This report provides a comprehensive analysis of biomarkers in clinical trials. The purpose of this report is to offer valuable insights into the landscape of clinical trials involving biomarkers by highlighting trends and patterns across various dimensions. Ultimately, this report serves as a resource for researchers, clinicians, and industry stakeholders seeking to understand the evolving role of biomarkers in clinical trials. The insights derived from this analysis can inform future research directions, enhance trial design, and contribute to feasibility planning.
This report presents a thorough analysis of biomarkers in clinical trials, aiming to illuminate the evolving landscape of biomarker utilization in research and development. By examining trends and patterns across various dimensions, this report serves as a vital resource for researchers, clinicians, and industry stakeholders who seek to understand the critical role biomarkers play in clinical trials. The insights derived from this comprehensive analysis are intended to inform future research directions, enhance trial design, and contribute to effective feasibility planning. Overall, this report provides critical insights that can guide stakeholders in navigating the complexities of biomarker integration in clinical trials, ultimately fostering innovation and improving patient outcomes in the evolving landscape of medical research.
This report presents a thorough analysis of biomarkers in clinical trials, aiming to illuminate the evolving landscape of biomarker utilization in research and development. By examining trends and patterns across various dimensions, this report serves as a vital resource for researchers, clinicians, and industry stakeholders who seek to understand the critical role biomarkers play in clinical trials. The insights derived from this comprehensive analysis are intended to inform future research directions, enhance trial design, and contribute to effective feasibility planning. Overall, this report provides critical insights that can guide stakeholders in navigating the complexities of biomarker integration in clinical trials, ultimately fostering innovation and improving patient outcomes in the evolving landscape of medical research.
Scope
- The clinical trials data used for these analyses were extracted from the analyst’s Clinical Trials Database. The data included clinical trials with biomarkers captured in the database from May 27-July 11, 2025. The trials were analyzed and segmented by year, endpoint status, duration, phase, single-country versus multinational trials, geography, sponsor type (industry versus non-industry), therapy area, indication, top sponsors, intervention, biomarkers, drug type, and DCT use. In this report, a small number of Phase 0, Phase I/II, Phase II/III, and Phase III/IV trials were combined with Phase I, Phase II, Phase III, and Phase IV trials, respectively.
Reasons to Buy
- In-Depth Analysis: Gain access to a comprehensive analysis of biomarkers in clinical trials, providing valuable insights into current trends, patterns, and the overall landscape of biomarker research.
- Data-Driven Insights: Leverage data-driven findings that highlight key metrics, such as trial durations and sponsorship trends, enabling informed decision-making for researchers and industry stakeholders.
- Strategic Planning: Utilize the insights from this report to enhance trial design and feasibility planning, ensuring that your research initiatives are aligned with the latest developments in biomarker utilization.
- Understanding Market Dynamics: Stay ahead of the curve by understanding the evolving role of biomarkers in clinical trials, including the factors contributing to the decline in biomarker usage since 2021.
- Resource for Stakeholders: This report serves as an essential resource for researchers, clinicians, and industry professionals, offering guidance on navigating the complexities of biomarker integration in clinical trials.
- Future Research Directions: Identify potential areas for future research and development, helping to shape your organization’s strategic focus and investment in biomarker-related projects.
- Competitive Advantage: Equip your organization with the knowledge needed to maintain a competitive edge in the rapidly evolving field of biomarker research and clinical trials.
- Networking Opportunities: By understanding the landscape of non-industry sponsored trials, stakeholders can identify potential collaborators and partnerships within the academic and independent research communities.
- Regulatory Insights: Gain insights into regulatory considerations and challenges associated with biomarker trials, helping to navigate compliance and approval processes more effectively.
- Comprehensive Resource: This report consolidates a wealth of information into a single resource, saving time and effort in research and analysis for busy professionals in the field.
Table of Contents
- 1.Tables and Figures
- 2.Executive Summary
- 3.Introduction
- 4.Clinical Trials: Biomarkers to Support Clinical Endpoints
- 5.Key Findings 6.Appendix
Figure 1: Proportion of total trials with and without biomarkers, by year
Figure 2: Number of biomarker trials and artificial intelligence trials, by year
Figure 3: Clinical trial cost estimates for trials with biomarkers and all trials, by phase
Figure 4: Percentage of trials with biomarkers used to assess efficacy and safety
Figure 5: Trials with or without biomarkers, by endpoint status
Figure 6: Percentage of trials with or without biomarkers, by region
Figure 7: Percentage of trials with biomarkers used to assess safety or efficacy, by region
Figure 8: Comparing ratio of multinational trials/single country trials in all trials and trials with biomarkers, by region
Figure 9: Trials with biomarkers used to assess safety or efficacy endpoints, by trial phase
Figure 10: Percentage of trials with and without biomarkers, by trial status
Figure 11: Percentage of trials with biomarkers used to assess safety or efficacy, by trial status
Figure 12: Total decentralized/virtual trials with or without biomarkers, by decentralized/virtual component
Figure 13: Percentage of biomarkers trials with virtual components, by endpoint classification
Figure 14: Diversity in trials with and without biomarkers
Figure 15: Duration of trials with and without biomarkers
Figure 16: Duration of trials utilizing biomarkers, by endpoint classification
Figure 17: Comparing all trials and trials with biomarkers, by molecule type
Figure 18 and 19: Top 10 therapy areas investigated in trials with biomarkers assessing safety or efficacy endpoints
Figure 20 and 21: Top 10 drugs investigated in trials using biomarkers to support safety or efficacy endpoints
Figure 22: Top 10 efficacy biomarkers supporting efficacy clinical endpoints
Figure 23: Top 10 safety biomarkers supporting safety clinical endpoints
Figure 24 and 25: Trials with biomarkers assessing safety or efficacy endpoints, by sponsor type
Figure 26 and 27: Trials with biomarkers assessing safety or efficacy endpoints, by sponsor type
Figure 28 and 29: Top 10 Industry sponsors in trials with biomarkers, by endpoint classification
Figure 30 and 31: Top 10 non-Industry sponsors in trials with biomarkers, by endpoint classification
Figure 32: Rare disease clinical trials with or without biomarkers and AI trials, by year
Figure 33 and 34: Rare disease trials using biomarkers to assess safety and efficacy endpoints, by endpoint status
