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1、The Pulse 2024Global R&D insights in pharmaceuticals Thought leadershipppdMethodology 4 Executive summary 9Detailed findings:Industry trends and challenges 16Detailed findings:Hot topics 27Detailed findings:Outsourcing 32Appendix 37Contents2The Pulse 2024 Thermo Fisher Scientific Inc.All rights rese

2、rved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.About The PulseThe future for drug developers is defined by how effectively they adopt innovative strategies and new technologies,while navigating industry challenges and complexities.Tha

3、ts why the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders at biotech and pharmaceutical organizations around the globe to assess trends in drug discovery and development.Respondents shared the therapeutic areas in their pipelines,barriers to bringing drugs to market,

4、innovations that are driving transformation,and attitudes toward key topics such as outsourcing,patient recruitment,diversity,decentralized trials,and more.In our third annual report,youll go beyond the data to learn what these insights mean for drug developers across the globe,and how you can prepa

5、re to successfully navigate the evolving drug development landscape.Discover what industry leaders are facing today,and how their outlook on pharmaceutical research and development is pushing the industry forward.3The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the

6、 property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Methodology4The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Methodology Participants were

7、screened to ensure they met the following criteria:Industry:Pharmaceutical,biopharmaceutical,or biotechnology company Level:Director level or higher with drug development decision-making responsibility Role:Work in a role related to drug development Company:Have at least one compound in development

8、Geography:Asia-Pacific,Europe,US-CanadaMethodology150 participants were surveyed in Q2 2024The online survey was conducted on behalf of the PPD clinical research business of Thermo Fisher Scientific by Life Science Strategy Group(LSSG)using its proprietary panel of more than 70,000 life science stak

9、eholders and biopharma/biotech industry outsourcing decision makers and its affiliated APAC partners respondent panel.Participants were provided an honorarium for their time.5The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific a

10、nd its subsidiaries unless otherwise specified.Respondents were classified into the following segmentsSegments*Ranges in China were adjusted to reflect market conditions Small/Mid=annual R&D spend 700 million Large=annual R&D spend 700 millionStatistical DifferencesStatistically significant differen

11、ces between segments at a 90%confidence level are indicated with letters throughout the report.Company Size Small/Mid-size Biopharma Companies:annual R&D spend$1 billion*(n=86)Large Biopharma Companies:annual R&D spend$1 billion*(n=64)6The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.

12、All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Sample profile overview:TotalSample Profile Overview Total1Primary Functional Area37%23%20%13%7%50%29%13%5%3%US/CanadaEuropeAsiaMiddle East/IndiaAustraliaNET:Asia:21%Headquarters LocationDrug

13、Development Categories62%24%14%Job Level/RoleDirectorVice PresidentPresident/C-Level43%57%Organization Typen=64n=86Large=annual R&D spend of$1 billion or moreSmall/Mid=annual R&D spend less than$1 billion60%55%38%38%30%23%20%18%14%3%BiologicsNovel small molecule drugsGene therapiesCell therapiesVacc

14、inesGeneric small molecule drugsBiosimilarsNucleic acid therapiesDiagnosticsOther(Please specify)Average number categories:3.0Clinical DevelopmentExecutive Management/C-levelPeri-/post-approval/Registries/HEORQuality and RegulatoryPre-trial/Preclinical Development*See Appendix for additional demogra

15、phic detailBase:All respondents(n=150).Charts may not total 100%due to rounding.S5.Which of the following best describes your current,primary functional area?(See Appendix for complete descriptions of functional areas)S4.What is your job level?S10.Which of the below ranges most closely represents yo

16、ur companys annual R&D spend?S3.In which of the below regions is your company headquarters located?Q1.In which categories is your organization/company developing or commercializing products?Please select all that apply.7The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks a

17、re the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Sample profile overview:Customer segmentsSample Profile Overview Customer Segments2Primary Functional Area44%14%27%11%5%33%29%15%14%9%ClinicaldevelopmentExec mgmt/C-levelPeri-/post-approval/Registries/HEORQua

18、lity and regulatoryPre-trial/preclinicaldevelopmentLarge(A)Small/Mid(B)Job Level/RoleHeadquarters Location42%56%33%27%14%12%6%5%Large(A)Small/Mid(B)AustraliaMiddle East/IndiaAsiaEuropeU.S./CanadaDrug Development Categories73%66%50%45%38%30%28%22%16%2%50%48%29%33%24%19%14%15%13%3%BiologicsNovel small

19、moleculedrugsGenetherapiesCelltherapiesVaccinesGeneric smallmoleculedrugsBiosimilarsNucleic acidtherapiesDiagnosticsOther77%51%20%27%22%Large(A)Small/Mid(B)President/C-levelVice PresidentDirectorSmall/Mid(B)Large(A)Avg.#Categories3.72.525%17%BAABBBBBBABLetters indicate statistically significant diff

20、erence between groups at the 90%confidence levelBase:All respondents.Large(annual R&D spend of$1 billion or more):n=64;Small/Mid(annual R&D spend less than$1 billion):n=86S5.Which of the following best describes your current,primary functional area?(See Appendix for complete descriptions of function

21、al areas)S4.What is your job level?S3.In which of the below regions is your company headquarters located?Q1.In which categories is your organization/company developing or commercializing products?Please select all that apply.8The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All tradem

22、arks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Executive summary9The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Drug develop

23、mentKey takeaways:Oncology(64%)is the leading therapeutic area for drug development,followed by Immunology/Rheumatology(41%)and Rare Diseases(31%).The rising cost of clinical trials is the top challenge followed by patient recruitment and the increasing complexity of clinical trials.Increasingly com

24、plex protocol designs and difficult patient recruitment are top challenges increasing the cost of clinical trials.Enrollment of hard-to-find populations and complex regulatory requirements are top challenges increasing the complexity of clinical trials.Innovative trial design,personalized/precision

25、medicine and AI are the top trends driving transformation in clinical trials.Adaptive trial design is the top element considered innovative,followed by novel endpoints,biomarker-driven approaches,and multiple trial arms.Experience with clinical development timelines is mixed.While 30%of participants

26、 report shorter timelines and one-quarter indicate no change,45%say producing a drug takes longer now than it did two years ago.Drug Development9Key Takeaways:Top 5 Challenges21%21%19%12%7%49%39%39%33%30%Rising cost of clinical trialsPatient recruitment in clinical trialsIncreasing complexity of cli

27、nical trialsMaximizing asset value/ROIFeasibility and site selection%Ranked Top 2%Selected Top 5Drug Development9Key Takeaways:Top 5 ChallengesTop 5 Opportunities22%22%29%19%18%52%51%50%47%43%Innovative trial designPersonalized/precision medicineArtificial intelligenceLeveraging new technologiesPati

28、ent-centricity%Ranked Top 2%Selected Top 510The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Drug developmentKey takeaways:Drug development leaders use a variety of technologies

29、 and innovations;the most common overall are innovative trial design,artificial intelligence(AI),and personalized/precision medicine.Biopharma companies also are pursuing multiple strategic initiatives,with maximizing asset values the most common overall,but the two segments differ somewhat on other

30、 top strategies.Other leading strategies for large biopharma:Patient-centricity Greater use of RWD/RWE Patient diversity Other leading strategies for small/mid biopharma:New approaches to investment and funding Vendor rationalization Greater use of RWD/RWEDrug Development10Key Takeaways:Drug develop

31、ment leaders use a variety of technologies and innovations;the most common overall are innovative trial design,artificial intelligence(AI),and personalized/precision medicine.Biopharma companies also are pursuing multiple strategic initiatives,with maximizing asset values the most common overall,but

32、 the two segments differ somewhat on other top strategies:Other Leading Strategies:Large Biopharma:Patient-centricityGreater use of RWD/RWEPatient diversityOther Leading Strategies:Small/Mid Biopharma:New approaches to investment and fundingVendor rationalizationGreater use of RWD/RWETop 5 Technolog

33、ies Pursuing:Large Biopharma66%59%56%55%52%Artificial Intelligence(AI)Personalized/precision medicineDigitalizationBig data and analytics(data science)Innovative trial designDrug Development10Key Takeaways:Drug development leaders use a variety of technologies and innovations;the most common overall

34、 are innovative trial design,artificial intelligence(AI),and personalized/precision medicine.Biopharma companies also are pursuing multiple strategic initiatives,with maximizing asset values the most common overall,but the two segments differ somewhat on other top strategies:Other Leading Strategies

35、:Large Biopharma:Patient-centricityGreater use of RWD/RWEPatient diversityOther Leading Strategies:Small/Mid Biopharma:New approaches to investment and fundingVendor rationalizationGreater use of RWD/RWETop 5 Technologies Pursuing:Large Biopharma66%59%56%55%52%Artificial Intelligence(AI)Personalized

