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1、Click here or press enter for the accessibility optimised version2025 PreviewClick here or press enter for the accessibility optimised versionForewordData run in Evaluate Pharma&Evaluate Omnium in Nov/Dec2024.Biotech will remain in recovery mode nextyear,after hitting rock bottom in 2023amid a post-

2、pandemic rout.The sectorhas taken its time recuperating from thoselows,and there are few reasons to expecta rapid rally in 2025.This is not to say that pessimism prevails.Investors and corporates alike expectmore deal making next year and improvedaccess to capital.But with muchuncertainty as the US

3、transitions to a newpresidential administration,the sector isskittish.Incoming President Trump has signalledhis willingness to rip up the status quowith unconventional nominations to headdepartments that matter a lot tobiopharma.For now,it remains unclearwhat Robert F.Kennedy Jr.,Martin Makaryand Me

4、hmet Oz mean for Health andHuman Services,the Food and DrugAdministration and Centers for Medicareand Medicaid Services.It could bemid-2025 until the appointments are allconfirmed,and longer for policy shifts toemerge.These US political changes are notnecessarily negative.A less hawkishFederal Trade

5、 Commission should injectlife into a moribund M&A market,hencethe expectations for a pickup indealmaking.The equity markets,meanwhile,are slowly opening to newissues and that trend is expected tocontinue next year.More IPOs and M&Aare good news for venture investors,andprivate financings are also se

6、en rising in2025.But the first half of the year,and possiblylonger,will be dominated by questionsabout the Trump administration and whatit means for the worlds largest healthcaremarket.And investors hate uncertainty.Against this backdrop,biopharmasbiggest news story will continue to unfoldin 2025:th

7、e roaring success of theGLP-1s,also known as the incretin class.Efforts by incumbents Novo Nordisk andLilly to tighten their grip on this space willbe a big focus.Data from follow-onagents and trials attempting to expandForewordInvestors and corporates alike expect more dealmaking next year and impr

8、oved access to capital.these drugs into ever more adjacentmetabolic conditions are among 2025smost anticipated datasets.The first halfwill see the first phase 3 data onorforglipron,Lillys leading oral obesitycandidate;later in the year Novo couldrelease early pivotal data on semaglutidein Alzheimers

9、 disease,a hugely importantbut high-risk readout.The incretin space is also likely to see muchdealmaking next year,as developers keento gain a foothold make a move on smallerplayers.Dramatic expansion of the class isforecast,and Big Pharma is being warnedthat it cannot afford to miss out on whatmany

10、 believe to be the most impactfuldrug mechanism to be discovered.That impact is already being felt,ofcourse,as this report reveals.Ozempic,Mounjaro,Zepbound and Wegovy,andmanufacturers Novo Nordisk and Lilly,lead the league tables of biggest drugsand fastest growing companies,compiledfrom Evaluate P

11、harmas consensusforecasts.The once dominant cancer field has beenpushed into second place in many ofthese analyses.The anti-PD-(L)1mechanism still features,though itsimpact is waning and next year will seeMerck&Co and Bristol Myers Squibb tryto prolong the franchises of Keytruda andOpdivo with subcu

12、taneous versions ofthese mega-blockbusters.The failure ofnumerous follow-on immuno-oncologyapproaches means that much focus incancer has shifted to new modalities likeantibody-drug conjugates,T cell engagersand radiopharmaceuticals.Two trends for 2025 collide here:bispecifics and China.Western bioph

13、armais enthusiastically looking east for in-licensing opportunities,and this journeywill continue next year.One such questyielded one of the highest profilebispecifics,Summit and Akesos anti-PD-1xVEGF ivonescimab.This projectpromises one of 2025s most keenlyanticipated cancer readouts:overallsurviva

14、l from a head-to-head trial versusKeytruda could emerge mid-year,and theoutcome will help determine whether thehype around ivonescimab,and thismechanism,is justified.Immunology and anti-inflammatorymedicines remain another huge area ofinterest for biopharma,with several so-called“pipeline in a drug”

15、products likeDupixent and Skyrizi looming over theleague tables.Much effort is ongoing tofind the next blockbusters in this fields,with the FcRn mechanism featuringheavily in analyses of highly valuedresearch projects.This report,drawn from Evaluate Pharmaand Evaluate Omnium,pinpoints theseand other

16、 many other pivotal events onthe horizon for biopharma in 2025.The incretin space isalso likely to see muchdealmaking next year,as developers keen togain a foothold make amove on smallerplayers.Click here or press enter for the accessibility optimised versionInnovationandRegulationA look at sales by

