SIC 2835 In Vitro and In Vivo Diagnostic Substances

Contenidos

• NAICS CODE(S).
• Integrated Pharmaceutical Leaders.
• Independent Diagnostics Leaders.
• FURTHER READING.

SIC 2835

This category covers establishments primarily engaged in manufacturing in vitro ("in glass," such as a test tube) and in vivo ("in the body") diagnostic substances, whether or not packaged for retail sale. These materials are chemical, biological, or radioactive substances used in diagnosing or monitoring the state of human or veterinary health by identifying and measuring normal or abnormal constituents of body fluids or tissues.

NAICS CODE(S)

325412

Pharmaceutical Preparation Manufacturing

325413

In Vitro Diagnostic Substance Manufacturing

Often viewed as an extension of the pharmaceutical industry, the diagnostics industry is closely intertwined with cutting-edge developments in the treatment of human and animal disorders. This includes a great deal of genetic research and studies centered around high-profile diseases like cancer and AIDS. Simultaneously, much of the industry's output involves comparatively low-tech, routine diagnostics like allergy assays and home pregnancy tests.

Shipments of in vitro diagnostic products, those used outside the body, totaled $8.74 billion in 2005, a drop from shipments in 2002, which were $9.17 billion. A total of 26,324 people were employed in the industry in 2005, as compared to 27,233 in 2002.

The primary market for these diagnostic substances is in hospitals and laboratories, but sales to physicians and individual consumers have seen considerable growth. In the commercial markets, in particular, users have emphasized the need for more automated test systems that free up staff time and reduce the likelihood of error. Diagnostic applications attracting the greatest market interest include those for sexually transmitted diseases, diabetes, and cellular disorders.

Most, if not all, of the industry's products are regulated by the U.S. Food and Drug Administration (FDA). The agency sets standards for safety and quality in manufacturing and, depending on the diagnostic, usually requires products to be formally reviewed and approved before they are used. For diagnostics an average review lasts two years.

The current trend in the industry is to miniaturize the machinery and make the items more portable. This point-of-care (POC) testing means tests may be performed at hospital patients' bedsides and in physicians' office labs, outpatient clinics, emergency rooms, and so on. POC...