Oncology Based In-vivo CRO Market – By Service, By Model, By End Use – Global Forecast, 2025 – 2034

Oncology Based In-vivo CRO Market Size

The global oncology based in-vivo CRO market size valued at USD 1.4 billion in 2024 and is projected to exhibit 8.8% CAGR from 2025 to 2034. The market is growing due to growing demand for immuno-oncology therapies, advancements in in-vivo models, and growing oncology drug approvals from small biotechnology and pharmaceutical companies.
 

Small biotechnology and pharmaceutical companies are increasingly driving oncology drug approvals, significantly boosting the growth of the oncology-based in-vivo CRO market. These firms are at the forefront of pioneering cancer research, exploring innovative treatments such as CAR-T cell therapy, monoclonal antibodies, and gene therapies. Their specialized focus enables them to address specific unmet needs in oncology. According to a study published by National Center for Biotechnology Information in February 2023, small pharmaceutical companies led the U.S. FDA oncology drug approvals during 2010 and 2020, securing over three times the number of FIC-approved drugs than their larger counterparts, boasting a 46% share against the latter's 14%.  
 

Oncology based in-vivo CRO specializes in providing outsourced preclinical and early-stage research services for cancer drug development. These services primarily involve in-vivo studies to evaluate the efficacy, safety, pharmacokinetics, and toxicity of oncology drugs.
 

Oncology Based In-vivo CRO Market Trends

The oncology-based in-vivo CRO market is evolving rapidly due to advancements in cancer research and the increasing demand for innovative drug development solutions, with several trends shaping the market.

• The surge in immunotherapies, such as immune checkpoint inhibitors and CAR-T cell therapies, has led to increased demand for in-vivo studies to evaluate immune-oncology interactions. Syngeneic models, which support immunocompetent systems, are becoming essential in this segment.
   
• Start-ups and mid-sized biotech companies are outsourcing preclinical research to CROs to leverage expertise and reduce costs. These companies focus on niche areas, fueling demand for specialized CRO services.
   
• Additionally, artificial intelligence and machine learning are being integrated into in-vivo studies to improve data analysis, enhance model predictability, and reduce study timelines. Advanced imaging technologies (e.g., PET, MRI) are being combined with AI to provide real-time insights into tumor progression and treatment efficacy.
   
• Moreover, pharmaceutical and biotech companies are forming strategic alliances with CROs to co-develop new therapies and expand access to advanced research models. For instance, in February 2021, Charles River Laboratories entered into a strategic partnership with Kibur Medical to provide exclusive access to Kibur's implantable microdevice. This collaboration aims to enhance in vivo preclinical oncology studies by enabling researchers to more accurately assess the efficacy of oncology compounds, both as individual treatments and in combination therapies.
   

Oncology Based In-vivo CRO Market Analysis

Based on service, the market is segmented into preclinical testing, efficacy testing, toxicology studies, pharmacokinetics, and other services. Preclinical testing segment dominate the market with a share of 33.2% in 2024.
 

• The preclinical testing segment leads the oncology-based in-vivo CRO market due to its pivotal role in the drug development process. Regulatory agencies, including the U.S. FDA and EMA, require preclinical testing before allowing clinical trials. This step guarantees the safety and efficacy of drug candidates prior to human testing. Preclinical studies provide crucial data on toxicity, pharmacokinetics, pharmacodynamics, and therapeutic potential, making them indispensable in the drug development pipeline.
   
• Additionally, the growing number of oncology drug candidates in the pipeline has significantly increased the demand for preclinical testing. Small and large biotech and pharmaceutical companies are heavily investing in cancer therapies, particularly in areas like immuno-oncology and targeted therapies, further fueling the need for preclinical evaluation. According to an American Health and Drug Benefits study published by National Center for Biotechnology Information in December 2021, about oncology accounted for 75% of pharmaceutical research and development efforts.
   

Based on model, the oncology based in-vivo CRO market is segmented into xenograft, syngeneic, other models. The xenograft is further sub-segmented as patient derived xenograft, cell-line derived xenograft, and other xenografts. The xenograft segment held a dominating share of 48.2% in the oncology-based in-vivo CRO market in 2024.
 

• The crucial factors contributing to the leading share of xenograft are their unmatched ability to simulate human tumor biology and provide critical insights into cancer drug efficacy. Xenograft models involve implanting human tumor cells or tissues into immunocompromised mice, offering a more accurate representation of human cancer biology compared to other models.
   
• Additionally, surge in immunotherapy research, such as immune checkpoint inhibitors and CAR-T cell therapies, has further surged the demand for xenograft models globally.
   
• Moreover, as these models are derived directly from patient tumor tissues, they preserve the genetic, molecular, and histological characteristics of the original tumor, which supports the development of precision oncology drugs, contributing to the increased use of xenograft models.
   

Based on end user, the oncology based in-vivo CRO market is segmented into pharmaceutical companies, biotechnology companies, and other end users. The pharmaceutical companies segment dominated the market with a share of about 52.1% in the year 2024.
 

• Pharmaceutical companies are increasingly dependent on CROs for continuous research and development, driven by the substantial revenue generated from cancer drugs. As a result, these companies have become the primary end-users of oncology in-vivo CRO services. According to a January 2022 study published by National Center for Biotechnology Information, over the past decade, the top 10 global pharmaceutical companies have experienced a 70% surge in cancer drug sales revenues.
   
• Pharmaceutical companies are increasingly adopting multi-drug regimens, which require comprehensive in-vivo testing to evaluate efficacy, toxicity, and pharmacokinetics. In-vivo CROs, with their specialized capabilities in combination therapy assessments, have become vital partners for these companies.
  
