Cell-Based Diagnostics: Technology, Applications, and Markets
This report covers clinical and drug discovery 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.
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.
The market for cell-based diagnostics is highly diversified involving several lab disciplines (hematology, histology, cytology, microbiology, and tissue transplant medicine) and several technologies (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 report aims to set out the coordinates of this new geography and then attempts to put a market value on cell-based testing markets in 2003 and 2008. 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 years 2003 to 2008. 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
- Scope and Methodology
- Size and Growth of the Market
- Market Trends
CHAPTER TWO: INTRODUCTION
- Background: Cell-Based Testing in the 21st Century
- The Status-Quo and Huge Potential
- Point of View
CHAPTER THREE: TRENDS AND ISSUES IN COMMERCIALIZATION
- Background
- The Molecular Revolution, New Testing Opportunities
- Reimbursement Issues and Novel Tests
- New Technology Commercialization
- Regulatory Affairs
- Specific Disease Statistics: Opportunities for Cell-Based Tests
- Cancer
- Diabetes
- Cardiovascular Disease
- Autoimmune Disease
- Drug Discovery
CHAPTER FOUR: ENABLING TECHNOLOGICAL TRENDS
- Background
- New Assay Designs
- Tissue Microarrays
- Miniaturization and Multiplexed Biological Assays
- Cell Marker Development
- Histology Automation
CHAPTER FIVE: TECHNOLOGIES AT THE FOREFRONT
- Background
- Hematology Analyzers
- Flow Cytometry
- Cell-on-a-Chip
- Microscopy and Image-Based Platforms
- Laser Capture Microdissection
- In Situ Hybridization
- DNA Extraction and Isolation Techniques
CHAPTER SIX: MARKET ANALYSIS
- Background
- Cell-Based Diagnostics and IVD Markets
- Cancer Management
- Hematology
- Histopathology/Cytology
- Immunohistochemical Stains (IHC) and In Situ Hybridization (ISH)
- Microbiology/Virology
- Blood Product Safety
- Tissue Transplant Management
- Prenatal Testing
CHAPTER SEVEN: CONCLUSIONS AND STRATEGIC IMPLICATIONS
- First Conclusion
- Second Conclusion
- Third Conclusion
- Fourth Conclusion
- Fifth Conclusion
CHAPTER EIGHT: COMPANY PROFILES
- Abbott Diagnostics
- ACLARA BioSciences, Inc.
- Advanced Analytical Technologies Inc.
- AdvanDx, Inc.
- Agilent Technologies, Inc.
- Amnis Corporation
- Aperio Technologies Inc.
- Applied Imaging Corp.
- Arcturus Bioscience Inc.
- Atto Bioscience, Inc.
- AVIVA Biosciences
- Bayer Corporation, Healthcare Division
- BD Biosciences, Immunocytometry Systems
- Beckman Coulter, Inc.
- Bender MedSystems GmbH
- Biocept, Inc.
- BioCurex, Inc.
- BioGenex Laboratories
- Bioview, Inc.
- Cancer Genetics Inc.
- CellaVision AB
- Cepheid
- ChromaVision Medical Systems, Inc.
- co.don Tissue Engineering, Inc.
- Compucyte Corporation
- Cylex Inc.
- Cytyc Corporation
- DakoCytomation A/S
- Genomic Health, Inc.
- Genoptix Inc.
- Guava Technologies, Inc.
- Horiba Medical Diagnostic Instruments & Systems
- iCyt Visionary Bioscience
- Ikonisys, Inc.
- Immunicon Corporation
- InterGenetics Incorporated
- IntraCellular Diagnostics, Inc.
- Invirion Inc.
- Ipsogen
- Luminex Corporation
- Matritech
- Micronics, Inc.
- Molecular Diagnostics, Inc. (MDI) formerly Ampersand Medical
- Molecular Probes
- NPE Systems, Inc.
- One Cell Systems, Inc.
- Orpegen Pharma
- Partec GmbH
- PointCare Technologies, Inc.
- QuantomiX Ltd.
- Sakura Finetek USA Inc.
- Silex Microsystems
- Spectral Genomics, Inc.
- Sysmex Corporation
- Targeted Diagnostics & Therapeutics, Inc. (TDT)
- Tessera Diagnostics
- Tranzyme Pharma
- TriPath Imaging, Inc.
- Union Biometrica, Inc.
- Ventana Medical Systems
- Veridex LLC
- Vision BioSystems Ltd.
- WaveSense LLC
- Zymed Laboratories, Inc.
APPENDIX: SELECTED CELL-BASED DIAGNOSTIC PRODUCTS ON THE MARKET AND IN DEVELOPMENT
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
- Table 1-1: Worldwide Cell Diagnostics Product Sales by Testing Area 2003-2008
CHAPTER THREE: TRENDS AND ISSUES IN COMMERCIALIZATION
- Table 3-1: Selected Cell-Based Test Products for Research
CHAPTER FOUR: ENABLING TECHNOLOGICAL TRENDS
- Table 4-1: Selected Tests and Cell Diagnostics Technology Crossovers by Company
CHAPTER FIVE: TECHNOLOGIES AT THE FOREFRONT
- Table 5-1: Selected New Hematology Analyzer Tests 1990s to 2004
- Table 5-2: Selected New Immunohematology Research Projects
- Table 5-3: Revenue History of Flow Cytometry by Major Competitor 2001-2003
- Table 5-4: Selected Flow Cytometry Competitors and Applications
- Table 5-5: Selected Flow Cytometry Product Companies
- Table 5-6: Selected Microscopy and Image Analysis Product Companies
- Table 5-7: Selected Image Cytometry Companies
- Table 5-8: Revenue of Selected Cytometry Imaging Companies 2001-2003
- Table 5-9: Major Molecular Markers for Tissue Staining
- Table 5-10: Selected In Situ Hybridization Histopathology Tests by Company
- Table 5-11: Selected DNA Sample Preparation Companies and Products
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 2003-2008
- Table 6-3: Selected IVD Cancer Markers
- Table 6-4: Selected New Hematology Analyzer Tests 1990s to 2004
- Table 6-5: Revenue History of the Five Major Hematology Vendors 2001-2003
- Table 6-6: Worldwide Histology/Cytology Sales by Type (Traditional Pap, Traditional non-Pap, IHC, ISH, Flow Cytometry, Tissue Microarrays) 2003-2008
- Table 6-7: Revenues of the Four Major Automated Histology Companies 1999-2003
- Table 6-8: Selected IHC and ISH Product Companies
- Table 6-9: Selected Simplified, Inexpensive CD4 Test Systems
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