In Vivo CRO Market Size, Share and Trends Analysis, By Type of Nucleotide (DNA-based ASOs, RNA-based ASOs, and Modified/Hybrid ASOs), By Technology (First Generation, Second Generation, and Third Generation), By Route of Administration, By Development Phase (Preclinical, Clinical, and Commercial), By Indication, and By Region, Forecast 2025-2032

In Vivo CRO Market Overview and Key Insights:

The in vivo CRO market size reached USD 5,133.7 million in 2024 and is expected to register a revenue CAGR of 9.0% during the forecast period. Animal models are used to investigate the drug’s biological effects, toxicity, and pharmacokinetics. In vivo CROs specialize in planning and carrying out tests that closely resemble human disease situations to anticipate therapeutic efficacy in future clinical trials.

Market Drivers:

Rising prevalence of chronic diseases is a key driver of revenue growth in the in vivo CRO market. According to the World Health Organization (WHO), it is estimated that more than 1.8 million people globally have MS. Multiple sclerosis is most common in northern Europe, North America, Australia, and New Zealand, prompting hypothesis that it was spread over the world by European colonists and immigrants. Furthermore, a new survey published by the MS Society in 2024 found that the number of people living with MS in the UK had climbed dramatically to over 150,000. This surge is assumed to be the result of improved diagnosis and people with MS living longer lives, rather than an increase in the chance of developing MS.

On April 2025, Debiopharm Research & Manufacturing S.A., a Swiss-based global biopharmaceutical company aiming to cure cancer and infectious diseases, and Oncodesign Services, a leading CRO specializing in drug discovery and preclinical services, announced the signing of a license agreement for the use of the AbYlink technology in preclinical services. AbYlink is a regio-selective bioconjugation method that produces conjugates suitable for therapeutic and non-invasive diagnostic purposes.

Market Opportunity:

Growth in gene therapy and regenerative medicine studies acts as opportunities for in vivo CRO market. Gene therapy has emerged as a promising way to treating a wide range of disorders by inserting genetic material into a patient’s cells. This groundbreaking sector has received a lot of attention and is fast evolving, creating a huge demand for specialized research services.

Gene therapy, a promising area of medical study, has the potential to transform the treatment of a variety of genetic illnesses. However, the complexity of generating and evaluating gene therapies necessitate the skills and resources of gene therapy contract research organizations. These organizations play an important role in the search for effective and safe gene treatments.

On January 2025, Lindus Health, “the anti-CRO” that runs dramatically faster, more reliable clinical trials, announced that it has raised USD 55 million in Series B funding. The investment was led by new investor Balderton Capital, with participation from Visionaries Club, Creandum, Firstminute, and Seedcamp. The new funding will allow the company to expand their AI technology and eClinical platform, Citrus, to optimize study design, automate central monitoring of study data, enable instant biostatistics, and more, as well as hire in critical areas such as clinical operations and product development.

Recent Trends:

Emerging trends include growing focus on personalized medicine, adoption of technologies for real-time data collection and remote monitoring of animal subjects, and integration of omics technologies.

Personalized medicine which tailors’ medical treatment to the individual characteristics of each patient, requires highly specific and detailed in vivo studies to understand the effects of treatments on diverse genetic profiles. This trend is pushing in vivo CROs to develop and utilise more sophisticated animal models that can mimic the genetic diversity found in human populations. The demand for precise and individualised therapeutic approaches is increasing the demand for in vivo CROs. Consequently CROs are heavily investing in omics and next generation sequencing (NGS) technologies.

Restraints & Challenges:

Study design frequently relies on out-of-date protocols, which can give inferior results than more recent but less-cited methodologies. Academic laboratories are especially prone to relying on inherited methods, but preclinical CROs have a greater responsibility to ensure that they are executing the best in vivo investigations based on current gold standards, rather than what has previously been employed.