17、 generic name,however,reveals the extent to which the incretinclass,also known as GLP-1 analogues,hascome to dominate the top table.NovoNordisks semaglutide,sold as Ozempicfor type 2 diabetes and Wegovy forobesity,and Lillys tirzepatide,respectivelysold as Mounjaro and Zepbound,are ontrack to genera

18、te more than$70bn incombined sales in 2025,according toEvaluate Pharmas consensus forecasts.These four products also top the table offastest growing drugs,shown in thesecond chart(next page).For Novo andLilly,one of their main priorities in 2025will be keeping up with demand,andmeeting expectations

19、of both patientsand investors.Make no mistake,thegrowth of this field is vast in terms of bothsize and speed,exemplified byZepbounds launch statistics.Sales of theLilly blockbuster are forecast to double in2025 on the previous year,to$11.3bn.Itwas only approved in obesity at the backend of 2023.Sale

20、s of Keytruda,meanwhile,areprojected to peak in 2025.Asubcutaneously administered version ofthe anti-PD-1 antibody will be filed withregulators next year,a project designed toextent the franchises life as loss ofexclusivity approaches.Bristol MyersSquibbs similarly acting Opdivo,whichhas been pushed

21、 out of the top 10 for theGrowing Biopharmas Topline:DrugsOn one measure Merck&Cos blockbuster cancer treatment,Keytruda,is set to retain its ranking as the worlds biggestselling product next year.Top selling drugs in 2025Note:Forecasts include sales booked by all global marketing partners,where rel

22、evant.Souce:Evaluate Pharma consensus forecasts.first time in several years by the incretins,is pursuing a similar strategy.Itssubcutaneous formulation could belaunched next year.Elsewhere among the top 10 mega-blockbusters are products that havedominated both of these tables for severalyears thanks

23、 to approvals in a wide rangeof autoimmune and inflammatorydisorders.Sanofi and RegeneronsDupixent for example,which is indicatedfor six settings included atopic dermatitisand allergic asthma.Standing out among the fastest growingdrugs is Enhertu.The antibody-drugconjugate is leading a new wave of a

24、gentsto emerge in this modality,withimpressive efficacy in breast and lungcancers demonstrating the potential oftargeting highly toxic chemotherapy.Top new sales:drugsNote:New sales is the difference between 2025 and 2024 sales.Source:Evaluate Pharma consensus forecasts.But while these two groups le

25、ad the packin sales growth in 2025,neither are placedin the top three drug makers by totalprescription sales.Lilly is on track to end 2024 as the 11thlargest drug company by prescriptionsales;by the end of 2025 current forecastsput it in fourth position.Novo Nordisk isseen climbing from 10thto sixth

26、 in thesame period.The numbers throughout thisreport are drawn from Evaluate Pharmasconsensus forecasts,which are based onmodels built by equity analysts.It is almost inevitable that Lilly and NovoNordisk will climb further up these rankingin subsequent years.But for now,Roche ispredicted to top the

27、 table in 2025,retaining its ranking as the largest drugmaker by prescription sales for a secondyear.The Swiss companys pole position issomewhat surprising given that none ofits products feature in the previousbiggest drugs analyses.The pharma gianthas breadth of portfolio,however,withseveral blockb

28、usters just outside the top10;eye disease therapy Vabysmo onlynarrowly missed out on a place in thefastest growing drugs table.Growing Pharmas Top Line:CompaniesBallooning incretin sales are set to catapult Lilly and Novo up the league tables next year,in this analysis of the worldsbiggest pharma co

29、mpanies ranked on revenues.Biggest drug makers by prescription sales in 2025It is almost inevitable that Lilly and Novo Nordisk will climb further up these ranking in subsequent years.Another interesting name in the topgrowth table is GSK,a company that hasstruggled in recent years to convinceinvest

30、ors about its prospects.Impressivegrowth is projected next year across itslarge vaccines and HIV business,and acouple of important new drug approvalsare on the slate for next year.Thepotential arrival of a vaccine sceptic in aninfluential US government role,however,raises the prospect of turbulence

31、aheadfor the UK company.Another group with clouds on the horizonis Pfizer,which has been criticised forfailing to capitalise on its pandemicwindfall.With sales of its Covid-19 vaccineComirnaty continuing to shrink,the formerhighflier will see its global ranking fall nextyear from 5thto 9thplace,acco

32、rding tocurrent sales forecasts.Top new sales:companiesNote:New sales is the difference between 2025 and 2024.Source:Evaluate Pharma consensus forecasts.The graph here shows which therapyareas are acting as growth drivers andbrakes.Among the drivers,cancer is ostensiblyleading the way with the incre

