The omics-based clinical trials market size was exhibited at USD 32.85 billion in 2024 and is projected to hit around USD 70.92 billion by 2034, growing at a CAGR of 8.0% during the forecast period 2024 to 2034.
| Report Coverage | Details |
| Market Size in 2025 | USD 35.48 Billion |
| Market Size by 2034 | USD 70.92 Billion |
| Growth Rate From 2024 to 2034 | CAGR of 8.0% |
| Base Year | 2024 |
| Forecast Period | 2024-2034 |
| Segments Covered | Phase, Study Design, Indication, Region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Regional Covered | North America; Europe; Asia Pacific; Latin America; MEA |
| Key Companies Profiled | Parexel International (MA) Corporation, Thermo Fisher Scientific Inc., Charles River Laboratories, ICON plc, SGS Société Générale de Surveillance SA, Eli Lilly and Company, Pfizer Inc., Laboratory Corporation of America, Novo Nordisk A/S, Rebus Biosystems, Inc. |
The growth of the market is mainly due to technological advancements, increasing demand for personalized medicine, growing investment by pharmaceutical companies for efficient drug development, and supportive regulatory environments. The development of next-generation sequencing (NGS) and high-throughput screening methods has dramatically reduced the cost and time required for genomic analysis. These technological advancements have enabled researchers to conduct large-scale studies efficiently, facilitating the identification of biomarkers and genetic variations associated with diseases.
Furthermore, increasing strategic initiatives by the market players is further contributing to market growth. Companies are increasingly focusing on enhancing genomic analysis workflow to streamline processes that minimize the time and effort required for genomic sample analysis. For instance, in October 2023, Revvity, Inc. entered into a partnership agreement with Element Biosciences, Inc., a developer of the AVITI System, an emerging and innovative genomic sequencing platform. This collaboration aims to develop workflow solutions designed to streamline the genomic analysis of samples, significantly reducing the time and effort involved in the process. Thus, the aforementioned would also promote the adoption of personalized medicine and targeted therapies.
Regulatory bodies are increasingly supporting the integration of omics data in clinical research, recognizing its potential to improve drug safety and efficacy. Collaborative initiatives between government agencies, academic institutions, and the private sector are further boosting omics-based trials. In addition, growing cases of chronic diseases have further boosted the demand for effective and advanced treatment options. According to an article published in April 2024, Omics-based biomarkers have emerged as valuable tools in the clinical practice of metabolic dysfunction-associated steatotic liver disease (MASLD). These biomarkers facilitate improved risk stratification, allowing healthcare providers to identify patients with advanced fibrosis and those at higher risk for adverse outcomes. Thus, increasing applications of omics-based clinical trials would further contribute to the market growth.
The phase III segment dominated the market, accounting for 55.0% of the total revenue share in 2024. Clinical trial statistics indicate that market growth is driven by an increase in phase III trials, which typically involve a large number of participants. The median cost for a single-phase III trial exceeds USD 19.0 million, reflecting the significant resources required. Omics-based approaches can streamline trial processes by enabling better patient stratification and more targeted therapeutic strategies, ultimately reducing costs and improving trial outcomes. In addition, as a significant portion of phase III trials are outsourced, the need for specialized omics services and expertise is projected to grow.
Phase I is projected to witness the fastest growth during the forecast period owing to increasing integration of omics technologies in clinical trial design and execution. As researchers seek to enhance the safety and efficacy of new drugs and devices, omics approaches provide valuable insights into patient-specific responses at a molecular level. This enables more accurate dosing and identification of potential adverse effects early in the development process.
The interventional studies segment dominated the market in 2024 owing to its growing emphasis on personalized medicine by facilitating tailored interventions based on individual patient profiles derived from omics technologies. They typically involve a larger patient pool further enhancing the statistical power, which allows for a more comprehensive analysis of the relationships between biomarkers and treatment responses. Moreover, growing application of omics-based data in supporting new therapeutic treatment options, several pharmaceutical and biotech companies are significantly investing in interventional studies.
The observational studies segment is projected to witness the fastest growth in the coming years. These studies allow for the collection of real-world data, which is increasingly valuable for understanding patient outcomes and treatment effectiveness in diverse populations. This type of data is essential for identifying correlations between omics profiles and clinical results, enhancing the relevance of findings in everyday clinical practice. Furthermore, advancements in data analytics and technology are making it easier to conduct large-scale observational studies, thereby attracting more investment from researchers and pharmaceutical companies.
The oncology segment dominated the market in 2024 owing to increasing prevalence of cancer globally coupled with growing need for more effective treatment strategies. According to an article published by the American Cancer Society in January 2024, it is estimated that there are approximately 2,001,140 new cancer cases and 611,720 cancer-related deaths in the U.S. Moreover, the same article states that the number of cancer cases is predicted to reach 35 million by 2050. Omics technologies, such as genomics, proteomics, and metabolomics, provide critical insights into the molecular mechanisms underlying various cancers, enabling the identification of biomarkers that can inform diagnosis, prognosis, and treatment selection.
The autoimmune/inflammation segment is projected to witness considerable growth in the coming years owing to a significant number of interventional studies focused on autoimmune and inflammatory conditions worldwide. These studies offer numerous advantages, including the reduction of confounding effects, the elimination of bias in the allocation of participants to exposure groups, and the efficient identification of small to moderate clinically significant effects.
