2026年脉搏：全球医药研发洞察

Global R&D insights in pharmaceuticals Contents Methodology4Executive summary8Detailed findings: Challenges, strategies and state of the industry15Detailed findings: Patient-focused strategies24Detailed findings: AI/ML in clinical development28Detailed findings: Outsourcing32Appendix34 About The Pulse The future for drug developers is increasingly shaped by their ability toadopt innovative strategies and new technologies while navigating anenvironment marked by complexity and rapid change. That’s why the PPD™clinical research business of Thermo FisherScientific surveyed 150 leaders at biotech and pharmaceuticalorganizations around the globe to assess trends in drug discoveryand development. Respondents shared barriers to bringing drugs tomarket, innovations influencing progress, and perspectives on topicssuch as AI, patient recruitment, the regulatory landscape and more. Now in its fourth year, The Pulse reveals a stark throughline:uncertainty has become the dominant backdrop for drugdevelopment. Many of the past year’s shifts–economic pressures,evolving care models, regulatory recalibration and rising expectationsto do more with less–continue to reverberate. As companies shoreup investments and reassess their portfolios, leaders are grapplingwith immense pressure to deliver in an environment where the groundkeeps moving. Across this year’s data, a clear picture emerges. Drug developersare navigating shifting sands: balancing long-term scientific ambitionwith short-term operational realities, confronting challenges that arebecoming more intertwined and less predictable, and working tomaintain momentum despite forces largely outside their control. The Pulse goes beyond the numbers to explore what this pervasiveuncertainty means for R&D teams today, and how leadingorganizations are positioning themselves to stay resilient, makeconfident decisions, and continue advancing therapies for patients inthe year ahead. Methodology Respondents^ Methodology and sample •Web-based, quantitative survey with supplementalin-depth interviews•Quota:n=150 (n=61 Large companies,n=89 Small/Mid-size companies)•Locations:U.S., Canada, Europe, Asia/Australia•Dates:July to August 2025•Survey Length:~20 minutes•Survey vendor/Sample source:Life ScienceStrategy Group (LSSG)•The PPD™clinical research business ofThermo Fisher Scientific was not identifiedas the research sponsor •Employed by a pharma, biopharma, or biotechcompany with one or more unique molecules/compounds in development•Job Level:Director or higher•Primary responsibilities in one of thefollowing areas:–Pre-trial/preclinical development–Clinical development–Peri-/post-approval/registries/HEOR–Quality/Regulatory–Business services (finance, procurement/purchasing,vendor management)–Executive management/C-level •Decision-making responsibility in one or more drugdevelopment phases (pre-clinical through Phase IV/late stage/registries)•Highly or somewhat involved in selecting vendorsfor clinical trial services (drug discovery throughPhase IV) Sample profile overview: TotalSample Profile Overview – TotalSample Profile Overview – TotalSample Profile Overview – Total Office LocationOffice LocationDrug Development ModalitiesDrug Development ModalitiesOffice Location Sample profile overview: Customer segmentsSample Profile Overview – Customer SegmentsSample Profile Overview – C Executive summary Top challenges •Therising cost of clinical trialsis the top challenge followed bypatient recruitmentand thechangingregulatory landscape.•Keeping up with regulatory changes is considerably more challenging this year than it was in 2024,when it was not in the top 10.•Uncertainty related to macro environmental and economic forces is a more vexing concern forLarge companies than Small/Mid-size organizations.•Small/Mid-size enterprises continue to struggle with lack of funding.ChallengesTop Challenges•The rising cost of clinical trials is the top challenge followed b Insights from interviews with sponsors Innovative trial designs help sponsors address key challenges–particularly the need to streamline execution, reduce developmenttimelines and lower costs.•Uncertainty related to macro environmental and economic forces is a morevexing concern for Large companies than Small/Mid-size organizations. Examples and reasons for innovative trial design provided by sponsors during in-depth interviews: •Testing across multiple indications at once with the use of basket trials•Utilizing statistical methods, such as Bayesian models, to reduce sample size for Phase II studies•Using investigator-initiated trials to quickly get proof-of-concept and engage with regulatory authorities to streamline trials•Obtaining proof-of-concept in Phase Ib to skip Phase IIa•Expanding Phase I trial design to act more like a Phase II study•Focusing on surrogate (vs. primary) endpoints for earlier readouts© 2025 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fis