Biomarker Discovery Outsourcing Services Market Booms with 14.5% CAGR: Persistence Market Research Forecast

The global biomarker discovery outsourcing services market has gained significant momentum in recent years, primarily driven by the evolving demand for personalized medicine and the increasing complexity of drug development pipelines. According to Persistence Market Research, the market size is projected to reach US$ 38.4 billion by 2032, up from US$ 14.8 billion in 2025, reflecting a compound annual growth rate (CAGR) of approximately 14.5% during the forecast period from 2025 to 2032.

This market is a vital component of the larger pharmaceutical and biotechnology ecosystems. Biomarker discovery involves identifying molecular indicators that can predict or measure disease progression, treatment response, or risk. As the demand for precision medicine grows, pharmaceutical and biotech companies face significant challenges in identifying, validating, and integrating biomarkers into their drug development programs. As a result, outsourcing these services to specialized Contract Research Organizations (CROs), which offer cutting-edge technologies and multi-omic platforms, has become increasingly common.

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Key Growth Drivers for this market include the rising adoption of personalized medicine, advancements in AI-driven analytics, and a growing preference for multi-omic and spatial biomarkers. These developments have created an environment where outsourcing biomarker discovery is an essential strategy for biotech and pharmaceutical companies to meet the growing demand for novel therapeutics.

Key Highlights from the Report:

➤ The global biomarker discovery outsourcing services market is projected to grow from US$ 14.8 billion in 2025 to US$ 38.4 billion by 2032.
➤ The market is expected to witness a CAGR of 14.5% between 2025 and 2032.
➤ North America is anticipated to lead the market with a share of 44.7% in 2025.
➤ Surrogate biomarkers are highly preferred, especially for oncology drug development.
➤ Predictive biomarkers are expected to experience strong growth due to their role in personalized treatments.
➤ Collaboration between pharmaceutical companies and academic institutions will fuel market opportunities.

Market Segmentation

The biomarker discovery outsourcing services market is categorized based on biomarker type, therapeutic areas, and end-users. Each of these segments has unique growth prospects and challenges, offering insights into the diverse landscape of the market.

By Biomarker Type

The market is segmented into four primary types of biomarkers: predictive, prognostic, safety, and surrogate biomarkers. Among these, the surrogate biomarkers segment is expected to hold the largest share in 2025, estimated at 55.3%. Surrogate biomarkers are particularly valuable in clinical trials, as they can substitute long-term clinical endpoints with measurable biological responses, making them highly useful in areas like oncology. For example, tumor mutational burden (TMB) and circulating tumor DNA (ctDNA) are increasingly being used as surrogate biomarkers for cancer progression.

On the other hand, predictive biomarkers are poised for significant growth from 2025 to 2032. These biomarkers are crucial for determining the likelihood of a patient responding to a specific therapeutic intervention, thus playing a vital role in drug efficacy and reducing trial attrition. This growth is further bolstered by the increasing use of predictive biomarkers in clinical trial designs for oncology treatments.

By Therapeutic Area

The biomarker discovery outsourcing services market is segmented into various therapeutic areas, including oncology, cardiology, neurology, and autoimmune diseases. Among these, the oncology segment is forecast to dominate the market, accounting for approximately 34.6% of the market share in 2025. The need for biomarker-based stratification of patients in cancer therapies is growing rapidly, especially with the rise of personalized cancer treatments. Molecular signatures, immune profiles, and gene mutations are being used to develop more effective cancer therapies.

Autoimmune diseases are also witnessing growth in biomarker discovery outsourcing, driven by the need for multi-dimensional biomarker panels that can help with early diagnosis and more accurate treatment selection. Autoimmune disorders, such as rheumatoid arthritis and multiple sclerosis, require complex biomarkers for precise differentiation and personalized treatment strategies.

