Humanized Mice Model Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Humanized Mice Models, Humanized Rat Models), By Application (Oncology, Immunology & Infectious Diseases, Toxicology, Others), By End User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic & Research Institutions), By Region and Competition, 2020-2030F

Market Overview

The Global Humanized Mice Model Market, valued at USD 1.90 Billion in 2024, is projected to experience a CAGR of 10.10% to reach USD 3.38 Billion by 2030. Humanized mice models are laboratory animals engineered to carry functional human genes, cells, or tissues, thereby closely replicating human physiological and pathological conditions for research purposes. The market's expansion is primarily driven by the increasing global incidence of chronic diseases, necessitating advanced models for drug discovery and development, particularly in oncology and infectious disease research. Furthermore, the growing emphasis on personalized medicine approaches and advancements in genetic engineering techniques, such as CRISPR, significantly bolster demand for these sophisticated preclinical tools.

A significant challenge impeding market expansion is the substantial cost associated with the development, maintenance, and ethical oversight of these complex models. These factors, alongside the inherent complexities in translating animal model results to human patients, necessitate considerable investment. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), in 2022, the research-based pharmaceutical industry invested an estimated €44,500 million in Research and Development in Europe, a portion of which directly supports the utilization of humanized mice models in preclinical studies.

Key Market Drivers

The Global Humanized Mice Model Market is significantly propelled by both substantial technological advancements in genetic engineering and the increasing demand for preclinical drug development. Genetic engineering innovations, particularly advanced gene editing tools, enable the creation of highly refined humanized models that precisely mimic human physiological and pathological conditions. This precision is essential for developing more accurate preclinical tools. For example, according to the Innovative Genomics Institute (IGI), in March 2024, "CRISPR Clinical Trials: A 2024 Update", CRISPR Therapeutics initiated two phase 1 trials in 2023 targeting cardiovascular disease, directly demonstrating the application of these genetic techniques in therapeutic development. Concurrently, the biopharmaceutical industry's escalating investment in early-stage research is a powerful market driver. Companies are committing considerable resources to preclinical phases to identify and validate new drug candidates, necessitating advanced models for assessing drug efficacy and safety prior to human trials. According to BioSpace, in May 2025, "Undeterred by Political, Economic Headwinds, Pharma Ups R&D Investment in 2024 and Beyond", drugmakers globally invested nearly $288 billion in research and development in 2024, much of which fuels the extensive preclinical testing crucial for novel therapeutic advancement.

This dynamic is further supported by a robust overall research ecosystem that fosters broad scientific inquiry. According to the AUTM 2024 US Licensing Survey, total research funding topped $109 billion in 2024, fostering the innovation and infrastructure essential for the continued evolution and application of humanized mouse models in biomedical research.

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Key Market Challenges

A substantial challenge impeding market expansion in the Global Humanized Mice Model Market is the significant cost associated with the development, maintenance, and ethical oversight of these complex models. These considerable financial requirements directly limit the accessibility and widespread adoption of humanized mice, particularly for smaller biotechnology firms, academic institutions, and emerging research initiatives that operate with more constrained budgets. The extensive investment needed for generating and sustaining these advanced research tools, alongside adherence to rigorous ethical guidelines, contributes to elevated preclinical research expenditures.

This financial burden can restrict the scope and number of drug discovery and development programs that can effectively utilize humanized mice, thereby slowing the overall market growth. For instance, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), in 2023, its member companies invested approximately $96 billion in research and development. A portion of this significant expenditure is allocated to preclinical studies involving animal models, where the high costs of humanized mice necessitate careful resource allocation, potentially diverting funds from other critical research areas or limiting the scale of humanized model usage in early-stage drug pipelines.

Key Market Trends

The increasing adoption of patient-derived xenograft (PDX) models is a significant trend driving the Global Humanized Mice Model Market, owing to their ability to closely mimic human tumor heterogeneity and response to therapies. These models provide a highly predictive preclinical platform essential for oncology drug development and the advancement of personalized medicine strategies. The American Association for Cancer Research (AACR), in its 2024 Cancer Progress Report, highlighted that from July 2023 to June 2024, the FDA approved several new anti-cancer therapeutics, including molecularly targeted drugs, underscoring the continuous output from intensive oncology research that relies on advanced preclinical tools. As featured in Genes & Diseases in June 2025, an article detailed how PDX models are becoming an indispensable tool in precision oncology, particularly through supporting co-clinical trials and integrating next-generation technologies like CRISPR gene editing.

