In Vivo Toxicology Market Report Scope & Overview:

The in vivo toxicology market size was valued at USD 7.76 billion in 2024 and is expected to reach USD 18.62 billion by 2032, growing at a CAGR of 11.58% over 2025-2032.

The global in vivo toxicology market is undergoing radical changes, driven by increasing regulatory pressure, ethical concerns, and new emerging in vivo toxicology methods. Growing demand for safer drugs and chemicals is an important growth driver, with pharmaceutical companies and CROs focusing on improving preclinical evaluations with in vivo models. In vivo toxicology market is being powered by burgeoning research and development spending, as America's National Institutes of Health (NIH) spends more than USD 3 billion towards toxicology studies every year, and the European Union (EU) has dedicated substantial funds to alternatives and refinement in animal testing regimens in its Horizon Europe program. The U.S. in vivo toxicology market is bound by FDA and EPA regulations, which mandate animal testing for final approval, even though there is increasing pressure to include alternative methods. Nonetheless, detailed modeling of human physiology is still required to be validated in vivo for important endpoints, including immunotoxicity, reproductive toxicology, and carcinogenicity.

For instance, an updated review by the Society of Toxicology (SOT) in March 2024 reaffirmed global trends that have seen animals used for toxicology testing beginning to fall through in silico modeling and AI-assisted pathology tools, both mirroring changes in ethical and scientific views that have rippled through the in vivo toxicology market.

The increasing requirement for biologics, oncology drugs, and environmental testing will help to grow the in vivo toxicology market revenue in North America, Europe, and APAC. An increase in the size of the in vivo toxicology market continues to be seen with emerging technologies like CRISPR-genetically modified animal models, real-time in vivo biosensors, and humanized mouse models. Furthermore, a growing prevalence of chronic diseases and an uptick in preclinical pipeline drugs are putting more pressure on drug developers to perform extensive safety evaluations. Some of the leading in vivo toxicology organizations are partnering with academia and industry to fine-tune methods, minimize the number of animals used and enhance predictivity. Additionally, the European Medicines Agency (EMA) has implemented regulations for animal testing that have demanded improved protocols, which are now considered more refined and ethical under specific use stipulations. These regulations have indirectly contributed to the improvement of in vivo toxicology market analysis by enhancing study design and reproducibility.

For instance, in April 2024, Charles River Laboratories’ partnership with a biotech company for creating highly sophisticated in vivo oncology models with 3D bioprinting and AI-driven imaging to enhance efficacy across each step of tumor response analysis emphasized advancements favoring the in vivo toxicology market size.

In Vivo Toxicology Market Dynamics:

Drivers:

• Rising Drug Development Pipelines and Regulatory Toxicology Requirements

The in vivo toxicology market growth is primarily driven by the increasing R&D expenditure in pharmaceutical and biopharmaceutical companies and the growing number of drug compounds. As of 2023, more than 18,000 drugs were actively being developed globally, with many dependent on in vivo safety and efficacy testing before entering clinical trials. Regulators (FDA and EMA) still require extensive in vivo testing for safety pharmacology and toxicokinetics, for instance, for NMEs (new molecular entities) and biosimilars. Furthermore, toxicological studies are also indispensable and useful for agrochemicals, food additives, and cosmetics in terms of REACH regulations and OECD guidelines. Global spending on life sciences R&D was over USD 230 billion in 2023, and 20%-30% was invested in preclinical testing. However, growing investments in in vivo toxicology companies are the new transgenic animal models and advanced imaging technology to drive innovation.

For instance, Envigo and Labcorp have invested in automation and AI tools for data interpretation in live models. The in vivo toxicology market share is further supported by growing collaboration between industry and academia, facilitating resource sharing and knowledge transfer.

Restraints:

• Ethical Challenges Surrounding Animal Use and Global Shifts Toward Non-Animal Models Are Restraining The In Vivo Toxicology Market’s Adoption Rates

The in vivo toxicology market is considerably restricted due to increasing ethical concerns towards animal testing, despite regulatory dependence. With more than 192 million animals used in experiments each year (Humane Society International), it was a practice that sparked a public uproar and demands for alternatives. Legislative changes (such as the U.S. FDA Modernization Act 2.0, passed in December 2022) that permit non-animal approaches to drug approval processes are driving subtle transformation in favor of in vivo studies.

Supply chain disruptions and lack of availability of genetically modified or some specialized animal models are also putting some pressure, particularly on the smaller in vivo toxicology companies. Moreover, increasing dependence on high-throughput in vitro and silico technologies is decreasing the necessity of live animal tests in early screening steps. Public and investor pressure has already resulted in divestments from companies that are highly dependent on animal-based science, and companies are under pressure to think differently. Some of these ethical, legislative, and technological developments are becoming barriers to the in vivo toxicology market expansion, despite the continuing need for in vivo assessments for certain toxicities assessments.

