of Competitors: Top Tier IVDs, Status Quos and Novel EntrantsIn addition to extensive reviews of products on the market and in development in each segment, the report provides detailed company profiles in three sections. The activities of the top IVD companies in cancer testing are presented in full, as are the activites of those ‘status quo’ companies who are leading in at least one segment. There is also coverage of the possible leaders of the future, the novel companies who have entered the market or developed a new approach. Companies profiled include the following:
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
- 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.
New Entrants
- 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. Market data is presented in dollar market size for categories of tests, and for specific analytes where possible.
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.
Table of Contents
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 3-3: Selected CLIA-certified labs established 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)
