nlike most segments of the research products marketplace, the market for molecular biology reagents to molecular diagnostic laboratories is still in its infancy. Rapid growth, characterized by annual rates exceeding 30% to 40% is the rule, not the exception. Yet many reagent manufacturers have yet to incorporate effective strategies to gain a foothold in this important market segment. The suppliers with the most complete understanding of nucleic acid based diagnostic procedures, as well as an intimate knowledge of the molecular pathologist that performs the assays and a firm grasp of the complicated regulatory environment stands to capture market share early and profit in the long run by the future expansion of this market.

To gain insight into this complex market segment, Clinical Marketing Consultants designed a survey to gather detailed information regarding the use of molecular biology reagents in clinical diagnostic laboratories. The purpose of the study was to discover how traditional molecular research reagents and kits e.g. restriction enzymes, nucleic acid purification kits, and amplification reagents are employed by molecular pathologists. In addition, an understanding of the segment required the development of a profile of the specific assays performed to test patient blood and tissue samples for inherited diseases, infectious diseases and malignancies. Surveys were sent to molecular pathologists from lists obtained from the American Association of Clinical Chemists, the Association of Molecular Pathology and the world wide web. Survey results were published by earlier this year in a report entitled Molecular Biology Reagents in Clinical Diagnostic Laboratories: A Detailed Analysis of the U.S. Market.

Demographics

The survey captured valuable information from key decision makers involved in the selection and purchase of molecular biology reagents - more than 90% of respondents characterized themselves as either the "primary decision maker" or "very involved" in this process. Demographic highlights include the following:

• There are currently about 800 laboratories performing nucleic acid based diagnostic testing of human samples for the identification of infectious organisms, inherited diseases and malignancies.
• Most are associated with university medical centers, with the remainder concentrated in private hospitals and private reference laboratories.
• The majority of laboratories are small, with less than 10 overall employees and fewer than 5 individuals that actually perform the molecular diagnostic procedures.
• Private reference laboratories tend to have larger facilities, performing a wider variety of test and higher throughput of specific diagnostic protocols.