Oncology-based In-vivo CRO Market Size and Share Forecast Outlook 2025 to 2035

The global Oncology-Based In-vivo CRO Market is estimated to be valued at USD 1.3 billion in 2025 and is projected to reach USD 3.4 billion by 2035, registering a compound annual growth rate of 10.4% over the forecast period.

Quick Stats for Oncology-based In-vivo CRO Market

  • Industry Value (2025): USD 1.3 billion
  • Forecast Value (2035): USD 3.4 billion
  • Forecast CAGR: 10.4%
  • Leading Segment in 2025:  Efficacy Studies
  • Key Growth Region: Asia-Pacific (China, Japan, South Korea)
  • Top Key Players: Charles River Laboratories, ICON, WuXi AppTec, Crown Bioscience, Labcorp Drug Development, Eurofins Scientific, Taconic Biosciences, The Jackson Laboratory, Evotec, Champions Oncology

Oncology Based In Vivo Cro Market Industry Value Analysis

Metric Value
2025 Market Size USD 1.3 billion
2035 Market Size USD 3.4 billion
CAGR (2025 to 2035) 10.4%

The Oncology-Based In-vivo CRO market is undergoing robust growth, driven by the rising complexity of cancer research and the shift toward outsourcing preclinical drug development. Increasing cancer incidence and the demand for novel therapies are prompting pharmaceutical and biotech companies to rely on CROs with specialized in-vivo capabilities.

The use of advanced technologies like AI and patient-derived xenograft models is enhancing study precision and translational value. Additionally, the industry’s focus on personalized medicine is increasing demand for tailored in-vivo testing. While North America remains the dominant region due to strong R&D investments, Asia-Pacific is emerging rapidly due to cost-efficiency and expanding research infrastructure. The market’s growth trajectory is shaped by innovation, regulatory support and the urgent need for targeted oncology solutions.

Analyzing Oncology-Based In-vivo CRO Market by Top Investment Segments

Efficacy Studies Dominate the Market Due to Rising Demand for Early-Stage Therapeutic Validation

Efficacy Studies holds a revenue share of 33.2% in 2025, making this the leading segment within the Oncology-Based In-vivo CRO market. This dominance has been attributed to the critical role efficacy studies play in validating therapeutic candidates before clinical trials. Rising oncology drug pipelines and increased regulatory scrutiny have necessitated robust in-vivo models that demonstrate measurable anti-tumor responses.

This phase is viewed as essential in reducing late-stage failures, making efficacy assessment a strategic priority. Moreover, the incorporation of advanced xenograft and syngeneic tumor models has been encouraged by sponsors to simulate clinical tumor behavior more accurately.

Investment inflows from biotech firms and early-stage biopharma ventures have been channeled toward efficacy assessments, owing to their predictive value. As a result, reliance on CROs for high-fidelity efficacy testing has been intensified. Continuous innovation in animal modeling and imaging technologies has further elevated demand for efficacy study services.

Oncology Based In Vivo Cro Market Analysis By Study Type

Lung Cancer Drives Market Growth Owing to High Global Incidence and Research Funding

Lung cancer has captured a 22.2% share in the Oncology-Based In-vivo CRO market in 2025, positioning it as the most significant cancer indication by revenue. Its leadership status has been largely shaped by the disease’s high global prevalence and mortality rates, which have created an urgent need for innovative therapies.

As a result, significant preclinical R&D expenditure has been allocated by pharmaceutical and biotech sponsors to lung cancer models. The adoption of genetically engineered and patient-derived xenograft models has been prioritized to emulate the heterogeneity of non-small cell and small cell lung cancers.

Funding from government health bodies and private oncology foundations has also been directed toward lung cancer drug development, fueling CRO engagement. Further, the rising burden of tobacco-related and environmental carcinogens in developing economies has underscored the need for scalable preclinical testing. In-vivo CROs have been actively leveraged for high-throughput screening of targeted therapies and immune-oncology agents, reinforcing the segment’s dominance.

Oncology Based In Vivo Cro Market Analysis By Cancer Type

Pharmaceutical Companies Lead the Market Due to Outsourcing of Complex Oncology Pipelines

Pharmaceutical companies have been identified as the leading end users, holding 52.13% share in the Oncology-Based In-vivo CRO market in 2025. This trend has been supported by the strategic shift of pharma firms toward outsourcing preclinical research to streamline R&D operations.

The growing complexity of oncology drug development, particularly in targeted therapies and immuno-oncology, has prompted large pharma to collaborate with specialized CROs for efficacy, toxicology, and PK/PD testing. Outsourcing has been seen as a cost-efficient model to reduce infrastructure burdens and improve turnaround time.

Additionally, global pharma companies have demonstrated increased reliance on CROs offering regulatory-compliant, GLP-certified in-vivo services to meet diverse regulatory expectations. The trend has been reinforced by a surge in early-stage investigational studies, which demand translational accuracy and rapid iteration. CROs with integrated services and oncology-focused capabilities have become preferred partners, positioning pharmaceutical companies as the primary demand drivers in this evolving landscape.

Oncology Based In Vivo Cro Market Analysis By End User

Challenges and Opportunities

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.

Country Wise Outlook

Oncology Based In Vivo Cro Market Cagr Analysis By Country

United States

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%

United Kingdom

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%

European Union

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%

Japan

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%

South Korea

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%

Competitive Outlook

Oncology Based In Vivo Cro Market Analysis By Company

The Oncology-Based In-vivo CRO market is characterized by moderate to high competition, with players actively expanding their service portfolios to meet the rising demand for specialized oncology research. A significant focus has been placed on the development of advanced preclinical models, including patient-derived xenografts and humanized mouse models, to enhance translational outcomes.

Strategic collaborations with biotech firms, academic institutions, and clinical-stage pharma companies are being pursued to broaden client reach and research capabilities. Investment in AI-driven analytics, imaging platforms and bioinformatics tools is being accelerated to improve study accuracy and data interpretation. Additionally, market participants are increasingly offering integrated solutions that span target validation, efficacy testing, and regulatory support to position themselves as full-service providers.

Key Development:

  • In 2025, The USA FDA granted accelerated approval to Regeneron's Lynozyfic (linvoseltamab-gcpt), a new bispecific antibody therapy for relapsed or refractory multiple myeloma. This drug targets cancer cells and immune T-cells, showing significant response rates in patients who have already received at least four prior therapies.
  • In 2025, Labcorp announced its acquisition of select assets of BioReference Health's oncology and related clinical testing services businesses from OPKO Health. The deal, worth up to USD 225 million, aims to strengthen Labcorp's leadership in oncology diagnostics and expand patient access to its services. BioReference Health will retain its core New York/New Jersey operations and its 4Kscore urology franchise. The acquisition is expected to close in the second half of 2025.

Companies

  • Charles River Laboratories
  • ICON
  • WuXi AppTec
  • Crown Bioscience
  • Labcorp Drug Development
  • Eurofins Scientific
  • Taconic Biosciences
  • The Jackson Laboratory
  • Evotec
  • Champions Oncology

Key Segments

By Study Type:

  • Efficacy Studies
  • Pharmacokinetics/Pharmacodynamics (PK/PD) Studies
  • Toxicology Studies
  • Biomarker Studies
  • Biodistribution Studies

By Cancer Type:

  • Lung Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Blood Cancer (Leukemia, Lymphoma, Myeloma)
  • Prostate Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Others (Head & Neck, Skin, etc.)

By End User:

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

By Region:

  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • Middle East Africa (MEA)

Table of Content

  1. Executive Summary
  2. Industry Introduction, including Taxonomy and Market Definition
  3. Market Trends and Success Factors, including Macro-economic Factors, Market Dynamics, and Recent Industry Developments
  4. Global Market Demand Analysis 2020 to 2024 and Forecast 2025 to 2035, including Historical Analysis and Future Projections
  5. Pricing Analysis
  6. Global Market Analysis 2020 to 2024 and Forecast 2025 to 2035
    • By Indication
  7. Global Market Analysis 2020 to 2024 and Forecast 2025 to 2035, By Indication
    • Blood Cancer
    • Solid Tumors
    • Other Indications
  8. Global Market Analysis 2020 to 2024 and Forecast 2025 to 2035, By Region
    • North America
    • Latin America
    • Western Europe
    • Eastern Europe
    • East Asia
    • South Asia Pacific
    • Middle East and Africa
  9. North America Sales Analysis 2020 to 2024 and Forecast 2025 to 2035, by Key Segments and Countries
  10. Latin America Sales Analysis 2020 to 2024 and Forecast 2025 to 2035, by Key Segments and Countries
  11. Western Europe Sales Analysis 2020 to 2024 and Forecast 2025 to 2035, by Key Segments and Countries
  12. Eastern Europe Sales Analysis 2020 to 2024 and Forecast 2025 to 2035, by Key Segments and Countries
  13. East Asia Sales Analysis 2020 to 2024 and Forecast 2025 to 2035, by Key Segments and Countries
  14. South Asia Pacific Sales Analysis 2020 to 2024 and Forecast 2025 to 2035, by Key Segments and Countries
  15. Middle East and Africa Sales Analysis 2020 to 2024 and Forecast 2025 to 2035, by Key Segments and Countries
  16. Sales Forecast 2025 to 2035 by Indication for 30 Countries
  17. Competition Outlook, including Market Structure Analysis, Company Share Analysis by Key Players, and Competition Dashboard
  18. Company Profile
    • Charles River Laboratory
    • ICON Plc
    • Covance
    • Eurofins Scientific
    • Taconic Biosciences
    • Crown Bioscience
    • Toxikon, Inc.
    • WuXi AppTec
    • EVOTEC
    • The Jackson Laboratory

