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1、 2023 Boston Consulting Group1Technological breakthroughs in new modalities will be a key driver of growth for the biopharmaindustry over the next decade.This opportunity has not escaped the notice of globalbiopharmaceutical,biotech,venture capital,and life science investment companies,which are rac
2、ingto invest in the most promising platforms.And the promise is already becoming a reality,as the enormous success of the COVID-19 mRNA-basedvaccines has demonstrated.Notably,2021 was the first year that new modalities,rather thanconventional small molecules,were responsible for more than half of fu
3、ture projected biopharmarevenues.(See Exhibit 1.)According to our analysis,over the past few years,revenues from new-New Drug Modalities 2023JUNE 30,2023 By Mike Brochu,Lu Chen,and Brian BushREADING TIME:8 MIN 2023 Boston Consulting Group2modality products increased by$60 billion,while revenues from
4、 conventional products declined by$10billion.We expect that new modalities will continue to be a big driver of revenue growth.In 2023,four of thesix top-selling biopharma products are based on new modalitiesin 2028,that will be true of all topsix products.(See Exhibit 2.)2023 Boston Consulting Group
5、3Yet it isnt easy to evaluate and compare the evolution of different modalities,with each advancingthrough development at its own pace.To our knowledge,there has been no standardized way oftracking the progress and potential of different modalities to date.BCGs first annual New Drug Modalities repor
6、t aims to fill this gap by tracking the evolution of 18modalities over time.Our analysis takes a cross-modality approach to determine which modalities areprogressing most rapidly,which hold the greatest promise,which diseases they are expected to treat,and what these findings imply for patient outco
7、mes and revenues.Six Categories of ModalitiesCompanies are developing new biopharma modalities for a diverse array of molecular targets.The 18modalities developed so far fall into six categories,which comprise proven modalities such asantibodies as well as nascent modalities,including oncolytic viru
8、ses,microbiomes,and proteolysis-targeting chimera(PROTAC).(See Exhibit 3.)2023 Boston Consulting Group4Antibodies.The oldest of the new modalities,antibody technologies,have been in use since 1986,when the FDA approved the first monoclonal antibody(mAb)product.Aer revolutionizing treatmentin immunol
9、ogy and oncology,these products are now considered a mainstay.There are more than 100mAbs on the market today.They include some of the most commercially successful products of alltime,such as Humira.Five of the top ten products by projected 2028 revenue are also mAbs:Keytruda,Dupixent,Skyrizi,Opdivo
10、,and Darzalex.Mercks pending$10.8 billion acquisition of Prometheus,whose lead candidate is a mAb,suggests that interest in this modality will remain strong.Companies are also using antibodies as platforms for other kinds of drugs,including antibody-drugconjugates(ADCs),which enable the targeted del
11、ivery of small-molecule chemotherapy drugs,andbispecific antibodies(BsAbs),which can target two antigens.This space is receiving significantinvestment attention,such as Pfizers pending$43 billion acquisition of Seagen for its ADC.Proteins and Peptides.Like antibodies,these modalities are highly matu
12、re.They consist of proteinswith enzymatic,regulatory,or targeting activity,as well as vaccines,and target a broad array oftherapeutic areas(TAs),including endocrine,immunology,and hematology.One fast-growing class ofmedications in the protein and peptide category is glucagon-like peptide-1 agonists,
13、which target 2023 Boston Consulting Group5incretin hormone action.These drugs,which include Trulicity and Mounjaro as well as Ozempic andWegovy,have rapidly become blockbuster treatments for type 2 diabetes and obesity.Aer revolutionizing treatment in immunology and oncology,monoclonal antibodiesare
14、 now considered a mainstay.Cell Therapies.Immune cell therapies have been used for treating various cancers since the FDAapproved the first chimeric antigen receptor T cell(CAR-T)therapy in 2017.Today,cell therapies arealso under development for endocrine,musculoskeletal,and dermatological condition
15、s.The newermodalities aim to improve upon the limitations of earlier cell therapies.For example,T-cell receptortherapy(TCR-T),unlike CAR-T,can recognize intracellular as well as cell surface antigens,so it mayhave more success in treating solid tumors.Gene Therapies.This category of modalities has t
