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1、1EXECUTIVE INSIGHTSL.E.K.Consultings Look at Key Trends in Pharma Services for 2023IntroductionBiopharma organizations face an increasingly complex landscape as new technologies,platforms and patient expectations necessitate innovation throughout the ecosystem,from R&D through commercialization and
2、manufacturing.Trial volume has increased across the industry,with particularly strong growth in certain therapeutic areas and modalities like oncology and specialty drugs.Yet operational hurdles stemming from the growing complexity of trials,such as the volume of data and the number of endpoints and
3、 geographies,will require pharmaceutical companies to enhance their capabilities across the trial workflow in areas like data collection,regulatory operations and patient recruitment.The broader biopharma landscape has evolved from high-volume blockbusters to diffuse low-volume,high-value drugs like
4、 rare disease and specialty drugs.This shift has altered both the size and structure of trials and the challenges that occur across a products life cycle,from early R&D through commercialization and manufacturing support,requiring pharmaceutical services companies to evolve in tandem(see Figure 1).A
5、s stakeholders respond to this shifting dynamic,forward-thinking pharmaceutical services organizations have strategic opportunities to drive differentiation and serve as critical partners to biopharma over the coming years,even in a mixed macroenvironment.Trial volumeComplexity(e.g.,trial design,ope
6、rations)Commercial landscapeWorldwide total trial volume has grown 1.25x over the span of five years*The volume of trials in emerging markets*has grown 2.17x over five years,*reflecting the increasingly global and complex nature of trials and oncology trial volume is growing at a particularly fast r
7、ate relative to other disease areas at 10%p.a.By 2023,65%of new drug launches are expected to be specialty drugs Phase 3 trials now collect on average 3x more data compared with 10 years ago and recently,the Food and Drug Administration has approved 60%more drugs annually relative to the previous de
8、cade and the number of endpoints for phase 2 and 3 protocols has grown 27%since 20192 L.E.K.ConsultingEXECUTIVE INSIGHTSL.E.K.Consultings Look at Key Trends in Pharma Services for 2023Figure 1Looking ahead at global trial volume*”Five years”denotes 2016-2021*“Emerging markets”refers to Africa,Asia,W
9、estern Asia/Middle East Source:L.E.K.research and analysis;Tufts Center for the Study of Drug Development;Trialtrove;Truveris;Congressional Budget OfficeIn recent years,pharmaceutical services have evolved from a nascent high-growth market to an established active market with sustained and significa
10、nt growth year over year.Several macro trends have impacted pharmaceutical services in the past and are expected to continue,including advanced modalities and increased trial complexity.Additionally,2023 will present intriguing new opportunities and challenges as the macro situation remains uncertai
11、n,point solutions mature and biopharma customers become more sophisticated.The current macroeconomic environment will cause customers to be more conscious of containing costs across the value chain,which offers both opportunity(e.g.,for solutions with clear business cases)and challenges(e.g.,for nas
12、cent,less-proven solutions).Pharmaceutical services will continue to offer a favorable,high-growth environment with strong opportunities for leading organizations able to offer interoperable,flexible solutions that work to bridge the gap from point solutions to broader workflows.Trends highlighted i
13、n these materials are particularly meaningful for management teams and investors as we enter the new year.Emphasis on internal integrationShift toward cost-efficient approachesEvolution of commercial strategyIncreasingly complex regulatory environmentEmphasis on ecosystem interoperabilityIndustry fo
14、cus is likely to shift to internal integration after recent deal volume;this will require an evolution of existing business models to ensure optimal go-to-market positioningCustomers may outsource more frequently given macroeconomic conditions,seeking solutions that offer compelling ROI propositions
15、Commercial offerings will need to be more tailored to differing customer segments during both the sales process and execution/service deliveryThe regulatory environment is evolving in complexity,both globally and in modality(e.g.,cell/gene therapy),necessitating more robust and global offeringsBioph
16、arma sponsors are increasingly valuing the interoperability of best-of-breed services to sync with other solution providers in the ecosystemInternal optimization trendsExternal market trends3 L.E.K.ConsultingEXECUTIVE INSIGHTSL.E.K.Consultings Look at Key Trends in Pharma Services for 2023Figure 2Ma
17、jor shifts in pharmaceutical servicesSource:L.E.K.research and analysisIndustrywide trendsRapid growth in the pharmaceutical services industry has increased the complexity of biopharma operations in the manufacturing,research and commercial spaces while driving new best practices,such as requiring e
18、cosystem interoperability.The increased scale of pharmaceutical services companies solutions has made their value proposition stronger as a partner to drive cost efficiencies and optimize operations for effective R&D,scale-up/manufacturing and ultimately a successful drug launch.The overall macroenv
