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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-Sep-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. 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.
參考文獻 1 曹佳琪. (2013,Last viewed: 2013/6/30). 今年來績效 生技基金漲逾三成, from http://money.udn.com/fund/storypage.jsp?f_MAIN_ID=339&f_SUB_ID=4199&f_ART_ID=291362
2 Anonymous (2012) 生技產業白皮書,11, Published by: 台灣經濟部工業局, from http://www.bpipo.org.tw/download/pdf/2012/Biotechnology_Industry_in_Taiwan_2012.pdf
3 John Kell. (2010,Last viewed: 2013/6/20). Pfizer to Acquire Veterinary Diagnostics Firm, from http://online.wsj.com/article/SB10001424052970203525404576049754208683440.html
4 Anonymous. (2013,Last viewed: 2013/6/20). Dako to Collaborate with Pfizer on Companion Diagnostics, from http://www.agilent.com/about/newsroom/presrel/2013/12feb-dk13002.html
5 劉翠玲. (2010). 前瞻醫藥生技,未來發展趨勢. 台灣經濟研究月刊, 33, 21-28.
6 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢驗及醫療之商機,I-III, Published by: 財團法人生物技術開發中心, from
7 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢測及醫療之商機,15-17, Published by: 財團法人生物技術開發中心, from
8 Gary Walsh. (2010). Biopharceutical benmarks 2010. Nature biotechnology, 28(9), 917-924.
9 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢測及醫療之商機,22, Published by: 財團法人生物技術開發中心, from
10 Anonymous. (Last viewed: 2013/6/20). HercepTest TM Dako, from http://www.dako.com/dist/ar39/p101510/prod_products.htm?setCountry=true&purl=ar39/p101510/prod_products.htm?undefined&submit=Accept%20country
11 Anonymous. (2013,Last viewed: 2013/6/28). FDA Approves Dako Assays as CDx for Genentech Breast Cancer Drug, from http://www.genomeweb.com/clinical-genomics/fda-approves-dako-assays-cdx-genentech-breast-cancer-drug
12 Stephen Little. (2008,Last viewed: 2013/6/12). Business opportunities and commercial challenges in personalized medicine, from http://www.ivdtechnology.com/article/business-opportunities-and-commercial-challenges-personalized-medicine
13 Maureen Kingsley. (2013,Last viewed: 2013/6/5). Top 10 Molecular Diagnostics Companies, from http://www.ivdtechnology.com/article/top-10-molecular-diagnostics-companies-0
14 Sara Whitmore Kamran Zamanian. (2012,Last viewed: 2013/6/10). Our Most-Read Story of 2012: U.S. IVD Market to Exceed $9.5 Billion by 2017, from http://www.ivdtechnology.com/article/us-ivd-market-exceed-95-billion-2017
15 Romain Prieur Frederick Eibl. (2011,Last viewed: 203/6/5). Tools for Molecular Diagnostics, from http://www.ivdtechnology.com/article/tools-molecular-diagnostics-11
16 Pwc (2013) From vision to decision pharma 2020, Published by: PWC, from www.pwc.com/pharma2020
17 Christine Lindgren Debbie Paul (2013) World Preview 2013, outlook to 2018- Retuning to growth, Published by: EValuatePharma, from www.evaluategroup.com/wp2013
18 Eric David Mark Beards, Jerel Davis, Aine Denari, Amar Desai, Michael Edwards, Matthias Evers (2010) Invention reinvented-Mckinsey perspectives on pharmaceutical R&D, Published by: McKisey&Company, from
19 Jim Kling. (2007). Diagnosis or drug? EMBO reports, 8, 903-906.
20 Anonymous. (Last viewed: 2013/5/14). 單株抗體, from http://www2.cmu.edu.tw/~rx50c/Biotechnology_Management/20081203.pdf
21 G. Kohler, & C. Milstein. (1975). Continuous cultures of fused cells secreting antibody of predefined specificity. Nature, 256(5517), 495-497.
22 Nobel Prize Award Ceremony. (1984,Last viewed: 2013/03/04). The Nobel Prize in Physiology or Medicine 1984: Niels K. Jerne ,Georges J.F. Köhler ,César Milstein, from http://www.nobelprize.org/nobel_prizes/medicine/laureates/1984/#
23 Anonymous. (Last viewed: 2013/6/10). 癌症治療用抗體新藥, from http://www.glyconex.com.tw/products.php
24 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢測及醫療之商機,11-38, Published by: 財團法人生物技術開發中心, from
