中国隐形正畸行业白皮书.pdf

中国隐形正畸行业白皮书2904(ICD)(Fellow)SCIInternational Journal of OralSciences0168I.II.III.IV.V.CONTENTS10-2000-11malocclusiondental and/or skeletal discrepancyWHOhandicapping dentofacial anomalyAngle1899IIIIII12II/III20-25%35-40%45-50%II/III%20222022II/III202258213510X8.82505371,041X4.2/70%II/III45-50%20-40%X=10II/III50-88%45-87%45-90%72-85%11 55-90%136-86610-12283252%71%7379%/III/III/LeFort I/14/ActivatorHerbstFR III/15/242-3202-3242-3242-34-845-608-12153-5604-845-600.5-31.2-5.53.5-62-3.5160602040802010212000200520132014201520162017201820191220212022344425830452020/20072008-201515102016-20212010020222100151020062009201320172019202120222022202216/20062010NMPA20101/220002010022200172/2200020073D2010660A20121700B20113D20152018MESFDA2019C2020202612021BPre-C2022IPSmartee TeenIPD2022Aditek 51%20142011-18G4G5G6G6E2015A6A72016angelalign Pro2018angelalign KiD2019A8S8S92020-23S10-20GI2021C32022A7 Speed2022MOOELI182014.1112016.101112016.121112017.022017-2025112019.022019-20251112019.061112021.0112021.08112021.03203512022.022021-2025112022.05“2022.072022112022.09112022.1012022.1112023.03202311191/2 2010220224282021201842192010201920202022133931373244352647492017362010/17-2250%100%201520052025151240%20%2005201520251512I.II.III.IV.V.CONTENTS22-20002010-70%-162320151.2202121,0001,500201520212,00020400201520330%50-90%60%/80%/28%/47%2015/21/30E92184371201520212030E2015/21/30E43102245202120152030ECAGR2015-212021-30E12%8%CAGR2015-212021-30E16%10%/97%201550016%/24CAGR2015-212021-30E16%7%13%9%7%9%12%8%3337414548445062105364351617365759516124293542515459711062019371202120151631082016201720181842025E20202030E921271481722282015-2030E252015-2030ECAGR2015-22CAGR2022-30E%2015-2030E2015-2030E=10.3%10.8%20152025E202020222030E010,00020,00030,00040,00050,000201520222025E20202030E0%10%20%30%40%20152030E202020222025E1.72.64.06.89.910.613.112.013.716.118.922.125.830.034.940.4202020172015202220162018201920212023E2027E2024E2025E2026E2028E2029E2030ECAGR2015-22CAGR2022-30E2015-2030E32.6%16.4%26 3DCBCT/18/3D/27NMPA3192132658922006-20142021-20222015-20162019-20202017-201813265892+59%2006-20222021-20222019-2020 1 6-1010 2-5 2006-201828 1000 3,000-6,0007,000 1.000-3,000 0%5%10%15%20%25%0.0%0.5%1.0%/22%26%53%52%24%22%20212022/%2022%2021-222923.1%202040.2%19.4%40.3%41.1%34.235.9%202141.7%31.8%26.5%202244.644.12020-20222023200020032006201320162017COMFOS201820102018Invisalign Go2022Invisalign Adult/Standard2019GS2021G II2022Smartee TeenSmartee Teen2015clickOS2022Alpha20172021C32016201920222022MOOELI2017Ortho Plus2023ClearCheck20212015GeSmarteeLink2019Invisalign First2020Invisalig Moderate30/SaaS/3D/SaaS3D3D/31/3D/A-TreatGSGI/M6EX 30/40321/3IOFCOS21IOFInternational Orthodontics FoundationIOF2022615IOF20236332021620228202362021202220231985199119942007Andrews200920152022COS332/3A-TECH2014 201420152016201720182019202020212022A6A7angelalign PromasterForcemasterControlmasterMultiA7 2.0Make itA8angelButtonangelArmIRSMEmasterControl SIRS 2.0angelAttachA7 SpeediOrtho 10.0MOOELI2021102021420158A-TECH2021618202282023angelLinkMOOELI343/32022120199202320179202022002022202112-2020122021122420201035/20221016/30%A30%30%70%270%/70%AB100%80%60%40%362,0005,00020%40%4,0008,00030%50%3,0006,00060%7,00070%9,00010,00010%11%AB30%70%AB100%70%A1 