Biomarker Clinical Phase Outsourcing Services Market Size & Share 2024 to 2032

Biomarker Clinical Phase Outsourcing Services Market Size

Biomarker Clinical Phase Outsourcing Services Market size was around USD 7.9 billion in 2023 is expected to grow at over 19.2% CAGR between 2024 and 2032. High market growth can be attributed to rapid advancements in biomarker technology, increasing use of biomarkers, rising government initiatives and funding, growing emphasis on precision medicine, and globalization of clinical trials. Advancements in biomarker technologies often lead to the development of more complex and specialized assays, that can be effectively used in clinical trials.

For instance, in 2020 FDA approved the use of programmed cell death ligand-1 (PD-L1) as a biomarker for cancer treatment in a tissue-agnostic manner based on the presence of specific genetic features. Therefore, as new biomarker platforms and technologies emerge, outsourcing partners can offer expertise in adopting and optimizing these platforms for clinical trials, thereby fostering the market expansion.
 

Biomarkers in clinical phase outsourcing services refer to the use of biological indicators to support various stages of clinical trials, including study design, patient stratification, treatment response assessment, and safety monitoring. These biomarkers are utilized to provide insights into the underlying biological processes, disease mechanisms, and treatment effects, ultimately aiding in the development of novel therapeutics and personalized medicine approaches.
 

COVID-19 Impact

The global COVID-19 pandemic had a positive impact on the biomarker clinical phase outsourcing services market. Biomarkers have been widely utilised in various stages of the clinical trials during the ongoing research on virus. The pandemic underscored the importance of identifying biomarkers for COVID-19 and other diseases, leading to increased interest in biomarker discovery and outsourcing services. This increased utilization of biomarkers in various stages of clinical trials. boosted the global market during the pandemic.
 

Biomarker Clinical Phase Outsourcing Services Market Trends

• The increasing use of biomarkers in the various phases of clinical trials play a pivotal role in driving the market. For instance, according to National Library of Medicine (NLM), in 2020, the biomarker, C-reactive protein (CRP) has been widely used in the clinical trials for its potential use as a diagnostic index of disease severity in COVID-19 infections.
   
• Also, biomarkers are increasingly used for the early detection of diseases in the clinical trials, enabling timely intervention and improved outcomes. Therefore, outsourcing services are involved in the validation of biomarkers for early detection and in the execution of clinical trials focused on the diagnostic potential of these biomarkers.
   

As the use of biomarkers in clinical trials continue to expand, the demand for outsourcing services that can provide specialized expertise, advanced parameters in the trials, and efficient execution of diagnostic-focused clinical phases is likely to grow. This trend aligns with the broader shift toward precision medicine and personalized healthcare approaches, thereby expanding the growth of the market.
 

Biomarker Clinical Phase Outsourcing Services Market Analysis

Based on biomarker type, the market is segmented into surrogate endpoints, predictive biomarker, prognostic biomarker, safety biomarker, and other biomarker types. The surrogate endpoints segment held the largest business share at 54.6% in 2023. The growing demand for precision medicines and the rise in the number of clinical trials involving the use of biomarker analysis are driving the growth of the surrogate endpoints segment.
 

• The use of surrogate endpoints in clinical trials has several advantages, including reducing the time and cost of clinical trials, facilitating the approval of new drugs, and guiding treatment decisions and assessing the effectiveness.
   
• Moreover, a surrogate endpoint is clearly shown to predict a beneficial effect through appropriate studies, its use generally allows clinical studies to be conducted in smaller numbers of people over shorter periods of time, thus leading to its acceptance and affordability.
   

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Based on therapeutic area, the biomarker clinical phase outsourcing services market is classified into oncology, neurology, cardiology, autoimmune disease, other therapeutic areas. The oncology segment is expected to reach the largest market revenue of USD 12.7 billion by 2032.
 