25 Anonymous. (2006). 台灣醫療器材查驗登記審查準則 TW: TFDA Retrieved from http://www.fda.gov.tw/TC/site.aspx?sid=39.
26 Anonymous. (Last viewed: 2013/4/10). Point-of-care testing Wikipedia, from http://en.wikipedia.org/wiki/Point-of-care_testing
27 Anonymous. (2008,Last viewed: 2013/4/20). Guidance for Industry-E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories, from http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm129286.htm
28 Webmaster. (Last viewed: 2013/4/26). 生物標誌蛋白質體學之產業觀, from http://www.atit.org.tw/ATIT/files/asset_pdf/74e8efb1bbabca58e7461aa16d9159d1/13-6-8.pdf
29 Anonymous. (1998,Last viewed: 2013/6/2). Herceptin (trastuzumab) Label on FDA from http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5256lbl.pdf
30 Grier C. I.; Nagalingam Lin, Sev V. (2000). CIM justification and optimisation.p.
36, London: Taylor & Francis.
31 Akbar Javadian Kootanaee. (2012,Last viewed: 2013/7/9). Weighted average cost of capital-A Comparison of Performance Measures for Finding the Best Measure of Business Entity Performance., from http://en.wikipedia.org/wiki/Weighted_average_cost_of_capital
32 Alex S. Baras and Kevin A. Schulman Aris I. Baras. (2012). Drug devlopment risk and the cost of capital. Nature Reviews Drug Discovery, Published online.
33 Anonymous. (2010,Last viewed: 2013/7/9). 資本資產定價模型CAMP, from http://wiki.mbalib.com/zh-tw/CAPM%E6%A8%A1%E5%9E%8B
34 Stephanie Van Bebber and Amalia M. Issa Kathryn A. Phillips. (2006). Diagnostics and biomarker devlipomet: priming the pieline. Nature Reviews Drug Discovery, 5, 463-469.
35 Daniel S. Mytelka Steven M. Paul, Christopher T. Dunwiddie, Charles C. Persinger, Bernard H. Munos, Stacy R. Lindborg and Aaron L. Schacht. (2010). How to improve R&D productivity: the pharmaceutical industry`s grand challenge. Nature Reviews Drug Discovery, 9, 203-214.
36 Tony Tramontin and Rodney Zemmel Eric David. (2009). Pharmaceutical R&D: The road to positve returns. Nature Reviews Drug Discovery, 8, 609-610.
37 Len Fisher 林俊宏 譯. (2009). 剪刀 石頭 布-生活中的賽局理論.p.116-120: 天下文化.
38 Joseph A. Dimasi and Henry G Grabowski. (2007). The cost of biopharmaceutical R&D: Is biotech different? Manage. Dexis. Exon. , 28, 469-479.
39 Joseph a Dimasi K. I. Kaitin. (2011). Pharmaceutical Innovation in the 21st Century: New Drug Approvals in the First Decade,2000-2009. Cinical pharmacology & therapeutics, 89(2), 183-188.
40 Laura Furstenthal Jerel C. Davis. (2009). The microeconomics of personalized medicine: today`s challenge and tomorrow`s promise. Nature Reviews Drug Discovery, 8(4), 279-286.
41 E. Rasmusen. (1995,Last viewed: 2013/6/30). Game and Information, from http://zh.scribd.com/doc/21005253/An-Introduction-to-Game-Theory-Eric-Rasmusen
42 Eric R. (1989.). Games and Information: An Introduction to Game Theory: Cambridge.
43 李秀玉. (1999). 應用賽局理論分析我國薄膜電晶體液晶顯示器產業之競爭策略. 碩士論文, 國立交通大學.
44 Anonymous. (1998,Last viewed: 2013/6/27). Ultimatum game, from http://en.wikipedia.org/wiki/Ultimatum_game
45 Werner Güth. (1982). An experimental analysis of ultimatum bargaining. Journal of Economic Behavior & Organization, 3(4), 367.
46 謝淑貞. (1995). 賽局理論 台北: 雙葉書廊有限公司.
47 Anonymous. (2013,Last viewed: 2013/6/27). Dako, from http://www.dako.com/dist/index.htm
48 Anonymous. (2013,Last viewed: 2013/6/27). XDx company web site, from http://www.xdx.com/
49 Anonymous. (2013,Last viewed: 2013/6/27). Oncotype Dx, from http://www.oncotypedx.com/en-US/Home
50 William R Strohl and David M Knight. (2009). Discovery and development of biopharmaceuticals: current issues. Current opinion in Biotechnology, 20, 668-672.
