The oncology-based in-vivo CRO (contract research organization) market is set to grow substantially as the demand for preclinical oncology studies continues to rise. In-vivo CROs play a vital role in helping pharmaceutical and biotechnology companies conduct animal studies to evaluate the efficacy and safety of novel cancer therapies. In 2025, the global oncology-based in-vivo CRO market is estimated to be valued at approximately USD 1,352.8 Million. By 2035, it is projected to grow to around USD 3,638.7 Million, reflecting a compound annual growth rate (CAGR) of 10.4%.
Key Market Metrics
| Metric | Value |
|---|---|
| Market Size in 2025 | USD 1,352.8 Million |
| Projected Market Size in 2035 | USD 3,638.7 Million |
| CAGR (2025 to 2035) | 10.4% |
With the growing prevalence of cancer worldwide, the increasing complexity of cancer research, and the need for rapid drug development, many companies are turning to specialized CROs for their expertise, advanced facilities, and regulatory compliance. Advancements in in-vivo models, personalized medicine, and targeted therapies are further driving the demand for preclinical oncology services, ensuring robust market growth through 2035.
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The oncology-based in-vivo CRO services market in North America dominated the global market, due to the well-established biotechnology and pharmaceutical industry, R&D spending, and regulatory framework. Industry leaders in the US and Canada, where many companies are in the field of cancer research and oncology drugs in development.
Another important market is Europe, which has a mature clinical research industry, substantial funding for cancer research and growing interest in personalized medicine respectively. Countries such as Germany, the UK, and France are steadily building their strength in in-vivo oncology studies, encouraged by a strong academic-industry link and clear regulatory pathways.
Oncology-based in-vivo CRO services find their most demand in Asia-Pacific since the pharmaceutical and biotech industries are growing rapidly in this region, with a rise in cancer incidence rates and increased R&D investments. Countries like China, Japan, and South Korea are heavily investing in oncology research, constructing cutting-edge preclinical research facilities that are fueling regional growth in the market.
Challenges
High Study Costs, Complex Regulatory Compliance, and Limited Translational Models
However, the Oncology-based In-vivo Contract Research Organization (CRO Market) size is hindered by high preclinical oncology study costs associated with specialized models, tumor xenografts, genetically engineered mouse models (GEMMs), and longitudinal imaging technologies.
These studies require a significant amount of resources and time and this impacts the lead time for results and the budget for R&D for the sponsors. Regulatory compliance is another area in which CROs face significant challenges, as they are subject to stringent GLP (Good Laboratory Practices) guidelines, IACUC, and international animal welfare protocols, all of which can be especially relevant for oncology studies that involve tumor burden and ethical endpoints.
In addition, caner drug development is an area that faces a critical bottleneck: The lack of high-predictive in-vivo models that rigorously mirror human tumor heterogeneity has led to the pitifully low translation rate from the bench to the clinical trials.
Opportunities
Precision Oncology, Humanized Models, and AI-Driven Data Analytics
Despite the restraints in the market, the oncology based in-vivo CRO market moving ahead through strong growth opportunities such as rising demand for personalized oncology, humanized mouse models and AI-enabled in-vivo study platforms. CROs providing biomarker-driven tumor profiling, PDX, and immuno-oncology platforms are currently witnessing a tremendous traction in checkpoint inhibitor and CAR-T therapeutic development.
Artificial intelligence and machine learning for automated tumor volume assessment, image analysis, and predictive modeling are improving data accuracy and turnaround time. In addition, alliances between biotechnology companies, academia and CROs are also paving the way for data-sharing networks and AI-enabled preclinical study design that will help drive the scalability and competitiveness of in-vivo oncology service offerings.
