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1 CEO
2
3 Agenda
4 Agenda
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6 )
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9 10 ~ ~ GLP: Good Laboratory Practice GCP: Good Clinical Practice GMP: Good Manufacturing Practice GPSP: Good Post-marketing Study 1 10,000 Practice GLP GMP GCP PMDA Pharmaceuticals and Medical Devices Agency 1 25,000 DATA PhRMA BOOK 2016 Profile 2013 GPSP
10 Agenda
11 , , ,145 J&J 4 5,245 5 GSK 5, , TAB 4,394 4, , , ,513 9,245 3 C 9,081 4 J&J 8, , , , , ,317 :
12
13 Omacetaxine for CML Ibrutinib for MCL Crizotinib for NSCLC Pomalidomide for MM Regorafenib for CRC Sorafenib for TC Ponatinib for CML and Ph+ ALL Trametinib for melanoma Lenalidomide for MCL Cabozantinib for TC Ado-trastuzumab emtansine for BC Dabrefenib for melanoma Abiraterone for PC Erlotinib for NSCLC Radium 223 for PC Nab-paclitaxelb for PC, NSCLC Afatinib for NSCLC Pertuzumab for BC Obinutuzumab for CLL Bevacizumab for CRC FDA 0 20,000 40,000 60,000 80, , , , , ,000
14 (%) Phase I to Phase II Phase II to Phase III Phase III to NDA/BLA /
15 Phase1 30 Phase2 Phase3 Launch TNF-α HER2 CD20 VEGF PD-1 EGFR Amyloid-β PD-L1 CD40 HER3 OX40 IL-2R IL-6 IgE CD19 GITR HGFR IL-23 CD22 C5 CD33 IL-13 HA CD37 CSF-1R LAG3 gp120 GP IIb/IIIa IL-6R IL-17 CGRP CD3 GM-CSF FGFR2 Clarivate Analytics, Citeline, Springer2017 1
16 9 80% % 65.5% 54.8% 59.5% 48.8%
17 % 7.2% 29.3% % 10.8% 21.9% 25.0% 30.0% 26.7% 26.7% Copyright(C)2017QuitilesIMS Quintiles IMS
18 Agenda
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21 2.525 Mil USD Source: DiMasi, J.A., Journal of Health Economics 47 (2016) Copyright (C) 2016 Chugai Pharmaceutical Co., Ltd. All Rights Reserved.
22 (US $ million) Pharma Rx Sales Ranking Company Pharma Rx Sales Pharma Rx Sales Growth rate Total Sales R&D Expenditure R&D Expenditure % to Total Sales Pfizer 48, % 52,824 7, % 2 2 Novartis 42, % 48,518 8, % 3 3 Roche 41, % 51,289 10, % 4 5 Merck 35, % 39,807 7, % 5 4 Sanofi 34, % 37,392 5, % 6 7 J&J 33, % 71,890 6, % 7 6 Gilead 30, % 30,390 5, % 8 8 GSK 28, % 32,468 3, % 9 10 AbbVie 25, % 25,638 4, % 10 9 AstraZeneca 23, % 23,002 5, % , % 15,915 2, % , % 12,052 1, % , % 8,775 1, % , % 10,984 1, % , % 4,953 1, % , % 4, % , % 3, % , % 3, % , % 3, % , % 3, %
23 * NEW Pharma Future 2016/06/30
24 Average / product: 3.0 bil USD Average / product: 2.0 bil USD Average / product: 2.5 bil USD Average / product: 1.9 bil USD Average / product: 2.0 bil USD
25 Average / product: 887 Average / product: 945 Average / product: 619 Average / product: 311 Average / product: 348
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30 36 $ (million) (billion) $125 $430 $ u u u
31 or
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33 IFReC
34
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36 San Diego Research Cluster (No.1 Bio-cluster in the US)
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将来見通し 本プレゼンテーションには 中外製薬の事業及び展望に関する将来見通しが含まれていますが いずれも 既存の情報や様々な動向についての中外製薬による現時点での分析を反映しています 実際の業績は 事業に及ぼすリスクや不確定な事柄により現在の見通しと異なることもあります 1
新薬創出環境の劇的な変化と継続的なイノベーション創出に向けた日本の製薬産業の課題 中外製薬株式会社代表取締役会長 CEO 永山治 2017.10.30 将来見通し 本プレゼンテーションには 中外製薬の事業及び展望に関する将来見通しが含まれていますが いずれも 既存の情報や様々な動向についての中外製薬による現時点での分析を反映しています 実際の業績は 事業に及ぼすリスクや不確定な事柄により現在の見通しと異なることもあります
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第１章 製薬産業を取り巻く環境変化
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Taro10-目次.PDF
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