51 Marketresearch.Com. (2012,Last viewed: 2012/6/28). Market Research Projects Antibody Drugs Market at $58 Billion by 2016, from http://finance.yahoo.com/news/market-research-projects-antibody-drugs-130800691.html
52 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢驗及醫療之商機,51-70, Published by: 財團法人生物技術開發中心, from
53 Anonymous. (2013,Last viewed: 2013/6/28). Deal struck over development of Herceptin biosimilar, from http://gabionline.net/Biosimilars/News/Deal-struck-over-development-of-Herceptin-biosimilar
54 Anonymous. (2013,Last viewed: 2013/6/14). Pfizer carrying out biosimilar trastuzumab trial in US, from http://www.gabionline.net/Biosimilars/Research/Pfizer-carrying-out-biosimilartrastuzumab-trial-in-US
55 Pwc Study. (2010,Last viewed: 2013/6/28). Biotech must retool business model, from http://www.accountingweb.co.uk/topic/technology/biotech-must-retool-business-model-says-pwc/460979
56 L Feldman Joseph a Dimasi, A Seckler and a Wilson. (2010). Trends in risks associated with new drug development: success rates for investigational drugs. Cinical pharmacology & therapeutics, 87(3), 272-277.
57 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢驗及醫療之商機,27-38, Published by: 財團法人生物技術開發中心, from
58 Raghuram Selvaraju (2012) Trovagene, Inc.-Rating: Buy, Published by: A. C. CORP., from http://www.trovagene.com/trovagene/media/Downloads/TROV-Initiation-Report-Aegis-Capital-Corp.pdf
59 Anonymous. (2013,Last viewed: 2013/7/12). Historical Product Sales Revenue-Theraputic Antibody, from http://pdl.com/royalty-revenue/historical-product-revenue/
60 Anonymous (2010) Oncology report 1119, Published by: Cowen/Scala, from http://oncology.healthace.com/111910/Oncology_Report_111910_S8.pdf
61 王緯書. (2010,Last viewed: 2010/6/30). 抗癌新藥：lapatinib, from http://cisc.twbbs.org/lifetype/index.php?op=ViewArticle&articleId=1866&blogId=1
62 劉憲. (2011,Last viewed: 2013/6/14). 乳癌治療新利器--談標靶治療, from http://www2.edah.org.tw/breastcenter/g/006.html
63 Anonymous (2011) GlaxoSmithKline: Tykerb Use in Adjuvant Breast Cancer Unlikely, Phase III Trials Fail; Consensus Sales Forecasts £550m By 2015 Too Optimistic, Published by: Deutsche-Bank/Clark, from http://oncology.healthace.com/120911/Oncology_Report_120911_S4.pdf
64 Anonymous. (2013,Last viewed: 2013/6/14). Gabi reprot: Roche does not see a threat from biosimilars until 2015, from http://gabionline.net/Biosimilars/News/Roche-does-not-see-a-threat-frombiosimilars-until-2015
65 Anonymous. (2013,Last viewed: 2013/6/14). Gabi report: Deal struck over development of Herceptin biosimilar, from http://gabionline.net/Biosimilars/News/Deal-struck-over-development-of-Herceptin-biosimilar
66 Anonymous. (2013,Last viewed: 2013/6/12). BioTrends Research group report: Biosimilar Versions of Monoclonal Antibodies for Cancer are Forecast to Garner Sales of $4.9 Billion, While the Branded Versions are Expected to Maintain Sales of $6.7 Billion Across the US, EU5, and Japanese Markets in 2021, from http://biotrends.com/News-and-Events/Press-Releases/A-New-Syndicated-Report-091912-(1)
67 Anonymous. (2010,Last viewed: 2013/7/10). STPI-科技產業市場報導：標靶藥物大躍進, from http://cdnet.stpi.narl.org.tw/techroom/market/bio/2010/bio_10_004.htm
68 Dermot Doherty. (2011,Last viewed: 2013/7/7). Roche Reduces Peak Sales Forecast for Avastin by 20 Percent as Sales Fall, from http://www.bloomberg.com/news/2011-02-02/roche-second-half-net-income-falls-on-costs-to-cut-jobs-franc-s-strength.html
69 Hector (2010) Roche: Avastin – $3B Peak Sales Opportunity for Prostate ($1.3M), Ovarian ($750M), and Gastric Cancers ($1.5M); 50% Probability of Launch in 2011,1-2, Published by: C. Suisse, from http://oncology.healthace.com/011410/Oncology_Report_011410_S2.pdf
