美云智數：2022年生物醫藥數字化白皮書（61頁）.pdf

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1、?1?務?務?MAH?5G?研?AMT?2?03?06?07?16?17?18?19?26?封?29?33?37?39?40?！銳?42?43?45?47?51?研?銳?研?54?55?56?3?/?副?副?研匹?匹?研?封?！紙?副?溶?3.0?2014?副?夠 1.0?2018?識?夠 2.0?2021?夠 3.0?副?溶?夯?研?確?研?務?/?CDO?封?告?割?封?/?務?割?太?封?宇?！?夠?宇?！銳?/?割告?！?紙?夠?副?蕾?務?宇?4?/?CTO?務?割?割?匹?匹?副?副?匹?！?匹?匹?/?IT?割?副?副?割?GMP?封?篩?/?副?匹?副?20?封?溶?割?確?！

2、銳?封?/?副?副?務?夠?封?研?務?研?研?割?5?/?篩?封?篩?溶?夠?紙?告?宇?/?5?盡?研?CRM?夯?！銳?封?封?副?模?研?！銳?/?匹?務?！銳?紙?！銳?/?篩?封?盡?副?！銳?務?愿?夠?副?匹?宇?副?6?務?務?7?割?封?,?務?去?封?割?割?副?務?覆?1?AMT&?務?封?覆?務?封?覆?8?封?盡?務?溶?蕾?API?2021?副?29288.5 廳?17.83%?研 Frost?&?Sullivan?研?2021?-2025?務?撐?7.2%?2025?22.87?廳?篩?映?2?AMT&?3?2016-2025?務?Frost&Sullivan?

3、AMT&?銳?9?匹?+?務?封?副?副?匹?封?務?紙副?1?研?副?映?1/4?2?2022?3?75%?副?篩?副?4?5?2019.01-2021.10?AMT&?AMT&?割?務?務?溶?映?封?蕾?副?封?務?撐?撐?副?匹?紙?副?去?割?割?10?割?篩?確?務?2025?務?篩?封?6 務?AMT&?務?篩?封?篩?稅?封?封?篩?2015?2004?映?！銳?2011?！銳?蕾?GMP?WHO2003?GMP?2016?2017?包?2017?！銳?紙?！銳?篩?11?2019?副?篩?副?封?7?AMT&?12 篩?夯?篩?2015?務?篩?模?封?務?8?2020-20

4、21?pharma?R&D?annual?review?2021?AMT&?篩?！銳?2018?溶?6 蕾?撐?割?的?2020?蕾?溶?14?2022?務?的?350?副?務?3?！銳?9?AMT&?13?匹?去?封?封?紙?篩?去?封?研?12?務?11.6?95%?2015?6?封?2021?夯?426?652?2019?副?導?封?割?10?2017-2021?AMT&?14?研?模?GxP?太?封?封?2019?12?！銳?映?務?！銳?務?！?！銳?GMP?！銳?GSP?！?GMP?GSP?2021?5?！銳?！?太?研?研?割?研?研?！銳?11?GxP?AMT&?！銳?！紙?！

5、銳?封?封?封?夠?封?！銳?15?封?溶?夯?封?溶?2021?7?AlphaFold2溶?35?98.5%?21?TOP20?AI?撐?AI?封?封?封?2022?1?務?襲?封?蕾?襲?模?送?封?2022?1?11?撐?封?盡?Insilico?Medicine?AI?封?研?QPCTL?撐?封?2?17?1?撐?撐?溶?封?QPCTL?務?確?研?2021?宇?3?1?紙?宇?夠?紙?夠?夠?副?夠?副?夠?！銳?夠?16?封?研?封?務?副?26%?12?務?AMT&?副?割?夯?封?封?！銳副?篩?封?！?！銳?映?封?研CIAPH?2021?4?！銳?夯?副?4?17?溶?研?

6、紙?！篩?匹?篩?封?溶?篩?告?！?務?割?封?5?割?宇?的?割?夠割?割?割?盡?割?副?銳?務?！銳?蕾?撐?18?研?19?的?封?模?務?研?夠?紙?13?AMT&?割?！銳?匹?務?去?割?20?封?封?封?研?研?研?封?研?封?封?銳?研?告?封?銳?去?割?研?稅?確?紙?/?/?紙?蕾?宇?！銳?研?夠?盡?愿?銳?愿?愿?撐?封?紙?！銳?！銳?研?稅?21?研 2021?CESI?50%?溶?務?21%?務?副?封?務?送?紙?務?6?14?務?CESI?AMT&?副割?割?割?務?！銳?！銳?務?務?15?22?封?務?封?封?AI?研?封?研?封?封?封?！?封?

7、宇?稅?研?封?！銳?紙?務?務?匹?AMT?封?銳?務?導?銳?稅?16?AMT?AMT?23?17?AMT?研?5?割?24?-?撐?副?割?！銳?愿?宇?宇?！銳?盡?蕾?挑?去?蕾?IIOT?研?5G?宇?！銳?匹?研?導?封?宇?務?宇?封?宇?宇?！銳?！銳?！銳?夠?18?AMT&?25?宇?務?宇?宇?宇?封?封?IT?愿?研?IT?夠?銳?！銳?19?AMT&?封?篩?宇?宇?宇?宇?宇?宇?務?宇?宇?！銳?！銳?務?宇?銳?！銳?宇?宇?宇?研?研?封?匹?蕾?26?封?封?盟?封?封務?CRO?封紙?封?封?封?IT?封?溶?封?AI?封?封?2-3?封?研?研?務?(

8、shortest?path)?(module?detection)?務?(network?centrality)?ML?(decision?tree)?研務封?務?封?7?銳?撐?NLP?紙?-?割?危?危?研?ADMET?模?研?務?封?8?2022?1?7?Exscientia?封?Exscientia?AI?研?封 15?研?Exscientia?1廳?52 廳?封?！?2022?1?5?AI?盡?Insilico?Medicine?12?封?ISM012-077?ISM012-042?2022?5?25?封?3CL?封?AI?27?去?銳?！銳?LIMs?封?溶?！銳?！銳?研?銳?C

9、DS?研！銳?SDMS?ELN?！銳?務?匹?研?副?研?LIMS?！銳?去?！銳?研?研?模?FDA?IND?IV?副?覆?4?紙?紙?20?AMT&?覆?撐?割?研?匹?研?研?研?模?！銳溶?副?！銳?CTMS?！銳?eTMF?eLC?研?告割?研?模?封?封?！銳?封?28?研?割?研?EDC?研?研?研?封?研?AI?研?銳?割?割?研?研?模?研?紙?研?研?務?務?AI?模?務?匹?社?29?夠?21?APS?AMT&?宇?！銳?夠?夠！銳?ERP?MES?夠?30?22?AMT&?匹?APS?夠?夠?篩?！銳?！銳?MRO?紙?撐?！銳?割?1?錫?2?紙?撐?研?銳?紙?3?

10、研?AI?割?研?4?名?！銳?送?紙?31?23?AMT&?去?！銳?割?研?副?盡?映?模?割?24?AMT&?T+3?！銳銳?！銳?研?銳?32?25?AMT&?務?研?研?！?蕾?33?撐?夠?研?IoT?！?！?9?研?封?務?務?！銳?封?務?2020?！銳?！銳?26?34?務?去?封?稅?Process?analytical?technology?PAT?2004?FDA?封?-PAT?PAT?映?撐?務?去?封?務?PAT?務?研?導?PAT?研?務?務?模?割?PAT?撐?10?27?PAT?PAT?GMP?告?夯?確?務?導?研?務?研?研?導?蕾?蕾?11?35?宇?紙

11、?副?務?GMP?裂?匹?研?研?群?紙?宇?模?務?務?模?模?AGV?研?！銳?務?！?QC?QA?宇?QC?！銳?！銳?！銳?！銳?務?！銳?！銳?！銳?CAPA?！銳?！銳?28?封?務?務?！銳?36?AI?務?愿?紙?AI?務?研?研?研?副?MES?去?銳?銳?紙?IoT?研?銳?5G?研?AI?映?告?夯?AII?盟?87%?撐?研 Gartner?2024?25%?IoT?12?29?MIoT.VC?AMT&?宇?務?銳?研?銳?蕾?夠?宇?37?封?匹?映?封?副?副?封?的?副?匹?匹?30?AMT&?務?割?的?割?！銳?封?務?副?匹?研?研?研?！銳?研?封?副?研

12、?13?去?副?CLM?導?研割?研?導?38?副?封?溶?去?匹?匹?封?副?39?！?！銳?！銳?！銳?AI?紙?去?封?紙?紙?紙?紙?著?紙?！?研?！銳?！銳?研?！銳?RFID?！銳?！銳?2017?封?模?篩?務?務?銳?！銳?！銳?告?！?副?割?！副?模?研?銳?匹?封?！?映?蕾?B2C?務?匹?！銳?40?！銳?！?稅?覆?！銳?！銳?！銳?！銳?稅?研?！銳?稅?銳?！銳?研?銳?的?！銳?研?研?研?研?割?稅?告?去?封?！銳?盟?！?研?！銳?研?！銳?務?封?AI?紙?！銳?Excel?研?封?AI?！銳?紙?RPA?撐?太?RPA 愿?銳?愿?紙?研?研?研！

13、銳?研?研?封?研?務！銳?研?研模?研務?研?研?銳?撐?研?BI?BI?封?研?研?盡?愿?研?研?！銳?封?封?研?41?31?AMT&?42?研?研?43?！?務?！?！?割?映?研?研?2022?5?封?！銳?務?！銳?銳?太?！銳?！?！?！?封?2022?6?！銳?封?研?研?2022?7?1?研溶?！銳?務?！銳?紙?GMP?紙?！銳?封?32?CSV?AMT&?44?33?AMT&?！銳?！銳?務?！銳?覆?研?副?研?務?研?盟?研?！銳?銳?割?！銳?研?研?銳?研?研?告?！銳?！銳?！銳?45?稅?覆?紙?2020?8118 廳?15.5%?3?研?2021 務?封?

14、研?務?溶?2022?12529 廳?5?2.5?夠?務?紙?紙?封?！?撐?夠?務?2020?4?務?送?撐?6?封?2021?12?31?28954?2020?25440?13.8%?務?19569?13971?2033?14?務?務?務?溶?3?告?7?務?務?務?封?34?AMT&?46?稅?去?封?研?封?去?UDI?！?封?15?UDI?ERP?WMS?PLM?！銳?！銳?！銳?研?16?封！銳?封?！銳?！銳?夠！銳?！銳?封?研?封?割?太?愿?！銳?模?愿?封?研?匹?撐?SKU?研?！銳?！銳?夠?！銳?盟?！?封?稅?封?！銳?！銳?稅?！?封?封?47?2021?200

15、0?務?386?168?218?務?193?封?50%17?封?封?副?副?TOP100?割?56%?務?18%?17%?9%18?35?2020?2021?AMT&?48?篩?2016?研?95%?83%?500?篩?夠務?研?封?10-15%?溶?夯?2021?匹?5?匹?+?/?15?篩?！?36?AMT&?務?封?封?告?19?研務?！?！銳?割?研?匹?稅?！銳副?研副?告?研?銳?割?割?的?篩?務?夠?！?IT?副?告?副?的?49?匹?匹?匹?匹?副?務?31%?務?！銳?！銳?！銳?！銳?37?AMT&?！銳?！銳?封?去?裂?OT?IT?銳?20?！?太?研?研?！銳?研?

16、50?！銳?！?封?模?務?研?研?稅?研?愿?務?割?封?篩?！?孿?孿?孿?24?銳?AI?研?封?！銳?銳?！銳?！銳?！銳?38?AMT&?51?研?研?研?研溶?封?研?割?研?研?封?確?研?務?映?研?映?研-?研?-?研?研?銳?研?研?研?研?研?割?研?銳?研?研?研?割?副?研?39?研?AMT&?研?銳?封?務?研?！銳?務?研撐?研?銳?研！銳?溶?研 AII?98.6%?研！銳?務?90%?溶?映?夠?研！銳?21?封?溶?研?告?研?52?研?研?夠割?割?研?割?研?研?割?研?告?研?研?！銳?研?割?研！銳?割?研?封?割?研?研?！銳?研！銳?研?/?研?

17、研?研?研！銳?映?研?研?研?研?！銳?映?研?研！銳?封?研?研?研?研務?研務?研?銳?研?研?OPC?研?IT?ESB?研?研?研?研?研?研?研！銳?送?研務?副?割?研?研?社?研?研?封?研！銳?研?銳?研?研?封?封?！銳?務?封?研?研?研?研?！銳?53 2021?研?務?40?研?AMT&?研?！銳?研?夠?研?研?研?研?研?研?紙?副?研?研?研?41?研?CCSATC601?研?54?割?！?封?！銳?映?封?溶?模?封?副?蕾?研?封?割?研?篩?研?稅?蕾?務?匹?篩?紙?確?紙?確?愿?封?55?1?Timothy?Morey,Theodore?TheoFor

18、bath?and?Allison?Schoop,Customer?Data:?Designing?for?Transparency?and?Trust,?Harvard?Business?Review,?October?10,2018.?2?務?3?Deloitt?4?CIAPH?務?2021?盟?5?封?務?&務?！銳?務?2020?6務?務?盟?2021?7?You,?Y.,?Lai,?X.,?Pan,?Y.?et?al.?Artificial?intelligence?in?cancer?target?identification?and?drug?discovery.?Sig?Tran

19、sduct?Target?Ther?7,?156?(2022).?https:/doi.org/10.1038/s41392-022-00994-0?8?盟?2021.05?9?封?務?&務?！銳?務?2020?10?Michael?Li?PAT?11?盡?宇?-?務?確?12?Gartner?2020.05?13?封?確?14?研?務?銳?15?千?&?精?UDI?去?16?UDI?務?2021?17?&?2021?18?&?2020?19?2021 務?20ABB?務?21?匹?2018?研?！銳?盟?56?1?紙?2?3?紙?4?(Decentralized?Clinical?Trial

20、s)?(Siteless?Clinical?Trials)?5?副?模?研?副?研?6?割?7?銳?first?in?class?8?License-in?割?封?封?9?License-out?封?封?副?10?ADMET?Absorption?Distribution?Metabolism?Excretion?Toxicity?去?11?CTD?Common?Technical?Document?務?CTD 太?57 12?MRO?Maintenance,?Repair?&?Operations?13?ICH?The?International?Council?for?Harmonisat

21、ion?of?Technical?Requirements?for?Pharmaceuticals?for?Human?Use?14?FDA?Food?and?Drug?Administration?！銳?15?CRO?Contract?Research?Organization?封?盡?封?封?16?CDMO?Contract?development?and?manufacturing?organization?封?盡?封?封?紙?17?UDI?Unique?Device?Identification?18?CSV?Computerized?System?Validation?紙?研?紙?1

22、9?NLP?Neuro-Linguistic?Programming?20?PAT?Process?Analytical?&?Measurement?Technology?21?EDC?Electronic?Data?Capture?System?研?/?研！銳?22?ELN?Electronic?Laboratory?Notebook?23?LIMS?Laboratory?Information?Management?System?！銳?24?MOM?Manufacturing?Operation?Management?！銳?25?APS?Advanced?Planning?and?Sche

23、duling?夠?26?AGV?Automated?Guided?Vehicle?27?WMS?Warehouse?Management?System?！銳?58 28?QMS?Quality?Management?System?！銳?29?EAM?Enterprise?Asset?Management?！銳?30?SRM?Supplier?Relationship?Management?！銳?31?OPC?OLE?for?Process?Control?OPC?OLE?副?研?紙?32?ESB?Enterprise?Service?Bus?33?RPA?Robotic?Process?Aut

24、omation 紙?34?SCRM?Social?Customer?Relationship?Management?！銳?35?研?匹?36?割?研?37?4M1E?4M?Man?Machine?紙?Material?Method?1E?Environments?！銳銳?務?38?GMP?Good?Manufacturing?Practice?of?Medical?Products?！銳?！銳?太?務?39?GSP?Good?Supply?Practice?！銳?封?封?！銳?40?！?副?！?務?！?！?！銳?41?夠?務?59 42?2017?1?封?宇?蕾封?蕾封?43?副?副?Marketing?Authorization?Holder?MAH?副?！銳?2019?12?1?！銳?MAH?44?研?務?研割?紙?45?副?！銳?2019?12?1?！銳?副?！銳?副?溶副?！銳?60