36、/precision medicineDigitalizationBig data and analytics(data science)Innovative trial designTop 5 Technologies Pursuing:Small/Mid-size Biopharma64%45%44%43%36%Innovative trial designPersonalized/precision medicineArtificial Intelligence(AI)Big data and analytics(data science)Digitalization11The Puls

37、e 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Patient recruitmentKey takeaways:Large biopharma participants express more positivity than their Small/Mid-size counterparts about recru

38、iting qualified patients and affecting diverse patient enrollment.Top patient recruitment/participation strategies include establishing or improving relationships with patient advocacy groups,using more sites for each clinical study,and conducting research in more countries.The primary goals of pati

39、ent-focused strategies are to remove barriers to patient participation and increase overall enrollment.Patient Recruitment11Large biopharma participants express more positivity than their Small/Mid-size counterparts about recruiting qualified patients and affecting diverse patient enrollment.Top pat

40、ient recruitment/participation strategies include establishing or improving relationships with patient advocacy groups,using more sites for each clinical study,and conducting research in more countries.The primary goals of patient-focused strategies are to remove barriers to patient participation an

41、d increase overall enrollment.Key Takeaways:Ability to Recruit Qualified Patients Compared to 2 Years Ago%More OptimisticAbility to Affect Diverse Patient Enrollment Compared to 2 Years Ago%Improved0%10%20%30%40%50%60%LargeBiopharmaSmall/Mid-sizeBiopharma0%10%20%30%40%50%60%LargeBiopharmaSmall/Mid-s

42、izeBiopharmaTop 5 Strategies for Removing Barriers to Patient Participation0%10%20%30%40%50%60%Establishing or improving relationships with patient advocacy groupsUsing more sites for each clinical studyConducting research in more countriesPatient assistance resourcesBuilding more inclusive entry cr

43、iteria into protocolsPatient Recruitment11Large biopharma participants express more positivity than their Small/Mid-size counterparts about recruiting qualified patients and affecting diverse patient enrollment.Top patient recruitment/participation strategies include establishing or improving relati

44、onships with patient advocacy groups,using more sites for each clinical study,and conducting research in more countries.The primary goals of patient-focused strategies are to remove barriers to patient participation and increase overall enrollment.Key Takeaways:Ability to Recruit Qualified Patients

45、Compared to 2 Years Ago%More OptimisticAbility to Affect Diverse Patient Enrollment Compared to 2 Years Ago%Improved0%10%20%30%40%50%60%LargeBiopharmaSmall/Mid-sizeBiopharma0%10%20%30%40%50%60%LargeBiopharmaSmall/Mid-sizeBiopharmaTop 5 Strategies for Removing Barriers to Patient Participation 2024 T

46、hermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.0%10%20%30%40%50%60%Establishing or improving relationships with patient advocacy groupsUsing more sites for each clinical studyConducting resea

47、rch in more countriesPatient assistance resourcesBuilding more inclusive entry criteria into protocols12The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Decentralized trialsKey

48、takeaways:The prevalence of decentralized trial elements continues to grow with 38%of trials currently using DCT.DCT growth is expected to continue,and in two years,over 90%expect to be using DCT in at least some of their trials,similar to 2023 estimates.Decentralized Trials12Key Takeaways:The preva

49、lence of decentralized trial elements continues to grow with 38%of trials currently using DCT.DCT growth is expected to continue,and in two years,over 90%expect to be using DCT in at least some of their trials,similar to 2023 estimates.Past,Current,and Expected Future Use of Decentralized Clinical T

50、rial Elements32%38%48%0%20%40%60%80%100%1 Yr AgoCurrentIn 2 YrsAverage%of clinical trials conducted with DCT elementsOver 50%of trials11%to 50%of trials10%of trials or lessProportion of trials using DCT:13The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property

51、 of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.OutsourcingKey takeaways:FSP outsourcing is growing faster than full-service outsourcing 35%of participants say they have increased FSP outsourcing versus just 29%who have upped their use of full-service outsourcing.However

52、,full-service outsourcing still makes up 34%of clinical work that is currently outsourced,with FSP and Hybrid models each comprising about 25%,and the remainder(13%)going to insourcing or temporary staffing.Patient recruitment and clinical laboratory&diagnostic services are the top drug development

53、activities likely to be outsourced,similar to 2023.Outsourcing13Key Takeaways:FSP outsourcing is growing faster than full-service outsourcing 35%of participants say they have increased FSP outsourcing versus just 29%who have upped their use of full-service outsourcing.However,full-service outsourcin

54、g still makes up 34%of clinical work that is currently outsourced,with FSP and Hybrid models each comprising about 25%,and the remainder(13%)going to insourcing or temporary staffing.Patient recruitment and clinical laboratory&diagnostic services are the top drug development activities likely to be

55、outsourced,similar to 2023.Top 5 Activities Likely to Outsource43%45%31%36%28%73%73%64%63%63%Patient recruitmentClinical laboratory and diagnostic servicesClinical data managementClinical trial management(end-to-end)RWD(i.e.,access to data)%Extremely Likely%Extremely likely/Very likely14The Pulse 20

56、24 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Large small/mid biopharma comparisonCategoryLarge Biopharma ResponsesSmall/Mid Biopharma ResponsesLeading Therapeutic Areas Oncology Immunol

57、ogy/Rheumatology Cardiovascular Neurology Hematology Rare Diseases Infectious Diseases Oncology Immunology/Rheumatology Rare Diseases Neurology Infectious Diseases CardiovascularClinical Development Timelines Increased timelines Increased timelinesChallenges Rising cost of clinical trials Increasing

58、 complexity of clinical trials Patient recruitment in clinical trials Maximizing asset value/ROI Rising cost of clinical trials Patient recruitment in clinical trials Increasing complexity of clinical trials Lack of fundingClinical Trial Cost Drivers Increasingly complex protocol designs Patient rec

59、ruitment is more difficult Increasingly complex protocol designs Patient recruitment is more difficultClinical Trial Complexity Drivers Enrollment of hard-to-find patient populations Innovative therapies that require complex protocols Enrollment of hard-to-find patient populations Compliance with co

60、mplex regulatory requirements Pressure to shorten trial timelinesTransformational Trends Personalized/precision medicine Artificial intelligence New drug development technologies RWD/RWE to complement clinical trial data Decentralized/hybrid trial elements Innovative trial design Artificial intellig

61、ence Personalized/precision medicine Digitalization New drug development technologiesTop Innovations Pursued Artificial intelligence Personalized/precision medicine Digitalization Innovative trial design Personalized/precision medicine Artificial intelligenceTop Strategies Pursued Patient-centricity

62、 Greater use of RWD/RWE Maximizing asset value Patient diversity Sustainability efforts Maximizing asset value New approaches to investment and funding Vendor rationalizationPatient Recruitment More optimistic about recruiting qualified patients More success in affecting patient diversity vs.2 years

63、 ago Utilizing patient advocacy groups and data/technology to target patients Primary goal of patient-focused strategies:Increase overall enrollment Mixed perceptions about ability to recruit qualified patients For many,too early to know if patient diversity efforts are working Utilizing patient adv

64、ocacy groups,more sites,and more countries Primary goal of patient-focused strategies:Remove barriers to patient participationTop Areas for Outsourcing Patient recruitment Clinical laboratory and diagnostic services Clinical monitoring/operations management Clinical trial management Patient recruitm

65、ent Clinical laboratory and diagnostic services Clinical data management Clinical trial management RWD(i.e.,access to data)Bulleted items in bold text indicate a variance between the large and small/mid biopharma subgroups.15The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All tradema

66、rks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Detailed findings:Industry trends and challenges16The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless o

67、therwise specified.Therapeutic areasOncology significantly outpaces all other therapeutic areas for drug development as indicated by participants from both large and small/mid-size biopharma companies.Immunology/Rheumatology,Rare Diseases,Cardiology,and Neurology are the next most prevalent therapeu

68、tic areas.Large company participants are more likely than those at Small/Mid-size companies to be developing therapeutics for Cardiovascular and Hematology.OncologyImmunology/RheumatologyRare DiseasesCardiovascularNeurologyInfectious DiseasesHematologyGastroenterologyMetabolic/EndocrineDermatologyRe

69、spiratory/AllergyAverage number TAs:3.5 3.8 3.3 71%41%35%20%28%21%13%17%12%9%13%70%43%31%29%29%21%19%15%14%13%11%69%47%25%42%30%20%27%13%17%17%9%Small/Mid(B)Large(A)TotalTherapeutic Areas17Leading Therapeutic Areas for Drug Development(TAs selected by 10%or more*)BBBLetters indicate statistically si

70、gnificant difference between groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Small/Mid:n=86Q2.Which therapeutic areas are leading your organizations drug development pipeline today?Please choose up to 5.*See Appendix for complete detailYOYThe same TAs made the top 10 in

