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研究生: 蘇郁清
Yu-Chin Su
論文名稱: 台灣幹細胞治療藥業競爭策略之賽局分析
Application of Game Theory to Analyze the Competitive Strategies in Stem Cell Therapy Pharmaceutical Industry in Taiwan - The Case of Acute Ischemic Stroke Cell Therapy
指導教授: 張順教
Shun-Chiao Chang
口試委員: 劉文獻
Wen-Hsien Liu
李嘉林
Chia-Lin Lee
學位類別: 碩士
Master
系所名稱: 管理學院 - 企業管理系
Department of Business Administration
論文出版年: 2019
畢業學年度: 107
語文別: 中文
論文頁數: 61
中文關鍵詞: 賽局理論幹細胞產業新藥開發
外文關鍵詞: Game Theory, Stem Cell Therapeutics Industry, New Drug Development
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  • 本論文以急性缺血性中風幹細胞治療新藥開發為例,運用賽局模式為主要分析工具,探討在動態且競爭激烈的幹細胞治療藥業的競爭策略及其影響。本論文著墨於M公司因應特管辦法的策略組合以及潛在競爭者的競合策略,針對特管辦法開放細胞治療所衍伸的1.細胞製劑供應市場以及2.細胞治療為醫療技術對新藥開發的衝擊提出見解。經由賽局分析利弊得失, M公司應活化原有GTP廠房的產能,拓展業務範圍,在各適應症的細胞製劑供應市場佔有一席之地。同時,應莫忘初衷,加速幹細胞新藥開發,如此一來,細胞治療無論是醫療技術或是新藥,M公司皆能在急性中風及慢性中風的細胞治療上成為主導者,為病患福祉努力。在面對潛在競爭者,M公司對細胞產品有高度信心,應積極與競爭對手形成聯盟,攜手打下中風幹細胞治療市場,創造雙贏的局面。


    This thesis conducts research on the stem cell drug development of acute ischemic stroke case study via game theory which explores the competitive strategy and the impact in the highly dynamic and competitive stem cell therapeutics industry. Focusing on the strategic combination in new regulations and the competition strategy with potential competitors. By analyzing pros and cons and calculating the payoff in each game, M Pharma should provide abound cell therapeutic drugs via activating the capacity of GTP plant`s production and expanding the business scope. Meanwhile, M Pharma should keep the original intention accelerating the development of stem cell drug. Therefore, M Pharma will be a leader in stroke treatment both in medical technology and new -drug territories. Moreover, M Pharma is confident with cell therapy products. Facing to potential competitors, M Pharma needs to form alliance with competitors and lead the Stem cell therapy in stroke treatment market and create a win-win business environment.

    中文摘要----------------------------------------------------------------------------------------Ⅰ 英文摘要----------------------------------------------------------------------------------------Ⅱ 誌謝----------------------------------------------------------------------------------------------Ⅲ 目錄----------------------------------------------------------------------------------------------IV 圖表索引----------------------------------------------------------------------------------------VI 第一章 緒論-------------------------------------------------------------------------------------1 1.1 背景與動機-----------------------------------------------------------------------------1 1.2 研究目的--------------------------------------------------------------------------------2 1.3 研究流程--------------------------------------------------------------------------------2 第二章 研究方法-------------------------------------------------------------------------------4 2.1 賽局理論--------------------------------------------------------------------------------4 2.1.1 構成賽局的要素---------------------------------------------------------------5 2.1.2 賽局的分類---------------------------------------------------------------------6 第三章 幹細胞藥業分析----------------------------------------------------------------------8 3.1 全球產業發展與趨勢-----------------------------------------------------------------8 3.2 幹細胞產品及市場成長性-----------------------------------------------------------9 3.3 幹細胞產業類別與特性-------------------------------------------------------------10 3.4 幹細胞新藥開發應用現況及類別分析-------------------------------------------12 3.5 台灣幹細胞治療管理沿革----------------------------------------------------------15 3.6 台灣現行幹細胞治療管理辦法----------------------------------------------------16 第四章 個案公司策略------------------------------------------------------------------------21 4.1 個案經營概況-------------------------------------------------------------------------21 4.2 個案潛在危機-------------------------------------------------------------------------23 4.3 個案因應「特管辦法」的競爭策略-------------------------------------------------24 4.3.1 GTP生產細胞製劑的市場大餅-------------------------------------------25 4.3.2 若特管辦法開放急性中風的細胞治療----------------------------------31 4.4 個案與潛在競爭者的競合策略----------------------------------------------------37 第五章 結論與建議---------------------------------------------------------------------------44 5.1 因應特管辦法的策略組合-分食GTP生產細胞製劑的大餅-----------------44 5.2 因應特管辦法的策略組合-一口吃下中風治療大餅---------------------------46 5.3 潛在競爭者的競合策略–和競爭對手合作--------------------------------------47 第六章 參考文獻------------------------------------------------------------------------------49

