Comprehensive Snapshot for Biomarker Discovery Outsourcing Services Market, Including Region and Segment Analysis in Brief.
Industry: Healthcare
Delivery Timelines: Please Contact Sales
Published Date: June-2025
Format: PPT*, PDF, EXCEL
Number of Pages: 189
ID: PMRREP35423
The global biomarker discovery outsourcing services market size is predicted to reach US$ 38.4 Bn in 2032 from US$ 14.8 Bn in 2025. It will likely witness a CAGR of around 14.5% in the forecast period between 2025 and 2032.
As per Persistence Market Research, biomarker discovery has become the epitome of therapeutic innovation for precision medicine. Yet, the increasing complexity of identifying, validating, and integrating novel biomarkers into drug development pipelines has outpaced the in-house capabilities of several pharmaceutical and biotech companies. This has boosted biomarker discovery outsourcing services, an ecosystem now teeming with specialized Contract Research Organization (CROs), multi-omic platforms, and AI-backed analytics.
Key Industry Highlights
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Global Market Attribute |
Key Insights |
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Biomarker Discovery Outsourcing Services Market Size (2025E) |
US$ 14.8 Bn |
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Market Value Forecast (2032F) |
US$ 38.4 Bn |
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Projected Growth (CAGR 2025 to 2032) |
14.5% |
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Historical Market Growth (CAGR 2019 to 2024) |
12.9% |
The global push toward personalized medicine is anticipated to propel the biomarker discovery outsourcing services market growth as it requires multi-layered, sophisticated data generation and analysis capabilities that most biotech and pharmaceutical companies lack in-house. Personalized therapies rely on the integration of metabolomic, proteomic, and genomic data to identify specific patient subgroups, requiring innovative platforms and specialized personnel. This demand is met by outsourcing firms equipped with AI-backed analytics, regulatory-grade validation protocols, and high-throughput sequencing technologies.
The surging demand is further augmented by the shift toward multi-analyte biomarker panels, which are increasingly required for companion diagnostics. Several companies are actively extending their biomarker innovation network through strategic collaborations with diagnostic and bioanalytical firms. For example, AstraZeneca, collaborated with ANGLE for liquid biopsy assay development. It has collaborated with Roche to co-develop digital pathology algorithms for biomarker identification.
Strict regulatory compliance is predicted to create bottlenecks in next-generation biomarker discovery outsourcing. Regulatory agencies, including the European Medicines Agency and the U.S. Food and Drug Administration (FDA), now require biomarker assays to meet analytical validation standards equivalent to those for commercial diagnostics. This increases the operational burden on outsourcing firms, many of which lack ISO 15189-accredited or CLIA-certified laboratories capable of generating such compliant data across global trial sites. The Tufts Center for the Study of Drug Development has highlighted regulatory challenges as significant impediments in the development of personalized medicine and biomarker programs.
Global variation in regulatory expectations further complicates outsourcing workflows. The European Union’s In Vitro Diagnostic Regulation (IVDR), for instance, requires extensive clinical evidence and quality documentation for biomarker assays used in trials. Service providers and CROs have had to restructure their biomarker pipelines to accommodate these requirements, resulting in increased time-to-initiation and backlogs in assay development.
The surging complexity of personalized medicine biomarker research is creating significant opportunities for outsourcing partners by augmenting biopharma companies to seek specialized capabilities they cannot maintain internally. As the industry moves beyond single-analyte biomarkers to multi-omic, spatial biomarkers, the technical and computational demands have increased. For example, spatial transcriptomics, requires high-end imaging platforms and AI-backed bioinformatics pipelines. CROs, including Veranome Biosystems and Genospace, are capitalizing on this trend by offering spatial multi-omics as a service.
Biomarker discovery involves real-world data, decentralized patient monitoring, and longitudinal bio-sample repositories. These require logistical and data integration expertise beyond conventional lab capabilities. It is pushing demand for outsourcing firms that manages cross-disciplinary workflows. For example, Thermo Fisher Scientific’s Olink Explore Platform was selected for the U.K. Biobank Pharma Proteomics Project to analyze over 5,400 proteins from 600,000 samples to enhance disease prediction and treatment.
By biomarker type, the market is divided into predictive, prognostic, safety, and surrogate biomarkers. Out of these, the surrogate biomarkers segment will likely account for 55.3% share in 2025 due to their ability with quick regulatory approvals and clinical validation, primarily in therapeutic areas where direct clinical endpoints are difficult to measure. For example, in oncology drug development, surrogate biomarkers such as Tumor Mutational Burden (TMB) or circulating tumor DNA (ctDNA) are increasingly used as proxies for disease progression. This shift has gained impetus owing to regulatory agencies, including the FDA, recognizing surrogate endpoints under novel approval programs.
Predictive biomarkers, on the other hand, are expected to witness a significant CAGR from 2025 to 2032, owing to their ability to directly inform treatment decisions and stratify patient populations for targeted therapies. These determine the likelihood of a patient responding to a specific therapeutic intervention for pharmaceutical sponsors looking to increase drug efficacy and reduce trial attrition. In 2024 alone, more than 70% of all new oncology trials registered on ClinicalTrials.gov used predictive biomarkers for patient selection, showcasing their surging relevance in outsourced trial designs.