71、2024 as in 2022 and 2023.17The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Clinical development timeline total marketYOYLike 2023,fewer than half state their development timeli

72、nes have extended,indicating the trend of lengthening timelines may have plateaued.Across the industry,somewhat more sponsors indicate that clinical development timelines are extending.For those whose timelines have increased,the split is fairly even between those who say timelines have lengthened b

73、y less than a year and those indicating timelines have increased by more than a year.Sponsors who have experienced shorter development timelines say the reduction has primarily been in the range of 1 to 11 months.LONGERSHORTERClinical Development Timeline Total Market183%19%23%26%23%6%45%30%Note:3%i

74、ndicated not applicable/dont knowChange in Timeline to Produce a Drug Compared to 2 Years Ago(from first in-human trials through regulatory submission)24+months12 to 23 months1 to 11 monthsNo change1 to 11 months12 to 23 months24+monthsLengthened by:Shortened by:Base:All respondents excluding dont k

75、now;Total:n=145Q7.Compared to two years ago,how has the average timeline to produce a drug(from first-in-human trials through regulatory submission)changed at your organization?18The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientif

76、ic and its subsidiaries unless otherwise specified.Clinical development timeline by market segmentParticipants from both biopharma segments indicate somewhat longer clinical development timelines compared to what they experienced two years ago.While similar proportions of participants from large and

77、 small/mid companies indicate increased timelines,this issue is more pronounced in the Small/Mid-size company segment,with 27%reporting increased timelines of over one year as opposed to just 16%among their counterparts at Large companies.No statistically significant difference between groups at the

78、 90%confidence levelBase:All respondents excluding dont know;Large:n=63,Small/Mid:n=82Q7.Compared to two years ago,how has the average timeline to produce a drug(from first-in-human trials through regulatory submission)changed at your organization?YOYFewer large company participants report shortenin

79、g timelines in 2024(33%)than did in 2023(48%),and more are reporting longer timelines,43%in 2024 vs.29%in 2023.In 2024,the pattern for large company participants is more similar to the small/mid segment than it was in 2023.Clinical Development Timeline by Market SegmentParticipants from both biophar

80、ma segments indicate somewhat longer clinical development timelines compared to what they experienced two years ago.19Change in Timeline to Produce a Drug Compared to 2 Years Ago(from first in-human trials through regulatory submission)LONGERSHORTER2%14%27%24%22%10%LONGERSHORTER4%23%20%27%23%4%Small

81、/Mid(B)Large(A)43%46%33%24+months12 to 23 months1 to 11 monthsNo change1 to 11 months12 to 23 months24+monthsLengthened by:Shortened by:27%19The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwi

82、se specified.Biggest challengesYOYTalent/staff shortages are less of an issue for those at Small/Mid companies in 2024(19%)than in 2023(35%).As in 2022 and 2023,patient recruitment and trial complexity continue to be large organizational hurdles,following the rising cost of clinical trials as the la

83、rgest hurdle(new challenge added in 2024).Participants from Small/Mid-size companies are more challenged by a lack of funding(similar to 2023),while the lack of internal expertise to utilize RWD is more problematic for those at Large biopharma companies.Letters indicate statistically significant dif

84、ference between groups at the 90%confidence levelRising cost of clinical trialsPatient recruitment in clinical trialsIncreasing complexity of clinical trialsMaximizing asset value/ROIFeasibility and site selectionLack of fundingFinding vendors w/scientific/therapeutic expertiseElongated study startu

85、p timeLack of or limited relevant RWD/RWELack internal resources/experts for RWD/RWENavigating changing regulatory landscapeTalent/staff shortagesBiggest Challenges20Pharmaceutical Companies Biggest Challenges(Challenges selected by 20%or more*)*See Appendix for complete detail21%21%19%12%7%19%13%11

86、%9%11%9%5%49%39%39%33%30%28%27%27%23%21%21%21%23%19%22%11%5%13%13%11%9%17%11%5%44%34%39%33%28%19%22%25%25%27%23%25%20%23%16%13%8%23%13%12%8%7%8%6%53%42%38%33%31%35%31%28%22%17%20%19%ASmall/Mid(B)Large(A)Total%Ranked Top 2%Selected Top 5Key:BALetters indicate statistically significant difference betw

87、een groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Small/Mid:n=86 Q3.What are the biggest challenges your organization is currently facing?Please select your top 5 biggest challenges.Q3b.Please rank these top challenges that your organization is facing,with Rank#1=Bigge

88、st challenge.20The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Deeper dive:Increasing cost of clinical trialsMultiple factors drive the cost of clinical trials,including increa

89、singly complex protocol designs,difficulty with patient recruitment,increasing length of clinical trials,inflation and other macroeconomic factors,development of innovative therapies that require complex protocols,and compliance with regulatory requirements.Participants from both segments are simila

90、r in their views about the factors that are most responsible for increasing clinical research costs.No statistically significant differences between groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Small/Mid:n=86 Q23.(NEW)What are the top 3 factors most responsible for th

91、e increasing cost of clinical trials?Please select up your top 3.21Deeper Dive:Increasing Cost of Clinical TrialsFactors Responsible for Increasing Cost of Clinical Trials0%10%20%30%40%50%Increasinglycomplex protocoldesignsPatientrecruitment ismore difficultIncreasing lengthof clinical trialsInflati

92、on andothermacroeconomicfactorsDevelopment ofinnovativetherapies thatrequire complexprotocolsCompliance withregulatoryrequirementsPressure toshorten trialtimelinesNeed to capturemore data andinsights fromclinical trialsIncreasingamount of trialdata collectedper studyAdoption of newtechnologiesGreate

93、remphasis on sitemonitoringTotalLarge(A)Small/Mid(B)12312321The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Deeper dive:Patient recruitment problems/difficultiesTop challenges

94、for patient recruitment include identifying the right patients and competition with other trials or sites,especially given low patient numbers for rare diseases and diversity requirements.Participants at Large companies are particularly impacted by competition with other trials or sites,while those

95、at Small/Mid-size biopharma companies struggle with identifying the right patients.Base:Respondents who selected“Patient recruitment in clinical trials”as a top 5 challenge(Q3a);Total:n=58,Large:n=22,Small/Mid:n=36 Q26(NEW):Earlier you indicated that“patient recruitment in clinical trials”is current

96、ly a challenge for your organization.What,specifically,is especially problematic or difficult about patient recruitment or managing patient recruitment?(free text/open-end response).Deeper Dive:Patient Recruitment Problems/Difficulties22Patient Recruitment Difficulties(number of mentions)Total(n=58)

97、Large(n=22)Small/Mid(n=36)Identifying the right patients27720Competition with other trials or sites20128Patient willingness and retention927Identification of sites734Diversity requirements633Lack of funding/resources523Timelines for recruitment514“Patient recruitment is often slower than estimated,s

98、ometimes due to competition over the“best”sites.”-Respondent from a large biopharma“Additional competitors within rare disease therapeutic areas limits the overall population of clinical trial amenable patients.Additionally,with new therapies that are novel and not approved globally inclusion and ex

99、clusion criteria are increasingly complex thus limiting amenable patients for long term clinical trials.Success within rare diseases increases difficulty for any future therapy.”-Respondent from a small/mid biopharma22The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are

100、 the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Deeper dive:Increasing cost of clinical trialsEnrollment of hard-to-find patient populations,compliance with complex regulatory requirements,and innovative therapies requiring complex protocols are the top fact

101、ors most responsible for the increasing complexity of clinical trials.The pressure to shorten trial timelines(particularly among those from Small/Mid-size companies)and the need to capture more data and insights from clinical trials are other key factors.Letters indicate statistically significant di

102、fference between groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Small/Mid:n=86 Q22.(NEW)What are the top 3 factors most responsible for the increasing complexity of clinical trials?Please select your top 3.23Deeper Dive:Increasing Complexity of Clinical TrialsFactors Re

103、sponsible for Increasing Complexity of Clinical Trials0%10%20%30%40%50%60%Enrollment ofhard-to-findpatientpopulationsCompliancewith complexregulatoryrequirementsDevelopment ofinnovativetherapies thatrequirecomplexprotocolsPressure toshorten trialtimelinesNeed tocapture moredata andinsights fromclini

104、cal trialsStudyprioritizationamong sitesManagingmultiplevendorsAdoption ofnewtechnologiesLack of or needto achievealignment ontrial strategy/designManagementof multiplestudyplatforms/technologiesIncreasinguse ofdecentralizedtrialsInability toachieve theright balance ofFSO and FSPoutsourcingmodelsTot

105、alLarge(A)Small/Mid(B)B123123=notably higher than the other segment23The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Top transformational trendsYOYStrengthening in 2024:Persona

