細胞診断技術、応用、および市場：第2版

Abstract

Cell analysis is not a new laboratory procedure. Clinical diagnostics using cells and tissues is one of the oldest disciplines in laboratory medicine. Histological study of biopsy samples, the complete blood count, and the enumeration of disease-bearing cells have been used routinely for at least 60 years. In many ways, these disciplines had changed little until the 1990s. What' s new, however, is the myriad of combinations of tests and technologies that come together to create a new map of cell diagnostics.

This report covers assay systems that use cells as the basic source material. Sources of the cells to be studied include peripheral blood, cord blood, bone marrow, urine, cerebrospinal and other body fluids and tissue samples. The market is highly diversified involving several lab disciplines, including

• hematology,
• histology,
• cytology,
• microbiology, and
• tissue transplant medicine

It also involves several technologies, including

• complete blood count,
• flow cytometry,
• microscopy, and
• molecular diagnostics

Until recently, there was little interaction between these disciplines and technologies; hematology analyzers were used for a complete blood count, flow cytometry for leukocyte analysis, stains for tissue section slides, etc. Further, most companies involved in one market were rarely active in another. However, the evolution of molecular tests, cell research, and cell analysis technologies has turned cell diagnostics into a melting pot of companies, clinical applications, and technologies.

This completely new edition of Kalorama' s best-selling 2005 report sets out the coordinates of this new geography and quantifies the market value of cell-based testing for various applications through 2011. This report considers the market for, and technology development and commercialization of, cell-based diagnostic tests for

• cancer management
• hematology
• histopathology/cytology
• microbiology/virology
• blood product safety
• tissue transplant management
• prenatal testing

Cell analysis techniques and trends are discussed from the point of view of their present and potential market impact. The report discusses cell-based diagnostic techniques that are currently available and those that are expected to take their place. The world market for cell and tissue diagnostics is provided in U.S. dollars for the base year of 2006 with forecasts to 2011. Market analysis in this report covers world markets; however the reader will find a bias toward the developed areas of the globe: North America, Japan, and Western Europe.

The report covers::

• A survey of cell and tissue diagnostics past, present, and future
• The impact of cell-based diagnostics on patient care in selected diseases
• Technological aspects of cell-based diagnostics that impact their use in routine patient care
• Market trends and issues that can make or break successful commercialization of cell-based diagnostics
• An analysis of current and future market opportunities for cell-based analysis
• Discussion of companies and technologies to watch as the cell diagnostics industry evolves

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

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

CHAPTER TWO: INTRODUCTION

• Background: Cell-Based Testing in the 21st Century
• The Cell, Inside and Out
• The Status Quo and Huge Potential of Cell-Based Diagnostics
• Point of View

CHAPTER THREE: MEDICAL TRENDS AND MARKET ISSUES IN THE COMMERCIALIZATION OF CELL BASED DIAGNOSTICS

• Background
• The Molecular Revolution, New Testing Opportunities
• Reimbursement and Commercialization of Novel Tests
• Regulatory Affairs
• Worldwide Opportunities for Cell-Based Tests
• Drug Discovery

CHAPTER FOUR: TECHNOLOGICAL TRENDS THAT ENABLE THE FUTURE OF CELL-BASED DIAGNOSTICS

• Background
• New Assay Designs
• The In Vitro/In Vivo Mix
• Personalized Medicine, Drug Selection, and Cell-Based Assays
• Rare Cell Event Testing
• Cancer Cells: Stem Cell Cousins
• Miniaturization and Multiplexed Biological Assays
• Cell Marker Development
• Histology Automation
• Cell Culture

CHAPTER FIVE: TECHNOLOGY PLATFORMS AT THE FOREFRONT OF CELL-BASED ASSAYS

• Background
• Hematology Analyzers
• Flow Cytometry
• Microscopy and Image-Based Platforms
• Laser Capture Microdissection and Tissue Microarrays
• In Situ Hybridization
• Molecular Techniques

