Omics-Based Clinical Trials Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Phase (Phase I, Phase II, Phase III, and Phase IV), By Study Design (Expanded Access Studies, Interventional Studies, and Observational Studies), By Indication (Cardiology, CNS Diseases, Genetic Diseases, Immunology, Oncology, Respiratory Diseases, and Skin Diseases), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 27.23 Billion
CAGR (2026-2031)	7.29%
Fastest Growing Segment	Interventional Studies
Largest Market	North America
Market Size (2031)	USD 41.53 Billion

Market Overview

The Global Omics-Based Clinical Trials Market will grow from USD 27.23 Billion in 2025 to USD 41.53 Billion by 2031 at a 7.29% CAGR. Omics-based clinical trials utilize high-throughput technologies including genomics, proteomics, and metabolomics to characterize biological molecules for patient stratification and biomarker identification. The primary drivers supporting market growth include the imperative shift toward precision medicine to improve therapeutic outcomes and the concurrent reduction in high-throughput sequencing costs. Furthermore, regulatory agencies increasingly encourage biomarker driven development strategies to expedite drug approval processes and provide a structural foundation for market expansion.

The seamless implementation of these trials is frequently impeded by the technical challenge of integrating complex multi-dimensional data into standardized clinical workflows. According to the Personalized Medicine Coalition, in 2024, personalized medicines represented approximately 38 percent of all newly approved therapeutic molecular entities. While this statistic underscores the growing reliance on omics methodologies for drug development, the substantial infrastructure required to validate and analyze these biological datasets across diverse populations remains a barrier to broader scalability.

Key Market Drivers

The accelerated shift towards precision and personalized medicine strategies acts as a primary catalyst for the Global Omics-Based Clinical Trials Market. This transition fundamentally alters drug development by prioritizing treatments tailored to specific genetic profiles over broad-spectrum therapies. By relying on biomarkers for patient stratification, researchers can identify sub-populations most likely to respond, significantly reducing trial failure rates. This trend is particularly dominant in oncology, where genomic profiling has become a standard protocol. According to the FDA, in October 2025, the Center for Drug Evaluation and Research approved 17 novel oncology drugs in 2024, demonstrating the tangible regulatory success of these targeted approaches.

Simultaneously, the integration of artificial intelligence for complex multi-omics data analysis is resolving the critical bottleneck of data interpretation. Clinical trials now generate vast datasets combining genomics, proteomics, and metabolomics that exceed human analytical capabilities. Advanced AI algorithms enable the rapid identification of non-obvious correlations, significantly expediting the discovery phase. This technological synergy is attracting substantial investment; according to GuruFocus, in January 2025, J.P. Morgan projected that NVIDIA’s healthcare AI sector would contribute $1 billion in recurring revenue by 2025. These drivers collectively fuel broader industry growth. For instance, according to Fierce Biotech, in March 2025, AstraZeneca increased its R&D budget by 24 percent in 2024 to support its expanding pipeline of next-generation therapeutics.

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Key Market Challenges

The most significant impediment to the growth of the Global Omics-Based Clinical Trials Market is the technical and operational complexity associated with integrating multi-dimensional biological data into standardized clinical workflows. As trial designs increasingly necessitate the collection of high-volume genomic, proteomic, and metabolomic datasets, the infrastructure required to validate and manage this information creates a substantial bottleneck. Clinical research sites often lack the advanced bioinformatic capabilities needed to process such disparate data streams efficiently, leading to prolonged study timelines and inflated operational costs. This friction limits the scalability of precision medicine initiatives, particularly for smaller sponsors who cannot absorb the capital expenditure required for specialized data management systems.

This infrastructure gap directly stifles market expansion by increasing the failure rate of study initiation and execution. According to the Association of Clinical Research Professionals, in 2024, 38 percent of clinical research sites identified rising protocol complexity as the primary operational challenge disrupting study timelines. This statistical evidence highlights a critical disconnect between the scientific potential of omics methodologies and the practical reality of trial execution. When research sites are overwhelmed by data requirements, patient recruitment slows and data quality risks increase, ultimately delaying regulatory approvals and dampening the overall commercial adoption of omics-driven clinical strategies.

Key Market Trends

The adoption of single-cell sequencing and spatial omics technologies is fundamentally reshaping clinical trial design by enabling high-resolution profiling of cellular heterogeneity. Unlike traditional bulk sequencing, these tools allow researchers to map the tumor microenvironment and immune responses at the individual cell level, facilitating the identification of resistance mechanisms and predictive biomarkers with unprecedented precision. This technological integration is rapidly scaling within the industry to support complex study endpoints and improve the granularity of biological data collected during drug development. According to 10x Genomics, in January 2025, the company reported that its cumulative instrument base had surpassed 7,000 units globally, reflecting the aggressive uptake of these platforms for generating spatially resolved biological data in clinical research.

