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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: 2013-09-02 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. 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.
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    描述: 碩士
    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
    顯示於類別:[科技管理研究所] 學位論文

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