70 Simon King. (2013,Last viewed: 2013/7/7). The Best Selling Drugs of All Time; Humira Joins The Elite, from http://www.forbes.com/sites/simonking/2013/01/28/the-best-selling-drugs-of-all-time-humira-joins-the-elite/
71 Kiran Meekings John Arrowsmith (2011) THOMSON REUTERS report: Implementing Drug Development Strategies: Maximising the Value of Pharmaceutical Assets Part 2, Published by: THOMSON-REUTERS, from http://business-review-webinars.com/webinar-slides/thomson-reuters-slides-25-10-2011.pdf
72 Eva Von Schaper. (2008,Last viewed: 2013/7/7). Merck KGaA Profit More Than Doubles on Erbitux Sales (Update1), from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=auuvVmVt1iVo
73 Anonymous. (2006,Last viewed: 2013/7/7). 主題：ERBITUX, 2015年ERBITUX將實現銷售額2.2億美元, from http://big5.39kf.com/my/tag_3_88a85a84a73a66a82a69/
74 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢驗及醫療之商機,38-47,102-121, Published by: 財團法人生物技術開發中心, from
75 杜蕙蓉、潘臆涵. (2011,Last viewed: 2013/7/1). 永昕TuNEX獲准3期臨床, from http://blog.xuite.net/flwlkv/blog/55578217-%E6%B0%B8%E6%98%95TuNEX%E7%8D%B2%E5%87%863%E6%9C%9F%E8%87%A8%E5%BA%8A
76 黃文奇. (2013,Last viewed: 2013/7/1). 東生華&永昕TuNEX 2015將上市 !! , from http://alveice.blogspot.tw/2013/01/2015.html
77 林宏文. (2012,Last viewed: 2013/6/30). 台灣新藥研發公司即將開花結果, from http://owenlin.pixnet.net/blog/post/38213019-%E5%8F%B0%E7%81%A3%E6%96%B0%E8%97%A5%E7%A0%94%E7%99%BC%E5%85%AC%E5%8F%B8%E5%8D%B3%E5%B0%87%E9%96%8B%E8%8A%B1%E7%B5%90%E6%9E%9C
78 Anonymous. (2012,Last viewed: 2013/6/30). 抗體新藥的藍海市場 醣聯開發價值更高的單抗藥物(Space)打造台灣新藥研發的新契機, from http://tw.mag.cnyes.com/Content/20121207/a0ac4396b92a421c846976480e28ff6f_1.shtml
79 Anonymous. (2010,Last viewed: 2013/6/30). 中天將有關癌症與病毒感染之抗體新藥業務分割新設泉盛生技, from http://www.nbic.org.tw/newsDetail.aspx?NEWS_ID=2633
80 Anonymous. (2013,Last viewed: 2013/6/29). 基亞生物科技業務-核酸檢驗(分子檢測), from http://www.medigen.com.tw/web/activities.php?id=2
81 Anonymous. (2013,Last viewed: 2013/6/29). 晶宇生物科技產品, from http://www.bio-drchip.com.tw/08OrchidELISA_Kit.asp
82 Anonymous. (2013,Last viewed: 2013/6/30). 晶宇生技產品資訊, from http://www.bio-drchip.com.tw/08Products.asp
83 羅敏菁. (2012,Last viewed: 2013/7/1). 分子檢測與應用市場, from http://www.caizischool.com/blog/15273
84 康照洲. (2011,Last viewed: 2013/7/1). 建立制度化合作機制-兩岸醫藥衛生協議，開啟生醫產業新紀元, from http://www.fda.gov.tw/upload/133/Content/2012102511380545297.pdf
85 De-Kuan Chang Han-Chumg Wu, Chien-Yu Chiu. (2013). US Patent. assignee: Academia Sinia, Taipei(TW)
86 Anonymous. (2011,Last viewed: 2013/7/6). 乳癌用藥介紹, from http://www.cancernews.com.tw/border/index.php?REQUEST_ID=cGFnZT1yZWFkJlBJRD02MDk=
87 Anonymous. (2011,Last viewed: 2013/7/6). 大腸癌用藥介紹, from http://www.cancernews.com.tw/border/hot.php?REQUEST_ID=cGFnZT1yZWFkJlBJRD0zMzM=
88 屠乃方. (2010,Last viewed: 2013/7/6). 卵巢癌化學治療新進展, from http://cisc.twbbs.org/lifetype/index.php?op=ViewArticle&articleId=2553&blogId=1
89 Michelle L. Butler. (2013,Last viewed: 2013/7/6). FDA Issues Final Orphan Drug Regulations, from http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/06/fda-issues-final-orphan-drug-regulations-.html
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
dc.contributor.advisor 陳桂恒zh_TW
dc.contributor.advisor Keith Chanen_US
dc.contributor.author (Authors) 劉昌昇zh_TW
dc.contributor.author (Authors) Johnson Liuen_US
dc.creator (作者) 劉昌昇zh_TW
dc.creator (作者) Johnson Liuen_US
dc.date (日期) 2012en_US
dc.date.accessioned 2-Sep-2013 15:34:34 (UTC+8)-
dc.date.available 2-Sep-2013 15:34:34 (UTC+8)-
dc.date.issued (上傳時間) 2-Sep-2013 15:34:34 (UTC+8)-