• Oncology has been at the forefront in the utilization of biomarkers for various clinical phases of different diagnostics and therapeutic areas. For instance, according to the report of The Journal of Precision Medicine in 2022, more than 55% of all cancer trials from 2018 to 2020 involved the use of biomarkers, compared with 15% in 2000. Therefore, outsourcing services specialized in oncology biomarkers leverage these technologies for comprehensive molecular profiling and analysis.
   

Based on end-user, the biomarker clinical phase outsourcing services market is segmented into pharmaceutical companies, biotechnology companies, and other end-users. The biotechnology companies’ segment is expected to exhibit 19.4% CAGR between 2024 – 2032 period.
 

• Biotechnology companies have increasingly adopted outsourcing strategies to streamline their operations and focus on core competencies. Outsourcing biomarker clinical phase services allows these companies to leverage external expertise and resources.
   
• Additionally, outsourcing services offer flexibility and scalability to biotechnology companies. As biomarker research needs fluctuate during different phases of clinical trials, outsourcing allows for the adjustment of resources and services accordingly. These firms leverage outsourcing for efficient, flexible, and globally compliant biomarker services, cementing their central role in the market.
   

In 2023, North America held a significant share of 42.1% in the biomarker clinical phase outsourcing services market.
 

• The region boasts advanced healthcare infrastructure, including state-of-the-art research facilities and laboratories. This infrastructure supports clinical trials, attracting firms seeking outsourcing services along with easy access to cutting-edge technologies and resources.
   
• Moreover, North America hosts few of the world's leading contract research organizations, fostering a robust environment for biomarker clinical phase outsourcing services. Such aforementioned factors are expected to propel the demand for biomarker clinical phase outsourcing services in the North America market.
   

Biomarker Clinical Phase Outsourcing Services Market Share

The market is characterized by diverse players competing in the healthcare industry. Laboratory Corporation of America Holdings, Parexel International Corporation, and Charles River Laboratories International, Inc., account for significant market share. These prominent players thrive through a combination of strategic initiatives, investing in research and development, meeting the specific needs of patients, geographical expansion, strategic approaches, product diversification, and regulatory compliance.
 

Biomarker Clinical Phase Outsourcing Services Market Companies

Foremost players operating in the biomarker clinical phase outsourcing services industry is as mentioned below:

• Laboratory Corporation of America Holdings
• Parexel International Corporation
• Charles River Laboratories International, Inc.
• ICON plc
• Proteome Sciences plc
• Fujirebio Inc
• WuXi AppTec Co., Ltd.
• NorthEast BioAnalytical Laboratories LLC.
• Celerion, Inc.
• GenScript ProBio Co., Ltd.
   

Biomarker Clinical Phase Outsourcing Services Industry News:

• In June 2023, Laboratory Corporation of America Holdings launched its new liquid biopsy test. This provided the identification of biomarkers at an early stage, helping to use available targeted therapies to enhance survival outcomes in metastatic solid tumours clinical trials. This strategy is expected to add value to its existing business portfolio.
   
• In November 2022, Celerion Inc, announced the expansion of service offering platforms for immune monitoring and biomarker screening with high-throughput flow cytometry and ELISpot testing. This helped to monitor the biomarker management, biostatistics, clinical monitoring, and bioanalytical services in the phases of clinical trials. Thus, it increased the foothold and service diversification of the company, thereby increasing the sales.
   

The biomarker clinical phase outsourcing services market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:

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By Biomarker Type, 2018 – 2032 (USD Million)

• Surrogate endpoints
• Predictive biomarker
• Prognostic biomarker
• Safety biomarker
• Other biomarker types

By Therapeutic Area, 2018 – 2032 (USD Million)

• Oncology
• Neurology
• Cardiology
• Autoimmune diseases
• Other therapeutic areas

By End-user, 2018 – 2032 (USD Million)

• Pharmaceutical companies
• Biotechnology companies
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of Middle East & Africa