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How much is the biomarker clinical phase outsourcing services market worth, and how is it expected to expand?
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 23.0%. 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.
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Which industry factors have accelerated the biomarker clinical phase outsourcing services market’s expansion?
The rise in clinical trials is expected to propel the growth of the biomarker clinical phase outsourcing services market going forward. Clinical trials are research studies conducted with human participants to evaluate the safety and effectiveness of new medical treatments, interventions, or diagnostic procedures. The surge in clinical trials is facilitated by advancements in medical research, rising prevalence of chronic diseases, increased funding from both governmental and private sources, and the growing demand for innovative treatments and therapies. Outsourcing providers often have specialized knowledge and experience in biomarker discovery, validation, and analysis. This expertise can enhance the quality and reliability of the biomarker data collected during the trial. For instance, in May 2023, according to the United States National Library of Medicine, registered clinical trials increased from 399,499 in 2022 to 437,533 in all 50 states and across 221 countries. Furthermore, it was reported that 140,492 studies (31%) are registered in the United States only, whereas 241,498 studies (53%) are recorded in non-U.S. locations. Therefore, the rise in clinical trials will drive the growth in the biomarker clinical phase outsourcing services market forward.
What are the primary segments of the biomarker clinical phase outsourcing services market?
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
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Which firms are leading 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 market trends are set to define the future of the biomarker clinical phase outsourcing services market?
Major companies in the biomarker clinical phase outsourcing services are focusing on advancements with high-throughput flow cytometry and ELISpot testing to gain a competitive edge in the market. High-throughput flow cytometry and ELISpot testing are utilized for biomarker analysis, offering rapid and precise assessment of immune responses and cellular markers. For instance, in November 2022, Celerion Inc., a US-based biotechnology outsourcing services company, expanded its service offering to include GLP/GCP-compliant molecular and cell biology testing. This strategic move aims to enhance Celerion’s capabilities in supporting clients throughout the drug development process, from early clinical research to regulatory submissions. Celerion can provide a more comprehensive range of services by adding GLP/GCP-compliant molecular and cell biology tests, such as pharmacokinetic (PK), pharmacodynamic (PD), and biomarker analysis. This expansion enables Celerion to assist clients in producing high-quality data that meets regulatory requirements, thereby speeding up the development of new medicines.
Which geographic trends are shaping the biomarker clinical phase outsourcing services market, and which region has the highest market share?
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 Biomarker Clinical Phase Outsourcing Services Market Report 2025 Offer?
The biomarker clinical phase outsourcing services market research report from The Business Research Company offers global market size, growth rate, regional shares, competitor analysis, detailed segments, trends, and opportunities.
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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