33、tins comingbehind.But with diabetes and obesityfalling into two separate therapy areas,thedominance of the incretin class is revealedonce again if the metabolic space isconsidered as one.The blood cancer therapy area featuresproducts like Darzalex and Carvykti,soldprimarily for multiple myeloma by J

34、&J,while dermatoses is dominated by largefranchises mentioned earlier like Dupixentand Skyrizi.The latter,sold for psoriaticconditions and inflammatory boweldisease,now counts as AbbVies mostimportant growth driver,with future salesforecast to top$20bn.Loss of exclusivity explains much of thecontrac

35、tion seen among the growth brakecategories.Arthritis for example iscontracting as sales of AbbVies Humiraare replaced by sales of lower costbiosimilars.The learning disorders field isbeing hit by the patent expiry of ADHDmedicine Vyvanse.Respiratory infections,of course,reflects the end of Covid-19,

36、with sales of vaccines and antiviralsexpected to dip again next year,as thepandemics impact on the sectorcontinues to fade.Growing Biopharmas Top Line:Therapy AreasEvaluate Pharma is forecasting an$82bn increase in pharmaceutical product sales next year,the largest jump since theCovid-19 pandemic,wi

37、th combined industry revenues topping$1tn for the first time.Therapy areas:growth drivers and brakesSource:Evaluate Pharma sales by indication model.It should be noted that this analysis onlyincludes forecasts where coveringanalysts have assigned specificindications for the sales,so the$1tn figureci

38、ted earlier should not be interpreted as aprojection for total biopharma sector salesin 2025.The wild card here is Novo Nordiskscagrisema,which has yet to yield phase 3data at time of writing and is thereforeincluded among the most valuable R&Dprojects,rather than biggest launches.With a speedy fili

39、ng and a priority reviewvoucher perhaps a 2025 approval ispossible for cagrisema.There is an incretin agent in this list ofbiggest launches,however:Innoventsmazdutide.This GLP-1 and glucagonreceptor agonist was originated at Lillybut licensed out while the US groupfocused on tirzepatide.The Chinesed

40、eveloper is seeking approval in its homemarket;2030 sales of$1.3bn might notmove the needle for a metabolic agent inthe West,but for the Chinese market thisis a substantial sum.Vertexs latest cystic fibrosis offering isranked as the biggest 2025 approvaldecision,in potential sales terms.Thesuccess o

41、f the companys existing CFfranchise means another commercial hit isexpected from this triple therapy.Vertexssecond 2025 regulatory decision sits withsuzetrigine which,if approved,wouldcount as the first novel pain mechanism toreach the market for decades.Acute painis the indication currently under r

42、egulatoryreview,and data in other neuropathic painsettings are keenly awaited next year.The FDAs decision on the second ADC toemerge from Daiichi and AstraZenecaspartnership is another big event;thepartners withdrew an initial filing in lungcancer in 2024.Huge expectations sitbehind the project,whic

43、h targets TROP2to deliver its toxic payload.Insmed and Cytokinetics carry the torchfor smaller,independent developers here,although both have a nervous wait untilthe end of 2025 for their decisions.Theformer is preparing to file brensocatib inthe lung disease bronchiecstatis,whileCytokinetics is app

44、roaching thecardiology world with aficamten,atreatment for hypertrophiccardiomyopathy.Waiting in the Wings:Biggest LaunchesObesity might suck much of the sectors attention next year,but 2025 is unlikely to see any novel weight loss approvals,at least not in the US.Biggest potential drug launches of

45、2025ProductCompaniesinvolvedDescriptionStatus2030esales($bn)Vanza TripleVertexTriple combination CFTR modulator for cystic fibrosisPDUFA January 2,2025;EU approval Q2258.3DatopotamabDeruxtecanDaiichi Sankyo/AstraZenecaAnti-Trop2 ADC for lung and breast cancersUS and EU decisions due Q1255.9Suzetrigi

46、neVertexNav1.8 channel blocker for acute and neuropathic painPDUFA January 20252.9AficamtenCytokineticsCardiac myosin inhibitor for hypertrophic cardiomyopathyUS and EU decisions due Q4252.8BrensocatibInsmedDPP1 inhibitor for neutrophil-mediated diseasesFiling planned by YE24(priority review expecte

