Omics-Based Clinical Trials Market Size, Share & Trends Analysis Report By Phase (Phase I, Phase II, Phase III, Phase IV), By Study Design, By Indication, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global omics-based clinical trials market size was valued at USD 26.2 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 7.4% from 2022 to 2030. There was unprecedented growth in 2020 due to the COVID-19 pandemic. The main drivers were rising investment in the pharmaceutical industry by the prominent participants to enhance their productivity, rising demand for omics-based clinical trials, and increasing prevalence of chronic disorders. With the increasing global prevalence and burden of various chronic diseases such as cancer, there is a demand to study various molecular targets that may not only provide biomarkers of clinical risk, but also therapeutic targets.

Advanced omics technologies such as single-cell omics, multi-omics, and typical omics approaches, have been used to evaluate various cancer immunotherapies. In addition, the rising use of “multi-omics” in research, along with the penetration of advanced sequencing platforms, is gaining popularity in the precision medicine scenario, which in turn is driving the market. The COVID-19 has caused a huge disruption in the supply chain of the overall pharmaceutical industry. However, several omics results have been observed for COVID-19. With the help of integrative analysis of genomic, proteomic, transcriptomic, lipidomic, and metabolomic profiles, a trans-omics landscape for COVID-19 was reported. This has created a huge opportunity for the market to grow. Various small companies have started omics-based clinical trials to understand the COVID-19 virus.

In recent years, the pharmaceutical industry has witnessed a significant number of consolidations in the market for omics-based clinical trials. For instance, In November 2021, Complete Omics’ Clinical Proteomics team announced a collaboration with Generate Biomedicines on a series of immunopeptidomics projects. The collaboration between Generate Biomedicines and Complete Omics will use the Complete world’s leading ultra-sensitive multiomics and clinical proteomics platforms on a variety of clinical and pharmaceutical projects. These consolidations were mainly aimed at business expansion and to stay competitive in the clinical trials market. Moreover, the companies are undertaking strategies to expand their customer base across the globe.

The demand is growing for a pattern shift toward the stratification of patients or even personalized medicine. There are several complex diseases that urgently need a better understanding of their analysis and more effective therapeutic strategies. Currently, omics-based studies make the majority of precision medicine-based data, e.g. DNA sequencing technique is already being used to identify genetic material that enhances specific cancers. Furthermore, recent technological advances in other high-throughput omics technologies allow the retrieval of holistic and comprehensive data, including genome, proteome, transcriptome, and metabolome.

Phase Insights

The phase II segment dominated the market for omics-based clinical trials and accounted for the largest revenue share of 37.8% in 2021. The segment is expected to witness a CAGR of 7.1% over the forecast period. This is attributed to a large number of ongoing clinical trials in phase II. Phase II clinical trials had the highest number of projects in 2020 and this trend is expected to grow further owing to increasing investments in R&D by industry and non-industry sponsors. Moreover, the globalization of clinical trials, the growing number of industry-sponsored and non-industry-sponsored clinical trials in phase II, and the complexity associated with phase II clinical trials are factors expected to drive the growth of the segment.

Phase II is followed by Phase I in the market for omics-based clinical trials. Phase I studies assess the safety of a device or drug and involve the evaluation of pharmacokinetics of molecules and tolerability. It determines the effect of a device or drug on humans including the way it is absorbed, metabolized, and excreted. For patients who have clear tolerability studies, oncology studies have to be conducted as a primary endpoint. The main aim of phase I is to evaluate doses and their adverse effects, and this phase includes testing about 70% of experimental drugs.

Study Design Insights

The interventional studies segment dominated the market for omics-based clinical trials and accounted for the largest revenue share of 78.3% in 2021. The segment is expected to exhibit a CAGR of 7.1% over the forecast period owing to the increasing number of interventional designs of clinical trials. Interventional studies are categorized based on the intervention that is to be studied which includes drug or biologic, surgical procedure, behavioral, and devices. There is a large number of interventional studies listed on clinicaltrials.gov, especially for oncology. There has been a significant increase in the number of interventional studies design carried out over time.

The expanded access studies segment is anticipated to witness a lucrative CAGR of 8.6% during the forecast period. Interventional study designs are known to provide the most reliable data in epidemiological research in genomics or any other omics-based studies. Intervention studies can generally be considered as either preventative or therapeutic. In the interventional study design, when research study design is significantly randomized, then the statistical test of significance is readily interpretable for researchers, this makes the study very beneficial in omics-based research.

Indication Insights

The oncology segment dominated the market for omics-based clinical trials and accounted for the largest revenue share of 46.7% in 2021. The segment is expected to witness a CAGR of 7.6% during the forecast period. The worldwide cancer cases are projected to grow by 50% and worldwide cancer deaths are expected to rise by 60% till 2030 which indicates growing potential for the omics-based clinical trial in this segment. Precision medicine has been successfully applied in oncology, with improved efficacy and better outcomes. It has been observed that precision medicine has a vast application in the branch of oncology, where the sequencing and targeting of tumor genomes have been used to promote clinicians’ ability to both assess and treat cancers.

The research on cardiology is ideally positioned to address the epidemic of noninfectious causes of death, as well as advance the understanding of human health and disease, through the development and implementation of precision medicine. The growing demand for precision medicine for cardiovascular diseases is likely to augment the cardiology segment in the omics-based clinical trials market. The skin diseases segment is expected to witness the highest CAGR over the forecast period owing to the growing prevalence of skin-related disorders including dermatitis, acne, skin cancer, driving the demand for omics-based clinical trials to provide better treatment.

Regional Insights

North America dominated the market for omics-based clinical trials and held the largest revenue share of 43.6% in 2021. This can be attributed to the huge R&D investments, the presence of global players, and their efforts to come up with newer patents. For instance, in January 2015, President Obama announced an investment of USD 215 million for a precision medicine initiative. The investment is for the NIH, National Cancer Institute (NCI), and FDA. The investment has been broken up for NIH (USD 130 Million) to encourage more volunteer participation by open responsible data sharing. The NCI has received USD 70 million for identifying genomic drivers in cancer and designing their treatment approaches. The FDA has received a smaller share of USD 10 million to evaluate Next Generation Sequencing for better patient care. Industry players are making advances in their approach to decrease the timelines by undertaking more of a technological approach.

Asia Pacific is the fastest growing market as many developed nations are investing in Asia-Pacific regions. Besides, the recruitment for clinical trials is increasing in Asia as compared to North America, and Europe. This is due to the large patient pool and low trial cost. Clinical research in the region is well developed with many international pharmaceutical companies and CROs have been in the region for more than 2 decades. Many organizations are expanding their production facility in the region for carrying out omics-based research. For instance, in March 2021, Changi General Hospital (CGH) of Singapore and Shimadzu (Asia Pacific) has built clinical omics research centers to perform omics research based on mass spectrometry to offer patients with personalized diagnosis and treatment programs.

Key Companies & Market Share Insights

The market for omics-based clinical trials is highly competitive in nature due to the presence of a substantial number of developed as well as medium to small-sized organizations Several market participants are privately held or are a part of private equity firms’ portfolios. For instance, In March 2018, Danaher Corporation acquired Integrated DNA Technologies. This acquisition aimed at expanding Danaher’s presence in the highly attractive genomics market. Another company is Rebus Biosystems Inc., a U.S.-based life science technology company in December 2021, announced that it has acquired the assay assets and IP of EEL Transcriptomics AB, a company that is privately held focused on high-plex spatial transcriptomics based on single-cell resolution. Some of the prominent players in 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 Inc.

• Covance Inc.

• Novo Nordisk

• Rebus Bio 

Recent Developments:

• In November 2021, ICON plc announced that its Accellacare Site Network has expanded in reach and capabilities through new partnerships with six research sites across four countries. 

• In February 2021, Parexel and NeoGenomics announced a strategic collaboration in precision medicine to improve study designs and accelerate patient matching in oncology clinical trials. 

• In March 2019, Mission Bio partnered with labcorp to accelerate targeted drug development with single-cell genomics. 

Omics-Based Clinical Trials Market Report Scope

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 in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global omics-based clinical trials market report on the basis of phase, study design, indication, and region:

• Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Study Design Outlook (Revenue, USD Million, 2018 - 2030)

  • Interventional Studies

  • Observational Studies

  • Expanded Access Studies 

• Indication Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Cardiology

  • Respiratory Diseases

  • Skin Diseases

  • CNS Diseases

  • Immunology

  • Genetic Diseases (includes the rare diseases)

  • Others (includes ophthalmic, ear diseases, etc)

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

  • Asia Pacific

    • China

    • Japan

    • India

    • Australia

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE