Omics-Based Clinical Trials Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 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 regi

Market Overview

Global Omics-Based Clinical Trials Market has valued at USD 26.67 billion in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 7.25% through 2028. Omics-based clinical trials are clinical research studies that incorporate omics technologies to gather comprehensive molecular data from patients participating in the trial. Omics refers to various high-throughput, large-scale approaches used in biology and medicine to analyze biological molecules at the molecular level. These approaches include genomics (study of genes and DNA), proteomics (study of proteins), metabolomics (study of small molecules and metabolites), transcriptomics (study of RNA and gene expression), and more. One of the primary goals of omics-based clinical trials is to stratify patients into subgroups based on their molecular profiles. This stratification helps identify which patients are most likely to benefit from a specific treatment or intervention, allowing for more targeted and personalized approaches to healthcare. Omics-based clinical trials face challenges related to data standardization, reproducibility, and the need for advanced bioinformatics expertise. Ensuring the accuracy and reliability of omics data is critical.

Continuous advancements in genomics, proteomics, metabolomics, and other omics technologies have enabled researchers to gather comprehensive molecular data about diseases and patients. These technologies provide valuable insights for designing and conducting clinical trials. The emergence of precision medicine, which tailors’ treatments to individual patients based on their genetic and molecular profiles, is a significant driver. Omics data are central to identifying biomarkers and genetic mutations that can guide treatment decisions, making clinical trials more targeted and effective. Patients and healthcare providers are increasingly seeking personalized treatment options that consider individual genetic variations. This demand has fueled the growth of omics-based clinical trials. Pharmaceutical and biotechnology companies are investing heavily in omics-based drug discovery and development. These companies are conducting clinical trials to bring targeted therapies to market, driving market growth.

Key Market Drivers

Advancements in Omics Technologies

High-throughput sequencing techniques have become faster, more accurate, and cost-effective. Single-cell sequencing allows researchers to analyze the genetic material of individual cells, uncovering cellular heterogeneity. Mass spectrometry instruments have improved in sensitivity and resolution, enabling the identification and quantification of proteins and metabolites in complex samples. Advances in mass spectrometry imaging (MSI) enable the spatial mapping of molecules within tissues. Cryo-electron microscopy (cryo-EM) has achieved near-atomic resolution, revolutionizing the structural analysis of proteins and complexes. X-ray crystallography and nuclear magnetic resonance (NMR) spectroscopy have also seen continuous improvements in resolving molecular structures. High-resolution mass spectrometry and nuclear magnetic resonance spectroscopy have expanded the coverage of metabolites in metabolomics studies. Stable isotope labeling and flux analysis provide insights into metabolic pathways. Quantitative proteomics techniques, such as isobaric labeling and label-free methods, allow for accurate protein quantification. Targeted proteomics approaches, like selected reaction monitoring (SRM) and parallel reaction monitoring (PRM), enable the precise quantification of specific proteins.

CRISPR-Cas9 and other genome-editing techniques have facilitated the manipulation of gene expression for functional studies. High-throughput RNA interference (RNAi) screens have accelerated the discovery of gene function. DNA methylation and histone modification analysis have advanced, shedding light on epigenetic regulation and its role in disease. Chromatin immunoprecipitation sequencing (ChIP-seq) and DNA methylation sequencing have become more accessible and cost-effective. The development of sophisticated bioinformatics tools and algorithms has improved the analysis and interpretation of omics data. Machine learning and artificial intelligence (AI) are increasingly applied to extract meaningful insights from large-scale omics datasets. Single-cell RNA sequencing (scRNA-seq) and other single-cell omics techniques have revealed cellular heterogeneity and rare cell populations. Multi-omics approaches allow the integration of multiple layers of single-cell data. Omics technologies are increasingly used in clinical settings for disease diagnosis, prognosis, and treatment selection (e.g., liquid biopsies). Pharmacogenomics uses genomic data to personalize drug therapies. This factor will help in the development of the Global Omics-Based Clinical Trials Market.