CHAPTER SIX: MARKET ANALYSIS

• Background
• Cell-Based Diagnostics and IVD Markets
• The Market for Cell Assays in Cancer Management
• The Market for Cell Assays in Hematology
• The Market for Cell Assays in Histopathology/Cytology
  • The Future of the Pap Smear & HPV Testing
  • IHC/ISH and Digital Cytometry
• The Market for Cell Assays in Microbiology/Virology
• The Market for Cell Assays in Blood Product Safety
• The Market for Cell Assays in Tissue Transplant Management
• The Market for Cell Assays in Prenatal Testing

CHAPTER SEVEN: CONCLUSIONS AND STRATEGIC IMPLICATIONS

• Conclusion
  • Implication
• Conclusion
  • Implication
• Conclusion
  • Implication
• Conclusion
  • Implication
• Conclusion
  • Implication

CHAPTER EIGHT: COMPANY PROFILES

• Abbott Diagnostics
• Accelr8 Technology Corporation
• Accuri Cytometers
• Acolyte Biomedica
• Advanced Analytical Technologies Inc. (AATI)
• AdvanDx, Inc.
• Advalytix AG
• Agendia B.V.
• Almac Diagnostics (formerly ArraDx)
• Amnis Corporation
• Aperio Technologies, Inc.
• Applied Imaging Corp./Genetix
• Asuragen, Inc.
• AviaraDx (formerly Arcturus Biosciences)
• AVIVA Biosciences Corporation
• Becton Dickinson & Company
• Beckman Coulter, Inc.
• Biocept, Inc.
• BioGenex Laboratories, Inc.
• Biomoda, Inc.
• BioMosaics
• BIOVIEW, Inc.
• Bruker Daltonics
• Cancer Genetics, Inc.
• Celera
• Celerus Diagnostics
• CellaVision AB
• Cellestis Ltd
• Clarient Inc. (formerly ChromaVision)
• Compucyte Corporation
• Cylex Incorporated
• CytoCore, Inc. (formerly Molecular Diagnostics, Inc.)
• Cytyc Corporation
• Dako A/S
• DiaGenic ASA
• Diagnostic Hybrids, Inc. (DHI)
• Diamics, Inc.
• Digene Corporation
• eGene Inc.
• Exagen Diagnostics, Inc.
• Genomic Health
• Greiner Bio-One International AG
• Guava Technologies, Inc.
• GW Medical Technologies, LLC
• Gynecor
• Hemosystem SA
• HistoRx, Inc,
• iCyt Visionary Bioscience
• Ikonisys Inc.
• Immunicon Corporation
• InterGenetics
• IntraCellular Diagnostics, Inc.
• Invirion Diagnostics, LLC
• Invitrogen Corporation
• IPSOGEN
• IRIS International, Inc.
• MDS/Molecular Devices Corporation
• Medion Diagnostics AG
• Micro Imaging Technology (MIT)
• Microgen Bioproducts
• Micronics, Inc.
• Milestone Medical
• Modern Technology Corp.
• MonoGen
• Monogram Biosciences Inc. (formerly Virologic, Inc.)
• MTM Laboratories AG
• Nalge Nunc International Corporation
• NorChip
• Nuvera Biosciences
• One Cell Systems, Inc.
• Orpegen Pharma
• Partec GmbH
• Pathwork Diagnostics (formerly Predicant Biosciences)
• Perceptronix Medical Inc.
• PerkinElmer, Inc.
• PointCare Technologies, Inc.
• Progenika Biopharma S.A.
• QBC Diagnostics Inc.
• QuantomiX Ltd.
• Rational Therapeutics
• Ravgen
• Sakura Finetek USA Inc.
• Sequenom Inc.
• Siemens Medical Solutions Diagnostics
• Signature Genomic Laboratories LLC
• Source MDx
• Sysmex Corporation
• Targeted Diagnostics & Therapeutics, Inc. (TDT)
• Tripath Imaging, Inc.
• Ventana Medical Systems. Inc.
• Verax Biomedical Inc.
• Veridex, LLC
• Vision BioSystems Ltd/Danaher Corp.
• Vitatex Inc.
• WaveSense LLC
• XDx, Inc
• Xytos Inc.
• Zila Inc.

