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1、BIOPHARMA TRENDS 2025 Focusing on Innovation amid ComplexityJanuary 2025 By Margot Bleys,Bilal Khan,John Wu,and Priya ChandranBoston Consulting Group Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportuniti

2、es.BCG was the pioneer in business strategy when it was founded in 1963.Today,we work closely with clients to embrace a transformational approach aimed at benefiting all stakeholdersempowering organizations to grow,build sustainable competitive advantage,and drive positive societal impact.Our divers

3、e,global teams bring deep industry and functional expertise and a range of perspectives that question the status quo and spark change.BCG delivers solutions through leading-edge management consulting,technology and design,and corporate and digital ventures.We work in a uniquely collaborative model a

4、cross the firm and throughout all levels of the client organization,fueled by the goal of helping our clients thrive and enabling them to make the world a better place.BIOPHARMA TRENDS 2025:FOCUSING ON INNOVATION AMID COMPLEXITY 3Countervailing winds of change are a constant in the biopharma industr

5、y,and they are picking up speed.Novel treatments based on innovative science and new modalities are emerging faster than ever.Intensifying competition,declining R&D productivity,payer pressures,and a steep patent cliff are testing the economic viability of biopharmas business model.More than ever,bi

6、opharma is a high-stakes business,fraught with risks.But it also remains capable of delivering life-changing benefits to patients worldwide.There are a couple of reasons why any management team can look to an uncertain future with confidence.First,this is a unique moment.An unprecedented level of kn

7、owledge about human biology is converging with the rise of novel therapeutic modalities to enable the development of transformative and potentially curative treatments.Second,technologies such as artificial intelligence(AI)and advanced translational models are poised to accelerate drug discovery and

8、 development.In this context,focus matters.Our research shows that over the past decade,companies that derive 70%or more of revenues from their top two therapeutic areas have seen a 65%increase in total shareholder return(TSR),compared with only 19%for more diversified firms.(See Exhibit 1.)We belie

9、ve that concentrating R&D and commercialization resources and expertise on areas of core strength is the most effective way to cut through complexity,de-risk investments,and deliver results for patients and shareholders alike.Looking ahead,the companies that thrive will focus on their core areas to

10、drive innovation and efficiency while accelerating speed and agility.By establishing deep connections with stakeholders,they can also more effectively shape the health care ecosystem and payment models to maximize patient access to innovative treatments.Heres our take on how biopharma companies can

11、navigate and thrive amid the industrys complexities.4 BOSTON CONSULTING GROUPIdentify Strengths and OpportunitiesScientific understanding of the biological drivers of disease,combined with the ability to influence human biology,has never been greater.Looking ahead,we expect new development to accele

12、rate,delivering a wave of breakthrough drugs that will transform the treatment of diseases in areas with significant unmet need.Momentum will be fueled by a surge in the identification of more compelling biological targets and the expansion of therapeutic modalities that enable modulation of both ne

13、wly discovered and historically undruggable targets.Examples of current new treatments include gene therapies for spinal muscular atrophy,hemophilia A,sickle cell disease,and CAR-T therapies for multiple myeloma.Already,the market share of first-in-class products has risen from 20%in 2000 to 50%toda

14、y.We estimate that some 15%of the market in 2030 will consist of novel modalities versus only about 5%in 2020.(See Exhibit 2.)In this context,biopharma companies must focus strategically on therapeutic areas(TAs)where they have both deep insight into the underlying disease biology and differentiated

15、 capabilities.To maximize R&D impact,companies should target a wide range of mechanisms within core TAs,balancing smaller and larger bets.Concentrated investments in R&D and commercialization can optimize ROI from core TAs and technology platforms,reducing selling,general,and administrative costs an

16、d ensuring that the company directs resources toward high-potential areas with measurable outcomes.By leveraging a combination of internal expertise and external innovation,the company can deploy an array of modalities to address underlying causal biology without overstretching internal resources.Gl

17、obal markets,such as China,present other opportunities for innovation and commercialization,but they require companies to navigate additional complexity.(See“The Opportunities and Challenges of China.”)As the treatment paradigm shifts from symptom management to disease modificationand even to curest

18、houghtful planning on issues of reimbursement and patient access is critical to achieve desirable patient impact.For example,while some curative gene therapies,such as Zolgensma and Luxturna,have seen commercial success,others have struggled despite positive clinical outcomes and a positive review f

19、rom the Institute for Clinical and Economic Review.Barriers include concerns about treatment durability and reimbursement structures,given the one-time up-front payment involved.To succeed,biopharma companies must work with payers,providers,policymakers,and patient advocates to create flexible payme

