数字化去中心化临床试验行业发展现状调研分析报告

湡䔶湡䔶..................................................................................................................................................................................................2I.䒸鎊I I.倰 岁III.⚺銳ⰻ㺂01:「霄罏㛇劥⥌䜂02:遤⚌㹊騨♸馋⸷03:DCT⯋稇䎾欽㖞兞.....................................04:DCT岁錞罌ꆀ05:DCT盗椚⡤禹䒊霃⿬罌俒柄꣡䔶:侨研㕃邍宨邍呔a:靈灇⿬♸罏⢪欽DCT䞔ⲃ............................................................................................................邍呔b:靈灇⿬♸罏䨾㖈絆絉⚰䎯霚낉垷䒭ⴔ䋒...........................................................................................邍呔c:鵴玐䬸⹫湱鳅⠛絡䬸⹫涸䕧ㆇ............................................................................................................邍呔d:歏㶩濼䞔湱鳅⠛絡濼䞔ず䠑涸䕧ㆇ.....................................................................................................邍呔e:鵴玐霄錠湱鳅模Ⰼ梡㖞霄錠涸䕧ㆇ...................................................................................................邍呔:⼕䝖❜崨湱鳅⠛絡垷䒭涸䕧ㆇ............................................................................................................邍呔g:蚋暟湬鴪䝖罏湱鳅⠛絡垷䒭涸䕧ㆇ.....................................................................................................