Mapping Emerging Trends to Understand Transformation in the Oncology Sector

1. MappingEmergingTrendstoUnderstand TransformationintheOncologySector • Overview • Substantialprogresstoward precisionmedicinesand continuedinnovation acrosscancerdiagnosis& treatmenttechnologieshaveled to phenomenalspending oncancercare.Theglobalexpenditureon cancermedicinedevelopmentwascloseto$200billionin2022,which isanticipatedto surpass $350 billionby2027.TheU.S.has beendominatingtheglobaloncologymarket,followedbymajor countriesinEurope.Inthelastfiveyears,China’soncologyspendingsurgedby$6.8Bnowingtothe expandedaccesstonewtherapies,increasingentrantsinthemarket,and offsetbylowerprices. • How hastheOncologySectorevolved inthe pastseveralyears? • During the lastdecade, the oncology landscapehas witnessed a transformative evolution characterized by strides in immunotherapy, precision oncology, and the integration of AI- drivensolutions.Someofthe keytrends drivingtheoncologysegmentareexplainedbelow: • Thecountof oncologytrials startedin2022remainedhistoricallyhigh,up22%from 2018,and primarilyfocusedonsolidtumorsandrarecancers • PhaseIItrials,includingPhaseI/II, IIa,andIIb,holdthelargestshare,with49%of oncologytrials startedin 2022beingPhaseIIcomparedto41% accountsforPhaseI and10%forPhaseIII. • Althoughtrialsrelatedtohematological cancersaresignificantlylowinnumber,the countincreasedby30%from2017,reachingmorethan550trials startedin 2022. • Emergingbiopharmacompaniesareleadingtheoncology-relatedinnovationandwere responsible for71%oftheoncologypipelinein2022,up from45%adecadeago • Thenumberofproductsunderdevelopmentincancertherapeuticshasremarkably increasedover thelastdecade,withmorethan2,000productsinthepipeline. • SincetheCOVID-19globalpandemic,theoncologypipelinegrowth patternhas becomesluggish,withanaveragegrowthofjust5% over thelasttwoyears. However,15% growthhasbeenwitnessedintheemergingbiopharmapipeline comparedtoa13%declineacrosslargercompanies. • Chineseenterprisesaregainingtractionintheoncologypipeline,accountingfor23% in2022, up fromonly5%adecadeago • Products from China-headquartered companies represented 23% of the oncology pipelinein 2022,upfrom10%fiveyearsagoand3%in 2007. • The U.S.shareoftheoncologypipelinehasfallen5% over thepast15yearsbut remains above40%.WhileEurope’s sharedeclinedto21%in 2022,downfrom26% fiveyearsago.

2. Theinitiation of PD-1/PD-L1inhibitor trialsper year grew 54% over thelastfive years,with81%ofongoinglate-stagetrialsinsinglecountries • In2022,1,236trialsstartedgloballytestingPD-1/PD-L1inhibitors,whichhas droppedby11%from2021butis upby54%from804trialsthatbeganin2017. • Outofover3,000ongoinglate-stagePD-1/PD-L1trialsin 2022,81%werebeing conductedin singlecountries. • China has 1,287 ongoing late-state PD-1/PD-L1 trials that are only being conducted domestically and reflect that the drugs being tested in these trials may not be bound forinternationalmarkets. • Sixbispecificantibodiesarecommercializedforoncology,withmanyinthe developmentphaseforrarehematologicalcancers • Therearecurrentlysixapprovedbispecificantibodiesforcancertreatment—threefor hematologicalcancers andthreeforsolidtumors—includingthebi-specific T-cell engagers (BiTEs)blinatumomabandtebentafusp. • Morethan 130bispecificantibodiesarecurrently inthedevelopmentstagesforcancer treatment,with 67% oftheantibodiesbeinginvestigatedto treatsolidtumorcancers, 24%forhematological cancers,andnearly9%beinginvestigatedforboth. • Over 50% of bispecific antibodies are in early clinical development, with only 7% of those under investigation for hematological cancers and 5% of those for solid tumors currentlyin PhaseIIItrials. • Thenext-generationbiotherapeuticpipelineisfocusedoncelltherapies,particularly CAR T inhematologicalcancers • In2022,194next-generationbiotherapeuticsforhematological cancerswereunder development,upfrom14adecadeago,and254forsolidtumors,upfrom73. • Across all therapy areas, oncology accounts for 42% of the next-generation biotherapeuticpipeline,highlightingsignificantresearch andpromiseforusingthese productstoimprovecareforcancerpatients. • Drivenbythesuccessof COVID-19vaccines,thedevelopmentof mRNAvaccinesfor solidtumorshasmorethandoubledsince2017 • TheCOVID-19pandemicbroughtincreasedinterestinmRNAvaccines,andthepace withwhichthesevaccinesweredevelopedwaslargelyduetodecadesofresearchon mRNAvaccinesin oncology. • Whileoncology madeupthelargestproportionofthepre-COVID-19mRNAvaccine pipeline,theoncology-focusedmRNAvaccineshavenotdrasticallyincreasedsince thenandaccountedfor8%ofthepipelinein 2022. • DevelopmentofmRNAvaccinesforcancertreatmentiswhollyfocusedontreating solidtumors,withlessthan40% ofthetargetingspecificsolidtumorindicationsand mosttargetingarangeofadvancedsolidtumors. • Severalongoingandnewtrendsthatwill likelyelevatetheoncologysectortonewpeaks