16、he potential to be curative because it treats diseaseby modifying the genetic material of the relevant cells.The therapy is introduced either directly into thepatient(in vivo)or into cells harvested from the patient,which are modified and transplanted back intothe patients body(in vitro).Key modalit
17、ies include gene augmentation,which delivers a functionalversion of the mutated gene,and gene editing,which uses CRISPR/Cas9 machinery to modify thegenetic material of the cells.So far,the only approved gene therapies treat rare diseases,particularlyin hematology and central nervous system TAs.Nucle
18、ic Acids.The first nucleic acidbased products received FDA approval only seven years ago.mRNA is especially well known because of its prominent role in two highly efficacious COVID-19vaccines.This category includes two other important modalities:antisense RNA for rare diseases andRNAi for liver,kidn
19、ey,and heart conditions.Other New Modalities.A few other modalities are relatively new but have already shown signs ofpotential:Oncolytic Viruses.These viruses selectively target and infect cancer cells,releasing antigens andstimulating an immune response.In 2015,Amgens Imlygic,a herpesvirus used fo
20、r treatingmetastatic melanoma,became the first oncolytic virus to receive FDA approval.2023 Boston Consulting Group6Evolving Potential over TimeTo better understand how each modalitys potential has evolved,we longitudinally tracked the year-over-year progression of projected pipeline revenue.For eac
21、h year,we look at the projected revenue forpipeline products five years into the future;for example,“2023 five-year forward-projected value”is therevenue projected for 2028 for all the products in industry pipelines across that particular modality asof 2023.This growth in value is therefore driven b
22、y the products ability to progress through the pipelineand an underlying belief in the modalitys economic potential.Growing Value.All modalities have demonstrated growth over the past four years.(See Exhibit 4.)Microbiomes.Therapeutic microbiomes engineer gut microbiota to regulate the microbiome an
23、dtreat dysbiosis,the imbalance of bacterial composition.While most microbiome therapies are stillin the clinical stage of development,the modality has attracted attention from biotechs and largepharma companies interested in potential applications beyond gastrointestinal diseases,including in oncolo
24、gy and immunomodulation.PROTACs.The PROTAC modality uses existing cellular machinery to target and destroy proteinsrelated to a particular disease.Unlike traditional small-molecule inhibitors,the PROTACdegrades the protein continuously.It is also far more potent and can be used to treat more-severed
25、iseases.Most of the PROTAC drugs currently in clinical trials target some form of cancer,but inthe future,they may be capable of treating immune-mediated inflammatory and neurologicaldiseases.2023 Boston Consulting Group7mRNA assets have shown an 84%spike in projected valuesignificantly more than ot
26、her modalities.This growth has been driven primarily by COVID-19 vaccines,which account for$13 billion of theroughly$20 billion in forecasted revenues,though vaccines for other pathogens,including influenzaand respiratory syncytial virus(RSV),also play a role.The next-largest group,immuno-oncology,i
27、ncludes mRNAs that encode tumor antigens and proteins that stimulate immune responses.Gene editing,which so far has seen a 78%increase in projected value,is still in its infancy:clinical datafor the most advanced gene therapy assets emerged only recently.It will be interesting to see if thistrajecto
28、ry continues as standards of care begin to improve.Antibodies have seen a 15%rise in projected value over the past four years.mAbs have experiencedgrowth of 12%owing to a jump in forecasted revenue of more than$100 billion.ADCs and BsAbs haveincreased even faster28%and 30%,respectivelywith revenue e
29、stimates rising by$21 billion and$9 2023 Boston Consulting Group8billion,respectively.Antibodies constitute the most mature category,with a majority of their expansioncoming from marketed products rather than clinical development.Recombinant proteins and peptides have also maintained a robust revenu
30、e forecast,with salesexpectations soaring by nearly$40 billion from 2019 to 2023.Some technologies that were leaders in 2019 have experienced slower growth in forecasted revenue.For example,gene therapy,the third-largest category in 2019 aer mAbs and recombinants,hasincreased by only$3 billion and i
