The U.S. preclinical CRO market size was valued at USD 2.12 billion in 2024 and is expected to surpass around USD 4.66 billion by 2034, growing at a compound annual growth rate (CAGR) of 8.2% over the forecast period 2025 to 2034.
Rising research and development spending in pharmaceuticals and biotech is estimated to drive the growth of the market in the near future. Pharmaceutical and biotech companies are increasing investments in drug discovery and development. Outsourcing to contract research organizations helps companies reduce costs and streamline the preclinical phase.
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U.S. Preclinical CRO Market Report Highlights
- Discovery research dominated the service segment with 33.6% share in 2024, owing to the rising trend of outsourcing research in the biotechnology and pharmaceutical companies to accelerate drug discovery and reduce cost.
- The bioanalysis and DMPK studies segment is expected to witness the fastest CAGR over the forecast period, owing to widescale applications of CROs in bioanalysis studies.
- Increasing demand for personalized medicine and advanced therapeutics, life science companies focusing on their core competencies, and the increasing trend of outsourcing are expected to drive the market growth over the forecast period.
- In August 2023, WuXi STA announced its new 190-acre pharmaceutical manufacturing campus in the U.S. This site would be its second facility, offering expanded capacity and flexibility to meet customers’ needs in the U.S. and across the globe.
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Preclinical CROs Are a Popular Choice for Outsourcing Biotechnology Research
Growth in personalized medicine and rare disease research is estimated to drive the growth of the U.S. preclinical CRO market in the near future. Increased focus on precision medicine requires extensive preclinical testing for tailored therapies. Research into orphan drugs for rare diseases is expanding, requiring specialized contract research organization services. Personalized medicine requires more targeted preclinical studies tailored to specific patient populations, unlike traditional "one-size-fits-all" drugs. Contract research organizations with expertise in biomarker research, pharmacogenomics, and patient-derived models are in high demand. The Orphan Drug Act (1983) has incentivized drug development for rare diseases through tax credits, grants, and exclusivity periods. Over 50% of new drug approvals in the United States are now for orphan drugs, increasing the need for preclinical testing services. Advanced therapies, such as CAR-T cell therapy and CRISPR-based gene editing, require highly specialized preclinical toxicology and efficacy studies. Many small biotech firms leading these innovations lack in-house capabilities, making preclinical CROs essential partners.
Preclinical contract research organizations help companies navigate evolving regulatory frameworks. Venture capital investment in personalized medicine and rare disease biotech startups is booming. CROs help streamline the preclinical phase through AI-driven analytics, high-throughput screening, and automation. Increased outsourcing to CROs specializing in biomarker-driven drug development, gene therapy toxicology, and rare disease models. There is considerable interest in applications aimed at other uncommon genetic conditions with a significant unmet need. Any form of therapy will be taken into account. The recipient of the prize or their organization retains ownership of the intellectual property rights.
Growth in biologics and biosimilars is estimated to drive the growth of the U.S. preclinical CRO market. Globalization of drug development is also majorly contributing to driving the growth of the market in the near future. Emerging markets (China, India) are growing hubs for preclinical research due to cost advantages and skilled labor. Many CROs are expanding operations to cater to global clients. Increased focus on safety and efficacy studies is estimated to drive the growth of the U.S. preclinical CRO market in the near future. Regulatory bodies require extensive toxicology, pharmacodynamics, and pharmacokinetics studies before human trials. The need to de-risk drug development leads to greater reliance on CROs.
U.S. Preclinical CRO Market Report Scope
|
Report Attribute |
Details |
|
Revenue forecast in 2034 |
USD 4.66 billion |
|
Growth rate |
CAGR of 8.2% from 2024 to 2030 |
|
Base year for estimation |
2024 |
|
Historical data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD million/billion and CAGR from 2025 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Service, model type, technology, end-use, state |
|
Country scope |
U.S. |
|
State scope |
New Jersey; Pennsylvania; Massachusetts; Florida; North Carolina; Texas; Illinois; Indiana; Michigan; California; Rest of U.S. |
|
Key companies profiled |
Laboratory Corporation of America; Lonza; WuXi AppTec, Inc.; Eurofins Scientific SE; Intertek Group plc; Medpace Holdings, Inc.; Charles River Laboratories International, Inc.; SGA SA; Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific, Inc.); ICON plc; CROWN bioscience |
U.S. Preclinical CRO Market Trends
• Toxicology Testing: This segment remains the largest revenue contributor, driven by stringent regulatory requirements and the need for comprehensive safety assessments.
• Bioanalysis and DMPK Studies: Projected to experience the fastest growth, these services are essential for understanding drug metabolism and pharmacokinetics, aiding in effective drug development.
• Artificial Intelligence (AI) Integration: AI is enhancing data analysis, predictive modeling, and efficiency in preclinical studies, leading to more accurate and faster drug development processes.
• Advanced Imaging and High : Throughput Screening: Innovations in imaging technologies and automated screening are improving the precision and speed of preclinical research.
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The Role of AI in the U.S. Preclinical CRO Market
Artificial Intelligence is transforming the U.S. preclinical CRO market by improving efficiency, accuracy, and cost-effectiveness in drug development. AI-driven algorithms can analyze large biological datasets to identify potential drug candidates more efficiently. Machine learning (ML) models help predict drug-target interactions, reducing the number of compounds needing preclinical testing. This shortens the timeline for lead optimization, increasing demand for AI-equipped preclinical CROs. AI-powered in silico modeling predicts drug toxicity and adverse effects before in vivo studies. AI can analyze historical preclinical data to identify patterns of drug failure, improving safety assessments. The AI integration reduces reliance on animal testing, aligning with U.S. Food and Drug Administration initiatives for alternative preclinical models. AI enhances high-throughput screening in drug testing by automating image analysis from cell-based assays. AI-driven pathology analysis speeds up histopathological evaluations in preclinical toxicology studies.
U.S. Preclinical CRO Market Segment Insights
Service Insights
The toxicology testing segment dominated the U.S. preclinical CRO market in 2024. As toxicological testing is widely used and noncore preclinical CRO investigations are increasingly being outsourced. Due to CROs' increased capacity to perform toxicological testing, toxicology is one of the primary services that is being outsourced to them. This segment's growth is anticipated to be driven over the projected period by the increasing rate of noncore preclinical study outsourcing to CROs and the CROs' expanding capacity to provide more value-added services.
The bioanalysis & DMPK studies segment is expected to grow at the fastest rate in the market during the forecast period of 2024 to 2034. Due to an increase in the need for pharmacokinetic services to support toxicological tests for IND-enabling studies, the market is anticipated to grow profitably. Furthermore, DMPK investigations and bioanalysis are essential to the entire drug development process. They are not limited to the preclinical stage but are carried out at every stage of the drug development process. These elements are also boosting the segment's expansion.
Model Type Insights
The small animal models segment accounted for the largest revenue share in 2024, owing to the increasing investments in CROs and extensive use of small animals in modern research activities & studies. Small animal models allow research and novel approaches with potential clinical applications in multiple areas. Mice and rats are easier to handle and maintain, have a short life cycle, and are more economical to use than larger animals. They are easy to house, scalable, cost-effective, and amenable to quantitative measures. They can be used to improve the efficiency of animal use while increasing the accuracy of results. Hence, small animal models have proven to be an important tool to take potential therapeutics from preclinical studies to humans.
The organoid models segment is expected to grow at the fastest CAGR from 2024 to 2030. This can be attributed to the increasing number of promising organoid models for drug discovery and development. In cancer research and drug discovery, these are relevant models owing to in vivo conditions; organoids are more biologically relevant to any model system and can manipulate gene sequence and niche components, which has led to rising demand for organoid models. In other diseases, these models have proven to be efficient. For instance, in February 2024, the Charcot-Marie-Tooth Association (CMTA) announced an investment of more than USD 200,000 to develop an organoid model of CMT1A, the common form of this disease. This approach would help scientists evaluate potential treatments that target defects in myelin, which is the protective sheath around peripheral nerves.
Technology Insights
The in vivo studies segment accounted for the largest revenue share in 2024. In vivo studies, as part of preclinical research, are continually evolving, driven by technological innovations, scientific discoveries, and the need for more accurate & predictive models. The development of genetically modified animals using techniques such as CRISPR/Cas9 enables researchers to create more precise and disease-relevant models for studying human diseases. These models better mimic the genetic and physiological characteristics of human conditions, leading to more clinically relevant findings.
The imaging technologies segment is expected to grow at the fastest CAGR from 2024 to 2034. Imaging technologies play a crucial role in preclinical CROs by enabling the visualization and analysis of biological processes in living organisms. These technologies help evaluate drug candidates, disease progression, and the development of new therapeutic interventions. Preclinical research is revolutionizing the delivery of modern medicine and the treatment of health issues. Preclinical imaging methods contribute to this transformation by minimizing biological variability and enabling the acquisition of extensive & diverse information while significantly decreasing the number of animals needed for studies, aligning with 3R (Replacement, Reduction, and Refinement) policies.
End Use Insights
The biopharmaceutical companies segment held a dominant presence in the market. Preclinical CRO services are anticipated to become more in demand in the future due to the growing trend of biopharmaceutical companies outsourcing end-to-end services, particularly small and mid-sized businesses that lack enough knowledge of the preclinical stage of drug development.
The government and academic institutes segment is projected to expand rapidly in the market in the coming years. The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) provide significant funding for early-stage drug discovery and preclinical studies. Programs like the Cancer Moonshot Initiative boost preclinical oncology research, increasing collaborations with CROs. Government incentives and grants support orphan drug development, increasing demand for preclinical services. FDA Requirements: The U.S. Food and Drug Administration (FDA) mandate thorough preclinical studies before Investigational New Drug (IND) applications. Academic medical centers are increasingly focused on translating lab discoveries into clinical trials, requiring preclinical CRO expertise. A significant percentage of early-stage clinical trials in the U.S. originate from government and academic-led research, increasing the need for preclinical CRO support.
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U.S. Preclinical CRO Market Top Key Companies:
- Laboratory Corporation of America
- Lonza
- WuXi AppTec, Inc.
- Eurofins Scientific SE
- Intertek Group plc
- Medpace Holdings, Inc.
- Charles River Laboratories International, Inc.
- SGA SA
- Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific, Inc.)
- ICON plc
- CROWN bioscience
Recent Developments
• In February 2025, Mangoceuticals, Inc. ("Mangoceuticals" or the "Company"), a business that specializes in creating, promoting, and selling a range of men's wellness products and services through a secure telemedicine platform, today announced noteworthy advancements in its ongoing HIN1 efficacy study on its patented respiratory illness prevention technology, which is being carried out in partnership with Intramont Technologies, Inc. ("Intramont") and Vipragen Biosciences ("Vipragen"*), a preclinical CRO in Mysuru, India, and accredited by the AAALAC.
• In January 2025, WuXi AppTec, a multinational corporation that offers a wide range of R&D and manufacturing services to support businesses in the life science and pharmaceutical sectors, announced that it has reached a final deal to sell its U.S. medical device testing operations to NASA, a MedTech testing, clinical, and regulatory consulting firm based in Toledo, Ohio.
• In November 2023, Crown Bioscience and JSR Life Sciences, LLC announced the launch of a service offering, OrganoidXplore. This organoid panel screening platform would provide reproducible, robust, and clinically relevant output, accelerating preclinical oncology drug discovery by reshaping the landscape of cancer treatment development.
U.S. Preclinical CRO Market Report Segmentation
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 2019 to 2034. For this study, Statifacts has segmented the global U.S. Preclinical CRO Market
By Service
• Bioanalysis and DMPK studies
o In vitro ADME
o In-vivo PK
• Toxicology Testing
o GLP
o Non-GLP
• Compound Management
o Process R&D
o Custom Synthesis
o Others
• Chemistry
o Medicinal Chemistry
o Computation Chemistry
• Safety Pharmacology
• Discovery Research
o Target Identification & Screening
o Target Validation & Functional Informatics
o Lead Identification & Candidate Optimization
o Preclinical Development
o Other Associated Workflow
• Others
By Model Type
• Small Animal Models
o Mice
o Rats
o Rabbits
o Others
• Large Animal Models
o Pig
o Others
• Organoid Models
• Cell Culture Models
• Others
By Technology
• In Vivo Studies
• In Vitro Studies
• Ex Vivo Studies
• Imaging Technologies
o Ultrasound Imaging
o MRI Imaging
o CT Imaging
o Radionuclide Imaging
o Other Imaging Technologies
• Other Technologies
By End-use
• Biopharmaceutical Companies
• Research and Academic Institutes
• Medical Device Companies
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