(MENAFN- EIN Presswire) EINPresswire/ -- The global biomarker discovery outsourcing services market is poised for significant expansion, with an anticipated rise from US$14.8 billion in 2025 to US$38.4 billion by 2032, reflecting a robust compound annual growth rate (CAGR) of 14.5% during the forecast period. The growing importance of biomarkers in the development of personalized medicines and the increasing complexity of drug development are driving this growth. Biomarker discovery outsourcing has become essential for pharmaceutical and biotechnology companies struggling to integrate complex biomarkers into their development pipelines.

As biomarkers play a critical role in precision medicine, the increasing complexity of identifying, validating, and integrating novel biomarkers into therapeutic applications has outpaced the in-house capabilities of several companies. This gap has opened up opportunities for Contract Research Organizations (CROs) and specialized service providers to offer expert outsourcing services. The market is now characterized by the rise of multi-omic platforms, artificial intelligence (AI)-powered analytics, and high-throughput sequencing technologies that have become key enablers of biomarker discovery and validation.

Get a Sample Copy of Research Report (Use Corporate Mail id for Quick Response):

Key Industry Highlights

Several key trends are shaping the biomarker discovery outsourcing services market. The growing emphasis on digital biomarkers, including those related to microbiomes for chronic and lifestyle diseases, is gaining significant traction. Pharma companies are increasingly collaborating with academic institutions to validate niche biomarkers, particularly in the areas of oncology, neurology, and autoimmune diseases. This collaboration is creating lucrative opportunities for outsourcing providers.

North America is expected to maintain a dominant market share, accounting for 44.7% of the market in 2025, primarily driven by the presence of leading CROs and biotech hubs supporting the end-to-end biomarker outsourcing process. Furthermore, surrogate biomarkers are becoming increasingly popular due to their ability to accelerate clinical trials by substituting long-term clinical endpoints with measurable biological responses.

Market Dynamics

Driver: Rise of Personalized Medicine Fuels Demand for Outsourced Discovery Services

The rise of personalized medicine is one of the primary drivers behind the growth of the biomarker discovery outsourcing services market. Personalized therapies require sophisticated data generation and analysis capabilities to identify specific patient subgroups, a need that most biotech and pharmaceutical companies cannot fulfill internally. The integration of metabolomic, proteomic, and genomic data is essential for identifying biomarkers that can inform targeted therapies. As such, specialized CROs equipped with AI-backed analytics, regulatory-grade validation protocols, and high-throughput sequencing technologies are increasingly sought after.

The rising demand for multi-analyte biomarker panels for companion diagnostics also fuels outsourcing demand. For example, AstraZeneca's collaboration with ANGLE for liquid biopsy assay development exemplifies the trend of pharma companies seeking strategic alliances with diagnostic firms to advance biomarker discovery.

Restraint: Strict Global Standards Create Operational Hurdles for Biomarker CROs

Despite the market's positive trajectory, strict global regulatory standards present a significant restraint. Regulatory bodies such as the U.S. FDA and European Medicines Agency (EMA) have increasingly stringent requirements for biomarker assays to meet analytical validation standards. These regulations make it more difficult for outsourcing firms to meet compliance across global trial sites. Many outsourcing partners lack the necessary infrastructure, such as ISO 15189-accredited or CLIA-certified laboratories, to produce compliant biomarker data.

The variation in global regulatory standards further complicates outsourcing operations. The European Union's In Vitro Diagnostic Regulation (IVDR), for instance, demands extensive clinical evidence and quality documentation for biomarkers used in clinical trials, delaying the development and initiation of biomarker assays.

Opportunity: Shift to Spatial and Multi-Omic Biomarkers Opens New Avenues

The increasing complexity of personalized medicine is creating new opportunities for outsourcing service providers. As the industry transitions from single-analyte biomarkers to multi-omic and spatial biomarkers, the technical and computational demands have grown. For example, spatial transcriptomics, which requires advanced imaging technologies and AI-powered bioinformatics pipelines, is an emerging field that many CROs are capitalizing on. Companies such as Veranome Biosystems and Genospace are offering spatial multi-omics services to meet these growing demands.

Outsourcing firms are also benefiting from the increasing reliance on real-world data, decentralized patient monitoring, and longitudinal bio-sample repositories. The complexity of these workflows necessitates specialized data integration expertise that traditional laboratories cannot offer. The selection of Thermo Fisher Scientific's Olink Explore Platform for the U.K. Biobank Pharma Proteomics Project is an example of how outsourcing providers are evolving to meet the industry's increasing needs.

