Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034

According to Nova One Advisor, the global 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.

The market growth is attributed to the growing investment by pharmaceutical companies, rising demand for personalized medicine, and rising technological advancements.

Omics-based Clinical Trials Market Size 2024 To 2034

Omics-Based Clinical Trials Market Key Takeaways:

• The phase III segment dominated the market, accounting for 55.0% of the total revenue share in 2024.

• The interventional studies segment dominated the market in 2024.

• The oncology segment dominated the market in 2024.

• North America omics-based clinical trials market dominated the global industry and accounted for a 38.0% share in 2024.

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The omics-based clinical trials market deals with extensive study of various biological components, such as epigenomics, metabolomics, proteomics, transcriptomics, and genomics, which allow researchers to understand and analyze the molecular interactions and profiles within a biotechnology and pharmaceutical companies, government agencies, and contract research organizations (CROs), who collaborate to conduct and design clinical trials that incorporate omics technologies. In addition, the growing analysis capabilities and data availability, increasing prevalence of chronic diseases, and accessibility and cost reduction are the major factors driving the market growth.

In addition, the omics-based clinical trials market creates notable opportunities. The omics-based trials address major challenges such as regulatory and reimbursement challenges, integration into clinical practice, and limited clinical validation. The increasing strategic initiatives by the major industry players are also driving market growth. Companies are focusing increasingly on improving genomic analysis workflow to streamline processes that reduce the effort and time needed for genomic sample analysis. Furthermore, the rising focus on precision medicine further drives the market growth.

Omics-based Clinical Trials Market Growth Factors:

• The rising development of high-throughput screening methods and next-generation sequencing has reduced the time and cost required for genomic analysis and contributed to propelling the market growth.

• The regulatory bodies are recognizing its capabilities to improve drug efficacy and safety and are increasingly supporting the integration of omics data in clinical trial research. 

• The increasing collaborative initiatives between the private sector, academic institutions, and government agencies are expected to drive the growth of the omics-based clinical trials market.

• The increasing demand for a pattern preference towards personalized medicine and stratification of patients is also driving the market growth.

Omics-Based Clinical Trials Market Report Scope

Report Attribute

Details

Market size value in 2025

USD 35.48 billion

Revenue forecast in 2034

USD 70.92 billion

Growth rate

CAGR 8.0% from 2024 to 2034

Actual data

2019 - 2023

Forecast period

2024 - 2034

Quantitative units

Revenue in USD million/billion and CAGR from 2024 to 2034

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Phase, study design, indication, region

Regional scope

North America, Europe, Asia Pacific, Latin America, MEA

Country scope

U.S.; Canada; Mexico; UK; Germany; France; Italy; Spain; Denmark; Sweden; Norway; Japan; China, India, South Korea, Thailand, Australia; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait.

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.

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope.

Segment Insights

By Phase Types

The phase III segment dominated the market, accounting for 55.0% of the total revenue share in 2024. The segment growth is attributed to a rise in phase lll trials, which typically include a huge number of participants. The median cost for a single-phase lll trial reflects the significant resources required and exceeds USD 19.0 million. By enabling more targeted therapeutic strategies and better patient stratification, omics-based approaches can streamline trial processes. In addition, the need for specialized omics expertise and services is projected to grow, as a significant portion of phase III trials are outsourced.

Omics-based Clinical Trials Market Share, By Phase 2024 (%)

The phase l is expected to grow fastest during the forecast period. The segment growth is attributed to the rising integration of omics technologies in clinical trial execution and design. The omics approaches provide valuable insights into patient-specific responses at a molecular level, as researchers seek to improve the efficacy and safety of new devices and drugs. This enables the identification of potential adverse effects and more accurate dosing early in the development process.

By Study Design Types

The interventional studies segment dominated the omics-based clinical trials market in 2024. The segment growth is attributed to the increasing emphasis on personalized medicine by enhancing tailored interventions based on patient profiles generated from omics technologies. They generally include a higher patient pool further improving the statistical power, which enables for a more extensive analysis of the relationships between treatment responses and biomarkers. In addition, various biotechnology and pharmaceutical companies are investing in interventional studies significantly, and increasing the application of omics-based data in supporting new therapeutic treatment options is further driving the segment growth.

The observational studies segment is expected to grow fastest during the forecast period. These studies enable the collection of real-world data, which is valuable for understanding treatment effectiveness and patient outcomes. This kind of data is necessary for identifying correlations between clinical results and omics profiles, further improving the prevalence of findings in everyday clinical practice. In addition, rising advancements in technology and data analytics are making it easier to conduct a large number of observational studies, thereby attracting more investment from pharmaceutical companies and researchers.