Increasing Pharmaceutical Industry Investment

Pharmaceutical companies invest heavily in research and development (R&D) to discover and develop new drugs and therapies. Omics-based clinical trials are a crucial part of this process, as they help identify potential drug candidates and assess their safety and efficacy. Omics technologies, such as genomics and proteomics, provide insights into the genetic and molecular basis of diseases. Pharmaceutical companies use this information to develop targeted therapies that can be more effective and have fewer side effects than traditional treatments. Omics-based clinical trials are essential for testing these targeted therapies. Pharmaceutical companies rely on omics data to discover and validate biomarkers associated with diseases. Biomarkers can serve as indicators of disease presence, progression, or treatment response. Omics-based clinical trials play a critical role in validating the clinical utility of these biomarkers. Omics data allow for the identification of patient-specific molecular profiles. Pharmaceutical companies are increasingly focused on personalized medicine, where treatments are tailored to individual patients based on their genetic and molecular characteristics. Omics-based clinical trials are essential for implementing and testing these personalized treatment approaches. Omics data enable the stratification of patients into different subgroups based on their molecular profiles. This patient stratification is crucial for designing clinical trials with homogeneous patient populations, increasing the chances of detecting treatment effects and improving trial outcomes.

Pharmaceutical companies are investing in the development of treatments for rare diseases, which often have a genetic or molecular basis. Omics-based clinical trials are instrumental in accelerating the development of therapies for these underserved patient populations. The pharmaceutical industry is highly competitive, with companies striving to bring innovative treatments to the market. Omics-based clinical trials represent a cutting-edge approach to drug development, and companies are eager to invest in these trials to stay at the forefront of innovation. Regulatory agencies, such as the FDA (Food and Drug Administration) in the United States, increasingly require omics data in drug development submissions. Pharmaceutical companies invest in omics-based clinical trials to meet regulatory requirements and gain approval for their therapies. The market potential for effective treatments is substantial, especially for diseases with limited treatment options or high unmet medical needs. Pharmaceutical companies see omics-based clinical trials to bring innovative therapies to market and capture a share of this potential market. Pharmaceutical companies often collaborate with academic institutions, research organizations, and biotechnology firms to conduct omics-based clinical trials. These collaborations leverage combined expertise and resources, accelerating trial progress. This factor will pace up the demand of the Global Omics-Based Clinical Trials Market.

Rising Demand of Precision Medicine

Precision medicine tailors’ medical treatments and interventions to the unique genetic, molecular, and clinical characteristics of individual patients. This approach maximizes treatment efficacy by addressing the specific factors driving a patient's disease. Genomics, a key component of precision medicine, provides insights into the genetic basis of diseases. Omics-based clinical trials leverage genomic data to identify genetic mutations, biomarkers, and molecular pathways associated with diseases, guiding the development of targeted therapies. Precision medicine relies on biomarkers—measurable indicators of a biological process or condition. Omics technologies, such as genomics and proteomics, play a crucial role in discovering and validating biomarkers that can be used for disease diagnosis, prognosis, and treatment selection. Precision medicine has made significant strides in oncology. Genetic testing and omics-based approaches allow for the identification of specific genetic mutations in cancer patients, enabling the selection of targeted therapies that inhibit these mutations. This has improved cancer treatment outcomes and reduced side effects. Omics-based clinical trials contribute to early disease detection by identifying genetic and molecular markers associated with disease risk. Detecting diseases at an earlier stage can lead to more effective interventions and better patient outcomes. Personalized therapies, a subset of precision medicine, are designed to treat patients based on their individual profiles. Omics data help determine the most appropriate treatment strategies, dosages, and drug combinations for each patient. Precision medicine offers hope for patients with rare and orphan diseases, where one-size-fits-all treatments are often ineffective due to the rarity and genetic diversity of these conditions. Omics-based clinical trials accelerate the development of therapies for rare diseases.

