The Worldwide Market for Cancer Diagnostics, 3rd Edition

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

• Introduction
• Scope and Methodology
• Size and Growth of the Market
• Market Trends

CHAPTER TWO: INTRODUCTION

• Background
• Cancer: Diagnosis and Management of a Chronic Disease
• Point of View

CHAPTER THREE: TRENDS AND ISSUES IN COMMERCIALIZATION

• Background
• Demographics of Cancer, Worldwide
• Cancer Testing in the World—Screening and Government Supported Programs
  • An Aging World Population
  • United States of America
  • Europe
  • People’s Republic of China
  • India
  • Canada
• Reimbursement and Commercialization of Novel Tests
• Consumerism and Web-Based Test Services
• Regulatory Requirements of New Products
• Strategic Alliances—Rx-Dx and Dx-Dx Partnerships
• From Research to the Clinical Lab

CHAPTER FOUR: TECHNOLOGICAL TRENDS ENABLING THE FUTURE OF CANCER DIAGNOSTICS

• Background
• Biomarker Revolution
• The Promise of Personalized Medicine
• Miniaturization and Multiplexed Biological Assays
• The Search for Non-Invasive Tools
  • Serum
  • Saliva
  • Transdermal/Optical
  • Breath
  • Hair
  • Sputum
• Role of Immunoassays in Cancer Management
• New Technologies Applied To Cancer Diagnostics
  • Proteomics, Mass Spectroscopy and the Role of the Immune System
  • Methylated Gene (meDNA) Patterns
  • Circulating Cell-Free Nucleic Acids
  • RNA—Ribonucleic Acid
  • Stem Cell Markers
• The Role of In Vivo Diagnostics—In vivo Cellular and Molecular Imaging

CHAPTER FIVE: MARKET ANALYSIS—IN VITRO TESTS FOR CANCER

• Background
• World Segments of the Market for Cancer Diagnostics
• Companies and Products
  • Screening Tests
    • DR-70
    • HAAH
    • ECPKA
    • The Cancer Profile
  • Cancer-Specific Tests
    • Bladder Cancer
    • Breast Cancer
    • Cervical Cancer
    • Colon Cancer
    • Lung Cancer
    • Ovarian Cancer
    • Prostate Cancer

CHAPTER SIX: MARKET ANALYSIS—CANCER TESTS IN IVD SEGMENTS

• Cancer Diagnostics and IVD Markets
• The Market For Cancer Tests In Clinical Chemistry
• The Market For Cancer Tests in Immunoassays—Lab-Based & Rapid
• The Market for Cancer Tests in Histology and Cytology
  • The Future of the Pap Smear & HPV Testing
  • IHC/ISH and Digital Cytometry
  • The Market for Tissue Microarrays
  • The Market for Cancer Tests in Flow Cytometry
  • The Market for Cancer Tests and Image Cytometry
• The Market for Circulating Tumor Cells in Cancer Diagnostics
• The Market for Molecular Assays in Cancer
• The Market for Pharmacodiagnostics Tests in Cancer
• The Market for Biochips and Arrays in Cancer Diagnostics
• Cancer Sample Preparation Techniques
• The Commercial Outlook for Cancer Diagnostics

CHAPTER SEVEN: CONCLUSIONS AND STRATEGIC IMPLICATIONS

• Conclusions
  • Conclusion One
    • Implication
  • Conclusion Two
    • Implication
  • Conclusion Three
    • Implication
  • Conclusion Four
    • Implication
  • Conclusion Five
    • Implication
  • Conclusion Six
    • Implication
• Unmet Market Needs
  • Unmet Need One
  • Unmet Need Two
  • Unmet Need Three

CHAPTER EIGHT: THE TOP TIER IVD COMPANIES AND THEIR INVESTMENT IN CANCER

• Abbott Diagnostics
  • Recent Revenue History
  • Key Comment
  • Details
    • Molecular Histology
    • PCR
    • Immunoassays
• Beckman Coulter, Inc.
  • Recent Revenue History
  • Key Comment
  • Details
    • Flow Cytometry
    • Cancer Immunoassays
    • FOB
• Becton Dickinson & Company
  • Recent Revenue History
  • Key Comment
  • Details
• bioMerieux Inc.
  • Recent Revenue History
  • Key Comment
  • Details
• Bio-Rad Laboratories Inc.
  • Key Comment
  • Details
• Inverness Medical Innovations, Inc.
  • Key Comment
  • Details
• Ortho Clinical Diagnostics
  • Key Comment
  • Details
• Roche Diagnostics
  • Key Comment
  • Details
• Siemens Medical Solutions Diagnostics
  • Recent Revenue History
  • Key Comment
  • Details
    • In vivo
    • Immunoassays
• Sysmex Corporation
  • Recent Revenue History
  • Key Comment
  • Details