I.II.III.IV.V.CONTENTS38-20-39 Angel EBegg Angel Tweed-Merrifield Andrews R-W AndrewsSWARoth SWASL40*1997Kesling1945SthridanRaintree Essix1993Zia ChishtiKelsey WirthAlign TechCAD/CAM1998*Align TechFDA20002003CFDA2006CAD/CAM41CAD/CAM1930s1970s1990s-421432/43124CAD/CAM354411 Andrews/451Biomechanics of clear aligners:hidden truths&first principles,Journal of the World Federation of Orthodontists生物力学研究关键问题隐形正畸生物力学parathyroid hormonePTH/PTHrPCT-46120212Chen-Lu,et al,Colour stabilities of three types of orthodontic clear aligners exposed to staining agents,International Journal of Oral Science,2016TPUEVAPPPCPETGPE27TPUPETGTPU471.0/CAD/CAMClinCheckOrthoDS2.0iOrthoClinCheckiTero3.0MEiOrtho19982012120122018120181/1.02.03.0CAD/CAMSaaS1 SaaSSaaSMEIRSMEMEMOOELI4820222018+1402863D3DiTero模型处理&排牙设计患者牙颌数据牙模3D打印矫治器热压膜成型智能分拣矫治器边缘切割矫治器清洗与包装49-COMFOSiOrthoMake itICSIRSMOOELImasterControlmasterControl SangelButtonangelArmangelLinkComprehensiveModerateGoFirstAdultStandardiTeroClinCheckOutcome SimulatorEX30/40SmartTrackMAPower RidgePower ArmMEmasterForcemasterControlA6A7A8A7 SpeedSmartStageSmartForceSmartTrackG4G5G6G6E2010-2013A6A7A8G3G5G6G72014-20152016-20172018-20192020-2023A7 SpeedSmartTrackmasterControlmasterForce masterControl SSmartForce/angelLink50-masterControl-masterForce-ME以三大平台为基础构建研发闭环MEmasterControlmasterForcemasterForce高精度实景力学平台测试正畸生物力学全景计算机精确定量的隐形正畸复杂施力系统完整力学数据精确释放预期矫治力masterForcemasterForcemasterControlA6 A7 A8 51COMFOS20172006201620183060masterControl masterControl SmasterControl6-12A6 A7 A8A7 SpeedmasterForcemasterControlmasterControl S52/KiD+masterForcemasterControlmasterControl S masterForcemasterControlmasterControl SAI IIIII53多款革新数字诊疗工具iOrtho：数字化正畸智能服务平台 masterForceME3DIRSiOrthoMake itMEIRSCBCTCBCT1:1masterForceMEMake itMake itMOOELIiOrthoMOOELI541SmartTrackSmartStageSmartForce iTeroexocadSmartTrackSmartStageSmartForce iTeroClinCheckInvisalign system1Invisalign system55 SmartSmartForce SmartTrackSmartStage 2013/SmartTrackEX30141000+10ClinCheckSmartForce*SmartTrackSmartStage SmartForce56Invisalign GoInvisalign ModerateInvisalign ComprehensiveInvisalign FirstInvisalign GoInvisalign Moderate9920/26I,II,III,/I/Non-ComprehensiveComprehensiveG4G5G61 2012SmartForce 2014 2015G6SmartForce SmartStageInvisalign StandardIIIInvisalign AdultIII6065571/21Johan Hartshorne,Mark Brian Wertheimer,Emerging insights and new developments in clear aligner therapy:A review of the literature,AJO-DO Clinical Companion,20222Nada Haouili,Neal D.Kravitz et al,Has Invisalign improved?A prospective follow-up study on the efficacy of tooth movement with Invisalign,AJO-DO,2020A7A8G6G8A6MAIRS发表于AJO-DO的前瞻性队列研究2隐形正畸技术在过去10年实现了显著进步AJO-DO 2020HaouiliKravitz200941%50%200920202020582/220212021”II/59011Johan Hartshorne,Mark Brian Wertheimer,Emerging insights and new developments in clear aligner therapy:A review of the literature,AJO-DO Clinical Companion,20222Madhur Upadhyay,Sarah Abu Arq ub,Biomechanics of clear aligners:hidden truths&first principles,J.World Fed.Orthod,20213Albertini et.al.,Stress Relaxation Properties of Five Orthodontic Aligner Materials:A 14-Day In-Vitro Study.Bioengineering,2022112345隐形矫治器材料的应力中断现象比较明显，对转矩等特殊移动形成了一定制约。