Based on therapeutic area, the market is segregated into oncology, cardiology, neurology, and autoimmune diseases. Among these, the oncology segment is predicted to account for approximately 34.6% of the biomarker discovery outsourcing services market share in 2025, backed by its high clinical heterogeneity and the increasing reliance on personalized therapies that require biomarker-based patient stratification. Cancer diagnostics mainly depend on molecular signatures, including immune profiles, protein expressions, or gene mutations. This makes biomarker discovery essential for drug development.
Autoimmune diseases are likely to exhibit average growth through 2032 amid their complex and overlapping symptom profiles, which make early diagnosis and treatment selection challenging. Autoimmune disorders such as multiple sclerosis and rheumatoid arthritis involve systemic immune dysregulation, requiring multi-dimensional biomarker panels for effective differentiation. As per a new study, the outsourcing of biomarker discovery in autoimmune conditions surged by 28% year-over-year in 2024, highlighting rising demand for transcriptomic analysis and multiplex cytokine profiling.
In 2025, North America is poised to account for a share of nearly 44.7% due to its innovative research and development ecosystem, presence of precision medicine-focused consortia, and deep funding pipelines. The region hosts most of the large-scale biomarker-based initiatives, including the NIH’s All of Us Research Program, which has collaborated with various CROs to identify population-wide biomarkers using genomic data. This long-term requirement has bolstered the outsourcing of sample logistics, bioinformatics analysis, and data integration, primarily among companies specializing in multi-omic profiling.
The U.S. biomarker discovery outsourcing services market is estimated to rise steadily in the foreseeable future, backed by the rapid expansion of local CROs and diagnostics companies into specialized biomarker services. For instance, Labcorp introduced a new biomarker development division targeting oncology and neurology biomarkers, integrating AI-enabled pathology and spatial biology tools. Thermo Fisher also opened a dedicated biomarker lab in California to support exploratory and companion diagnostics under GLP and CAP/CLIA frameworks.
The industry is currently undergoing significant transformation due to the full implementation of the EU In Vitro Diagnostic Regulation (IVDR). It has surged demand for specialized CROs capable of producing biomarker data that meets strict analytical and clinical validation standards. Several pharma and biotech companies are turning to outsourcing partners to navigate these complex compliance hurdles. For instance, BioVendor, recently extended its regulatory and assay validation services to address IVDR-related biomarker qualification.
The surge of biomarker discovery hubs in countries, including Switzerland, the Netherlands, and Belgium is highly prevalent. These countries provide dense biotech ecosystems, proximity to academic research centers, and generous research and development tax incentives. For example, Switzerland-based ProteoMediX, collaborated with pharma sponsors across Europe to develop proteomic biomarkers for prostate and breast cancer. The partnerships are leveraging localized CROs that specialize in multi-omic analysis and patient stratification.
Asia Pacific is rapidly emerging as a strategic hotspot for biomarker discovery outsourcing, augmented by increasing government-led precision medicine programs and expanding clinical trial infrastructure. China’s National Precision Medicine Initiative received a funding boost of approximately US$ 1.4 Bn in 2024, which has directly fueled partnerships with local CROs for biomarker-driven drug discovery projects. Significant CROs in the country, including Tigermed and WuXi AppTec are increasingly contracted by domestic pharma and international sponsors for diagnostic biomarker development services.
Japan is another key hub, especially for aging-related biomarker research. The country’s biopharma sector is investing heavily in neurodegenerative and cardiometabolic biomarkers for its aging population. In the recent past, Daiichi Sankyo outsourced its Alzheimer’s biomarker discovery program to RIKEN and a network of local CROs using multi-omic approaches. Japan’s Pharmaceutical and Medical Device Agency (PMDA) has also been providing fast-track support for biomarker validation studies under its Sakigake designation.
The global biomarker discovery outsourcing services market consists of integrated pharmaceutical service providers, niche biotech firms, and well-established CROs. Key companies are differentiating themselves through specialization in specific therapeutic areas and their technological capabilities in multi-omics platforms. Instead of generalized services, they are initiating co-development models and long-term strategic partnerships with biotech and pharma companies to support targeted therapies. Innovation-focused firms are emerging as key disruptors by delivering deep expertise in narrow biomarker categories, including metabolomics-based signatures.
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Report Attribute |
Details |
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Historical Data/Actuals |
2019 - 2024 |
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Forecast Period |
2025 - 2032 |
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Market Analysis Units |
Value: US$ Bn/Mn, Volume: As Applicable |
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Geographical Coverage |
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Segmental Coverage |
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Competitive Analysis |
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Report Highlights |
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Customization and Pricing |
Available upon request |
By Biomarker Type
By Therapeutic Area
By Discovery Phase
By End-use
By Region
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The biomarker discovery outsourcing market is projected to reach US$ 14.8 Bn in 2025.
Increasing use of multi-omic platforms and a shift toward decentralized sample collection models are the key market drivers.
The market is poised to witness a CAGR of 14.5% from 2025 to 2032.
Expansion of biomarker services in aging-related disorders and high demand for precision medicine are the key market opportunities.
Laboratory Corporation of America Holdings, Celerion, and Charles River Laboratories are a few key market players.