A growing emphasis on infectious disease and vaccine research represents another pivotal trend influencing the market. The persistent global threat of emerging and re-emerging pathogens necessitates substantial investment in understanding host-pathogen interactions and developing effective prophylactics and therapeutics. Humanized mouse models are critical for these efforts, offering in vivo platforms to evaluate vaccine efficacy and test antiviral compounds. For instance, the National Institute of Allergy and Infectious Diseases (NIAID), a primary funding body for such investigations, received a request for approximately $7.29 billion in its fiscal year 2026 budget to support research aimed at combating infectious and immunologic diseases. This significant funding supports initiatives like those at the La Jolla Institute for Immunology, which, in an October 2024 study, developed six new lines of humanized mice specifically to model human COVID-19 infection and vaccination settings, thereby providing crucial insights into viral dynamics.

Segmental Insights

The Oncology segment is experiencing rapid growth in the Global Humanized Mice Model Market, primarily driven by the critical need for advanced preclinical models that accurately represent human cancer development and immune interactions. These humanized models are indispensable for evaluating novel immunotherapies, such as checkpoint inhibitors and cell-based treatments, which necessitate a human immune system context for effective assessment. The increasing global incidence of cancer, coupled with substantial investments in oncology research by pharmaceutical and biotechnology companies and support from institutions like the National Cancer Institute, further accelerates the demand for sophisticated humanized mouse models in drug discovery and development. This specialized application enables more precise studies of tumor growth, metastasis, and therapeutic responses, bridging the gap between preclinical findings and clinical outcomes.

Regional Insights

North America is the dominant region in the global humanized mice model market, primarily driven by robust research and development activities within its prominent biotechnology and pharmaceutical sectors. This leadership is further supported by substantial government funding for life sciences research, particularly in areas like oncology, and the increasing demand for precision medicine approaches. The presence of well-established research infrastructure and key market players, along with supportive initiatives from bodies such as the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) in encouraging the use of humanized models for preclinical drug testing, significantly contribute to the region's market expansion.

Recent Developments

• In June 2025, Taconic Biosciences announced a strategic partnership with the Michael J. Fox Foundation. This collaboration focuses on advancing preclinical research specifically aimed at understanding and addressing Parkinson's disease. By leveraging Taconic Biosciences' expertise in developing specialized humanized mouse models, this alliance seeks to accelerate the discovery and development of effective therapies for neurodegenerative disorders. The partnership underscores a commitment within the humanized mice model market to provide targeted, high-fidelity research tools that can directly impact the progression of debilitating human conditions, fostering innovative therapeutic solutions.

• In April 2025, Crown Bioscience unveiled its 3D bone marrow niche (BMN) in vitro models, designed to advance hematological cancer research. Introduced at AACR 2025, these cutting-edge models provide a dynamic platform for studying liquid malignancies by replicating the physical environment and growth factors necessary for cancer cell proliferation. This development bridges a crucial gap between in vitro and in vivo models, integrating into Crown Bioscience's existing expertise in areas such as AML mouse models. This contributes to more predictive preclinical screening within the humanized mice model market, fostering innovation in drug development.

• In July 2024, a significant breakthrough in humanized mice model research was announced by scientists at The University of Texas Health Science Center at San Antonio. They successfully developed a novel humanized mouse model, named TruHuX, which features a fully functional human immune system alongside a human-like gut microbiome. This advancement provides a more accurate in vivo system, overcoming previous limitations in modeling human immune responses. The development is poised to substantially enhance research capabilities for immunotherapy and various human diseases, marking a crucial step forward for the global humanized mice model market by offering more clinically relevant therapeutic testing platforms.

• In May 2024, Crown Bioscience, a global contract research organization, formalized a five-year global collaboration agreement with the Shanghai Model Organisms Center (SMOC). This extended partnership aims to broaden access to innovative immuno-oncology platforms and services across all Crown Bioscience facilities worldwide. The strategic alliance encompasses the procurement and supply of a diverse array of genetically engineered mouse models, including numerous knock-in and knock-out humanized models, along with services for genetically engineered cell line development. This collaboration significantly strengthens the offerings in the humanized mice model market by providing enhanced resources for preclinical research.

Key Market Players

• Allentown LLC
• Charles River Laboratories International, Inc.
• HBM Holdings
• Horizon Discovery Group plc
• Ingenious Targeting Laboratory Inc.
• Janvier Labs
• Trans Genic Inc.
• PolyGene AG
• Aragen Life Sciences Ltd.
• The Andersons, Inc.

Report Scope:

In this report, the Global Humanized Mice Model Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Humanized Mice Model Market, By Type:

o   Humanized Mouse Models

o   Humanized Rat Models

• Humanized Mice Model Market, By Application:

o   Oncology

o   Immunology & Infectious Diseases

o   Toxicology

o   Others

• Humanized Mice Model Market, By End User:

o   Pharmaceutical & Biotechnology Companies

o   Contract Research Organizations

o   Academic & Research Institutions

• Humanized Mice Model Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Humanized Mice Model Market.

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Company Information

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