The Humanised Mouse and Rat Model Market is an emerging yet highly strategic segment within preclinical research tools. Humanised rodent models—engineered to express human genes, cells, or tissues—play a pivotal role in translational medicine, enabling the evaluation of drug efficacy, immunotherapy, and disease mechanisms before human clinical trials. These models have become indispensable in oncology, immunology, infectious diseases, and neuroscience research.
In 2025 (base year), the global humanised mouse and rat model market was valued at USD 141.47 million. With increasing investment in biotechnology, rising adoption of advanced preclinical models, and expansion in immuno-oncology therapies, the market is projected to grow at a CAGR of 10.10% from 2026 to 2035, reaching over USD 370.29 million by 2035. The market’s growth underscores its strategic importance for pharmaceutical companies, academic institutions, and contract research organizations (CROs) aiming to accelerate drug discovery.
Humanised mouse and rat models are laboratory animals modified to carry human genes, immune cells, or tissues, providing a platform that closely mimics human physiology. These models are critical for:
Drug efficacy testing: Predicting therapeutic outcomes before clinical trials.
Immunotherapy development: Evaluating human immune responses to cancer therapies.
Disease modeling: Studying human-specific disease mechanisms for infectious diseases, oncology, and neurological disorders.
Toxicology assessments: Preclinical safety evaluation for novel therapeutics.
Bridging preclinical and clinical research: Reduces the translational gap between animal studies and human trials.
Accelerating innovation: Facilitates the development of targeted therapies in oncology, hematology, and immunology.
Supporting regulatory approval: High predictive accuracy aids regulatory submissions and clinical study design.
| Metric | Value |
|---|---|
| Base Year (2025) | USD 141.47 Million |
| Forecast Period | 2026–2035 |
| CAGR | 10.10% |
| Forecast Value (2035) | USD 370.29 Million |
The market’s growth is driven by:
Increasing R&D investments by pharmaceutical and biotechnology companies.
Rising demand for humanised models in immuno-oncology and infectious disease research.
Expansion of contract research organizations (CROs) offering preclinical services.
The surge in immuno-oncology therapies has accelerated the need for models capable of mimicking human tumor-immune interactions. Humanised models such as PBMC, CD34, and BLT mice are widely used in checkpoint inhibitor and CAR-T cell therapy studies.
Growing investments in personalized medicine, gene therapy, and biologics have fueled adoption of advanced preclinical models, particularly in North America and Europe.
CRISPR/Cas9 and other gene-editing technologies have enhanced the development of genetic humanised mouse models, improving precision and reproducibility.
CROs utilize humanised rodent models to provide preclinical testing services, enabling pharmaceutical companies to outsource costly early-stage studies.
Government grants, rare disease research programs, and university-led immunology studies are expanding the demand for humanised models.
Despite significant growth opportunities, several factors constrain the market:
High development costs: Generating humanised rodent models is resource-intensive.
Ethical concerns: Animal welfare regulations and ethical approvals limit large-scale usage.
Technical limitations: Some humanised models may not fully recapitulate human biology.
Limited access in emerging markets: Cost and infrastructure constraints restrict adoption outside developed regions.
Developing patient-derived xenograft (PDX) models allows testing therapies specific to individual genetic profiles, enhancing precision medicine.
Humanised mice are increasingly used to study immune checkpoint inhibitors, CAR-T therapies, and vaccine responses.
Combining in vivo humanised models with organ-on-chip and computational modeling is emerging as a hybrid approach for predictive drug testing.
Companies are investing in proprietary gene-editing technologies to develop next-generation humanised models with higher fidelity and reproducibility.
Collaboration between pharma and CROs is growing, with contract-based preclinical testing becoming a mainstream strategy for cost efficiency.
Humanised Mouse Models
Cell-based Models
CD34
PBMC
BLT
Genetic Humanised Models
Humanised Rat Models
Humanised mouse models dominate the market due to their extensive use in immunology and oncology research.
Oncology – Largest revenue contributor due to high demand for immuno-oncology studies.
Immunology and Infectious Diseases – Critical for vaccine development and immunotherapy evaluation.
Neuroscience – Emerging applications in neurodegenerative disease modeling.
Haematopoiesis – Studies related to blood disorders.
Toxicology – Safety assessments for novel drugs.
Others – Rare disease and metabolic disorder modeling.
Pharmaceutical and Biotechnology Companies – Primary revenue generators due to internal R&D programs.
Contract Research Organizations (CROs) – Provide preclinical services using humanised models.
Academic and Research Institutions – Use models for fundamental research and translational studies.
Direct sales from model providers
Third-party distributors
Online and platform-based procurement
Dominates the global market due to robust R&D infrastructure, high pharmaceutical spending, and strong adoption of advanced preclinical models.
U.S. and Canada lead in immuno-oncology research and government grants.
Significant growth driven by Germany, the UK, and France, with increasing public-private partnerships and CRO activity.
EU regulations support ethical animal research while enabling high-quality preclinical studies.
High CAGR potential in Japan, China, and India due to expansion of biotech and pharma research, government grants, and CRO growth.
Market still emerging compared to North America and Europe.
Moderate growth supported by academic research and pharmaceutical R&D in Brazil and Argentina.
Nascent market with limited adoption, primarily in academic and government research centers.
Growth expected with infrastructure development and foreign collaborations.
The humanised mouse and rat model market is competitive, with several specialized biotech and preclinical model providers. Companies focus on R&D, partnerships, and expansion into emerging markets.
The Jackson Laboratory – Leading global supplier of humanised rodent models.
GenOway S.A. – Offers genetic humanised models and research services.
TransGenic Inc. – Provides custom humanised mouse models.
Horizon Discovery Group plc – Focused on humanised mouse and rat models for oncology and immunology.
Vitalstar Biotechnology Co., Ltd. – Supplies humanised preclinical models and research tools.
Others – Include specialized CROs and university-linked preclinical providers.
Licensing and co-development agreements for proprietary humanised models.
Expansion into emerging markets to capture new demand.
Development of next-generation humanised models using CRISPR and stem cell technologies.
Strategic partnerships with pharma and biotech companies for preclinical research services.
North America: FDA oversees animal research, while Institutional Animal Care and Use Committees (IACUCs) ensure ethical compliance.
Europe: EU Directive 2010/63/EU regulates animal research, emphasizing ethical considerations and 3Rs (Replacement, Reduction, Refinement).
Asia-Pacific: Emerging regulations in Japan, China, and India, gradually aligning with global ethical standards.
Compliance with ethical and regulatory standards is critical for market acceptance and global distribution.
The humanised mouse and rat model market is projected to exceed USD 370.29 million by 2035, supported by:
Expansion in immuno-oncology applications with personalized and patient-derived models.
Gene editing and stem cell integration improving model fidelity.
CRO partnerships facilitating cost-effective preclinical research.
Growth in emerging markets driven by government funding and academic research.
Hybrid preclinical platforms combining in vivo and in silico models to reduce time-to-clinic.
Investors and decision-makers should focus on companies developing next-generation humanised models, strategic collaborations, and emerging regional opportunities to optimize returns.
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