47、d)2.8TolebrutinibSanofiBTK inhibitor for multiple sclerosisFiling planned before YE241.4MazdutideInnovent/LillyGLP-1&glucagon receptor agonist for T2D and obesityChina obesity approval due H125;T2D due H2251.3DepemokimabGSKLong-acting anti-IL-5 Mab for severe allergic asthmaFiling planned before YE2

48、41.2MenABCWYGSKMeningococcal A,B,C,W-135&Y vaccinePDUFA February 14,20251.2NipocalimabJ&JFcRn antagonist in broad autoimmune developmentprogrammeUS and EU decisions due H1251.2Note:T2D=type 2 diabetes.Source:Evaluate Pharma.Consensus for datopotamab deruxtecan pre-dates withdrawal of US lung cancer

49、filing.Cagrisema carries huge hopes for NovoNordisk,which hopes the dual-actingagent will give it an obesity propositionthat can offer similar levels of weight lossas Lillys tirzepatide.Impressive phase 2 data have triggeredsubstantial expectations around Lillys ownfollow-on,retatrutide,which is now

50、 in alarge pivotal programme.Another Lillyasset,orforglipron,is the leadingcontender in the race to develop an oralobesity drug;phase 3 data due later in theyear count as one of 2025s most keenlyanticipated readouts.MariTides valuationis likely to have been trimmed since thedata for this report was

51、collected,in thewake of Amgens disappointing phase 2disclosure in late November.Elsewhere in the sectors pipeline are twoagents,batoclimab and IMVT-1402,thattheir developers hope will compete in theanti-FcRn space.For now this is owned byArgenyx and its hugely successfulVyvgart,though will be likely

52、 be joined onthe market next year by J&Js nipocalimab,which made the previous biggestlaunches table.The inflammatory diseasefield is set to remain a huge focus nextyear,with Moonlake and its highly valuedsonelokimab another example of thisenthusiasm.In the last few years biopharma hasshifted much at

53、tention towardsimmunology and,more recently,metabolic science.To some extent thathas happened at the expense of oncology,although a handful of modalities withinthe expansive cancer field continue toattract much attention.Bispecifics is onesuch area,and ivonescimab a primeexample.The projects success

54、 versusKeytruda in a study conducted in Chinatriggered much interest in the anti-PD-1xVEGF mechanism.Ivonescimab,which was discovered by Akeso andlicensed by Summit,also speaks toanother theme likely to continue playingout in 2025:the hunt for China-originatedprojects,where early-stage developmentca

55、n be carried out much more cheaply,and quickly,than in the West.Waiting in the Wings:Most Valuable R&D ProjectsA look at some of the most valuable R&D projects means a return to the story of incretins dominance,with the top fourpositions occupied by novel anti-obesity/type 2 diabetes agents.Note:T2D

56、=type 2 diabetes;MG=myasthenia gravis;CIDP=chronic inflammatory demyelinating polyneuropathy;TED=thyroid eye disease.Consensus estimates for Cagrisemaand MariTide pre-date clinical readouts in late 2024,both of which disappointed.Source:Evaluate Pharma.Biopharmas valuable R&D projectsProductCompanie

57、s involvedDescriptionNPV($bn)CagrisemaNovo NordiskFixed-dose combination of amylin and GLP-1 agonists for obesity and T2D;ph3 data late 202487.3RetatrutideEli LillyGLP-1,GIP and glucagon tri-agonst for obesity and T2D;ph3 data in 202638.6OrforglipronEli Lilly/ChugaiOral GLP-1 receptor agonist for T2

58、D and obesity;ph3 data from late 202537.9MariTideAmgenGLP-1 agonist&GIP antagonist for obesity and T2D;ph3 to start 202531.4IMVT-1402Immunovant/RoivantAnti-FcRn Mab,broad autoimmune pivotal development programme to start 20255.3BatoclimabImmunovant/RoivantAnti-FcRn Mab;ph3 data in MG,CIDP and TED du

59、e 20255.8SonelokimabMoonlake ImmunotherapeuticsTrivalent nanobody against IL-17A,IL-17F and albumin for inflammatory disease;ph3 data from mid-20258.0OlpasiranAmgenApoA RNAi therapeutic for elevated Lp(a)and atherosclerotic cardiovascular disease;ph2 data from 20267.9mRNA-4157Moderna/Merck&CoIndivid

60、ualised neoantigen immunotherapy for melanoma;ph3 data from late 20255.2IvonescimabAkeso/SummitAnti-PD-1&VEGF bispecific for lung cancer;ph3 data from mid-20257.2This includes the 10 detailed earlier whichare seen as the most commerciallypromising.This estimate is far from set instone,of course,with

