Biomarker Clinical Phase Outsourcing Services Market Report 2025

This Biomarker Clinical Phase Outsourcing Services market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The biomarker clinical phase outsourcing services market size has grown exponentially in recent years. It will grow from $9.71 billion in 2024 to $11.94 billion in 2025 at a compound annual growth rate (CAGR) of 23%. The growth in the historic period can be attributed to rising government initiatives and funding, increasing diagnostic applications of biomarkers, a rise in R&D funding from the government, rapid advancements in technologies such as genomics, proteomics, and imaging, and the increasing demand for cancer biomarkers.

The biomarker clinical phase outsourcing services market size is expected to see exponential growth in the next few years. It will grow to $27.09 billion in 2029 at a compound annual growth rate (CAGR) of 22.7%. The growth in the forecast period can be attributed to the increasing use of biomarkers in the various phases of clinical trials, the use of biomarkers in clinical trials continues to expand, as does the growing demand for precision medicines, the rising adoption of companion diagnostics, and the and the increasing demand for personalized medicine. Major trends in the forecast period include advanced parameters in the trials, diagnostic-focused clinical phases, rapid advancements in biomarker technology, rising government initiatives and funding, and advancements in technology.

The anticipated increase in clinical trials is set to drive the growth of the biomarker clinical phase outsourcing services market in the future. Clinical trials involve research studies conducted with human participants to assess the safety and effectiveness of new medical treatments, interventions, or diagnostic methods. This surge in clinical trials is facilitated by advancements in medical research, the growing prevalence of chronic diseases, augmented funding from governmental and private sources, and the rising demand for innovative treatments and therapies. Outsourcing providers often possess specialized knowledge and expertise in biomarker discovery, validation, and analysis, which can enhance the quality and reliability of biomarker data collected during trials. For example, data from the United States National Library of Medicine in May 2023 revealed an increase in registered clinical trials from 399,499 in 2022 to 437,533 across all 50 states and 221 countries. Additionally, the report indicated that 140,492 studies (31%) were registered in the United States alone, while 241,498 studies (53%) were recorded in non-U.S. locations. Therefore, the rise in clinical trials is expected to propel the growth of the biomarker clinical phase outsourcing services market.

Key players in the biomarker clinical phase outsourcing services market are concentrating on advancements in high-throughput flow cytometry and ELISpot testing to gain a competitive advantage. These technologies are utilized for biomarker analysis, providing rapid and precise assessment of immune responses and cellular markers. For instance, in November 2022, Celerion Inc., a U.S.-based biotechnology outsourcing services company, broadened its service portfolio to encompass GLP/GCP-compliant molecular and cell biology testing. This strategic expansion aims to bolster Celerion's capabilities in supporting clients throughout the drug development process, from early clinical research to regulatory submissions. By adding GLP/GCP-compliant molecular and cell biology tests, such as pharmacokinetic (PK), pharmacodynamic (PD), and biomarker analysis, Celerion can offer a more comprehensive range of services to assist clients in generating high-quality data meeting regulatory standards, thereby expediting the development of new medicines.

In March 2023, SSI Strategy, a US-based life sciences consulting firm, partnered with Koneksa, a US-based health technology company specializing in digital biomarkers and clinical research. This collaboration aims to enhance patient monitoring and streamline research processes, enabling pharmaceutical and biotech companies to gain deeper insights and accelerate the development of new therapies. The partnership focuses on advancing the use of real-world and remote monitoring technologies to support more efficient and patient-centered clinical studies.

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.

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. The countries covered in the biomarker clinical phase outsourcing services market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Biomarker clinical phase outsourcing services involve contracting specialized firms or organizations to handle various aspects of clinical trials related to biomarkers. Biomarkers are measurable indicators of biological states or conditions, commonly utilized in medical research and clinical trials to evaluate the effectiveness or safety of drugs or treatments.

The primary types of biomarker clinical phase outsourcing services include surrogate endpoints, predictive biomarkers, prognostic biomarkers, safety biomarkers, and others. Surrogate endpoints serve as biomarkers intended to substitute for a clinical endpoint. Outsourcing services utilize surrogate endpoints to streamline clinical trials by providing early indications of efficacy, reducing trial duration, and potentially accelerating regulatory approvals. Service types such as biomarker validation, biomarker testing services, and biomarker sample analysis cater to therapeutic areas including oncology, neurology, cardiology, autoimmune diseases, and others. The end users typically include pharmaceutical companies, biotechnology companies, as well as academic and research institutions.

The biomarker clinical phase outsourcing services market research report is one of a series of new reports that provides biomarker clinical phase outsourcing services market statistics, including biomarker clinical phase outsourcing services industry global market size, regional shares, competitors with an biomarker clinical phase outsourcing services market share, detailed biomarker clinical phase outsourcing services market segments, market trends and opportunities, and any further data you may need to thrive in the biomarker clinical phase outsourcing services industry. This biomarker clinical phase outsourcing services market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The biomarker clinical phase outsourcing services market includes revenues earned by entities by consulting services, diagnostic tests, clinical trial design, and biomarker sample analysis. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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