Global Biomarker Clinical Phase Outsourcing Services Market Size To Exceed USD 46.5 Billion By 2033 l CAGR of 20.02%

The Global Biomarker Clinical Phase Outsourcing Services Market Size was Valued at USD 7.5 Billion in 2023 and the Worldwide Biomarker Clinical Phase Outsourcing Services Market Size is Expected to Reach USD 46.5 Billion by 2033, according to a research report published by Spherical Insights & Consulting. Companies covered: Laboratory Corporation of America Holdings, Fujirebio lnc., Charles River Laboratories, Parexel International Corporation, ICON plc, Proteome Sciences, WuXi AppTec, NorthEast BioAnalytical Laboratories LLC, Eurofins Scientific, GenScript ProBio, Celerion, and Others


New York, United States , June 20, 2024 (GLOBE NEWSWIRE) -- The Global Biomarker Clinical Phase Outsourcing Services Market Size is to Grow from USD 7.5 Billion in 2023 to USD 46.5 Billion by 2033, at a Compound Annual Growth Rate (CAGR) of 20.02% during the projected period.


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Biomarker clinical phase outsourcing services refer to the use of biological indicators in drug development, supporting various stages of clinical trials, including study design, patient stratification, treatment response assessment, and safety monitoring. Mediating a better understanding of the underlying mechanisms of diseases and evaluating the efficacy of potential treatments. These services are typically provided by CROs or academic research institutes, which have the necessary infrastructure, resources, and experience to conduct complex biomarker studies. The advancement in biomarker technologies often leads to the development of more complex and specialized assays that can be effectively used in clinical trials. The growing demand for cancer biomarkers for early detection and diagnosis of the conditions is driving the market growth. The increasing government initiatives and funding for R&D activities are significantly contributing to driving the market. Further, the rapid advancements in OMICS technologies and the shift toward precision medicine are the factors responsible for driving the market. On the contrary, the high cost associated with biomarkers is restraining the market. Regulatory framework for ensuring the safety and efficacy of the products and the lack of standardization affecting the quality and reliability of biomarkers are negatively affecting the drug development process ultimately leading to restraining the global biomarker clinical phase outsourcing services market.
Browse key industry insights spread across 200 pages with 110 Market data tables and figures & charts from the report on the " Global Biomarker Clinical Phase Outsourcing Services Market Size, Share, and COVID-19 Impact Analysis, By Biomarker Type (Surrogate Endpoints, Predictive Biomarker, Prognostic Biomarker, Safety Biomarker, and Others), By Therapeutic Area (Oncology, Neurology, Cardiology, Autoimmune Diseases, and Others), By End-User (Pharmaceutical Companies, Biotechnology Companies, and Others), and By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2023 – 2033 "

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The surrogate endpoints segment dominates the market with the largest revenue share in 2023.
Based on biomarker type, the global biomarker clinical phase outsourcing services market is segmented into surrogate endpoints, predictive biomarker, prognostic biomarker, safety biomarker, and others. Among these, the surrogate endpoints segment dominates the market with the largest revenue share in 2023. The use of surrogate endpoint biomarkers reduces the time and cost of clinical trials, which accelerates the process of drug development. A number of pharmaceutical sponsors are consistently making huge investments in the creation of surrogate endpoints. The increasing number of clinical studies and the expanding need for precision medicine are propelling the market demand.     

The oncology segment is anticipated to hold the largest market share through the forecast period.
Based on the therapeutic area, the global biomarker clinical phase outsourcing services market is segmented into oncology, neurology, cardiology, autoimmune diseases, and others. Among these, the oncology segment is anticipated to hold the largest market share through the forecast period. The Journal of Precision Medicine reports that from 2018 to 2022, biomarkers were used in over 55% of all cancer trials. The use of biomarkers in oncology clinical trials is growing and tremendous surge in the total percentage of cancer trials using biomarker analysis for efficient treatment discovery. The growing need for cancer biomarkers for earlier diagnosis and detection of disease is propelling the market demand.

The biotechnology companies segment is expected to grow at the fastest CAGR during the forecast period.
Based on the end-user, the global biomarker clinical phase outsourcing services market is segmented into pharmaceutical companies, biotechnology companies, and others. Among these, the biotechnology companies segment is expected to grow at the fastest CAGR during the forecast period. Several biopharmaceutical companies are funding the discovery of novel biomarkers to diagnose and monitor a variety of chronic illnesses. Consequently, the investments made by a number of biopharmaceutical companies in the creation of innovative biomarker testing services are augmenting market growth.

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North America dominates the market with the largest market share over the forecast period.

North America dominates the market with the largest market share over the forecast period. The United States is the leading biomarker outsourcing market in the region. A large number of pharmaceutical organizations prefer to outsource their manufacturing services to U.S. based CROs in North America, fostering a robust environment for biomarker clinical phase outsourcing services. Further, the robust and advanced healthcare infrastructure and the availability of state-of-the-art research facilities and laboratories are significantly contributing to regional market growth.

Asia-Pacific region is expected to grow the fastest during the forecast period. The supportive regulatory reforms as well as economical clinical research alternatives in countries like India and China are driving the market in the region. In addition, the rising number of Western pharmaceutical companies outsourcing their manufacturing activities to developing economies such as China and India is augmenting the market growth in the region.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the global market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market. Major vendors in the global biomarker clinical phase outsourcing services market are Laboratory Corporation of America Holdings, Fujirebio lnc., Charles River Laboratories, Parexel International Corporation, ICON plc, Proteome Sciences, WuXi AppTec, NorthEast BioAnalytical Laboratories LLC, Eurofins Scientific, GenScript ProBio, Celerion, and Other Key Players.

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Recent Developments

  • In June 2023, Labcorp launched a liquid biopsy test to enable targeted therapy selection for patients with advanced or metastatic solid tumors. The test, called Labcorp Plasma Focus, uses genetic sequencing to evaluate circulating cell-free DNA (cfDNA) released by tumor cells so that oncologists can better manage the care of their patients, the firm said.

Market Segment
This study forecasts revenue at global, regional, and country levels from 2020 to 2033. Spherical Insights has segmented the global biomarker clinical phase outsourcing services market based on the below-mentioned segments:

 Global Biomarker Clinical Phase Outsourcing Services Market, Biomarker Type Analysis

  • Surrogate Endpoints
  • Predictive Biomarker
  • Prognostic Biomarker
  • Safety Biomarker
  • Others

Global Biomarker Clinical Phase Outsourcing Services Market, Therapeutic Area Analysis

  • Oncology
  • Neurology
  • Cardiology
  • Autoimmune Diseases
  • Others

Global Biomarker Clinical Phase Outsourcing Services Market, End-User Analysis

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Others

Global Biomarker Clinical Phase Outsourcing Services Market, Regional Analysis

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • Uk
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia Pacific
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Middle East & Africa
    • UAE
    • Saudi Arabia
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

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