106、lized/precision medicine Leveraging new technologies Increasing focus on patient diversity(especially with Small/Mid)AI(especially with Large)While there is little consensus about which trends are most impactful,trial design innovation(especially for those in Small/Mid-size organizations),personaliz

107、ed medicine,and AI top the list.Those at Small/Mid-size companies also consider digitalization to be a top trend,while their counterparts at Large organizations put more emphasis on greater use of RWD/RWE.Innovative trial designPersonalized/precision medicine(e.g.,companion diagnostics)Artificial in

108、telligenceLeveraging new tech dev(e.g.,mRNA,CRISPR,gene-editing)Patient-centricityIncreasing focus on patient diversityDecentralized/hybrid trial elementsAccelerated development/approvals in rare/orphan diseaseGreater use of RWD/RWE to complement data from clinical trialsBig data and analytics(data

109、science)Digitalization(e.g.,cloud computing,APIs,digital platforms)Sustainability effortsTop Transformational Trends24Trends Driving Transformation in Clinical Trials22%22%29%19%18%10%15%17%16%11%15%5%52%51%50%47%43%43%42%41%41%39%36%15%16%25%33%20%20%9%9%17%22%9%8%9%42%53%50%50%44%42%45%38%48%38%23

110、%25%27%20%27%19%16%10%19%17%12%12%20%59%49%50%44%43%43%40%43%35%40%45%8%Small/Mid(B)Large(A)Total%Ranked Top 2%Selected Top 5Key:ABBABABSee Appendix for full trend descriptions provided in the survey.Letters indicate statistically significant difference between groups at the 90%confidence levelBase:

111、All respondents;Total:n=150;Large:n=65,Small/Mid:n=85Q4.What are the top five trends that are driving transformation in clinical trials?Please select your top 5 trends.Q4b.Please rank these top trends,with Rank#1=Most impactful trend.24The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.

112、All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Key initiativesReflecting the dispersion of opinions about leading transformational trends,sponsors are pursuing a wide variety of technologies and innovations chief among them is innovative t

113、rial design,followed by AI,personalized medicine,big data,and digitalization.Among Large company participants,AI,personalized medicine,and digitalization are the top innovations and technologies.Innovative trial design is the key pursuit among those at Small/Mid-size companies,and similar to their L

114、arge company counterparts,AI and personalized medicine are receiving a lot of attention along with big data.Innovations and Technologies Employed by Pharmaceutical Companies0%10%20%30%40%50%60%70%Innovative trial designArtificial intelligencePersonalized/precisionmedicineBig data and analyticsDigita

115、lizationLeveraging newtechnologies in drugdevelopmentDigital/hybridtrial elementsTotalLarge(A)Small/Mid(B)Average number innovations/technologies:3.03.73.3Key Initiatives25BBB123123BLetters indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents;To

116、tal:n=150;Large:n=64,Small/Mid:n=86Q5.(REVISED innovations/technologies separated from strategies in Q6)Which specific innovations and/or technologies are being pursued currently by your organization?Please select all that apply.YOYSponsors are engaging nearly all of these innovations and technologi

117、es more in 2024,especially AI.The only exception is digital/hybrid trial elements.25The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Current strategiesYOYLarge company participa

118、nts are more apt to be looking for new approaches to investment and funding in 2024(33%)than they were in 2023(14%).Multiple strategies are also currently pursued,with top strategies overall including efforts to maximize asset value,greater use of RWD/RWE,and patient-centricity.RWD/RWE and patient-c

119、entricity strategies are strategies that a majority of Large company participants are engaged in.Maximizing asset value and finding new avenues for funding are top strategies among those from Small/Mid-size companies.S St tr ra at te eg giie es s P Pu ur rs su ue ed d b by y P Ph ha ar rmma ac ce eu

120、 ut tiic ca all C Co ommp pa an niie es s0%10%20%30%40%50%60%70%Efforts tomaximizeasset valueGreater use ofRWD/RWEPatient-centricityVendorrationalizationPatient diversityStrategiesto reduce siteburdenNew approaches toinvestment andfundingMergers andacquisitionsRisk-basedcontracts withvendorsSustaina

121、bilityeffortsTotalLarge(A)Small/Mid(B)A Av ve er ra ag ge e n nu ummb be er r s st tr ra at te eg giie es s:3 3.8 84 4.4 44 4.1 1BBB1 12 23 31 12 23 3BLetters indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Small/Mid:

122、n=86Q6.(REVISED strategies separated from innovations/technologies in Q5)Which specific strategies are being pursued currently by your organization?Please select all that apply.26The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientif

123、ic and its subsidiaries unless otherwise specified.Detailed findings:Hot topics27The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Patient recruitmentExperience with patient recr

124、uitment is mixed and varies significantly by organization size almost half of those from Large companies are more optimistic about their ability to recruit qualified patients,but this drops to only 30%among Small/Mid-size participants.Tracking patient diversity is very widespread,and there is more p

125、ositivity than negativity about progress being made in this area among those who have been monitoring long enough to see results,but for about 1 in 5 it is still too early to tell.Large company participants are significantly more likely to claim improvement in their ability to enroll diverse patient

126、s compared to their counterparts in the Small/Mid-size segment,where a higher proportion indicate it is too early to tell,similar to their responses in 2023.Letters indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Smal

127、l/Mid:n=86.Q18.How would you describe your ability to recruit qualified patients for your studies compared to two years ago?Base:All respondents excluding dont know;Total:n=145;Large n=63;Small/Mid:n=82.Q21.What type of change,if any,has your organization seen in its ability to affect diverse patien

128、t enrollment into your studies compared to two years ago?YOYOptimism remains unchanged since 2023,though ability to affect diverse patient enrollment has improved,with 42%feeling improvement compared to just 29%in 2023.This change is largely driven by Large company participants,with 59%saying it has

129、 improved compared to only 32%saying so in 2023.28Letters indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Small/Mid:n=86.Q18.How would you describe your ability to recruit qualified patients for your studies compared

130、to two years ago?Base:All respondents excluding dont know;Total:n=145;Large n=63;Small/Mid:n=82.Q21.What type of change,if any,has your organization seen in its ability to affect diverse patient enrollment into your studies compared to two years ago?Ability to Recruit Qualified Patients Compared to

131、2 Years AgoMore optimisticNo changeLess optimistic38%34%28%48%27%25%30%40%30%Small/Mid(B)Large(A)TotalBABA28Letters indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Small/Mid:n=86.Q18.How would you describe your abilit

132、y to recruit qualified patients for your studies compared to two years ago?Base:All respondents excluding dont know;Total:n=145;Large n=63;Small/Mid:n=82.Q21.What type of change,if any,has your organization seen in its ability to affect diverse patient enrollment into your studies compared to two ye

133、ars ago?Ability to Recruit Qualified Patients Compared to 2 Years AgoMore optimisticNo changeLess optimistic38%34%28%48%27%25%30%40%30%Small/Mid(B)Large(A)TotalAbility to Affect Diverse Patient Enrollment Compared to 2 Years Ago42%32%4%19%3%59%30%2%10%29%33%6%27%5%Small/Mid(B)Large(A)TotalImprovedNo

134、 changeWorsenedToo early to knowDo not track patient diversityBA28The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Patient strategiesYOYNotable changes vs 2023TotalPAG relations

135、hips More sites Remote monitoring Telehealth Home visits Large BiopharmaMore countries Patient assistance Remote monitoring Patient education Telehealth Home visits Small/Mid-size BiopharmaPAG relationships More sites More countries Inclusive protocols Telehealth While building patient advocacy grou

136、p relationships is a key strategy used by participants from both large and small/mid-size biopharma companies,sponsors continue to employ multiple strategies to encourage patient participation.As the pandemic recedes into the past,the use of remote monitoring,telehealth visits,and home visits have d

137、eclined substantially as methods for removing barriers to patient participation.Added in 2024Letters indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Small/Mid:n=86Q19.(REVISED)What patient-focused or recruitment strat

138、egies are being used currently by your organization?Select all that apply.Average number strategies:4.84.94.7Relationships with patient advocacy organizationsUsing more sites for each clinical studyConducting research in more countriesPatient assistance resourcesBuilding inclusive entry criteria int

139、o protocolsLeveraging data/tech to identify target patientsPatient-centric platforms/appsPatient educationRemote monitoring51%52%51%45%38%34%34%33%38%56%46%45%41%39%39%37%35%35%63%38%36%34%41%45%41%39%31%Small/Mid(B)Large(A)TotalPatient Strategies29Top Patient-focused/Recruitment Strategies Currentl

140、y Used(Strategies selected by 30%or more*)=draws attention*See Appendix for complete detailAA29The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Patient strategy goalsTop goals o

141、f patient-focused strategies include removing barriers to patient participation and increasing overall enrollment.Removing barriers to patient participation is driven primarily by Small/Mid-size biopharma participants.Those from Large organizations focus on increasing overall enrollment,followed by

