Omics-Based Clinical Trials Market Size, Share, By Phase Type (Phase I, Phase II, Phase III, and Phase IV), By Study Design Type (Interventional Studies, Observational Studies, and Expanded Access Studies), By Indication Type (Oncology, Cardiology, Respiratory Diseases, Skin Diseases, CNS Diseases, Immunology, Genetic Diseases, and Others), and By Region - Trends, Analysis and Forecast till 2034

Report Code: PMI555724 | Publish Date: August 2024 | No. of Pages: 184

Omics Based Clinical Trials Market Overview

Omics-Based Clinical Trials Market Size was valued at USD 31.5 Billion in 2024 and is expected to reach USD 68.7 Billion by 2034 growing at a CAGR of 8.9%

Omics-based clinical trials are entering a new frontier of medical research by incorporating broad molecular data into the design, execution, and analysis of clinical studies. One such innovative methodology incorporates various "omics" technologies to capture, on a large scale, biological information from trial participants, including genomics, transcriptomics, proteomics, metabolomics, and epigenomics. The main idea behind collecting and analyzing these independent datasets is to derive insights into mechanisms of disease, response to drugs, and characteristics of individual patients at the molecular level.

The intuitive point behind this omics-based clinical trial is personalized medicine. One can profile genes, proteins, and metabolites for interactions within each subject to eventually identify biomarkers predictive of treatment efficacy, adverse reactions, or disease progression in a much more finely tuned way, permitting very accurate patient stratification that leads to therapies targeted against specific molecular profiles. Moreover, such data can reveal new subtypes of diseases or mechanisms that give rise to new targets for treatment. In real situations, clinical trials based on omics usually include collections of blood, tissue, or urine bio-samples from participants at multiple time points in a study. These are then subjected to deep molecular profiling using high-throughput technologies like next-generation sequencing, mass spectrometry, or even microarray platforms. The data obtained is further combined with the clinical outcomes and analyzed by extensive bioinformatics tools and machine learning algorithms in search of patterns and correlations, and maybe even causes.

One of the greatest advantages of omics-based clinical trials is the provision of insights into drug responses and disease processes. This improvement may result in clear, predefined endpoints usually anticipated within conventional clinical trials. Omic approaches, on the other hand, could capture a mass of molecular information, possibly revealing unexpected effects or mechanisms. Such a holistic view could likely drive efficient drug development procedures, better selection of patients for clinical trials, and effective personally tailored treatment strategies.

While they present quite a few challenges, omics-based clinical trials also hold great potential for betterment in medical research and improvement in the quality of care extended to patients. This modality will likely become integral to drug development and clinical practice with improvements in technology and deepening knowledge about molecular biology. Such can be the future: tailored treatment at the molecular level for each patient, to maximize effectiveness while minimizing adverse effects, by putting at the service of researchers and health providers the power of omics technologies.

Omics-Based Clinical Trials Market Share

Disclaimer: This data is only a representation. Actual data may vary and will be available in the report.

Omics Based Clinical Trials Market Dynamics

Key Drivers of Target Market:

Prevalence of Chronic Diseases:

  • An increase in the prevalence of chronic diseases, such as diabetes, cancer, and cardiovascular diseases, is presently observed globally. Most of these complex diseases have unclear means of treatment, resulting in the presence of a large unmet medical need. Omics-based research provides one of the most promising approaches toward understanding the molecular basics of chronic diseases and the discovery of new therapeutic targets. How these diseases come about at the molecular and cellular levels has been studied, showcasing the opportunity for more effective and personalized options toward treatment.

Regulatory Support and Industry Collaboration:

  • In addition to that, facilitation of regulatory policies and efforts on the part of the regulators to hasten the process of drug development encourages the development of an environment in which clinical trials can be conducted using omics. Collaboration among pharmaceutical companies, academic institutions, and government bodies is bringing knowledge-sharing and innovation on the rise. These partners bring a spectrum of complementing expertise, resources, and funding to bear on the acceleration of the translation of omic technologies and research discoveries to clinical applications.

Restrains:

High Costs and Resource-Intensive Nature:

  • Most omics-based clinical trials are considered to be highly expensive, as every technology dealt with is complex—from the generation to the analysis of generated data. Besides, such studies heavily depend on specialized expertise and infrastructure, which may represent a huge financial burden both for pharmaceutical companies and research institutions. The major costs of omics-based clinical trials are focused on the development and validation of omics-based assays and biomarkers, which can be very expensive and time-consuming.

Opportunities:

Early Disease Detection and Prevention:

  • Omics technologies, through early disease detection and prevention, hold great promise in changing the facets of health care. After identifying those patients at high risk of acquiring certain diseases, it is possible to direct implementations of interventions or measures to avert or delay the incidence of disease. Such a proactive approach to providing health care impacts population health with a reduction in health costs and improvement in the quality of life of the patient.

Omics Based Clinical Trials Market Segmentation

The market is segmented based on Phase Type, Study Design Type, Indication Type, and Region.

Phase Type Insights:

  • Phase I: This is the first study involving humans in clinical research, conducted with a new drug or any other treatment on 20-80 subjects for assessing safety and establishing the safe dosage range; characterization of the side effects under such treatment. Omics-based approaches during this phase may be useful in explaining the response of the body to such treatment at the molecular level.Phase II: In Phase II, the drug is administered to a more significant population of 100-300 to additionally assess its effectiveness and safety. Omics technologies will help in identifying biomarkers that predict response to treatment, thus increasing the accuracy of trial results.
  • Phase III: Extensive treatment testing in conditions that can replicate the noted effectiveness, monitoring side effects, and comparative analysis with standard treatments on a population of participants ranging from 1,000-3,000. Omics-based data lies at the very core of stratifying patient populations and personalizing treatment protocols.
  • Phase IV: Conducted after the treatment is approved for public use, Phase IV trials monitor long-term effects and real-world efficacy. Omics data can reveal late-emerging biomarkers and inform post-market surveillance.

Study Design Type Insights:

  • Interventional Studies: These are studies in which the treatment or intervention is purposefully induced in participants and the changes are observed. In the case of omics-based clinical trials, these studies are directly required for testing hypotheses about the behavior of specific molecular changes under treatments.
  • Observational Studies: In contrast to interventional studies, these are studies without active treatment, but rather the observation of outcomes in a natural setting. Omics data in these studies serve to understand the progress of diseases and to identify natural biomarkers.
  • Expanded Access Studies: Extended access studies, also called compassionate use studies, allow patients with a serious or life-threatening disease to have access to experimental treatments outside of clinical trials. Omics data are in the position to identify those patients whose molecular profile would potentially benefit from these therapies.

Indication Type Insights:

  • Oncology: Omics-based trials in oncology are focused on the molecular underpinnings of different cancers, identifying genetic mutations that cause the disease condition, and developing targeted therapies. These trials come in handy in moving personalized medicine forward in cancer treatment.
  • Cardiology: In cardiology, omics-based trials identify genetic predispositions for heart diseases, the molecular basis of cardiovascular conditions, and develop interventions targeting specific biomarkers associated with these diseases.
  • Respiratory Diseases: To determine the molecular basis of respiratory diseases like asthma and COPD, the application of omics in identifying biomarkers for severity and treatment response is studied.
  • Skin Diseases: Omics-based research into skin disorders in dermatology focuses on the genetic and molecular contributors that cause diseases like psoriasis and eczema, with the view of developing person-tailored targeted treatments.
  • CNS Diseases: Application of omics technologies in central nervous system diseases involves the unraveling of complicated genetic and molecular interactions leading to disorders such as Alzheimer's, Parkinson's, and multiple sclerosis, thus culminating in more targeted treatment strategies.
  • Immunology: The omics-based clinical trials for immunological disorders pursue the molecular basis of immune-related diseases like autoimmune disorders and allergies, hence leading to the development of personalized immunotherapies.
  • Genetic Diseases: These would be for rare and genetically acquired conditions where omics technologies play a key role in the identification of genetic mutations responsible for a particular disease and the subsequent development of gene-based therapies.
  • Others: Under this category are trials for various other diseases in which omics data is used in the search for mechanisms of disease, biomarkers, and targeted treatments across an extremely broad range of medical fields.

Regional Insights

  • North America: North America, in particular the United States, dominates the case in question by having advanced healthcare infrastructure, a strong research base, and investments by several market participants in personalized medicine. On the volume side, clinical trials are carried out on a large scale in the region; therefore, it presents a key market for omics technologies.
  • Asia Pacific: The omics-based clinical trials market is growing at a rapid pace in the Asia Pacific driven by rising investments in research, a high volume of patient population, and increasing adoption of advanced technologies in healthcare. Key contributors include China and India.
  • Europe: Europe represents a major share of the omics-based clinical trials market. This would be driven by strong regulatory frameworks, large research networks, and a key focus on innovation in healthcare. Some of the countries leading in this sector are Germany, UK, and France.
  • Latin America: Latin America represents a new frontier of opportunity for omics-based clinical trials. International pharmaceutical companies are increasingly showing interest in this region due to rapidly growing interest in health innovation. Countries such as Brazil and Mexico lead the pack in this region.
  • Middle East and Africa: This region is in its early days in terms of omics-based clinical trials. However, as the burden of chronic diseases surges, interest in personalized treatments is brewing. With improvements in healthcare infrastructure, there is a huge market awaiting this technology.

Omics-Based Clinical Trials Market Report Scope:

Attribute

Details

Market Size 2024

USD 31.5 Billion 

Projected Market Size 2034

USD 68.7 Billion

CAGR Growth Rate

8.9%

Base year for estimation

2023

Forecast period

2024 – 2034

Market representation

Revenue in USD Billion & CAGR from 2024 to 2034

Market Segmentation

By Phase Type - Phase I, Phase II, and Phase III.

By Study Design Type - Interventional Studies, Observational Studies, and Expanded Access Studies.

By Indication Type - Oncology, Cardiology, Respiratory Diseases, Skin Diseases, CNS Diseases, Immunology, Genetic Diseases, and Others.

Regional scope

North America - U.S., Canada

Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe

Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific

Latin America - Brazil, Mexico, Argentina, Rest of Latin America

Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa

Report coverage

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

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2024 to 2034. For the purpose of this study segmented the target market report based on Phase Type, Study Design Type, Indication Type, and Region.

By Phase Type:

  • Phase I
  • Phase II
  • Phase III

By Study Design Type:

  • Interventional Studies
  • Observational Studies
  • Expanded Access Studies

By Indication Type:

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

By Region:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Russia
    • Italy
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC
    • Israel
    • South Africa
    • Rest of Middle East & Africa

Omics Based Clinical Trials Market Key Players

The key players operating the Omics-Based Clinical Trials Market include Parexel International Corporation, Pharmaceutical Product Development (PPD), Charles River Laboratory, ICON plc, SGS SA, Eli Lilly and Company, Pfizer, Covance, Rebus Bio, Novo Nordisk.

Omics-Based Clinical Trials Market Key Players

Disclaimer: This data is only a representation. Actual data may vary and will be available in the report.

Omics Based Clinical Trials Market Key Issues Addressed

  • In May 2024, Mayo's new 'omics' strategy looks to the future. Building on this core science, Mayo Clinic's Center for Individualized Medicine has developed a new "omics" strategy aimed at incorporating precision medicine into routine clinical care. The technique will benefit Rare Disease Omics, Population Omics, Functional Omics, and Digital Omics. This new method constitutes a giant leap into a new era of medicine. These four interconnected 'omics' pillars will enable us to increase our impact, drive advances in tailored medicine, and revolutionize patient care.
  • In April 2024, Longitudinal multi-omics monitoring enables early pancreatic cancer diagnosis. A study published in the Journal of Integrative Biology reveals how longitudinal multi-omics monitoring (LMOM) helped detect a precancerous pancreatic tumor, resulting in a successful surgical intervention.
  • The patient received an annual blood-based LMOM, during which 143 endogenous metabolites in serum and 140 proteins in plasma were examined.  This case report demonstrates the promise of blood LMOM for precision/personalized medicine, as well as innovative approaches to medical innovation for a possibly life-saving early diagnosis of pancreatic cancer.

Omics Based Clinical Trials Market Company Profile

  • Parexel International Corporation*
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Pharmaceutical Product Development (PPD)
  • Charles River Laboratory
  • ICON plc
  • SGS SA
  • Eli Lilly and Company
  • Pfizer
  • Covance
  • Rebus Bio
  • Novo Nordisk

“*” marked represents similar segmentation in other categories in the respective section.

FAQs

Omics-Based Clinical Trials Market Size was valued at USD 31.5 Billion in 2024 and is expected to reach USD 68.7 Billion by 2034 growing at a CAGR of 8.9%.

Omics-Based Clinical Trials Market is segmented into Phase Type, Study Design Type, Indication Type, and Region.

Factors driving the market include the growing Prevalence of Chronic Diseases, Regulatory Support and Industry Collaboration.

Omics-Based Clinical Trials Market's restraints include High Costs and Resource-Intensive Nature.

Omics-Based Clinical Trials Market is segmented by region into North America, Asia Pacific, Europe, Latin America, and the Middle East and Africa. North America is expected to dominate the Market.

The key players operating the Omics-Based Clinical Trials Market include Parexel International Corporation, Pharmaceutical Product Development (PPD), Charles River Laboratory, ICON plc, SGS SA, Eli Lilly and Company, Pfizer, Covance, Rebus Bio, Novo Nordisk.