論文提要
生技製藥業的新產品上市是個很冗長，且耗費龐大的一個過程，但是只有一定年限的專利保護。新藥上市須考慮到藥品的療效、副作用、與安全性，也須經過主管機關的審核。新藥的行銷與銷售需透過醫院採購、醫師處方、病患服用等過程來完成，如果醫院不採購、醫師不處方、病患不適用或不服藥，整個銷售過程就會中斷。所以利用新藥上市模型來擬定新藥上市的策略是有幫助的。本研究主要是探討新藥上市模型的適用性，及利用新型抗憂鬱劑做驗證，擬定新型抗憂鬱劑的上市策略。
新藥上市模型包含外部分析與內部分析。外部分析，主要是要做顧客分析、市場分析、競爭者分析、討論管理議題和區域議題。內部分析，在做績效分析、策略選擇分析、討論產品議題和技術議題。分析完成之後根據結果找出關鍵成功因素，參考競爭標竿，再做策略展開。
抗憂鬱劑市場是個成熟的市場，但是仍有未被醫師及病患滿足的地方，包括低的反應率及緩解率、憂鬱症的殘餘症狀不易根除、復發率高等。新的抗憂鬱劑想要成為市場領導者，首先是療效需讓醫師及病患滿意；第二是必須快速進入各個通路，如醫院、診所、藥局；第三是要讓醫師及病人接受憂鬱症包含情緒症狀及身體症狀，是可治療的；第四是要讓憂鬱症病人出來接受治療；最後是要讓憂鬱症病人能夠完成整個治療計畫。
整個結果顯示，新藥上市模型是個很好的策略展開工具，抗憂鬱劑市場是個成熟市場但是還有未被醫師和病人滿足的地方，新型抗憂鬱劑可切入利基市場。
關鍵字：新藥上市模型、競爭標竿、策略、憂鬱症、抗憂鬱劑

Abstract
Although developing a new drug produced with bio-technologies is a time-consuming and costly process, the patent of such kind of new products can only be protected for only few years. Therefore, the launch for new drug can not be made without thorough consideration of the market and its environment.
Introducing a new medicament to the market needs considering various factors, such as its efficiency, side-effects, and safety. The introduction requires also the approval from relevant government authorities.
The sales of a new drug depend on the purchase from hospitals, the prescription from doctors and the utilization from patients to complete the process. If one of these three elements is missing, the whole process will be broken up. Therefore, it is helpful to take the sales process and its model as a reference to define the strategy for launching a new drug to the local market.
The model to introducing a new drug includes two sides of analysis – external and internal analysis. The external analysis covers mainly areas such as studies of customers, market and competitors, it includes as well issues concerning regulatory and geography area division. The internal analysis is with focus on studies regarding efficiency, strategy alternatives, products and relevant technologies. Only after the analysis as such, the key factors for a successful marketing can be identified. Taking lessons learnt from products, the strategy can be defined accordingly and implemented.
Today although the market for antidepressants is well developed, there are areas which remain unsatisfied by doctors and patients, inter alia, its low response and remission rate, the difficulty of a total recovery, and the high probability of relapse. Any new antidepressants, should it wish being the leading medicament in the market, the satisfaction from both users – the medical doctors and the patients – is a must. Secondly, the product must be introduced through all kind of relevant channels to reach out to actual and potential users (not necessarily those working in the hospitals and clinics). Last but not least, the society should remove any stigma on people suffering from depression and encourage them (and their relatives) to go for the treatment and complete the treatment for their own and the society’s well-being.
Finally, new drug launch model is a useful tool for developing marketing strategy. Market of antidepressant is a mature market. Nevertheless doctors and patients remain unsatisfied vis a vis certain aspects of the antidepressant. Any new antidepressant if it can meet the requirement, it certain has chance to enter niche market.
Key word: new drug launch model, competitive benchmarking, strategy, depression, antidepressant

目 錄
論文提要 I
Abstract II
目錄 IV
表目錄 V
圖目錄 VI
第一章 前言 1
第二章 理論架構 3
第一節 新產品上市模型 3
第二節 競爭標竿 10
第三章 憂鬱症概述及個案公司介紹 19
第一節 憂鬱症概述 19
第二節 個案公司介紹 28
第四章 策略分析與展開 35
第一節 外部分析 35
第二節 內部分析 46
第三節 生技製藥業特性 47
第四節 機會與威脅、優勢與劣勢 58
第五節 關鍵成功因素 60
第六節 策略展開 61
第五章 討論與結論 64
第一節 討論 64
第二節 結論 71
第六章 參考文獻 74

表 目 錄
表一、抗憂鬱藥物藥費申報統計分析 28
表二、禮來公司中樞神精用藥銷售量 33
表三、抗憂鬱劑產品佔有率分析 38
表四：主要抗憂鬱劑的優缺點 39
表五、抗憂鬱產品建議劑量及價格 42
表六、Cymbalta的SWOT分析 58


















圖 目 錄
圖一、生技製藥業的新產品上市模型 3
圖二、漢氏憂鬱症量表症狀比例 21
圖三、憂鬱症療程 24
圖四、中央健保局抗憂鬱藥物藥品申報情形 27
圖五、禮來公司股價 34
圖六、藥品費用成長分析 44
圖七、藥費申報點數統計 45
圖八、抗憂鬱藥物的發展 48
圖九、Cymbalta對憂鬱症的改善 49
圖十、Cymbalta對憂鬱症的緩解率 49
圖十一、Cymbalta的治療時間對憂鬱症的改善程度 51
圖十二、Cymbalta對焦慮症狀的改善 51
圖十三、Cymbalta對憂鬱症伴隨疼痛的改善 52
圖十四、Cymbalta對憂鬱症伴隨各種疼痛的改善 52
圖十五、Cymbalta對憂鬱症病被痛的改善程度 53
圖十六、Cymbalta長期使用對憂鬱症的緩解率 54
圖十七、Cymbalta的副作用發生率 54
圖十八、Cymbalta停藥後戒斷症狀的發生率 55
圖十九、修正後的生技製藥業的新產品上市模型（新藥上市模型） 65

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