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INDUSTRY BUSINESS ENVIRONMENT -- A Global Perspective Life Sciences Industry -- March 1995 (Source: Marvin A. Friedman, Biotechnology Industry Representative) (Note: This industry writeup is mapped to the biotechnology industry because biotechnology is a significant component of the life sciences industry.) PURPOSE The Industry Business Environment (IBE) describes the critical forces driving an industry. In doing so, the IBE provides a perspective from which our auditors can understand the business of specific clients in terms of broad industry risks and issues. The IBE accomplishes these objectives by: ￥ Presenting a brief description of the industry, current performance information, and a future outlook. ￥ Discussing the critical factors affecting the industry ￥ Outlining additional resources available to our personnel OVERVIEW AND OUTLOOK Description and Scope of the Industry: Domestic - The US life sciences industry is young and has grown rapidly in the last two decades as a result of rapid technological advances. The first biotech company, Cetus Corporation, was founded in the 1970?s, and most companies in the industry have commenced operations since 1980. The number of independent life sciences companies in the US now exceeds 1,400, excluding the large pharmaceutical companies, most or all of whom are very active in biotechnology research and development, and the medical device industry.1 1Medi The most important common denominator to the life sciences industry is the employment of the techniques of modern molecular and cell biology to create new products. These techniques include gene mapping, gene sequencing, gene splicing, gene synthesis, the creation of recombinant genes, gene cloning and polymerase chain reaction (PCR) amplification, genetic engineering of plants, the creation of transgenic animals, monoclonal antibodies, protein engineering, and improved regulation of cell signaling, among others. The manufacturing of products developed by the