Pharmacogenomics, a branch of precision medicine, uses genetic information to predict how individuals will respond to medications. Omics data inform the selection of the most suitable drugs and dosages for patients, minimizing adverse reactions and improving treatment outcomes. Precision medicine places patients at the center of their healthcare decisions. Patients are increasingly interested in genetic testing and personalized treatment options, driving the demand for clinical trials that align with their individual preferences and needs. Pharmaceutical companies invest in omics-based clinical trials to develop targeted therapies that align with the principles of precision medicine. These therapies have the potential to provide better treatment options for patients and generate revenue for the pharmaceutical industry. Regulatory agencies, recognizing the value of precision medicine, have established guidelines and pathways for the development and approval of precision therapies. This support encourages the growth of omics-based clinical trials. Precision medicine drives advancements in research, particularly in genomics, proteomics, and bioinformatics. These advancements, in turn, lead to more sophisticated clinical trials and a deeper understanding of disease mechanisms. This factor will accelerate the demand of the Global Omics-Based Clinical Trials Market.

Key Market Challenges

Sample Size and Diversity

Obtaining an adequate number of patient samples, particularly for rare diseases or specific genetic subpopulations, can be challenging. The availability of patient samples is crucial for omics-based clinical trials, as these trials often require a sufficiently large and diverse cohort to draw meaningful conclusions. Biological variability among patients, even within a specific disease category, can be substantial. To account for this variability, omics-based clinical trials may require a larger sample size to ensure statistical power and the ability to detect significant differences. Genetic and ethnic diversity is essential for the generalizability of trial results. In some regions, clinical trial populations may be less diverse, which can limit the applicability of findings to broader patient populations. Omics-based trials often involve subgroup analysis based on specific genetic or molecular characteristics. Achieving adequate sample sizes within each subgroup can be challenging, especially for rare genetic variants or biomarkers. Identifying and recruiting eligible patients who meet specific genetic or molecular criteria can be time-consuming and resource intensive. This challenge can delay the initiation and completion of omics-based clinical trials. Collecting omics data often involves obtaining informed consent from participants for extensive genetic and molecular profiling. Ensuring that patients fully understand the implications and privacy concerns associated with such data collection can be a challenge. With diverse omics data sets, integrating and interpreting the data can be complex. Large and diverse sample sizes can exacerbate the data analysis challenge, requiring advanced bioinformatics and computational tools.

Standardization and Reproducibility

Omics technologies generate vast and complex datasets, and data can vary significantly between different platforms, instruments, and laboratories. Lack of standardized protocols and data formats can hinder data integration and comparability. Reproducing omics experiments across different laboratories can be challenging due to variations in sample preparation, data acquisition, and analytical methods. Inconsistent results between labs can undermine the reliability of findings. Inaccuracies, biases, and artifacts in omics data can arise from technical and analytical factors. Ensuring data quality and minimizing systematic errors is essential for producing reliable and reproducible results. Omics-based clinical trials often lack universally accepted reference materials and standards for calibrating instruments, validating methods, and benchmarking results. Standardization efforts are needed to establish common reference points. Biological samples themselves can introduce variability due to inherent differences between individuals, tissues, and time points. Standardizing protocols for sample collection, handling, and storage is crucial to minimize this source of variability. The analysis of omics data relies heavily on bioinformatics tools and pipelines. Ensuring the reproducibility of bioinformatics analyses across different research groups can be challenging due to differences in software versions, parameters, and workflows. Designing omics-based clinical trials that produce reproducible results can be complex. Factors such as patient selection, sample size, and control groups must be carefully considered to ensure the validity of trial outcomes.

