Oncology Based In-vivo CRO Market By Model Type (Syngeneic Models, Xenograft Models, Orthotopic Models, Genetically Engineered Models {GEMs}, and Others), By Service Type (Toxicology Testing, Efficacy Testing, Drug Discovery and Development, Pharmacokinetics and Pharmacodynamics (PK/PD), Biomarker Analysis, and Others), By Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Prostate Cancer, Hematological Malignancies, and Others), By End-User (Pharmaceutical and Biotechnology Companies, Academic and Research Institutions, Government and Non-Profit Organizations, and others), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Oncology Based In-vivo CRO market accounted for USD 1.54 Billion in 2024 and is expected to reach USD 3.21 Billion by 2035, growing at a CAGR of around 6.9% between 2025 and 2035. The Oncology Based In-vivo CRO Market means the oncology business of preclinical research outsourcing using live animal models.

These services help the pharmaceutical, biotechnology, and research establishments to establish the potency, toxicity, and pharmacokinetics profile of oncology drugs in preclinical medicine trials. It uses complex model procedures such as xenografts, genetically engineered models, and orthotopic models to imitate human tumor formation. Market: This market is important in an area that needs to be closely addressed to accelerate the identification and development of cancer medication.

Report Scope:

Market Dynamics

Rising cancer prevalence increasing demand for preclinical research in oncology drug development

The Oncology Based In-vivo CRO Market is slowly on the rise due to the increasing occurrence of cancer across the world. While cancer rates continue to increase, so does the pressure on pharmaceutical and biotechnology organizations to deliver effective drugs faster. The use of live animal models in preclinical research is paramount in this respect due to its ability to determine drug effectiveness, recklessness, and kinetics before a clinical trial. This has led to a higher need for the niche services offered by oncology-based in vivo CROs, which employ state-of-the-art models, including xenografts and genetically modified systems, to mimic actual tumor behavior. The listed services are crucial for the acceleration of drug discovery and relevant oncological treatments’ safety.

Higher healthcare spending and raised funding for cancer activities also help develop the oncology-based in-vivo CRO industry. Cancer-related programs are effectively supported by governments, non-profit organizations, and corporations. This has increased the global market for preclinical CRO services. In addition, with new and improved animal model technology, these CROs are now able to present better and more accurate results for the pharmaceutical and biotech companies they work with, leading to increased clientele. This is especially true since the overall number of people diagnosed with cancer is rising, and innovations in research methods and technology for oncology-focused in-vivo CROs make the industry a key participant in today’s drug development.

Growing R&D investments by pharmaceutical and biotechnology companies driving market expansion

The Oncology Based In-vivo CRO Market is expected to grow at a fast pace owing to the rising research and development expenditures carried out by the pharma and biopharma industries. These expenditures are important because cancer is still one of the most dangerous diseases in the world and new therapies have to be discovered. In-vivo CROs are helpful for corporations in offering exclusive preclinical research: effectiveness and toxicity of medication, and pharmacokinetics. Lately, there has been a rising trend of funds dedicated to oncology research and development allowing firms to outwardly outsource initiatives to CROs to optimize value chains, minimize costs, and gain release time frames for new cancer treatments. This reliance makes a drug candidate heavily analyzed in models that mimic the clinical environment, thus enhancing the trials.

The Market shares the same advantage with the consolidating outsourcing trend, which defrays internal infrastructure expenses and capitalizes on CRO’s expertise. It has also recently emerged that pharmaceutical and biotechnology enterprises use CROs that offer sophisticated animal models like patient-derived xenografts and genetically altered models, which properly mimic human cancer characteristics. Such partnerships allow firms to focus on the main original research and development aims, leaving the intricacies of the preclinical stages to other parties. Cancer treatment has gained much attention worldwide, and now there is a great potential for growth of the market owing to an increase in the R&D expenditure and improvements in the endowed capabilities of the CRO industry.

