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Modern pharmaceutical biotechnology. Situation worldwide and in Germany 1995.

A variety of new diagnostics and drugs have been developed with the aid of modern biotechnology which has opened up new medical possibilities and will yield novel solutions in the future. The remarkable dynamics of the innovation process in the pharmaceutical sector is reflected by the number of drugs under development. In 1995, 771 projects were known to be in development worldwide. The leadership of North America in research and development of drugs from modern biotechnology is clearly demonstrated. Whereas the number of development recombinant DNA products remained practically constant in the triade (North America, Europe, Japan), the number of preclinical and clinical somatic gene therapy projects increased considerably in 1995 compared to 1994 in the United States and in Europe; Japan is virtually absent in this new emerging research field. In Europe, the vast majority of drugs from modern biotechnology, are developed in Great Britain, Germany, Switzerland, France, the Netherlands, and Italy. The number of gene therapy projects show a remarkable growth of more than 60% in 1995 compared with 1994; at the same time, the absolute and relative share of recombinant DNA products decreased distinctly. In Germany, about two thirds of the development of biotechnological drugs are conducted in cooperation with a foreign partner, mostly hightech companies from the United States. A variety of drugs manufactured with modern biotechnology, however, has not only provided significant medical progress and has closed therapeutic gaps but has also demonstrated considerable economic success. In 2000, further significant growth is expected especially for growth factors and cytokines.