19、ironment offers significant opportunity for organizations to demonstrate the value of their solutions to biopharma and overcome the inertia of legacy ways of operating,akin to how COVID-19 enabled more rapid adoption of decentralized solutions recently.These dynamics have helped foster rapid growth
20、and a robust M&A landscape.Coming out of this period of growth,experimentation and solutioning,we expect to see five key trends impact the industry,with an overarching focus on internal and ecosystem-wide interoperability(see Figure 2).Management teams will need to ensure their strategies operate in
21、 concert with an industrywide desire for flexible,interoperable solutions.This may take on several forms when put into operation:4 L.E.K.ConsultingEXECUTIVE INSIGHTSL.E.K.Consultings Look at Key Trends in Pharma Services for 2023 Different customer segments will necessitate unique offerings and proc
22、esses,so pharmaceutical services companies will need to fulfill those segments individual needs to differentiate their capabilities.As a result,management teams will proactively address their commercial strategy to ensure they are positioned to serve a broad range of potential customers.Forward-thin
23、king management teams will need to ensure that offerings are able to support integration of disparate data,like claims/scripts or economics/genomics,into a cohesive ecosystem that is interoperable internally and with third-party software providers to maintain best-in-breed status.Management teams wi
24、ll need to ensure that solutions maintain flexibility across an expanding pool of modalities,such as cell and gene therapy,while remaining alert to evolving global data privacy and ethical requirements(e.g.,biospecimen management).Leading players must be extremely agile in their response to the chan
25、ging landscape of customer needs and revise their internal capabilities,regulatory approach and ecosystem interoperability to position themselves for success.For investors,it will be critical to assess how any additional point solutions can mesh into broader offerings and create further synergies am
26、ong ecosystems.This will allow investors potential targets to have a value proposition offering across the unique customer segments.Specific forms this may take include:Ensuring that a targets business model can adjust and support the integration of data both internally and with the relevant third-p
27、arty software providers to have best-in-breed services Evaluating their targets ability to remain agile as the number of advanced modalities increases and simultaneously comply with the evolving regulatory demandsResearch trendsInnovations in clinical research are crucial to driving value for biopha
28、rma organizations.Two areas helping drive the next wave of research innovation are upfront research design and at the trial site level(see Figure 3).Research design is poised to benefit from a sharper use of analytics,including to de-risk discovery efforts and shape clinical trial design(e.g.,artifi
29、cial intelligence(AI)/machine learning).Taking clinical trial stakeholder feedback into consideration and properly implementing that feedback will maximize the ability to recruit for a diverse set of trial design requirements across site levels.This ultimately feeds into innovations at the site leve
30、l,where solutions that enable sites to work more efficiently can help drive better patient engagement and outcomes.Greater use of analytics to de-risk discoveryGreater use of analytics for trial designGrowth in nontraditional trial designIncreased focus on site optimizationIncreased site-of-care fle
31、xibilityAI/machine learning will continue to be used to de-risk the discovery stage of researchAI/machine learning may be used more extensively to shape clinical trial designBiopharma will continue to seek out nontraditional trial designs,including phase 0 trials and master protocols,even as direct-
32、to-consumer tapersBiopharma will increase its focus on solutions that can optimize clinical site operations to reduce timelines and site burdenFunctionality and deployment of pharma services solutions will become more compatible and easier to use for clinical sites(e.g.,flexible site of care,trial p
33、rotocols)Emphasis on patient engagementCompanies are improving patient engagement throughout the clinical trial timeline to better drive patient enrollment and retention Research design trendsResearch site trends5 L.E.K.ConsultingEXECUTIVE INSIGHTSL.E.K.Consultings Look at Key Trends in Pharma Servi
34、ces for 2023Management teams can benefit from this broad evolution in research by incorporating analytics and nontraditional trial strategies into their portfolios.Organizations that can proactively solution and drive cost savings for biopharma partners are poised to have success as both macro condi
35、tions and overall industry complexity increase their value.For example:Forward-thinking management teams have clear policies and procedures for incorporating stakeholder(patient,physician)feedback into clinical design and work to“close the loop”with the patient community.Leveraging solutions to driv
36、e better patient engagement creates benefits throughout a trial from enhancing recruitment,retention and crossover to commercialization which,for biopharma,helps drive a differentiated“sponsor of choice”status at the individual trial site level.Management will need to create a“playbook”for successfu