邍呔h:䒸Ⰶ劥㖑⼕毫湱鳅⠛絡务䗱⻊垷䒭涸䕧ㆇ.......................................................................................邍呔:鵴玐港叅湱鳅⠛絡梡㖞港叅垷䒭涸䕧ㆇ.............................................................................................暵ⵆ뚅靧 .......................................................................................................................................................44..............44..............45..............46..............46..............46..............46..............46..............46..............46..................................................................................................................................................................................47 䒸鎊⚰䎯霚낉곭㚖姻㖈絑⾎ꅾ㣐」ꬠ⿡务䗱⻊⚰䎯霚낉DCT⡲⚹♧猫Ⱒꝶ⴯倝垷䒭鷶幯Ⱓ饰կ繠㕂굹ㅷ蚋ㅷ港漛盗椚㽷FDAծ务㕂㕂㹻蚋ㅷ港漛盗椚㽷NMPA⟄⿺Ⰼ椕Ⱖ➭港盗纸匬䊺㽠㥵⡦㹊倶姼碫⴯倝〄䋒✫䭷㼋俒⟝Vayena,2023կ㽴盗ぢDCT涸鲮㘗⢪遤⚌䠭ⵌ傁Ⱓ㤃⿶朔韟㽍Ⱖ僽㖈务㕂㢕勇涸港盗梠㞯♴告遤⚌䊺鷶幯雩霋ⵌ鷓䎾涸䗳銳䚍կ⚹䲀⸓务㕂侨㶶⻊/⿡务䗱⻊⚰䎯霚낉DCT涸〄㾝匆䊜岲呔⼕蚋猰䪮肅⼝剣ꣳⰖ尽ㄤ⻌❩⼸ず⼕蚋⼕㷖⴯倝⤛鵳务䗱CMAC翫ざ䒓㾝շ2024䎃务㕂DCT遤⚌㹊騨靈灇ո䊨⡲կ靈灇䫣デ⡲⚹2024䎃灇瑕⠔用고շ务㕂DCT港盗瘻殜♸㹊騨灇瑕ո靃곿(綘〿2024-Y-Y-007)涸♧鿈ⴔ㼆鵛䎃DCT⿺ぐ銳稇涸掚挿Ⱒ岤ծ㹊騨䙼罌ծ筛瘻劍䖉ծ굥ꤗ盗椚瘝〄饰确雭ㄤ灇瑕կ㛇✵2023䎃靈灇涸䧭⸆2024䎃务㕂DCT遤⚌㹊騨靈灇儑爙遤⚌㼆DCT涸Ⱓ馰ㄤ⿬♸䏞儑衼䲿⼮կ䨔荛2025䎃1剢25傈Ⱏ995➃⿬♸靈灇鳅⿡䎃㟞Ɤ11.9%导僥ⴀ遤⚌㼆侨㶶⻊ㄤ⿡务䗱⻊霚낉垷䒭涸佅䭯傈渤㟞䔂կ⿬♸靈叅涸絆絉碫㘗㢴猫㢴呋Ⱖ务57.4%涸꡼⽷勻荈灇瑕纸匬/⼕ꤎ15.8%勻荈ざず灇瑕絆絉CRO13.6%勻荈ⵖ蚋䧴⼕毫㐼唒Ⱆ尽կ「霄罏巑渷✫➢プ䊨侨ꆀ500➃⟄♴涸㼭㘗絆絉ⵌプ䊨侨ꆀ10,000➃⟄副涸㣐㘗⟱⚌邍僈DCT涸悶⸂䖤ⵌ✫䎛岌雩〳կꥥ满DCT涸⢪欽桧䭯絯副⼮告Ⱒꝶ䮋䧶⣜搬㶸㖈կ䪮助侮ざծ港盗㢕勇䚍⟄⿺䝖罏䬸⹫僽剒䌢鄄䲿⿺涸ꥻ烯⛓♧կ搬罜遤⚌䊺䕎䧭僈烁Ⱏ霋⽰DCT㼜䧭⚹劢勻馋⸷կⰌ椕DCT䋑㖞㖈2024䎃⠮⧩鴪81.9➉繠⯋곫雦㼜⟄14.8%涸䎃㢕ざ㟞Ɤ桧CAGR㟞Ɤⵌ2032䎃 鴪 ⵌ249.7➉ 繠 ⯋Business ResearchInsights,2025կ鵯❈〄梡⚹遤⚌劢勻涸港盗呥卹ㄤ䧶殜錞够䲿⣘✫〳乼⡲涸錛鍒կ ⿬⸈⽀⡙⻌❩㣐㷖痦♧⼕ꤎ⻌❩㣐㷖胅泿⼕ꤎ⻌❩⼕ꤎ⻌❩⡡㸝⼕ꤎ幡⼶Ɤ䏊⼕ꤎ务㿋㣐㷖胅泿꣈屛务䗱䬺羭务㕂剣ꣳⰖ尽㺢゗潇⼕蚋灇〄⻌❩剣ꣳⰖ尽鳋榰务㕂灇瑕䒓〄剣ꣳⰖ尽爞勻务㕂灇〄剣ꣳⰖ尽匆䊜樢潇欰ㄐ猰䪮剣ꣳⰖ尽饋紿➬⼕蚋ㅐ霧(副嵳)剣ꣳⰖ尽暭㣢⽀⡙匆䊜岲呔⼕蚋猰䪮肅⼝剣ꣳⰖ尽⻌❩⼸ず⼕蚋⼕㷖⴯倝⤛鵳务䗱CMAC) 倰岁2024䎃务㕂DCT遤⚌㹊騨靈灇✵2024䎃12剢24傈゗⸓䎇✵2025䎃1剢25傈絕勲鸑鵂㛇✵緸絞涸㹁ꆀ靈叅Ⱏ佐꧋✫989⼝剣佪꡼⽷կ嫦⡙「霄罏䎂㖲蔄餩12ⴔꛦ模䧭꡼⽷㞅ⱗկ靈灇呋劥Ⱘ剣㢴呋䚍巑渷✫DCT곭㚖涸䎛岌ⵄ渤湱Ⱒ罏կ㹊ぜ⿬♸涸「霄罏⺫䭍71㹻ⵖ蚋䧴⼕毫㐼唒Ⱆ尽ծ262㹻灇瑕纸匬/⼕ꤎծ24㹻CROծ18㹻SMO⟄⿺10㹻DCT䪮助⣘䎾㉁կ鵯猫䎛岌䚍烁⥂✫Ⱒ✵DCT⢪欽ծ䮋䧶ㄤ港盗倰꬗涸Ⰼ꬗錠錭կ霪靈叅傋㖈佐꧋Ⱒꝶ遤⚌곭㚖涸錛鍒IndustryStandardResearch,2021Ⱖ䲿⣘涸㹈餥侨研㼜⚹劢勻涸遤⚌䧶殜ㄤ佅䭯DCT䭯絯㟞Ɤ䨾꨽涸港盗呥卹䲿⣘⿬罌կ ⚺銳ⰻ㺂꡼⽷佐꧋傞ꢂ2024䎃12剢24傈-2025䎃1剢25傈⿬♸➃侨995剣佪꡼⽷989⟧鳅2023㟞Ɤ11.9%嫦⡙「霄罏䎂㖲蔄餩12ⴔꛦ㹊ぜ⿬♸靈灇涸⟱⚌71㹻灇瑕⚥䗱262㹻CRO24㹻SMO18㹻DCT䪮助⣘䎾㉁10㹻 「霄罏㛇劥⥌䜂 「霄罏㛇劥⥌䜂劥 妃 靈 叅 涸 ⿬ ♸ 罏 去 邍 ✫ 㢴 猫 絆 絉 碫 㘗2024䎃 㣐 㢴 侨 「 霄 罏 勻 荈 灇 瑕 纸 匬/⼕ ꤎ57.4%鳅2023䎃55.9%殜剣䲿⼮կ2024䎃ⵖ蚋䧴⼕毫㐼唒Ⱆ尽涸「霄罏⽑嫱⚹13.7%CRO⽑嫱⚹15.8%Ⱖ务CRO涸⿬♸ 䏞 鳅2023䎃18.9%儑 衼 ♴꣭9.7%涸⿬♸⳼儑✫㼆⚰䎯霚낉梡㖞盗椚ㄤ⼸靈涸䭯絯Ⱒ岤կ姼㢪DCT䪮助⣘䎾㉁1.9%涸鳅㼭纈⡤导僥✫⚰䎯灇瑕ぢ刿㢴䪮助끮⸓鍒Ɀ倰呩涸鲮」կ㖈絆絉錞垷倰꬗㼭㘗絆絉500➃⟄♴⽑「霄罏涸29.9%鳅副䎃涸36.5%剣䨾♴꣭կ务㘗絆絉1,000-5,000➃涸嫱⢾殜剣副⼮2024䎃⚹25.4%罜2023䎃⚹16.8%կ㣐㘗絆絉5,000➃⟄副涸嫱⢾➢2023䎃涸37.19%殜䗎♴꣭荛2024䎃涸34.7%կ2024䎃㖈 ꬋ 灇 瑕 纸 匬/⼕ ꤎ 「 霄 罏 