• The global in vivo CRO market was valued at approximately USD 4.98 billion in 2024 and is projected to reach USD 7.96 billion by 2030, growing at a CAGR of 8.13% from 2025 to 2030. This growth is driven by increasing demand for preclinical testing services in oncology, neurology, and immunology research.

• Rodent-based models accounted for the largest market share of 81.95% in 2024, due to their cost-effectiveness and well-established use in toxicology, pharmacokinetics, and efficacy studies.

• The oncology indication led the market with a revenue share of 29.02% in 2024, driven by the growing prevalence of solid tumors and the need for advanced preclinical models to evaluate novel therapeutics.

• North America held the largest market share of 50.00% in 2024, attributed to the presence of major pharmaceutical and biotechnology companies, robust research infrastructure, and favorable regulatory frameworks.

• Technological advancements, such as the development of genetically modified animal models, non-invasive imaging techniques, and high-throughput screening methods, are enhancing the capabilities and efficiency of in vivo CRO services.

• Key players in the market include Charles River Laboratories, WuXi AppTec, Evotec, Crown Bioscience, and Biocytogen, focusing on expanding their service offerings and geographic presence to cater to the growing demand for in vivo research services.

• Challenges such as ethical considerations, regulatory compliance, and the need for standardized models may impact market growth. However, ongoing research and development efforts are focused on addressing these challenges to improve the reliability and reproducibility of in vivo studies.

In this report, the In Vivo Contract Research Organizations (CROs) Market has been segmented by Modality, Model, Indication, GLP and Geography. The segmentation helps stakeholders and investors understand the detailed structure of the market, identifying emerging opportunities and the competitive landscape across different therapeutic and operational dimensions.

In Vivo Contract Research Organizations (CROs) Market, Segmentation by Modality

The In Vivo CRO market is segmented by Modality into small molecules and large molecules. This classification captures the evolving pharmaceutical landscape, as the industry witnesses growing investments in biologics and novel therapy platforms. Each modality type presents unique requirements for preclinical evaluation, study design, and regulatory compliance, driving CRO partnerships and technological innovation in research models.

Small Molecules

Small molecule studies form the foundation of the traditional drug discovery landscape. CROs specializing in this segment focus on rapid screening, pharmacokinetic profiling, and toxicity studies. With advancements in automation and AI-driven analytics, this segment continues to demonstrate strong adoption, especially for generic drug development and early-stage screening programs.

Large Molecules

The Large Molecules segment includes complex biologics, requiring specialized capabilities such as immunogenicity testing and cell-line optimization. The rise in monoclonal antibodies and biotherapeutics has enhanced demand for CROs capable of handling advanced molecular platforms. Within this segment, the sub-segments highlight growing diversification into cell and gene therapy categories.

• Cell & Gene Therapy

  The cell and gene therapy segment represents a rapidly expanding frontier in biomedical research. CROs are investing in advanced facilities and regulatory frameworks to support novel therapies, which are projected to account for over 20% of total biopharma R&D investments globally.

  • CAR T-Cell Therapies

    CAR T-cell therapy CRO partnerships are accelerating, driven by the need for precision-engineered immune response models. These therapies are revolutionizing oncology treatment and demand high-standard animal modeling expertise.

  • CAR-NK Cell Therapy

    CAR-NK therapies extend immunotherapy’s reach by utilizing natural killer cells. CROs specializing in these studies are expanding capabilities for tumor efficacy models and safety evaluations to support commercialization.

  • TCR-T Cell Therapy

    TCR-T therapy development emphasizes antigen-specific targeting, requiring in vivo validation. CROs engaged here leverage bioinformatics and AI integration for immune mapping and predictive safety modeling.

  • Others

    This includes next-generation modalities such as stem-cell and exosome-based treatments. CROs in this field focus on translational models that mimic human tissue response more accurately, aiding faster clinical progression.

• RNA Therapy

  RNA therapy is an emerging area gaining traction post the success of mRNA vaccines. CROs offering this service emphasize bioavailability, delivery systems, and toxicity evaluation, which are vital for advancing precision medicine applications.

• Others

  This category includes hybrid biologic modalities that combine small and large molecule features. CROs supporting these studies provide cross-functional platforms to integrate pharmacodynamics and metabolic analytics.

In Vivo Contract Research Organizations (CROs) Market, Segmentation by Model

The market by Model is divided into Rodent-Based and Non-Rodent-Based systems. This segmentation underscores the diversity in experimental design and compliance requirements for preclinical validation. With regulatory emphasis on safety and reproducibility, both model types play critical roles in drug discovery and development cycles.

Rodent-Based

Rodent models remain the cornerstone of in vivo testing, offering cost efficiency, reproducibility, and genetic manipulation ease. CROs specializing in these models have developed expertise in behavioral, metabolic, and oncology-related studies. Increasing use of humanized mice is further enhancing translational accuracy.

• Rat Models

  Rat models provide extensive physiological insights for cardiovascular, neurological, and endocrine research. CROs leverage advanced breeding programs to ensure phenotype stability and reproducibility.

• Mice Models

  Mice models are widely used for genetic and oncological research, representing over 60% of preclinical in vivo studies. The growing adoption of CRISPR-based mice accelerates target validation and translational studies.

• Others

  This includes guinea pigs, hamsters, and transgenic strains for niche applications. These models are crucial for rare disease and vaccine-related research where standard rodent models are inadequate.

Non-Rodent-Based

The non-rodent models segment caters to advanced toxicological and efficacy testing, typically required for regulatory submissions. This includes species like dogs, pigs, and primates. CROs focusing here invest heavily in ethical compliance, 3Rs principles, and simulation-based reductions to minimize animal usage while ensuring data accuracy.

In Vivo Contract Research Organizations (CROs) Market, Segmentation by Indication

By Indication, the market captures the wide therapeutic diversity addressed through preclinical studies. The increasing complexity of chronic and degenerative conditions continues to drive CRO demand, with oncology and autoimmune disorders being among the most lucrative sectors.

Autoimmune & Inflammation Conditions

Autoimmune & inflammation studies require robust in vivo models to assess immune modulation and inflammatory response. CROs are integrating imaging technologies and biomarker analytics for better prediction of clinical outcomes.

• Rheumatoid Arthritis

  Advanced arthritis models allow assessment of joint inflammation and bone erosion. CROs in this field are aligning studies with biologic and biosimilar therapy evaluations to support regulatory filings.

• Multiple Sclerosis

  MS research CROs emphasize CNS demyelination and remyelination mechanisms. Enhanced imaging tools are improving efficacy evaluation of immunotherapies in these models.

• Osteoarthritis

  Preclinical CROs utilize surgical and chemical induction models for osteoarthritis studies to test regenerative compounds and pain modulation agents.

• Irritable Bowel Syndrome

  IBS models support gut microbiome studies and motility assessments. CROs offer both acute and chronic IBS simulations to test novel gastrointestinal therapeutics.

• Others

  Additional inflammation models address psoriasis and lupus, leveraging advanced immunopathology frameworks for targeted drug screening.

Pain Management

Pain management CROs play a critical role in evaluating both opioid and non-opioid analgesics. Increasing R&D for neuropathic and inflammatory pain contributes to steady segment growth.

• Chronic Pain

  Chronic pain models are crucial for assessing long-term analgesic efficacy and tolerance development. CROs apply behavioral metrics and electrophysiological endpoints to improve drug predictability.

• Acute Pain

  Acute pain models aid in early-stage drug screening and formulation evaluation. The segment benefits from increased investment in safer, non-addictive analgesics.

Oncology

Oncology remains the largest revenue-generating segment, representing nearly 35% of in vivo CRO contracts. CROs focus on high-fidelity tumor models to enhance translational predictability.

• Blood Cancer

  Blood cancer models support leukemia and lymphoma studies. CROs employ xenograft models with human hematopoietic cells for improved therapeutic validation.

• Solid Tumor

  Solid tumor research drives innovation in patient-derived xenograft (PDX) and syngeneic models, allowing more accurate drug efficacy profiling.

  • Syngeneic Model

    Syngeneic models enable immune-competent tumor growth evaluation, crucial for immuno-oncology studies.

  • Patient-Derived Xenograft

    PDX models replicate clinical heterogeneity, improving translational success rates in solid tumor therapeutics.

  • Xenograft

    General xenograft studies support human tumor implantation in animal hosts for initial efficacy assessment of novel oncology drugs.

CNS condition studies form one of the most technically demanding CRO services, involving behavioral, imaging, and molecular endpoints. Rising neurodegenerative disease prevalence sustains robust CRO engagement.

• Epilepsy

  Epilepsy models support anticonvulsant screening, with growing use of electrical and chemical induction systems for high reproducibility.

• Parkinson's Disease

  Parkinson’s disease research employs toxin and genetic models to replicate dopaminergic neuron loss, supporting regenerative therapy evaluation.

• Huntington's Disease

  CROs utilize transgenic Huntington’s disease models to test neuroprotective agents and gene-silencing strategies.

• Stroke

  Stroke models are vital for acute neuroprotection and post-stroke recovery research. CROs apply advanced imaging and telemetry for precision monitoring.

• Muscular Dystrophy

  Preclinical CROs offer muscular dystrophy studies using dystrophin-deficient mice, focusing on gene correction and muscle regeneration therapies.

• Alzheimer’s Disease

  Alzheimer’s models simulate amyloid and tau pathology, aiding in screening of disease-modifying agents.

• Traumatic Brain Injury

  TBI studies are gaining traction with advanced biomarker tracking and imaging-assisted evaluations to test neuroprotective drugs.

• Amyotrophic Lateral Sclerosis (ALS)

  ALS CRO programs focus on motor neuron degeneration models, emphasizing translational biomarkers for therapeutic validation.

• Spinal Muscular Atrophy

  SMA models assist in testing gene therapies and small molecules for neuromuscular recovery.

• Muscle Regeneration

  These models explore tissue recovery post-injury, with CROs using advanced histological and imaging methods for assessment.

• Other

  Additional CNS research areas include autism, depression, and anxiety modeling, which are increasingly supported by behavioral analytics.

Diabetes models are essential for evaluating insulin analogs and glucose-lowering compounds. Rising global diabetes prevalence drives sustained CRO demand for metabolic and genetic studies.

Obesity models aid in studying metabolic syndrome and related complications. With the surge in anti-obesity drug pipelines, CROs are investing in advanced rodent and non-rodent nutrition models.

Other indications include cardiovascular, infectious, and respiratory diseases, reflecting CRO diversification across therapeutic domains.

In Vivo Contract Research Organizations (CROs) Market, Segmentation by GLP

The GLP segmentation defines the operational and compliance frameworks of CROs, divided into GLP Toxicology and Non-GLP services. This distinction plays a crucial role in aligning preclinical outcomes with regulatory expectations for safety, efficacy, and data integrity.

GLP Toxicology

GLP toxicology services form the backbone of regulatory submissions. CROs offering this ensure adherence to OECD and FDA guidelines, focusing on study reproducibility, data traceability, and electronic reporting systems.

Non-GLP

Non-GLP studies enable early discovery flexibility, supporting exploratory efficacy, mechanism of action, and proof-of-concept testing. CROs here contribute to faster preclinical decision-making and cost optimization.

In Vivo Contract Research Organizations (CROs) Market, Segmentation by Geography

In this report, the In Vivo Contract Research Organizations (CROs) Market has been segmented by Geography into five regions: North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

North America

North America leads the in vivo CRO market, driven by strong regulatory frameworks, advanced R&D infrastructure, and high biopharma investments. The U.S. dominates regional revenues with robust oncology and CNS study demand.

Europe

Europe exhibits significant growth with CROs expanding specialized services for gene and RNA therapies. The region’s stringent compliance standards foster quality-driven partnerships and multi-center preclinical programs.

Asia Pacific

Asia Pacific is the fastest-growing market, supported by lower operational costs, expanding biopharma clusters, and government-backed innovation hubs in China, India, and South Korea. Regional CROs are increasingly partnering with global sponsors to support large-scale trials.

Middle East & Africa

Middle East & Africa represents emerging potential in biomedical research infrastructure. Regional initiatives to attract biopharma investments are gradually enhancing preclinical testing capabilities.

Latin America

Latin America shows steady expansion led by Brazil and Mexico, where local CROs are aligning services with global GLP standards. Growing academic-industry collaborations are supporting regional R&D ecosystem development.

This report provides an in depth analysis of various factors that impact the dynamics of In Vivo Contract Research Organizations (CROs) Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Advancements in Biopharmaceutical Research
• Extensive Use of In Vivo Studies

• Increased Focus on Biologics - Increased focus on biologics is a major driver of growth in the in vivo contract research organizations (CROs) market. Biologics, including monoclonal antibodies, cell therapies, and gene therapies, require complex and highly specialized preclinical testing to evaluate efficacy, safety, and immune response in living models. As pharmaceutical and biotech companies expand their biologics pipelines, they increasingly rely on in vivo CROs with advanced capabilities and regulatory expertise to support the development process.

  In vivo CROs offer the infrastructure, technologies, and experience needed to conduct rigorous animal model testing aligned with global standards. The growing demand for precision testing in biologics—along with rising R&D investments and a shift toward outsourcing strategies—is driving long-term market growth. These services accelerate time-to-market and allow sponsors to focus on core innovation while ensuring compliance and data integrity.

Restraints

• Ongoing Regulatory Approval Challenges
• Significant Biopharma Cost Constraints

• Prevailing Ethical Research Concerns - Prevailing ethical research concerns serve as a significant restraint in the in vivo contract research organizations (CROs) market. The use of animal models in preclinical research often raises public and institutional scrutiny over animal welfare, testing justifiability, and transparency in research practices. These concerns have prompted the implementation of stricter ethical guidelines and increased pressure on CROs to justify the scientific necessity of animal studies, adding complexity to study design and approval processes.

  Compliance with animal rights regulations and standards such as the 3Rs principle—Replacement, Reduction, and Refinement—requires significant investment in infrastructure, monitoring, and reporting. Failure to meet ethical expectations can lead to reputational damage, regulatory delays, or even trial discontinuation. As advocacy for alternative testing models gains traction, in vivo CROs may face limitations in scalability and broader market acceptance unless they adopt more transparent, ethically sound practices.

Opportunities

• Advancements in Biosimilar Development
• Widespread Use of Monoclonal Antibodies

• Emerging Focus on Bispecific Antibodies - The emerging focus on bispecific antibodies offers strong growth potential for the in vivo contract research organizations (CROs) market. These advanced biologics, capable of binding to two different targets simultaneously, are gaining momentum in the treatment of cancer, autoimmune diseases, and other complex conditions. Their unique mechanisms require detailed in vivo studies to assess efficacy, safety, and immune interactions, driving demand for CROs with advanced preclinical capabilities.

  With an expanding pipeline of bispecific therapeutics, pharmaceutical and biotech companies are increasingly outsourcing preclinical testing to specialized CROs. These organizations provide access to customized animal models, humanized systems, and regulatory expertise, all of which are essential for accelerating development. As bispecifics become central to biologic innovation, in vivo CROs are well-positioned to capitalize on this growing market segment.

In Vivo Contract Research Organizations (CROs) Market is defined by competition among pharmaceutical service providers, preclinical research organizations, and regional distributors. Companies adopt strategies such as mergers, partnerships, and collaboration to enhance study accuracy, compliance, and operational efficiency. With nearly 60% of share concentrated among leading players, continuous innovation in animal models, data management, and automated workflows drives steady growth across drug discovery, toxicology, and pharmacology studies.

Market Structure and Concentration
The industry demonstrates moderate concentration, with about 55% of revenues controlled by multinational in vivo CROs. Regional players contribute to expansion through specialized study services and cost-effective preclinical solutions. This combination of consolidated leadership and fragmented innovation shapes competitive strategies, ensuring consistent growth in in vivo CRO adoption.

Brand and Channel Strategies
Leading firms strengthen their brands through partnerships with pharmaceutical companies, collaborations with academic institutions, and direct contracts with biotech firms. Nearly 60% of adoption occurs via direct B2B contracts, while regional service providers and online laboratory networks support channel expansion. Effective strategies emphasize compliance, study accuracy, and operational efficiency, reinforcing sustainable growth in the market.

Innovation Drivers and Technological Advancements
Ongoing innovation focuses on automated monitoring systems, advanced animal models, and data analytics. Around 45% of R&D investments target technological advancements that improve study reproducibility, efficiency, and regulatory compliance. Strategic collaboration between CROs and research institutions drives strategies, enabling measurable growth in in vivo research services.

Regional Momentum and Expansion
North America accounts for nearly 40% of demand, driven by pharmaceutical R&D and clinical research adoption. Europe demonstrates steady growth with preclinical and toxicology studies, while Asia-Pacific shows rapid expansion surpassing 25% due to increasing drug discovery investments and CRO infrastructure development. Regional strategies enhance market penetration and competitive positioning.

Future Outlook
The market is projected to sustain robust growth as demand for high-quality, compliant, and efficient in vivo CRO services rises. Stronger partnerships and mergers will reshape competitive landscapes, while continuous innovation ensures improved study accuracy, throughput, and operational efficiency. The future outlook highlights broad expansion supported by pharmaceutical R&D and technological advancements.

Key players in In Vivo Contract Research Organizations (CROs) Market include:

• Charles River Laboratories
• Labcorp Drug Development
• Thermo Fisher Scientific (PPD)
• WuXi AppTec
• Eurofins Scientific
• SGS
• Intertek
• Crown Bioscience
• Medpace
• ICON plc
• PRA Health Sciences
• Altasciences
• Covance
• SGA
• Fortrea

In this report, the profile of each market player provides following information:

• Market Share Analysis
• Company Overview
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis