2025年全球新药研发格局及BD交易趋势报告

Shuhua Zhou（周淑华）Ph.DCiteline26th Aug2025 C I T E L I N E . C O M Our Mission: Smoothing Access To LifeSaving Therapies Outline TheglobaldrugR&Dpipelinein202501 02Partnership trends 03Outlook in future TotalPipelineSizeHasGrownby4.6% 23,875Drugsunderactivedevelopment Expansionrateslightlylower▪2024wasup7.2% 1,050moredrugsindevelopment▪4,546newdrugsidentifiedandadded Newdrugstatistics▪38.8%wereanticancers ▪13.8%neurologicals Novartisaddedthemostnewcandidates▪38added,JiangsuHengruiadded36 Chinaclosesthegap▪1,683newdrugsinUSdevelopment ▪1,495newdrugsinChinesedevelopment BreakdownofThePipelinebyPhase Growthatallclinicalstages ▪PhaseIupby6.8%▪PhaseIIupby6.3%▪PhaseIIIupby8.8% Preclinicalupby1.8%▪Lowerthan2024’s5.5% R&DPipelinebyTherapeuticArea 2025vs2024 OncologyremainsthebiggestTA▪9,746drugsin2025 ▪Expansionof3.7%from2024,lowerthantheglobalpipelineexpansionrate▪39.7%ofalldrugs,downfrom40.1% Neurologicalalsobelowtheaverage▪4.2%growthratefrom2024to2025 Alimentary/metabolic stalled,aftera13.1%growthratein2024 Anti-infectiveR&Dactuallydeclined▪Pipelinesizefellby2.4% Top25CompaniesbyPipelineSize ▪Pfizerreturnstothetopspot ▪SwissrivalsRocheandNovartisfollow ▪SanofimakesbiggestjumpwithinTop10 ▪JiangsuHengruiPharmaceuticalsfallsoutoftheTop10afteritslandmarkdebutlastyear ▪ButfurtheradvancesfromotherChinesecompanies,andstrongJapanesepresencetoo ▪Top10companiescontributed5.4%ofalldrugs,Top2510.0%.19.4%comesfromcompanieswithjust1or2drugs Pharmaprojects,Jan2025 DiseaseFocusAreasofTheTop10PharmaCompanies Pharmaprojects,Jan2025Cancerremainsthetopfocus ▪BMShasthelargestcancerportfolio,with 144ofitsdrugsbeingoncology-focused▪Therearenow3Top10companieswhichdon’thaveoncologyastheirprimaryarea Bigpharmamaintainsdiverseportfolios ▪GSKexhibitsstrongpreferenceforanti-infectives▪EliLillygoesforalimentary/metabolics▪5/10companieshavedrugsindevelopmentinall14TAs,5/10donotincludehormonalproductsorantiparasitics▪Overall,signsofdivergenceinTopcompanies’focuses Breastcancerremainsontop▪Big9.5%pipelinesizeincrease LeadoverNSCLCin2ndmaintained▪10.0%pipelineexpansion EntireTop6allcancerindications▪Prostatecancerreplacesbraincancer Type2diabetesreturnstoTop10diseases▪12.8%pipelineincrease 8oftheTop10arestillcancerindications Non-cancerindications▪CoronavirusdropstooutofTop10 ▪Alzheimer’sremainstheonlyothernon-oncologydiseaseintheTop10▪43.3%increaseintheR&Dofdrugstreatingobesity,astheWegovy/Mounjaroeffectescalates Top25DrugProteinTargets I-O-basedtargetsprevalentintop25▪CD3etopforasecondyearinarow EGFRreplacesHer-2inrunner-upposition ▪Establishedtargetforbreastcancer,NSCLC,colorectalcancerandmanyotherformsofcancer Top6targetsfocusedonanticancerindications▪Asare8outoftop10 GLP1Rnow4thmostpopulartarget▪Increaseof32% Top20PharmaCompaniesWithaRareDiseaseFocus 7.8Kdrugsfor786rarediseasesunderdevelopmentat3.8Kcompanies Novartiscomesoutontopwith132drugs▪Overhalfofitsdrugsforareforrarediseases ▪TieswithAmgenfortopcompanywithhighest%againstrarediseases(52.0)▪Pfizer,BMSandRochealsohave>100drugs EliLillyhasthelowestpercentagewithjust26.3%▪JiangsuiHengruinextwith28.3% TherapeuticAreaFocusofRareDiseaseR&D Alimentary/Metabolicaccountsforlargestshareofraredisordersat18% ▪Manyrareinheritedgeneticconditionscausemetabolismdisorders▪Butaccountsforonly6%ofrarediseasedrugR&D Cancerdominatesintermsofdrugs,ifnotdiseases ▪Accountsforonly13%ofdiseases▪Buthaslargestshareofdrugsindevelopmentforrarediseasesat41%▪Morethan3xnearestrival,Neurologicals BiotechDrugs:Monoclonalantibodies Over4KMAbsindevelopment Humanizedandhumanmonoclonalsthemostpopularstrategies Bigincreaseinthedevelopmentofbispecificantibodies Bispecificcellengagersalsoahotstrategy R&D enginesTripolar innovation ecosystem asChina’s emergencesqueezes Europe into a distant third Outline TheglobaldrugR&Dpipelinein202501 Partnership trends 03Outlook in future Business Development Pharma–Commercialisation Biotech–Early Innovation Cash and Innovation Flow in Pharma Large Pharma R&D Spend Efficiency Upfront ratio in China BD deals Preclinical is the most deals phase Preclinical is the most deals phase 11% of active pipeline with partnership in China company Outline TheglobaldrugR&Dpipelinein202501 02Partnership trends Outlook in future What are Industriesfocusing on in today’senvironment? Forecasting with Evolving Assumptions at Various Drug Life Cycle Better business decision withopportunity assessment Outcome & value: Detailed analysis of asset/TPP positioning, commercial potential, and valuation, incorporatingscenarios for key variables and value drivers Find Opportunity. Accelerate Growth.Clarify Risk. Thank You ShuhuaZhou（周淑华）Ph.DCitelineGreater ChinaMobile:+86 13764291718 (WeChat)Email:shuhua.zhou@Citeline.com