大藥廠之藥品生命週期管理策略—以威而鋼®、犀利士®與樂威壯®為例

藥品生命週期管理策略是透過一連串經創新與制度的應用來延長藥品生命週期，並將獲利極大化的作為。近年來，由於大藥廠之研發能量不足等困境，藥品生命週期管理之議題更加受到重視，其應用的策略亦相當豐富與多樣，相當值得開始有新藥成果的台灣廠商參考與學習。本研究以輝瑞—威而鋼®、禮來—犀利士®以及拜耳—樂威壯®作為研究對象，並將藥品生命週期管理策略分為研究開發、商業化、智財法規等三大策略構面，藉由回顧性個案分析法以及案例比較分析法，了解個案公司在藥品生命週期管理議題之策略運用、時機選擇及互動關係，從中歸納出結論並提供台灣藥廠對應之建議。本研究發現，威而鋼®透過積極的藥品生命週期管理策略之佈局與運用，大大延續了藥物之競爭力與獲利，包含擴張新適應症、建構產品家族、善用商業外觀、創造連續的專屬權等等。犀利士®亦透過積極投入藥品生命週期管理，包含新劑型、新適應症、差異化的推廣策略、創造連續的專屬權…等方式，最終擊敗威而鋼®成為市場的領頭羊。反觀樂威壯®則較為不作為，使得營收與其他兩名競爭者有顯著差距。透過本研究歸納之發現與結論，可得知藥品生命週期管理是一門搶時間的學問；藥廠對於藥品生命週期管理策略的積極與消極作為對藥物之營收表現有顯著影響；藥品生命週期管理策略亦有風險；藥品生命週期不僅為跨部門跨領域之議題，更可透過合作來創造優勢…等。期許本研究能嘗試補足台灣關於藥品生命週期管理策略之研究領域，同時促進國內生技產業界對該領域之重視。

關鍵字

藥品；生命週期管理策略；大藥廠；威而鋼® ；犀利士® ；樂威壯®

並列摘要

Drug life cycle management (LCM) strategy is a way to maximize revenue and the lifespan of a drug compound. With the increasing costs and time on the R&D processes and many other reasons, LCM becomes a significant topic for the pharmaceutical companies. The key LCM strategies can be categorized into development, commercial and IP/regulatory scopes. This thesis focuses on the top 3 PDE5 inhibitor class drugs, Viagra®, Cialis® and Levitra®, trying to illustrate the different options and strategies in their drug LCM through retrospective study and case analysis method. This thesis indicates that Viagra® performed the best in its LCM via combining multiple strategies at the right timing, inclusive of new indication expansion, family of products establishment, trade dress protection, etc. And Cialis®, the third-in-class drug in the PDE5i class, competed with Viagra® by aggressively applying various LCM strategies, including new formulation, new indication expansion, promotion differentiation and sequential exclusivities. In contrast, Levitra® was a relatively passive player in the game. As the result, Viagra® ranked the top in erectile dysfunction market for many years. While® Cialis pursued closely and beat Viagra® in the end. Levitra®, without a doubt, earned far less than the other two drugs. This thesis shows that the drug LCM is a cross-functional task, and the strategies are extremely rich and varied. A successful LCM needs lots of preparations and investments in order to earn more time and to differentiate from the competitors.