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題名 台灣再生醫學廠商的創新獲利策略
Strategies of Profiting from Innovation: The Case Studies of Taiwan Regenerative Medicine Companies作者 黃柏穎
Huang, Po-Ying貢獻者 許牧彥
Hsu, Mu-Yen
黃柏穎
Huang, Po-Ying關鍵詞 再生醫學
從創新中獲利
產業架構
關鍵節點
Regenerative medicine
Profiting from Innovation
Industrial architecture
Bottlenecks日期 2022 上傳時間 1-Aug-2022 18:51:53 (UTC+8) 摘要 隨著生物技術、基因工程等科學的進步下，以細胞、基因、組織工程作為治療方法的再生醫學是21世紀醫藥產業重要的發展方向。與過往醫藥產品因技術特性不同，造就了產業有可能出現不同的機會。如此的新興產業中，台灣企業可以扮演什麼樣的角色以及有哪些創新獲利的機會是本研究想了解的。產業演化的動態過程中，一項創新的科技從發明到商業化的路程中，企業必須要設法將科技創新商業化後的價值獲取，這是Teece於1986年所發表的「從創新中獲利」所關注的重點。Jacobides於2006年的研究提出產業架構觀點擴展了Teece的論述，企業能否獲取價值是受到外部影響因素而不斷改變產業內的分工方式以及價值分配的方式。企業可以透過佔有產業中某些重要的節點，成為「關鍵節點」形成架構優勢，而有更好價值獲取的機會。因此本研究想以產業層級的觀點，分析再生醫學產業的外部影響因素來了解再生醫學的產業架構在重新建構的過程中，有哪一些新的關鍵節點。接著再以台灣本土企業做為個案研究標的，分析企業是如何掌握關鍵節點，而有創新獲利的機會。透過本研究的分析與討論獲得以下兩點結論：一、 再生醫學產業與以往的醫藥產業不同，若要佔有產業最多的價值，不能僅依靠專有權制度的佈建，需要透過互補性資產的配置才能夠達成。需要以治療中心以及患者為中心來設計流程，流程設計越完善之企業越能夠掌握產業的架構。二、 互補企業投資的互補性資產應是位在整個製造流程中所涉及到的資源，如：耗材、培養基、自動化設備、監控流程系統以及原料的整合等，能因此提高與創新者的互補程度以及降低互補資產的移動性。
Cell, gene, and tissue engineering as treatment methods are an important direction for the pharmaceutical industry in the 21st century, it makes patients have a new hope to cure their disease, we call it “Regenerative medicine”. Different from small molecule drugs due to their technical characteristics, the industry may have different opportunities. In such an emerging industry, what role can Taiwan’s local companies play, and is there any new opportunities that can let the company capture their value from the innovation, these are the key issue in this study we would like to find out.During the industry evolution dynamic process, how to capture the value from innovation is a core question that was explored by David J. Teece in Journal of Research Policy, 1986; also known as the “Profiting from innovation”. Jacobides` research in 2006 extended Teece`s argument by proposing an “Industrial Architecture” perspective. Whether a firm can capture value is affected by external factors that constantly change the division of labor and value distribution. Firm should control some important interface in the value chain, then become the "Bottlenecks" in the industry, to create “architectural advantage” and have better opportunities to capture value.Base on previous literatures, first, this study will analyze the external factors of the Regenerative medicine industry to understand what the industrial architecture would like, and where are the bottlenecks in the Regenerative medicine industry. Second, I will use Taiwan`s local companies as a case study, to find out how Taiwan companies occupy the bottlenecks and capture their value.This study attained two research results：1. Regenerative medicine industry is different from the pharmaceutical industry we have known before. In order to capture the value of the industry, it cannot only rely on the legal instruments but can be achieved through the complementary assets. The treatment process needs to design around the treatment center and patient. The more complete treatment process design, the better value firm can capture.2. Complementary assets investment should be involved in the entire manufacturing process, such as consumables, culture medium, automation equipment, monitoring system, and the integration of raw materials, etc., which can improve the complementarity with innovators and reduce the mobility of complementary assets.