61、 both small and largecompanies liable to encounter regulatoryhick ups.Matching 2023s record 71 novelapprovals would be notable,however.The chart here shows how biopharma andthe FDA have filled in the hole thatCovid-19 put in sector productivity.Thepandemic impact can really be seen infifth-year sale

62、s,with the classes of 2020and 2021 showing substantially lowermarket potential than surrounding years,presumably as the sector focused itsefforts on combating the virus.The big unknown for the FDA regulatornext year is the identity of its newcommissioner,and what agenda theymight pursue.Martin Makar

63、y,Trumps pickfor the job is,like the incoming Presidentsother nominees,a controversial name whohas criticised the agency on severalissues.Vaccine sceptic Robert F.KennedyJr.has been proposed to run the U.S.Department of Health and HumanServices,which is technically in control ofthe FDA.What the foll

64、owing years might hold fordrug regulation and the biopharmasector more widely depends a lot on thepeople that end up with the top jobs inTrumps new administration.It is alsoThe Regulatory EnvironmentNext year holds the potential to see a historically high number of novel approvals,with Evaluate Omni

65、um yielding 71projects with a good chance of reaching the US market.Tracking US approvalsNote:Count includes novel therapeutics approved by both CDER andCBER.Source:FDA and Evaluate Pharma.worth remembering that the PrescriptionDrug User Fee agreement that funds newdrug reviews at the FDA must berea

66、uthorised by the end of September2027.The coming few years hold thepotential for much turbulence at theinfluential regulator.Click here or press enter for the accessibility optimised versionAnalysisTrumps Return:PharmaTrades Disagreeable WhiteHouse for UnpredictableOneBy Nielsen HobbsGiven the many

67、travails the biopharmaindustry experienced during the Bidenadministration from Medicare pricecontrols to antitrust actions on mergersand partnerships it would be natural thatindustry may see the return of DonaldTrump as a boon to their fortunes.Thefirst Trump Administration,for all itscampaign attac

68、ks on pharma,ushered in acollaborative atmosphere that saw arecord number of FDA approvals and thelaunch of several review-expediting pilots.The culmination of the approach wasOperation Warp Speed,the COVID-eraeffort to create vaccines faster than anymedicine had ever been developed.Thefact that it

69、worked,but has basically beendisavowed by Trump,offers a window intohow his second administration couldunfold.Those hoping for a rerun of the first Trumpterm will be disappointed,and they needlook no further than the selection ofRobert F.Kennedy Jr.to head the Healthand Human Services Department(HHS

70、).Even if RJR Jr.s expected nomination isTrumps Return:Pharma Trades DisagreeableWhite House for Unpredictable Oneby Nielsen HobbsNo regulator is perfect,but the FDA has been consistently offering smooth,flexible reviews over the past many years.blocked by the Senate,tapping a vaccinesceptic for the

71、 post sets a vastly differenttone than the cooperation with regulatedindustry that pharma was hoping toreceive.The new GOP governing trifecta could ofcourse help biopharma achieve keylegislative priorities,such as reforms ofthe 340B outpatient drug discountprogram,revision of the Medicare drugpricin

72、g program,and limits on pharmacybenefit manager(PBM)rebating tactics.But drug pricing will not be an immediatefocus for lawmakers.Trumps 2017 taxcuts and the enhanced Affordable CareAct insurance premium subsidies providedby the Biden Administrations COVID-eraAmerican Rescue Plan are scheduled toexp

73、ire at the end of 2025,so Congresswill be preoccupied with the debate onthose issues.Even when it becomes the pharmaindustrys turn for must-pass legislation,they may not like the results.ThePrescription Drug User Fee agreementthat funds new drug reviews at the FDAmust be reauthorised by the end ofSe

74、ptember 2027 a perfect opportunityfor the dealmaker-in-chief to demandconcessions from an unpopular industry.Last time he was in the White House,Trump proposed doubling user fees tofully fund reviews,but the idea neveradvanced.This time,his administration willoversee the entire negotiation cycle for

75、the new agreement,so the idea couldreemerge,especially since reducingfederal spending is a key rhetorical focusfor him.On the other side of the threat ledger,RFKJr.has called users fees a corruptinginfluence,and if his perspective prevailsduring the negotiation process,that wouldlikely mean a consid

76、erable resource lossfor the FDA,which could force thedeparture of experienced FDA staff.Agency employees may be under pressureregardless of the user fee situation,due tothe potential for a Kennedy-infusedleadership to push disruptive policychanges or even attempt to purge staff byweakening civil ser

