Schlumberger H D, Stadler P
BioConsult Beratungsgesellschaft mbH, Wuppertal, Germany.
Arzneimittelforschung. 1997 Jan;47(1):106-10.
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.
借助现代生物技术已开发出多种新型诊断方法和药物，这为医学带来了新的可能性，并将在未来产生新的解决方案。制药行业创新过程的显著活力体现在正在研发的药物数量上。1995年，全球已知有771个项目正在研发中。北美在现代生物技术药物研发方面的领先地位得到了明确体现。在北美、欧洲、日本这三个地区，重组DNA产品的研发数量基本保持不变，而1995年美国和欧洲临床前及临床体细胞基因治疗项目的数量与1994年相比大幅增加；日本在这个新兴研究领域几乎没有涉足。在欧洲，绝大多数现代生物技术药物是在英国、德国、瑞士、法国、荷兰和意大利研发的。与199４年相比，1995年基因治疗项目的数量显著增长超过60%；与此同时，重组DNA产品的绝对份额和相对份额明显下降。在德国，约三分之二的生物技术药物研发是与外国合作伙伴合作进行的，这些合作伙伴大多是来自美国的高科技公司。然而，多种用现代生物技术生产的药物不仅带来了显著的医学进步，填补了治疗空白，还取得了可观的经济成功。预计到2000年，特别是生长因子和细胞因子将进一步显著增长。
