U.S. Preclinical CRO Market is Rising Rapidly Up to USD 6.39 Bn by 2033

According to recent study by nova one advisor, the U.S. Preclinical CRO market size was valued at USD 3.19 billion in 2023 and is anticipated to reach around USD 6.39 billion by 2033, growing at a CAGR of 7.2 % from 2024 to 2033.

The growth of the U.S. preclinical CRO market is furled by its pivotal role in ensuring the safety and ethical integrity of clinical trials, crucial for the development of transformative drugs and medical devices benefiting millions of patients.

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U.S. Preclinical CRO Market Overview

The rapid growth of the U.S. preclinical CRO market stems from its pivotal role in assisting medical product developers in demonstrating the safety and efficacy of their innovations prior to clinical trials or other regulatory approvals. Preclinical CROs conduct tests using live models that closely approximate human anatomy, as stipulated by the FDA. These organizations play a crucial role in helping products navigate the regulatory pathway, including obtaining approvals like 510Ks. A high-value preclinical CRO distinguishes itself by its deep understanding of its customers’ scientific needs. They typically employ a significant number of biomedical engineers who are well-equipped to support sponsors at various stages of the product development journey, from concept to commercialization. In the United States, the preclinical CRO landscape comprises over 2,800 organizations, reflecting the industry’s robustness and its critical role in advancing medical innovation.

Key Takeaways:

• The discovery research segment dominated the market with a revenue share of 29.16% in 2023.
• The bioanalysis and DMPK studies segment is anticipated to grow at the fastest CAGR of 8.1% over the forecast period.
• The small animal models segment accounted for the largest revenue share in 2023.
• The small animal models segment accounted for the largest revenue share in 2023.
• The in vivo studies segment accounted for the largest revenue share in 2023.
• The imaging technologies segment is expected to grow at the fastest CAGR from 2024 to 2033.
• The biopharmaceutical companies segment accounted for the largest revenue share 75.11% in 2023.
• The medical device companies’ segment is expected to grow at the fastest CAGR over the forecast period.
• Massachusetts held a significant market share in 2023.
• California is expected to witness growth at the fastest CAGR over the forecast period.

Preclinical CRO Market Size in the global 2024 to 2033

The global preclinical CRO market size reached USD 5.95 Billion in 2023 and is expected to hit around USD 13.83 billion by 2033, growing at a CAGR of 8.8% from 2024 to 2033. North America accounted for the largest share of 47.11% in 2023.

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U.S. Preclinical CRO Market Dynamics

Driver

The Increasing Role of CROs in Pharmaceutical R&D

In pharmaceutical research and development (R&D), Contract Research Organizations (CROs) are emerging as pivotal partners, mitigating the capital-intensive, complex, and time-consuming nature of the R&D process. Offering comprehensive solutions, CROs cover preclinical trials, including Bioanalytical studies, DMPK studies, Safety and toxicology studies, and In vitro and vivo efficacy studies. By serving as alternative service providers to the pharmaceutical industry, CROs provide a wide array of pharmaceutical research services, supporting innovation and drug development for pharmaceuticals and medical devices. This strategic outsourcing model not only enhances efficiency but also fosters growth in the U.S. preclinical CRO market, as CROs continue to play an indispensable role in driving advancements in pharmaceutical R&D.

Restraint

Evaluation Stringency in Selecting Non-clinical CROs Limits Growth

Engaging a Contract Research Organization (CRO) for non-clinical, Good Laboratory Practice (GLP) preclinical, and Investigational New Drug (IND)-enabling studies represents a crucial stage in drug or biologics development. However, this process entails rigorous scrutiny of the CRO’s capabilities, expertise, infrastructure, and adherence to regulatory standards. A thorough on-site visit, involving direct observation of operational procedures and discussions with key personnel, is imperative for robust selection procedures. While ensuring quality and compliance, this stringent evaluation approach inadvertently constrains the growth potential of the U.S. preclinical CRO market by imposing significant barriers to entry and expansion.

Opportunity

Integration of AI

The complexity and duration of drug development processes are being addressed through the integration of AI-based technologies into various facets of preclinical research trials. This trend is gaining momentum, benefiting CROs, pharmaceutical, biotechnology, and medical device companies by accelerating drug development timelines, enhancing preclinical trial efficacy, automating testing processes, and improving the accuracy of data analysis, management, and collection. Advanced AI algorithms have the potential to predict adverse events, better understand chemical compound toxicity, and mitigate potential drug side effects. This integration presents a significant opportunity for the U.S. preclinical CRO market, positioning it to capitalize on the efficiencies and innovations brought forth by AI-driven advancements in drug development.

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By End-use

The U.S. preclinical CRO market is dominated by the biopharmaceutical companies segment accounted for the largest revenue share 75.11% in 2023. Biopharmaceutical firms often encounter obstacles in conducting clinical trials, requiring significant expertise, time, and financial investments. To surmount these challenges, many companies opt to outsource their clinical trials to contract research organizations (CROs) equipped with established protocols, global networks, and specialized therapeutic knowledge. Acting as third-party entities, CROs provide invaluable support and resources to pharmaceutical, biotech, and medical device companies, along with research institutions, universities, and government entities, collectively known as sponsors, facilitating their research endeavours. This strategic partnership between biopharmaceutical companies and CROs enables streamlined and efficient execution of clinical trials, ultimately accelerating the development of life-saving therapies and medical innovations.

In the U.S. preclinical CRO market, the medical device companies’ segment is projected to experience the fastest growth. CRO services tailored for the medical device industry encompass a wide array of functions, including regulatory affairs, clinical trial planning, site selection and initiation, recruitment support, clinical monitoring, data management, trial logistics, biostatistics, medical writing, and project management. Medical device sponsors often leverage the expertise of CROs to outsource critical services such as clinical research, trial design, site selection, and regulatory consulting, reaping multiple advantages in return. These benefits include streamlined and more efficient clinical trials, access to specialized therapeutic knowledge, mitigation of risks and compliance with evolving regulations, cost savings, and the economic advantages associated with outsourcing. Collaborating with CROs empowers medical device companies to optimize their research and development processes, expedite product development timelines, and ultimately deliver innovative solutions to market with greater speed and efficacy.

By Service

In the U.S. preclinical CRO market, The discovery research segment dominated the market with a revenue share of 29.16% in 2023. With the pharmaceutical industry under mounting pressure to not only populate their pipelines but also deliver value to both payers and shareholders, outsourcing drug discovery has emerged as a strategic imperative. Projections suggest a continued annual growth rate of 5-10% over the next decade, particularly in the drug discovery chemistry market. the clientele of drug discovery CROs has expanded beyond traditional pharmaceutical and biotech firms. Now, academic institutions with an interest in drug discovery are leveraging the expertise of CROs to enhance the value of their projects, thereby attracting potential future pharma partners. This trend underscores the pivotal role of preclinical CROs in driving innovation and efficiency in the drug discovery process, offering tailored services to a diverse array of clients across the pharmaceutical sector.

In the rapidly evolving landscape of the U.S. preclinical CRO market, bioanalysis and DMPK studies segment stands out as a beacon of growth and innovation. With a sharp focus on precision and reliability, offer a comprehensive suite of services designed to support the entire drug development journey. From radiolabel mass balance and in vivo metabolism studies to structural optimization in early discovery and pharmacokinetic assessments in a range of animal models, expertise ensures thorough insights into compound behaviour and efficacy. Capabilities extend to encompass in vitro ADME studies, non-GLP bioanalytical assessments, radiolabel studies, and metabolite identification/profiling. Provide tailored bioanalytical solutions that support every stage of drug development, including preclinical, clinical, TK/PK, and BE studies.

By Model Type

In the U.S. preclinical CRO market, the small animal models segment reigns supreme, boasting the largest share. This segment encompasses two primary categories: rodents, which include mice, rats, guinea pigs, and hamsters, and nonrodents, such as ferrets and rabbits. Small animal models play a pivotal role in biomedical research, enabling the elucidation of critical biological mechanisms across a spectrum of contexts. From understanding intrahepatic disease progression to unraveling interorgan crosstalk and systemic dysregulation, these models serve as indispensable tools in advancing scientific understanding and driving therapeutic innovation.

In the dynamic landscape of the U.S. preclinical CRO market, the organoid models segment emerges as a frontrunner poised for rapid growth. Organoids represent three-dimensional constructs comprising multiple cell types, derived from stem cells through self-organization. Notably, they possess the capability to mimic the architecture and functionality of native organs with remarkable fidelity. Particularly valuable are organoids derived from primary tissues, which bridge the gap in preclinical models between traditional 2D cell culture/xenografts and patient-derived xenograft (PDX) models. Leveraging the versatility and physiological relevance of organoid models, preclinical research endeavors stand to gain unprecedented insights into complex biological processes, thereby propelling therapeutic innovation and efficacy.

• In November 2023, Crown Bioscience unveiled a groundbreaking large-scale organoid panel screening platform, aimed at expediting preclinical oncology drug discovery efforts.

By Technology

U.S. preclinical CRO market, the in vivo studies segment claimed the largest share. This branch of preclinical research centers on assessing potential therapeutic interventions using in vivo models, which encompass various animal models. Similar to human studies, animal testing undergoes stringent regulation in most jurisdictions, necessitating approval from local ethical review boards to safeguard experimental subjects from undue harm. Recent technological advancements have revolutionized the utilization of animal models in drug development, leveraging non-invasive imaging technologies, microsampling techniques, and telemetric monitoring to enhance research precision and efficiency.

In the U.S. preclinical CRO market, the imaging technologies segment is poised for rapid growth. Preclinical imaging, a well-established technology, integrates both functional and structural imaging modalities to assess specific in vivo processes, providing critical insights into spatial orientation within the model under study. Molecular imaging, with its distinctive attributes, offers investigators an early-stage solution with unparalleled potential. In vivo imaging finds widespread application across diverse development endeavors, including gaining insights into disease processes, validating new therapeutic targets, assessing target and non-target organ interactions, elucidating mechanisms of action, determining biodistribution, and more. Leveraging the capabilities of preclinical imaging technology promises to revolutionize research methodologies and accelerate therapeutic innovation in the pharmaceutical and biotechnology sectors.

Recent Developments

• In January 2024, the clinical trial services unit launched by CRO Ichor Life Sciences.
• In September 2023, Canadian CRO Cirion Biopharma was acquired by the French diagnostic group Cerba HealthCare.
• In January 2023, a partnership was formed between Biognosis and Bruker to offer advanced proteomics CRO services to global biopharma and biomarker customers.

Key U.S. Preclinical CRO Company Insights

Some of the key players operating in the market include Laboratory Corporation of America, Eurofins Scientific SE, Charles River Laboratories International, Inc., CROWN bioscience.

• Labcorp operates in the healthcare services industry, offering clinical diagnostics, drug development, Contract Research Organization (CRO) services, drug monitoring solutions, and technology solutions. It provides comprehensive laboratory testing, pathology services, molecular diagnostics, & genomic testing for medical conditions. The company supports pharmaceutical and biotechnology companies with clinical trials, central laboratory testing & safety assessments.
• Eurofins Scientific SE (Eurofins) is a provider of preclinical services globally. It has a portfolio of 150,000 analytical methods for evaluating the composition, authenticity, and purity of biological substances. It also provides AgroTesting, consumer product testing, environment testing, medical device testing, and chemical registration & authorization services.

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

U.S. Preclinical CRO Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Preclinical CRO market.

By Service

• Bioanalysis and DMPK studies
  • In vitro ADME
  • In-vivo PK
• Toxicology Testing
  • GLP
  • Non-GLP
• Compound Management
  • Process R&D
  • Custom Synthesis
  • Others
• Chemistry
  • Medicinal Chemistry
  • Computation Chemistry
• Safety Pharmacology
• Discovery Research
  • Target Identification & Screening
  • Target Validation & Functional Informatics
  • Lead Identification & Candidate Optimization
  • Preclinical Development
  • Other Associated Workflow
• Others

By Model Type

• Small Animal Models
  • Mice
  • Rats
  • Rabbits
  • Others
• Large Animal Models
  • Pig
  • Others
• Organoid Models
• Cell Culture Models
• Others

By Technology

• In Vivo Studies
• In Vitro Studies
• Ex Vivo Studies
• Imaging Technologies
  • Ultrasound Imaging
  • MRI Imaging
  • CT Imaging
  • Radionuclide Imaging
  • Other Imaging Technologies
• Other Technologies

By End-use

• Biopharmaceutical Companies
• Research and Academic Institutes
• Medical Device Companies

By State

• New Jersey
• Pennsylvania
• Massachusetts
• Florida
• North Carolina
• Texas
• Illinois
• Indiana
• Michigan
• California
• Rest of U.S.

Frequently Asked Questions

1. What geographic regions does your market research cover for the U.S. Preclinical CRO market?

• We have a global reach, with expertise spanning across continents, including North America, Europe, Asia-Pacific, Latin America, and the Middle East. We leverage a combination of primary and secondary research methodologies to offer country-level analysis.

2. How does your firm conduct cross-sectional analysis for the U.S. Preclinical CRO market?

• We conduct cross-sectional analysis by examining data from different individuals at a single point in time to identify patterns and trends across diverse segments of the market.

3. Can your firm customize market research solutions to meet specific client needs?

• Our experienced team works closely with clients to gain a thorough understanding of their business goals and target markets. We have the expertise and flexibility to develop bespoke research solutions.

4. Do you offer ongoing support or consultation to clients after the completion of a market research project?

• Our team of experienced analysts is available to address any questions, concerns and needs that may arise following the delivery of the report.

5. Can your market research firm help with competitor analysis for U.S. Preclinical CRO market?

• Through a combination of quantitative and qualitative research methodologies, we meticulously assess the strengths, weaknesses, strategies, and market positioning of your competitors.

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