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艾昆纬：2024全球肿瘤研发趋势报告（英文版）

医药生物2024-05-01-IQVIA善***

AI智能总结

全球肿瘤趋势概览至2028年

概述：全球肿瘤治疗领域正面临显著增长与挑战。预计至2050年，癌症患者人数将大幅增加，特别是在低收入国家。新疗法的开发与应用为提升生存率和生活质量提供了希望，但全球肿瘤社区和患者仍面临治疗可及性和质量的不平等问题。

趋势：

癌症发病率与死亡率：未来几十年，癌症发病率预计会显著增长，特别是在低收入国家。这突显出对新疗法的需求以提高生存率和生活质量。
研究与开发活动：尽管2023年肿瘤临床试验启动数量有所下降，但仍比2019年高出11%，其中关注实体瘤的试验占比最大。新兴生物制药公司占总试验启动的60%，比十年前增加了27个百分点。中国公司参与临床研究的比例从5%上升至35%，显示其在肿瘤研究中的日益重要角色。
新型疗法：细胞和基因疗法、抗体药物偶联物（ADC）、多特异性抗体等新型治疗模式展现出巨大潜力，并成为临床研究的焦点。PD-1/PD-L1抑制剂在过去五年内增长了29%，并被广泛应用于多种肿瘤的早期和晚期治疗。CAR T细胞疗法试验数量在过去一年超过250项，主要针对血液系统恶性肿瘤，但也逐渐扩展至多种实体瘤。
临床开发生产力：2023年，肿瘤复合成功率提高了10%，所有阶段均有所改善，尤其是在罕见肿瘤和实体瘤研究中。尽管整体复杂性略有增加，但与其它疾病领域相比，肿瘤试验的复杂度降低了8%。尽管入组患者数量减少11%，但由于“白空间”（即完成一个阶段到开始下一个阶段的时间）的增加，整个项目的平均长度仅缩短了五个月。这导致2023年肿瘤临床开发生产力提高了23%。

新型活性物质： 2023年，全球有25个新的肿瘤活性物质（NASs）上市，自2014年以来总数达到192个。中国的NAS上市数量超过了美国，显示了国内创新的重要性。欧洲的NAS引入速度放缓，导致某些创新药物在欧洲的可用性滞后于美国。美国2023年引入了18种新的癌症药物，更多关注罕见癌症、重组药物，并基于单一临床试验获得批准。欧洲药品管理局（EMA）在2023年批准了8个用于血液学癌症的NAS和5个用于实体瘤的NAS，相较于前一年有所减少。

患者获取与科学进展的应用：全球癌症治疗方案的数量自2019年来平均每年增长9%，得益于更高的癌症发病率和更好的医疗可及性。尽管如此，新型癌症疗法的患者获取存在不均，各国之间的生物标志物检测率、新型疗法采用率和先进疗法输送能力存在差异。免疫检查点抑制剂的使用激增，各国之间的人口平均水平存在显著差异。这些疗法现在被用于更广泛的肿瘤早期治疗，并被用于更多类型的肿瘤。女性癌症、前列腺癌和晚期多发性骨髓瘤的治疗已取得进展。