   

In 2024, the U.S. led the North American oncology based in-vivo CRO market, generating a revenue of about USD 509 million.
 

• The leading share of the country can be primarily attributed to significant investments in cancer research, and strong presence of pharmaceutical and biotechnology companies. For instance, according to the American Society of Clinical Oncology, NIH invests about USD 65 billion in cancer-based research each year in the U.S.
   
• Moreover, The U.S. is home to leading companies such as Pfizer, Merck, Bristol-Myers Squibb, and Amgen, which are heavily invested in oncology drug development. These companies outsource preclinical and in-vivo studies to CROs, driving demand for advanced in-vivo testing services.
   
• Additionally, FDA's accelerated approval pathways and orphan drug designation to many pipelines under clinical stages have boosted the availability of oncology therapies for rare cancers in the U.S., driving the demand for preclinical studies and pharmacokinetics in the country.
   

The UK is set to see a robust expansion in its oncology based in-vivo CRO market from 2025 to 2034.
 

• Increasing incidence of cancer is driving the demand for advanced cancer therapies, further contributing to an increased demand for oncology-based in-vivo studies across CROs in the country. According to Cancer Research UK, each year, the UK witnesses over 385,000 new cancer diagnoses.
   
• Further, the UK has some of the world’s leading research institutions, such as the University of Oxford, University of Cambridge, and The Institute of Cancer Research. The presence of these esteemed research institutions together with growing investment in research and development for new oncology therapies is driving the revenue growth in UK oncology-based in-vivo CRO market.
   
• For instance, according to the UK Research and Innovation (UKRI), in October 2024, Innovate UK and the Office for Life Sciences (OLS) have announced additional funding to support innovation in cancer treatment. As part of the advancing precision medicines competition, Innovate UK and OLS will invest USD 4.2 million in six projects. This funding aligns with the Life Sciences Vision Cancer Mission. This announcement follows a 2023 initiative where seven cancer projects received a total of USD 4.73 million.
   

Japan's oncology based in-vivo CRO market is set for lucrative growth from 2025 to 2034.
 

• Growing support from government initiatives for cancer research to address the country's aging population and increasing cancer incidence is driving the Japan's oncology-based in-vivo CRO market. For instance, in April 2021, the US and Japan governments launched the US-Japan CoRe Partnership, emphasizing their continued collaboration in cancer research.
   
• Moreover, Japan has been at the forefront of developing immuno-oncology therapies, such as immune checkpoint inhibitors and cancer vaccines, which require extensive preclinical testing using in-vivo models. For instance, in February 2024, ONO secured supplemental approval in Japan for an expanded indication of Opdivo, targeting the treatment of unresectable advanced or recurrent malignant epithelial tumours.
   

Saudi Arabia's oncology based in-vivo CRO market is expected to witness substantial growth during the forecast period.
 

• Saudi Arabia is fostering a burgeoning biotech sector with a focus on oncology. Biotech startups in the region are developing innovative cancer therapies that necessitate advanced preclinical testing. Many of these companies outsource to CROs with specialized expertise in in-vivo models.
   
• Regulatory authorities, such as the Saudi Food and Drug Authority (SFDA), play a crucial role in regulating and supporting oncology drug development in Saudi Arabia. The SFDA's alignment with international standards, including those of the U.S. FDA and EMA, has facilitated the approval of oncology drugs and emphasized the necessity for rigorous preclinical testing, including in-vivo studies.
   

Oncology Based In-vivo CRO Market Share

The global oncology-focused in-vivo CRO market exhibits intense competition, comprising both established global and regional companies. The market is fragmented with numerous companies providing specialized services across various aspects of in-vivo testing, including preclinical studies, efficacy testing, safety evaluations, and pharmacokinetics. While larger, established CROs maintain a dominant global presence, many regional players offer localized services, leveraging their deep understanding of specific oncology research requirements. Additionally, smaller CROs focus on niche areas such as immuno-oncology and preclinical efficacy studies, contributing to a diverse range of specialized services.
 

Oncology Based In-vivo CRO Market Companies

Some of the eminent market participants operating in the oncology based in-vivo CRO industry include:

• Charles River Laboratories
• Crown Bioscience
• Eurofins Scientific
• Evotec SE
• ICON plc
• IMV
• Laboratory Corporation of America Holdings
• Medidata 
• Merck KGaA
• OncoOne
• Pharmaron
• Taconic Biosciences
• The Jackson Laboratory
• Thermo Fisher Scientific
• WuXi AppTec.
   

Oncology Based In-vivo CRO Industry News:

• In November 2023, Charles River Laboratories entered into a strategic agreement with Aitia. This collaboration grants Aitia access to Logica, Charles River’s AI-driven drug solution platform. The focus is on optimizing the discovery and early development of various therapeutic programs targeting neurodegenerative diseases and oncology.
   
• In October 2024, Crown Bioscience, a San Diego, California-based global contract research organization (CRO) affiliated with JSR Life Sciences and Japan's JSR Corporation, announced an expansion of its facility in Singapore. This enhancement brings in advanced oncology research models and state-of-the-art imaging technologies.
   

The oncology based in-vivo CRO market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Service

• Preclinical testing
• Efficacy testing
• Toxicology studies
• Pharmacokinetics
• Other services

Market, By Model

• Xenograft
  • Patient derived xenograft
  • Cell-line derived xenograft
  • Other xenografts
• Syngeneic
• Other models

Market, By End Use

• Pharmaceutical companies
• Biotechnology companies
• Other end users

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America 
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE