Global In Vivo Contract Research Organizations (CROs) Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

The Global In Vivo Contract Research Organizations (CROs) Market is segmented by Modality, GLP Type, Product Type, Applications, and Geography, providing a comprehensive view of the services offered by CROs in the drug development process. This segmentation covers various aspects of in vivo research, from the types of molecules being tested to the regulatory standards adhered to and the specific applications in which these services are used.

By Modality, the market is divided into Small Molecules and Large Molecules. CROs focused on small molecules typically support the development of traditional chemical-based drugs, providing services for preclinical testing, safety assessments, and toxicology. Those focused on large molecules cater to the biologics market, offering specialized services for the development of complex therapies such as monoclonal antibodies and gene therapies. GLP Type segmentation includes Non-GLP and GLP Toxicology, with Non-GLP services primarily used in early-stage research for exploratory testing, and GLP Toxicology services required for more rigorous, regulated testing in later stages of development to meet compliance standards for regulatory approval.

The Product Type segment encompasses various services offered by CROs, including Preclinical Testing, Safety & Toxicology Testing, and Pharmacokinetics Testing, among others. These services are crucial for determining the viability, safety, and effectiveness of new drug candidates before clinical trials. The Applications segment includes Pharmaceuticals, Biotech, Medical Devices, and Environmental Testing, with pharmaceuticals being the largest segment as CROs are heavily involved in drug development and regulatory testing. Lastly, Geography plays a significant role in the market dynamics, with North America and Europe leading due to strong regulatory frameworks, advanced healthcare infrastructure, and increasing R&D spending. Asia-Pacific is expected to witness significant growth due to the expansion of the pharmaceutical industry and the rising demand for outsourced research services. Each of these segments reflects the diverse needs within the market, driven by technological advances and regulatory demands in drug development.

Global In Vivo Contract Research Organizations (CROs) Segment Analysis

In this report, the Global In Vivo Contract Research Organizations (CROs) Market has been segmented by Modality, GLP Type, Product Type, Applications and Geography.

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

The Global In Vivo Contract Research Organizations (CROs) Market has been segmented by Modality into Smalll Molecules Modality, and Large Molecules Modality.

The Global In Vivo Contract Research Organizations (CROs) Market is segmented by Modality into Small Molecules Modality and Large Molecules Modality, each representing distinct approaches and challenges in drug development. This segmentation highlights the different services offered by CROs based on the type of molecules being studied and the associated therapeutic areas.

The Small Molecules Modality segment involves the development of traditional chemical-based drugs, such as antibiotics, painkillers, and cardiovascular treatments. Small molecules are typically easier to synthesize and test compared to biologics, and they dominate the pharmaceutical industry due to their well-established development processes. CROs involved in small molecules support pharmaceutical and biotech companies with preclinical and clinical testing, safety assessments, pharmacokinetics, and toxicology studies. Small molecules are often the focus of CROs' early-stage services, as they generally require fewer resources and can be developed more quickly.

The Large Molecules Modality refers to biologics such as monoclonal antibodies, recombinant proteins, and gene therapies, which are more complex and require specialized testing methods. Large molecules are increasingly in demand due to the rise in biologics-driven therapies for cancer, autoimmune diseases, and genetic disorders. CROs specializing in large molecules provide services related to immunogenicity testing, pharmacodynamics, pharmacokinetics, and stability studies, often working with more advanced technologies. The demand for large molecules has been growing rapidly, requiring CROs to adapt and provide specialized expertise to support the intricate requirements of biologic drug development. These two modalities reflect the growing diversification in drug development, with CROs playing an essential role in both traditional small molecule drugs and the more innovative biologics market.

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

The Global In Vivo Contract Research Organizations (CROs) Market has been segmented by GLP Type into Non GLP and GLP Toxicology.

The Global In Vivo Contract Research Organizations (CROs) Market is segmented by GLP Type into Non-GLP and GLP Toxicology, which reflect different regulatory standards and testing requirements in the drug development process. This segmentation plays a crucial role in determining the type of services CROs provide based on the specific needs of pharmaceutical companies and the regulatory environments in which they operate.

