Global biomarker clinical phase outsourcing services Market
Healthcare Services

Unlocking Opportunities in the Biomarker Clinical Phase Outsourcing Services Market: Key Growth Trends and Forecast Insights

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What is the Growth Potential of the Biomarker Clinical Phase Outsourcing Services Market, and How Will It Perform by 2034?

The market size of outsourcing services for clinical phases of biomarkers has seen substantial expansion in the previous years. The market which was valued at $9.71 billion in 2024, is expected to reach up to $11.94 billion in 2025, implying a compound annual growth rate (CAGR) of 23.0%. Various factors like increased governmental initiatives and funding, a surge in the diagnostic utilization of biomarkers, a growth in R&D financial support from the government, rapid progress seen in technological landscapes like genomics, proteomics, and imaging, as well as a rising demand for cancer biomarkers, have notably contributed to this historic period’s growth.

The market size of biomarker clinical phase outsourcing services is predicted to undergo a significant surge in the coming years. The market is projected to reach a valuation of $27.09 billion by 2029, with a compound annual growth rate (CAGR) of 22.7%. The growth forecasted for this period is attributed to the escalating utilization of biomarkers across various stages of clinical trials. There is a broadening scope of biomarker use in clinical trials, which is further influenced by an increased demand for precision medicines, a heightened rate of companion diagnostics adoption, and a growing preference for personalized medicine. Several trends forecasted for this period include advancements in trial parameters, a focus on diagnostic-related clinical phases, quick progression in biomarker technology, an incline in government initiatives and funding, and the evolution in technology.

What External and Internal Drivers Are Contributing to the Growth of the Biomarker Clinical Phase Outsourcing Services Market’s Growth?

The biomarker clinical phase outsourcing services market is forecasted to grow due to the rising number of clinical trials. These trials involve human participants and are designed to gauge the safety and efficacy of novel medical treatments, interventions or diagnostic procedures. The growth in clinical trials can be attributed to progress in medical research, an escalating prevalence of chronic diseases, rising investment from both public and private sectors, and an increasing demand for innovative treatment methods and therapies. Biomarker discovery, validation, and analysis are areas often specialised by outsourcing providers. This specialist knowledge can help in improving the quality and trustworthiness of the biomarker data gathered throughout the trial. For example, the United States National Library of Medicine pointed out in May 2023 that registered clinical trials had risen from 399,499 in 2022 to 437,533 across all 50 states and in 221 other countries. It was also highlighted that the United States had recorded 140,492 studies (31%), while 241,498 studies (53%) were registered outside the U.S. Therefore, the increasing number of clinical trials is projected to stimulate the growth of the biomarker clinical phase outsourcing services market.

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Who Are the Major Companies Shaping the Competitive Landscape of 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.

What Are the Key Emerging Trends in the Biomarker Clinical Phase Outsourcing Services Market for the Next Decade?

Top-tier companies in the biomarker clinical phase outsourcing services sector are working on the advancement of high-throughput flow cytometry and ELISpot testing techniques to achieve a competitive edge in the market. These techniques are used for biomarker analysis, offering swift and accurate evaluations of immune responses and cellular markers. For example, in November 2022, Celerion Inc., a biotechnology outsourcing services firm based in the US, broadened its portfolio to incorporate GLP/GCP-compliant molecular and cell biology testing. This strategic step is designed to boost Celerion’s abilities in aiding clients all through the drug development cycle, from early clinical studies to regulatory filings. By incorporating GLP/GCP-compliant molecular and cell biology tests, like pharmacokinetic (PK), pharmacodynamic (PD), and biomarker analysis, Celerion is now able to provide a broader range of services. This expansion equips Celerion to help clients in generating superior quality data that complies with regulatory standards, ultimately accelerating the creation of new pharmaceuticals.

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How Are the Key Segments of the Biomarker Clinical Phase Outsourcing Services Market Impacting Its Expansion and Revenue Streams?

The biomarker clinical phase outsourcing services market 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

Which Regions Are Making a Mark in the Biomarker Clinical Phase Outsourcing Services Market Growth?

North America was the largest region in the biomarker clinical phase outsourcing services market in 2023. 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.

What Does the Definition of the Biomarker Clinical Phase Outsourcing Services Market Include?

Biomarker clinical phase outsourcing services refer to the practice of contracting specialized firms or organizations to conduct various aspects of clinical trials related to biomarkers. Biomarkers are measurable indicators of biological states or conditions, often used in medical research and clinical trials to assess the effectiveness or safety of a drug or treatment.

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