| Market Shift | 2020 to 2024 Trends |
|---|---|
| Regulatory Landscape | Compliance with GLP, IACUC, OECD guidelines, and ethical tumor burden regulations. |
| Consumer Trends | High demand for PDX models, orthotopic tumor models, and immuno-oncology trials. |
| Industry Adoption | Strong growth from biotech startups and early-phase oncology drug developers. |
| Supply Chain and Sourcing | Use of commercial mouse colonies, syngeneic tumor cells, and imaging reagents. |
| Market Competition | Dominated by niche oncology CROs, academic labs, and boutique preclinical service providers. |
| Market Growth Drivers | Boosted by immunotherapy research, orphan oncology designations, and academic-industry partnerships. |
| Sustainability and Environmental Impact | Low emphasis on green lab practices or data reuse. |
| Integration of Smart Technologies | Early use of IVIS imaging, digital calipers, and electronic lab notebooks (ELNs). |
| Advancements in Oncology Modeling | Growth in GEMMs, syngeneic and xenograft tumor studies. |
| Market Shift | 2025 to 2035 Projections |
|---|---|
| Regulatory Landscape | Enhanced enforcement of AI-assisted compliance audits, digital animal welfare tracking, and 3Rs principle integration. |
| Consumer Trends | Surge in fully humanized models, CRISPR-edited mouse lines, and AI-designed translational oncology pipelines. |
| Industry Adoption | Widespread integration by big pharma, CDMOs, and AI-drug discovery platforms. |
| Supply Chain and Sourcing | Shift toward biobank-driven tumor sourcing, patient-derived explant repositories, and 3D tumor co-culture supplements. |
| Market Competition | Entry of AI-integrated CRO networks, global preclinical alliances, and digital twin-based trial simulations. |
| Market Growth Drivers | Accelerated by precision oncology R&D, AI-guided dosing models, and digital pathology standardization. |
| Sustainability and Environmental Impact | Adoption of AI-optimized trial reduction, virtual tumor modeling, and sustainable animal housing systems. |
| Integration of Smart Technologies | Expansion into cloud-based LIMS, AI for tumor burden analytics, and blockchain -enabled data traceability. |
| Advancements in Oncology Modeling | Evolution toward multi-omics-integrated in-vivo trials, digital twins, and 4D tumor mapping systems. |
The USA based oncology-oriented in-vivo CRO industry growth is also supported by the increasing investments for research and development in the field of cancer therapeutics and robust pipeline of oncology drugs, which has increased the demand for preclinical efficacy and safety studies. The presence of major CROs and biotechnology hubs in the country, along with support from the National Cancer Institute (NCI) and FDA for the expedite of oncology research is aiding the market growth.
| Country | CAGR (2025 to 2035) |
|---|---|
| USA | 10.6% |
The United Kingdom market is growing due to the increasing partnerships between clinical research organizations (CROs) and academic research institutions, the rising trend of outsourcing clinical trial and a nationwide push towards precision oncology. The increasing demand for in-vivo models that closely mimic human tumor biology is stampeding the requirement for specialized CRO services.
| Country | CAGR (2025 to 2035) |
|---|---|
| UK | 10.2% |
The oncology-based In-vivo CRO market across European Union is emerging in a stable manner propelled by EU-funded programs to support cancer research programs, enhancing bioscience clusters, and increasing involvement in immuno-oncology studies. The move towards personalized medicine and targeted therapies is creating demand for advanced in-vivo models and translational research services.
| Country | CAGR (2025 to 2035) |
|---|---|
| European Union (EU) | 10.4% |
The Japan Oncology-based In-vivo CRO market is growing at a healthy rate due to government incentives for cancer drug development, rising clinical trials activity, and an increasing focus on the treatment of geriatric oncology. In Japan, the humanized mouse models and genetically engineered models (GEMs) are gaining widespread popularity among CROs.
| Country | CAGR (2025 to 2035) |
|---|---|
| Japan | 10.3% |
The market in South Korea is spearheaded by rapid growth witnessed in biotech start-ups, conducive regulatory support for preclinical outsourcing and increasing emphasis on biosimilar oncology development. The use of xenograft models and syngeneic tumors is improving the preclinical assessment of oncology pipelines.
| Country | CAGR (2025 to 2035) |
|---|---|
| South Korea | 10.6% |
There is a significant growth in the oncology-based in-vivo CRO market due to the growing number of preclinical research services that provide service with increased human cancer biology similarity. Pharmaceutical and biotechnology companies rely on contract research organizations (CROs) that provide oncology-based in-vivo models service for drug efficacy testing, pharmacokinetics, toxicology, and tumor biology research.
These CROs help with development timelines, predictability of the drug, and transition to trials. It is segmented by Indication (Blood Cancer, Solid Tumors), Model Types (Xenograft, Patient-Derived Xenograft [PDX], Syngeneic Models.
| Indication | Market Share (2025) |
|---|---|
| Solid Tumors | 48.2% |
Based on indication type, the solid tumor segment currently holds the largest part of the global oncology-based in-vivo CRO market and is expected to reach 48.2% by 2025. This group consists of several cancer types such as breast, lung, colorectal, pancreatic, and prostate cancers, which together represent a significant percentage of global cancer incidence. CROs are much more commonly engaged by drug developers to determine tumor growth inhibition, angiogenesis, metastasis and immune modulation in solid tumor models.
CROs offer very well validated xenograft and PDX based solid tumor models that mimic human tumor heterogeneity for more predictive translational outcomes. As immunotherapy and targeted biologics remain the dominant modality in oncology pipelines, the need for accurate in-vivo models of solid tumor indications are likely to remain strong across both early discovery and late-stage preclinical programs.
| Model Type | Market Share (2025) |
|---|---|
| Xenograft | 42.7% |
Xenograft model types lead the list of oncology in-vivo CRO services model types with an anticipated market share of approximately 42.7% by the year 2025. In this type of model, human cancer cells are implanted in immunodeficient mice which are then used to study tumor phenotypic and genotypic evolution, drug metabolism, and the response to therapy in a system relevant to humans.
Xenograft models are commonly favored because of their scalability, reproducibility, and reliability in standard oncology drug development programs. They are particularly well-suited to screening cytotoxic drugs, to testing tumor-targeting agents, and to exploring combinatorial treatments. While PDX as well as syngeneic models are gaining traction, xenografts are still the model of choice for companies that want the quickest turnaround with the strongest scientific validity at the best price.
The oncology-based in-vivo CRO (Contract Research Organization) market is growing at a healthy pace due to the increasing prevalence of cancer, the growing complexity of cancer preclinical efficacy studies, and improvements in humanized mouse models and artificial intelligence (AI)-guided imaging technologies.
CROs are investing in tumor xenograft models, immuno-oncology platforms, and personalized drug response testing. Strategic investments, worldwide expansion and implementation of 3D tumor modeling and predictive analytics are a few trends dominating the competitive landscape.
Market Share Analysis by Company
| Company Name | Estimated Market Share (%) |
|---|---|
| Charles River Laboratories | 18-22% |
| Crown Bioscience Inc. (JSR Life Sciences) | 14-18% |
| Envigo (part of Inotiv Inc.) | 10-14% |
| Champions Oncology, Inc. | 8-12% |
| The Jackson Laboratory | 5-9% |
| Other Companies (combined) | 30-40% |
| Company Name | Key Offerings/Activities |
|---|---|
| Charles River Laboratories | In February 2024 , expanded its humanized tumor model portfolio for checkpoint inhibitor testing. In January 2025 , introduced AI-driven in-vivo imaging platforms to support faster preclinical oncology trials. |
| Crown Bioscience | In March 2024 , launched new PDX models for hematologic cancers and expanded multi-omics tumor profiling. In February 2025 , opened a new preclinical oncology center in Europe to meet rising demand for in-vivo CRO services. |
| Envigo ( Inotiv Inc.) | In April 2024 , introduced rapid-response oncology screening services using murine models. In January 2025 , rolled out AI-based analytics for tumor volume prediction and drug efficacy scoring. |
| Champions Oncology | In May 2024 , released TumorGraft ® PDX models tailored for rare cancers. In February 2025 , added personalized immune-oncology study design services integrated with real-world oncology datasets. |
| The Jackson Laboratory | In August 2024 , expanded its syngeneic and GEMM platforms for immunotherapy studies. In March 2025 , deployed AI-enhanced behavioral monitoring tools for assessing tumor-burden-related endpoints. |
Key Company Insights
Charles River Laboratories (18-22%)
A dominant player in the preclinical CRO space, Charles River offers a comprehensive suite of in-vivo oncology models, including humanized mouse systems, and real-time imaging for tumor progression tracking. Their 2025 AI rollout enhances precision in early-phase cancer research.
Crown Bioscience (14-18%)
CrownBio leads in PDX and CDX platforms for solid and hematologic tumors. It continues to expand geographically and technologically with multi-omics capabilities and next-gen tumor profiling tools that support global biotech clients.
Envigo (Inotiv Inc.) (10-14%)
Envigo has strengthened its position with quick-turnaround screening platforms, especially for targeted therapies and immunomodulators. The company leverages AI for faster decision-making in preclinical pipelines.
Champions Oncology (8-12%)
Focused on precision oncology, Champions offers customizable PDX models, AI-backed tumor analytics, and real-world data integration to help biopharma partners accelerate drug development in niche and rare indications.
The Jackson Laboratory (5-9%)
Renowned for its genetically engineered mouse models (GEMMs), Jackson Lab plays a critical role in immune-oncology drug testing. Its 2025 innovation focuses on behavioral endpoints and advanced syngeneic tumor assessments.
Other Key Players (30-40% Combined)
The overall market size for the oncology-based in-vivo CRO market was USD 1,352.8 Million in 2025.
The oncology-based in-vivo CRO market is expected to reach USD 3,638.7 Million in 2035.
Growth is driven by the rising global cancer burden, increasing demand for preclinical oncology drug testing, advancements in personalized medicine, and growing outsourcing of R&D by pharmaceutical and biotech companies to accelerate oncology drug development.
The top 5 countries driving the development of the oncology-based in-vivo CRO market are the USA, China, Germany, Japan, and the UK.
Solid Tumor and Xenograft Models are expected to command a significant share over the assessment period.
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Oncology-Based In-vivo CRO Market
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