The global Humanized Mouse and Rat Model Market, valued at US$255.8 million in 2024, is projected to grow at a robust CAGR of 8.2%, reaching US$276.2 million in 2025 and US$409.8 million by 2030. This growth is fueled by the rising adoption of humanized models in preclinical research, increasing demand for personalized medicine, and expanding R&D activities in the pharmaceutical and biotechnology sectors. Emerging genetic engineering technologies such as CRISPR are creating new opportunities, particularly in oncology and immunology research.

Humanized models, particularly humanized mice (hu-mice), are increasingly crucial in evaluating drug metabolism, immune system functioning, and therapeutic efficacy, making them indispensable in modern drug development pipelines.

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Market Segmentation: Type and Form

The market is primarily segmented into:

1. Humanized Mouse Models

   • Further divided into genetic humanized mice and cell-based humanized mice

   • Genetic humanized mice dominate revenue in 2024 and are expected to maintain their lead, driven by applications in safety testing, pharmacokinetics, and novel therapeutics evaluation. Genetic models are widely used for analyzing immune response, drug efficacy, and disease progression, making them indispensable in preclinical oncology research.

2. Humanized Rat Models

   • Preferred for larger-scale studies and detailed physiological analyses, particularly in cardiovascular and metabolic disease research. While their adoption is growing, mice models continue to hold the majority share due to established protocols and broad applicability.

Application Insights: Oncology Leads

Oncology is the largest application segment in 2024, fueled by government funding, rising cancer research initiatives, and preclinical immuno-oncology studies. Humanized models allow researchers to simulate human immune responses in cancer studies, accelerating the evaluation of checkpoint inhibitors, CAR-T therapies, and biologics.

Other applications include infectious diseases, autoimmune disorders, metabolic disorders, and regenerative medicine, where humanized models provide critical translational insights for novel therapies.

End-User Insights: Pharma & Biotech Lead the Way

The primary end users of humanized models include:

• Pharmaceutical and Biotechnology Companies

  • Invest heavily in preclinical and translational research, particularly for immuno-oncology, cell and gene therapies, and biologics

  • Require humanized models for PK/PD studies, efficacy testing, and toxicology evaluations

• Contract Research Organizations (CROs) & CDMOs

  • Procure models from specialized vendors to deliver outsourced preclinical services

  • Serve as intermediaries providing models for research and clinical trial support, particularly in oncology and personalized medicine

• Academic & Research Institutes

  • Utilize models for basic and translational research, contributing to innovation in drug discovery pipelines

Regional Insights: Asia Pacific Emerges as a Growth Hotspot

While North America and Europe currently hold significant shares due to robust research infrastructure and funding, the Asia Pacific market is expected to register the highest growth through 2030. Key drivers include:

• Rising R&D activities in China and India

• Expansion of CROs and contract lab services

• Government support for preclinical and clinical research

• Growing pharmaceutical manufacturing base and biotechnology investments

China, in particular, is witnessing rapid adoption of outsourced preclinical services for small and large molecules, driving demand for humanized mouse and rat models.

Market Drivers: Innovation and Research Expansion

1. Advances in Genetic Engineering: Techniques such as CRISPR, gene targeting, and cell-based humanization enhance model precision and applicability.

2. Personalized Medicine: Rising demand for patient-specific therapeutics encourages the use of humanized models to predict clinical outcomes.

3. Immuno-Oncology Growth: Humanized models provide critical insights for immune-targeted therapies and biologics.

4. Pharma & Biotech R&D Investment: Expanding budgets in preclinical studies and translational research sustain market growth.

5. Emerging Markets: Expansion of CROs, academic collaborations, and government-funded initiatives accelerate adoption in Asia Pacific and Latin America.

Key Players: Strategic Growth and Innovation

The Jackson Laboratory (JAX) – US

JAX is a market leader in humanized mouse and rat models, maintaining a diverse portfolio across North America, Europe, and Asia Pacific. The company leverages its expertise in drug discovery and disease modeling, focusing on long-term contracts, ancillary markets, and customer retention to strengthen market position.

Charles River Laboratories – US

Charles River provides a comprehensive suite of drug discovery and early-stage development services. The company has executed strategic acquisitions and partnerships, including SAMDI Tech (HTS solutions) and collaborations with NJ Bio (ADC development), expanding its capabilities in preclinical research and enhancing its humanized model offerings.

Inotiv – US

Inotiv is notable for its robust product portfolio and global presence, particularly across North America and Europe. Revenue growth from USD 347.8 million in 2021 to USD 490.7 million in 2024 demonstrates its successful adoption of humanized models for preclinical research and translational studies.

genOway – France

A pioneer in genetically engineered mouse and rat models, genOway is recognized for innovation and quality, serving pharmaceutical companies, biotech firms, and academic institutions worldwide. Its focus on customized genetic models positions it as a critical partner in drug discovery.

Other prominent players include Taconic Biosciences, Champions Oncology, CLEA Japan, JSR Corporation (Crown Biosciences), Altogen Labs, Vitalstar Biotechnology, Ingenious Targeting Laboratory, and Cyagen Biosciences. These companies are actively expanding product portfolios, global reach, and preclinical service offerings to capture market growth.

Market Outlook: Toward Precision Preclinical Research

The Humanized Mouse and Rat Model market is poised for sustained growth, driven by:

• Increasing adoption of genetic and cell-based humanized models

• Expansion of oncology and immuno-oncology research

• Rising outsourcing of preclinical services in Asia Pacific

• Continued technological innovations, including CRISPR and advanced genetic engineering

• Strategic alliances, mergers, and partnerships by leading market players

As pharmaceutical and biotechnology companies continue to expand R&D investments and develop personalized therapies, humanized models will remain critical for predictive translational research, enabling faster, safer, and more efficient drug development.

Conclusion

The Humanized Mouse and Rat Model market represents a vital enabler of precision medicine and drug discovery, forecasted to reach US$409.8 million by 2030. With genetic engineering innovations, expanding R&D investment, and CRO adoption, the market is set to deliver transformative solutions for preclinical studies, particularly in oncology and immunology. Companies leveraging these models effectively will secure competitive advantages in developing next-generation therapeutics.

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