一旦形成材料方面的革新，隐形正畸生物力学性能会上一个新台阶。在目前条件下，我们可以积极利用生物力学进行一些规避，探索更好的应用方法及解决方案。“”2050010001500200025003000Ni-Ti603D1Johan Hartshorne,Mark Brian Wertheimer,Emerging insights and new developments in clear aligner therapy:A review of the literature,AJO-DO Clinical Companion,20222Nic Shirey,Gustavo Mendonca,Christian Groth,Hera Kim-Berman,Comparison of mechanical properties of 3-dimensional printed and thermoformed orthodontic aligners,AJO-DO,20233Dvs.3D/+Dental LT/Accura 60 SLA/Material X/OD-Clear TF1PET/PETG/TPU/PC/PP/EVA3D3D1141393860537EX303DMaterial X3DOD-Clear TFMPa2%2%3D212%3%3D3D61主要趋势发展路径iOrthoGPT621 202212312 11/2022.11CMDE2022.093D2022.082022.063D2022.052022.052021.032020.022016.032016.032011.122/39976974414232193151628638646745541321105141101400102I.II.III.IV.V.CONTENTS64-204080-65/中国优秀正畸人才仍有缺乏，目前，系统的规范化培养体系还没有建立，几大院校之间也存在较大差异。相关领域的基础研究仍然缺乏引领性、综合性人才，我们要给基础研究时间、支持和试错机会，才有望实现产业上的突破。“”661960s2003111980s1 200867AJO-DO19962022Web of ScienceWeb of ScienceAMERICAN JOURNAL OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS(/)OR AMERICAN JOURNAL OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS OFFICIAL PUBLICATION OF THE AMERICAN ASSOCIATION OF ORTHODONTISTS ITS CONSTITUENT SOCIETIES AND THE AMERICAN BOARD OF ORTHODONTICS(/)and Case Report()and PEOPLES R CHINA/USA(/)19972022Web of Scienceorthodontics()AND China/USA()and Web of Science()3028353844484630262928262822191634563535312005201112000 2002140134222006522012 2013362014 201520202016 2017 2018 20192220211202224312947513629172833211263111511142321162823423048263563 63749410107082 818652825871798597 9610786114951128913786122122136126120117681 1.31.220212021202130%70%30%70%12017-21/25E/1416172022312017201820192025E2021202012021/2021/226086x2.70.53.26.0 x7.01 WHO692-3105-8*3-5500IOF IOF70 202130%90%7120196A-TECH 2017UCLAEAUCLA 2019 2022722003801500713TweedCharles H.Tweed20081220239135734/420 A-TECH10GS102530 2018-74政策、学界、厂商各方共同探索更科学、更符合中国国情人才培育体系IOF2021I.II.III.IV.V.CONTENTS76-/-77%2015/2022/2030E0%10%20%30%40%50%0%10%20%30%CAGR 22-30E%20222030E-2015100202240025%-2030/-2015202235%-2022203020%78“2030”5-1079Web of Science1996-20221288177202020192021270/2019-20215,70012,50020092021+119%2009/20215042772019202020212019-2021CSA200204060801001201401995 2000 2005 2010 2015 2020 20258012/3456781/2023E2021202260%40%70%30%/5%18%45%77%2021%2021-2023E%2022/70-80%20-30%/1-21-5mm1-5mmII22mm455mm20822015202026%33%+27%2015/20201526%202030%.01248010020020222610%832020202140.2%202240.3%41.1%35.9%41.7%31.8%+5%20032010奥博资本投资的660万美元A20121700B201520211202162078.16580070173400131%183%401131.79%664.9202220202021+32%2017201420132019201520162020201820212022+30%30%32%41%2021480183%1684004011.3841 Pre-XXPre-AA2 1320171820152010201920122014201620182020202120224386101752BDEACIPO12010-202220102011B2016DTC3D20212016%2010-20222%2020-20222021-2022202015%14%77%2%14%3%59%63%2010-20168%3%6%5%6%8%6%2017-20207%3%2021-202222%78%62%38%3D/8520212022+16%/2021/2286EMEA3APAC4$0$1,000$2,000$5,000$10,000$20,000$50,000$100,000$200,000GDP2020XXXXXXXX/125206715780APACEMEA1 20222 /3 EMEA4 APAC872018FDAAditek2023200320032022Aditek 51%40Aditek 1990 1996 2012ANVISA2018FDA/Aditek