77、vice protections.Beyond either of those concerns,thegeneral uncertainly of the situation coulddrive staff to depart for jobs they view asmore stable.Indeed,expected FDA Commissionernominee Martin Makary has criticised thework ethic of the FDA staff,as well asreview times.Makary also has advocatedfor

78、 evidence-based medicine,butsometimes has distorted data to supporthis conclusions.In addition,Jim ONeill,the expectednominee for deputy HHS secretary,hassuggested that medical products onlyshould be proven safe prior to enteringthe market,potentially creating moreanxiety inside the agency,as well a

79、samong sponsors.No regulator is perfect,but the FDA hasbeen consistently offering smooth,flexible reviews over the past many years.Large-scale staff changes run the risk ofchanging that atmosphere.A Republican Congress could have achance to work on some pharma-friendlylegislation over the next few y

80、ears,but fullGOP control probably will mean moreattention on China and challenges forindustrys manufacturing anddevelopment activities in the country,perhaps most immediately with theBIOSECURE legislation,aimed at breakingsponsors ties with Chinese contractdevelopment and manufacturingorganisations(

81、CDMOs).If Trump imposes broad tariffs and pharmacant get exceptions,that would be asubtle headwind for industry,butcompanies could get a few subtletailwinds over the next few years.TheFederal Trade Commission likely will bemore flexible in its attitude towardbiopharma mergers and acquisitions,which

82、is expected to facilitate moredealmaking in the industry,even as theFTCs enforcement action against themajor PBMs probably will continue.How many of the various policy ideascome to pass remains to be seen.As the first Trump administrationconcluded,Trump himself was at a lowpoint,condemned for encour

83、aging the 6January 2021 insurrection and blamed fordragging the GOP brand down enoughthat the party lost control of the Senate.Pfizer CEO Abert Bourla,on the otherhand,seemed triumphant.His companyproduced a world-saving vaccine and nowhad a technology platform to addressmany diseases.Four years lat

84、er,things appear verydifferent.Trump consolidated his controlof the Republican party and convincedvoters to give him a second chance.Bourla,on the other hand,has beenunable to build significantly on hiscompanys COVID windfall and now facesan activist investor challenge.The relative reversal of fortu

85、nes is areminder that no trajectory is permanent,and luck can sometimes have as big animpact on events as good decision-making.Hopefully the US FDA and thepharmaceutical industry will benefit from alot of both over the next four years.Nielsen Hobbswrites for Pink Sheetand In Vivo.How many of the var

86、ious policy ideas come to passremains to be seen.Click here or press enter for the accessibility optimised versionMoney,Markets andM&ATrue,the closely watched index that tracksUS biotechnology stocks,the XBI is,inearly December marginally higher than atthe start of the year.But over the secondhalf o

87、f 2024 the XBI essentially movedsideways.Ongoing concerns aboutinflation and interest rates,which looklikely to remain higher for longer,makerisky drug development stocks anunappealing prospect for non-specialistinvestors.The situation was exacerbated inNovember by Trumps leftfield choices forrunnin

88、g US healthcare.The chart hereshows how this issue hit more established,larger biopharma companies than smallbiotechs.The XLV,a broader index thatencompasses the wider healthcare sector,remains below its pre-US election peak.President Trumps plans for the AffordableCare Act,Medicare drug price negot

89、iationand tariffs on imports from abroad are allkeenly awaited and how they play out willbe big themes for healthcare in 2025.It is this latter issue Trumps threat toimpose tariffs on imports from countriesaround the world that is promptingconcern in the financial markets aboutpersistently high infl

90、ation and interestrates.This is not good news for cash-hungry sectors like biotech.Despite this,investors are not completelypessimistic about 2025.Sentiment is seenimproving next year,even for smallerbiotechs,along with access to capital.Theglacial pace of improvement feels lockedin,however.A pickup

91、 in M&A,which manyare predicting,should help attract non-specialist investors back to biopharma.But with so much uncertainty around thenew Trump administrations stance onhealthcare,there are also plenty ofreasons for caution.Stock Market PerformanceAt time of writing,the year is not quite over but i

92、t is probably safe to say that expectations of a sustained recovery inbiotech stocks in 2024 failed to materialise.Ongoing concerns about inflation and interest rates,which look likely to remain higher for longer,makerisky drug development stocks an unappealingprospect for non-specialist investors.S

93、tock market performanceNote:This chart shows the relative performance of three equal weightedexchange traded funds that track US listed companies.XBI includesbiotech stocks from across the market cap spectrum.XLV includespharmaceutical companies,healthcare equipment and medtech.RSPincludes all stock

