2026年全球医药研发洞察（The Pulse 2026）

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 an 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 discovery 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 expectations 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 are 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, make 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 •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: •Decision-making responsibility in one or more drugdevelopment phases (pre-clinical through Phase IV/late stage/registries) Sample profile overview: TotalSample Profile Overview – TotalSample Profile Overview – TotalSample Profile Overview – Total Sample profile overview: Customer segmentsSample Profile Overview – Customer SegmentsSample Profile Overview – C © 2025 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.Avg. # ModalitiesLarge (A)Avg. # Modalities4.05© 2025 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Executive summary Top challenges •Therising cost of clinical trialsis the top challenge followed bypatient recruitmentand thechangingChallenges •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 forTop Challenges patient recruitment and the changing regulatory landscape. •Keeping up with regulatory changes is considerably more challenging this ye Insights from interviews with sponsorsthan it was in 2024, when it was not even in the top 10. timelines and lower costs.Examples and reasons for innovative trial design provided by sponsors during in-depth interviews:vexing concern for Large companies than Small/Mid-size organizations. •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 Fisher Scientific and its subsidiaries unles Top challenges Deeper look at two key challenges Clinical development timelines Trial complexity •While the time from first-in-human trials toregulatory submission is stable or decreasingfor over half of organizations,45% indicate their •The increasing complexity of clinical trialsstems primarily frominternal factors withincompanies and regulatory requirements–with •Trial complexity is somewhat of a paradox for theclinical development industry–70% say studyprotocols are more complex than is necessary,while 54% agree that complex protocols areClinical Trial Complexity enrollment, and regulatory requirements.Deeper Look at Two Key Challenges •Nearly all sponsors are actively employing tacticsto reduce timelines–chief among these arek at Two Key ChallengesClinical Development Timelines outsourcing, and utilizing artificial intelligence andmachine learning (AI/ML).elopment Timelinessubmission is stable or decreasing for over half of organizations,45% indicate their clinical timelines have increased compared to choosing to use more complex trial design–chiefamong these are regulatory considerations andoverall trial costs.•The increasing complexity of clinical trials stems prwith Large organizations putting m