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題名 藥物開發和診斷開發的投資回報率之間的比較研究/以抗體藥物與抗體應用檢驗為例
ROI Comparison Study Between Drug Development and Diagnostic Development/ Antibody As An Example.作者 劉昌昇
Johnson Liu貢獻者 陳桂恒
Keith Chan
劉昌昇
Johnson Liu關鍵詞 抗體藥物
體外檢測
分子檢測
投資回報率
淨現值
antibody medicine
IVD
molecular diagnostic
ROI
NPV日期 2012 上傳時間 2-九月-2013 15:34:34 (UTC+8) 摘要 近幾年的生物技術逐漸成熟，讓全球的生技產業逐漸蓬勃發展，我國也不例外地將其列為重點產業之一。然而在近期國際間主流的藥物大多為生物製藥，大多是抗體以及重組蛋白的產品，而這些藥物主要都是利用找尋到人體的生物標誌(biomarker)後所設計出來，因此從而衍生出個人化醫療藥物的新概念，隨之發展出許多利用相同原理的檢測產品，因此探究此類檢測產品與藥品的生物技術的根源，大多是同源的。而通常在發展新穎、創新技術的單位大多是學術研發單位，在考慮商業化的方向時，到底該考慮那些因素？以抗體為例，是該發展成藥物，還是該發展成體外檢測產品，會對於該技術而言有最佳成功率及最好的投資回報？本文就歷年來的雙方產業已有的文獻加以收集，並分析市場資訊及報酬率，並利用現有的市場抗體Herceptin與伴隨藥物的分子檢測產品Herceptest為例子，進行淨現值的運算。其中整理文獻結果發現：同樣是10年的NPV，是以抗體藥的12.6億美元較高 (分子檢測10年NPV為1480萬美元)，但是雙方的投入的成本相當懸殊，發展藥品的入需要的成本為22.67億美元，檢測產品只需要4500萬美元，相差相當懸殊。但NPV/cost還是以投資藥業來得高(0.56 vs. 0.32)，其原因主要來自於藥物發展是一個較成熟的市場，分子檢測產品是一個新的產品，仍有許多層面的問題，如：付款者、醫生、相關利益關係供應商、產品信賴度等問題，造成市場發展較為遲緩。 然而廠商是否該投入藥物產業或者是檢測產業，不應該僅只由獲利面來觀看，而應由全面的檢視團隊的能力，利用｢計畫決策衡量評分表(Project decision measure score sheet)」來對預投入的產品方向、疾病作評估，才能夠做出最適合及最有可能成功的技術商業化方向。
Most blockbuster medicine in recent years is biopharmaceutical, especially made for antibody and recombinant protein products. These products are designed from human biomarkers and they drive a new idea of “Personalized Medicine.” When scientists in a laboratory of universities or research institutes establish a novel antibody, what is the key factor to decide the way of commercialization? What is the best moneymaker to the investment, the therapeutic antibody or the vitro diagnostic? The topic is aiming at the expense and the ROI (return of investment) comparison between the development of antibody medicine and molecular diagnostic. The published papers and the market information are collected and analyzed the ROI of two different product directions by Net Present Value (NPV) and the costs. The therapeutic antibody, Herceptin, and its companion diagnostic products, Herceptest, are given as examples to calculate the NPV and the Internal Rate of Return (IRR); some results has been published: the ten-year NPV of antibody medicine is 1.26 billion, higher than 14.8 million, the NPV of molecular diagnostic. However, the cost of antibody medicine is 2.267 billion, much higher than the diagnostic, 45 million. The returning ratio of antibody medicine (NPV/cost=0.56) is also higher than diagnostic (0.32). The molecular diagnostic products might be novel for traditional diagnostic technology, and thus, the pharmacy business seems to be a better choice. Also, lots of challenges need to be overcome for diagnostic, such as payer coverage, physicians’ habits, relevant beneficial suppliers, and product reliabilities. They all slow down the market to grow. The ROI cannot be the only factor for a company to decide the program practicability. 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國立政治大學
科技管理研究所
100359034
101資料來源 http://thesis.lib.nccu.edu.tw/record/#G0100359034 資料類型 thesis dc.contributor.advisor 陳桂恒 zh_TW dc.contributor.advisor Keith Chan en_US dc.contributor.author (作者) 劉昌昇 zh_TW dc.contributor.author (作者) Johnson Liu en_US dc.creator (作者) 劉昌昇 zh_TW dc.creator (作者) Johnson Liu en_US dc.date (日期) 2012 en_US dc.date.accessioned 2-九月-2013 15:34:34 (UTC+8) - dc.date.available 2-九月-2013 15:34:34 (UTC+8) - dc.date.issued (上傳時間) 2-九月-2013 15:34:34 (UTC+8) - dc.identifier (其他 識別碼) G0100359034 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/59276 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 科技管理研究所 zh_TW dc.description (描述) 100359034 zh_TW dc.description (描述) 101 zh_TW dc.description.abstract (摘要) 近幾年的生物技術逐漸成熟，讓全球的生技產業逐漸蓬勃發展，我國也不例外地將其列為重點產業之一。然而在近期國際間主流的藥物大多為生物製藥，大多是抗體以及重組蛋白的產品，而這些藥物主要都是利用找尋到人體的生物標誌(biomarker)後所設計出來，因此從而衍生出個人化醫療藥物的新概念，隨之發展出許多利用相同原理的檢測產品，因此探究此類檢測產品與藥品的生物技術的根源，大多是同源的。而通常在發展新穎、創新技術的單位大多是學術研發單位，在考慮商業化的方向時，到底該考慮那些因素？以抗體為例，是該發展成藥物，還是該發展成體外檢測產品，會對於該技術而言有最佳成功率及最好的投資回報？