dc.identifier (Other Identifiers) G0100359034en_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) 100359034zh_TW
dc.description (描述) 101zh_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 i
Abstract 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/#G0100359034en_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 medicineen_US
dc.subject (關鍵詞) IVDen_US
dc.subject (關鍵詞) molecular diagnosticen_US
dc.subject (關鍵詞) ROIen_US
dc.subject (關鍵詞) NPVen_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) thesisen
dc.relation.reference (參考文獻) 1 曹佳琪. (2013,Last viewed: 2013/6/30). 今年來績效 生技基金漲逾三成, from http://money.udn.com/fund/storypage.jsp?f_MAIN_ID=339&f_SUB_ID=4199&f_ART_ID=291362
2 Anonymous (2012) 生技產業白皮書,11, Published by: 台灣經濟部工業局, from http://www.bpipo.org.tw/download/pdf/2012/Biotechnology_Industry_in_Taiwan_2012.pdf
3 John Kell. (2010,Last viewed: 2013/6/20). Pfizer to Acquire Veterinary Diagnostics Firm, from http://online.wsj.com/article/SB10001424052970203525404576049754208683440.html
4 Anonymous. (2013,Last viewed: 2013/6/20). Dako to Collaborate with Pfizer on Companion Diagnostics, from http://www.agilent.com/about/newsroom/presrel/2013/12feb-dk13002.html
5 劉翠玲. (2010). 前瞻醫藥生技,未來發展趨勢. 台灣經濟研究月刊, 33, 21-28.
6 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢驗及醫療之商機,I-III, Published by: 財團法人生物技術開發中心, from
7 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢測及醫療之商機,15-17, Published by: 財團法人生物技術開發中心, from
8 Gary Walsh. (2010). Biopharceutical benmarks 2010. Nature biotechnology, 28(9), 917-924.
9 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢測及醫療之商機,22, Published by: 財團法人生物技術開發中心, from
10 Anonymous. (Last viewed: 2013/6/20). HercepTest TM Dako, from http://www.dako.com/dist/ar39/p101510/prod_products.htm?setCountry=true&purl=ar39/p101510/prod_products.htm?undefined&submit=Accept%20country
11 Anonymous. (2013,Last viewed: 2013/6/28). FDA Approves Dako Assays as CDx for Genentech Breast Cancer Drug, from http://www.genomeweb.com/clinical-genomics/fda-approves-dako-assays-cdx-genentech-breast-cancer-drug
12 Stephen Little. (2008,Last viewed: 2013/6/12). Business opportunities and commercial challenges in personalized medicine, from http://www.ivdtechnology.com/article/business-opportunities-and-commercial-challenges-personalized-medicine
13 Maureen Kingsley. (2013,Last viewed: 2013/6/5). Top 10 Molecular Diagnostics Companies, from http://www.ivdtechnology.com/article/top-10-molecular-diagnostics-companies-0
14 Sara Whitmore Kamran Zamanian. (2012,Last viewed: 2013/6/10). Our Most-Read Story of 2012: U.S. IVD Market to Exceed $9.5 Billion by 2017, from http://www.ivdtechnology.com/article/us-ivd-market-exceed-95-billion-2017
15 Romain Prieur Frederick Eibl. (2011,Last viewed: 203/6/5). Tools for Molecular Diagnostics, from http://www.ivdtechnology.com/article/tools-molecular-diagnostics-11
16 Pwc (2013) From vision to decision pharma 2020, Published by: PWC, from www.pwc.com/pharma2020
17 Christine Lindgren Debbie Paul (2013) World Preview 2013, outlook to 2018- Retuning to growth, Published by: EValuatePharma, from www.evaluategroup.com/wp2013
18 Eric David Mark Beards, Jerel Davis, Aine Denari, Amar Desai, Michael Edwards, Matthias Evers (2010) Invention reinvented-Mckinsey perspectives on pharmaceutical R&D, Published by: McKisey&Company, from
19 Jim Kling. (2007). Diagnosis or drug? EMBO reports, 8, 903-906.
20 Anonymous. (Last viewed: 2013/5/14). 單株抗體, from http://www2.cmu.edu.tw/~rx50c/Biotechnology_Management/20081203.pdf
21 G. Kohler, & C. Milstein. (1975). Continuous cultures of fused cells secreting antibody of predefined specificity. Nature, 256(5517), 495-497.
22 Nobel Prize Award Ceremony. (1984,Last viewed: 2013/03/04). The Nobel Prize in Physiology or Medicine 1984: Niels K. Jerne ,Georges J.F. Köhler ,César Milstein, from http://www.nobelprize.org/nobel_prizes/medicine/laureates/1984/#
23 Anonymous. (Last viewed: 2013/6/10). 癌症治療用抗體新藥, from http://www.glyconex.com.tw/products.php
24 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢測及醫療之商機,11-38, Published by: 財團法人生物技術開發中心, from
25 Anonymous. (2006). 台灣醫療器材查驗登記審查準則 TW: TFDA Retrieved from http://www.fda.gov.tw/TC/site.aspx?sid=39.
26 Anonymous. (Last viewed: 2013/4/10). Point-of-care testing Wikipedia, from http://en.wikipedia.org/wiki/Point-of-care_testing
27 Anonymous. (2008,Last viewed: 2013/4/20). Guidance for Industry-E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories, from http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm129286.htm
28 Webmaster. (Last viewed: 2013/4/26). 生物標誌蛋白質體學之產業觀, from http://www.atit.org.tw/ATIT/files/asset_pdf/74e8efb1bbabca58e7461aa16d9159d1/13-6-8.pdf
29 Anonymous. (1998,Last viewed: 2013/6/2). Herceptin (trastuzumab) Label on FDA from http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5256lbl.pdf
30 Grier C. I.; Nagalingam Lin, Sev V. (2000). CIM justification and optimisation.p.
36, London: Taylor & Francis.
31 Akbar Javadian Kootanaee. (2012,Last viewed: 2013/7/9). Weighted average cost of capital-A Comparison of Performance Measures for Finding the Best Measure of Business Entity Performance., from http://en.wikipedia.org/wiki/Weighted_average_cost_of_capital
32 Alex S. Baras and Kevin A. Schulman Aris I. Baras. (2012). Drug devlopment risk and the cost of capital. Nature Reviews Drug Discovery, Published online.
33 Anonymous. (2010,Last viewed: 2013/7/9). 資本資產定價模型CAMP, from http://wiki.mbalib.com/zh-tw/CAPM%E6%A8%A1%E5%9E%8B
34 Stephanie Van Bebber and Amalia M. Issa Kathryn A. Phillips. (2006). Diagnostics and biomarker devlipomet: priming the pieline. Nature Reviews Drug Discovery, 5, 463-469.
35 Daniel S. Mytelka Steven M. Paul, Christopher T. Dunwiddie, Charles C. Persinger, Bernard H. Munos, Stacy R. Lindborg and Aaron L. Schacht. (2010). How to improve R&D productivity: the pharmaceutical industry`s grand challenge. Nature Reviews Drug Discovery, 9, 203-214.
36 Tony Tramontin and Rodney Zemmel Eric David. (2009). Pharmaceutical R&D: The road to positve returns. Nature Reviews Drug Discovery, 8, 609-610.
37 Len Fisher 林俊宏 譯. (2009). 剪刀 石頭 布-生活中的賽局理論.p.116-120: 天下文化.
38 Joseph A. Dimasi and Henry G Grabowski. (2007). The cost of biopharmaceutical R&D: Is biotech different? Manage. Dexis. Exon. , 28, 469-479.
39 Joseph a Dimasi K. I. Kaitin. (2011). Pharmaceutical Innovation in the 21st Century: New Drug Approvals in the First Decade,2000-2009. Cinical pharmacology & therapeutics, 89(2), 183-188.
40 Laura Furstenthal Jerel C. Davis. (2009). The microeconomics of personalized medicine: today`s challenge and tomorrow`s promise. Nature Reviews Drug Discovery, 8(4), 279-286.
41 E. Rasmusen. (1995,Last viewed: 2013/6/30). Game and Information, from http://zh.scribd.com/doc/21005253/An-Introduction-to-Game-Theory-Eric-Rasmusen
42 Eric R. (1989.). Games and Information: An Introduction to Game Theory: Cambridge.
43 李秀玉. (1999). 應用賽局理論分析我國薄膜電晶體液晶顯示器產業之競爭策略. 碩士論文, 國立交通大學.
44 Anonymous. (1998,Last viewed: 2013/6/27). Ultimatum game, from http://en.wikipedia.org/wiki/Ultimatum_game
45 Werner Güth. (1982). An experimental analysis of ultimatum bargaining. Journal of Economic Behavior & Organization, 3(4), 367.
46 謝淑貞. (1995). 賽局理論 台北: 雙葉書廊有限公司.
47 Anonymous. (2013,Last viewed: 2013/6/27). Dako, from http://www.dako.com/dist/index.htm
48 Anonymous. (2013,Last viewed: 2013/6/27). XDx company web site, from http://www.xdx.com/
49 Anonymous. (2013,Last viewed: 2013/6/27). Oncotype Dx, from http://www.oncotypedx.com/en-US/Home
50 William R Strohl and David M Knight. (2009). Discovery and development of biopharmaceuticals: current issues. Current opinion in Biotechnology, 20, 668-672.