CHAPTER NINE: NEW ENTRANTS AND NOVEL PRODUCT DEVELOPERS

• 20/20GeneSystems Inc.
• 454 Life Sciences Corporation
• A&G Pharmaceutical
• AdnaGen AG
• Affymetrix Inc.
• Agendia B.V.
• Agilent Technologies Inc.
• Alethia Biotherapeutics Inc.
• Almac Diagnostics (formerly ArraDx)
• Althea Technologies, Inc.
• Ambrilia Biopharma Inc.
• AMDL, Inc.
• American Diagnostica Inc.
• Aperio Technologies, Inc.
• Applied Genomics, Inc. (AGI)
• Applied Imaging Corp./Genetix
• Asuragen, Inc.
• AsymmetRx, Inc.
• AviaraDx (formerly Arcturus Biosciences)
• AVIVA Biosciences Corporation
• BioCurex, Inc.
• BioGenex Laboratories, Inc.
• BioImagene, Inc.
• Biomoda, Inc.
• BioMosaics
• BioNanomatrix
• Biophysical Corp.
• BioServe
• Biosite Incorporated
• BIOVIEW, Inc.
• Bostwick Laboratories, Inc.
• Bruker BioSciences Corporation
• CCC Diagnostics LLC
• Cancer Genetics, Inc.
• Cangen Biotechnologies, Inc.
• Celera
• Celerus Diagnostics
• Cellumen, Inc.
• CeMines, Inc.
• ChemSensing
• Clarient Inc. (formerly ChromaVision)
• CombiMatrix Molecular Diagnostics (CMDX)
• CompuCyte Corporation
• Correlogic Systems, Inc.
• CytoCore, Inc. (formerly Molecular Diagnostics, Inc.)
• Cytyc Corporation
• Dako A/S
• diaDexus Inc.
• DiaGenic ASA
• DiagnoCure
• Diamics, Inc.
• Digene Corporation (Acquired by Qiagen)
• DNA Direct, Inc.
• DxS
• eGene Inc.
• Epigenomics AG
• EXACT Sciences Corporation
• eXagen Diagnostics, Inc.
• Exiqon A/S
• Falcon Genomics, Inc.
• Fermiscan Holdings Limited (FER)
• Fluidigm Corporation
• Fujirebio Diagnostics. Inc. (FDI)
• GeneNews Limited (formerly ChondroGene Limited)
• GenoMed, Inc.
• Genomic Health
• Genoptix Inc.
• Gen-Probe Incorporated
• Genzyme Corporation
• Greiner Bio-One International AG
• Gynecor
• Health Discovery Corporation
• HistoRx, Inc,
• Ikonisys Inc.
• Illumina
• ImmunArray Ltd.
• Immunicon Corporation
• Immunotope, Inc.
• InterGenetics, Inc.
• Invirion Diagnostics, LLC
• Ipsogen
• Kronus Inc.
• Laboratory Corporation of America Holdings (LabCorp)
• Luminex Corporation
• MacroArray Technologies, LLC
• Matritech
• MDS/Molecular Devices Corporation
• Med BioGene, Inc. (MBI)
• Menssana Research, Inc.
• Micronics Inc.
• Miraculins Inc.
• Modern Technology Corp.
• MolecularMD
• MonoGen
• Monogram Biosciences Inc. (formerly Virologic, Inc.)
• mtm laboratories AG
• Myriad Genetics, Inc.
• NeoMatrix, LLC
• NorChip
• NorDiag ASA
• Nuvera Biosciences
• Olympus Life and Material Science Europa, GMBH
• Onco Detectors International LLC
• Oncolab Inc.
• OncoMethylome Sciences S.A.
• Onconome, Inc. (formerly Tessera Diagnostics)
• One Cell Systems, Inc.
• Orion Genomics
• Oxford Genome Sciences Ltd. (OGeS)
• OXIS International
• Pacific Edge Biotechnology Ltd. (PEB)
• Panacea Pharmaceuticals, Inc.
• Pathwork Diagnostics (formerly Predicant Biosciences)
• Perceptronix Medical Inc.
• PerkinElmer, Inc.
• Perlegen Sciences, Inc.
• PersonaDX
• Power3 Medical Products, Inc.
• Precision Therapeutics
• Predictive Biosciences
• PreMD Inc.
• Primagen Holding B.V.
• Proteome Systems Limited
• Provista Diagnostics (formerly Biomarker Technologies LLC)
• Qiagen N.V.
• Quest Diagnostics Incorporated
• RainDance Technologies, Inc. (RDT)
• Rational Therapeutics
• Response Genetics, Inc.
• Rosetta Genomics Ltd.
• Rubicon Genomics, Inc.
• Rules-Based Medicine, Inc.
• Saladax Biomedical, Inc. (SBI)
• Signet Laboratories, Inc.
• Source MDx
• Targeted Diagnostics & Therapeutics, Inc. (TDT)
• Targeted Molecular Diagnostics, LLC (TDM)
• Tripath Imaging, Inc.
• US LABS
• Ventana Medical Systems. Inc.
• Veridex, LLC
• Vermillion, Inc. (formerly Ciphergen Biosystems, Inc.)
• Vision BioSystems Ltd/Danaher Corp.
• Vitatex Inc.
• Wako Chemicals USA
• WaveSense LLC
• Xenomics, Inc.
• Xytos Inc.
• Zila Inc.