In vivo preclinical studies are expensive, and group directors must endeavor to keep expenses as low as feasible while maintaining research quality. Dosage, time scales, and the number of animals can all have a significant impact on experimental results and lab budgets.

Service Type Segment Insights and Analysis:

Based on the service type, the In Vivo CRO market is segmented into preclinical services and clinical services.

Preclinical services segment contributed the largest market share and the highest growth rate in 2024. These studies are critical for building a scientific foundation for moving forward with human trials, and regulatory bodies require them to assure safety and reduce hazards to human participants. Preclinical CROs may provide access to cutting-edge facilities, equipment, and technologies that pharmaceutical and biotechnology businesses may not have in-house.

On September 2024, PharmaLegacy Laboratories, which provides in vitro and in vivo preclinical drug development services, has acquired BTS Research, a preclinical contract research organization (CRO) based in San Diego. The collaboration between PharmaLegacy and BTS Research results in a potent combination that will enable pharmaceutical, biotechnology, medical device, and diagnostics businesses to get speedy and trustworthy pharmacology data in order to promote patient cures.

Modality Segment Insights and Analysis:

Based on the modality, the In Vivo CRO market is segmented into the small molecules, and large molecules.

Small molecules segment contributed the largest market share in 2024. The development of small molecule inhibitors requires thorough preclinical testing to confirm their safety, effectiveness, and ideal pharmacological characteristics before progressing to clinical trials. This step is essential for turning groundbreaking scientific discoveries into effective treatments. Small molecule drugs have played a crucial role in medicine for more than a hundred years, with well-known examples including aspirin and penicillin. As drug discovery CROs continually seek innovative strategies to develop future therapies, targeting disease-driving biological pathways at the RNA level is emerging as a promising approach for addressing difficult targets. Research labs are actively investigating the potential of using small molecule drugs to interact with RNA.

On January 2024, Oncodesign Services (ODS), a leading Contract Research Organization (CRO) specializing in drug discovery and preclinical services, announced its worldwide growth with the purchase of ZoBio, a Dutch CRO specializing in biophysics-driven small molecule drug development. This purchase enables ODS to develop and expand its experience and skills in the field of small molecule discovery, resulting in a fully integrated offering to support its customers’ innovative initiatives from target validation through candidate selection.

Indication Segment Insights and Analysis:

Based on the indication, the in vivo CRO market is segmented into autoimmune/inflammatory conditions, pain management, oncology, CNS conditions, diabetes, obesity, and others.

Oncology segment contributed the largest market share in 2024. According to Leukemia & Lymphoma Society, every three minutes, one individual in the United States is diagnosed with leukemia, lymphoma, or myeloma. An estimated 187,740 persons in the United States will be diagnosed with leukemia, lymphoma, or myeloma by 2024. New instances of leukemia, lymphoma, and myeloma are predicted to make up 9.4 percent of the estimated 2,001,140 new cancer cases diagnosed in the United States in 2024.

On November 2023, Crown Bioscience, a global contract research organization (CRO) and JSR Life Sciences subsidiary, announced the launch of OrganoidXplore, a groundbreaking service offering. This large-scale organoid panel screening platform offers robust, reproducible, and clinically relevant results in record time, expediting preclinical oncology drug discovery by empowering researchers and altering the cancer treatment development landscape.

Geographical Outlook:

In Vivo CRO market is strategically segmented by geography to provide a comprehensive understanding of regional market dynamic. Discover demand analysis, emerging trends, and growth opportunities shaping market performance across different region and countries.

North America In Vivo CRO Market:

North America is registered to have highest market share in In Vivo CRO market in 2024. This is mainly driven by rising demand for cost-effective preclinical studies, rising prevalence of chronic diseases, and adoption of humanized and transgenic animal models. According to the Centre of Disease Control and Prevention (CDC), around 53.2 million persons in the United States have arthritis. There are over 100 forms of arthritis, but OA is the most common, affecting 32.5 million individuals in the US. American Indians have one of the highest rates of arthritis among any population in the US. Over 50% of persons with knee osteoarthritis will require a total knee replacement during their lifetime.