Segmentation Analysis:

By Product

Instruments held a substantial share of the in vivo toxicology market globally in 2024, with more than 58% of the market. The prevalence is due to the increasing use of state-of-the-art imaging devices, telemetry systems, and physiological monitoring equipment for the real-time data collection of animal studies. They are also critical for the chronic and systemic toxicology studies within pharma R&D pipelines.

Consumables are also experiencing high demand as they are used repeatedly in various testing rounds. Reagents, animal diets, and surgical kits are consumed in large amounts in toxicity studies, and their repeated use, especially in multi-dose studies, warrants higher utility within CROs and in-house laboratories.

By Test Type

Acute toxicity tests dominated in 2024 with a market size of close to 34% on account of their need as a part of regulations to evaluate the immediate toxic reactions caused by drugs and chemicals. These tests are essential for screening studies and are mandated by the OECD.

The highest rate of growth for testing is in chronic test type, which is being driven by the pipeline of long-term treatment drugs. As the number of therapies for chronic diseases is increasing, there is a growing demand for long-term safety profiling for longer periods.

By Testing Facility

Based on the model, outsourced testing accounted for the larger market share of the drug discovery services market in 2024, which is primarily attributed to the cost benefits, accessibility to advanced technologies, and savings offered by outsourced testing for drug developers (including small biotech firms).

In-house testing is gaining momentum, particularly for the larger pharma companies that are investing in building standalone preclinical research units to have more control over study design, data security, and compliance.

By Toxicity Endpoint

The systemic toxicity testing segment dominated the market in 2024 and accounted for more than 29% of the market due to the compulsion that almost all drug and chemical candidates are tested to measure the multi-organ effects, which is a critical element required across any drug approval pathway.

DART research is expanding rapidly, given increasing concerns regarding drug safety in pregnancy and its effects on fertility. However, the growing demand for reproductive health products has also led to the need for specialized toxicity endpoints.

By End User

The pharma and biotech companies were the largest end users in 2024, holding about 45% of the market, supported by increasing preclinical R&D investments and demand for faster drug approvals.

Fastest-growing CROs are those benefiting from increased outsourcing by pharma and biotech companies in their efforts to reduce costs and improve scalability. Their global presence and regulatory knowledge have made them ideal for toxicity testing.

Regional Analysis:

North America held 51.3% of the global share in the in vivo toxicology market in 2024 due to a robust pharmaceutical R&D industry, supportive regulations, and significant public and private investments. The U.S. in vivo toxicology market size was valued at USD 3.01 billion in 2024 and is expected to reach USD 6.63 billion by 2032, growing at a CAGR of 10.43% over 2025-2032. The US is the largest, holding more than 68% of the regional market due to the presence of sophisticated research facilities, FDA-approved test procedures, and major in vivo toxicology companies like Charles River and Labcorp. The pressure is additionally bolstered by the surge of chronic disease drug discovery and the continued growth of biologics pipelines. Canada is up and coming largely due to greater government financing in the early-stage science and blossoming biotech clusters in provinces such as Ontario and Quebec. Similarly, Mexico is emerging through an increasing number of CRO partnerships and OECD guideline adherence.

Europe is the second largest market for in vivo toxicology due to strict environmental guidelines of REACH, an established pharmaceutical industry, and public health initiatives. Germany is the regional leader, accounting for more than 26% of the European market, due to a strong toxicology R&D sector, a large pharma presence, and government-mandated safety testing schemes. A major presence is also exerted by France and the United Kingdom, mainly based on the increasing implementation of developmental and reproductive toxicity testing and intense academic-industry cooperation, respectively. The fastest-developing country in Europe is Poland, driven by increases in outsourcing and EU-funded R&D support, which is stimulating Polish CROs and GD. The regulated-led demand in the region and existing laboratory capacity make the region a major market for the long term.

Asia Pacific is expected to be the most lucrative in vivo toxicology market, with a burgeoning pharma industry, low cost of operations, and investment in research infrastructure. China is leading the way in the region with more than 40% market share primarily due to massive government investment in preclinical R&D, a well-established CRO ecosystem, and the adoption of global best practices about regulatory policy. India is the second-largest growing country, having a large number of contract research organizations and positive government reforms towards in vivo safety testing. Japan is also among the top three contributors and is strong in chronic disease research due to its aging population and increasing investments in drug discovery.

In Vivo Toxicology Market Key Players:

Leading vivo toxicology companies in the market include Charles River Laboratories, Envigo, The Jackson Laboratory, Taconic Biosciences, JANVIER LABS, Thermo Fisher Scientific, Danaher Corporation, Waters Corporation, Agilent Technologies, and Shimadzu Corporation.

Recent Developments:

• In Feb 2025, CN Bio introduced the PhysioMimix DILI Assay Kit – Human 24, a high-throughput liver-on-a-chip system aimed at improving preclinical toxicology testing, particularly for predicting drug-induced liver injury (DILI) with greater accuracy and human relevance.

• In Sep 2024, Emulate, Inc. launched the Chip-R1 Rigid Chip, a novel organ-on-chip platform with a minimally drug-absorbing design, enhancing biological modeling for ADME and toxicology studies by reducing compound loss during experiments.