In Vivo CRO Market Size, Share & Trends Analysis Report By Model Type (Rodent based, Non-rodent based), By Modality (Small Molecule, Large Molecule), By Indication, By GLP Type (Non GLP, GLP Toxicology), By Region, And Segment Forecasts, 2023 - 2030

In Vivo CRO Market Size & Trends

The global in vivo CRO market size was valued at USD 4.23 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 8.1% from 2023 to 2030.The increasing burden of cancer patients, growing in vivo pharmacology studies, and the emerging number of pharma and biotechnology companies focusing on the research and development of novel therapeutics are expected to drive market growth during the forecast period. In addition, in vivo CROs are specifically backed by the rising number of CROs, research and development activities and preclinical studies, which have led to a rise in market growth. Furthermore, growing investments across in vivo gene-modified cell therapies are expected to boost market growth. For instance, in September 2022, Capstan Therapeutics, Inc. announced the financing of USD 165 million to combine genetic medicines and cell therapy to help bring first-in-class and safer medicines to patients for multiple conditions using its foundational precision in vivo engineering technology.

The COVID-19 pandemic has negatively impacted the clinical trials industry as well as the in vivo CRO industry. However, the effect of the pandemic was comparatively moderate across the in vivo CRO market, as several contract research organizations continuously focused on the R&D of COVID-19 treatment therapeutics, thereby providing in vivo preclinical services for the same.The integrity of over 330,000 clinical trials registered on clinicaltrials.gov remains vulnerable as the outbreak of coronavirus continues to spread worldwide. Furthermore, as of March 2020, at least 18 pharmaceutical or biotechnology companies have reported a disturbance to a clinical trial as a result of this pandemic.However, post pandemic, there was growing demand for novel technologies and the increasing need for patient-friendly drugs which has led improvement in pipeline of pharmaceuticals. Owing to stringent regulations by regulatory agencies such as the FDA and EMA, pharmaceutical & biopharmaceutical companies outsource their medical affairs needs to streamline the regulatory process. Thus, this is expected to have a positive impact on market growth in the coming years.

Moreover, rising complexity with respect to new drug development has fueled the in vivo CRO market’s growth. Manufacturing high-quality and safe drugs for patient care is a major concern for drug manufacturers. Moreover, the regulations related to drugs and biologics are vast and a rapidly growing field and are complicated by legal technicalities. The complexity of the drug development process has considerably grown in the last few years. Pharmaceutical and biotechnology companies are outsourcing their complex in vivo activities to CROs and focusing on business development.

Additionally, the rising demand for advanced products, such as rare disease therapies and anti-cancer medicines, is one of the major factors supporting the growth of the in vivo CRO market. For instance, Organizations such as the European Society of Medical Oncology (ESMO) and Latin American Society of Clinical Oncology (SLACOM) engage in collaborative work with the Peruvian Cooperative Oncology Group. These favorable initiatives are anticipated to generate lucrative revenue over the forecast period. Likewise, in June 2022, National Resilience, Inc. and the University of Texas MD Anderson Cancer Center signed a joint venture, the Cell Therapy Manufacturing Center, to accelerate the discovery and production of cutting-edge cell therapies for cancer patients.

Furthermore, a growing pipeline of cell and gene therapies is expected to grow the opportunity for market growth. Advancements in manufacturing, including improved accuracy, manufacturing, and control regulations, have led to tremendous growth in the past few years. According to the American Society of Gene + Cell Therapy (ASGCT), as of Q4 2022, the number of gene therapy candidates under development crossed more than 2,000. As of May 2021, the number of gene therapies under development was 3,726. This is expected to increase the demand in-vivo CRO market, thereby contributing to market profits.

Model Type Insights

In 2022, the rodents segment dominated market and accounted for the revenue share of 81.6%. Rodents based category is further sub-segmented to rat models, mice models, others. Rodents are commonly used as models in medical research due to their similarities to humans in behavior, biology, and genetics. They are extensively used in medical trials and studies, making them the most prevalent species in such research. According to the Foundation for Biomedical Research (FBR), rodents account for around 95% of all laboratory animals.Also, rodents born without immune systems, such as Severe Combined Immune Deficiency (SCID) mice, can be models for malignant and normal human tissue research.Moreover, according to the Koshland Science Museum, rats share approximately 90% of genes with humans. Thereby, increased adoption of rodents based models across in-vivo studies has fueled the demand for outsourced in vivo services, thus contributing to the market growth.