51 Marketresearch.Com. (2012,Last viewed: 2012/6/28). Market Research Projects Antibody Drugs Market at $58 Billion by 2016, from http://finance.yahoo.com/news/market-research-projects-antibody-drugs-130800691.html
52 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢驗及醫療之商機,51-70, Published by: 財團法人生物技術開發中心, from
53 Anonymous. (2013,Last viewed: 2013/6/28). Deal struck over development of Herceptin biosimilar, from http://gabionline.net/Biosimilars/News/Deal-struck-over-development-of-Herceptin-biosimilar
54 Anonymous. (2013,Last viewed: 2013/6/14). Pfizer carrying out biosimilar trastuzumab trial in US, from http://www.gabionline.net/Biosimilars/Research/Pfizer-carrying-out-biosimilartrastuzumab-trial-in-US
55 Pwc Study. (2010,Last viewed: 2013/6/28). Biotech must retool business model, from http://www.accountingweb.co.uk/topic/technology/biotech-must-retool-business-model-says-pwc/460979
56 L Feldman Joseph a Dimasi, A Seckler and a Wilson. (2010). Trends in risks associated with new drug development: success rates for investigational drugs. Cinical pharmacology & therapeutics, 87(3), 272-277.
57 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢驗及醫療之商機,27-38, Published by: 財團法人生物技術開發中心, from
58 Raghuram Selvaraju (2012) Trovagene, Inc.-Rating: Buy, Published by: A. C. CORP., from http://www.trovagene.com/trovagene/media/Downloads/TROV-Initiation-Report-Aegis-Capital-Corp.pdf
59 Anonymous. (2013,Last viewed: 2013/7/12). Historical Product Sales Revenue-Theraputic Antibody, from http://pdl.com/royalty-revenue/historical-product-revenue/
60 Anonymous (2010) Oncology report 1119, Published by: Cowen/Scala, from http://oncology.healthace.com/111910/Oncology_Report_111910_S8.pdf
61 王緯書. (2010,Last viewed: 2010/6/30). 抗癌新藥：lapatinib, from http://cisc.twbbs.org/lifetype/index.php?op=ViewArticle&articleId=1866&blogId=1
62 劉憲. (2011,Last viewed: 2013/6/14). 乳癌治療新利器--談標靶治療, from http://www2.edah.org.tw/breastcenter/g/006.html
63 Anonymous (2011) GlaxoSmithKline: Tykerb Use in Adjuvant Breast Cancer Unlikely, Phase III Trials Fail; Consensus Sales Forecasts £550m By 2015 Too Optimistic, Published by: Deutsche-Bank/Clark, from http://oncology.healthace.com/120911/Oncology_Report_120911_S4.pdf
64 Anonymous. (2013,Last viewed: 2013/6/14). Gabi reprot: Roche does not see a threat from biosimilars until 2015, from http://gabionline.net/Biosimilars/News/Roche-does-not-see-a-threat-frombiosimilars-until-2015
65 Anonymous. (2013,Last viewed: 2013/6/14). Gabi report: Deal struck over development of Herceptin biosimilar, from http://gabionline.net/Biosimilars/News/Deal-struck-over-development-of-Herceptin-biosimilar
66 Anonymous. (2013,Last viewed: 2013/6/12). BioTrends Research group report: Biosimilar Versions of Monoclonal Antibodies for Cancer are Forecast to Garner Sales of $4.9 Billion, While the Branded Versions are Expected to Maintain Sales of $6.7 Billion Across the US, EU5, and Japanese Markets in 2021, from http://biotrends.com/News-and-Events/Press-Releases/A-New-Syndicated-Report-091912-(1)
67 Anonymous. (2010,Last viewed: 2013/7/10). STPI-科技產業市場報導：標靶藥物大躍進, from http://cdnet.stpi.narl.org.tw/techroom/market/bio/2010/bio_10_004.htm
68 Dermot Doherty. (2011,Last viewed: 2013/7/7). Roche Reduces Peak Sales Forecast for Avastin by 20 Percent as Sales Fall, from http://www.bloomberg.com/news/2011-02-02/roche-second-half-net-income-falls-on-costs-to-cut-jobs-franc-s-strength.html
