黃恆獎Huang, Heng-Chiang臺灣大學:國際企業學研究所樊淑惠Fan, Shu-HuiShu-HuiFan2010-05-112018-06-292010-05-112018-06-292009U0001-0707200915133200http://ntur.lib.ntu.edu.tw//handle/246246/182736新藥的研發與上市，一直是原開發生技製藥廠創造利潤、永續經營的重要支撐命脈。但新藥研發失敗率高，成本節節高漲，使藥廠在研發經費的投資策略上日益保守。加上全球各國新藥審查的流程與規定日益繁瑣，延緩新藥上市的黃金時機，明顯縮短新藥享有專利保護的市場獨佔期，進而影響投資報酬率。儘管新藥研發過程充滿變數，也不保證獲利，但原開發跨國藥廠每年仍持續投注超過百分之十營業額之研發資金，期望能有突破性的創新發明。 近年國際藥業面臨諸多挑戰，新藥研發的瓶頸及降低藥價的壓力，使得藥廠的管理階層紛紛重新審視並調整新藥研發的國際定位。拉丁美洲與亞洲迅速崛起成為新興市場，全球焦點市場重新洗牌，同時也牽動跨國性原開發藥廠在新藥研發方面的全球性佈局。亞太地區由於人口眾多、醫藥需求急增，加上過去長期被歐美藥廠忽略，市場潛力與成長空間更是受到全球矚目。在此趨勢下，台灣與鄰近亞太國家無不競逐爭取亞太新藥研發中心的地位。 本研究選定國際公認較具競爭力的中國、印度、韓國、新加坡、泰國、以及台灣為競爭力分析對象，依「Porter鑽石模型」分析生技製藥國家競爭力，同時以「產業價值鏈與策略聯盟」分析臨床試驗競爭力；最後，歸納結論並提出台灣未來強化競爭優勢的相關建言。Innovative new drug development is always a key success factor for biotech and pharmaceutical companies in order for business continuity. The dynamics of drug development is one of the defining characteristics of the biotech and pharmaceutical industry. Owing to the high failure rate and dramatically growing cost, the biotech and pharmaceutical industry is facing tremendous new challenges in innovative drug research and development. Asian Pacific pharmaceutical sales revenue has continued to boom in recent years. Meanwhile, most Asian Pacific countries strive to get more and more involved in global clinical development. How to strengthen international competitiveness has become a key issue for attracting global investment in innovative new drug development. The thesis focuses on the establishment of research and development bases for the acceleration of innovation in new drug research and strengthening of international competitiveness of the Asian Pacific biotech and pharmaceutical industry. By analyzing the competiveness among Asian Pacific countries, we expect to come up with valid suggestions and strategies for the stakeholders including government, academia and industry to strengthen international competitiveness in order to promote biotech and pharmaceutical research and development.口試委員審定書 ii謝 iii文摘要 iv文摘要 v 錄 vi目錄 viii目錄 x一章 緒 論.............................................................................................................1一節、 研究背景.............................................................................................1二節、 研究動機與目的.................................................................................4三節、 研究範圍.............................................................................................5四節、 研究步驟.............................................................................................6二章 文獻探討.........................................................................................................7一節、 競爭力的定義與範疇........................................................................7二節、 國家競爭力分析– Porter鑽石模型................................................10三節、 產業競爭力分析–價值鏈與策略聯盟............................................13三章 新藥研發之現況與分析................................................................................19一節、 全球生技製藥產業概述..................................................................19二節、 新藥研發過程簡介..........................................................................26三節、 新藥研發產業價值鏈與策略聯盟..................................................29四節、 全球新藥研發的現況分析與趨勢預測..........................................32五節、 亞太地區新藥研發的現況..............................................................43六節、 台灣新藥研發的現況......................................................................47四章 亞太國家新藥研發之競爭力分析............................................................,...51一節、 研究方法..........................................................................................51二節、 以「Porter鑽石模型」探討亞太國家生技製藥研發競爭力.......51三節、 新藥臨床試驗競爭力評估指標之界定..........................................72四節、 以「價值鏈與策略聯盟」探討亞太國家臨床試驗競爭力..............75五章 結論與討論....................................................................................................86一節、 主要發現..........................................................................................86二節、 管理及政策意涵..............................................................................89三節、 研究限制..........................................................................................92四節、 後續研究建議..................................................................................92考文獻 94application/pdf1560159 bytesapplication/pdfen-US新藥研發亞太研發中心臨床試驗競爭力innovative new drugresearch and developmentbiotech and pharmaceutical industryinternational competivenessthesishttp://ntur.lib.ntu.edu.tw/bitstream/246246/182736/1/ntu-98-P95746013-1.pdf