94、s in the S&P 500.Source:Yahoo Finance.While the US election caused flotations topause in late 2024,as companies andtheir backers chose to avoid any potentialvolatility around the outcome,the pace isexpected to pick up again.With the markets effectively closed for solong,there is a huge amount of pen

95、t-updemand sitting in the private world.Theequity markets can provide the sort ofgrowth capital beyond the means of theventure world,a world that has had tosupport many portfolio companies formuch longer than desirable.But whilemany predict that 2025 will see anotheruptick in these IPO statistics,fe

96、w arepredicting the flood gates to suddenlyopen.The equity markets are skittish,and blowups like BioAge in early December do nothelp improve biotechs reputation.BioAgecame to market in October 2024 with ahigh-profile mid-stage obesity candidatethat was derailed by toxicity concernsonly two months af

97、ter floating.In theopening months of 2025 only the safestbets,and those heavily supported byexisting investors,will make it onto thestock market.Market conditions need toimprove for that situation to change,andit is hard to see that happening until theTrump administration is in place and layingout f

98、irm policy directions.All of this refers to the US IPO markets,ofcourse;Europe has not seen a notableIPOsThe slow return of the IPO market from 2022s nadir continues.The slow return of the biotech IPONote:IPOs of pure-play drug developers on Western exchanges only.2024 to end-November.Source:Evaluat

99、e Pharma.biotech listing,outside of the tiny regionalmarkets in Scandinavia,for years.Thecontinent lacks a deep pool of specialistinvestors which,combined with a morerisk averse culture,erases any prospect ofa local listing for private Europeanbiotechs.They will continue to look to theUS for access

100、to the capital markets in2025.Substantial funds are being raised by themost successful investors in the US andEurope.And the most appealing portfoliocompanies are being bestowed with largefunding rounds.The bursting of the pandemic bubblecaused equity markets to close andprompted buyers to walk away

101、 fromfrothy valuations,scenarios that created adifficult exit environment for venturefirms.But with the IPO market opening,albeit slowly,and a string of takeoutsemerging in the private world,ventureinvestors are seeing more opportunities topass on their investments.Venture is increasingly becoming a

102、 worldof haves and have nots,however.Moneyis being concentrated in fewer hands,atrend that has been developing for someyears but shows no sign of reversing.Newcompany creation is a number to watch in2025,as venture investors continue toseek safety in numbers and create broadsyndicates.In terms of wh

103、ere the money is flowing,the therapy areas driving the sectors topline growth,detailed in earlier sections ofthis report,will remain in favour.Immunology and inflammation,metabolicdiseases,antibody drug conjugates,radiopharmaceuticals,to name a few hotareas.Venture FundingPrivate investors are enter

104、ing 2025 in a more optimistic mood,suggesting that the climb out of 2023s trough iscontinuing.Venture capital:another down year?Note:All data concerns venture funds raised by developers oftherapeutics;medtech and diagnostics excluded.2024 data to end-October.The data here concern full companytakeout

105、s,but all sorts of dealmaking hasbeen subdued,even product licensingdeals.Much blame has been laid at thefeet of the Federal Trade Commission,whose hawkish stance has caused causedboardrooms to rule out moves that mightattract scrutiny and suck time and money.This is one area where the new Trumpadmi

106、nistration spells good news forbiopharma,with a complete change instance expected.In fact,many hopes for asector pick up in 2025 rest on an increasein dealmaking.Again,what exactly might transpire at thenew Trump administration is unclear.But itis undeniable that numerous largedevelopers need pipeli

107、ne expansion.Thismakes an M&A uptick next year almostinevitable,as big pharma boardroomscome under pressure to deliver long termgrowth.M&AAn absence of M&A has not helped the downtrodden biotech sector in 2024.Biopharma company takeoutsNote:Full takeouts of biopharma companies only.2024 to mid-Novem

108、ber.Source:Evaluate Pharma.Click here or press enter for the accessibility optimised versionEyes onChinaBy Paul VerdinA global theme to watch in 2025 is Chinasgrowing impact on pharmaceutical R&D.This influence is readily apparent inpipeline data,which reveals the extent ofthe countrys reach.Across

109、the industrys total clinical pipeline,a Chinese company is involved in at leasta fifth of development programs,EvaluatePharma reveals.Within specific nextgeneration therapeutic niches Chinasdominance is even more clear.More than50%of the antibody-drug conjugate,bispecific antibody,and chimeric antig

