The humanised mouse and rat model market is experiencing strong momentum as pharmaceutical, biotechnology, and academic institutions increasingly adopt models that better recapitulate human biology. In 2024, the global market surpassed approximately USD 128.49 million, and it is projected to expand at a CAGR of ~10.10% from 2025 to 2034, reaching over USD 336.31 million by 2034. The push toward improved translational validity, the rise of immuno-oncology, and advances in genetic engineering are major growth catalysts.

Humanised models—either carrying human immune system components or human genes in rodents—are invaluable in drug discovery, immunology, cancer research, infectious disease models, toxicity testing, and beyond. As conventional rodent models often fail to mimic certain human-specific pathways, the demand for humanised mouse and rat models has grown significantly.

Below is a detailed exploration of market segmentation, regional dynamics, competitive landscape, challenges, and future outlook.

Market Overview and Key Segments

Types of Humanised Models

The market can be segmented by type:

• Humanised Mouse Models
    • Cell-based Humanised Mouse Models: Includes CD34-derived, PBMC-derived, and BLT (Bone marrow–Liver–Thymus) models, where human hematopoietic or immune cells are engrafted into immunodeficient mice.
    • Genetic Humanised Mouse Models: Mice engineered to express specific human genes, receptors, or immune system elements.

• Humanised Rat Models: A more recent and growing segment, offering larger size, physiologic advantages, and more human-like pharmacokinetics.

Of these, humanised mouse models currently dominate, particularly genetic humanised models, but cell-based models are witnessing fast growth due to their relevance in immuno-oncology and infectious disease research.

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Applications

Humanised models are used across a spectrum of research areas:

• Oncology: For immunotherapy testing, tumor microenvironment studies, and human–mouse xenografts.

• Immunology and Infectious Diseases: To study human immune responses, viral infections (HIV, SARS-CoV-2), and immune-modulating therapies.

• Neuroscience: Modeling human-specific neural or neuroimmune pathways.

• Haematopoiesis: Tracking development and behavior of human blood lineages in vivo.

• Toxicology: Evaluating human-specific toxicity or off-target effects of drug candidates.

• Others: Metabolism, pharmacokinetics, regenerative medicine.

Within applications, oncology remains the largest share, reflecting the surge in immuno-oncology and checkpoint inhibitor research. According to MarketsandMarkets, the oncology application segment held a dominant position in 2024. 

End Users

• Pharmaceutical & Biotechnology Companies: The primary users, leveraging humanised models in preclinical pipelines.

• Contract Research Organisations (CROs): Provide in vivo testing services using humanised models for clients.

• Academic & Research Institutions: Use models for mechanistic studies, translational biology, and proof-of-concept work.

Pharma/biotech firms generally account for the largest market revenue share, closely followed by CROs. 

Humanised Mouse and Rat Model Market: Regional Dynamics

North America

North America, particularly the United States, dominates the global humanised rodent model market owing to high R&D investments, advanced biopharma infrastructure, and early adoption of next-generation in vivo models. MarketsandMarkets cites North America as the largest regional market. 

Europe

Europe holds the second-largest share, with strong life sciences ecosystems in the U.K., Germany, and France. A high concentration of immuno-oncology research, regulatory focus, and academic collaborations drive demand.

Asia Pacific

Asia Pacific is projected to be the fastest-growing region—driven by expansion of biotechnology sectors in China, Japan, South Korea, and India. Increased government funding and rising CRO presence enhance adoption of humanised models. 

Latin America & Middle East & Africa

These regions represent emerging opportunity zones. While currently limited in adoption, increasing local biotech capacities and partnerships with global players are expected to fuel moderate growth.

Market Drivers, Challenges & Trends

Key Market Drivers

• Translational Relevance and Predictivity
  Humanised models bridge the gap between preclinical rodent data and human clinical outcomes, making them valuable for immunotherapies, biologics, and targeted treatments.

• Boom in Immuno-Oncology & Cell & Gene Therapies
  The explosion in checkpoint inhibitors, CAR-T, bispecifics, and personalized therapies relies heavily on humanised in vivo platforms for validation.

• Technological Advancements
  CRISPR/Cas gene editing, improved immunodeficient strains, and better human cell engraftment techniques enhance model reliability and throughput.

• Outsourcing to CROs
  Pharma/biotech firms increasingly outsource humanised model services to CROs, creating robust demand for scalable model manufacturing and testing.

Challenges & Restraints

• High Cost & Complexity: Establishing and maintaining humanised models require substantial cost, specialized staff, and infrastructure.

• Engraftment Variability & Model Limitations: Human immune engraftment is not always reproducible; differences in microenvironment and human–mouse interactions persist.

• Ethical and Regulatory Barriers: Animal welfare regulations and regulatory scrutiny may increase costs and compliance burdens.

• Competition from Alternative Models: In vitro organoids, microphysiological systems (organs-on-chips), and computational models may reduce reliance on in vivo models over time.

Emerging Trends

• Refinement of Humanised Rat Models: Larger size and physiologic advantages drive interest.

• Multi-Humanised Systems: Models combining human immune, liver, and microbiome elements to more accurately mimic human physiology.

• Commercialization & Model Catalog Expansion: Providers are offering off-the-shelf, well-characterized humanised strains, reducing lead time for adoption.

• Integration with Omics & Imaging: Coupling humanised models with genomics, transcriptomics, and in vivo imaging enhances mechanistic insight.

Competitive Landscape & Key Players

Prominent organizations in the humanised model market are actively developing proprietary strains, expanding service offerings, or forming collaborations. Key companies include:

• The Jackson Laboratory

• GenOway S.A.

• TransGenic Inc.

• Horizon Discovery Group plc

• Vitalstar Biotechnology Co., Ltd.

• Additional players in the broader space include Charles River Laboratories (via humanised model services) and various specialized CROs. 

These players compete on model fidelity, reproducibility, speed of delivery, service breadth, and global presence.

Market Forecast & Outlook

Although your provided base and growth numbers (USD 128.49 million in 2024, ~10.10% CAGR to USD 336.31 million in 2034) suggest robust expansion, market intelligence reports portray somewhat different baselines and growth rates. For instance:

• MarketsandMarkets estimates the market at USD 255.8 million in 2024, projecting a CAGR of 8.2% to reach USD 409.8 million by 2030.

• FactMR places humanised mice (a subset) at USD 101.6 million in 2024, with growth to USD 182 million by 2034 (CAGR ~6.0%) 

Despite these variances, the consensus is strong growth driven by adoption in drug development. Under either projection, the market is poised for significant enlargement over the next decade.

Regions such as Asia Pacific may outpace the global average, while North America and Europe remain stable revenue centers. The share of humanised rat models is expected to gradually increase as these models mature and prove advantageous in pharmacokinetic and toxicology studies.

Frequently Asked Questions (FAQs)

Q1. What is the size and growth projection for the humanised mouse and rat model market?
The humanised mouse and rat model market in 2024 is estimated to be around USD 128.49 million, with forecasts suggesting growth at a CAGR of ~10.10% to exceed USD 336.31 million by 2034 (based on your base data). Industry sources like MarketsandMarkets project higher baselines (~USD 255.8 million in 2024) with CAGR ~8.2% to reach ~USD 409.8 million by 2030.

Q2. What segments drive demand in the humanised mouse and rat model market?
Growth is driven mainly by humanised mouse models, especially genetic humanised and cell-based models (CD34, PBMC, BLT). On the application side, oncology is the leading segment, with strong demand in immunotherapy, tumor models, and human–mouse xenograft studies.

Q3. Why are humanised models preferred over conventional rodent models?
Humanised models incorporate human immune, genetic, or cellular components, enabling experiments that better reflect human biology. They help evaluate human-specific drug responses, immune therapies, and disease mechanisms that standard mouse models cannot fully replicate.

Q4. Which region leads the humanised model market, and where is growth fastest?
North America leads in absolute revenue share due to the mature biotech sector and research investment. However, Asia Pacific is expected to register the highest CAGR over time, as countries like China and India expand R&D capabilities and CRO ecosystems.

Q5. What are the major challenges in adopting humanised mouse and rat models?
Challenges include high cost and technical complexity, variability in human cell engraftment, regulatory and ethical constraints, and the rising competition from alternative in vitro models such as organoids and microphysiological systems.