142、strengthening relationships with physicians who serve more diverse patients.Increasing patient diversity is more of a goal for participants at Large companies than it is for those in the Small/Mid-size segment.Letters indicate statistically significant difference between groups at the 90%confidence

143、levelBase=Using one or more patient-focused or recruitment strategies(Q19);Total:n=148;Large:n=64;Small/Mid:n=84Q20.(NEW)Which of the following are the top intended goal(s)of the patient-focused strategies your organization is using currently?Rank up to 3.Remove barriers to patient participationIncr

144、ease overall enrollmentStrengthen relationships with physicianswho serve more diverse patientsImprove patient retention ratesIncrease patient-centricityIncrease patient diversityStrengthen connection to the community15%26%18%12%10%10%9%54%52%48%45%36%33%30%16%22%16%13%5%17%13%41%53%47%41%42%45%31%14

145、%30%19%12%14%5%6%64%51%49%49%32%24%29%30Patient Strategy GoalsGoals of Patient-Focused StrategiesSmall/Mid(B)Large(A)TotalBA=draws attention%Ranked#1%Ranked Top 3Key:B30The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its

146、 subsidiaries unless otherwise specified.Clinical trial decentralizationParticipants indicate they have increased their use of decentralized clinical trial(DCT)elements from a year ago,and this trend is expected to continue,with about half of clinical trials estimated to be using DCT in 2026.While p

147、articipants from both large and small/mid-size participants reported similar DCT use and expectations in 2023,this year the Small/Mid segment indicates somewhat greater use of DCT and higher expected use by 2026.Letters indicate statistically significant difference between groups at the 90%confidenc

148、e levelBase:All respondents excluding not applicable/dont know;Total:n=131,137,143;Large:n=61,63,63,Small/Mid:n=70,74,80Q8.One year ago,what percentage of your companys clinical trials would you estimate were conducted with decentralized elements?Q9.What percentage of your companys current clinical

149、trials would you estimate are being conducted with decentralized elements?Q10.Finally,what percentage of your companys clinical trials would you estimate will be conducted using decentralized elements in two years(2026)?YOYCompared to 2023,DCT usage has softened among participants in the Large segme

150、nt,averaging use in 35%of current trials versus 43%reported in 2023.6%8%5%20%21%19%39%43%36%16%17%15%19%11%25%TotalLarge(A)Small/Mid(B)19%18%20%40%43%39%24%21%27%7%8%6%9%10%9%TotalLarge(A)Small/Mid(B)15%14%15%34%40%28%28%25%30%14%13%15%10%8%12%TotalLarge(A)Small/Mid(B)0.00%10.00%20.00%30.00%40.00%50

151、.00%60.00%1 Year AgoCurrentIn 2 yearsTotalLarge(A)Small/Mid(B)Past,Current,and Expected Future Use of Decentralized Clinical Trial(DCT)ElementsAverage%of Clinical Trials Conducted with DCT ElementsProportion of Clinical Trials Conducted with DCT ElementsOver 70%of trials51%to 70%of trials31%to 50%of

152、 trials11%to 30%of trials0%to 10%of trialsIn 2 Years(%of respondents)Current(%of respondents)1 Year Ago(%of respondents)A31The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Detai

153、led findings:Outsourcing32The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Outsourcing modelsThe full-service model is used for the greatest share of current clinical developmen

154、t work,and it is most preferred.FSP and hybrid models also account for a substantial share of clinical development work and are preferred by many,with insourcing as the least used and preferred.Participants in Large biopharma use FSP more than their counterparts in the small/mid-size segment.Letters

155、 indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Small/Mid:n=86 Q13.For the areas in your company with which you are familiar,what percent of current clinical development work is accomplished via the following outsour

156、cing models?Q14.Which outsourcing model for clinical development work do you most prefer?YOYThe general pattern of outsourcing model usage in 2024 is consistent with 2023 and 2022.33Letters indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents;To

157、tal:n=150;Large:n=64,Small/Mid:n=86 Q13.For the areas in your company with which you are familiar,what percent of current clinical development work is accomplished via the following outsourcing models?Q14.Which outsourcing model for clinical development work do you most prefer?Outsourcing ModelsShar

158、e of Current Clinical Development Work34%30%36%27%33%23%26%21%29%13%15%11%TotalLarge(A)Small/Mid(B)Insourcing/Temp StaffHybridFSPFull-ServiceB33Letters indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents;Total:n=150;Large:n=64,Small/Mid:n=86 Q1

159、3.For the areas in your company with which you are familiar,what percent of current clinical development work is accomplished via the following outsourcing models?Q14.Which outsourcing model for clinical development work do you most prefer?Outsourcing ModelsShare of Current Clinical Development Work

160、34%30%36%27%33%23%26%21%29%13%15%11%TotalLarge(A)Small/Mid(B)35%27%33%38%27%31%No preferenceInsourcing/Temp StaffHybridFSPFull-ServiceMost Preferred Outsourcing Modelfor Clinical DevelopmentSmall/Mid(B)Large(A)Total33%27%34%B 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are t

161、he property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.33The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Outsourcing trendsFSP outsourcing is g

162、rowing faster than full-service outsourcing(FSO),and this is the case for participants in both large and small/mid-size biopharma segments.Participants in both segments appear to be switching away from full-service outsourcing to some degree,with over 15%in each segment decreasing their use of FSO.L

163、etters indicate statistically significant difference between groups at the 90%confidence level Base:All respondents;Total:n=150;Large:n=64,Small/Mid:n=86Q15.Over the past two years,how has your company changed its full-service(FSO)clinical trial outsourcing behavior?Q16.Over the past two years,how h

164、as your company changed its functional service provider(FSP)outsourcing behavior?YOYWhile still growing at a faster rate than FSO,the growth rate of FSP may be starting to slow,with 35%indicating increased usage of FSP in 2024 compared to 41%in 2023.34Change in Use of Full-Service and FSP Models Com

165、pared to 2 Years AgoIncreased Use of Outsourcing ModelDecreased Use of Outsourcing ModelTotal29%35%Full-ServiceFSP17%11%Small/Mid(B)29%37%Full-ServiceFSP19%12%Large(A)30%33%Full-ServiceFSP16%9%Indicating:34The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the propert

166、y of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Outsourcing of drug development activitiesOutsourcing will comprise a wide variety of drug development activities in the next two years,particularly patient recruitment and clinical lab and diagnostic services.Not surprisi

167、ngly,those at Small/Mid-size companies expect to use outsourcing more extensively than their counterparts in the Large biopharma segment.Letters indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents excluding dont know;varies by activity statemen

168、t.Total:n=143-150;Large:n=63-64,Small/Mid:n=80-86Q17.Using the scale provided,please indicate how likely your company is to outsource each of the following drug development activities in the next 2 years.5-point scale:Not at all likely to Extremely likely.YOYSignificant increases in 2024:Data manage

169、ment Preclinical evaluations Regulatory consulting Patient recruitmentClinical laboratory and diagnostic servicesClinical data managementClinical trial managementRWD(i.e.,access to data)Clinical monitoring/operations managementClinical supply managementRWE(i.e.,generation of insights)Pharmacovigilan

170、ce solutionsMarket access/Value demonstrationPre-and post-approval safety analysisBiostatistical servicesRegulatory consultingMedical writing35Likelihood to Outsource Drug Development Activities in the Next 2 Years(Activities selected by 55%or more*)43%45%31%36%28%35%35%26%30%24%27%26%21%26%73%73%64

171、%63%63%63%60%59%58%58%56%56%56%55%23%31%19%22%17%20%23%14%14%16%19%13%13%16%64%63%48%52%48%56%50%46%43%44%44%39%48%42%58%55%40%47%36%45%44%35%41%31%33%36%27%34%80%81%76%72%75%67%67%70%69%68%66%69%62%64%Small/Mid(B)Large(A)Total%Extremely likelyExtremely/Very likelyAAAAAAAAAAAAAAAAAAAAAAAAAAA=draws a

172、ttention*See Appendix for complete detailAAA35The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Sponsor Vendor Relationship Models36Most Preferred Sponsor Vendor Relationship Mod

173、el32%38%28%40%45%36%14%6%20%7%10%5%5%6%TotalLarge(A)Small/Mid(B)Transactional study-basedInformal preferred partnerStrategic partnerFormal preferred partnerTransactional compound/program-basedSponsor Vendor Relationship ModelsShare of Current Clinical Development Work28%33%24%21%28%17%21%16%25%18%14

174、%22%12%10%13%TotalLarge(A)Small/Mid(B)Transactional study-basedInformal preferred partnerStrategic partnerFormal preferred partnerTransactional compound/program-basedBBAANot sure/No preference 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scie

175、ntific and its subsidiaries unless otherwise specified.Sponsor Vendor Relationship Models36Most Preferred Sponsor Vendor Relationship Model32%38%28%40%45%36%14%6%20%7%10%5%5%6%TotalLarge(A)Small/Mid(B)Transactional study-basedInformal preferred partnerStrategic partnerFormal preferred partnerTransac

176、tional compound/program-basedANot sure/No preferenceSponsor vendor relationship modelsFormal and strategic partnerships are used more than other types of relationship models and are the most preferred,however,a substantial proportion of clinical development work uses informal partners or is transact

177、ional in nature.Participants from Large companies currently use significantly more strategic and formal preferred partners and prefer to use these models as well.Almost half prefer the strategic partner model a change from 2023 when more than half preferred the formal partner model.Although a mix of

178、 models is used by those at Small/Mid-size companies,and they are significantly more likely to use the study-based transactional model,many would prefer a strategic partnership.Letters indicate statistically significant difference between groups at the 90%confidence levelBase:All respondents;n=150;L

179、arge:n=64,Small/Mid:n=86 Q11.For the areas in your company with which you are familiar,what percentage of current clinical development work is accomplished via the following sponsor-vendor relationship models?Q12.Which sponsor-vendor relationship model do you most prefer?36The Pulse 2024 Thermo Fish

180、er Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Appendix37The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries

181、 unless otherwise specified.Survey participant screening criteriaCurrently work for:Pharmaceutical,biopharma,or biotech company Geography:Asia Australia Europe Middle East/India US/CanadaDrug development phases:Decision-making responsibility in at least at least one of the following Drug discovery P

182、reclinical Phase I Phase II Phase III Phase IV/Lage stage/RegistriesNote:those who selected only“Drug discovery”were excluded from the survey.Pipeline:Company has at least one(1)unique molecule/compound in development pipelineJob level:Director or higherDecision Maker:Highly or somewhat involved in

183、outsourcing services to vendors/CROs(e.g.,deciding to keep activities in-house vs.outsource,vendor selection,vendor management,etc.)in support of clinical trialsPrimary functional area:Pre-trial/Preclinical Development(preclinical/toxicology,translational medicine)Clinical Development(clinical devel

184、opment,clinical operations,clinical data management,clinical research,feasibility,patient recruitment,biostatistics/statistical programming,safety/pharmacovigilance(PV),other R&D)Peri-/post-approval/Registries/HEOR(medical affairs,market access,HEOR)Quality and Regulatory(regulatory affairs,quality

185、assurance/control(QA/QC)and compliance)Executive Management/C-level Participants were compensated according to their agreement to participate in the Life Science Strategy Group(LSSG)panel.38The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fish

186、er Scientific and its subsidiaries unless otherwise specified.Participant demographics(1 of 3)Company size*Ranges in China were adjusted to reflect market conditions.to USD Conversion:Under 350M=Under$50M,350M to 700M=$50M to$100M,700M to 3.5B=$100M to$500M,Over 3.5B=Over$500MLetters indicate statis

187、tically significant difference between groups at the 90%confidence levelS10.Which of the below ranges most closely represents your companys annual R&D spend?S9.What is the size of the organization you work for in terms of employees?Your best estimate is fine.S8.How many unique molecules/compounds ar

188、e in your companys development pipeline?Demographics-Company SizeTotalLargeSmall/MidUS/CanadaEuropeAsia(A)(B)Base:All respondents1506486734631Annual R&D SpendChina to USD ConversionUnder$100 million/Under 350 million*29%0%50%33%17%35%(Under$50M USD)$100 million to$999 million/350 million to 700 mill

189、ion*29%0%50%30%35%16%($50M to$100M USD)Small/Mid-size Biopharma Sub-Total57%0%100%63%52%52%$1 billion to$2 billion/700 million to 3.5 billion*17%41%0%16%11%29%($100M to$500M USD)Over$2 billion/3.5 billion*25%59%0%21%37%19%(Over$500M USD)Large Biopharma Sub-Total43%100%0%37%48%48%Number of Employees1

190、-49 employees11%0%20%21%0%6%50-199 employees23%6%35%15%28%32%200-999 employees22%13%29%16%24%32%1,000-9,999 employees19%25%15%22%15%19%10,000 or more employees25%56%1%26%33%10%Number of Unique Molecules/Compunds in Pipeline1 molecule/compound2%0%3%3%0%3%2 to 3 molecules/compounds22%9%31%25%13%29%4 t

191、o 5 molecules/compounds23%11%33%22%20%32%6 to 7 molecules/compounds17%13%20%14%22%16%8 to 9 molecules/compounds9%17%3%5%13%13%10 ore more molecules/compounds27%50%9%32%33%6%ABBBBAAABAAABA39The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fishe

192、r Scientific and its subsidiaries unless otherwise specified.Participant demographics(2 of 3)Location/Job level/Primary functionLetters indicate statistically significant difference between groups at the 90%confidence levelS3.In which of the below regions is your company headquarters located?S2.In w

193、hich of the below regions is your office located?S4.What is your job level?S5.Which of the following best describes your current,primary functional area?Demographics-Company SizeTotalLargeSmall/MidUS/CanadaEuropeAsia(A)(B)(C)(D)(E)Base:All respondents1506486734631S10Annual R&D SpendChina to USD Conv

194、ersionUnder$100 million/Under 350 million*29%0%50%33%17%35%(Under$50M USD)$100 million to$999 million/350 million to 700 million*29%0%50%30%35%16%($50M to$100M USD)Small/Mid-size Biopharma Sub-Total57%0%100%63%52%52%$1 billion to$2 billion/700 million to 3.5 billion*17%41%0%16%11%29%($100M to$500M U

195、SD)Over$2 billion/3.5 billion*25%59%0%21%37%19%(Over$500M USD)Large Biopharma Sub-Total43%100%0%37%48%48%S9Number of Employees1-49 employees11%0%20%21%0%6%50-199 employees23%6%35%15%28%32%200-999 employees22%13%29%16%24%32%1,000-9,999 employees19%25%15%22%15%19%10,000 or more employees25%56%1%26%33%

196、10%S8Number of Unique Molecules/Compunds in Pipeline1 molecule/compound2%0%3%3%0%3%2 to 3 molecules/compounds22%9%31%25%13%29%4 to 5 molecules/compounds23%11%33%22%20%32%6 to 7 molecules/compounds17%13%20%14%22%16%8 to 9 molecules/compounds9%17%3%5%13%13%10 ore more molecules/compounds27%50%9%32%33%

197、6%Demographics-Geography/Job Level/Primary Function TotalLargeSmall/Mid(A)(B)Base:All respondents1506486734631Company Headquarters LocationUS/Canada50%42%56%89%15%10%Europe29%33%27%5%85%3%Asia/Australia/Middle East/India Sub-Total21%25%17%5%0%87%Asia13%14%12%4%0%52%Australia3%5%1%1%0%10%Middle East/

198、India5%6%5%0%0%26%Office LocationUS/Canada49%42%53%100%0%0%Europe31%34%28%0%100%0%Asia/Australia/Middle East/India Sub-Total21%23%19%0%0%100%Asia12%13%12%0%0%58%Australia3%5%1%0%0%13%Middle East/India6%6%6%0%0%29%Job LevelDirector62%77%51%58%70%61%Vice President24%20%27%21%22%35%President1%0%1%1%0%0

199、%C-level13%3%21%21%9%3%Primary Functional ResponsibilityPre-trial/Preclinical Development7%5%9%8%9%3%Clinical Development37%44%33%44%37%23%Peri-/Post-approval/Registries/HEOR20%27%15%14%35%13%Quality and Regulatory13%11%14%8%7%32%Executive Management/C-level23%14%29%26%13%29%ABBA40The Pulse 2024 The

200、rmo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Participant demographics(3 of 3)Drug developmentLetters indicate statistically significant difference between groups at the 90%confidence levelQ1.

