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Omics-based Clinical Trials Market Report Scope & Overview:

The omics-based clinical trials market size was valued at USD 32.75 billion in 2024 and is expected to reach USD 61.98 billion by 2032, growing at a CAGR of 8.36% over the forecast period of 2025-2032.

The global omics-based clinical trials market is experiencing strong growth due to the disruptive nature of genomics, proteomics, metabolomics, and transcriptomics on drug development and precision medicine. Acceptance is being driven by the growing need for tailor-made treatments, next-generation sequencing technology, and the availability of multiple AI-driven data analytics. Over the years, the pharmaceutical and biotechnological companies have been relying extensively upon omics insights for precise stratification of patients and to improve the chances of success of their trials.

The U.S. omics-based clinical trials market size was valued at USD 9.37 billion in 2024 and is expected to reach USD 17.43 billion by 2032, growing at a CAGR of 8.11% over the forecast period of 2025-2032.

North America's omics-based clinical trials market has been dominated by the U.S. due to the large research infrastructure, presence of Pharmaceutical and Biotech companies, and the high clinical trial activity in the country. It is backed by favorable regulatory support and major R&D investments, further fortifying its leadership within the region.

Market Dynamics:

Drivers

  • Increasing Demand for RNA-Based Therapeutics and Vaccines is Expected to Drive the Growth of the Omics-based Clinical Trials Market

The growing number of research studies on circRNA therapeutics and vaccines is a key factor driving the growth of the circRNA synthesis market. Existing mRNA vaccines, such as those against COVID-19, reaffirm the promise of these RNA platforms against infectious diseases. On the other hand, circRNAs are advantageous over linear RNAs as they are more stable, less degradable by exo-nucleases, and provide sustained protein expression compared to linear RNA species. This design makes them appealing to be used in the next generation of vaccines, gene therapy, and rare disease therapies. Several pharmaceutical and biotechnology companies are investing substantial resources to understand and develop therapeutics based on circRNA, which is creating an urgent need for advanced circRNA synthesis technologies and services.

According to the Personalized Medicine Coalition, the number of personalized medicines in the U.S. more than doubled from 132 in 2016 to 286 in 2020, and personalized therapies represented 25% of new FDA drug approvals in 2019, an increase from just 5% 2005

An Applied Clinical Trials review highlights that multi-omics data—which integrate genomics, transcriptomics, and proteomics—are critical for elucidating disease biology and optimizing treatment response as precision medicine advances in practice.

  • Investments in Biotech and Genomic Research on the Rise are Fueling the Market

The growing wave of investment that has been seen across the public and private sectors in providing funding for biotechnological and genomic research is driving the omics-based clinical trials market growth. Governments and research institutes alike, and venture capitalists, are betting big on RNA-based innovation, and circRNA is emerging as an attractive new class of molecules with far-reaching potential in diagnostics, therapeutics, and personalized medicine. CircRNAs have recently gained attention as potential biomarkers for cancer and other complex diseases, and are being researched heavily and their potential. (Science Direct) Such an increase in capital inflow from both regions facilitates the building of advanced synthesis platforms, scalable production capacities, and stronger biotech-academia collaborations, which in turn are aiding the market growth of circRNA synthesis.

Roche recently launched its new Sequencing by Expansion (SBX) technology, increasing speed and scalability in next-generation sequencing, which has the capability of powering big omics (genomic, transcriptomic, and epigenomic data across multiple domains) studies in clinical research.

Spatial biology is foreseen as an emerging discipline by the industry starting from 2025, aided by breakthroughs in high-throughput sequencing technologies that allow large, affordable-scale analyses of tissue microenvironments essential for both translational and clinical uses.

BRB-seq, an ultra-high-throughput RNA sequencing technology employing early-stage sample barcoding, provides a cost reduction of up to 25-fold relative to standard RNA-seq, thus accelerating transcriptomic characterization in patient studies.                          

Restraint

  • Expensive Omics Technologies Hamper the Growth of the Omics-Based Clinical Trials Market, Thus Limiting Their Wide Adoption

High capital expenditures for omics technologies such as genomics, metabolonomics, or proteomics render large numbers of samples financially impractical for many research facilities and clinical environments, posing a serious barrier. Moreover, the validation of data from multi-omics platforms presents a complex landscape of integration and interpretation where the need for specialized bioinformatics tools can create skill gaps and operational challenges. Regulatory roadblocks, such as strict protocols associated with privacy, the ethical use of omics data, and the standardization of relevant methodology, delay trial approvals. In addition, a clear infrastructure gap and lack of clarity on reimbursement policies in many developing regions are further challenges in making omics-driven clinical trials globally accessible and scalable.

