Cell-Based Diagnostics: Technology, Applications, and Markets, 2nd Edition

No longer is cell-based diagnostics simply a histological study of biopsied and surgical tissues. Combinations of tests and technologies are coming together to create a new map of cell diagnostics. Image cytometry, microfluidics, microarrays, and biosensors, special immunohistochemical and in situ hybridization probes are creating new approaches to cell and tissue observation, diagnostics and pharmacogenomics.

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

• Cell assays in cancer management—flow cytometry, circulating tumor cells, tissue microarrays
• Cell assays in hematology—CBC and new immunocytometry assays
• Cell assays in histopathology/cytology- IHC, ISH, traditional stains, processors and imaging systemsc
• Cell assays in microbiology/virology—FISH, flow cytometry
• Cell assays in blood product safety—flow cytometry
• Cell assays in tissue transplant management—molecular assays
• Cell assays in prenatal testing—PCR, FISH

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

The following are examples of market data within this report:

• Selected Acquisitions and Collaborations in Cell Diagnostics
• 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
• Selected IVD Cancer Markers
• 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
• Selected New Hematology Analyzer Tests, 1990s-2007
• Revenue History of the Top 5 Hematology Vendors 2001-2006
• Selected POC CBC Systems
• Worldwide Histology/Cytology Sales by Type (Traditional Non-Pap, Pap, IHC, ISH, Image Cytometry, Tissue Microarrays) 2006-2011
• Selected Vendors of Traditional Histology Stains
• Selected Automated Pap Systems
• Selected HPV Test Innovators
• Selected IHC and ISH Product Companies
• Major Protein and Molecular Markers Used in Tissue Staining
• Selected Digital Pathology Systems
• Selected Cell Diagnostics for Microbiology/Virology
• Selected Simplified, Inexpensive CD4 Test Systems

As with all Kalorama Information reports, this survey of the cell-based diagnostics is the result of primary research. The analyst based models and captured trends with thorough research of company, trade and government soruces, enhanced by interviews with executives in the diagnostic industry.