Category-wise Analysis

Biomarker Type Insights

The market can be segmented by biomarker type into predictive, prognostic, safety, and surrogate biomarkers. Among these, surrogate biomarkers are expected to dominate the market, accounting for a 55.3% share in 2025. Surrogate biomarkers are particularly valuable in therapeutic areas such as oncology, where direct clinical endpoints are difficult to measure. Tumor Mutational Burden (TMB) and circulating tumor DNA (ctDNA) are examples of surrogate biomarkers used in cancer drug development.

Predictive biomarkers, on the other hand, are expected to experience significant growth between 2025 and 2032, as they directly inform treatment decisions and patient stratification for targeted therapies. For instance, predictive biomarkers are increasingly used in oncology trials, with more than 70% of new oncology trials using these biomarkers for patient selection in 2024.

Therapeutic Area Insights

The market is also segmented by therapeutic area, including oncology, cardiology, neurology, and autoimmune diseases. The oncology segment is expected to account for the largest market share in 2025, driven by the increasing reliance on personalized therapies and the need for biomarker-based patient stratification. The molecular signatures associated with cancer, such as immune profiles, protein expressions, and gene mutations, make biomarker discovery crucial for drug development.

Autoimmune diseases, while more complex and difficult to diagnose due to their overlapping symptoms, are also experiencing a surge in demand for biomarker discovery outsourcing. The increasing focus on transcriptomic analysis and multiplex cytokine profiling is driving this demand, particularly in diseases like rheumatoid arthritis and multiple sclerosis.

Request for Customization of the Research Report:

Regional Insights

North America

In 2025, North America is projected to hold nearly 44.7% of the biomarker discovery outsourcing services market, fueled by its established infrastructure for precision medicine and cutting-edge R&D ecosystem. The U.S. is home to several large-scale biomarker initiatives, including the NIH's All of Us Research Program, which has partnered with CROs for population-wide biomarker identification.

Europe

In Europe, the implementation of the EU In Vitro Diagnostic Regulation (IVDR) is reshaping the landscape for biomarker discovery outsourcing. CROs with specialized expertise in regulatory and assay validation are in high demand to help navigate the complexities of these regulations. Switzerland, the Netherlands, and Belgium are becoming key hubs for biomarker discovery outsourcing, thanks to their dense biotech ecosystems and proximity to academic research centers.

Asia Pacific

The Asia Pacific region is emerging as a key player in the biomarker discovery outsourcing market, with China's National Precision Medicine Initiative and Japan's focus on aging-related biomarker research driving demand. Local CROs such as Tigermed and WuXi AppTec are expanding their capabilities to serve both domestic and international clients.

Competitive Landscape

The biomarker discovery outsourcing services market is highly competitive, with a mix of integrated pharmaceutical service providers, specialized biotech firms, and established CROs. These companies are differentiating themselves through technological innovations in multi-omics platforms, strategic partnerships, and deep expertise in specific therapeutic areas.

Key Players:

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

Buy Now the Detailed Report:

Key Industry Developments

In May 2025, Labcorp expanded its precision oncology portfolio by introducing new biomarker test offerings for solid tumors and hematologic malignancies. Evotec SE, in February 2023, extended its drug discovery agreement with Related Sciences to expand their joint portfolio, leveraging Evotec's capabilities in multi-target drug discovery.

Market Segmentation

By Biomarker Type

Predictive Biomarkers
Prognostic Biomarkers
Safety Biomarkers
Surrogate Biomarker

By Therapeutic Area

Oncology
Cardiology
Neurology
Autoimmune Diseases
Others

By Discovery Phase

Biomarker Identification
Biomarker Validation
Biomarker Profiling
Biomarker Panel Development
Biomarker Selection

By End-use

Pharmaceutical Companies
Biotechnology Companies
Others

By Region

North America
Europe
East Asia
South Asia and Oceania
Latin America
Middle East and Africa

Future Outlook

The biomarker discovery outsourcing services market is on a clear growth trajectory, driven by the increasing complexity of precision medicine, the demand for multi-omic analysis, and regulatory advancements. With major players focusing on technological innovation and long-term strategic partnerships, the market is set to witness continued expansion, particularly in oncology, neurology, and autoimmune diseases. As the demand for specialized biomarker services continues to rise, outsourcing will remain a critical strategy for pharmaceutical and biotechnology companies aiming to accelerate drug development and enhance patient outcomes.

Read More Related Reports:

Autoimmune Disease Testing Market : The autoimmune disease testing market will reach US$13.4 Bn by 2032 from US$6.6 Bn in 2025, growing at a strong CAGR of 10.8% during 2025–2032.

Autism Spectrum Disorder Treatment Market : The global autism spectrum disorder treatment market is set to grow US$3.2 Bn by 2031, driven by awareness, early diagnosis, and personalized therapies.

MENAFN16102025003118003196ID1110204018