Global In Vivo Toxicology Market Size By Testing Facility (Out-Source Testing Facility and In-House Testing Facility), By End User (Academic and Research Institutes, Pharmaceutical and Biotechnology Companies, Contract Research Organizations), By Toxicity End Point (Immunotoxicity, Systemic Toxicity, Genotoxicity), By Test Type (Acute, Sub-Acute, Sub-Chronic, Chronic), By Product (Instruments and

In Vivo Toxicology Market Size And Forecast

In Vivo Toxicology Market size was valued at USD 6.25 Billion in 2024 and is projected to reach USD 9.11 Billion by 2031, growing at a CAGR of 5.31% from 2024 to 2031.

Development of exclusive In Vivo Toxicology tests, increasing R&D activities in the pharmaceutical industry, innovations in animal models and the growing demand for personalized medicine are the primary drivers of the growth of the market. The Global In Vivo Toxicology Market report provides a holistic evaluation of the market. The report offers a comprehensive analysis of key segments, trends, drivers, restraints, competitive landscape, and factors that are playing a substantial role in the market.

Global In Vivo Toxicology Market Definition

The scientific studies performed within an intact, living organism such as a laboratory animal, to understand the toxic effects of various chemical substances administered in the test subject are called In Vivo Toxicology. Rats, mice, rabbits, guinea pigs, hamsters, etc. are the various test subjects on which these chemicals can be administered. These test subjects can be exposed to these chemical substances in a variety of ways, such as oral, intravenous, intraperitoneal, intramuscular, and subcutaneous.

Non-clinical (or preclinical) toxicology studies are essential to have a detailed understanding of the toxicological profiles of new drug candidates prior to human exposure and improvise the existing profile of various drugs, for instance, new indications, new formulations, new routes of administration, etc. Non-clinical toxicology studies vary in length (e.g., acute, subchronic, chronic) depending on the length of exposure in the clinical trial that they support. It is important to have a thorough knowledge of a drug’s efficacy, safety, and mechanism of action (MOA) prior to its release in the market.

The establishment of efficacy is critical so that the drug yields positive results on a maximum number of people that administer the drugs upon them. In vivo animal models are used for research work to minimize the adverse side effects and maximize the therapeutic properties of a drug before it is taken for clinical trials. Genetically engineered mouse models play a critical role in the process of drug discovery. Research on these genetically engineered mouse models facilitates the study and characterization of disease pathology, target identification, and in vivo evaluation of novel therapeutic agents and treatments.

Global In Vivo Toxicology Market Overview

An important driver of growth of the Global In Vivo Toxicology Market is the investment in increasing R&D efficiency. An increasing number of pharma companies and medical device manufacturers focus on innovation and increasing their R&D efficiencies. The changing dynamics of the healthcare market in terms of its significance due to a rising number of populations needing medical attention in various countries have compelled pharmaceutical and biotechnology companies to develop drugs that are used to mitigate the combat the disease-causing pathogen without heavy side effects. R&D activities, however, are associated with a high risk of failure. In the U.S., only 5 in 5000 drugs are able to progress to the preclinical trial phase progress for its administration on human beings. Also, it is very important to increase the approval rate of drugs in phase I, which, at present is R&D’s foremost objective. To achieve this, a large amount of R&D is conducted in the early stages of drug development. The In Vivo Toxicology method activities are likely to increase due to this intensive R&D in the earlier stages, which is expected to drive the market. before the drug reaches the more expensive clinical stage.

Biotechnology Industry Organization (BIO) in 2019 states that R&D investments in emerging therapeutics and novel drugs by emerging growth companies (EGCs) in the U.S. over the last decade constitute about 82.7% of the total venture capital investments. The COVID-19 outbreak has had a detrimental impact on many markets across the globe. However, it has acted as a major growth driver for the In Vivo Toxicology Market. This is because of the global focus on the development of effective vaccines for the virus, due to which many drugs have been in the pre-clinical / clinical trial phase. According to the NY Times, Researchers are currently testing 89 vaccines in clinical trials on humans and 23 have reached the final stages of testing. And at least 77 vaccines are under active investigation in animals. This has also surged the demand for various kinds of animal models for the testing of the effects of the virus, which has resulted in a growth of the Global In Vivo Toxicology Market.

One of the best mouse models used for COVID 19 is the K18-hACE2 transgenic mouse. Several other models used to test for various effects of the virus on mice are the AC70 transgenic mice, hCAE2 Tg mice. A More rapid, reproducible murine model for SARS-CoV-2 was the Adeno-associated virus (AAV) delivery-based mouse model. Various other mouse strains such as BALB/c, C57BL/6 mice strains were also used. Apart from mice, the Golden Syrian Hamster has also been deemed as a good model for the study of COVID 19. However, the current supply is not at par with the surging demand. A significant market restraint is a pressure of not using Laboratory animals for testing, and alternative ways of examining the effects of various drugs such as In Vitro Tests, which are tests performed after isolating and purifying a set of tissues of a subject. These tests are performed in laboratories outside the anatomy of a living organism in a controlled environment.

Ex Vivo Tests involve testing on the tissues of an animal or living organism with minimal alteration of the organism’s natural conditions. In Silico tests are testing in the form of computer simulations. The growing awareness about the benefits of In Vivo testing among physicians and patients is expected to further drive the growth of the Global In Vivo Toxicology Market. Also, the emergence of humanized animal models for the study of various diseases such as HIV/AIDS, Cancer, and Hepatitis are expected to further drive the market in the forecast period. Small animals such as mice and rats are widely used mammalian model systems due to their small size, ease of maintenance and handling, short reproductive cycle, sharing of genomic and physiological properties with humans and ability to be readily manipulated genetically.

Global In Vivo Toxicology MarketSegmentation Analysis

The Global In Vivo Toxicology Market is segmented based on Testing Facility, End User, Toxicity End Point, Test Type, Product, and Geography.

In Vivo Toxicology Market, By Testing Facility

• Out-Sourced Testing Facility• In-House Testing Facility

Based on Testing Facility, the market is segmented into Out-Source Testing Facility and In-House Testing Facility. The outsourced testing facilities held a large market segment in 2019, and this large market share is expected to continue in the forecast period. This is because outsourcing to CRO’s (Contract Research Organizations) is more cost-effective for pharmaceutical companies.

In Vivo Toxicology Market, By End User

• Academic and Research Institutes• Pharmaceutical and Biotechnology Companies• Contract Research Organizations• Other End Users

Based on End User, the market is segmented into Academic and Research Institutes, Pharmaceutical and Biotechnology Companies, Contract Research Organizations, and Other End Users. The academic and research institutes segment accounted for the largest share of the In Vivo Toxicology Market in 2019. This market prevalence can be attributed to a growing number of academic researches in the field of In Vivo Toxicology, coupled with funding to the academic and research institutes to conduct In Vivo Toxicology research.

In Vivo Toxicology Market, By Toxicity End Point

• Immunotoxicity• Systemic toxicity• Carcinogenicity• Genotoxicity• Developmental & reproductive toxicity (DART)• Other toxicity Endpoints

Based on Toxicity End Point, the market is segmented into Immunotoxicity, Systemic Toxicity, Carcinogenicity, Genotoxicity, Developmental and Reproductive Toxicity (DART), and Other Toxicity Endpoints. Other Toxicity Endpoints, namely, Organ Toxicity, Skin Irritations, Endocrine, Juvenile Toxicity, Disruptor Toxicity, Phototoxicity, Ocular Toxicity, and Others. Immunotoxicity accounted for the largest share of the global In Vivo Toxicology Market. It was followed by the systemic toxicity segment. Growing demand for Biologic Drugs (Drugs produced from Living Organisms) and Biosimilars (An appropriately approved variant of a certain Biologic) is driving the growth of the immunotoxicity segment.

In Vivo Toxicology Market, By Test Type

• Acute• Sub-Acute• Sub-Chronic• Chronic

Based on Test Type, the market is segmented into Acute, Sub-Acute, Sub-Chronic, and Chronic. Chronic and Sub-Chronic segments led the market respectively in that order in 2019, owing to the increasing demand for medicinal drugs used for the treatment of diseases that persist over the long term like Cancer, Arthritis, Convulsions, and Hypertension.

In Vivo Toxicology Market, By Product

• Instruments• Consumable

Based on Product, the market is segmented into Instruments and Consumables. Consumables are further divided into Reagents and Kits and Animal models on the basis of Product. Consumables are the market leaders in this segment and their dominance is expected to persist over the forecast period owing to the high growth of Animal Model demands, in addition to an incremental R&D expenditure on the healthcare sector globally.

In Vivo Toxicology Market, By Geography

• North America• Europe• Asia Pacific• Rest of the world

On the basis of Geography, the Global In Vivo Toxicology Market is classified into North America, Europe, Asia Pacific, and the Rest of the world. North America has been a dominant region in the market owing to its technological leadership and the presence of major players such as Danaher, Thermo Fischer, Jackson in this region.

Key Players

The “Global In Vivo Toxicology Market” study report will provide valuable insight with an emphasis on the global market. The major players in the market are Danaher Corporation (U.S.), Envigo (U.S.), Charles River Laboratories (U.S.), Waters Corporations (U.S.), Bruker Corporation (U.S.), Transcure BioServices SAS (France), GenOway S.A. (France), Harbour BioMed (U.S.), Merck KGaA (Germany), and GVK Biosciences Pvt. Ltd. (India).

The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Key Developments

• Harbour BioMed (HBM) on March 2021 announced the dosing of the first patient in its open Phase I clinical study of HBM4003 for Chinese patients suffering from advanced melanoma and other solid tumors.

• On 31st March 2020, Danaher Corporation announced the completion of its acquisition of the Biopharma business from General Electric Company’s Life Sciences division. The business was named Cytiva and will be a standalone operating company within Danaher’s Life Sciences segment.

• Thermo Fisher Scientific Inc, the world leader in serving science, today announced the launch of the Thermo Scientific AerosolSense Sampler, a new surveillance solution designed to deliver fast and highly reliable insight into the presence of in-air pathogens, including SARS-CoV-2.

• Taconic Biosciences, a global leader in providing drug discovery animal model solutions, announces an expansion of its immuno-oncology portfolio through the Jh Mouse Model.

• On the 13th of April 2021, Waters Corporation and Genovis AB (Nasdaq First North Growth Market) formally announced a collaboration to develop and market complete routine biopharmaceutical characterization workflows based on the Waters™ BioAccord™ LC-MS System, Andrew+ pipetting robot, and Genovis SmartEnzymes™. The goal of the collaboration is to develop automated workflows for the rapid and consistent characterization of critical quality attributes (CQAs) of monoclonal antibodies (mAbs) and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control (QC).

Report Scope

Research Methodology of Market Research