參考文獻 英文文獻Akerlof, G. A. (1970). The Market for "Lemons": Quality Uncertainty and the Market Mechanism. The Quarterly Journal of Economics, 84(3), 488-500.Arthur, W. B. (1996). Increasing returns and the new world of business. Harv Bus Rev, 74(4), 100-109.Baldwin, C. Y. (2015). Bottlenecks, modules and dynamic architectural capabilities. Harvard Business School Finance Working Paper(15-028).Bulcha, J. T., Wang, Y., Ma, H., Tai, P. W. L., & Gao, G. (2021). Viral vector platforms within the gene therapy landscape. Signal Transduction and Targeted Therapy, 6(1), 53.Dwivedi, A., Karulkar, A., Ghosh, S., Rafiq, A., & Purwar, R. (2019). Lymphocytes in Cellular Therapy: Functional Regulation of CAR T Cells. Frontiers in Immunology, 9(3180).Forostyak, O., Dayanithi, G., & Forostyak, S. (2016). CNS Regenerative Medicine and Stem Cells. OPERA MEDICA ET PHYSIOLOGICA, January 2016(1), 69-76.Fu, Z., Zhou, J., Chen, R., Jin, Y., Ni, T., Qian, L., & Xiao, C. (2020). Cluster of differentiation 19 chimeric antigen receptor T‑cell therapy in pediatric acute lymphoblastic leukemia (Review). Oncol Lett, 20(4), 36.Gómez-de Frutos, M. C., Laso-García, F., Diekhorst, L., Otero-Ortega, L., Fuentes, B., Jolkkonen, J., . . . consortium, R. (2019). Intravenous delivery of adipose tissue-derived mesenchymal stem cells improves brain repair in hyperglycemic stroke rats. Stem cell research & therapy, 10(1), 212-212.Good, C. R., Kuramitsu, S., Samareh, P., Donahue, G., Ishiyama, K., Ma, Y., . . . June, C. H. (2021). Abstract 60: Induction of T cell dysfunction and NK-like T cell differentiation in vitro and in patients after CAR T cell treatment. Cancer Research, 81(13 Supplement), 60-60.Gutierrez-Aranda, I., Ramos-Mejia, V., Bueno, C., Munoz-Lopez, M., Real, P. J., Mácia, A., . . . Menendez, P. (2010). Human induced pluripotent stem cells develop teratoma more efficiently and faster than human embryonic stem cells regardless the site of injection. Stem cells (Dayton, Ohio), 28(9), 1568-1570.Inaba, H., Greaves, M., & Mullighan, C. G. (2013). Acute lymphoblastic leukaemia. Lancet, 381(9881), 1943-1955.Jacobides, M. G., Knudsen, T., & Augier, M. (2006). Benefiting from innovation: Value creation, value appropriation and the role of industry architectures. Research policy, 35(8), 1200-1221.Jacobides, M. G., MacDuffie, J. P., & Tae, C. J. (2016). Agency, structure, and the dominance of OEMs: Change and stability in the automotive sector. Strategic management journal, 37(9), 1942-1967.Jacobides, M. G., & Tae, C. J. (2015). Kingpins, Bottlenecks, and Value Dynamics Along a Sector. Organization Science, 26(3), 889-907.Jacobides, M. G., & Winter, S. G. (2005). The co‐evolution of capabilities and transaction costs: Explaining the institutional structure of production. Strategic management journal, 26(5), 395-413.Katz, M. L., & Shapiro, C. (1985). Network Externalities, Competition, and Compatibility. The American Economic Review, 75(3), 424-440.Kenderian, S. S., Ruella, M., Gill, S., & Kalos, M. (2014). Chimeric antigen receptor T-cell therapy to target hematologic malignancies. Cancer Res, 74(22), 6383-6389.Kirsch, D. (2014). Therapeutic Drug Development and Human Clinical Trials. Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies, 315-330.Levine, B. L. (2015). Performance-enhancing drugs: design and production of redirected chimeric antigen receptor (CAR) T cells. Cancer Gene Therapy, 22(2), 79-84.Lippman, S. A., & Rumelt, R. P. (2003a). A bargaining perspective on resource advantage. Strategic management journal, 24(11), 1069-1086.Lippman, S. A., & Rumelt, R. P. (2003b). The payments perspective: micro‐foundations of resource analysis. Strategic management journal, 24(10), 903-927.Maude, S. L., Frey, N., Shaw, P. A., Aplenc, R., Barrett, D. M., Bunin, N. J., . . . Grupp, S. A. (2014). Chimeric Antigen Receptor T Cells for Sustained Remissions in Leukemia. New England Journal of Medicine, 371(16), 1507-1517.Pendharkar, A. V., Chua, J. Y., Andres, R. H., Wang, N., Gaeta, X., Wang, H., . . . Guzman, R. (2010). Biodistribution of neural stem cells after intravascular therapy for hypoxic-ischemia. Stroke, 41(9), 2064-2070.Pisano, G. P., & Teece, D. J. (2007). How to capture value from innovation: Shaping intellectual property and industry architecture. California management review, 50(1), 278-296.Ruella, M., Xu, J., Barrett, D. M., Fraietta, J. A., Reich, T. J., Ambrose, D. E., . . . Melenhorst, J. J. (2018). Induction of resistance to chimeric antigen receptor T cell therapy by transduction of a single leukemic B cell. Nature Medicine, 24(10), 1499-1503.Snell, S., & Yemen, G. (2017). AstraZeneca: Transforming How New Medicines Flow to Patients. Darden Business Publishing Cases, 1, 1-25.Takahashi, K., & Yamanaka, S. (2006). Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell, 126(4), 663-676.Takahashi, K., & Yamanaka, S. (2013). Induced pluripotent stem cells in medicine and biology. Development, 140(12), 2457-2461.Teece, D. J. (1986). Profiting from technological innovation: Implications for integration, collaboration, licensing and public policy. Research policy, 15(6), 285-305.Teece, D. J. (2006). Reflections on “Profiting from Innovation”. Research policy, 35, 1131-1146.Teece, D. J. (2018). Profiting from innovation in the digital economy: Enabling technologies, standards, and licensing models in the wireless world. Research policy, 47(8), 1367-1387.Thomson, J. A., Itskovitz-Eldor, J., Shapiro, S. S., Waknitz, M. A., Swiergiel, J. J., Marshall, V. S., & Jones, J. M. (1998). Embryonic stem cell lines derived from human blastocysts. Science, 282(5391), 1145-1147.Utterback, J. M., & Suárez, F. F. (1993). Innovation, competition, and industry structure. Research policy, 22(1), 1-21.Vulto, A., & Jaquez, O. (2017). The process defines the product: what really matters in biosimilar design and production? Rheumatology (Oxford, England), 56, iv14-iv29.Waldman, A. D., Fritz, J. M., & Lenardo, M. J. (2020). A guide to cancer immunotherapy: from T cell basic science to clinical practice. Nature Reviews Immunology, 20(11), 651-668.Yu, J., Vodyanik, M. A., Smuga-Otto, K., Antosiewicz-Bourget, J., Frane, J. L., Tian, S., . . . Thomson, J. A. (2007). Induced pluripotent stem cell lines derived from human somatic cells. Science, 318(5858), 1917-1920.中文文獻王兆儀、林意筑. (2018). 細胞及基因治療產品管理之立法探討. 全國律師, 22(5), 33-38.孫世昌, & 劉憶成. (2010). 我國細胞治療產品法規範初探－以美歐法規範爲借鏡. 科技法律透析, 22(8), 46-62.殷本惠、劉宗榮. (2019). 細胞治療之細胞品質要求與細胞製備場所管理重點. 生物醫學, 第十二卷(第二期), 59.高尚志、林致凡、劉雅芳. (2020). 台灣特管辦法通過之免疫細胞治療. Taiwan Mdeical Journal, 63(4).蔡孟庭. (2020). 人類細胞治療產品臨床試驗法規及審查效率分析. 當代醫藥法規月刊, 114, 1-9.簡文斌. (2019). 國際基因治療產品開發研究與最新非臨床藥毒理法規科學審查考量. 當代醫藥法規月刊, 106, 1-14.書籍Scott, W. R., Ruef, M., Mendel, P. J., & Caronna, C. A. (2000). Institutional change and healthcare organizations: From professional dominance to managed care: University of Chicago Press.Yu, J., & Thomson, J. A. (2009). Chapter 37 - Induced Pluripotent Stem Cell Derivation. In R. Lanza, J. Gearhart, B. Hogan, D. Melton, R. Pedersen, E. D. Thomas, J. Thomson, & I. Wilmut (Eds.), Essentials of Stem Cell Biology (Second Edition) (pp. 329-337). San Diego: Academic Press.財團法人生物技術開發中心. (2020). 醫藥產業年鑑. 台北: 財團法人生物技術開發中心碩士論文薛碧玲. (2007). 製藥產業專業分工與新興經營模式探討. 國立臺灣大學 描述 碩士
