U.S. Preclinical CRO Market Size To Reach $3.1 Billion By 2033

U.S. Preclinical CRO Market Growth & Trends

The U.S. preclinical CRO market size is anticipated to reach USD 3.1 billion by 2033, growing at a CAGR of 7.7% from 2024 to 2030, according to a new report by Grand View Research, Inc. Factors such as the increasing expenditure on R&D activities and the focus of pharmaceutical companies on cost reduction are driving the market growth.

There has been a significant increase in the R&D budget for early-stage and late-stage drug development processes, which is expected to contribute to market growth. The rising biopharmaceutical failure rates and the costs they entail have also driven the biopharmaceutical & life sciences companies to focus more on the early stage of the drug discovery and development process. This is likely to propel the growth of the market for preclinical CRO.

The increasing cases of Alzheimer's disease globally, demand for cutting-edge gene therapies, incidence of neurodegenerative diseases, and high prevalence of genetic disorders are some of the factors promoting the growth of advanced therapies. A substantial number of major & small biotechnology companies are driving innovation in this field in terms of technology & manufacturing capabilities, thereby offering commercial opportunities for market expansion.

Furthermore, the recent approval of new products has accelerated R&D activities. For instance, in December 2023, the FDA approved two groundbreaking treatments-Casgevy and Lyfgenia. These treatments mark a significant milestone as the first cell-based gene therapies suggested for the treatment of sickle cell disease in patients aged 12 and older.

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U.S. Preclinical CRO Market Report Highlights

• The toxicology testing segment led the market with the largest revenue share of 25.5% in 2025. The segment growth is attributed to the essential role of toxicology studies in evaluating drug safety before clinical trial initiation.

• The preclinical optimization, efficacy & PK/PD segment led the U.S. preclinical CRO industry with the largest revenue share of 34.3% in 2025. The segment growth is supported by the growing need to refine lead candidates, evaluate therapeutic efficacy, and establish exposure-response relationships before IND-enabling studies.

• The oncology segment led the U.S. preclinical CRO market with the largest revenue share of 35.7% in 2025. The segment’s growth is driven by the strong oncology drug pipeline, high R&D investment, and increasing demand for predictive cancer models.

• The in vivo segment led the U.S. preclinical CRO industry with the largest revenue share of 56.7% in 2025. The segment growth is attributed to the continued requirement for animal-based studies in safety, efficacy, toxicology, PK, biodistribution, and IND-enabling evaluations.

U.S. Preclinical CRO Market Segmentation

Grand View Research has segmented the U.S. preclinical CRO market report based on service, development stage, indication, model type, and end use:

U.S. Preclinical CRO Service Outlook (Revenue, USD Million/Billion, 2021 - 2033)

• 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

• Others

U.S. Preclinical CRO Development Stage Outlook (Revenue, USD Million/Billion, 2021 - 2033)

• Target Discovery

• Preclinical Optimization, Efficacy & PK/PD

• IND-Enabling Safety (GLP)

• Bioanalysis & Analytics

U.S. Preclinical CRO Indication Outlook (Revenue, USD Million/Billion, 2021 - 2033)

• Oncology

• CNS

• Infectious Diseases

• Cardiovascular Diseases

• Metabolic Disorders

• Rare Diseases

• Others

U.S. Preclinical CRO Model Type Outlook (Revenue, USD Million/Billion, 2021 - 2033)

• In Vitro

• In Vivo

• Ex Vivo

U.S. Preclinical CRO End Use Outlook (Revenue, USD Million/Billion, 2021 - 2033)

• Pharmaceutical and Biopharmaceutical Companies

• Medical Device Companies

• Academic and Research Institutes

• Others

List of Key Players of U.S. Preclinical CRO Market

• Eurofins Scientific

• ICON plc

• Medpace Holdings, Inc.

• Charles River Laboratories

• PPD (Thermo Fisher Scientific, Inc.)

• SGS SA (SGS Société Générale de Surveillance SA.)

• Intertek Group plc (IGP)

• Labcorp

• Crown Bioscience