North America omics-based clinical trials market dominated the global industry and accounted for a 38.0% share in 2024. The growth in the region is attributed to the presence of established market players and an increasing number of clinical trials are anticipated to drive market growth. Moreover, supportive regulatory frameworks in the region facilitate the advancement of omics technologies in clinical research. Regulatory agencies, such as the FDA, are increasingly recognizing the importance of omics data in supporting drug development and approval processes. Thus, a supportive environment encourages more companies to conduct omics-based trials, further driving the regional market growth.
U.S. Omics-Based Clinical Trials Market Trends
The omics-based clinical trials market in the U.S. is driven by the growing emphasis on personalized medicine. Researchers and healthcare providers are increasingly utilizing genomic, proteomic, and metabolomic data to tailor treatments to individual patients. This shift enhances the efficacy of therapies and minimizes adverse effects, making omics-based trials essential for developing targeted therapies. According to an article published by the Mayo Clinic in February 2023, an innovative approach to genomics research is emerging, aimed at moving some omics-related studies out of traditional settings like hospitals, labs, and clinics and into the homes and communities of individuals. Thus, increasing access to clinical trials for individuals in rural and underserved areas will expand the participant pool, allowing for more diverse and representative data.
Europe Omics-Based Clinical Trials Market Trends
The omics-based clinical trials market in Europe is anticipated to witness lucrative growth over the projected period. The growth is due to the expansion of outsourcing activities among pharmaceutical companies. Several companies are entering into a partnership and collaboration agreement to advance their service offerings and accelerate their clinical trial process. This trend is contributing to the growth of the contract manufacturing market across the region.
The UK omics-based clinical trials market is anticipated to experience considerable growth over the forecast period. Increasing government support from agencies such as MHRA has increased investment and collaboration between academia, industry, and healthcare providers. Key therapeutic areas include oncology, cardiovascular diseases, and neurodegenerative disorders. Thus, increasing focus on the development of better treatment options would further drive the demand for omics based clinical trials in the country.
The omics-based clinical trials market in Germany is expected to grow at a considerable rate over the forecast period. Several government initiatives for clinical research activities have accelerated the clinical trials market in the country. Furthermore, advancements in technology and availability of high-quality clinical resources are some of the main factors responsible for the country’s market growth.
Asia Pacific Omics-Based Clinical Trials Market Trends
The omics-based clinical trials market in Asia Pacific is expected to grow at the highest CAGR over the forecast period.The growth can be attributed to constant advancement and growth in the clinical research field. Low cost per patient in Asia Pacific countries and the presence of a diverse group of patients that are easy to recruit are some of the factors contributing to the market growth. According to the data published by Clinical Trials Arena in January 2023, Asia Pacific has emerged as one of the reliant and most promising markets for clinical trials. In addition, more than 27,000 clinical trials were initiated in 2021, and nearly half of them were conducted in the Asia Pacific region. Thus, constant advancements and developments in the field of clinical trials are expected to further contribute to the market growth.
China omics-based clinical trials market is projected to witness significant growth in the coming years owing to the increasing demand for biopharmaceuticals. Pharmaceutical companies in the country are increasing their focus on developing innovative therapies, particularly in oncology and chronic diseases. Thus, these factors are boosting the demand for omics based clinical trials in the country. According to the data published by Labiotech UG, in February 2023, China is leading phase 1 clinical trials globally. The trend is driving the entry of major players such as Catalent Pharma Solutions in China, which is expected to contribute to the market growth.
The omics-based clinical trials market in Japan is expected to witness lucrative growth over the forecast period. Japan is a major potential destination for biopharmaceuticals and global CROs due to advancements in technology, policy reforms, faster recruitment of patients, and presence of a developed R&D infrastructure. Moreover, growing government support such as faster clinical trial approval is expected to encourage market players to invest in the country’s market as it would be easy for the companies to accelerate their product launches. Thus, these factors are expected to drive clinical research studies in the country, further increasing the demand for efficient clinical trial options.
India omics-based clinical trials market is poised to grow in the coming years. Low labor costs, improvements in healthcare infrastructure, and easy availability of technical expertise are expected to be some of the major factors propelling market growth over the forecast period. Moreover, increasing number of clinical trials in India, owing to growing demand for treatment options for cardiovascular diseases, kidney diseases, and diabetes, is one of the major factors driving market growth. Therefore, to meet the growing demand, market players are undertaking several initiatives such as entering into partnership agreements with several clinical trial outsourcing firms in the country to accelerate their product launches.
MEA Omics-Based Clinical Trials Market Trends
The omics-based clinical trials market in the Middle East and Africa is projected to grow at a lucrative rate. Growth in the region can be attributed to rising incidence of chronic diseases. Furthermore, MEA is one of the emerging markets for conducting clinical trials owing to increase in the demand for quality care, presence of a diverse population, and ease in patient recruitment. The region has much to offer with its untapped market for clinical trials with expanding pharmaceutical, biopharmaceutical, and medical devices companies. In addition, the number of CROs in the region has been experiencing an upsurge in the past years. The country's attractive incentive policies have pulled big pharmaceutical companies such as Pfizer, AstraZeneca, and Amgen to expand in the region.
Saudi Arabia omics-based clinical trials market is projected to witness the fastest growth rate owing to the growing awareness about the benefits of effective pharmaceutical solutions, and rising investments in R&D. The pharmaceutical industry in Saudi Arabia is expected to gain substantial benefits over the forecast period due rising prevalence of diseases, presence of CMOs, and the growing number of clinical trials.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the omics-based clinical trials market
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