69 Hector (2010) Roche: Avastin – $3B Peak Sales Opportunity for Prostate ($1.3M), Ovarian ($750M), and Gastric Cancers ($1.5M); 50% Probability of Launch in 2011,1-2, Published by: C. Suisse, from http://oncology.healthace.com/011410/Oncology_Report_011410_S2.pdf
70 Simon King. (2013,Last viewed: 2013/7/7). The Best Selling Drugs of All Time; Humira Joins The Elite, from http://www.forbes.com/sites/simonking/2013/01/28/the-best-selling-drugs-of-all-time-humira-joins-the-elite/
71 Kiran Meekings John Arrowsmith (2011) THOMSON REUTERS report: Implementing Drug Development Strategies: Maximising the Value of Pharmaceutical Assets Part 2, Published by: THOMSON-REUTERS, from http://business-review-webinars.com/webinar-slides/thomson-reuters-slides-25-10-2011.pdf
72 Eva Von Schaper. (2008,Last viewed: 2013/7/7). Merck KGaA Profit More Than Doubles on Erbitux Sales (Update1), from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=auuvVmVt1iVo
73 Anonymous. (2006,Last viewed: 2013/7/7). 主題：ERBITUX, 2015年ERBITUX將實現銷售額2.2億美元, from http://big5.39kf.com/my/tag_3_88a85a84a73a66a82a69/
74 湯谷清、秦慶堯、洪于婷 (2010) 抗體應用於檢驗及醫療之商機,38-47,102-121, Published by: 財團法人生物技術開發中心, from
75 杜蕙蓉、潘臆涵. (2011,Last viewed: 2013/7/1). 永昕TuNEX獲准3期臨床, from http://blog.xuite.net/flwlkv/blog/55578217-%E6%B0%B8%E6%98%95TuNEX%E7%8D%B2%E5%87%863%E6%9C%9F%E8%87%A8%E5%BA%8A
76 黃文奇. (2013,Last viewed: 2013/7/1). 東生華&永昕TuNEX 2015將上市 !! , from http://alveice.blogspot.tw/2013/01/2015.html
77 林宏文. (2012,Last viewed: 2013/6/30). 台灣新藥研發公司即將開花結果, from http://owenlin.pixnet.net/blog/post/38213019-%E5%8F%B0%E7%81%A3%E6%96%B0%E8%97%A5%E7%A0%94%E7%99%BC%E5%85%AC%E5%8F%B8%E5%8D%B3%E5%B0%87%E9%96%8B%E8%8A%B1%E7%B5%90%E6%9E%9C
78 Anonymous. (2012,Last viewed: 2013/6/30). 抗體新藥的藍海市場 醣聯開發價值更高的單抗藥物(Space)打造台灣新藥研發的新契機, from http://tw.mag.cnyes.com/Content/20121207/a0ac4396b92a421c846976480e28ff6f_1.shtml
79 Anonymous. (2010,Last viewed: 2013/6/30). 中天將有關癌症與病毒感染之抗體新藥業務分割新設泉盛生技, from http://www.nbic.org.tw/newsDetail.aspx?NEWS_ID=2633
80 Anonymous. (2013,Last viewed: 2013/6/29). 基亞生物科技業務-核酸檢驗(分子檢測), from http://www.medigen.com.tw/web/activities.php?id=2
81 Anonymous. (2013,Last viewed: 2013/6/29). 晶宇生物科技產品, from http://www.bio-drchip.com.tw/08OrchidELISA_Kit.asp
82 Anonymous. (2013,Last viewed: 2013/6/30). 晶宇生技產品資訊, from http://www.bio-drchip.com.tw/08Products.asp
83 羅敏菁. (2012,Last viewed: 2013/7/1). 分子檢測與應用市場, from http://www.caizischool.com/blog/15273
84 康照洲. (2011,Last viewed: 2013/7/1). 建立制度化合作機制-兩岸醫藥衛生協議，開啟生醫產業新紀元, from http://www.fda.gov.tw/upload/133/Content/2012102511380545297.pdf
85 De-Kuan Chang Han-Chumg Wu, Chien-Yu Chiu. (2013). US Patent. assignee: Academia Sinia, Taipei(TW)
86 Anonymous. (2011,Last viewed: 2013/7/6). 乳癌用藥介紹, from http://www.cancernews.com.tw/border/index.php?REQUEST_ID=cGFnZT1yZWFkJlBJRD02MDk=
87 Anonymous. (2011,Last viewed: 2013/7/6). 大腸癌用藥介紹, from http://www.cancernews.com.tw/border/hot.php?REQUEST_ID=cGFnZT1yZWFkJlBJRD0zMzM=
88 屠乃方. (2010,Last viewed: 2013/7/6). 卵巢癌化學治療新進展, from http://cisc.twbbs.org/lifetype/index.php?op=ViewArticle&articleId=2553&blogId=1
89 Michelle L. Butler. (2013,Last viewed: 2013/7/6). FDA Issues Final Orphan Drug Regulations, from http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/06/fda-issues-final-orphan-drug-regulations-.html		zh_TW