201、In which categories is your organization/company developing or commercializing products?Please select all that apply.S6.In which development phase(s)do you have decision-making responsibility?Please select all that apply.S7.Over the past 2 years,what is your level of involvement with outsourcing ser

202、vices to vendors/CROs(e.g.,deciding to keep activities in-house vs.outsource,vendor selection,vendor management,etc.)in support of your clinical trials?Demographics-Company SizeTotalLargeSmall/MidUS/CanadaEuropeAsia(A)(B)(C)(D)(E)Base:All respondents1506486734631S10Annual R&D SpendChina to USD Conve

203、rsionUnder$100 million/Under 350 million*29%0%50%33%17%35%(Under$50M USD)$100 million to$999 million/350 million to 700 million*29%0%50%30%35%16%($50M to$100M USD)Small/Mid-size Biopharma Sub-Total57%0%100%63%52%52%$1 billion to$2 billion/700 million to 3.5 billion*17%41%0%16%11%29%($100M to$500M US

204、D)Over$2 billion/3.5 billion*25%59%0%21%37%19%(Over$500M USD)Large Biopharma Sub-Total43%100%0%37%48%48%S9Number of Employees1-49 employees11%0%20%21%0%6%50-199 employees23%6%35%15%28%32%200-999 employees22%13%29%16%24%32%1,000-9,999 employees19%25%15%22%15%19%10,000 or more employees25%56%1%26%33%1

205、0%S8Number of Unique Molecules/Compunds in Pipeline1 molecule/compound2%0%3%3%0%3%2 to 3 molecules/compounds22%9%31%25%13%29%4 to 5 molecules/compounds23%11%33%22%20%32%6 to 7 molecules/compounds17%13%20%14%22%16%8 to 9 molecules/compounds9%17%3%5%13%13%10 ore more molecules/compounds27%50%9%32%33%6

206、%Demographics-Geography/Job Level/Primary Function TotalLargeSmall/MidUS/CanadaEuropeAsia(A)(B)(C)(D)(E)Base:All respondents1506486734631S3Company Headquarters LocationUS/Canada50%42%56%89%15%10%Europe29%33%27%5%85%3%Asia/Australia/Middle East/India Sub-Total21%25%17%5%0%87%Asia13%14%12%4%0%52%Austr

207、alia3%5%1%1%0%10%Middle East/India5%6%5%0%0%26%S2Office LocationUS/Canada49%42%53%100%0%0%Europe31%34%28%0%100%0%Asia/Australia/Middle East/India Sub-Total21%23%19%0%0%100%Asia12%13%12%0%0%58%Australia3%5%1%0%0%13%Middle East/India6%6%6%0%0%29%S4Job LevelDirector62%77%51%58%70%61%Vice President24%20

208、%27%21%22%35%President1%0%1%1%0%0%C-level13%3%21%21%9%3%S5Primary Functional ResponsibilityPre-trial/Preclinical Development7%5%9%8%9%3%Clinical Development37%44%33%44%37%23%Peri-/Post-approval/Registries/HEOR20%27%15%14%35%13%Quality and Regulatory13%11%14%8%7%32%Executive Management/C-level23%14%2

209、9%26%13%29%Demographics-Drug DevelopmentTotalLargeSmall/Mid(A)(B)Base:All respondents1506486734631Categories Engaged in for Drug Development/CommercializationNovel small molecule drugs55%66%48%66%54%32%Generic small molecule drugs23%30%19%12%37%29%Biologics60%73%50%59%65%55%Biosimilars20%28%14%22%17

210、%19%Cell therapies38%45%33%30%52%35%Gene therapies38%50%29%33%48%35%Nucleic acid therapies18%22%15%12%30%13%Vaccines30%38%24%25%39%29%Diagnostics14%16%13%10%13%26%Other3%2%3%3%4%0%Average number of categegories3.03.72.52.73.62.7Clinical Development Phases Where Respondent is Responsible for Making D

211、ecisionsDrug discovery34%23%42%37%33%29%Preclinical53%39%64%62%50%39%Phase I77%66%85%78%78%71%Phase II80%75%84%82%87%65%Phase III70%72%69%77%67%58%Phase IV/Late stage/Registries47%50%45%53%41%42%Level of Involvement in Outsourcing Clinical Trial ActivitiesHighly involved91%88%93%96%85%87%Somewhat in

212、volved9%13%7%4%15%13%BBBBBAAA41The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Transformational trendsFull descriptions provided in the survey Accelerated development/approvals

213、 in rare/orphan disease Artificial intelligence(e.g.,to enable recruitment,advanced analytics,RWD/RWE)Big data and analytics(data science)Decentralized/hybrid trial elements Digitalization(e.g.,cloud computing,APIs,digital platforms)Greater use of RWD/RWE to complement data from clinical trials Incr

214、easing focus on patient diversity Innovative trial design Leveraging new technologies in drug development(e.g.,mRNA,CRISPR,gene-editing technologies)Patient-centricity(e.g.,patient participation in protocol design,partnering with patient advocacy groups,etc.)Personalized/precision medicine (e.g.,com

215、panion diagnostics)Sustainability effortsQ5.(REVISED)Which specific innovations,strategies,and/or technologies are being pursued currently by your organization?Please select all that apply.Q6.(NEW)Which specific strategies are being pursued currently by your organization?Please select all that apply

216、.42The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Innovations/technologies and strategiesFull descriptions provided in the survey Artificial intelligence(e.g.,to enable recrui

217、tment,advanced analytics,RWD/RWE)Big data and analytics(data science)Digital/hybrid trial elements Digitalization(e.g.,cloud computing,APIs,digital platforms)Innovative trial design Leveraging new technologies in drug development (e.g.,mRNA,CRISPR,gene-editing technologies)Personalized/precision med

218、icine (e.g.,companion diagnostics)Efforts to maximize asset value Greater use of RWD/RWE Mergers and acquisitions New approaches to investment and funding Patient-centricity Patient-diversity Risk-based contracts with vendors Strategies to reduce site burden Sustainability efforts Vendor rationaliza

219、tion(i.e.,reduce the number of vendors used)Q5.(REVISED)Which specific innovations and/or technologies are being pursued currently by your organization?Please select all that apply.Q6.(NEW)Which specific strategies are being pursued currently by your organization?Please select all that apply.43The P

220、ulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Leading therapeutic areas for drug developmentLetters indicate statistically significant difference between groups at the 90%confiden

221、ce levelQ2.Which therapeutic areas are leading your organizations drug development pipeline today?Please choose up to 5.TotalLargeSmall/Mid(A)(B)Base:All respondents1506486Oncology70%69%71%Immunology/Rheumatology43%47%41%Rare Diseases31%25%35%Cardiovascular29%42%20%Neurology29%30%28%Infectious Disea

222、ses21%20%21%Hematology19%27%13%Gastroenterology15%13%17%Metabolic/Endocrine14%17%12%Dermatology13%17%9%Respiratory/Allergy11%9%13%Pediatrics9%8%9%Ophthalmology8%13%5%Orthopedics/Rheumatology7%6%8%Analgesic/Pain Management7%6%7%Womens Health6%6%6%Urology5%8%3%Hepatology5%9%1%Nephrology/Renal Diseases

223、4%5%3%Critical Care3%2%3%Other1%2%0%Average number of TAs3.53.83.3BBB44The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Biggest challengesLetters indicate statistically signific

224、ant difference between groups at the 90%confidence levelQ3.What are the biggest challenges your organization is currently facing?Please select your top 5 biggest challenges.Q3b.Listed below are the top challenges you indicated your organization is facing.Please rank these top challenges that your or

225、ganization is facing,with Rank#1=Biggest challenge.Base:All respondentsSelected Top 5Ranked Top 2Selected Top 5Ranked Top 2Selected Top 5Ranked Top 2Rising cost of clinical trials49%21%44%23%53%20%Patient recruitment in clinical trials39%21%34%19%42%23%Increasing complexity of clinical trials39%19%3

226、9%22%38%16%Maximizing asset value/ROI33%12%33%11%33%13%Feasibility and site selection30%7%28%5%31%8%Lack of funding28%19%19%13%35%23%Finding appropriate scientific/therapeutic expertise in vendors27%13%22%13%31%13%Elongated study startup time27%11%25%11%28%12%Lack of or limited relevant RWD/RWE23%9%

227、25%9%22%8%Lack of internal resources/expertise to use RWD/RWE21%11%27%17%17%7%Navigating the changing regulatory landscape21%9%23%11%20%8%Talent/staf shortages21%5%25%5%19%6%Diversity of patients enrolled19%3%28%5%13%2%Patient retention in clinical trials19%3%20%6%19%1%Logistics issues17%7%16%5%19%9

228、%Research site burden17%6%13%5%21%7%Using artificial intelligence(AI)in clinical development15%4%19%3%13%5%Data integration15%5%20%6%10%5%Data management15%5%14%5%15%5%Incorporating decentralized/hybrid trial elements in trial designs13%3%13%2%13%3%Business continuity planning9%5%13%5%7%5%1506486(A)

229、(B)TotalLargeSmall/MidBBAAB45The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Patient participation strategiesOutsourcing of drug development activitiesLetters indicate statisti

230、cally significant difference between groups at the 90%confidence levelQ19.(REVISED)Which patient-focused or recruitment strategies are being used currently by your organization?Select all that apply.Letters indicate statistically significant difference between groups at the 90%confidence levelBase:A

231、ll respondents excluding dont know;varies by activity statement.Q17.Using the scale provided,please indicate how likely your company is to outsource each of the following drug development activities in the next 2 years.5-point scale:Not at all likely to Extremely likely.TotalLargeSmall/MidUS/CanadaE

