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Top Market Shifts Transforming the Biomarker Clinical Phase Outsourcing Services Market Landscape: Key Insights

11-19-2025 09:47 AM CET | Health & Medicine

Press release from: The Business Research Company

Biomarker Clinical Phase Outsourcing Services

Biomarker Clinical Phase Outsourcing Services

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What Is the Expected CAGR for the Biomarker Clinical Phase Outsourcing Services Market Through 2025?
The market encompassing outsourcing services for biomarker clinical phases has experienced substantial expansion lately. Projecting forward, this market is anticipated to expand from a valuation of $9.71 billion in 2024 to reach $11.91 billion in 2025, reflecting a robust compound annual growth rate of 22.7%. This upward trajectory observed during the past period is fueled by several key factors, including escalating governmental support and financial backing, a widened scope of biomarker utility in diagnostics, amplified governmental investment in research and development activities, swift technological progress across fields like proteomics, genomics, and medical imaging, alongside a growing need specifically for cancer-related biomarkers.

What's the Projected Size of the Global Biomarker Clinical Phase Outsourcing Services Market by 2029?
Anticipation is for the market encompassing outsourcing services for biomarker clinical phases to experience rapid, substantial expansion over the foroming years, culminating in a valuation of $25.87 billion by 2029, propelled by a compound annual growth rate (CAGR) of 21.4%. This considerable upswing throughout the projection timeframe is fundamentally linked to the escalating incorporation of biomarkers across disparate stages of clinical testing, the persistent broadening application of biomarkers within trials, the heightened need for therapeutics tailored to individual needs (precision medicines), the progressive uptake of complementary diagnostic tools, and the intensifying requirement worldwide for customized medical approaches. Key developments expected to shape this era involve the introduction of more sophisticated metrics within research protocols, a greater concentration on diagnostics within clinical proceedings, swift technological breakthroughs in biomarker identification and use, boosts from governmental support and financial backing, alongside continuous technological evolution.

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Top Growth Drivers in the Biomarker Clinical Phase Outsourcing Services Industry: What's Accelerating the Market?
Anticipated expansion in the volume of clinical studies is positioned to fuel the advancement of the market for outsourcing biomarker clinical phase services moving ahead. These clinical investigations represent research endeavors involving human subjects, designed to assess the security and efficacy of novel medical therapeutics, interventions, or diagnostic methodologies. A variety of factors contribute to this escalation in clinical trials, including progress made in medical science, a growing incidence of persistent illnesses, augmented financial support from both public and private entities, and an increasing need for novel therapeutic approaches. Specialists in outsourcing frequently possess distinct proficiency and hands-on experience in the identification, confirmation, and interpretation of biomarkers, which can serve to boost the integrity and trustworthiness of the biomarker data gathered throughout the trial process. Illustratively, data from the United States National Library of Medicine in May 2023 indicated that the number of registered clinical trials escalated from 399,499 in 2022 to reach 437,533, spanning all fifty states and involving 221 nations; moreover, this data revealed that solely the United States hosts 140,492 of these studies, accounting for 31%, while non-U.S. sites currently house 241,498 studies, representing 53%. Consequently, this increase in clinical trial activity is set to be the impetus for the expansion of the biomarker clinical phase outsourcing services sector.

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What Trends Will Shape the Biomarker Clinical Phase Outsourcing Services Market Through 2029 and Beyond?
Leading firms within the outsourcing sector for biomarker clinical phases are prioritizing enhancements in high-throughput flow cytometry and ELISpot assessments to secure an advantage over rivals. These specific testing methods, high-throughput flow cytometry and ELISpot, serve to analyze biomarkers, delivering expedient and accurate evaluations of cellular markers and immune system reactions. Illustratively, in the penultimate month of 2022, Celerion Inc., an American firm providing biotechnology outsourcing solutions, broadened its repertoire by incorporating GLP/GCP-compliant testing in molecular and cell biology. This calculated step is intended to bolster Celerion's capacity to assist clientele across the entire spectrum of drug advancement, ranging from initial clinical investigations up to submissions for regulatory approval. Through the incorporation of these GLP/GCP-compliant molecular and cell biology assays, encompassing pharmacokinetic (PK), pharmacodynamic (PD), and biomarker analyses, Celerion is now positioned to offer a more complete suite of services, facilitating the generation of superior data that satisfies compliance mandates, thus accelerating the path for novel therapeutic agents.

What Are the Main Segments in the Biomarker Clinical Phase Outsourcing Services Market?
The biomarker clinical phase outsourcing servicesmarket covered in this report is segmented -

1) By Type: Surrogate Endpoints; Predictive Biomarker; Prognostic Biomarker; Safety Biomarker; Other Biomarker Types
2) By Service Type: Biomarker Validation; Biomarker Testing Services; Biomarker Sample Analysis
3) By Therapeutic Area: Oncology; Neurology; Cardiology; Autoimmune Diseases; Other Therapeutic Areas
4) By End-User: Pharmaceutical Companies; Biotechnology Companies; Academic And Research Institutions

Subsegments:
1) By Surrogate Endpoints: Tumor Marker-Based Endpoints; Imaging-Based Endpoints; Genetic or Genomic Markers
2) By Predictive Biomarker: Genetic Predictive Biomarkers; Protein Predictive Biomarkers; Metabolomic Predictive Biomarkers
3) By Prognostic Biomarker: Cancer Prognostic Biomarkers; Cardiovascular Prognostic Biomarkers; Neurological Prognostic Biomarkers
4) By Safety Biomarker: Toxicity Biomarkers; Adverse Drug Reaction Biomarkers; Drug Interaction Biomarkers
5) By Other Biomarker Types: Inflammation Biomarkers; Infectious Disease Biomarkers; Autoimmune Disease Biomarkers

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Which Top Companies are Driving Growth in the Biomarker Clinical Phase Outsourcing Services Market?
Major companies operating in the biomarker clinical phase outsourcing services market are Thermo Fisher Scientific Inc., Labcorp Drug Development Inc., ICON plc, Eurofins Scientific SE, WuXi AppTec Co. Ltd., Syneos Health Inc., Intertek Group plc, Charles River Laboratories International Inc., Parexel International Corporation, QIAGEN N.V., Medpace Inc., Bioclinica Inc., Evotec SE, GenScript Biotech Corporation, Precision for Medicine Inc., BioAgilytix Labs LLC, Celerion Inc., Frontage Laboratories Inc., SomaLogic Inc., Selvita S.A., BioIVT LLC, Discovery Life Sciences LLC, Metabolon Inc., Caprion Proteomics Inc., Canopy Biosciences LLC

Which Regions Will Dominate the Biomarker Clinical Phase Outsourcing Services Market Through 2029?
North America was the largest region in the biomarker clinical phase outsourcing services market in 2024. The regions covered in the biomarker clinical phase outsourcing services market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

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