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Regional Insights

North America

North America is predicted to lead the biomarker discovery outsourcing services market, accounting for 44.7% of the market share in 2025. The region's market dominance is attributed to its well-established research and development infrastructure, along with numerous biotechnology hubs and pharmaceutical companies. The U.S. government's support for precision medicine initiatives, such as the NIH's All of Us Research Program, has further bolstered the outsourcing of biomarker discovery. Additionally, the increasing number of partnerships between local CROs and biotech companies, particularly in oncology and neurology, strengthens North America's position.

Europe

Europe is also witnessing significant growth in the biomarker discovery outsourcing market, largely driven by the full implementation of the EU In Vitro Diagnostic Regulation (IVDR). The regulation's stricter compliance standards have led pharmaceutical and biotech companies to outsource biomarker discovery to CROs capable of adhering to these stringent requirements. Countries such as Switzerland, the Netherlands, and Belgium are emerging as key hubs for biomarker discovery outsourcing, owing to their robust biotech ecosystems and proximity to academic research institutions.

Asia Pacific

Asia Pacific is rapidly becoming a hotspot for biomarker discovery outsourcing, especially in countries like China and Japan. China's National Precision Medicine Initiative, which received a substantial funding boost, is driving numerous biomarker discovery projects in collaboration with local CROs. Similarly, Japan is increasingly focusing on biomarkers related to aging-related diseases, such as neurodegenerative disorders and cardiometabolic diseases, making it an important player in the market.

Market Drivers

The key driver behind the growth of the biomarker discovery outsourcing services market is the global shift toward personalized medicine. Personalized medicine requires multi-layered, sophisticated data generation and analysis, which most pharmaceutical and biotech companies cannot achieve in-house. As a result, there is a growing reliance on specialized outsourcing firms that can handle the complex demands of biomarker discovery and validation.

Additionally, the increasing demand for multi-analyte biomarker panels, especially for companion diagnostics, is fueling the need for outsourced services. These panels help in tailoring therapies to individual patients, which is especially critical in oncology treatments, where precision is paramount.

Market Restraints

One of the major restraints faced by the biomarker discovery outsourcing services market is the stringent regulatory environment. Regulatory agencies such as the FDA and the European Medicines Agency (EMA) require biomarker assays to meet the same standards as commercial diagnostics, which places operational burdens on outsourcing firms. The global variation in regulatory expectations further complicates outsourcing workflows, creating challenges for CROs to maintain compliance across different markets.

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Market Opportunities

A significant opportunity for market growth lies in the shift toward spatial and multi-omic biomarkers. These advanced biomarkers are required for the next generation of personalized medicine, which is becoming increasingly complex. With technologies like spatial transcriptomics and AI-backed bioinformatics platforms, CROs can provide specialized services that go beyond traditional biomarker discovery. This trend is opening new avenues for outsourcing, especially in the areas of oncology and neurology.

Reasons to Buy the Report

✔ Gain a comprehensive understanding of the global biomarker discovery outsourcing services market.
✔ Identify the leading market players and their strategic initiatives.
✔ Access market trends and insights on the most promising therapeutic areas.
✔ Evaluate the impact of regulatory challenges and opportunities in biomarker discovery.
✔ Leverage market data to make informed decisions on investment and business expansion.

Key Players

✦ Laboratory Corporation of America Holdings
✦ Celerion
✦ Charles River Laboratories
✦ Eurofins Scientific
✦ GHO Capital
✦ ICON plc
✦ Evotec
✦ Parexel International Corporation
✦ Thermo Fisher Scientific Inc.
✦ Proteome Sciences

Key Industry Developments

In May 2025, Labcorp launched new oncology test offerings to boost companion diagnostic development.

In February 2023, Evotec SE extended its multi-target drug discovery agreement with Related Sciences, focusing on biomarker-driven drug discovery.

Conclusion

The biomarker discovery outsourcing services market is poised for strong growth, driven by the accelerating demand for personalized medicine and technological advancements in multi-omic and spatial biomarkers. While challenges like regulatory compliance exist, the increasing complexity of therapeutic research provides abundant opportunities for outsourcing firms. By 2032, the market is set to reach new heights, with key regions such as North America, Europe, and Asia Pacific playing critical roles in shaping its future trajectory.

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About Persistence Market Research:

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