3. 1.Novelmodalitiesandemergingtargets: • Anextensivepipelineofmulti-specificantibodies(e.g., TrAb,quad-specific)is engineered to enhancetheantitumoreffectbyredirectingimmunecells,suchas Tand NKcells,tospecifictumorantigens.Whiletargetingmultipleantigensresultsin significantimmuneresponsesagainsttumors;optimizationisstillneededtomitigate thechallenges,suchasinvivodurabilityandoff-targeteffects. • Non-coding RNAs are being explored as potential targets (e.g., piRNA in lung and breast cancer) and as diagnostic markers to guide risk stratification. This may open new RNA-related therapeutic opportunities once optimal drug delivery, tolerability, andspecificityarerealized. • 2. Novelmodalities,targetedtherapies andtheiruseinearlierLoT: • ADCs,BsAbs,andCAR-Tshavesucceededinlate-stagediseaseandareanticipated tocontinueadvancingintoearlierline oftherapies(LoT)[e.g.,CARTapproval in2L DLBCL;CAR Texpansioninto1LDLBCL]. • PD-1/PD-L1inhibitorsandtargetedtherapyarealsoshifting towardsearlierLoT [e.g.,nivolumab+chemoin resectablenon-small-celllungcancer(NSCLC); osimertinibinEGFR+adjuvantNSCLC].Also,additional immunotherapiesare anticipatedtoenterearlierlinesto becomeSOC. • Recently announced regulatory programs, such as Project Frontrunner—an initiative to enable drug approval in earlier LoT to help accelerate innovation in oncology—is anticipatedtoencouragestakeholders toreimagineoncologyR&D. • 3.Novelcombinationstotargetdrugresistance: • Giventheeventualleapfrogging ofnovelmodalitiesintoearlierlines,awide poolof treatment-resistantpopulationisanticipatedtoemerge.Itwillrequirecreative therapeuticcombinationstoprovidepatientswiththerapyoptionswithadurable response.Mixedprogresstodatein successfullycombiningtherapies(e.g.,failure of pembrolizumab+lenvatinibinmelanoma;pembrolizumab+mRNA-4157/V940 demonstratedsuccessfulsignalinmelanoma). • 4.Nextwave of IOtargets beyondPD-1/PD-L1: • ImmunecheckpointtargetssuchasLAG-3andTIM-3haveemergedwithpositive resultsinmelanomaandothers,pavingthewayforinnovationinimmunotherapy beyondPD-1/PD-L1.Thiswillenablepotentialcombination therapieswith existing PD-1/PD-L1toprovideenhancedimmunomodulatingeffects. • 5.Clinicalprogress of mRNA cancervaccines: • COVID-19mRNAvaccinesuccess acceleratedinterestinthepotentialofmRNA vaccines totargettumors enablingexcitingcombinationstudies[e.g.,BNT 122+ atezolizumab(PDAC),BNT111+cemiplimab (melanoma)]thatareanticipatedto advance tolate-stageclinicaltrials. • 6. Disease/patientsegmentationbasedon biomarkersidentification: • Therewillbecontinueddiseasefragmentationbased onnovelbiomarkers(e.g., Trop- 2,CEACAM5)supportinginnovationintargetedtherapy. • Technologies thatenablesequencingaccuracyfromsolidandliquidbiopsies to identifybiomarkerswill drivebiomarkeruseforpredictiveandprognosticpurposes. • 7.Integrationof ctDNAuseinclinicalcare:

4. ctDNAwill increasinglybeusedatdifferentstepsofthepatientjourney,rangingfrom earlydiseasedetectiontounderstandingdiseaseresistancemechanisms. • Advancement of sequencing accuracy will ensure a multitude of ctDNA/MRD usage, includingthepotentialtobeusedas asurrogateendpointin clinicaltrials. • Conclusion: • Afterwitnessingaremarkable evolutionintheoncologysectormarkedbysignificant advancementsinprecisiontreatments,immunotherapy,andAIintegration; IeBexperts precisely anticipate the potential opportunities andchallengesin the cancer care field.Based on the ongoing and emerging trends, we assist biopharma enterprises in efficiently developing drugs and equipment for cancer care through technology benchmarking, market foresighting, competitiveintelligence, opportunitylandscaping,Go-to-marketstrategy,andother key services. • To gather deeper insights that can remarkably thrive your business operations, connect with seasonedIeBhealthcareexperts byemailingthematcontact@iebrain.com. • Formoreinformation,pleasevisitbelowpageandscheduleacallwithourexperts@ https://www.iebrain.com/mapping-emerging-trends-to-understand-transformation-in- the-oncology-sector/ • About Ingeniouse-Brain:– • Ingeniouse-Brainprovideshigh-quality,customized,andcost-effectiveTechnologyResearch, BusinessResearch,and Intellectual Property Research solutions toindustryleaders, and innovative companies across the globe. Innovation, knowledge, and transparency form the basis of our company’s mission and vision. Along with cost benefits, we provide highest qualityresultsensuring fool-proof confidentialityandsecurity.Weare an ISOcertified companywithofficesin IndiaandUSA. • Ingenious e-Brain has a strong team of analysts, and subject matter experts with domain proficiency which is devoted to help clients grow. Our highly qualified professionals offer tailored, value-added and cost-effective services to our clients. We believe in building long termrelationshipswithourclientswhoincludenationaland internationalcorporations,Fortune 500 companies, world’s leading research institutes and universities as well as independent inventors. • Get inTouch:– • USAOffice: • 646SuttonWay#1006 • GrassValley, CA95945 UnitedStates • +1-347-480-2054 • IndiaOffice • 207-208WelldoneTechPark,SohnaRoad

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