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Worldwide Market for Cancer Diagnostics, 4th Edition, The

  1. 1.    Get more info on this report!The Worldwide Market for Cancer Diagnostics, 4th EditionApril 1, 2010Since Kalorama Information last updated our comprehensive market report on cancertesting, changes in the industry abound. Developments that were novel two years agosuch as the commercialization of service products , PGx testing and tissue microarraysare showing an increased presence. Some companies who promised much in the pasthave not produced results. And new entrants have entered the field.These changes and more are addressed in Kalorama Informations Worldwide Marketfor Cancer Diagnostics, 4th. Edition. This report authored by Kalorama DiagnosticAnalyst Shara Rosen, contains detailed market data on the following IVD segments fortheir 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. Diagnostictests for effective cancer screening are obviously needed more than ever. As cancerbecomes more treatable, diagnostics are finding multiple expanded roles, includingpharmacodiagnostics for matching the targeted treatment to the patient and ongoingdisease monitoring as treatable cancer enters the realm of the chronic disease. Oftenthese 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
  2. 2. particular attention to important market trends that are more important to understandthan todays numbers. Shara Rosen not only defines the marketplace and providesmarket numbers, but her report also examines trends that are driving cancer testingnow and determining where it will go in the future. Some of the trends examined in thisreport 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 TestsBased on an analysis of these trends, the report includes a Technology Forecast to2025 that takes each particular technology used now in solid tumor testing and predictsits future role. Helpful Data Points for Business PlanningKalorama Informations Worldwide Market for Cancer Diagnostics, 4th Editionrepresents the fourth time Kalorama has engaged in an exhaustive study on the statusof this important diagnostic market. The report contains scores of tables with data pointsthat 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
  3. 3. developments both qualitatively and quantitatively. The report provides revenue andgrowth forecasts through 2014 and, as in the previous edition, analyzes the market intwo ways: • Tests for specific cancers, and • Cancer tests in specific IVD segmentsThis 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 eachsegment, the report provides detailed company profiles in three sections. The activitiesof the top IVD companies in cancer testing are presented in full, as are the activites ofthose status quo companies who are leading in at least one segment. There is alsocoverage of the possible leaders of the future, the novel companies who have enteredthe 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.
  4. 4. • 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
  5. 5. • 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
  6. 6. • 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
  7. 7. • 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 orreimbursement payments. For cancer testing, this means that the actual dollar market -that is what manufacturers earn from the sale of their products is undervalued. Marketdata is presented in dollar market size for categories of tests, and for specific analyteswhere possible.The report discusses tests and technologies that are currently available and those thatare expected to take their place. Generally, current products and technologies establishthe standard of care and its value to payers. Many of the assays and imagingtechniques 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 technologiesadoption, the market value and thus penetration capabilities of newer approaches maybe limited.The information presented in this report is derived on publicly available informationsources such as company, government, and medical organization reports. The analysisis based on the authors industry knowledge combined with literature searches andinterviews with industry professionals and experts in the areas of in vitro diagnostics,imaging industries and cancer specialists.
  8. 8. Table of ContentsCHAPTER 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 PriceCHAPTER TWO: Introduction Background Pharmacogenomics Test Service Commercialization Cancer - Diagnosis and Therapy Management Point of ViewCHAPTER THREE: Market Trends In The Commercialization Of CancerDiagnostics 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 CommercializationCHAPTER 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
  9. 9. Overview New Platforms Mass Spectrometry Chromosome Analysis Next-Generation Sequencing RNA - Ribonucleic Acid The In Vitro/In Vivo MixCHAPTER 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 CancerCHAPTER 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 DiagnosticsCHAPTER SEVEN: Conclusions Conclusions and Strategic Implications Conclusion 1 Implication: Conclusion 2 Implication: Conclusion 4 Implication Conclusion 5 Implication:
  10. 10. Conclusion 6: Unmet Market Needs Unmet Need #1 Unmet Need #2 Unmet Need #3CHAPTER EIGHT: The Top Tier of IVD Companies and their investment in cancerdiagnostics 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 Recent Revenue History ($ million) Histology Immunoassays PCR Research Siemens Medical Solutions Diagnostics Molecular In Vivo Sysmex CorporationCHAPTER 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
  11. 11. 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, IncCHAPTER TEN: New Entrants And Novel Product Developers 20/20 GeneSystems, Inc 454 Life Sciences Corporation Acrometrix Corporation (Life Tech.)
  12. 12. Acupath Laboratories, IncAdvalytixAffymetrix, IncAllegro DiagnosticsAlthea Technologies, IncAmorfix Life Sciences LtdArbor Vita CorporationArcticDx IncArrayit Diagnostics IncAVEO Pharmaceuticals, IncAxela, IncBaypoint Biosystems, IncBiodesix, IncBiologix Diagnostics, LLCBioMarker Strategies, LLCBiomodaBioMosaicsBioProspecting NB, Inc. (BPNBI)BioServeBiosystems International SAS (BSI)BioTrove, IncCambridge Research & Instrumentation, Inc. (CRi)Cangen Biotechnologies, IncCaris DiagnosticsCastle Biosciences IncCelerus DiagnosticsCell BiosciencesCeMines, IncCepheidChromoCure IncChronix Biomedical IncClinical Genomics Pty LtdCombiMatrix Molecular Diagnostics (CMDX)Comprehensive Cancer Cell (CCC) Diagnostics IncCompugen LtdCorrelogic Systems, IncCS-Keys, IncdeCode Genetics Inc. ---DiaGenic ASADiagnoCure --DiagnoplexDiagnostic Biosystems CompanyDNA Direct, IncDexTerity DiagnosticsEDP Biotech CorporationEpistem Plc
  13. 13. Exact Sciences CorpExiqon A/SExonHit TherapeuticsExosome Diagnostics IncExpression Pathology IncFalcon Genomics, IncFASgen Diagnostics, LLCFluxion BiosciencesFoligo Therapeutics, IncGastrocorGenelex CorporationGeneNews LimitedGenoptixiKaryos DiagnosticsIlluminaInostics GmbHInteRNA Technologies B.VIntrinsic Bioprobes IncInvirion Diagnostics, LLCInVivoScribe TechnologiesIris BioTechnologies IncIRIS International, IncMabCure IncMacroArray Technologies, LLCMagArray IncMartell Biosystems, IncMed BioGene, Inc. (MBI)Medical Prognosis InstituteMetabolon, IncMiraculins IncMolecularMD CorpNeogenix Oncology, IncNextGen SciencesNuvera BiosciencesOlink ABOncimmune LLCOncoMethylome Sciences S.AOn-Q-ityOrion GenomicsOxford BioTherapeuticsPacific Edge Biotechnology Ltd. (PEB)Photocure ASAPower3 Medical Products, IncPrediction SciencesPredictive BiosciencesPrognosDx Health, Inc
  14. 14. 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 LtdLIST OF EXHIBITSCHAPTER ONE: EXECUTIVE SUMMARYCHAPTER 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 PlatformsCHAPTER 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
  15. 15. 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, 2008-2009CHAPTER 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)
  16. 16. Available immediately for Online Download at   US: 800.298.5699UK + +1.240.747.3093Fax: 240.747.3004