Key Market Trends

Integration of Multi-Omics Data

Different omics technologies provide unique insights into the molecular mechanisms underlying diseases. Integrating data from multiple omics disciplines allows researchers to create a more holistic and nuanced picture of disease processes, including the interplay of genes, proteins, metabolites, and other factors. Multi-omics data integration enhances the discovery and validation of biomarkers for disease diagnosis, prognosis, and treatment response. Combining genetic, protein, and metabolic profiles can lead to the identification of more accurate and robust biomarkers. Integrating multi-omics data enables the stratification of patients into subgroups based on their molecular profiles. This precision in patient classification is crucial for designing targeted clinical trials and ensuring that treatments are tailored to the right patient populations. Multi-omics data integration supports the development of personalized therapies by considering a patient's genetic, proteomic, and metabolic characteristics. This approach can lead to more effective and individualized treatment strategies. For drug development, integrating multi-omics data can provide insights into how drugs interact with various molecular components within the body. This knowledge can inform drug design and help identify potential adverse effects. Many diseases, especially complex ones like cancer, involve intricate molecular interactions. Multi-omics data integration helps unravel these complexities, facilitating the identification of novel therapeutic targets and treatment strategies. Integrating omics data aligns with a systems biology approach, which views biological systems as interconnected networks of genes, proteins, and metabolites. This approach allows for a more comprehensive and dynamic understanding of biological processes.

Segmental Insights

Phase Insights

In 2022, the Global Omics-Based Clinical Trials Market was dominated by phase II segment and is predicted to continue expanding over the coming years.

Study Design Insights

In 2022, the Global Omics-Based Clinical Trials Market was dominated by interventional studies segment and is predicted to continue expanding over the coming years.

Indication Insights

In 2022, the Global Omics-Based Clinical Trials Market was dominated by

Regional Insights

The North America region dominates the Global Omics-Based Clinical Trials Market in 2022. North America, particularly the United States and Canada, boasts highly advanced healthcare infrastructure, including research facilities, academic institutions, and hospitals. This infrastructure supports the conduct of cutting-edge clinical trials, including those involving omics technologies. North American countries have consistently invested heavily in biomedical research and development. Government funding, private sector investment, and academic institutions in the region actively support omics research and clinical trials. The region is home to a significant number of pharmaceutical and biotechnology companies that are at the forefront of drug development. These companies often lead omics-based clinical trials to develop new therapies and treatments.

Recent Developments

• In November 2021, ICON plc,a worldwide provider of drug development and commercialization services topharmaceutical, biotechnology, medical device, and government entities, hasrevealed the expansion of its Accellacare Site Network. This expansion involvesforming new partnerships with six research sites located in four differentcountries, thereby increasing its geographical reach, and enhancing itsresearch capabilities. With these newlyestablished partnerships, Accellacare is further strengthening its expertise inthe fields of central nervous system (CNS) and immune-inflammationtherapeutics. This expansion of the Accellacare Site Network serves to enhanceconnectivity and involvement with research sites and their patient populations.Consequently, it facilitates accelerated recruitment and contributes to thereduction of both the time and expenses associated with drug development forclients. Notably, Accellacare now boasts access to a patient pool exceeding 9million individuals.
• In February 2021, Parexel,a prominent provider of solutions aimed at expediting the development anddistribution of innovative therapies for global health improvement, spanningfrom clinical phases to commercialization, has entered a strategic partnershipwith NeoGenomics, Inc. NeoGenomics is a leading provider of genetic testingservices with a focus on cancer and offers global oncology contract researchservices. This collaboration is aimed at advancing the utilization of precisionmedicine in clinical trials within the field of oncology. It involves theapplication of real-world genomics data to expedite patient matching, optimizetrial design, refine site selection, enhance clinical development, and advancetranslational research efforts. The partnership with NeoGenomics will bolsterParexel's utilization of real-world data across a range of applications. Theseapplications encompass tasks such as identifying and assessing the prevalenceof genomic mutations in specific populations, employing genomic patterns tocategorize patients based on emerging biomarkers, and leveraging de-identifiedpatient data for precise targeting of patient groups. These collective datasetsaim to enhance the assessment of clinical trial feasibility, improve patientmatching, and establish a comprehensive understanding of the patient journey bylinking genomic information with clinical and consumer data. Ultimately, thiscollaboration will expedite the enrollment of patients with both common andrare cancer mutations into relevant clinical trials, increasing the likelihoodof successful treatment outcomes.

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