Non-GLP studies are typically used for early-stage research and development, where preliminary data is required before committing to formal regulatory testing. Non-GLP studies are less stringent in terms of compliance with Good Laboratory Practices (GLP), allowing for faster, more cost-effective testing, especially in the discovery phase or for internal purposes. These studies are often employed for initial safety screening, compound profiling, and assessing potential candidates for further development. CROs offering Non-GLP services are focused on providing flexibility and speed to clients during the early phases of drug development.

GLP Toxicology studies, on the other hand, are conducted under strict regulatory guidelines to ensure the safety, consistency, and reproducibility of the data, making them essential for later stages of drug development. GLP-compliant toxicology studies are crucial for regulatory submissions and are required for preclinical safety evaluations of new drugs before they can proceed to clinical trials. These studies are more formal and comprehensive, focusing on the long-term effects of drug candidates, dose-response relationships, and toxicological profiles. CROs specializing in GLP Toxicology provide in-depth safety assessments and are key partners for pharmaceutical companies looking to meet regulatory standards set by agencies like the FDA and EMA. This segmentation indicates the diverse needs in the CRO market, with some companies focusing on the early-stage, less-regulated testing and others offering high-compliance, regulatory-driven services.

Global In Vivo Contract Research Organizations (CROs) Market, Segmentation by Product Type

The Global In Vivo Contract Research Organizations (CROs) Market has been segmented by Product Type into Rodent Based and Non Rodent Based.

The rodent-based studies involve the use of mice, rats, and other rodents as experimental models for conducting preclinical research. These models are widely employed in various fields of biomedical research, including pharmacology, toxicology, and disease modeling, owing to their physiological similarities to humans and well-established genetic tools. In vivo CROs specializing in rodent-based research offer a range of services, such as safety assessments, efficacy studies, and pharmacokinetic evaluations, using rodent models to test the safety and efficacy of pharmaceutical compounds and biologics.

On the other hand, non-rodent-based research services utilize alternative animal models, such as rabbits, guinea pigs, dogs, non-human primates, and various other species, to conduct preclinical studies. Non-rodent models offer distinct advantages, such as larger body size, closer resemblance to human physiology in certain aspects, and relevance to specific disease conditions. In vivo CROs specializing in non-rodent-based research cater to the diverse needs of biopharmaceutical companies and research institutions, offering customized study designs and experimental protocols tailored to the unique requirements of different therapeutic areas and drug development programs.

The choice between rodent-based and non-rodent-based research models depends on various factors, including the research objectives, target species, regulatory requirements, and ethical considerations. While rodent models are commonly used due to their availability, cost-effectiveness, and ease of handling, non-rodent models are preferred for certain studies requiring larger animal sizes, specialized physiological features, or specific disease models. In vivo CROs play a pivotal role in providing access to a wide range of research models, expertise, and resources to support drug discovery and development efforts, helping biopharmaceutical companies navigate the complexities of preclinical research and accelerate the translation of promising therapies from bench to bedside.

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

The Global In Vivo Contract Research Organizations (CROs) Market has been segmented by Applications into Autoimmune, Pain Management, Oncology, CNS Conditions, Diabetes, Obesity and Others.

The diverse needs of biopharmaceutical companies and research institutions. One significant segment is oncology, which encompasses research related to the prevention, diagnosis, and treatment of cancer. In vivo CROs specializing in oncology conduct preclinical studies to evaluate the safety and efficacy of potential cancer therapies, including novel drug candidates, targeted therapies, and immunotherapies. These studies play a crucial role in advancing oncology research and development, guiding clinical trial design, and ultimately improving patient outcomes.

Another important application segment is autoimmune diseases, which involve conditions where the body's immune system mistakenly attacks its own tissues. In vivo CROs focusing on autoimmune research conduct preclinical studies to investigate the underlying mechanisms of autoimmune diseases and evaluate potential therapeutic interventions. These studies may involve animal models designed to mimic specific autoimmune conditions, such as rheumatoid arthritis, multiple sclerosis, or lupus. By providing insights into disease pathogenesis and therapeutic targets, in vivo CROs contribute to the development of innovative treatments for autoimmune disorders.

In vivo CROs play a crucial role in preclinical research related to central nervous system (CNS) conditions, including neurodegenerative diseases, psychiatric disorders, and neurological disorders. CNS research encompasses a wide range of conditions such as Alzheimer's disease, Parkinson's disease, depression, anxiety disorders, and epilepsy. In vivo CROs specializing in CNS research conduct preclinical studies to evaluate the safety and efficacy of potential CNS therapies, assess drug pharmacokinetics and pharmacodynamics, and investigate disease mechanisms. These studies are essential for advancing our understanding of CNS disorders and developing new treatments to address unmet medical needs in this therapeutic area.

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

In this report, the Global 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.

Global In Vivo Contract Research Organizations (CROs) Market Share (%), by Geographical Region, 2024

North America and Europe stand out as mature markets for in vivo CROs, driven by advanced healthcare infrastructure, robust pharmaceutical and biotechnology industries, and stringent regulatory frameworks. These regions host numerous IV-CROs offering a wide range of preclinical research services, including pharmacokinetics, toxicology studies, and efficacy testing. Additionally, the presence of leading biopharmaceutical companies and academic research institutions in North America and Europe contributes to the demand for specialized in vivo research expertise and resources.

In contrast, the Asia Pacific region is witnessing rapid growth in the in vivo CRO market, propelled by increasing investments in biomedical research, outsourcing trends, and a growing focus on biosimilar development. Countries like China, India, and South Korea are emerging as attractive destinations for outsourcing preclinical research activities due to their cost advantages, skilled workforce, and supportive regulatory environment. Moreover, the Asia Pacific region offers access to diverse patient populations, facilitating the conduct of clinical trials and translational research studies. As a result, both domestic and international IV-CROs are expanding their presence in Asia Pacific to capitalize on these opportunities and cater to the evolving needs of biopharmaceutical companies.

Latin America and the Middle East & Africa regions also present growth opportunities for in vivo CROs, driven by increasing investments in healthcare infrastructure, rising prevalence of chronic diseases, and expanding pharmaceutical markets. While these regions may face challenges such as regulatory complexities and infrastructure limitations, there is a growing recognition of the importance of preclinical research in drug discovery and development. IV-CROs operating in Latin America and the Middle East & Africa often collaborate with local research institutions and government agencies to address healthcare needs and accelerate medical innovation. Overall, the segmentation of the global in vivo CRO market by geography reflects the evolving dynamics of the pharmaceutical industry and the increasing globalization of research and development activities.

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

Drivers, Restraints and Opportunity Analysis

Drivers

• Biopharmaceutical Research
• In Vivo Studies
• Biologics

• Monoclonal Antibodies (mABs): Monoclonal antibodies (mABs) represent a significant area of focus within the Global In Vivo Contract Research Organizations (CROs) Market. As biologic therapeutics, mABs have garnered considerable attention in drug development due to their specificity, efficacy, and potential for targeted therapy across various disease indications. In vivo CROs play a crucial role in supporting the preclinical development of mABs, conducting studies to evaluate their pharmacokinetics, pharmacodynamics, safety profiles, and efficacy in animal models. These studies are essential for gaining insights into mABs' therapeutic potential, optimizing dosing regimens, and informing subsequent clinical trial designs.

  In response to the growing demand for mABs in the pharmaceutical industry, in vivo CROs are increasingly specializing in supporting mAB development programs. These specialized CROs offer a comprehensive range of services tailored to the unique requirements of mAB research, including hybridoma generation, antibody production, in vivo efficacy studies, pharmacokinetic assessments, and immunogenicity testing. By leveraging their expertise and infrastructure, in vivo CROs enable biopharmaceutical companies to expedite the preclinical development of mAB candidates, mitigate risks, and make informed decisions regarding their advancement into clinical trials.

  As the pipeline's focus shifts towards next-generation mABs, such as bispecific antibodies and antibody-drug conjugates (ADCs), in vivo CROs are adapting their capabilities and offerings to accommodate these evolving needs. Bispecific antibodies, which can simultaneously target two different antigens or pathways, hold promise for treating complex diseases and overcoming treatment resistance. In vivo CROs play a critical role in assessing the pharmacokinetics, target engagement, and therapeutic efficacy of bispecific antibodies in preclinical models, facilitating their translation into clinical development. Similarly, in vivo CROs are well-positioned to support the preclinical evaluation of ADCs, which combine the specificity of mABs with the cytotoxic properties of small molecule drugs, offering targeted and potent anticancer therapies. Overall, the segment focused on mABs underscores the integral role of in vivo CROs in advancing biologic therapeutics and driving innovation in drug discovery and development.