本文就歷年來的雙方產業已有的文獻加以收集，並分析市場資訊及報酬率，並利用現有的市場抗體Herceptin與伴隨藥物的分子檢測產品Herceptest為例子，進行淨現值的運算。其中整理文獻結果發現：同樣是10年的NPV，是以抗體藥的12.6億美元較高 (分子檢測10年NPV為1480萬美元)，但是雙方的投入的成本相當懸殊，發展藥品的入需要的成本為22.67億美元，檢測產品只需要4500萬美元，相差相當懸殊。但NPV/cost還是以投資藥業來得高(0.56 vs. 0.32)，其原因主要來自於藥物發展是一個較成熟的市場，分子檢測產品是一個新的產品，仍有許多層面的問題，如：付款者、醫生、相關利益關係供應商、產品信賴度等問題，造成市場發展較為遲緩。 然而廠商是否該投入藥物產業或者是檢測產業，不應該僅只由獲利面來觀看，而應由全面的檢視團隊的能力，利用｢計畫決策衡量評分表(Project decision measure score sheet)」來對預投入的產品方向、疾病作評估，才能夠做出最適合及最有可能成功的技術商業化方向。 zh_TW dc.description.abstract (摘要) Most blockbuster medicine in recent years is biopharmaceutical, especially made for antibody and recombinant protein products. These products are designed from human biomarkers and they drive a new idea of “Personalized Medicine.” When scientists in a laboratory of universities or research institutes establish a novel antibody, what is the key factor to decide the way of commercialization? What is the best moneymaker to the investment, the therapeutic antibody or the vitro diagnostic? The topic is aiming at the expense and the ROI (return of investment) comparison between the development of antibody medicine and molecular diagnostic. The published papers and the market information are collected and analyzed the ROI of two different product directions by Net Present Value (NPV) and the costs. The therapeutic antibody, Herceptin, and its companion diagnostic products, Herceptest, are given as examples to calculate the NPV and the Internal Rate of Return (IRR); some results has been published: the ten-year NPV of antibody medicine is 1.26 billion, higher than 14.8 million, the NPV of molecular diagnostic. However, the cost of antibody medicine is 2.267 billion, much higher than the diagnostic, 45 million. The returning ratio of antibody medicine (NPV/cost=0.56) is also higher than diagnostic (0.32). The molecular diagnostic products might be novel for traditional diagnostic technology, and thus, the pharmacy business seems to be a better choice. Also, lots of challenges need to be overcome for diagnostic, such as payer coverage, physicians’ habits, relevant beneficial suppliers, and product reliabilities. They all slow down the market to grow. The ROI cannot be the only factor for a company to decide the program practicability. The operational team should be evaluated comprehensively in the first place, and then use “Project Decision Measure Score Sheet” to measure the targeted product and disease is highly advised and believed to be helpful for the commercialization. en_US dc.description.tableofcontents 摘要 iAbstract ii圖目錄 vi表目錄 viii第一章 緒論 1第一節 研究動機與目的 1第二節 研究問題 3第三節 研究範圍 6第四節 論文架構 8第二章 相關名詞與技術介紹 9第一節 抗體藥物相關介紹 9一、 抗體定義 9二、 單株抗體原理與目前技術發展 11第二節 抗體體外檢測應用相關介紹 13一、抗體技術成熟的應用於： 15二、抗體技術應用於新興領域： 16第三章 文獻與市場資料蒐集 18第一節 理論文獻蒐集 18一、 投資回報 18二、 藥物發展與體外檢測發展 22三、 賽局理論 32第二節 市場資料蒐集 42一、 抗體藥物市場 42二、 抗體於體外診斷市場應用 45第四章 數據分析結果與討論 47第一節 抗體技術於藥物發展與體外檢測技術發展之投資回報率 47一、 抗體藥物 47二、 抗體應用之體外檢測 47三、 以抗腫瘤藥物以及伴隨檢測(分子檢測)為模型計算 48第二節 伴隨檢測獲利遲緩的背後因素討論 57第三節 伴隨檢測市場上的賽局困局與可能的解決方式 59一、賽局的困境： 59二、可能的解決方式： 60第四節 台灣廠商狀況與可行的著力點 62一、 抗體藥物 65二、 抗體檢測應用：分子檢測，台灣廠商以基因序列產品為主 68三、 台灣廠商未來可能的利基 69第五章 結論與建議 72參考資料： 83附錄A. Herceptin抗體藥物預估現值計算模型 91附錄B. Herceptest分子檢測預估現值計算模型 93 zh_TW dc.format.extent 2727944 bytes - dc.format.mimetype application/pdf - dc.language.iso en_US - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0100359034 en_US dc.subject (關鍵詞) 抗體藥物 zh_TW dc.subject (關鍵詞) 體外檢測 zh_TW dc.subject (關鍵詞) 分子檢測 zh_TW dc.subject (關鍵詞) 投資回報率 zh_TW dc.subject (關鍵詞) 淨現值 zh_TW dc.subject (關鍵詞) antibody medicine en_US dc.subject (關鍵詞) IVD en_US dc.subject (關鍵詞) molecular diagnostic en_US dc.subject (關鍵詞) ROI en_US dc.subject (關鍵詞) NPV en_US dc.title (題名) 藥物開發和診斷開發的投資回報率之間的比較研究/以抗體藥物與抗體應用檢驗為例 zh_TW dc.title (題名) ROI Comparison Study Between Drug Development and Diagnostic Development/ Antibody As An Example. en_US dc.type (資料類型) thesis en dc.relation.reference (參考文獻) 1 曹佳琪. 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