基於未來預防醫學市場的興起,推測在分子檢測方面的需求可能會大幅提昇,並且在生物科技產業中扮演一個重要的角色。因此本研究主要想探討分子檢測產業,受到哪些關鍵要素的影響,以及各個關鍵要素影響此產業的重要性,最後提出產業未來可行的發展方向,提供未來研究者參考。 只要專注在產業的成功要素上,就能事半功倍的建立起競爭力,避免耗用無效的資源,將來也能夠發展地更加長遠。本研究先經由前測問卷挑選出十項關鍵成功要素,並且分成三個構面,接著利用專家訪談法,親自詢問此領域專家的意見,然後從中探討一些現象。在研究結果發現影響分子檢測產業發展的關鍵成功要素,從三個構面中選出一個最重要的因素,分別是法律政策面中「政府政策的支持」、創新研發與人力資源面中「創新研發能力」、產業環境面中「投入的研發資金多寡」。因此分子檢測是屬於高研發經費的,在技術尚未變成一個上市產品之前,所需要付出的成本是極高的。台灣已具有充足的高素質研發人才,如果在研發的創新能力上加強,才能尋找到一個市場及使用者能接受的商品。任何具有醫療效果的器材,要公開上市得通過政府法令規定的流程,所以政府的法令評審標準決定未來產業是否能發展迅速的主要因素之一。 Because of preventive medicine market springing up, this study speculates demand of molecular diagnosis area increasing and playing a key role in biotechnology industry. For this reason, we want to research molecular diagnosis industry by which the impact of key factors. Besides, we discuss the importance of each key factor for the field. Finally, we propose the industry direction of development future reference for future researchers. If we focus on the industry success factors, we would yield twice the result with half the effort to have competitiveness maybe. It could not prevent expending invalid resource, but also set up long-term development for the future. This study use pre-test questionnaire in advance to pick and choose ten key success factors, and it divided into three dimensions, which are legal policy dimension、research and development and human resources dimension、industrial environment dimension. Next using expert interview, we consult the field professionals in person;furthermore, we to explore some phenomenon in the process. The study found success factors affecting molecular diagnosis industry from the three dimensions, and select one from each dimension.They are “government policy support” of legal policy dimension、”Innovation research and development capacity” of research and development and human resources dimension、“R & D budget” of industrial environment dimension. Therefore, molecular diagnosis industry is a high R & D budget. Before techniques become listed products yet, its suck costs are really high. There are high-quality and adequate R & D personnel In Taiwan. If we strengthen on the innovation research and development capacity, finding accepted goods of market and user. Any medical equipment with the medical effects must pass through government decree act procedures, if the goods would enter the market. Consequently, evaluation criteria of government decree become a main success factors determining industry could rapid develop in the future of or not.