Appendix: Selected Cell-Based Tests and Technologies

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1: Worldwide Cell Diagnostics Product Sales by Type 2006-2011

MEDICAL TRENDS AND MARKET ISSUES IN THE COMMERCIALIZATION OF CELL BASED DIAGNOSTICS

• Table 3-1: Selected Cell-Based Molecular Tests
• Table 3-2: Selected Commercial Cell-Based Molecular Tests
• Table 3-3: Selected Cell-Based Tests Used in Drug Discovery

CHAPTER FOUR: TECHNOLOGICAL TRENDS THAT ENABLE THE FUTURE OF CELL-BASED DIAGNOSTICS

• Table 4-1: Selected Tests and Cell Diagnostics Technology Crossovers
• Table 4-2: Selected Cell-Based Lateral Flow Tests
• Table 4-3: Selected Cell-Based Pharmacodiagnostic Tests
• Table 4-4: Selected Rare Cell Event Tests
• Table 4-5: Selected Cell Culture Tests

CHAPTER FIVE: TECHNOLOGY PLATFORMS AT THE FOREFRONT OF CELL-BASED ASSAYS

• Table 5-1: Selected New Hematology Analyzer Tests, 1990s-2007
• Table 5-2: Selected New Immunohematology Research Projects
• Table 5-3: Revenue History of Leading Companies in Flow Cytometry 2001-2006
• Table 5-4: Selected Flow Cytometry Applications
• Table 5-5: Selected Flow Cytometry Product Companies
• Table 5-6: Selected Microscopy and Image Analysis Product Companies
• Table 5-7: Cytometry Imaging Market Revenues by Competitor 2006
• Table 5-8: Selected LCM Systems on the Market, 2007
• Table 5-9: Major Molecular Markers for Tissue Staining
• Table 5-10: Selected In Situ Hybridization Histopathology Tests
• Table 5-11: Selected Cell-Based Molecular Tests
• Table 5-12: Selected DNA Sample Preparation Companies

CHAPTER SIX: MARKET ANALYSIS

• Table 6-1: Selected Acquisitions and Collaborations in Cell Diagnostics
• Table 6-2: Worldwide Cell Diagnostics Product Sales by Testing Area (Hematology, Histology/Cytology without Pap, Flow Cytometry, DNA Microarrays, Pap, Protein Microarrays, Prenatal Testing, Tissue Typing, Tissue Microarrays, Microbiology/Virology, Rare Cell Event Detection, Blood Safety) 2006-2011
• Table 6-3: Selected IVD Cancer Markers
• Table 6-4: Worldwide Market for Cell Diagnostics for Cancer by Testing Area (Histology/Cytology without Pap, Flow Cytometry, Pap, Tissue Microarrays, DNA Microarrays, Protein Microarrays, Rare Cell Event Detection, In Situ Hybridization, Immunohistochemical Staining) 2006
• Table 6-5: Selected New Hematology Analyzer Tests, 1990s-2007
• Table 6-6: Revenue History of the Top 5 Hematology Vendors 2001-2006
• Table 6-7: Selected POC CBC Systems
• Table 6-8: Worldwide Histology/Cytology Sales by Type (Traditional Non-Pap, Pap, IHC, ISH, Image Cytometry, Tissue Microarrays) 2006-2011
• Table 6-9: Selected Vendors of Traditional Histology Stains
• 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
• Table 6-15: Selected Cell Diagnostics for Microbiology/Virology
• Table 6-16: Selected Simplified, Inexpensive CD4 Test Systems