31、ts projected value has now been surpassed by ADCs and mRNA.The projected value of many of the nascent modalities,including newer cell therapies as well asoncolytic viruses,microbiomes,and PROTACs,is each concentrated in several large clinical-stageproducts.These modalities have not yet experienced t
32、he breakthroughs seen in other categories,suchas nucleic acids.Rates of Progress.Interestingly,new and conventional modalities have experienced similar rates ofprogress across clinical phases over the five-year period from 2019 to 2023.So,as a cohort,newermodalities have not yet proved to be riskier
33、 propositions that the broader industry.To ascertain which,if any,technologies stand out,we determined the percentage of preclinical assets in the new-andconventional-modality pipelines in 2019 that progressed to clinical or marketed status by 2023.We alsoevaluated the clinical assets that advanced
34、to marketed status over the same time.On average,new modalities have progressed slightly faster than conventional assets in earlier phasesof development,but a smaller portion of new-modality clinical assets has reached the market.Amongthe new-modality agents,mAbs,BsAbs,and CAR-T therapies have seen
35、higher than average rates ofprogress,particularly at the preclinical stage.New and conventional products have also experienced similar failure rates;however,there is a widedistribution of failure rates among modalities.PROTACs,oncolytic viruses,and TCRT have some of thelowest failure rates,although
36、this is due,to some extent,to the relatively small number of those assetsin the pipeline in 2019.(See Exhibit 5.)2023 Boston Consulting Group9Looking AheadThe future of new modalities is bright.Although the broader investment environment is down,thebiotech sector remains strong as investors perceive
37、 innovative health care to be less vulnerable to apotential recession.In addition,the 2022 Inflation Reduction Act(IRA),which aims to curb drugpricing,will likely benefit many of the newer modalities relative to small-molecule products.The lawcompletely exempts Medicare Part A products,which are adm
38、inistered in hospitals,from all three drugpricing provisions,and thus will likely incentivize development in areas like cell and gene therapies.Italso grants biologic drugs longer periods of patent protection than traditional products,regardless ofchannel.At the same time,once the biopharma industry
39、 exhibits interest in a particular target or modality,itscommon for many other companies to want to get in on the act.So it is increasingly important forplayers with strong clinical development capabilities to move quickly on scientifically differentiatedassets.The sweet spot is early in Phase II,wh
40、en preliminary data on effectiveness becomes clearer.Weexpect that deal activity will increase as more assets move through Phase II.2023 Boston Consulting Group10In the longer term,the potential of each new modality will depend on its individual value propositionand ability to drive improvements in
41、the standard of care.When the level of investment is high,theimprovement in outcomes needs to be commensurate.But that has rarely been the case.For example,while oncology is the TA that has seen the greatest investment activity,the significant therapeuticadvances of PD-1s like Keytruda have yet to b
42、e matched by other new modalities.As more assets movethrough trials,it will be important to monitor their clinical benefits.AuthorsMike BrochuMANAGING DIRECTOR&SENIOR PARTNERPhiladelphiaLu ChenMANAGING DIRECTOR&PARTNERNew YorkBrian BushPARTNERNew YorkABOUT BOSTON CONSULTING GROUPBoston Consulting Gr
43、oup partners with leaders in business and society to tackle their most importantchallenges and capture their greatest opportunities.BCG was the pioneer in business strategy when it wasfounded in 1963.Today,we work closely with clients to embrace a transformational approach aimed atbenefiting all sta
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45、dge managementconsulting,technology and design,and corporate and digital ventures.We work in a uniquely collaborativemodel across the firm and throughout all levels of the client organization,fueled by the goal of helping ourclients thrive and enabling them to make the world a better place.2023 Boston Consulting Group11 Boston Consulting Group 2023.All rights reserved.For information or permission to reprint,please contact BCG at .To find the latestBCG content and register to receive e-alerts on this topic or others,please visit .Follow BostonConsulting Group on Facebook and Twitter.