Ethical concerns and regulatory restrictions on animal testing impacting market growth

The Oncology Based In-vivo CRO Market faces several challenges because of legal issues tied to the utilization of live animals in research. A lot of times, business associations and certain social pressure groups regard the issue of animal testing as immoral interference with the rights of animals. Many places have implemented rules requiring CROs to follow ethical guidelines and minimize the use of animals as a result of these concerns. Furthermore, public opposition to animal testing frequently compels governments and academic institutions to find alternative approaches. The scalability of preclinical oncology investigations may be impacted by these limitations since they can generally slow down research operations.

Changing dynamics within the field of oncology Higher expenses and greater operational complexity result from the need to adhere to new and more stringent ethical standards in the in-vivo CRO market. They noted that study clearance typically takes a while since many nations require evidence and justification for using animals. To compete with in vivo investigations, this environment also facilitates the adoption of other approaches, such as computational simulation models and in vitro methods. These regulations have the effect of restricting the expansion and acceptability of the new service, particularly if it is carried out in an area with strict laws, even if they are necessary to maintain professionalism and ethical standards when using in-vivo CRO services.

Increasing focus on personalized medicine creates demand for specialized In-vivo CRO services.

The focused treatment is expected to strongly boost Oncology Based In-vivo CRO Market services demand. This idea of making treatment relative to an individual’s genotype requires the employment of quite sophisticated animal models that mimic human tumor-related genotypes. About oncology-based in-vivo CRO market companies could utilize more sophisticated models like PDX models to make improved estimates relating to medication responses, resulting in more proper medicines for multiple populations. This trend is therefore creating a call for suitably custom preclinical scientific studies as well as services.

In vivo models that mimic patients’ characteristics of a tumor allow researchers to study the outcomes of targeted treatments more objectively. This potential is driving the growth of the Oncology Based In-vivo CRO Market and positioning it as part of innovative customized medication design. As advanced cancer therapy options become even more personalized, there is an increasing need for CROs to provide unique preclinical testing that is suggestive of the latest genomics and biomarker investigations.

Emerging markets offering untapped potential for preclinical oncology research outsourcing growth

The Oncology Based In-vivo CRO Market has the advantage of great opportunities in emerging markets, as there have been rising tendencies in investments in the continued development of healthcare facilities and research capabilities. With the growth of Asian-Pacific and Latin American nations, as well as certain Middle Eastern and African nations, the need to develop oncotherapy drugs also rises. These markets offer the opportunity for efficiency in terms of cost for pharmaceutical and biotechnology firms so that they can do preclinical studies, hence contributing to the expansion of the Oncology Based In-vivo CRO Market in these regions.

Local research institutions and international drug makers are strategically partnering more frequently in emerging countries to expedite the discovery of new oncology products. Because of the advanced oncology research facilities at the resulting local research hubs, BioTek sees a fast-growing market for some preclinical services, such as in-vivo cancer models. It has enormous growth potential in the oncology-based in vivo CRO industry, allowing CRO firms to extend their services to nations where there is a growing need for oncology drugs.

Industry Experts Opinion

“We are still not able for the most part to separate the more indolent cancers from those that are more aggressive. As we find more cancers, that has become an increasingly important distinction. For now, suffice to say – especially for prostate cancer – we are probably treating many more people with aggressive therapies that they really don’t need.”

• Dr Len Lichtenfeld, Deputy Chief Medical Officer, American Cancer Society

Segment Analysis

Based on Model Type, the Oncology-Based In-vivo CRO Market is divided into syngeneic models, xenograft models, orthotopic models, and genetically engineered models. In the types of models within the Oncology Based In-vivo CRO Market, xenograft models are the most numerous and important type. These models involve the injection of human tumor cells into immunodeficient mice and subsequently allow investigation of tumor biology and therapeutic efficacy. This is due to the high resemblance of xenograft models to human specimens, and they are crucial to preclinical cancer drug development. They are most useful in assessing new cancer therapies, including targeted therapy and immunotherapy. These findings in mimicking human tumor behavior and predicting clinical outcomes do strengthen their preeminent position in the market proficiently.

Based on Service Type, the Oncology-Based In-vivo CRO Market is categorized into efficacy testing, toxicology testing, drug discovery and development, pharmacokinetics and pharmacodynamics (PK/PD), biomarker analysis, and others. The Oncology Based In-vivo CRO Market’s largest and most evident segment is efficacy testing. This testing assesses the anticancer efficacy of oncology drugs in in vivo models for determining tumor sensitivity/resistance, survival, and therapeutics. The efficacy testing is crucial when it comes to proving the efficiency of the newly developed therapy types Such as chemotherapy, immunotherapy, and target therapy. Part of its value is found in clinical implications and the progression of pharmaceutical compounds, from experimental stages into formal processes and preclinical evaluation. Since there is a trend towards individualized therapy in cancer, this segment is large because it directly affects the identification of successful treatment strategies and the enhancement of the development of these treatments.

Regional Analysis

The North American Oncology Based In-vivo CRO Market is growing rapidly. due to the substantial number of thriving biotech and pharmaceutical firms as well as established healthcare systems. Due to strong R&D funding and a significant demand for preclinical oncology services, the United States currently leads the world in cancer research and treatment development. The presence of well-known contract research organizations (CROs) in North America contributes to the market's dominance and leadership on a global scale.

The Asia-Pacific Oncology Based In-vivo CRO Market has the highest growth rate because of the progressing financial development rate, emerging healthcare spending, and improved research capabilities in countries including China and India. The cost advantage when carrying out preclinical research in these nations and the growing partnership between national and international pharmaceutical enterprises are other factors contributing to the demand to outsource oncology research. These factors are enabling Asia-Pacific to become an important zone for oncology drug development and subsequently fuel the market growth.

Competitive Landscape

The Oncology Based In-vivo CRO Market is very much concentrated, and the players that are industry-leading are few. They consist of Charles River Laboratories, Envigo, and Labcorp drug development, among others, offering strategic in vivo oncology research solutions for different models and therapeutic areas. These companies hold established expertise in the research of cancer and preclinical services due to advanced technologies and worldwide facilities. Being established and highly operational with the capacity to provide tailored systems, they are leading rivals in the market.

New entrants, including Crown Bioscience and Horizon Discovery, are entering the highly competitive industry through service niches, especially in oncology research and model systems. These firms have concentrated on innovative types like genetically engineered mice models and patient-derived xenografts to provide expert services for the development of cancer treatments. These rising companies will be able to capture a larger share of the future Oncology Based In-vivo CRO Market since there remains a greater demand for greater precision therapies and more target-specific therapies.

Oncology Based In-vivo CRO Market, Company Shares Analysis, 2024

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Recent Developments:

• In March 2024, ND-based Agathos Biologics, Fargo launched its recombinant adeno-related virus (rAAV) production service using AE1-BHK, the company’s proprietary cell line. Agasthos recorded its first sale of rAAV to CMO, CRO, and Genovac
• In February 2024, building the leading platform for cell programming and biosecurity, Ginkgo Bioworks announced a groundbreaking ecosystem of cutting-edge technology partners, the freation of the Ginkgo Technology Network. This new Ginkgo provides integrated and new capabilities to improve success in consumer R&D activities.

Report Coverage:

By Model Type

• Syngeneic Models
• Xenograft Models
• Orthotopic Models
• Genetically Engineered Models (GEMs)
• Others

By Service Type

• Toxicology Testing
• Efficacy Testing
• Drug Discovery and Development
• Pharmacokinetics and Pharmacodynamics (PK/PD)
• Biomarker Analysis
• Others

By Indication

• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Prostate Cancer
• Hematological Malignancies
• Others

By End-User

• Pharmaceutical and Biotechnology Companies
• Academic and Research Institutions
• Government and Non-Profit Organizations
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Charles River Laboratories
• Labcorp Drug Development
• ICON plc
• WuXi AppTec
• Parexel International
• Envigo
• Medpace
• Pharmaron
• Syneos Health
• IQVIA
• Taconic Biosciences
• Champions Oncology
• Crown Bioscience
• XenTech
• Horizon Discovery
• InVivo Biosystems
• Oncodesign
• GemPharmatech
• Eurofins Scientific
• Polaris Biotechnology

Frequently Asked Questions (FAQs)