On the other hand, the non-rodent segment is expected to witness a stable CAGR of 7.1% CAGR over the forecast period. Non-rodent is mostly used animal models for research and offers several advantages, such as genetic homology to humans, metabolism, body weight, sequential sampling, life span, and organ structure. However, breeding, housing, and handling non-rodent animals can be challenging. According to the U.S. government, in 2019, around 797,546 laboratory animals were utilized in research, marking a 2.2% increase compared to the previous year.

Modality Insights

In 2022, the small molecules segment held the largest share, accounting for about 64.0% in the in vivo CRO market. The small molecules are studied across small molecule APIs, Highly Potent Active Pharmaceutical Ingredients (HPAPI), etc. The number of small molecule drug candidates are far more extensive than large molecules. Furthermore, these molecules support in preclinical & clinical development of drug candidates with extensive academic research for novel targets. For instance, in November 2022, Rgenta Therapeutics announced that the company raised USD 52 million in Series A Financing led by AZ-CICC Healthcare Investment Fund. Thereby, different advantages of small molecules and constant investment across small molecules drug development are some of the factor supporting the segment growth.

Additionally, large molecules is anticipated to expand as the fastest CAGR of 10.4% during the forecast period. The segment further sub-segmented to Cell & Gene Therapy (CAR T-cell therapies, CAR-NK cell therapy, TCR-T cell therapy, Other (Includes- TCR-NK, CAR-M, and TAC-T)), RNA Therapy, Others. In vivo CROs play a crucial role in the investigation of large molecules in preclinical and clinical trials.These organizations have special skills and expertise in handling and testing large molecules in appropriate animal models. Safety and toxicity studies, Pharmacokinetic (PK) studies, Efficacy studies, and Immunogenicity studies are some of the common services offered by CROs.Therefore, these factors favor the growth of the segment.

Indication Insights

The oncology segment held the highest market share of 28.8% in 2022. In oncology, mouse model is considered an ideal model for human cancer research across in vivo studies due to the relatively similar physiological and genomic characteristics of tumors in humans and mice. Mice have several similar molecular, cellular, and anatomical characteristics to humans. These characteristics are known to have critical functions & properties in cancer. Mice genes, particularly RNI-like genes, exhibit more than 80% similarity to their human counterparts, enabling researchers to use mice as experimentally tractable models to investigate treatment responses and basic mechanisms of cancer development. The most widely used and affordable traditional models for tumor studies are immunodeficient and immunocompetent mice models with xenografted and syngeneic tumors transplanted orthotopically or subcutaneously. Hence, the aforementioned factors contribute to the lion’s share of the segment during the analysis period.

The CNS conditions segment is expected to register the fastest growth of 9.3% over the forecast period. Epilepsy, Parkinson’s disease (PD), Huntington’s disease (HD), stroke, and Traumatic Brain Injury (TBI), among others, are some of the major CNS disorders. In vivo CROs play a key role in CNS research by offering specialized services and understanding for carrying out preclinical investigations in animal models. Furthermore, at present, several pipeline of CNS drugs are available in the market. However, the discovery & development of new drugs possess efficacy & tolerability is still a major concern.

GLP Type Insights

The GLP toxicology segment dominated the market with the largest revenue share of over 80.0% in 2022. Clinical studies such as safety pharmacology, genotoxicity, and repeated dose toxicity are mandatory for safe exposure to humans and must be performed as per the GLP standards. These studies are required to be conducted before the IND application. After IND approval, other GLP experiments to evaluate chronic toxicity, developmental and reproductive toxicity, genotoxicity, and carcinogenicity must be carried out during the clinical phase of development. For the evaluation of safety studies, compliance with GLP standards is mandatory.

Increasing clinical trials for oncology studies are expected to boost market growth. For instance, in January 2023, Qualigen Therapeutics initiated the GLP toxicology studies of its QN-302, an oncology program. The research would be carried out by WuXi AppTec. GLP toxicology tests are a crucial part of QN-302's investigational new drug (IND) filing package, which was anticipated to happen in the first half of 2023. After the IND is approved by the U.S. FDA, human clinical trials will be conducted. Hence, the growing number of clinical research for novel therapeutics is one of the major factors contributing to the segment’s growth.