37、l trials that enables clinical trials to scale both locally and globally(i.e.,at a per-site level and at the site network level)to ensure the ability to drive meaningful data collection while providing comprehensive care.For investors,research services are a robust area of opportunity.Solutions that
38、 help optimize clinical trial sites are particularly attractive,as they can offer a trifecta of supporting biopharma,improving the patient experience and driving returns.Maximizing this opportunity will require several focus areas,including:Figure 3The rise of AI in pharma servicesNote:AI=artificial
39、 intelligence Source:L.E.K.research and analysisIncreased overall volume/spendEmergence of RWE/HEOR differentiatorsGreater impact from AI/machine learningEmphasis on sales force rebalancingIncreased investment in analyticsCompanies expect to outsource more of their commercial functions in the future
40、,driven by solution maturity and macro conditionsThe recent growth in RWE/HEOR solutions will accelerate as select players have demonstrated value in RWE/HEOR offeringsAI/machine learning will be leveraged more extensively to enhance existing solutions,in particular for pharmacovigilance offeringsBi
41、opharma will look to right-size and optimize its sales force efforts after several years of post-COVID-19 disruption,including optimizing use of digital vs.in-person models of engagement Data analytics will be used more extensively to shape commercial engagement strategy across all solutions Externa
42、l commercial trendsInternal commercial trends6 L.E.K.ConsultingEXECUTIVE INSIGHTSL.E.K.Consultings Look at Key Trends in Pharma Services for 2023 Ensuring targets have a clear strategy to incorporate stakeholder feedback and properly account for the experience of participating in a clinical trial fo
43、r each stakeholder by taking key actions,like ensuring that solutions must be additive to each stakeholder and not an additional logistical burden for some Evaluating targets data and analysis capabilities as well as site and patient experience prioritization to assess their levels of differentiatio
44、n and assess the opportunity to enhance/gain a moat among their competitorsCommercial trendsCommercial services will see evolutions driven by the holistic incorporation of data to drive sharper targeting(e.g.,decile,digital vs.in person)paired with strong data/evidence packages(e.g.,real-world evide
45、nce(RWE)and health economic and outcomes research(HEOR).Commercial solutions that can efficiently process,manage and operationalize data will be at the forefront of the industry(see Figure 4).The increased use of commercial services will have subsequent effects on internal operations,such as optimiz
46、ing digital vs.in-person touchpoints,as sales forces are rebalanced and analytics continue to drive more precise targeting.We also expect to see the use of RWE and HEOR grow into a true strategic differentiator for select players.Figure 4Growth among data and analyticsNote:RWE=real-world evidence;HE
47、OR=health economic and outcomes research;AI=artificial intelligence Source:L.E.K.research and analysis7 L.E.K.ConsultingEXECUTIVE INSIGHTSL.E.K.Consultings Look at Key Trends in Pharma Services for 2023Management teams will need to ensure their internal strategies are poised to benefit both from bro
48、ad secular tailwinds and focused excellence in analytics and targeting efforts.Specific areas of focus for forward-thinking management teams over the next several years will include:Evaluating commercial services abilities to improve their existing offerings and distribution to execute a targeted(by
49、 customer type)sales strategy.Identifying how to operationalize and monetize the wealth of data collected as part of ongoing operations.This requires a clear data management and monetization plan that is supportive of the organizations strategic objectives;for example,incorporating RWE across the wo
50、rkflow to highlight a solutions differentiation in the market.In aggregate,many organizations have developed a collection of point solutions,and they now need to take the next step to drive value that is greater than the sum of the parts.For investors,we expect to see continued interest in acquiring
51、 and integrating data-forward solutions into point solutions and portfolio offerings.Several areas of renewed focus will include the following:The accumulation,management and analysis of data will become increasingly important with scale and will be essential for investors to evaluate to understand
52、the level of investment(s)required to drive differentiation Leading management teams will not only execute on driving more value from the data but will advertise their ability to do so as a best-in-breed partnerManufacturing trendsManufacturing partners will continue to see increasing fragmentation
53、and diversification in demand coming from their customers as advanced modalities grow and batch sizes shrink.These advanced modalities,such as rare disease therapy,and corresponding technologies often have lower and/or irregular demand,requiring a new lens through which to view attractive investment
54、 and expansion opportunities.This is occurring while the industry emerges from COVID-19 and must adjust for demand shifts and a renewed focus on supply chain risks and vulnerabilities(see Figure 5).Capacity constraints will persist across the industry;however,these trends will impact which portions
55、of the market(inputs,equipment,end products)are subject to the most constraints.Modality and technology fragmentationShift from large-to small-batch operationsReplacing COVID-19 demandManaging global supply chain riskGrowth in advanced modalities will require CDMOs to invest in technologies and faci
56、lities that are flexible and compliantAs advanced modalities treating smaller patient populations continue to be developed,more value will be placed on flexible,small-batch manufacturingCOVID-19 vaccine demand is expected to decrease,leaving open mRNA bioprocessing capacity and freeing up capacity f
57、or other aF/F productsSupply chains will need to be reinforced through redundancies/increased inventories and built to support smaller,less predictable manufacturingFragmentation and diversification of demand trendsEmergence from COVID-19 trends8 L.E.K.ConsultingEXECUTIVE INSIGHTSL.E.K.Consultings L
58、ook at Key Trends in Pharma Services for 2023These trends will have broad implications for leading management teams as they assess their internal operations and internal/external growth drivers.Specific areas of focus will include:Carefully assessing which inputs,technologies/equipment types and end
59、-product demand are best suited to drive growth.As advanced modalities and technologies have inconsistent manufacturing processes,identifying growth vectors that enable a more“product agnostic”approach will be critical to avoiding binary risk.As the manufacturing world has been affected by COVID-19
60、vaccine capacity and the pandemics effect on exposing the supply chain,forward-thinking manufacturer players will proactively grow capacity in demanded areas while improvising their supply chain management to avoid future disruptions and differentiate to win biopharma business.For investors,this bro
61、ad assessment of capacity,operations and growth drivers across manufacturing offers ample opportunity.For example:Investors must evaluate targets ability to invest in the proper inputs(e.g.,product agnostic)proactively and effectively to offer best-in-breed solutions for biopharma Valuable targets f
62、or investors will be well positioned to capitalize on demand for small-batch manufacturing and to drive product-agnostic growthFigure 5Increased innovation across the ecosystemNote:CDMO=contract development and manufacturing organization Source:L.E.K.research and analysis9 L.E.K.ConsultingEXECUTIVE
63、INSIGHTSL.E.K.Consultings Look at Key Trends in Pharma Services for 2023Management teams and investors must plan and strategize thoughtfully to achieve considerable growth for pharmaceutical services in 2023Across the entirety of pharmaceutical services,industry tailwinds are poised to support conti
64、nued strong growth.However,there are broader macro trends that need to be acknowledged and considered in stakeholders broader strategic goals in order to achieve success.Strategies will need to evolve,including sharper go-to-market approaches and strategic planning that involves innovations like add
65、ing features and monetizing data.Leading pharmaceutical services organizations and investors have an unparalleled opportunity to enhance patients lives through faster,more targeted and better therapeutics.For more information,please contact .10 L.E.K.ConsultingEXECUTIVE INSIGHTSL.E.K.Consultings Loo
66、k at Key Trends in Pharma Services for 2023About L.E.K.ConsultingWere L.E.K.Consulting,a global strategy consultancy working with business leaders to seize competitive advantage and amplify growth.Our insights are catalysts that reshape the trajectory of our clients businesses,uncovering opportuniti
67、es and empowering them to master their moments of truth.Since 1983,our worldwide practice spanning the Americas,Asia-Pacific and Europe has guided leaders across all industries,from global corporations to emerging entrepreneurial businesses and private equity investors.Looking for more?Visit .L.E.K.
68、Consulting is a registered trademark of L.E.K.Consulting LLC.All other products and brands mentioned in this document are properties of their respective owners.2023 L.E.K.Consulting LLCMatt WheelerMatt Wheeler is a Managing Director and Partner in L.E.K.Consultings Boston office and a leader in the
69、Pharma Services practice within Life Sciences.Matt joined L.E.K.in 2010 and advises clients on a range of topics,including corporate and business-unit growth strategy,platform and portfolio development,new market prioritization and entry,and strategic mergers and acquisitions.Within the pharmaceutic
70、al services space,he has particular expertise and deep experience across clinical services,eClinical tools and commercial services.Ian TzengIan Tzeng is a Managing Director and Partner in L.E.K.Consultings Boston office and leads the firms Pharma Services practice within Life Sciences.Ian joined the
71、 company in 1998 and has extensive experience in growth strategy,regulated markets,innovation,pricing,and mergers and acquisitions.His expertise includes developing strategy for clients in the following areas:pharmaceuticals,vaccines,medical devices,CROs,CDMOs,supply chain operations and distributio
72、n,as well as commercial medical and market access services.Kevin GiffelsKevin Giffels is an Engagement Manager in L.E.K.Consultings Boston office and a member of the Pharma Services practice within Life Sciences,where he works with pharmaceutical services and biopharma clients.Kevin joined L.E.K.in 2016 and has experience in portfolio prioritization,strategic mergers and acquisitions,and growth strategy.About the Authors