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題名 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
Drug life cycle management strategies for big pharma - The case studies on Viagra®, Cialis® and Levitra®
作者 張恭銘
Chang, Kung-Ming
貢獻者 陳桂恒
Chan, Keith
張恭銘
Chang, Kung-Ming
關鍵詞 藥品
生命週期管理策略
大藥廠
威而鋼®
犀利士®
樂威壯®
Drug
Life cycle management strategy
Big pharma
Viagra®
Cialis®
Levitra®
日期 2017
上傳時間 10-Aug-2018 11:05:02 (UTC+8)
摘要 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。\n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。\n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。\n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。
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.\nThe 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.\nThis 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.\nThis 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.
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Foundations of Marketing. Berkshire, England: Mcgraw-Hill Education.\nDonald Kirsch (2014). Therapeutic Drug Development and Human Clinical Trials. In Craig Shimasaki, et al. (Eds.). Biotechnology Entrepreneurship. Massachusetts, MA: Elsevier Inc.\nJay Baglia (2005). The Viagra Ad Venture: Masculinity, Media, and the Performance of Sexual Health. New York, NY: Peter Lang Publishing Inc.\nKappe Eelco (2014). Pharmaceutical Life Cycle Extension Strategies. In Min Ding, Jehoshua Eliashberg, and Stefan Stremersh, et al. (Eds.). Innovation and Marketing in the Pharmaceutical Industry. Philadelphia, PA: Springer Science + Business Media.\nTony Ellery and Neal Hansen (2012). Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand. New Jersey, NJ: A John Wiley & Sons, Inc., Publication.\n\n期刊\nAsher Mullard (2017). 2016 FDA Drug Approvals. Nature Reviews Drug Discovery, Vol. 16, Feb. 2017, pp. 73-76.\nDavid Cavalla (2003). The Extended Pharmaceutical Enterprise. Drug Discovery Today, Vol. 8, No. 6, Mar. 2003, pp. 267-274.\nHenry Feldman, et al. Impotence and Its Medical and Psychosocial Correlates, Massachusetts Male Aging Study. The Journal of Urology, Vol. 151, Jan. 1994, pp. 54-61.\nHossein Ghofrani, Ian Osterloh and Friedrich Grimminger (2006). Sildenafil: from Angina to Erectile Dysfunction to Pulmonary Hypertension and Beyond. Nature Review Drug Discovery, Vol. 5, Aug. 2006, pp. 689-702.\nJames Conley, Peter Bican and Holger Ernst (2013). Value Articulation: A Framework for the Strategic Management of Intellectual Property. California Management Review, Vol. 55, No. 4, pp. 102-120.\nJeremy Greene and and Aaron Kesselheim (2011). Why Do the Same Drugs Look Different? Pills, Trade Dress, and Public Health. The New England Journal of Medicine, Vol. 365, Jul. 2011, pp. 83-89.\nKatherine Neumeyer and Peter Kirkpatrick (2004). Fresh from the Pipeline: Tadalafil and vardenafil. Nature Reviews Drug Discovery, Vol. 3, Apr. 2004, pp. 295-296.\nLaura Mahecha (2006). Rx-to-OTC Switches: Trends and Factors Underlying Success. Nature Reviews Drug Discovery, Vol. 5, May. 2006, pp. 380-386.\nMannching Sherry Ku (2015). Recent Trends in Specialty Pharma Business Model, Journal of Food and Drug Analysis, Vol. 23, Dec. 2015, p. 595-608.\nMaría José Abud, Bronwyn Hall and Christian Helmers (2015). An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile. PLoS ONE. Vol. 10, Apr. 2015, pp. 1-17.\nMaria Kubin, Gorm Wagner and Alex Fugl-Meyer (2003). Epidemiology of Erectile Dysfunction. International Journal of Impotence Research, Vol. 15, Feb. 2003, pp. 63-71.\nMyoung Cha, Abhishek Saxena, Katarzyna Smietana & Roerich Bansal (2015). Deal watch: Panning for gold: sourcing pharmaceutical innovation. Nature Reviews Drug Discovery, Vol. 14, May. 2015, p. 376.\nPeter Sandner and Karl Ziegelbauer (2008). Product-related Research: How Research Can Contribute to Successful Life-Cycle Management. Drug Discovery Today, Vol. 13, No. 9/10, May. 2008, pp. 457-463.\nRaymond Vernon (1966). International Investment and International Trade in the Product Cycle. The Quarterly Journal of Economics, Vol. 80, No. 2, May. 1966, pp. 190-207. Source: http://www.sba.muohio.edu/dunlevja/Course%20Links/EC441/Vernon.pdf, last visited: 2017/4/3.\nSharon Huang and Janette Lie (2013). Phosphodiesterase-5 (PDE5) Inhibitors in the Management of Erectile Dysfunction. Pharmacy and Therapeutics, Vol. 38, No. 7, Jul. 2013, pp. 414-419.\nShraddha Chowdhary (2015). A Study of Product Life Cycle Extension Strategies of Patented Drugs to Deter Entry of Generics. International Journal of Pharmaceutical Science and Health Care, Vol. 3, No. 5, May. - Jun. 2015, pp. 99-108.\nVentola Lee (2011). Direct-to-Consumer Pharmaceutical Advertising. 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Source: https://www.bayer.com/en/history.aspx, last visited: 2017/4/24.\nBeth Bulik (2017). FiercePharma: Second time`s the charm? Pfizer tries again with OTC Viagra in the U.K. Source: http://www.fiercepharma.com/marketing/second-time-charm-pfizer-tries-again-for-otc-viagra-uk, last visited: 2017/5/12.\nBio JobBlog (2008). Direct-to-Consumer Drug (DTC) Pharmaceutical Advertising Really is Big Business! Source: http://biojobsblog.com/2008/06/13/direct-to-consumer-drug-dtc-pharmaceutical-advertising-really-is-big-business/, last visited: 2017/5/8.\nDavid Phillips (2013) Forbes: Pfizer`s Expiring Viagra Patent Adversely Affects Other Drugmakers Too. Source: https://www.forbes.com/sites/investor/2013/12/20/pfizers-expiring-viagra-patent-adversely-affects-other-drugmakers-too/#26ba30a468d4, last visited: 2017/5/12.\nDon Amerman (2012). AccessRx: The Current Price of Viagra. 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Harvard Business School Publishing, Harvard University.\nElie Ofek and Natalie Kindred (2012). Cialis Lifecycle Management: Lilly’s BPH Dilemma. Harvard Business School Publishing, Harvard University.\nGerry Yemen and Scott Snell (2012). AstraZeneca: Transforming How New Medicines Flow to Patients. Darden Graduate School of Business Publishing, University of Virginia.\nHarvard Business School Publishing. Harvard University.\nMark Parry (2003). Cialis. Darden Graduate School of Business Publishing, University of Virginia.
描述 碩士
國立政治大學
科技管理與智慧財產研究所
104364102
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0104364102
資料類型 thesis
dc.contributor.advisor 陳桂恒zh_TW
dc.contributor.advisor Chan, Keithen_US
dc.contributor.author (Authors) 張恭銘zh_TW
dc.contributor.author (Authors) Chang, Kung-Mingen_US
dc.creator (作者) 張恭銘zh_TW
dc.creator (作者) Chang, Kung-Mingen_US
dc.date (日期) 2017en_US
dc.date.accessioned 10-Aug-2018 11:05:02 (UTC+8)-
dc.date.available 10-Aug-2018 11:05:02 (UTC+8)-
dc.date.issued (上傳時間) 10-Aug-2018 11:05:02 (UTC+8)-
dc.identifier (Other Identifiers) G0104364102en_US
dc.identifier.uri (URI) https://ah.lib.nccu.edu.tw/item?item_id=137237-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 科技管理與智慧財產研究所zh_TW
dc.description (描述) 104364102zh_TW