On the other hand, non GLP segment is anticipated to witness a stable CAGR during the analysis period. Non-GLP toxicology studies are conducted and carried out to the same high standards but need not to adhere to all GLP guidelines. These toxicological studies are carried out in accordance with high standards of quality that ensure the validity and accuracy of the study data required to assess test object or item. Additionally, the drug development process involves clinical and nonclinical studies. Theses nonclinical studies are conducted using different protocols, including animal studies, which mostly comply with GLP regulations. Thereby, non-GLP toxicology is expected to witness growth at stable growth rate over the estimated time period.

Regional Insights

North America dominated the in vivo CRO market with a share of 50.0% in 2022. Growth in the region can be attributed to the presence of technologically advanced contract research organizations and the increasing number of grants provided by the government organizations, such as the National Institute of Health (NIH), to foster research activities. The region’s CROs have established a good reputation and demonstrated exceptional performance, making them attractive for research investments during the forecast period. Moreover, extensive drug development activities, the presence of several pharmaceutical & biotech companies, and a surge in clinical trials in the region are some of the factors boosting the demand for in vivo research, thereby supporting the growth of the outsourced in vivo services.

Asia Pacific is expected to witness the fastest CAGR of 8.8% during the forecast period. Growth in the region is due to several factors, including the cost-effectiveness of CROs across India and China, economic development, and advanced healthcare infrastructure. Increasing partnerships and investments by CROs and the growing percentage of outsourcing in vivo services to emerging economies are some factors expected to propel growth during the forecast period.

Key Companies & Market Share Insights

Key players operating across the globe are adopting notable strategic initiatives such as new merger & acquisition, and partnership to increase their market share. For instance, in January 2023, Evotec SE entered into a partnership agreement with Janssen Biotech to develop targeted immune-based therapies for oncology. Alternatively, in December 2022, Crown Bioscience entered into a partnership agreement with ERS Genomics Limited, which grants it global permission to utilize CRISPR/Cas9 for gene editing. This agreement enabled the company to access ERS’s foundational CRISPR/Cas9 patent portfolio. Some of the prominent players in the global in vivo CRO market include:  

• IQVIA Inc.

• Crown Bioscience

• Taconic Biosciences, Inc.

• PsychoGenics Inc.

• Evotec

• Janvier Labs

• Biocytogen

• GemPharmatech

• Charles River Laboratories

• Icon Plc

• Labcorp Drug Development

• Parexel International Corporation

• SMO Clinical Research (I) Pvt Ltd.

In Vivo CRO Market Report Scope

Global In Vivo CRO Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the global in vivo CRO market report on the basis of model type, modality, indication, GLP type, and region:

• Model Type Outlook (Revenue, USD Billion, 2018 - 2030)

  • Rodent based

    • Rat Models

    • Mice Models

    • Others

  • Non-Rodent based

• Modality Outlook (Revenue, USD Billion, 2018 - 2030)

  • Small Molecules

  • Large Molecules

    • Cell & Gene Therapy

      • CAR T-cell therapies

      • CAR-NK cell therapy

      • TCR-T cell therapy

      • Other (Includes- TCR-NK, CARM, and TAC-T)

    • RNA Therapy

    • Others

• Indication Outlook (Revenue, USD Billion, 2018 - 2030)

  • Oncology

    • Blood cancer

    • Solid tumor

      • Syngeneic model

      • Patient derived xenograft

      • Xenograft

    • Others

  • CNS Conditions

    • Epilepsy

    • Parkinson's disease

    • Huntington's disease

    • Stroke

    • Muscular Dystrophy

    • Alzheimer’s Disease

    • Traumatic brain injury

    • Amyotrophic lateral sclerosis (ALS)

    • Spinal Muscular Atrophy

    • Muscle regeneration

    • Other Neurodevelopment Disorders

  • Diabetes

  • Obesity

  • Pain management

    • Chronic pain

    • Acute pain

  • Autoimmune/inflammation conditions

    • Rheumatoid Arthritis

    • Multiple Sclerosis

    • Osteoarthritis

    • Irritable Bowel Syndrome

    • Others

  • Others

• GLP Type Outlook (Revenue, USD Billion, 2018 - 2030)

  • GLP Toxicology

  • Non GLP

• Regional Outlook (Revenue, USD Billion, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait