U.S. Markets for Clinical Laboratory Products

The evolution of healthcare delivery systems in the United States (U.S.) is driving a broad restructuring of the clinical diagnostic testing products market. Suppliers are facing an increasingly challenging environment due to changing customer requirements.
Although cost containment is the overriding determinant driving change in the industry, other considerations playing important roles include the need to maintain the quality of healthcare in the face of reduced resources; the impact of government regulations designed to improve the quality of laboratory results, such as the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) and new laws mandating proper patient testing/treatment from managed care companies; and pressure to shorten test result turnaround times, which enables the physician to provide the patient with more rapid and effective treatment.
The critical shortage of qualified laboratory technologists is also driving change in the clinical laboratory, resulting in the increasing use of automated systems as well as the significant adoption of consolidated workstations. In addition, the continuing trend toward the formation of large integrated healthcare delivery networks is resulting in the downsizing or closing of smaller laboratories and the formation of core laboratories. 

Clinical diagnostic testing products include those used for patient specimen analysis in the areas of clinical chemistry, hematoly, flow cytometry, coagulation, urinalysis, conventional microbiology, nucleic acid diagnostics, immunodiagnostics, therapeutic drug monitoring (TDM), drugs-of-abuse (DOA) detection, immunohematology, pathology, cytology, and cytogenetics.

In 1999, the clinical diagnostic testing products market was valued at approximately $8.6 billion. The market is projected to grow at a compound annual growth rate of 5.2% during the forecast period covered by this report, reaching an estimated $11.5 billion in the year 2005. Certain niche markets, including those for point-of-care (POC), nucleic acid, pathology, cytology, and cytogenetic testing products, will exhibit growth rates in excess of the overall market. Exhibit ES-2 presents the U.S. clinical diagnostic testing products market forecast for the years 1999 through 2005.