By Indication Types

The oncology segment dominated the omics-based clinical trials market in 2024. The segment growth is attributed to the increasing prevalence of chronic diseases such as cancer globally combined with the increasing need for more efficient treatment strategies. Omics technologies, such as metabolomics, proteomics, and genomics, provide critical insights into the molecular mechanisms underlying several cancers, allowing the identification of biomarkers that can inform treatment selection, prognosis, and diagnosis.

• For instance, it is estimated that there are approximately 2,001,140 new cancer cases and 611,720 cancer-related deaths in the U.S., according to an article published by the American Cancer Society in January 2024.

• For instance, in January 2024, the number of cancer cases is expected to reach 35 million by 2050.

The inflammation/ autoimmune segment is expected to grow fastest during the forecast period. The segment growth is attributed to the increasing significant number of interventional studies concentrated on inflammatory and autoimmune diseases around the globe. These studies provide various advantages such as the efficient identification of small to moderate clinically significant effects, the elimination of bias in the allocation of participants to exposure groups, and the reduction of confounding effects.

By Regional Insights

North America omics-based clinical trials market dominated the global industry and accounted for a 38.0% share in 2024. The market growth in the region is attributed to the increasing number of clinical trials and the increasing presence of developed market players. In addition, the increasing supportive regulatory frameworks in North America enhance the advancement of omics technologies in clinical research. Regulatory agencies, including the FDA, are rapidly identifying the presence of omics data in supporting approval processes and drug development. In addition, to conduct omics-based trials, a supportive environment encourages more companies to further enhance the market growth in North America.

U.S. Omics-based Clinical Trials Market Trends

The market growth in the U.S. is enhanced by the increasing preference for personalized medicine. Healthcare providers and researchers are rapidly using metabolomic, proteomic, and genomic data to tailor treatments to individual patients. This preference minimizes adverse effects enhances the efficacy of therapies and makes omics-based trials necessary for emerging targeted therapies. In addition, rising access to clinical trials for individuals from underserved and rural areas allows for more representative and diverse data and will expand the participant pool. 

The market growth in Asia Pacific is attributed to the constant growth and advancement in the clinical research field. The presence of a diverse group of patients in the region that are easy to recruit is contributing to propel the market growth. In adoption, constant developments and advancements in the field of clinical trials are further anticipated to drive the growth of the omics-based clinical trials market in the region. 

• For instance, in January 2023, Asia Pacific emerged as one of the promising and reliant markets for clinical trials, according to the data published by Clinical Trials Arena

China Omics-based Clinical Trials Market Trends

China has the fastest growing market in the region. The market growth in China is attributed to the rising demand for biopharmaceuticals. Pharmaceutical companies are increasing their focus on emerging innovative therapies, especially in chronic diseases and oncology. Thus, these factors are accelerating the demand for omics-based clinical trials in China.

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.

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Omics-based Clinical Trials Market Top Companies

• Parexel International (MA) Corporation

• Thermo Fisher Scientific Inc.

• Charles River Laboratories

• SGS Société Générale de Surveillance SA

• Pfizer Inc.

• Laboratory Corporation of America

• Rebus Biosystems, Inc.

• ICON plc

• Eli Lilly and Company

• Novo Nordisk A/S

• Rebus Biosystems, Inc.

Recent Developments

In October 2024, the opening of a new laboratory was announced by Macrogen and PacBio to enhance genomics innovation in Singapore. The aim behind this announcement was to enhance genomic discoveries into clinical and commercial solutions ultimately expanding the scope of omics-based research and trials and advancing personalized medicine.

In September 2024, Eli Lily entered into a collaborative agreement with the 5 Prime Sciences to target discovery in the field of cardio-metabolic diseases and accelerate early development. The aim behind this launch was to attract further investment in biotechnology and personalized medicine and enhance patient outcomes.

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U.S. Clinical Trials Market- The U.S. clinical trials market size was valued at USD 25.81 billion in 2023 and is projected to surpass around USD 41.57 billion by 2033, registering a CAGR of 4.88% over the forecast period of 2024 to 2033.

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Segments Covered in the Report

By Phase Outlook

• Phase I

• Phase II

• Phase III

• Phase IV

By Study Design Outlook

• Interventional Studies

• Observational Studies

• Expanded Access Studies

By Indication Outlook

• Autoimmune/inflammation

• Pain management

• Oncology

• CNS conditions

Diabetes

• Obesity

Cardiovascular

• Others

By Regional Outlook

North America

• The U.S.

• Canada

Europe

• UK

• Germany

• France

• Italy

• Spain

• Denmark

• Norway

• Sweden

Asia Pacific

• Japan

• China

• India

South Korea

• Latin America

• Brazil

• Argentina

MEA

• South Africa

• Saudi Arabia

• UAE

• Kuwait

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