Simultaneously, the market is witnessing a strategic expansion of omics research beyond oncology into autoimmune and rare disease indications. Sponsors are increasingly leveraging genomic and transcriptomic data to stratify heterogeneous patient populations in complex autoimmune conditions and to develop targeted RNA interference therapies for monogenic disorders. This shift is driven by the growing capability of multi-omics to elucidate obscure disease pathways and validate novel targets in non-malignant conditions, creating a lucrative new frontier for clinical investigation. According to Alnylam Pharmaceuticals, in October 2025, the company reported a 103 percent year-over-year increase in total net product revenues, underscoring the surging clinical and commercial demand for omics-guided therapeutics in the rare disease sector.

Segmental Insights

The Interventional Studies segment currently demonstrates the most rapid expansion within the Global Omics-Based Clinical Trials Market due to the rising demand for targeted therapeutic validation. This growth is primarily fueled by the pharmaceutical industry's shift toward precision medicine, necessitating rigorous testing of drug efficacy based on specific genomic and proteomic profiles. Furthermore, regulatory bodies such as the U.S. Food and Drug Administration increasingly prioritize biomarker-driven development pathways, thereby encouraging the initiation of clinical studies that actively administer treatments to evaluate direct patient outcomes. This trend underscores the essential role of interventional protocols in modern drug discovery.

Regional Insights

North America leads the global omics-based clinical trials market due to the high concentration of major pharmaceutical and biotechnology enterprises within the region. This dominance is supported by a well-established infrastructure for clinical research and consistent investment in drug discovery programs. Additionally, the U.S. Food and Drug Administration actively encourages the inclusion of genomic data and biomarkers in clinical studies to facilitate precision medicine. The combination of supportive regulatory frameworks and accessible funding allows companies to effectively integrate omics technologies into development pipelines, maintaining the region's strong market position.

Recent Developments

• In April 2025, Tempus AI entered into a multi-year collaboration with AstraZeneca and Pathos AI to co-develop a large-scale multimodal deep learning model dedicated to oncology. This foundation model was designed to utilize vast amounts of de-identified clinical and molecular data to extract biological insights, identify novel drug targets, and support the development of next-generation cancer therapies. The agreement, which included $200 million in payments to Tempus, aimed to accelerate clinical development and increase the probability of success for new oncology treatments through data-driven precision. The companies planned to share the completed model to advance their respective research and development efforts.
• In August 2024, Illumina received FDA approval for its TruSight Oncology Comprehensive test as a companion diagnostic for solid tumors. This in vitro diagnostic assay was designed to interrogate over 500 genes to profile a patient's tumor, facilitating the identification of actionable biomarkers for targeted therapy and clinical trial enrollment. The approval included specific indications for identifying patients eligible for certain treatments in lung cancer and solid tumors harboring specific gene fusions. This regulatory milestone enabled Illumina to provide a standardized, distributable solution that supports precision oncology and assists clinicians in matching patients with appropriate therapeutic options.
• In July 2024, Thermo Fisher Scientific completed the acquisition of Olink, a provider of next-generation proteomics solutions, in a transaction valued at approximately $3.1 billion. This strategic integration incorporated Olink's proprietary technology into Thermo Fisher’s life sciences portfolio, significantly bolstering its capabilities in the high-growth omics market. The addition of these protein research technologies was intended to accelerate precision medicine and enable a more comprehensive understanding of human biology for clinical research. By combining mass spectrometry strengths with these new proteomics assets, the company aimed to support pharmaceutical customers in streamlining biomarker discovery and drug development processes globally.
• In March 2024, Owkin announced an expansion of its strategic collaboration with Sanofi to include immunology therapeutic programs. Building upon an existing partnership focused on oncology, this agreement leveraged Owkin's AI-driven target discovery engine to identify optimal candidate gene targets and associated patient subpopulations. The collaboration aimed to utilize multimodal data and machine learning to improve drug positioning within Sanofi’s pipeline. This initiative was designed to enhance precision medicine strategies by understanding patient heterogeneity, ultimately facilitating the design of more effective clinical trials and tailored treatments for complex immunological conditions.

Key Market Players

• Parexel International Corporation
• Pharmaceutical Product Development (PPD)
• Charles River Laboratory
• ICON plc
• SGS SA
• Eli Lilly and Company
• Pfizer Inc.
• Covance Inc.
• Novo Nordisk
• Rebus Bio

By Phase	By Study Design	By Indication	By Region
Phase I Phase II Phase III Phase IV	Expanded Access Studies Interventional Studies Observational Studies	Cardiology CNS Diseases Genetic Diseases Immunology Oncology Respiratory Diseases Skin Diseases	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Omics-Based Clinical Trials Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Omics-Based Clinical Trials Market, By Phase:

• Phase I
• Phase II
• Phase III
• Phase IV

• Omics-Based Clinical Trials Market, By Study Design:

• Expanded Access Studies
• Interventional Studies
• Observational Studies

• Omics-Based Clinical Trials Market, By Indication:

• Cardiology
• CNS Diseases
• Genetic Diseases
• Immunology
• Oncology
• Respiratory Diseases
• Skin Diseases

• Omics-Based Clinical Trials Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE