Humanized Mouse and Rat Model Market Size, Share, Growth, and Industry Analysis, By Type (Genetic & Cell-Based), By Application (Pharmaceutical, Biotechnology Companies & CRO) and Regional Insights and Forecast to 2034

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HUMANIZED MOUSE AND RAT MODEL MARKET REPORT OVERVIEW

The global Humanized Mouse and Rat Model Market size was USD 0.137 billion in 2025, and the market is projected to touch USD 0.263 billion by 2034, exhibiting a CAGR of 7.6% during the forecast period.

Humanized mouse and rat models are specific preclinical research models that are developed by inoculating immunocompromised rodents, usually mice, with functional human cells, tissues or genes to further represent human biology and disease states. They are engineered by such techniques as transplantation of human hematopoietic stem cells (HSCs) or peripheral blood mononuclear cells (PBMCs) to form a Human Immune System (HIS), or by genetic engineering to substitute rodent genes with their human equivalents, thus producing human proteins.

COVID-19 IMPACT

Market Growth Accelerated by Pandemic due to Humanized ACE2-Expressing Models

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to market's growth and demand returning to pre-pandemic levels.

This market was given a major and strong positive impetus by the COVID-19 pandemic, mainly due to the fact that the traditional rodent models did not have the human ACE2 receptor needed to be infected with SARS-CoV-2, resulting in an immediate and huge worldwide demand to make humanized ACE2-expressing models. The urgency of this research requirement led to the spur in technology development and more investing by the pharmaceutical/biotechnology industries and the governments and the invention and commercialization of new and advanced humanized mouse and rat models.

LATEST TRENDS

Genetic Engineering Methods to Propel Market Growth

The current trends in this market can be characterized by several factors, the first of which is the growing popularity of genetic engineering methods such as CRISPR-Cas9 to develop more specifically targeted and complex models, which is why the number of orders in the genetic humanization models increases. The key area of market growth is its use in immuno-oncology and an ever-expanding interest in infectious disease, which has also seen a significant change to an increased focus in the next-generation Humanized Immune System (HIS) models that better replicate complex human immune responses when testing new cell and gene therapies.

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HUMANIZED MOUSE AND RAT MODEL MARKET SEGMENTATION

By Type

Based on type the market can be categorized into Genetic & Cell-Based

• Genetic: A genetic humanized model is produced through direct alteration of the animal genome and more commonly done by inserting or replacing a particular human gene (or piece of human DNA) into the chromosomes of the host animal. It is done through the application of sophisticated genetic engineering tools like CRISPR-Cas9 to make an expression of a protein or gene product of interest of a human being in a physiologically relevant context.

• Cell-Based: cell-based models are cellular models that have been generated by transplanting functional human cells, tissues, and organs into an immunodeficient host animal (usually a mouse, in either the NSG or NOG strain, both of which lack a functional immune system). This is aimed at ensuring that the human cells engraft, grow and work in the host just like the biological system in a human being.

By Application

Based on application the market can be categorized into Pharmaceutical, Biotechnology Companies & CRO

• Pharmaceutical Companies: the biggest revenue column in this market, usually alongside biotechnology companies in the market reports. They are major end-users because they have a large Research and Development (R&D) business and enormous investments in drug discovery and development.

• Biotechnology Companies: It is often compared with pharmaceutical companies, but they are also a large market driver, as companies are interested in new advanced therapeutics, such as biologics, cell and gene therapies, and precision medicine. To create and test complex therapies, including monoclonal antibodies and immune checkpoint inhibitors, which demand the presence of a humanized immune system or expression of the target to be assessed in vivo correctly, biotechnology companies will often use humanized models.

• Contract Research Organizations (CROs): they are estimated to be the most rapidly expanding in the market. CROs are also the outsourcing partner of the pharmaceutical and biotechnology firms, where they offer preclinical research services such as maintenance, testing and execution of studies using these models.

MARKET DYNAMICS

Driving Factors

Personalized Medication and Patient-Focused Treatment to Drive the Market Advancement

One of the major driving factors of the Humanized Mouse and Rat Model Market Growth because of the rising amount of worldwide demand for personalized medication and patient-focused treatment. Individual medicine needs a profound knowledge of human-specific disease processes and a specific therapeutic reaction that may not be effectively reproduced with the help of the standard animal models. Humanized models that use human genes, cells, or tissues address this gap by offering a more realistic in vivo system to investigate human diseases and to test the effectiveness of drugs and to determine the potential toxicity of individualized therapy, especially in complicated systems such as oncology and infectious diseases.

Investment Made in Research and Development to Expand the Market

The second major force is the sharp and escalating amount of investment made in research and development by pharmaceutical and biotechnology firms. These companies are ever multiplying the pipeline of new drugs, biologics, and cell and gene technologies, and these require the application of sophisticated preclinical models. The large spending on R and D, which in most cases is supported either by government or by companies, drives the need to have a humanized rodent model that has a high predictive value to clinical outcome to minimize the risk and cost caused by drug flops at the later stage of development.

Restraining Factor

Expensive Nature and Complicated Technical Skills to the Market Growth

The expensive nature and complicated technical skills necessary to develop and maintain custom models and models are one of the main forcing factors in this market. Production of humanized models entails complex genetic engineering methodologies and special breeding methods that require huge initial investment in advanced laboratory equipment as well as highly trained professionals. Moreover, the continuous immunodeficient, isolated colonies are maintained, which are subject to strict ethical and regulatory principles, adding to an expensive operation cost.

Personalized Medicine to the Market Growth

Opportunity

The most significant opportunity driver in this market is the increasing global demand for personalized medicine and complex therapeutics, especially in oncology and immunology, which are associated with the need to have more predictive preclinical models.

Humanized models, and in particular those with reconstituted human immune systems (HIS) or patient-derived xenografts (PDX), are the only models that can replicate human disease pathology and drug response and are therefore essential in testing next-generation therapeutics, such as immunotherapies and gene therapies, thereby driving the pharmaceutical and biotechnology industries into massive investment and adoption.

Limited Fidelity and Functionality to Challenge the Market Growth

Challenge

The only factor of challenge of this market is that the engrafted human system has limited fidelity and functionality, which makes it uncertain to translate the research findings to the human being. Although these models have human components (cells, tissues, or genes), they nonetheless function in a non-human rodent environment, with the result being a partially or imperfectly reconstituted immune system of humans.

This leads to functional defects, including the failure to induce robust and long-term adaptive immune responses (including class-switched antibodies and memory T-cells) and the persistence of interference of the residual innate immune system of the mouse, which can eventually limit the predictive capability of the models to human drug efficacy and safety, especially in complex diseases and immunotherapies.

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HUMANIZED MOUSE AND RAT MODELR MARKET REGIONAL INSIGHTS

The market is primarily segregated into Europe, Latin America, Asia Pacific, North America, and Middle East & Africa.

• North America

North America has emerged as the most dominant region in the Humanized Mouse and Rat Model Market share as it has always had most of the market share. This dominance is fueled by the concentration of large pharmaceutical and biotechnology enterprises, huge government and private investment in life sciences research, particularly in oncology and infectious disease research, and a strong and mature research infrastructure that is built on major academic institutions and Contract Research Organizations (CROs). The availability of major market forces such as Charles River Laboratories and The Jackson Laboratory, with a high rate of adoption of advanced models for customized medicine and large-scale clinical trials, makes North America the main thrust of technological innovation, research output, and market consumption.

• Europe

Europe is the second-largest market and has a different role, which is frequently marked by a powerful regulatory framework and a predisposition to cooperative research. The area has major pharmaceutical and biotech R&D, but its market future is being influenced especially by other stringent animal welfare and ethical policies, including the concept of the Three Rs (Replacement, Reduction and Refinement), which, on the one hand, may contain overall restraints on the use of animals, but on the other hand, provoke the need to have more complex, highly predictive humanized models to refine and reduce the use of animals. Moreover, the biotech firms and laboratories in Europe are also playing a big role in genetic engineering and model building, which are also essential in creating innovation, especially in France and the UK.

• Asia

Asia Pacific (APAC) Asia Pacific is quickly becoming the most promising market, as huge growth in terms of R&D spending is being made in China, India, Japan and South Korea. This has been driven by the increasing national pharmaceutical and biopharmaceutical sectors, increasing chronic disease rates (such as cancer), and positive government policies to fund biomedical research and translational research. The region is undergoing a fast development of the sophisticated vivarium, and it is a serious center of outsourced preclinical research by Contract Research Organizations (CROs), making it a critical engine of future development as well as an important location for capacity expansion by global model providers.

KEY INDUSTRY PLAYERS

Key Players Transforming the Humanized Mouse and Rat Model Landscape through Innovation and Global Strategy

This market is bombarded by the high rate of research and development (R&D) within the pharmaceutical and biotechnology industries that are the highest end users in the market. Their power lies in the fact that the world is increasingly desperate to have precision medicines, immuno-oncology and complicated therapeutics to cure chronic and infectious diseases, and they need to test the drugs' safety and efficacy before any clinical trials can take place by using highly predictive in vivo models. This pressure is further enhanced by the fact that Contract Research Organizations (CROs) are becoming increasingly important sources of outsourcing of complex preclinical research and the development of custom models that allow pharma/biotech firms to speed up the drug discovery process and engage in sustained innovation in the market segments of genetic engineering (such as CRISPR) and services.

List Of Market Players Profiled

• The Jackson Laboratory (U.S.)
• Taconic Biosciences (U.S.)
• Horizon Discovery Group (U.K.)
• genOway (France)
• Charles River Laboratories (U.S.)

INDUSTRIAL DEVELOPMENT

March 2025: Major recent news in this market was the declaration of a world strategic partnership between AstraZeneca and Harbour BioMed in March 2025. The partnership aims at the discovery and development of the next-generation multi-specific antibodies through Harbour BioMed's proprietary technology platform, the Harbour Mice fully human antibody, which comprises a key source of in vivo humanized models in preclinical drug discovery, in immunology and in oncology.

REPORT COVERAGE

The study encompasses a comprehensive SWOT analysis and provides insights into future developments within the market. It examines various factors that contribute to the growth of the market, exploring a wide range of market categories and potential applications that may impact its trajectory in the coming years. The analysis considers both current trends and historical turning points, providing a holistic understanding of the market's components and identifying potential areas for growth.

The research report delves into market segmentation, utilizing both qualitative and quantitative research methods to provide a thorough analysis. It also evaluates the impact of financial and strategic perspectives on the market. Furthermore, the report presents national and regional assessments, considering the dominant forces of supply and demand that influence market growth. The competitive landscape is meticulously detailed, including market shares of significant competitors. The report incorporates novel research methodologies and player strategies tailored for the anticipated timeframe. Overall, it offers valuable and comprehensive insights into the market dynamics in a formal and easily understandable manner.