Segmentation Analysis:

By Phase

The phase III segment dominated the omics-based clinical trials market share in 2024 with 52.4%, as it is the resource-intensive and large-scale stage of clinical development. During the validation stage, omics technologies are critical for validating biomarkers, stratifying patient populations, and characterizing safety and efficacy in different populations. For new therapies, approval by glonal regulatory authorities is such a high-stakes bet that Phase III trials command the highest proportions of clinical R&D costs and resources.

The Phase I segment is anticipated to experience the highest growth in the forecast years, owing to the rising adoption of omics-based approaches in early phase trials for patient selection due to biomarker discovery. The increasing focus on precision medicine, personalized treatments, and lowering clinical trial attrition rates promotes the adoption of genomics/transcriptomics/proteomics earlier in development. The early utilization of omics in phase I aids in making faster decisions and improving trial efficiency, which prepares the ground for the tertiary phase-driven rapid growth.

By Study Design

The omics-based clinical trials market for the interventional studies segment held the largest share in 2024, with 42.15%, as these trials are crafted to evaluate new therapies directly, often informed by omics-driven insights, evaluating their safety, efficacy, and outcomes. Genomics, proteomics, and transcriptomics have major contributions to interventional studies as these tools are used to identify biomarkers, to aid with patient population stratification, and to assist with therapeutic stratification. Due to these trials are mostly used by pharmaceutical and biotech companies for drug development, regulatory approvals, and precision medicine strategies, most of the resources go into interventional trials, perpetuating a cycle of continued dominance for interventional trials.

The fastest growth segment of the omics-based clinical trials market will be the observational studies segment, owing to the growing significance of real-world evidence and longitudinal patient data. These types of observational, omics-based research allow for the tracking of disease, treatment outcomes, and biological marker transitions in real-world scenarios alongside clinical trial data. The expanding availability of clinical and genomic data, due to the increasing adoption of electronic health records (EHRs), population-based genomic initiatives, and big data analytics, facilitates observational studies that represent an essential component of next-generation clinical research and play an important role in their rapid expansion.

By Indication

Due to the wide applications of omics technologies in both cancer research and drug development, the oncology segment held a dominant share in the omics-based clinical trials market in 2024, with a 46.18%. Oncology research has been particularly dependent on genomics, proteomics, and transcriptomics to discern predictive biomarkers, characterize tumor heterogeneity, and ultimately inform the individualization of treatment approaches. Since the global cancer burden is on the rise and the pharmaceutical companies are investing significantly in precision oncology, there is an ever-increasing need for omics-driven clinical trials predominantly in oncology, which cements the frontrunner pedestal to oncology in terms of market scope.

The autoimmune/inflammation segment is anticipated to grow significantly during the forecast period, owing to the application of omics approaches to understand the etiology of immune-mediated diseases. Recent advances in genomics, metabolomics, and proteomics are improving biomarker discovery and patient stratification in diseases including rheumatoid arthritis, lupus, and inflammatory bowel disease. The increasing incidence of autoimmune diseases, along with increased CAPEX in novel biologics and targeted therapy developments, is expected to make this segment a prominent growth lever, thereby expanding the footprint of omics-based trials.

By End User

The pharmaceutical & biotechnology companies segment accounted for the largest share of the omics-based clinical trials market in 2024 with 39.5% market share, and is expected to remain dominant in the coming years, owing to the increasing focus of these companies on drug discovery, biomarker development, and precision medicine. With funding, infrastructure, and sophisticated collaborations to scale omics technologies into large-scale clinical trials, these companies are positioned well. Their focus on biomarker-driven strategies to expedite drug development timelines, decrease trial failures, and regulatory approvals further solidifies their leadership position within this market segment.

The academic & research institutes segment is estimated to grow at the highest growth rate throughout the forecast period, driven by government funding support and joint programs with industry players. These institutions are increasingly utilizing queuing omics technologies to perform exploratory and translational research. With genomics and systems biology emerging as major areas of research at universities and other research centers, early-stage discovery efforts are being accelerated. As the momentum around innovation and foundational science continues to build, these academic institutions will emerge as key players in powering the next generation of this discipline for omics-based clinical trials.

Regional Analysis:

The global omics-based clinical trials market is dominated by North America with a 37.61% market share in 2024, owing to its advanced healthcare infrastructure, constant presence of leading pharmaceutical and biotechnology companies in the region, and investment in precision medicine research. They have strong regulatory frameworks, such as those offered by the U.S. FDA, encouraging the application of genomics, transcriptomics, proteomics, and metabolomics in the clinical trials process. Apart from it, North America has the highest number of clinical research organizations (CROs), academic research institutes, and technology providers, which drives innovation and enables faster execution of trials. Coupled with huge funding initiatives backed by government or corporates, personalized medicine will have another level of shelf from the region.