List of Tables

  • Table 1: Global Market Value (USD Million) Forecast by Region, 2020 to 2035
  • Table 2: Global Market Value (USD Million) Forecast by Indication, 2020 to 2035
  • Table 3: North America Market Value (USD Million) Forecast by Country, 2020 to 2035
  • Table 4: North America Market Value (USD Million) Forecast by Indication, 2020 to 2035
  • Table 5: Latin America Market Value (USD Million) Forecast by Country, 2020 to 2035
  • Table 6: Latin America Market Value (USD Million) Forecast by Indication, 2020 to 2035
  • Table 7: Europe Market Value (USD Million) Forecast by Country, 2020 to 2035
  • Table 8: Europe Market Value (USD Million) Forecast by Indication, 2020 to 2035
  • Table 9: Asia Pacific Market Value (USD Million) Forecast by Country, 2020 to 2035
  • Table 10: Asia Pacific Market Value (USD Million) Forecast by Indication, 2020 to 2035
  • Table 11: Middle East and Africa Market Value (USD Million) Forecast by Country, 2020 to 2035
  • Table 12: Middle East and Africa Market Value (USD Million) Forecast by Indication, 2020 to 2035

List of Figures

  • Figure 1: Global Market Value (USD Million) by Indication, 2025 to 2035
  • Figure 2: Global Market Value (USD Million) by Region, 2025 to 2035
  • Figure 3: Global Market Value (USD Million) Analysis by Region, 2020 to 2035
  • Figure 4: Global Market Value Share (%) and BPS Analysis by Region, 2025 to 2035
  • Figure 5: Global Market Y-o-Y Growth (%) Projections by Region, 2025 to 2035
  • Figure 6: Global Market Value (USD Million) Analysis by Indication, 2020 to 2035
  • Figure 7: Global Market Value Share (%) and BPS Analysis by Indication, 2025 to 2035
  • Figure 8: Global Market Y-o-Y Growth (%) Projections by Indication, 2025 to 2035
  • Figure 9: Global Market Attractiveness by Indication, 2025 to 2035
  • Figure 10: Global Market Attractiveness by Region, 2025 to 2035
  • Figure 11: North America Market Value (USD Million) by Indication, 2025 to 2035
  • Figure 12: North America Market Value (USD Million) by Country, 2025 to 2035
  • Figure 13: North America Market Value (USD Million) Analysis by Country, 2020 to 2035
  • Figure 14: North America Market Value Share (%) and BPS Analysis by Country, 2025 to 2035
  • Figure 15: North America Market Y-o-Y Growth (%) Projections by Country, 2025 to 2035
  • Figure 16: North America Market Value (USD Million) Analysis by Indication, 2020 to 2035
  • Figure 17: North America Market Value Share (%) and BPS Analysis by Indication, 2025 to 2035
  • Figure 18: North America Market Y-o-Y Growth (%) Projections by Indication, 2025 to 2035
  • Figure 19: North America Market Attractiveness by Indication, 2025 to 2035
  • Figure 20: North America Market Attractiveness by Country, 2025 to 2035
  • Figure 21: Latin America Market Value (USD Million) by Indication, 2025 to 2035
  • Figure 22: Latin America Market Value (USD Million) by Country, 2025 to 2035
  • Figure 23: Latin America Market Value (USD Million) Analysis by Country, 2020 to 2035
  • Figure 24: Latin America Market Value Share (%) and BPS Analysis by Country, 2025 to 2035
  • Figure 25: Latin America Market Y-o-Y Growth (%) Projections by Country, 2025 to 2035
  • Figure 26: Latin America Market Value (USD Million) Analysis by Indication, 2020 to 2035
  • Figure 27: Latin America Market Value Share (%) and BPS Analysis by Indication, 2025 to 2035
  • Figure 28: Latin America Market Y-o-Y Growth (%) Projections by Indication, 2025 to 2035
  • Figure 29: Latin America Market Attractiveness by Indication, 2025 to 2035
  • Figure 30: Latin America Market Attractiveness by Country, 2025 to 2035
  • Figure 31: Europe Market Value (USD Million) by Indication, 2025 to 2035
  • Figure 32: Europe Market Value (USD Million) by Country, 2025 to 2035
  • Figure 33: Europe Market Value (USD Million) Analysis by Country, 2020 to 2035
  • Figure 34: Europe Market Value Share (%) and BPS Analysis by Country, 2025 to 2035
  • Figure 35: Europe Market Y-o-Y Growth (%) Projections by Country, 2025 to 2035
  • Figure 36: Europe Market Value (USD Million) Analysis by Indication, 2020 to 2035
  • Figure 37: Europe Market Value Share (%) and BPS Analysis by Indication, 2025 to 2035
  • Figure 38: Europe Market Y-o-Y Growth (%) Projections by Indication, 2025 to 2035
  • Figure 39: Europe Market Attractiveness by Indication, 2025 to 2035
  • Figure 40: Europe Market Attractiveness by Country, 2025 to 2035
  • Figure 41: Asia Pacific Market Value (USD Million) by Indication, 2025 to 2035
  • Figure 42: Asia Pacific Market Value (USD Million) by Country, 2025 to 2035
  • Figure 43: Asia Pacific Market Value (USD Million) Analysis by Country, 2020 to 2035
  • Figure 44: Asia Pacific Market Value Share (%) and BPS Analysis by Country, 2025 to 2035
  • Figure 45: Asia Pacific Market Y-o-Y Growth (%) Projections by Country, 2025 to 2035
  • Figure 46: Asia Pacific Market Value (USD Million) Analysis by Indication, 2020 to 2035
  • Figure 47: Asia Pacific Market Value Share (%) and BPS Analysis by Indication, 2025 to 2035
  • Figure 48: Asia Pacific Market Y-o-Y Growth (%) Projections by Indication, 2025 to 2035
  • Figure 49: Asia Pacific Market Attractiveness by Indication, 2025 to 2035
  • Figure 50: Asia Pacific Market Attractiveness by Country, 2025 to 2035
  • Figure 51: Middle East and Africa Market Value (USD Million) by Indication, 2025 to 2035
  • Figure 52: Middle East and Africa Market Value (USD Million) by Country, 2025 to 2035
  • Figure 53: Middle East and Africa Market Value (USD Million) Analysis by Country, 2020 to 2035
  • Figure 54: Middle East and Africa Market Value Share (%) and BPS Analysis by Country, 2025 to 2035
  • Figure 55: Middle East and Africa Market Y-o-Y Growth (%) Projections by Country, 2025 to 2035
  • Figure 56: Middle East and Africa Market Value (USD Million) Analysis by Indication, 2020 to 2035
  • Figure 57: Middle East and Africa Market Value Share (%) and BPS Analysis by Indication, 2025 to 2035
  • Figure 58: Middle East and Africa Market Y-o-Y Growth (%) Projections by Indication, 2025 to 2035
  • Figure 59: Middle East and Africa Market Attractiveness by Indication, 2025 to 2035
  • Figure 60: Middle East and Africa Market Attractiveness by Country, 2025 to 2035

Frequently Asked Questions

What was the overall size of the oncology-based in-vivo CRO market in 2025?

The overall market size for the oncology-based in-vivo CRO market was USD 1.3 billion in 2025.

How big is the oncology-based in-vivo CRO market expected to be in 2035?

The oncology-based in-vivo CRO market is expected to reach USD 3.4 billion in 2035.

What will drive the demand for the oncology-based in-vivo CRO market during the forecast period?

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.

List the top 5 countries contributing to the oncology-based in-vivo CRO market.

The top 5 countries driving the development of the oncology-based in-vivo CRO market are the USA, China, Germany, Japan, and the UK.

Which segment in type is expected to lead in the oncology-based in-vivo CRO market?

Solid Tumor and Xenograft Models are expected to command a significant share over the assessment period.

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