232、uropeAsia(A)(B)(C)(D)(E)Base:All respondents1506585654837Establishing or improving relationships with patient advocacy groups/organizations56%63%51%Using more sites for each clinical study46%38%52%Conducting research in more countries45%36%51%Patient assistance resources(e.g.,patient concierge,trave

233、l reimbursement,etc.)41%34%45%Building more inclusive entry criteria into protocol designs39%41%38%Leveraging data and technology to identify target patients39%45%34%Patient-centric platforms/apps37%41%34%Patient education35%39%33%Remote monitoring35%31%38%Improving the diversity of clinical trial a

234、nd ofce staf27%34%22%Increasing patient compensation27%27%28%Virtual/telehealth visits20%23%17%Home visits17%22%14%Mobile clinics11%16%7%None of the above1%0%2%3%0%0%0%0%0%0%0%0%70%70%70%70%70%70%TotalBiopharmaBiotechUS/CanadaEuropeAsiaQ19.Patient Participation StrategiesTotalBiopharmaBiotechUS/Cana

235、daEuropeAsia1Establishing or improving relationships with patient advocacy groups/organizations56%63%51%58%52%58%2 Using more sites for each clinical study46%38%52%55%43%29%3Conducting research in more countries45%36%51%49%52%23%4 Patient assistance resources(e.g.,patient concierge,travel reimbursem

236、ent,etc.)41%34%45%47%30%42%5Building more inclusive entry criteria into protocol designs39%41%38%40%41%35%6 Leveraging data and technology to identify target patients39%45%34%36%46%35%7 Patient-centric platforms/apps37%41%34%36%43%29%8 Patient education35%39%33%32%26%58%9 Remote monitoring35%31%38%3

237、8%46%13%10 Improving the diversity of clinical trial and office staff27%34%22%26%33%23%11 Increasing patient compensation27%27%28%22%26%42%12 Virtual/telehealth visits20%23%17%25%13%19%13Home visits17%22%14%22%11%16%14 Mobile clinics11%16%7%10%15%6%15 None of the above1%0%2%3%0%0%Sample Size15064867

238、34631AABBTotalLargeSmall/MidUS/CanadaEuropeAsia(A)(B)(C)(D)(E)Base:All respondents(excluding NA/dont know;varies by activity)143-15061-6480-8668-7344-4629-31Patient recruitment73%64%80%Clinical laboratory and diagnostic services73%63%81%Clinical data management64%48%76%Clinical trial management-full

239、-service/end-to-end trial support63%52%72%RWD(i.e.,access to data)63%48%75%Clinical monitoring/Clinical operations management63%56%67%Clinical supply management60%50%67%RWE(i.e.,generation of insights)59%46%70%Pharmacovigilance solutions58%43%69%Market access/Value demonstration58%44%68%Pre-and post

240、-approval safety analysis56%44%66%Biostatistical services56%39%69%Regulatory consulting56%48%62%Medical writing55%42%64%Post-approval support53%42%61%Site/KOL identification52%44%58%Quality and compliance services49%40%56%Preclinical evaluations49%46%51%Product registration48%41%53%Study design37%33

241、%40%26%39%58%0%0%0%0%0%0%100%100%100%100%100%100%Q17.OutsourcingTotalBiopharmaBiotechUS/CanadaEuropeAsiaAlpha OrdSorte Q17.%Extremely/Very Likely to Outsource(Top 2 Box)91 Patient recruitment73%64%80%78%65%74%32 Clinical laboratory and diagnostic services73%63%81%71%80%68%23 Clinical data management

242、64%48%76%64%61%68%64 Clinical trial management-full-service/end-to-end trial support63%52%72%62%61%71%175 RWD(i.e.,access to data)63%48%75%59%70%62%46 Clinical monitoring/Clinical operations management63%56%67%59%72%58%57 Clinical supply management60%50%67%61%57%61%188 RWE(i.e.,generation of insight

243、s)59%46%70%49%74%62%109 Pharmacovigilance solutions58%43%69%51%52%81%710 Market access/Value demonstration58%44%68%53%59%68%1211 Pre-and post-approval safety analysis56%44%66%46%67%65%112 Biostatistical services56%39%69%53%60%58%1613 Regulatory consulting56%48%62%49%63%61%814 Medical writing55%42%64

244、%52%59%55%1115 Post-approval support53%42%61%46%61%57%1916 Site/KOL identification52%44%58%39%67%58%1517 Quality and compliance services49%40%56%37%54%71%1318 Preclinical evaluations49%46%51%46%48%58%1419 Product registration48%41%53%32%59%70%2020 Study design37%33%40%26%39%58%Alpha OrdSorte Q17.%Ex

245、tremely Likely to Outsource91 Patient recruitment43%23%58%48%46%29%32 Clinical laboratory and diagnostic services45%31%55%47%43%42%23 Clinical data management31%19%40%29%30%39%64 Clinical trial management-full-service/end-to-end trial support36%22%47%36%39%32%175 RWD(i.e.,access to data)28%17%36%24%

246、28%38%46 Clinical monitoring/Clinical operations management35%20%45%38%37%23%57 Clinical supply management35%23%44%32%41%32%188 RWE(i.e.,generation of insights)26%14%35%19%43%14%109 Pharmacovigilance solutions30%14%41%29%28%32%710 Market access/Value demonstration24%16%31%24%24%26%1211 Pre-and post-

247、approval safety analysis27%19%33%23%27%35%112 Biostatistical services26%13%36%25%33%19%1613 Regulatory consulting21%13%27%18%17%32%814 Medical writing26%16%34%26%33%16%1115 Post-approval support24%11%34%24%27%20%1916 Site/KOL identification23%19%26%11%35%32%1517 Quality and compliance services20%14%

248、25%17%24%23%1318 Preclinical evaluations23%20%25%24%23%19%1419 Product registration18%8%25%15%22%17%2020 Study design14%13%15%7%17%26%Alpha OrdSorte Q17.%Very Likely to Outsource91 Patient recruitment30%41%22%30%20%45%32 Clinical laboratory and diagnostic services28%31%26%24%37%26%23 Clinical data m

249、anagement33%30%36%36%32%29%64 Clinical trial management-full-service/end-to-end trial support27%30%26%26%22%39%175 RWD(i.e.,access to data)35%30%39%35%41%24%46 Clinical monitoring/Clinical operations management28%36%22%21%35%35%57 Clinical supply management25%27%24%29%15%29%188 RWE(i.e.,generation o

250、f insights)34%32%35%29%30%48%109 Pharmacovigilance solutions28%29%28%22%24%48%710 Market access/Value demonstration34%28%38%29%35%42%1211 Pre-and post-approval safety analysis30%25%34%24%40%29%112 Biostatistical services30%27%33%29%27%39%1613 Regulatory consulting35%35%35%31%46%29%814 Medical writin

251、g29%27%30%26%26%39%1115 Post-approval support29%31%27%22%34%37%1916 Site/KOL identification29%25%32%28%33%26%1517 Quality and compliance services29%25%32%20%30%48%1318 Preclinical evaluations26%26%26%21%25%39%1419 Product registration30%33%28%17%37%53%2020 Study design23%20%24%19%22%32%Alpha OrdSort

252、e Q17.Sample Sizer per Statement(excl NA/dont know)91 Patient recruitment150648673463132 Clinical laboratory and diagnostic services149648572463123 Clinical data management148648473443164 Clinical trial management-full-service/end-to-end trial support1506486734631175 RWD(i.e.,access to data)14663837

253、1462946 Clinical monitoring/Clinical operations management150648673463157 Clinical supply management1496485724631188 RWE(i.e.,generation of insights)1436380684629109 Pharmacovigilance solutions1496386724631710 Market access/Value demonstration14964857246311211 Pre-and post-approval safety analysis14

254、76483714531112 Biostatistical services14964857345311613 Regulatory consulting1496386724631814 Medical writing15064867346311115 Post-approval support14664827244301916 Site/KOL identification14964857246311517 Quality and compliance services14863857146311318 Preclinical evaluations1456184704431AAAAAAAA

255、AAAAAAAA%extremely/very like to outsource46The Pulse 2024 Thermo Fisher Scientific Inc.All rights reserved.All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Copyright,2024 by Pharmaceutical Product Development(PPD),the clinical research busin

256、ess of Thermo Fisher Scientific.All rights reserved.This report,including the information contained herein and commentary associated herewith(“materials”),is provided as a service of PPD.These Materials,based on publicly available information,market research conducted on behalf of PPD,as well as the

257、 knowledge and experience of PPDs employees,have been prepared solely for informational and educational purposes and should not be relied upon for professional advice.Any further use of these Materials requires the express written consent of PPD.Stay ahead of the curve with our experts takes on how these insights will influence the future of the drug development industry.Go deeper at