dc.description.abstract (摘要) 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。\n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。\n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。\n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。zh_TW
dc.description.abstract (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.\nThe 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.\nThis 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.\nThis 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.en_US
dc.description.tableofcontents 第一章 緒論 1\n第一節 研究背景 1\n第二節 研究動機 4\n第三節 研究目的與問題 6\n第四節 研究方法 6\n第五節 研究架構 9\n第六節 研究限制 10\n\n第二章 文獻探討 11\n第一節 製藥產業 11\n壹、 全球製藥產業現況 11\n貳、 製藥產業之價值鏈 14\n參、 美國藥品之重要法規制度 19\n第二節 生命週期管理 27\n壹、 產品生命週期管理理論 27\n貳、 製藥產業之產品生命週期 29\n參、 藥品生命週期管理策略 31\n第三節 勃起功能障礙適應症 43\n壹、 適應症簡介 43\n貳、 藥品機轉簡介 45\n參、 主要領導廠商與藥品 47\n\n第三章 個案研究 50\n第一節 輝瑞—威而鋼®(Pfizer—Viagra®)50\n壹、 公司與藥品發展簡介 50\n貳、 藥品生命週期管理分析 53\n一、 研究開發策略構面 53\n二、 商業化策略構面 56\n三、 智財法規策略構面 60\n參、 威而鋼®個案小節 65\n第二節 禮來—犀利士®(Eli Lilly—Cialis®)67\n壹、 公司與藥品簡介 67\n貳、 藥品生命週期管理分析 70\n一、 研究開發策略構面 70\n二、 商業化策略構面 72\n三、 智財法規策略構面 76\n參、 犀利士®個案小節 79\n第三節 拜耳—樂威壯®(Bayer—Levitra®)81\n壹、 公司與藥品簡介 81\n貳、 藥品生命週期管理分析 84\n一、 研究開發策略構面 84\n二、 商業化策略構面 85\n三、 智財法規策略構面 86\n參、 樂威壯®個案小節 89\n\n第四章 研究發現與討論 90\n第一節 個案彙總比較 90\n壹、 個案藥物之營收表現 90\n貳、 個案之藥品生命週期週期管理策略比較彙總 91\n參、 個案之藥品生命週期管理策略選擇與時間點 94\n第二節 發現與討論 98\n壹、 整體面之研究發現 98\n貳、 研究開發構面之研究發現 101\n參、 商業化構面之研究發現 105\n肆、 智財法規構面之研究發現 108\n\n第五章 結論與建議 109\n第一節 研究結論 109\n壹、 個案公司之藥品生命週期管理策略運用與時機選擇 109\n貳、 個案公司生命週期管理之互動關係 110\n參、 個案公司生命週期管理之成效與啟示 110\n肆、 研究總結 111\n第二節 研究建議 112\n壹、 對實務界之建議 112\n貳、 對後續研究之建議 114\n\n參考文獻 117\n中文部分 117\n英文部分 120zh_TW
dc.format.extent 6750004 bytes-
dc.format.mimetype application/pdf-
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0104364102en_US
dc.subject (關鍵詞) 藥品zh_TW
dc.subject (關鍵詞) 生命週期管理策略zh_TW
dc.subject (關鍵詞) 大藥廠zh_TW
dc.subject (關鍵詞) 威而鋼®zh_TW
dc.subject (關鍵詞) 犀利士®zh_TW
dc.subject (關鍵詞) 樂威壯®zh_TW
dc.subject (關鍵詞) Drugen_US
dc.subject (關鍵詞) Life cycle management strategyen_US
dc.subject (關鍵詞) Big pharmaen_US
dc.subject (關鍵詞) Viagra®en_US
dc.subject (關鍵詞) Cialis®en_US
dc.subject (關鍵詞) Levitra®en_US
dc.title (題名) 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zh_TW
dc.title (題名) Drug life cycle management strategies for big pharma - The case studies on Viagra®, Cialis® and Levitra®en_US
dc.type (資料類型) thesisen_US
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Drug Discovery Today, Vol. 8, No. 6, Mar. 2003, pp. 267-274.\nHenry Feldman, et al. Impotence and Its Medical and Psychosocial Correlates, Massachusetts Male Aging Study. The Journal of Urology, Vol. 151, Jan. 1994, pp. 54-61.\nHossein Ghofrani, Ian Osterloh and Friedrich Grimminger (2006). Sildenafil: from Angina to Erectile Dysfunction to Pulmonary Hypertension and Beyond. Nature Review Drug Discovery, Vol. 5, Aug. 2006, pp. 689-702.\nJames Conley, Peter Bican and Holger Ernst (2013). Value Articulation: A Framework for the Strategic Management of Intellectual Property. California Management Review, Vol. 55, No. 4, pp. 102-120.\nJeremy Greene and and Aaron Kesselheim (2011). Why Do the Same Drugs Look Different? Pills, Trade Dress, and Public Health. The New England Journal of Medicine, Vol. 365, Jul. 2011, pp. 83-89.\nKatherine Neumeyer and Peter Kirkpatrick (2004). Fresh from the Pipeline: Tadalafil and vardenafil. 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dc.identifier.doi (DOI) 10.6814/THE.NCCU.TIIPM.013.2018.F08-