20、nt models(such as pay-over-time or outcome-based agreements)and invest in infrastructure to track outcomes and streamline treatment delivery.EXHIBIT 1Investors Have Rewarded Companies Whose Portfolios Are FocusedSources:S&P Capital IQ;EvaluatePharma;BCG ValueScience Center.Note:Company names in the

21、forward price-to-revenue multiple chart are New York Stock Exchange ticker abbreviations.TA=therapeutic area;TSR=total shareholder return.EXHIBIT 1Investors Have Rewarded Companies Whose Portfolios Are FocusedSources:TSR INDEX(DECEMBER 31,2013=100)TSRs favor companies whose portfolios are more focus

22、edEquity valuations tend to be higher for companies with greater product concentrationFocused(Top 2 TAs 70%of revenues)Diversified(Top 2 TAs 55%of revenues)0501001502002503002013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023+65%+19%FORWARD PRICE-TO-REVENUE MULTIPLE(AS OF DECEMBER 2023)0246810121

23、416910 11 12 13 14 15 16 17 18 19 20 2102262378ABBVAMGNAZNBIIBBMYNUMBER OF PRODUCTS REPRESENTING 80%OF SALES(2023)GILDGSKMRKNVSNOVOPFELLYSNYROGHighLowProduct concentrationBIOPHARMA TRENDS 2025:FOCUSING ON INNOVATION AMID COMPLEXITY 5EXHIBIT 2A Combination of Better Understanding of Causal Biology an

24、d Novel Modalities Is Fueling the Growth of First-in-Class ProductsSources:First-in-class productsFollow-on productsMarket share of first-in-class products doubled in past 20 yearsNovel modalities will account for 15%of total market by 2030US SALES OF FIRST-IN-CLASS VS FOLLOW-ON PRODUCTS,19902024($B

25、ILLIONS)US SALES BY DRUG MODALITY,19902030($BILLIONS)$200B$400B$600B$800B19902000201020202030EmergingmodalitiesmAbsPeptides and vaccinesSmall molecules20222028 CAGR(%)287116$0B$200B$400B$600B23%199022%200036%201046%202047%2024Sales,historical and forecastSales,historical and forecast15%5%ADCs Bispec

26、ifics Cell therapies Gene therapies Gene-modified cell treatments Genome editing DNA and RNA therapeutics mRNA vaccines Plasma-derived therapyInvest in New ToolsTechnological advances,most notably AI and new translational models,will accelerate drug discovery in coming years.AIs Rising Impact.The ab

27、ility of AI to analyze vast data sets quickly,screen compounds,and design potential drug candidates could help shorten timelines and reduce the cost of preclinical activities,giving companies with strong AI capabilities an edge over those using traditional methods.AI-driven approaches have shown ini

28、tial promise,with reported Phase 1 success rates greater than 85%in some cases.In addition,modeled scenarios suggest that AI could reduce preclinical discovery time by 30%to 50%and lower costs by 25%to 50%.Despite this promise,however,traditional pharma and biotech companies have been slow to adopt

29、AI.More than 40%of them have yet to incorporate AI materially into their drug discovery processes.In contrast,AI-first biotech startups are building therapeutic pipelines more quickly,especially in data-rich,commercially viable TAs such as oncology.Although these early pipelines,which are largely fo

30、cused on small molecules,are expanding,it remains to be seen whether AI-driven discoveries will consistently outperform traditional approaches,particularly with regard to late-stage success rates,where the data is still immature(and highly anticipated).If AI is to truly transform drug discovery,comp

31、anies must refine their AI strategies,adapt their operating models,and upskill their workforce to harness its full potential over the long term.New Translational Models.New translational models can be a game changer in preclinical validation.Our research indicates that the availability of a good tra

32、nslational model has often been the factor that unleashes a companys ability to innovate and make progress in combating a disease.One example is the history of developing a cure for hepatitis C.By 1993,researchers had identified viral targets that were accessible to small molecules.But despite repea

33、ted efforts,development proved fruitless until the discovery in 1999 of the replicon model,which resulted in the successful development of direct-acting antivirals that specifically target hepatitis C.Today cure rates for chronic hepatitis C have reached 90%.Many traditional models based on animals

34、or biochemical assays have a low concordance with actual human disease biology,particularly in neuroscience.Advances in translational models,such as organoids and organ-on-a-chip technologies,could transform preclinical drug development by providing more human-relevant models of disease.These models

35、 aim to replicate tissue and organ functions more accurately,improving the predictive power of preclinical testing.By identifying ineffective compounds earlier,they could help reduce late-stage failures and accelerate the path to clinical trials.EXHIBIT 2A Combination of Better Understanding of Caus