110、enreceptor T cell(CAR-T)clinical pipeline isChina-originated or China-partnered.That China is such a driver of these laudedfrontiers of pharmaceutical innovation istestament to the countrys growingimportance on the global pharma stage.This report confirms this trend,withproducts being developed by C

111、hinesecompanies featuring in the biggestlaunches of 2025 and most valuablepipeline assets.Deals tell a similar story,with licensingfrom China-based companies ever-present on the industry newswires.Aprominent recent example is Merck&Coslicensing of LM-299,an investigationalanti-PD-1/VEGF bispecific a

112、ntibody,fromChina-based LaNova Medicines in a dealworth up to$3.3 billion.The transaction isa clear example of established pharmalooking to China for innovation andpotential best-in-class candidates.It is not only large groups looking to Chinafor assets.A similar bispecific,ivonescimab,was licensed

113、by SummitTheraputics from Akeso Biopharma at theend of 2022,an asset that has alreadyEyes on ChinaAcross the industrys total clinical pipeline,a Chinese company is involved in atleast a fifth of development programs,Evaluate Pharma reveals.demonstrated Keytruda-beatingoutcomes in a China-based lung

114、cancerstudy.More recently,BioNTech acquiredChina-based Biotheus in November in adeal worth close to$1 billion,again toaccess anti-PD-1/VEGF bispecificinnovation.These trends indicate that Chinasinfluence on the global pharma industry islikely to deepen in 2025.There is a bigbut here,however,in the s

115、hape of theincoming Trump administration(see earlierchapter:Trumps Return:Pharma TradesDisagreeable White House forUnpredictable One).President-electTrump has expressed a clear desire toprotect US interests,that many fear couldtrigger a trade war.And dont forget theBiosecure Act,which seeks to limit

116、 USbusiness with China headquartered lifescience companies.The act,which has yetto be passed,could find renewed supportfrom the new administration.Click here or press enter for the accessibility optimised versionHow We HelpProviding contextualised marketinsights,helping to identify newopportunities,

117、minimise risk,and gain acompetitive advantage.Discover thedifference our solutions can make toyour competitive advantage.Evaluate provides trustedcommercial intelligence for thepharmaceutical industry.We help our clients to refine andtransform their understanding ofthe global pharmaceutical marketto

118、 drive better decisions.Whenyou partner with Evaluate,ourconstantly expanding solutionsand our transparent methodologiesand datasets are instantly at yourdisposal,along with personalised,expert support.Discover the difference oursolutions can make to yourcompetitive advantage.Get in touch to learn m

119、ore COMMERCIALOPPORTUNITYASSESSMENTUse a wide range of detailed insights to prioritiseopportunities and enhance commercial success.We merge company financials,product details,forecasts,and market expertise to guide yourproduct strategy effectively.LEARN MOREMARKETOPPORTUNITYSIZINGGain valuable insig

120、hts into success rates,projecttimelines,R&D spending,and patient costs.Useour solutions to assess therapy area potential,identify unmet needs,and strategically positionyourself against competitors.LEARN MORECOMPETITIVE LANDSCAPEOur solutions provide insights to manage risk,uncover unmet needs,and gr

121、asp your growth drivers and productuniqueness.We simplify complexity,analyse niche-specific competition,uncover opportunities,evaluate risks,plan investments,and maintain competitiveness in the face of market shifts.LEARN MOREEXPLORE HOW OUR SOLUTIONS CAN ASSIST YOU AND YOUR TEAMClick here or press

122、enter for the accessibility optimised versionRelated ReoursesRELATED RESOURCESGet all our 2025Preview contenthereBiotech is expected to continue its recovery nextyear after a sharp decline during the post-pandemic downturn.While a swift resurgence isunlikely in 2025,both investors and companiesantic

123、ipate increased deal-making and improvedaccess to funding.However,significantuncertainties tied to the USs transition to a newpresidential administration are prompting cautionin the sector.Our 2025 Preview Content Hub is your go-tosource for all the data,analysis and expertperspectives shaping the y

124、ear ahead.We breakdown the key companies,drugs and therapyareas set to lead the way,while exploring whatthese trends mean for investor sentiment and thesectors future recovery.2025 Preview WebinarThursday 23rd January,3pm GMT|10am ESTJoin our panel as they discuss the topdrugs and companies in 2025,

125、the therapyareas driving growth,and the state of themarkets for the year ahead.REGISTER NOW 2025 Preview Infographic:Whats driving pharmagrowth?The speediest way to get the datahighlights,our infographic gives you aquick spin through the potential talkingpoints of the year ahead.DOWNLOAD NOW Click h

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