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

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