36、al Biology and Novel Modalities Is Fueling the Growth of First-in-Class ProductsSources:EvaluatePharma;BCG analysis.Note:Analysis includes all assets with 19902030 FDA approval.ADC=antibody drug conjugate;mAbs=monoclonal antibodies.6 BOSTON CONSULTING GROUPThe Opportunities and Challenges of ChinaCh

37、ina is rapidly emerging as an innovation hub,posing opportunities for sourcing innovation.At the same time,seizing its potential as a commercial market is becoming more challenging because of the potential introduction of new tariffs and trade barriers.China has historically been a key manufacturer

38、of active pharmaceutical ingredients,and it has become a leader in drug innovation,particularly in oncology.Regulatory reforms,significant R&D investments,and the rise of over 1,600 biotech companiessuch as BeiGene and Zai Labfrom 2010 to 2020 have catapulted Chinas biopharma sector into the ranks o

39、f global leaders.In 2022,China held a 15%share of global pipeline assets,up from just 4%in 2012.(See the exhibit.)While traditional Chinese pharma companies focus on fast-follower strategies,local biotech startups are increasingly pioneering competitive or potentially superior treatments as well as

40、first-in-class therapies.They are also expanding globally through strategic partnerships.Successful collaborations,such as Mercks partnership with Kelun-Biotech and Janssens with Legend Biotech,highlight the growing potential for sourcing innovation from China.At the same time,commercialization in C

41、hina is becoming more complex for multinational companies.Challenges arise from complex regulatory processes,IP risks,pricing pressure,and geopolitical tensions,the last exemplified by the USs proposed BIOSECURE Act,which“prohibits entities that receive federal funds from using biotechnology that is

42、 from a company associated with a foreign adversary.”Local competition and operational complexities within Chinas health care system further intensify these challenges.Still,global pharma companies should regard China as a source of innovation and explore creative structures beyond traditional in-li

43、censing and partnership models.The rise of larger innovation players in China also creates commercialization challenges for multinational companies,posing strategic questions about how best to serve the Chinese market.One thing is clear:no large multinational pharma company can afford to ignore Chin

44、a,given its increasing importance as a source of innovation and its potential as a market.To maximize its opportunities,however,each company will need a coherent strategy aligned with its global goals and context.China Is Rapidly Emerging as a Key Hub for Innovation While Becoming a More Challenging

45、 Market for CommercializationSources:IQVIA Global Trends in R&D 2023;DXY Insight database;BCG analysis.Note:R&D stages include Phase 1,Phase 2,Phase 3,and NDA,excluding marketed products.Country designation is based on the location of corporate head-quarters.BLA=biologics license application;IND=inv

46、estigational new drug application;MNC=multinational corporation;NDA=new drug application.1For purposes of this graph,“Europe”comprises all of the countries in continental Europe.China Is Rapidly Emerging as a Key Hub for Innovation While Becoming a More Challenging Market for CommercializationSource

47、s:headquarters.BLA=biologics license application;IND=investigational new drug application;MNC=multinational corporation;NDA=new drug application.1For purposes of this graph,“Europe”comprises all of the countries in continental Europe.China has seen explosive growth in innovation:China is driving rap

48、id expansion in pipeline assets,approaching US levels,positioning itself as a major global playerChina has grown as a global source of innovation:Rapid pipeline expansion has fueled a significant increase in out-licensing deals from China in recent yearsThe China market presents challenges and oppor

49、tunities:MNCs are responding differently to evolution of China market with some achieving double-digit growth while others are growing relatively slowlyTotal pipeline assets by country/regionNumber of license-out deals from localChinese playersRevenue of select MNCs in China2019202302468$BILLIONSPfi

50、zer$1 BILLION)5541435912968CUMULATIVEREVENUE IMPACT AS A PERCENTAGEOF INNOVATIVEMARKET(%)19213530IMPACT FROMTOP 5PRODUCTS(%)2011201238%201339%201444%201518%2016201738%201847%201937%202019%202120%202274%202367%202431%2025F13%2026F24%2027F58%2028F68%2029F64%2030F$25B$32B$51B$33B$34B$46B$39B$27B$27B$46

51、B$17B$8B$22B$46B$31B$60B$47B$38B$89B$62B$48B94%98%61%56%82%89%62%53%63%81%80%62%33%69%87%76%42%32%36%201026%Cozaar/LovenoxLipitorPlavixLantusRituxanHerceptinRevlimidHumiraEliquisKeytrudaDarzalex11%2%6%EXHIBIT 3Although the Share of Revenue That Will Lose Exclusivity by 2030 Is Roughly in Line With P

52、revious Patent Cliffs,More Biologics Are at Risk This TimeSources:EvaluatePharma;BCG analysis.Note:Innovative market size is calculated for each year as total sales across all NMEs still patented in that year.Revenue impact percentage is calculated by dividing revenue impact from LoEs over a five-ye

53、ar period by total innovative market size over the same five-year period.Total revenue impact/revenue at risk is calculated as sales in the last year prior to LoE.Major LoEs are defined as LoEs with a revenue impact exceeding$1 billion.LoE=loss of exclusivity;NME=new molecular entity.BIOPHARMA TREND

54、S 2025:FOCUSING ON INNOVATION AMID COMPLEXITY 9EXHIBIT 4The Period of Market Advantage Is Shortening as Rapid Innovation Fuels Heated Competition in Key Disease AreasSources:therapeutic areas.Graph covers the period 19912018.Treatment paradigms have evolved quickly as new therapies with varying MoAs

55、 have emergedThe time between market entrants has shortened,even within the same MoA1990202005101520201960IMPROVEMENT IN OUTCOME FOR 1L TREATMENTSMetastaticNsq NSCLCMetastaticRCCMetastaticmultiplemyelomaAvastinThalidomidNexavar+9New therapies,6 MoAs+11 New therapies,3 MoAs+16 New therapies,9 MoAsYEA

56、RS BETWEEN FIRST AND SECOND NME FOR THE SAME MoA1The time between first and second NME to market for the same MoA has decreased from 4 years to less than 1 year in the past decadeChemotherapies Novel 1L treatments without outcome improvementcompared to chemoFirst 1L treatment with significant outcom

57、eimprovement compared to chemoAlthough there currently is sufficient growth in the market to replenish LoE revenue losses,the sources of this growth are primarily concentrated in a combination of the top 20 pharma companies(where consolidation would require a megamerger that might attract government

58、 scrutiny)and a long tail of more than 100 smaller companies with revenues of$3 billion or less.The highly competitive industry environment may drive companies to pursue multiple smaller to medium-size acquisitions.The magnitude of the coming LoE impact on revenue will shape M&A strategy and feasibi

59、lity for each individual company,and the change in US presidential administrations could affect the regulatory outlook for M&A.Finally,as we argue in an upcoming paper on margin pressures,top companies will need to take a strong,structural approach to costs.In recent years the percentage of companie

60、s with eroding margins has steadily risen.For winners over the next decade,effective cost control will be a source of advantage.ConclusionPharma has dealt with the challenges of change beforemany times.The revenue pressures may be more powerful,but the opportunities,especially for transformative tre

61、atments and cures,are bigger than ever before.By focusing their resources and efforts on the TAs where they have the greatest strength,the clearest distinguishing capabilities,and the strongest strategies,pharma companies can approach a fast-changing future with confidence.EXHIBIT 4The Period of Mar

62、ket Advantage Is Shortening as Rapid Innovation Fuels Heated Competition in Key Disease AreasSources:American Society for Clinical Oncology;American Cancer Society;US Food and Drug Administration;Decision Resource Guide;EvaluatePharma.Note:Data comprises worldwide approved,marketed,R&D,and filed dru

63、gs.1L=first-line;MoA method of action;NME new molecular entity;NSCLC=non-small-cell lung cancer;Nsq=non-squamous;RCC=renal cell carcinoma.1 Industry average number of years from first FDA approval of a drug with novel MoA to second FDA approval for a new drug with the same MoA across all therapeutic

64、 areas.Graph covers the period 19912018.10 BOSTON CONSULTING GROUPAbout the Authors Margot Bleys is a partner in the Boston office of Boston Consulting Group.You may contact her by email at .Bilal Khan is a managing director and partner in the firms Washington,DC office.You may contact him by email

65、at .John Wu is a managing director and partner in BCGs Boston office.You may contact him by email at .Priya Chandran is a managing director and senior partner in the firms New Jersey office.You may contact her by email at .For Further ContactIf you would like to discuss this report,please contact th

66、e authors.AcknowledgmentsThe authors would like to thank their colleagues Elizabeth Howell,Katarina Sirka,Aayush Sarkar,and Carlo Cristobal for their contributions to this report.For information or permission to reprint,please contact BCG at .To find the latest BCG content and register to receive e-alerts on this topic or others,please visit .Follow Boston Consulting Group on LinkedIn,Facebook and X(formerly Twitter).Boston Consulting Group 2025.All rights reserved.1/25