GlobalOncologyTrends2024 OUTLOOKTO2028 MAY 2024 Introduction Latestestimatesindicatethatthenumberofpatientsaffectedbycancerwillincreasedramaticallythroughthemiddleofthecenturyacrossallregionsoftheworld.Atthesametime,theinnovationecosystemthatdiscovers,develops,anddeliversbreakthroughtherapiesinentirenewareasofscienceisoperatingnearpeaklevels.Risingincidence,increasingnumbersoftreatedpatients,andtheresultingexpectedgrowthinspendinginthisareawilltriggeranarrayofcomplexchallengesoverthenextseveralyearsthatarereflectedinthetrendshighlightedinthisreport. Ourresearchprofileslatestavailabledataoncancerincidenceandsurvival,thecurrentstateofresearchanddevelopmentactivityinoncology,including keymechanisms,targetsandcancertypesbeinginvestigated.Wealsolookatmetricsofclinicaldevelopmentproductivity.Asmorenovelcancermedicinesarelaunched,patientaccessanduseofthosedrugsvarywidelyaroundtheworldandbysomemeasuresthegapsbetweenthescienceandpatientsisexpanding.Trendsintheuseofnovelmechanismsin specificcancertypesarereportedhereaswellascurrentexpectationsforhowspendingdynamicswillplayoutoverthenextfiveyears. Together,thiscontentisintendedtoprovideanevidencebasethatencouragesmulti-stakeholderdiscussionaboutpriorities,policies,andactionsthatcanbetakentoimproveindividualpatientoutcomes,populationhealth,andsustainabilityofhealthsystems. ThisstudywasproducedindependentlybytheIQVIAInstituteforHumanDataScienceasapublicservice,withoutindustryorgovernmentfunding.ThecontributionstothisreportofVaibhavBhalotia, TanyaBhardwaj,HeenaDarira,JuliaKern,KimMehle,BhagyashreeSitaramNawar,UrvashiPorwal,SurbhiRohilla,DurgeshSoni,TanushreeThakuranddozensofothersatIQVIAaregratefullyacknowledged. FindOutMore IfyouwishtoreceivefuturereportsfromtheIQVIAInstituteforHumanDataScienceorjoinourmailinglist,visitiqviainstitute.org. MURRAYAITKEN ExecutiveDirector IQVIAInstituteforHumanDataScience REFERENCINGTHISREPORT Pleaseusethisformatwhenreferencingcontentfromthisreport: Source:IQVIAInstituteforHumanDataScience.GlobalOncologyTrends2024:Outlookto2028,May2024.Availablefromwww.iqviainstitute.org ©2024IQVIAanditsaffiliates.Allreproductionrights,quotations,broadcasting,publicationsreserved.Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopy,recording,oranyinformationstorageandretrievalsystem,withoutexpresswrittenconsentofIQVIAandtheIQVIAInstitute. GlobalOncologyTrends2024:Outlookto2028 Tableofcontents Overview2 Trendsincancerincidenceandmortality4 Oncologyresearchanddevelopmentactivities9 Oncologyclinicaldevelopmentproductivity23 Novelactivesubstancesinoncology32 Cancerpatientaccessanduseofscientificadvances47 Spendingononcologymedicines59 Notesonsources66 Appendix67 References69 Abouttheauthors70 AbouttheInstitute71 Overview Newtherapiesforadvancedcancersandsomeofthemostadvancednovelscienceareunderdevelopmentorhavebeenrecentlylaunched.Thesetherapiesrepresentthelargestareaofcollectiveresearchandthelargestoverallareaofdrugspendingacrossallofhealthcare. Newtreatmentsinoncologyareincreasinglybecominghighlytargeted,providingprecisionmedicineforsubpopulationsofpatientsthatmaynothavebenefittedfromtraditionalstandardofcare.Despitesignificantadvancesintreatment,theglobaloncologycommunityandpatientscontinuetostrugglewithdisparitiesinaccessandcare.Theoutlookforthenextfiveyearsincludesthecontinuationofsomeofthesetrendsandshiftsinothers. TRENDSINCANCERINCIDENCEANDMORTALITY Cancerincidenceisexpectedtorisesignificantlythrough2050,particularlyinlower-incomecountries,withanincreaseofover12millionnewcasesannually.Thegrowingdiseaseburdenunderscorestheurgentneedfornewtreatmentstoenhancesurvivalandqualityoflife.Disparitiesin5-yearcancersurvivalacrosscountries,evenwithsimilarGDPlevels,indicatethatdifferenthealthcarestrategiesmayleadtobetteroutcomesforcertaincancers.Thevariabilityincancerseverityandprogression,alongwithhealthcaresystemdifferences,suggeststhattailoredstrategiescouldbemore effectiveforcertaincancers,includingearlydetectionorenhancingsurvivorshipandqualityoflife.Benchmarkingandsharingbestpracticesacrosscountriescouldhelpaddressvariationsandoptimizecareforcancerswithsignificantdifferencesinsurvivorship. ONCOLOGYRESEARCHANDDEVELOPMENTACTIVITIES In2023,oncologytrialstartsdecreasedbutwerestill11%higherthanin2019,withafocusonsolidtumors.Emergingbiopharmacompaniesaccountedfor60%ofthesetrials,asignificantincreasefrom33%adecadeearlier.China-basedcompaniesareplayinganincreasingroleinclinicalresearch,representing35%oftrialstartsin2023,upfrom5%adecadeago.Novelmodalities,includingcellandgenetherapies,antibody-drugconjugates(ADCs),andmultispecificantibodies,show significantpromiseforcancertreatmentandrepresentagrowingshareofclinicalresearch.Trialsinvolving PD-1/PD-L1inhibitorsgrew29%overthelastfiveyears,withthesetherapiesbeinginvestigatedacrossmoretumorsandearlierlinesoftherapy.Morethan250trialstestingCART-celltherapiesinoncologystartedin2023,withmostbeinginvestigatedforhematologicalcancersbutincreasinglylookedatacr

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