    網路資訊:
    1. 衛生福利部食品藥物管理署。Retrieved from https://www.fda.gov.tw/
    2. 台灣腦中風學會。Retrieved from https://www.stroke.org.tw/
    3. Anterogen. Retrieved from http://anterogen.com/main/en/
    4. Athersys. Retrieved from https://www.athersys.com/
    5. ClinicalTrials. Retrieved from https://clinicaltrials.gov/
    6. CoreStem. Retrieved from http://corestem.com/en/
    7. HEALIOS K.K. Retrieved from https://www.healios.co.jp/en/
    8. JCR Pharmaceutical. Retrieved from http://www.jcrpharm.co.jp/en/
    9. Medipost. Retrieved from http://www.medi-post.com/
    10. Osiris. Retrieved from http://www.osiris.com/
    11. PHARMICELL. Retrieved from http://www.pharmicell.com/
    12. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/
    13. World Health Organization. Retrieved from http://www.who.int/en/
    14. 日本NHK (2012). 600公里的危機. Retrieved from https://www.youtube.com/watch?v=HOeAKuzF1h0
    15. Visiongain (2017). Global Stem Cell Technologies and Applications Market 2017-2027. Retrieved from https://www.visiongain.com/report/global-stem-cell-technologies-and-applications-market-2017-2027/
    16. Technavio (2018). Global Stem Cell Therapy Market 2018-2022. Retrieved from https://www.businesswire.com/news/home/20181130005493/en/
    17. Grand View Research (2018). Cell Therapy Market Size, Share, & Trends Analysis Report by Use (Clinical, Research), By Type (Stem & Non-stem Cells) By Therapy Type (Autologous, Allogenic), By Region, And Segment Forecasts, 2018-2025. Retrieved from https://www.grandviewresearch.com/industry-analysis/cell-therapy-market
    18. Medgadget (2018). Stem Cell Therapy Market Synopsis, Revenue, Top Industry Players, Upcoming Trends, Demand, Business Analysis and Forecast to 2023. Retrieved from https://www.medgadget.com/2018/12/stem-cell-therapy-market-synopsis-revenue-top-industry-players-upcoming-trends-demand-business-analysis-and-forecast-to-2023.html
    19. Visiongain (2019). Stem Cell Technologies and Applications Will Generate $15.8bn in 2019, A New Visiongain Analysis Predicts. Retrieved from https://www.visiongain.com/stem-cell-technologies-and-applications-will-generate-15-8bn-in-2019-a-new-visiongain-analysis-predicts/
    20. Reuters (2019). Stem Cell Therapy Market 2019 Global Trends, Size, Competition, Facts, Synopsis, Demand, Increasing Awareness, Impressive Growth, Segmentation, Manufacturers Analysis by 2024. Retrieved from https://www.reuters.com/brandfeatures/venture-capital/article?id=80359
    21. BioPharma Report (2019). Cell Therapy Market to Triple in Size by 2025. Retrieved from https://www.biopharma-reporter.com/Article/2019/03/04/Cell-therapy-market-to-triple-in-size-by-2025
    中文文獻:
    1. 張順教。(2015) 賽局與策略管理個案分析
    2. 行政院衛生署食品藥物管理局。(2011) 體細胞及基因治療臨床試驗計畫申請作業流程(草案) 。
    3. 行政院衛生署食品藥物管理局。(2014) 人類細胞治療產品臨床試驗申請作業及審查基準。
    4. 行政院衛生署食品藥物管理局。(2015) 人類細胞治療產品查驗登記審查基準。
    5. 行政院衛生署食品藥物管理局。(2018) 再生醫療製劑管理條例(草案) 。
    6. 行政院衛生署食品藥物管理局。(2018) 特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法。

    英文文獻:
    1. John Von Neumann and Oskar Morgenstern (1944) Theory of Games and Economic Behavior.
    2. John F. Nash (1950) Equilibrium points in n-person games. PNAS 36 (1): 48-49
    3. John F. Nash (1951) Non-cooperative Games. Annals of Mathematics 54(2): 286-295
    4. Selten. R. (1965) Spieltheoretische Behandlung eines Oligopolmodells mit Nachfrageträgheit – Teil I Bestimmung des dynamischen Preisgleichgewichts. Zeitschrift für die gesamte Staatswissenschaft 121: 301–324.
    5. Harsanyi J. (1967) Games with incomplete information played by “Bayesian” players, I–III Part I. The basic model. Management science 14(3): 167-261.
    6. Reinhard Selten (1975) Re-examination of the Perfectness Concept for Equilibrium Points in Extensive Games. International Journal of Game Theory 4: 25–55.
    7. David M. Kreps and Robert Wilson (1982). Sequential Equilibria. Econometrica 50 (4): 863-894
    8. Valery L Feigin, Carlene MM Lawes, Derrick A Bennett, Craig S Anderson (2003) Stroke epidemiology: a review of population-based studies of incidence, prevalence, and case-fatality in the late 20th century. Lancet Neurology 2:43-53.
    9. Boris V. Afanasyev, Elena E. Elstner, Axel R. Zander (2009) A. J. Friedenstein, founder of the mesenchymal stem cell concept. Cellular Therapy and Transplantation 1(3):35-37
    10. Michael Hay, David W Thomas, John L Craighead, Celia Economides, Jesse Rosenthal (2014) Clinical development success rates for investigational drugs. Nature Biotechnology 32, 40–51
    11. David C Hess, Lawrence R Wechsler, Wayne M Clark, Sean I Savitz, Gary A Ford, David Chiu et al. (2017) Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol.16(5):360-368

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