The omics-based clinical trials market trend in the Asia Pacific is anticipated to be the fastest growing, owing to the increase in clinical research activity, rapidly growing biotechnology sectors, and increasing patient enrollment capabilities in the region. The future appears to be solid for precision medicine and genomics research in countries such as China, India, South Korea, and many others, with government policies that are attractive for researchers and substantial international collaborations. It provides a price benefit to perform trials and numerous genetic populations beneficial for omics-based research. Increasing expenditures on healthcare, improving regulatory frameworks, and the acceptance of advanced technologies are also complementing growth.

Europe is the second fastest-growing region in the omics-based clinical trials market on account of investments in precision medicine, the availability of a well-established research infrastructure, and collaborative multi-stakeholder initiatives orchestrated at the level of academic institutions, biopharmaceutical companies, and regulatory authorities. Supportive European Medicines Agency (EMA) policies, growing uptake of genomics, proteomics, and metabolomics technologies, and a growing number of clinical trials on rare diseases and personalised therapies are factors contributing to the growth, the report said.

The omics-based clinical trials market analysis in Latin America and the Middle East & Africa (MEA) is expected to observe moderate growth owing to factors such as gradual cleansing of healthcare infrastructure, rising research collaborations, and capital investments in precision medicine. Low funding scenarios, regulatory constraints, and low adoption of advanced omics technologies vs. developed regions limit growth in these regions to moderate growth rather than rapid expansion.

Key Players:

Omics-based clinical trials market companies are Parexel International Corporation, Pharmaceutical Product Development (PPD), Charles River Laboratories, ICON plc, SGS SA, Eli Lilly and Company, Pfizer Inc., Covance Inc. (Labcorp Drug Development), Novo Nordisk A/S, Rebus Biosystems, Thermo Fisher Scientific, Illumina, Agilent Technologies, Qiagen, Roche, Eurofins Scientific, Siemens Healthineers, Fulgent Genetics, NeoGenomics Laboratories, Tempus Labs, and other players.

Recent Developments:

  • January 2025, Parexel's newest findings outline how combining multi-omics data—involving genomics, transcriptomics, proteomics, metabolomics, epigenomics, and new spatial genomics—with the latest computational technology, such as machine learning (ML) and deep learning (DL), is revolutionizing biomarker discovery in precision oncology. The technologies allow sponsors to identify diagnostic, prognostic, and predictive biomarkers more quickly. This simplifies patient selection, enhances trial design, and enhances response prediction, ultimately allowing for quicker, more patient-focused cancer treatments
  • Oct 2023, Charles River Laboratories highlights how omics-based testing technologies streamline drug discovery and minimize animal use. Through the incorporation of high-precision omics data sets—genomics, proteomics, and metabolomics—these New Approach Methodologies (NAMs) facilitate more ethical, data-enabled pipeline selection and facilitate the transition to alternatives for conventional in vivo testing.

    Omics-based Clinical Trials Market Report Scope:
    Report Attributes Details
    Market Size in 2024 USD 32.75 Billion 
    Market Size by 2032 USD 61.98 Billion 
    CAGR CAGR of 8.36% From 2025 to 2032
    Base Year 2024
    Forecast Period 2025-2032
    Historical Data 2021-2023
    Report Scope & Coverage Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook
    Key Segments • By Phase (Phase I, Phase II, Phase III, Phase IV)
    • By Study Design (Interventional Studies, Observational Studies, Expanded Access Studies)
    • By Indication (Autoimmune/Inflammation, Pain Management, Oncology, CNS Conditions, Diabetes, Obesity, Cardiovascular, Others)
    • By End User (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes, Contract Research Organizations (CROs), Hospitals & Clinics)
    Regional Analysis/Coverage North America (US, Canada, Mexico), Europe (Germany, France, UK, Italy, Spain, Poland, Turkey, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America)
    Company Profiles Parexel International Corporation, Pharmaceutical Product Development (PPD), Charles River Laboratories, ICON plc, SGS SA, Eli Lilly and Company, Pfizer Inc., Covance Inc. (Labcorp Drug Development), Novo Nordisk A/S, Rebus Biosystems, Thermo Fisher Scientific, Illumina, Agilent Technologies, Qiagen, Roche, Eurofins Scientific, Siemens Healthineers, Fulgent Genetics, NeoGenomics Laboratories, Tempus Labs, and other players.