In Vivo CRO Market Overview
According to a new market analysis, the In Vivo CRO Market was valued at USD 4.7 billion in 2023, is projected to more than double, reaching USD 9.2 billion by 2032, reflecting a compound annual growth rate (CAGR) of 8% over the forecast period from 2024 to 2032. The market is witnessing significant expansion due to the increasing reliance on preclinical animal models, a strong pipeline of oncology drugs, and a surge in GLP-compliant toxicology studies.
Growth Drivers
One of the core drivers fueling the growth of the In Vivo CRO market is the pharmaceutical industry’s rising emphasis on targeted therapies and personalized medicine, especially in oncology. Drug developers are increasingly outsourcing preclinical testing to CROs for cost efficiency, access to advanced animal models, and regulatory compliance support. Further, technological advancements such as AI-powered imaging and genetically modified rodent models are enhancing the speed and reliability of in vivo studies.
The global push for new drug development, supported by significant R&D investments across the U.S., Europe, and Asia Pacific, continues to strengthen market dynamics. In 2023 alone, the U.S. biopharmaceutical sector invested over USD 102 billion in research and development, with the FDA approving 53 new drugs, 85% of which underwent in vivo preclinical testing, primarily using rodent models.
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Rodents Dominate Model Type Segment
Rodents remain the cornerstone of in vivo research, holding 80% of the market share in 2023. Their dominance stems from genetic similarities with humans, short reproductive cycles, and cost-effective maintenance. According to the U.S. Department of Agriculture, rodents comprised 95% of all research animals used in 2023, with mice (61%) and rats (18%) leading the way.
These models are central to pharmaceutical research due to extensive genomic mapping and availability of transgenic strains. The NIH Knockout Mouse Project (KOMP) has produced over 8,500 unique mouse strains, enabling researchers to dissect gene function and disease mechanisms. Moreover, organizations such as the European Mouse Mutant Archive (EMMA) reported a 25% increase in rodent model requests in 2023, signaling growing demand for this segment.
Small Molecules Lead by Modality
The small molecules segment was the top contributor to market revenue in 2023, accounting for the majority share. These compounds continue to dominate drug discovery pipelines because of their favorable pharmacokinetics, lower production costs, and regulatory clarity. In the same year, 62% of all FDA-approved drugs were small molecules, with 75% of oncology clinical trials also targeting small molecule therapies.
Public-private initiatives are accelerating small molecule development. The NIH Molecular Libraries Program has screened over 500,000 molecules, and the European Lead Factory reported a 30% year-on-year increase in screening projects. The GAO has highlighted that small molecule drug development is 20–30% more cost-effective than biologics, which is crucial for early-stage pharmaceutical ventures.
Oncology Remains Leading Indication
Oncology was the largest indication segment in 2023, representing 28% of the total in vivo CRO market revenue. This is largely due to the global cancer burden and continued innovation in targeted therapies. Cancer remains one of the top causes of mortality globally, accounting for 10 million deaths in 2023, according to the World Health Organization (WHO).
The U.S. National Cancer Institute (NCI) allocated USD 6.9 billion in funding for cancer research in 2023, a 5% increase from the previous year. Regulatory activity reflects this trend: the FDA reported a 20% rise in IND applications for oncology drugs, while the EMA noted that 35% of marketing applications were for cancer-related products.
Additionally, the widespread adoption of patient-derived xenograft (PDX) models has improved translational relevance. The NCI’s PDX repository recorded a 40% jump in model requests in 2023, reflecting the growing reliance on personalized models in drug development.
GLP Toxicology Holds Strong Market Share
GLP-compliant toxicology testing held the largest revenue share by GLP type in 2023, a testament to its regulatory necessity and critical role in assessing drug safety. Every Investigational New Drug (IND) application submitted to the FDA requires robust GLP toxicology data.
In 2023, over 4,000 IND applications were approved, all necessitating such preclinical studies. The EMA reinforced this trend, stating that 95% of marketing authorizations included GLP toxicology data. This requirement is further validated by the OECD GLP guidelines, adhered to by more than 30 countries.
The demand is particularly high for gene therapies and nanomedicines, with the NIH’s National Toxicology Program observing a 25% increase in custom toxicology requests. This shows that as therapies evolve, the complexity of preclinical toxicology testing will continue to grow, further solidifying the role of GLP CROs.
Regional Insights: North America Leads, Asia Pacific Surges
North America dominated the in vivo CRO market in 2023, with a 49% market share, led by the U.S. pharmaceutical and biotechnology sectors. The NIH’s USD 41.7 billion research grant funding, combined with strong infrastructure and technological adoption, drives this dominance.
Asia Pacific is expected to register the fastest CAGR through 2032, owing to rapid outsourcing to nations like India and China. India’s “Pharma Vision 2023” and China’s “Healthy China 2030” programs are pushing R&D capabilities forward. In 2023, India saw a 15% increase in pharma R&D investment, while China increased biomedical research funding by 20%, according to the National Natural Science Foundation of China.
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Key Market Players
The in vivo CRO market is moderately fragmented with prominent players offering full-service capabilities across toxicology, pharmacokinetics, and animal model development. Key participants include:
Charles River Laboratories
Labcorp Drug Development
WuXi AppTec
Covance
Parexel International
ICON plc
Syneos Health
Crown Bioscience International
Medpace
Envigo
Pharmaron
Eurofins Scientific
Biocon
Frontage Laboratories
BASi
QuintilesIMS (IQVIA)
PPD
MPI Research
Recent Developments
Covance launched an AI-powered imaging analysis platform in November 2024, which reportedly reduces data analysis time by up to 40%, enhancing preclinical efficiency.
WuXi AppTec opened a new in vivo pharmacology facility in Suzhou, China, in March 2024, boosting capabilities in immuno-oncology and neuroscience research.
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