Prior to discussing the overall market demand for biomedical buildings or laboratories, it is important to understand construction and design attributes relating to various facilities and the safety features presently required to work with bio-toxins. Building design and handling have been evolving since 1941.
Although modest improvements in interior barrier designs and handling practices were evident since that time, significant and formal building design and practice changes occurred after 1980 with the discovery of the HIV. Even prior to this discovery, there was growing concern over the treatment of medical waste and its disposal. Since 1980, formalized approaches to facility design and the construction of primary and secondary barriers which impede the transmission of harmful pathogens have become national standards.
Present facility design and construction has evolved into four design types known as Bio-Safety Levels (BSL), and building classification depends on the biological agents present in the facility. Understanding the building type enhances the appraiser's knowledge regarding marketability, demand, and probable target industry issues. Table 1 outlines the current four biosafety levels.
According to the U.S. Department of Commerce, International Trade Administration's Chemicals, Pharmaceuticals, and Biotechnology Division, in its publication, U.S. Industry and Trade Outlook 1998: Chemicals and Allied Products, the United States leads the worldwide pharmaceutical industry in market share, research and development (R&D) spending, and the development of new therapeutic products. American firms accounted for 30 percent of the total worldwide market in 1994, followed by Europe (27 percent); Japan (22 percent); Latin America (7 percent); Southeast Asia (6 percent); and other areas (8 percent).
In terms of R&D spending, U.S. companies account for about one-third of all pharmaceutical R&D work worldwide. U.S. firms spend heavily on new drug R&D, and enjoy a high degree of productivity from those investments. Of the 265 major new drugs developed between 1970 and 1992, almost half originated from U.S. firms, based on data from the Pharmaceutical Research and Manufacturers of America (PhRMA).
U.S. companies have found eager markets abroad, especially in developing and emerging economics. Based on PhRMA data, U.S. pharmaceutical companies expanded their drug sales from $10.5 billion in 1980 to an indicated $33.4 billion in 1996. Readily available and relatively low in cost, prescription drugs are typically the first line of medical therapy throughout the world. With leading U.S. drug manufacturers generating, on average, close to two-fifths of their sales abroad, U.S. firms are affected by overseas demand, the tempo of foreign business, international regulatory conditions, and fluctuations in the dollar compared with other world currencies.
The European Community's Economic Union, formed in 1993, has made marketing in Europe more efficient and has streamlined the process for new drug approvals there. The union's new Committee for Proprietary Medicinal Products is a universal regulatory agency; drugs approved by this organization are automatically cleared for marketing in all 15-member states. In the past, regulatory clearance had to be obtained in each country where a drug was to be sold. Foreign sales have benefited recently from the formation of the economic union, the passage of NAF[A in 1994, and the revision of the General.