务N=421♸2023䎃涸59.23%湱ず㣐㢴侨➢✲⚰䎯鵘蠒䊨⡲61.8%կ⼕㷖猰㷖ծ⼕㷖港叅ㄤ蚋暟险䧯錭蒀涸⽑嫱ⴔⵆ⚹3.1%ծ6.2%ㄤ0.7%蚋暟险䧯涸去邍䚍➠搬♶駈կ⧩䖤岤䠑涸僽2024䎃剣19.7%涸「霄罏➢✲Ⱖ➭翟腊鵯邍僈灇瑕鵂玐务剣刿䎛岌涸錭蒀⿬♸կ կSMO 㖈灇瑕纸匬/⼕ꤎ碫㘗倰꬗♲歌⼕ꤎ⽑「霄罏涸94.0%♸2023䎃涸94.8%Ⳝ⛖䭯䎂ⱄ妃儑梡ⴀⰦ㖈⚰䎯灇瑕务涸呍䗱㖑⡙կ✳紩纸匬ㄤⰦ➭灇瑕纸匬涸⽑嫱鳅㼭⚂㛇劥⥂䭯♶」կ㖈㖑椚ⴔ䋒副靈叅⿬♸罏銻渷务㕂㢴⚡㖑⼓Ⱖ务屎⽂12%ծ䎛⚎8.5%ㄤ㿋⚎7.6%䨾⽑嫱⢾剒넞կ资꡶ծ껺度ㄤ銯诡瘝㖑⼓➠偽「霄罏邍僈鵯❈㖑⼓涸灇瑕⿬♸䏞㶸㖈悶㖈䊵騄կ靈灇⿬♸罏纸匬/⼕ꤎ⡙縨ⴔ䋒 㖈翟⸉倰꬗2024䎃纸匬盗椚➃プ55.1%➠⽑⚺㼋㖑⡙Ⱖ妃僽灇瑕➃プ32.6%ㄤ⠡椚㨼プ⠔7.7%կ⧩䖤岤䠑涸僽⚺銳灇瑕罏7.9%ㄤ灇瑕䫡㡦4.8%涸⽑嫱♸2023䎃湱嫱⥂䭯珘㹁կ靈叅侨研䳶爙✫务㕂⚰䎯灇瑕곭㚖涸⸓䙖䚍ㄤ㖑椚㢴呋䚍⚰䎯霚낉僈儑鲮ぢ䪮助끮⸓DCT䪮助⣘䎾㉁կ㽴盗⚰䎯鵘蠒➠⽑⚺㼋㖑⡙告灇瑕鵂玐务涸錭蒀㢴呋⻊馋⸷僈儑导僥✫➭⼜㖈灇瑕鵂玐务涸⿬♸䏞刿帿կ搬罜⼓㚖䊵䒗⣜搬㶸㖈㽍Ⱖ僽㖈资꡶ծ껺度ㄤ銯诡瘝㖑⼓鵯❈㖑⼓㖈⿬♸䏞ㄤ㟞Ɤ桧倰꬗➠㶸㖈瑟ꢂկ鵯♧馋⸷⳼儑✫䪮助㖈⚰䎯霚낉务涸的㾝⡲欽䎇⚹絆絉鵳♧姿䒓〄DCT鍒Ɀ倰呩䎇㖈♶ず㖑⼓ㄤ絆絉곭㚖的㣐䕧ㆇ⸂䲿⣘✫䧶殜纸麁կ 遤⚌㹊騨♸馋⸷ 鵂⿡❀䎃务DCT䪮助涸⢪欽桧珘姿副⼮կ2023䎃靈灇⿬♸罏䨾㖈絆絉务剣28.8%㖈⚰䎯霚낉务⢪欽⿡务䗱⻊䪮助կ2024䎃鵯♧嫱⢾副⼮荛37.4%㟞Ɤ✫8.6%կ鵯♧㟞Ɤ䖤渤✵侨㶶㛇炄霃倶涸鵳姿ծ港盗佅䭯涸的㣐⟄⿺㼆刿⾝崞ծ⟄䝖罏⚹务䗱涸霚낉霃雦涸꨽宠㟞⸈կ搬罜ꥥ满⢪欽桧涸䭯絯副⼮➠꨽鵳♧姿⸖⸂⟄烁⥂遤⚌㼆DCT涸䎛岌椚鍒ㄤ넞佪ⵄ欽կⵖ㹁ꛏ㼆䚍筛瘻䎇⸈䔂㛆雲雦够㼆✵佅䭯鵯♧鲮」䎇鍒Ɀ絆絉㖈的㾝侨㶶⻊ㄤ⿡务䗱⻊霚낉倰岁䎾欽鵂玐务꬗⚰涸䮋䧶荛Ⱒꅾ銳կ꡼곿鵛5䎃勻䝠涸絆絉僽や㖈⚰䎯霚낉⚥⢪欽✫DCT湱Ⱒ涸侨㶶⻊/⿡⚥䗱⻊䪮助䧴垷䒭 28.8%37.4%靈灇⿬♸罏䨾㖈絆絉僽や⢪欽DCT Ⱒꝶ䪮助eCOA/ePRO/eDiaryծ鵴玐港叅ㄤ歏㶩佅➰涸⢪欽桧儑衼㟞⸈կeCOA/ePRO/eDiary涸⢪欽桧➢2023䎃涸19.3%㣐䌴副⼮荛2024䎃涸29.3%邍僈遤⚌姻劊满刿⟄䝖罏⚹务䗱涸侨研佐꧋倰岁鲮」կ鵴玐港叅涸⢪欽桧➢16.6%㟞Ɤ荛20.5%鵯䖤渤✵㼆⚰䎯梠㞯㢪䭯絯㹊傞侨研佐꧋涸꨽宠կ歏㶩佅➰涸⢪欽桧⛲➢2023䎃涸12.9%副⼮荛2024䎃涸16.8%儑爙ⴀ歏㶩佅➰㖈䲿넞DCT餒⸉❜僒鷳僈䏞ㄤ鵘蠒佪桧倰꬗涸馋⸷կ歏㶩彂侨研♸EDC涸㼆䱹儑衼㟞⸈➢2023䎃涸7.1%副⼮荛2024䎃涸11.3%皍⻊✫侨研盗椚կ歏㶩濼䞔ず䠑涸⢪欽桧➢11.4%㼭䌴副⼮荛12.8%邍僈歏㶩濼䞔崨玐涸鷶姿兜⿺կ㽴盗鵴玐⼕毫瘝䪮助㔔氋䞔た꬗㼆꬗ㅐ霧涸䛪㢕罜殜剣♴꣭告Ⱖ➭䪮助㥵