On January 2024, Sygnature Discovery, a leading integrated drug discovery partner, has announced the purchase of NuChem Sciences, one of North America’s major discovery contract research organizations. The deal gives Sygnature a substantial competitive advantage as it expands its global network and commercial operations to harness discovery experience in the North American market. Sygnature Discovery and NuChem are forming a worldwide team that will provide drug discovery expertise to customer programs from target validation to candidate selection, integrating the finest of North American and UK operations.

Asia Pacific In Vivo CRO Market:

Asia Pacific is expected to register the fastest growth rate during the forecasted period, driven by rising prevalence of chronic diseases, growth in gene therapy and regenerative medicine studies, and advancements in imaging and biomarker technologies. As geopolitical risks and regulatory challenges transform the global pharmaceutical landscape, the Asia-Pacific (APAC) region has become an increasingly appealing location for clinical trials. While trials in the European Economic Area (EEA) have seen a gradual drop since 2018, APAC has experienced extraordinary growth, owing largely to the region’s work to create a landscape that supports global drug developers’ clinical trials.

On October 2024, Crown Bioscience, a global contract research organization (CRO) headquartered in San Diego, California, and a subsidiary of JSR Life Sciences and JSR Corporation that was recently acquired by Japan Investment Corporation Capital Co., Ltd. (JICC), has announced the expansion of its Singapore facility. The upgraded facility, located in the heart of Asia’s biomedical sciences hub, is expected to strengthen the company’s support for both global and local biotech and pharmaceutical businesses involved in preclinical and translational oncology drug discovery and development.

Europe In Vivo CRO Market:

Europe is expected to have considerable market share in 2024. The EU is known for its strong regulatory framework and competent healthcare infrastructures, making it a desirable location for clinical trials. Every year, around 2,800 clinical studies are approved in the EU, with each experiment including an average of two EU Member States. European CROs play an important role in helping biotechnology and pharmaceutical businesses plan and carry out clinical studies in the EU.

On November 2024, Concept Life Sciences (CLS), a UK-based medicine discovery, development, and manufacturing company financed by Limerston Capital, has acquired Charnwood Discovery. The transaction strengthens CLS’s position as a leading provider of pharmaceutical and life science services, which is consistent with the company’s ambitious expansion strategy. Charnwood Discovery, a well-known UK-based drug discovery research organization, has a large global client base and extensive experience in chemistry, biology, and ADME/DMPK.

Competition Analysis:

The In Vivo CRO market is characterized by a fragmented structure, with several players competing across various segments and regions. list of major players included in the In Vivo CRO market report are:

• Syngene International Limited
• Inotiv, Inc.
• Pharmaron
• Aurigene Pharmaceutical Services Ltd.
• WuXi Biologics
• Charles River Laboratories
• EUROFINS SCIENTIFIC
• Viva Biotech
• Thermo Fisher Scientific Inc.
• ICON plc
• Melior Discovery
• Crown Bioscience
• Jubilant Biosys Limited
• Pacific BioLabs
• Scantox Holding Aps
• Oncodesign Services

Strategic Developments in In Vivo CRO Market:

• In May 2025, Crown Bioscience, a global contract research organization (CRO) headquartered in the United States and a subsidiary of JSR Life Sciences and Japan-based JSR Corporation, has announced the expansion of its collaboration with NEXT Oncology, one of the world’s largest Phase I Oncology Clinical Trial networks. Crown Bioscience’s vast experience in producing clinically relevant cancer organoids and patient-derived xenograft (PDX) models, together with NEXT Oncology’s global clinical network and Phase I clinical trial expertise, will be leveraged in this strategic relationship.
• In March 2024, Agathos Biologics, a leading biotechnology business in genetic medicine, has announced the launch of a recombinant adeno-associated virus (rAAV) production service based on the company’s innovative proprietary cell line, AE1-BHK. The company made its first sale of rAAV to Genovac, a contract research and manufacturing organization (CRO/CMO) that discovers, develops, and produces antibodies for the therapeutic, diagnostic, and research markets. Agathos used a well-established method known as triple transfection to create rAAV with a transgene sequence given by Genovac in AE1-BHK.