Restraints

• Regulatory Challenges
• Cost Constraints
• Ethical Concerns

• Limited Expertise: The Global In Vivo Contract Research Organizations (CROs) Market faces significant challenges stemming from limited expertise in specialized areas of research and development. While in vivo CROs offer a broad spectrum of preclinical research services, including pharmacokinetics, toxicology studies, and efficacy testing, they often encounter difficulties in addressing niche therapeutic domains or emerging scientific methodologies. Conducting research on rare diseases or specialized indications demands specific knowledge and experience, which may not be readily available within every IV-CRO. Consequently, biopharmaceutical companies seeking support for complex research endeavors may confront obstacles in finding IV-CROs equipped with the necessary expertise to fulfill their requirements adequately.

  The swift pace of technological advancement in biomedical research poses a formidable challenge for in vivo CROs to keep abreast of evolving scientific methodologies and tools. Emerging technologies like gene editing, CRISPR-Cas9, and organ-on-a-chip models are reshaping the landscape of preclinical research, offering novel avenues for understanding disease mechanisms and drug development. However, the adoption and incorporation of these advanced technologies into IV-CRO services necessitate specialized training, infrastructure, and resources. IV-CROs that fail to invest in staying abreast of technological innovations risk falling behind, compromising their competitiveness and ability to meet the evolving demands of biopharmaceutical clients.

  The global in vivo CRO market grapples with talent shortages and intense competition for skilled professionals, particularly in regions with limited access to specialized training programs or research facilities. Recruiting and retaining qualified scientists, veterinarians, and technical staff proficient in in vivo research methodologies present ongoing challenges for IV-CROs. The shortage of experienced professionals in specific therapeutic domains or research disciplines further impedes IV-CROs' capacity to expand their service offerings and cater effectively to the diverse needs of biopharmaceutical clients.

Opportunities

• Biologics
• Biosimilar development
• Monoclonal antibodies (mABs)

• Bispecifics: Bispecific antibodies represent a growing area of interest within the Global In Vivo Contract Research Organizations (CROs) Market. Bispecific antibodies are engineered molecules that can simultaneously target two different antigens, offering unique therapeutic advantages in treating various diseases, including cancer, autoimmune disorders, and infectious diseases. As the development of bispecific antibodies gains momentum in the biopharmaceutical industry, in vivo CROs are increasingly called upon to provide specialized expertise and services for preclinical evaluation and validation of these novel therapeutics.

  In vivo CROs play a crucial role in supporting bispecific antibody development through a range of preclinical research services, including pharmacokinetic studies, safety assessments, and efficacy testing in relevant disease models. These CROs leverage their expertise in in vivo research methodologies, animal models, and regulatory compliance to conduct comprehensive evaluations of bispecific antibodies, helping biopharmaceutical companies assess their pharmacological properties, safety profiles, and therapeutic potential. Moreover, in vivo CROs may offer customized study designs and specialized models to address the unique challenges associated with bispecific antibody development, such as target specificity, pharmacokinetics, and immunogenicity.

  The demand for in vivo CRO services in the field of bispecific antibodies is driven by the increasing complexity and diversity of these therapeutics, as well as the growing competition among biopharmaceutical companies to bring innovative products to market. As bispecific antibody pipelines expand and diversify, in vivo CROs are expected to play an integral role in supporting preclinical development programs, facilitating the translation of promising candidates from early-stage research to clinical trials. By providing high-quality, scientifically rigorous preclinical data, in vivo CROs contribute to the de-risking of bispecific antibody candidates and the optimization of therapeutic strategies, ultimately advancing the field of biopharmaceutical innovation.

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

• PPD Inc
• Quintiles
• ICON Plc
• Parexel International Corporation
• American Preclinical Services
• LLC
• Labcorp Drug Development
• Theorem Clinical research
• WuXi AppTec
• Syneos Health
• Evotec
• Charles River Laboratories

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

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