Omics-based Clinical Trials

Global Omics-based Clinical Trials Market to Reach US$53.7 Billion by 2030

The global market for Omics-based Clinical Trials estimated at US$35.2 Billion in the year 2024, is expected to reach US$53.7 Billion by 2030, growing at a CAGR of 7.3% over the analysis period 2024-2030. Phase I, one of the segments analyzed in the report, is expected to record a 8.6% CAGR and reach US$23.3 Billion by the end of the analysis period. Growth in the Phase II segment is estimated at 5.1% CAGR over the analysis period.

The U.S. Market is Estimated at US$9.3 Billion While China is Forecast to Grow at 7.0% CAGR

The Omics-based Clinical Trials market in the U.S. is estimated at US$9.3 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$8.6 Billion by the year 2030 trailing a CAGR of 7.0% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 6.9% and 6.0% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 5.7% CAGR.

Global Omics-Based Clinical Trials Market – Key Trends & Drivers Summarized

Why Are Omics-Based Clinical Trials Redefining Drug Development and Precision Medicine?

Omics-based clinical trials are transforming the landscape of drug development by offering unprecedented insights into the molecular underpinnings of disease and therapeutic response. By integrating genomic, transcriptomic, proteomic, metabolomic, and epigenomic data into trial design and patient stratification, these trials enable more targeted, predictive, and efficient approaches to evaluating drug efficacy and safety. Unlike conventional trials, which rely heavily on generalized population-based models, omics-informed trials identify specific biomarkers or molecular signatures that correlate with treatment response, allowing for the selection of subpopulations most likely to benefit from a therapy. This reduces trial failure rates, accelerates timelines, and enhances clinical outcomes. In oncology, for example, next-generation sequencing (NGS) is routinely used to match patients to targeted therapies or immunotherapies based on their tumor’s genetic mutations. Similar approaches are gaining traction in neurology, immunology, and rare disease studies. As personalized medicine becomes central to healthcare, omics-based clinical trials are becoming indispensable tools for pharmaceutical and biotech companies seeking to develop therapies that are not only effective but also tailored to individual patient profiles. Their ability to integrate molecular diagnostics into therapeutic evaluation is reshaping the very framework of modern clinical research.

How Is Technology Enabling More Efficient, Multi-Dimensional Trial Design?

Rapid advancements in omics technologies and computational tools are significantly enhancing the design and execution of omics-based clinical trials. High-throughput sequencing platforms, mass spectrometry, and single-cell analysis are enabling deeper and more precise characterization of biological samples across multiple omics layers. At the same time, big data analytics, artificial intelligence (AI), and machine learning (ML) are revolutionizing the way omics data is interpreted and used to drive decision-making during clinical trials. These tools facilitate the identification of predictive biomarkers, the clustering of patient subgroups based on molecular phenotypes, and the optimization of dosage and treatment regimens. Digital health platforms are now integrating real-time omics data with clinical endpoints, wearable sensor data, and electronic health records (EHRs), enabling continuous and adaptive trial models. Cloud-based bioinformatics infrastructure allows for secure, scalable, and collaborative data processing, making global, multi-center omics trials more feasible than ever before. Furthermore, advances in sample preservation and logistics are streamlining biospecimen handling, ensuring data quality from source to analysis. These technological innovations are not only driving the feasibility and accuracy of omics-based trials but are also empowering a more agile, adaptive, and cost-effective clinical research environment that meets the demands of modern therapeutic innovation.

Is Regulatory Support and Industry Collaboration Accelerating Omics-Based Trial Adoption?

Growing support from regulatory agencies and strategic collaborations among industry players are significantly accelerating the adoption of omics-based clinical trials. Regulatory bodies like the FDA, EMA, and PMDA are increasingly open to biomarker-driven trial designs, particularly in oncology and rare disease research, where traditional trial structures often fall short. The FDA’s support for Real-Time Oncology Review (RTOR) and breakthrough therapy designations has created a more favorable regulatory climate for omics-based approaches. Moreover, regulatory frameworks are evolving to accommodate adaptive trial designs, companion diagnostics, and the co-development of therapeutic–diagnostic pairs, enabling faster approval pathways for personalized treatments. Strategic partnerships between pharmaceutical companies, diagnostics firms, academic institutions, and contract research organizations (CROs) are playing a pivotal role in creating shared databases, validating biomarkers, and building integrated omics platforms that support large-scale clinical studies. Industry-wide initiatives such as the Cancer Moonshot and the All of Us Research Program are providing rich datasets and infrastructure for omics-driven research. Furthermore, patient advocacy groups are increasingly involved in trial design and recruitment, particularly for rare and genetic diseases, ensuring that trials are patient-centered and inclusive. As regulatory frameworks become more responsive and ecosystems more collaborative, omics-based clinical trials are gaining momentum as the gold standard for personalized drug development and therapeutic validation.

What’s Driving the Global Expansion of the Omics-Based Clinical Trials Market?

The growth in the omics-based clinical trials market is driven by several interrelated factors rooted in technological innovation, unmet clinical needs, evolving therapeutic models, and increased investment in precision medicine. One of the primary drivers is the escalating demand for targeted therapies, especially in oncology, immunotherapy, and rare diseases, where traditional one-size-fits-all approaches have limited efficacy. The explosion of genomic and multi-omics data is enabling researchers to design trials that are more selective, hypothesis-driven, and efficient, improving the probability of clinical success. Additionally, pharmaceutical and biotech companies are increasingly investing in omics-based platforms to de-risk drug pipelines, optimize patient recruitment, and gain competitive advantage through biomarker-driven product differentiation. The increasing affordability and accessibility of NGS and bioinformatics tools are democratizing omics trial capabilities across mid-sized companies and academic research institutions. Meanwhile, global initiatives promoting population genomics and personalized medicine—particularly in the U.S., U.K., China, and the Middle East—are creating a robust infrastructure and funding base for large-scale omics-enabled trials. Regulatory encouragement for adaptive trial designs and real-world evidence integration is also shortening approval timelines and boosting industry confidence. Furthermore, rising public awareness around personalized health, genetic testing, and disease prevention is creating a more engaged and informed patient population, facilitating recruitment and retention in biomarker-based studies. Together, these dynamics are powering the global expansion of the omics-based clinical trials market, cementing its role as a transformative force in next-generation drug development and individualized healthcare.

SCOPE OF STUDY:

The report analyzes the Omics-based Clinical Trials market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Phase (Phase I, Phase II, Phase III, Phase IV); Study (Interventional Studies, Observational Studies, Expanded Access Studies); Indication (Oncology Indication, Cardiovascular Indication, CNS Conditions Indication, Pain Management Indication, Diabetes Indication, Autoimmune / Inflammation Indication, Obesity Indication, Other Indications)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 32 Featured) -

• Abbott Laboratories
• Agilent Technologies, Inc.
• Bristol-Myers Squibb Company
• Charles River Laboratories
• Covance Inc.
• Eli Lilly and Company
• Fulgent Genetics
• ICON plc
• Illumina, Inc.
• Laboratory Corporation of America
• Novo Nordisk A/S
• Parexel International Corporation
• PerkinElmer, Inc.
• Pfizer Inc.
• Pharmaceutical Product Development (PPD)
• Q2 Solutions
• Rebus Biosystems, Inc.
• SGS Société Générale de Surveillance SA
• Siemens Healthineers
• Thermo Fisher Scientific Inc.

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

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APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

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CHINA
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JAPAN
INDIA
176 OTHER COUNTRIES.

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