國立政治大學
科技管理與智慧財產研究所
108364121資料來源 http://thesis.lib.nccu.edu.tw/record/#G0108364121 資料類型 thesis dc.contributor.advisor 許牧彥 zh_TW dc.contributor.advisor Hsu, Mu-Yen en_US dc.contributor.author (Authors) 黃柏穎 zh_TW dc.contributor.author (Authors) Huang, Po-Ying en_US dc.creator (作者) 黃柏穎 zh_TW dc.creator (作者) Huang, Po-Ying en_US dc.date (日期) 2022 en_US dc.date.accessioned 1-Aug-2022 18:51:53 (UTC+8) - dc.date.available 1-Aug-2022 18:51:53 (UTC+8) - dc.date.issued (上傳時間) 1-Aug-2022 18:51:53 (UTC+8) - dc.identifier (Other Identifiers) G0108364121 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/141358 - 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) 108364121 zh_TW dc.description.abstract (摘要) 隨著生物技術、基因工程等科學的進步下，以細胞、基因、組織工程作為治療方法的再生醫學是21世紀醫藥產業重要的發展方向。與過往醫藥產品因技術特性不同，造就了產業有可能出現不同的機會。如此的新興產業中，台灣企業可以扮演什麼樣的角色以及有哪些創新獲利的機會是本研究想了解的。產業演化的動態過程中，一項創新的科技從發明到商業化的路程中，企業必須要設法將科技創新商業化後的價值獲取，這是Teece於1986年所發表的「從創新中獲利」所關注的重點。Jacobides於2006年的研究提出產業架構觀點擴展了Teece的論述，企業能否獲取價值是受到外部影響因素而不斷改變產業內的分工方式以及價值分配的方式。企業可以透過佔有產業中某些重要的節點，成為「關鍵節點」形成架構優勢，而有更好價值獲取的機會。因此本研究想以產業層級的觀點，分析再生醫學產業的外部影響因素來了解再生醫學的產業架構在重新建構的過程中，有哪一些新的關鍵節點。接著再以台灣本土企業做為個案研究標的，分析企業是如何掌握關鍵節點，而有創新獲利的機會。透過本研究的分析與討論獲得以下兩點結論：一、 再生醫學產業與以往的醫藥產業不同，若要佔有產業最多的價值，不能僅依靠專有權制度的佈建，需要透過互補性資產的配置才能夠達成。需要以治療中心以及患者為中心來設計流程，流程設計越完善之企業越能夠掌握產業的架構。二、 互補企業投資的互補性資產應是位在整個製造流程中所涉及到的資源，如：耗材、培養基、自動化設備、監控流程系統以及原料的整合等，能因此提高與創新者的互補程度以及降低互補資產的移動性。 zh_TW dc.description.abstract (摘要) Cell, gene, and tissue engineering as treatment methods are an important direction for the pharmaceutical industry in the 21st century, it makes patients have a new hope to cure their disease, we call it “Regenerative medicine”. Different from small molecule drugs due to their technical characteristics, the industry may have different opportunities. In such an emerging industry, what role can Taiwan’s local companies play, and is there any new opportunities that can let the company capture their value from the innovation, these are the key issue in this study we would like to find out.During the industry evolution dynamic process, how to capture the value from innovation is a core question that was explored by David J. Teece in Journal of Research Policy, 1986; also known as the “Profiting from innovation”. Jacobides` research in 2006 extended Teece`s argument by proposing an “Industrial Architecture” perspective. Whether a firm can capture value is affected by external factors that constantly change the division of labor and value distribution. Firm should control some important interface in the value chain, then become the "Bottlenecks" in the industry, to create “architectural advantage” and have better opportunities to capture value.Base on previous literatures, first, this study will analyze the external factors of the Regenerative medicine industry to understand what the industrial architecture would like, and where are the bottlenecks in the Regenerative medicine industry. Second, I will use Taiwan`s local companies as a case study, to find out how Taiwan companies occupy the bottlenecks and capture their value.This study attained two research results：1. Regenerative medicine industry is different from the pharmaceutical industry we have known before. In order to capture the value of the industry, it cannot only rely on the legal instruments but can be achieved through the complementary assets. The treatment process needs to design around the treatment center and patient. The more complete treatment process design, the better value firm can capture.2. Complementary assets investment should be involved in the entire manufacturing process, such as consumables, culture medium, automation equipment, monitoring system, and the integration of raw materials, etc., which can improve the complementarity with innovators and reduce the mobility of complementary assets. en_US dc.description.tableofcontents 第一章 緒論................................................8第一節 研究背景與動機.......................................8第二節 研究目的與問題......................................10第二章 文獻探討...........................................11第一節 從創新中獲利(Profiting from Innovation, PFI).......11第二節 產業架構...........................................16第三節 文獻探討總結.......................................24第三章 研究方法...........................................25第一節 研究架構...........................................25第二節 研究設計...........................................26第三節 資料蒐集方式.......................................27第四節 研究限制...........................................28第四章 再生醫學產業架構分析................................29第一節 醫藥產業的專業分工..................................29第二節 再生醫學產業發展背景................................33第三節 再生醫學各領域介紹..................................35第四節 產業外部影響因素分析................................48第五節 產業架構中的關鍵節點................................76第五章 個案分析...........................................78第一節 長聖國際生技股份有限公司............................78第二節 賽昂生醫...........................................85第三節 三顧股份有限公司....................................88第四節 創新獲利策略.......................................93第六章 結論與建議.........................................95第一節 研究發現...........................................95第二節 研究結論與建議.....................................99參考文獻.................................................103 zh_TW dc.format.extent 5822237 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0108364121 en_US dc.subject (關鍵詞) 再生醫學 zh_TW dc.subject (關鍵詞) 從創新中獲利 zh_TW dc.subject (關鍵詞) 產業架構 zh_TW dc.subject (關鍵詞) 關鍵節點 zh_TW dc.subject (關鍵詞) Regenerative medicine en_US dc.subject (關鍵詞) Profiting from Innovation en_US dc.subject (關鍵詞) Industrial architecture en_US dc.subject (關鍵詞) Bottlenecks en_US dc.title (題名) 台灣再生醫學廠商的創新獲利策略 zh_TW dc.title (題名) Strategies of Profiting from Innovation: The Case Studies of Taiwan Regenerative Medicine Companies en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 英文文獻Akerlof, G. A. (1970). The Market for "Lemons": Quality Uncertainty and the Market Mechanism. The Quarterly Journal of Economics, 84(3), 488-500.Arthur, W. B. (1996). Increasing returns and the new world of business. Harv Bus Rev, 74(4), 100-109.Baldwin, C. Y. (2015). Bottlenecks, modules and dynamic architectural capabilities. Harvard Business School Finance Working Paper(15-028).Bulcha, J. T., Wang, Y., Ma, H., Tai, P. W. L., & Gao, G. (2021). Viral vector platforms within the gene therapy landscape. Signal Transduction and Targeted Therapy, 6(1), 53.Dwivedi, A., Karulkar, A., Ghosh, S., Rafiq, A., & Purwar, R. (2019). Lymphocytes in Cellular Therapy: Functional Regulation of CAR T Cells. Frontiers in Immunology, 9(3180).Forostyak, O., Dayanithi, G., & Forostyak, S. (2016). CNS Regenerative Medicine and Stem Cells. OPERA MEDICA ET PHYSIOLOGICA, January 2016(1), 69-76.Fu, Z., Zhou, J., Chen, R., Jin, Y., Ni, T., Qian, L., & Xiao, C. (2020). 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