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1: Market Summary Worldwide Market for In Vitro Cancer Diagnostics 2004-2009

CHAPTER THREE: TRENDS AND ISSUES IN COMMERCIALIZATION

• Table 3-1: Major Cancer Incidence Estimates by Cancer Type and Geographic Market Development (More Developed vs Less Developed) 2000
• Table 3-2: Worldwide Major Cancer Incidence and Mortality Estimates by Cancer Type, 2000
• Table 3-3: Old-Age Dependency Ratios Comparative Projections by Leading Country 2000, 2025
• Table 3-4: Selected DTC Cancer Tests
• Table 3-5: Selected Company Alignments for Cancer Diagnostics, 2005 – 2007
• Table 3-6: Selected Agreements Between Companies and Reference Laboratories
• Table 3-7: Selected Tests Offered by Company Accredited Laboratories
• Table 3-8: Selected IVDs used in Drug Development

CHAPTER FOUR: TECHNOLOGICAL TRENDS ENABLING THE FUTURE OF CANCER DIAGNOSTICS

• Table 4-1: Selected Tumor Markers as Applied to Specific Cancers and Drugs
• Table 4-2: Selected Chemotherapy Resistance Tests
• Table 4-3: Selected Arrays and Biochip Tests for Cancer
• Table 4-4: Selected Non-Invasive Cancer Tests (Company, Sample, Test Details, Marketing Status)
• Table 4-5: Selected Methylated DNA Tests (Company, Technology, Test Details, Marketing Status)
• Table 4-6: Selected RNA-Based Cancer Tests

CHAPTER FIVE: MARKET ANALYSIS—IN VITRO TESTS FOR CANCER

• Table 5-1: Cancer Demographics: Populations, Cancer Incidence, Share of Incidence, and Share of IVD Cancer Market by Geographic Region 2005
• Table 5-2: World Cancer Test Sales by Geographic Region (North America, Europe, Japan, Rest of World) 2007-2012
• Table 5-3: Cancer Diagnostics and the Top Tier IVD Companies Segments of Participation 2005
• Table 5-4: Revenues of Selected Cancer Diagnostic Companies 2001-2005
• Table 5-5: Selected Breast Cancer Test Innovations
• Table 5-6: Selected FOB Test Innovations
• Table 5-7: Selected Prostate Cancer Test Innovations (Company, Test Details, Marketing Status)

CHAPTER SIX: MARKET ANALYSIS—CANCER TESTS IN IVD SEGMENTS

• Table 6-1: Worldwide Market for Selected Cancer In Vitro Diagnostics Revenues and Growth Rate by Testing Segment (Histology/Cytology, Immunoassays, Flow Cytometry, Rapid Tests, Molecular Assays, Tissue Arrays, Circulating Tumor Cells, Pharmacodiagnostics) 2007-2012
• Table 6-2: Selected Tissue Function Clinical Chemistry Tests
• Table 6-3: Major Players For Clinical Chemistry Analyzers And Reagents
• Table 6-4: Lab-Based Cancer Immunoassay Sales 2004-2009
• Table 6-5: Potential Cancer Biomarkers
• Table 6-6: Selected Cancer Immunoassay Innovations
• Table 6-7: Worldwide Rapid Cancer Test Sales by Test Category (Fecal Occult Blood, PSA, H. pylori, NMP22, Other) 2004-2009
• Table 6-8: Worldwide Histology/Cytology Sales by Test Type (Traditional non-Pap, Pap, IHC, ISH) 2004-2009
• Table 6-9: Top Vendors of Traditional Histology Stains
• Figure 6-1: Geographical Distribution of Pap Testing Volume (in millions of tests) by Region (U.S., Europe, Japan, ROW)
• Table 6-10: Selected Automated Pap Systems
• Table 6-11: Selected HPV test innovators
• Table 6-12: Selected IHC and ISH Product Companies
• Table 6-13: Major Protein and Molecular Markers Used in Tissue Staining
• Table 6-14: Selected Digital Pathology Systems
• Figure 6-2: The Market for Tissue Microarrays in Clinical Labs 2007-2012
• Table 6-15: Selected Laser Microdissection Instruments
• Table 6-16: Selected Flow Cytometry Innovation (Company, Technology Details, Marketing Status)
• Figure 6-3: The World Market for Clinical Flow Cytometry 2007-2012
• Figure 6-4: The World Market for Clinical Image Cytometry Systems, Reagents, and Consumables 2007-2012
• Table 6-17: Selected Circulating Tumor Cell Products (Company, Technology, Product Details, Marketing Status)
• Figure 6-5: The World Market for Commercial CTC-Based Diagnostic Tests 2007-2012
• Table 6-18: Selected Molecular Tests for Cancer
• Figure 6-6: The World Market for Commercial Pharmacodiagnostics Cancer Tests 2007-2012
• Table 6-19: Selected Cancer Pharmacodiagnostic Tests (Company, Test Details, Marketing Status)
• Figure 6-7: World Market for DNA Test Sample Preparation Reagents
• Figure 6-8: Technology Penetration Forecast for Cancer IVDs 2007-2025