Key Advantages for Stakeholders:

Navistrat Analytics’ industry report provides an in-depth quantitative analysis of various market segments, historical and current trends, market forecasts, and dynamics within the global market. The historical years covered in this report are 2022 to 2023, with 2024 serving as the base year for market size calculations. The forecast period extends from 2025 to 2032.

The report includes an executive summary and a comprehensive overview of market drivers, restraints, opportunities, and challenges (DROC), along with insights into regulatory standards. It features detailed analyses such as PORTER’s Five Forces, SWOT, and PESTLE, as well as assessments of technological trends and the competitive landscape.

PORTER’s Five Forces analysis helps stakeholders evaluate the impact of new entrants, competitive rivalry, supplier power, buyer power, and substitution threats, enabling them to assess the level of competition and the attractiveness of the global market. The competitive landscape provides stakeholders with a clear understanding of the current market positions of key players, offering valuable insights into their competitive environment.

Scope And Key Highlights Of The In Vivo CRO Market Report:

The In Vivo CRO market report offers a detailed analysis of market size, including historical revenue (in USD Million) data for 2022-2023 and revenue forecasts for 2025-2032 across the following segments:

• Service Type Outlook (Revenue, USD Million; 2022-2032)
  • Preclinical Services
    • Pharmacokinetics and Pharmacodynamics (PK/PD) Studies
    • Toxicology Testing
    • Bioanalytical Services
    • ADME Studies
    • Efficacy Studies
    • Safety Pharmacology
    • Genotoxicity Testing
    • Carcinogenicity Testing
  • Clinical Services
    • Phase I Clinical Trial
    • Phase II Clinical Trials
    • Phase III Clinical Trials
    • Phase IV Clinical Trials

• Model Type Outlook (Revenue, USD Million; 2022-2032)
  • Rodent based
    • Rat Models
    • Mice Models
    • Others
  • Non-Rodent Based
    • Hamsters
    • Guinea Pigs
    • Others

• Modality Outlook (Revenue, USD Million; 2022-2032)
  • Small Molecules
    • Organic Compounds
    • Natural Products
    • Synthetic Compounds
  • Large Molecules
    • Cell & Gene Therapy
      • CAR T-cell therapies
      • CAR-NK cell therapy
      • TCR-T cell therapy
      • Others
    • RNA Therapy
    • Others

• Indication Outlook (Revenue, USD Million; 2022-2032)
  • Autoimmune/Inflammatory Conditions
    • Rheumatoid Arthritis
    • Multiple Sclerosis
    • Osteoarthritis
    • Irritable Bowel Syndrome
    • Others
  • Pain Management
    • Chronic Pain
    • Acute Pain
  • Oncology
    • Blood cancer
    • Solid tumor
      • Syngeneic model
      • Patient derived xenograft
      • Xenograft
      • Others
    • CNS conditions
      • Epilepsy
      • Parkinson’s disease
      • Huntington’s disease
      • Stroke
      • Muscular Dystrophy
      • Others
    • Diabetes
    • Obesity
    • Others

• End-Use Outlook (Revenue, USD Million; 2022-2032)
  • Pharmaceutical Companies
  • Biotechnology Companies
  • Academic and Research Institutes
  • Government and Public Health Organizations
• Regional Outlook (Revenue, USD Million; 2022-2032)
  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Benelux
    • Nordic Countries
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Oceania
    • ASEAN Countries
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Israel
    • Turkey
    • Rest of MEA

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