USA Animal Model Market to Reach USD 1.6 Billion by 2035, Driven by Advancements in Drug Development and Gene Editing Technologies

The USA animal model market, a crucial component of preclinical research for drug development and biomedical studies, is set to experience steady growth over the next decade. Estimated at USD 1.06 billion in 2025, the market is projected to expand to USD 1.62 billion by 2035, reflecting a compound annual growth rate (CAGR) of 4.3% over the forecast period. This growth is driven by the increasing demand for animal models in drug discovery, biotechnology, and medical research, with advancements in genetic engineering and emerging technologies fueling demand.

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Market Dynamics: Drivers and Growth Factors

Several factors are contributing to the expansion of the USA animal model market. The rising importance of animal models in preclinical trials is a key driver, particularly for pharmaceutical companies and academic institutions focused on drug safety and efficacy. With regulatory requirements demanding drug testing before clinical trials, the demand for reliable animal models continues to rise. Additionally, the development of personalized medicine and immunology-based research further amplifies the need for accurate disease models.

Technological advancements, especially the widespread adoption of CRISPR gene editing, have transformed the landscape of animal model development. These innovations allow for more precise genetic modifications, enabling faster, more efficient research. As a result, animal models are becoming increasingly specialized, offering critical insights into complex diseases such as cancer, autoimmune disorders, and rare genetic conditions.

Key Segments in the USA Animal Model Market

The mice species segment is the dominant player in the market, accounting for a significant share of over 60% in 2025. Mice are widely used due to their genetic similarity to humans, adaptability in laboratory environments, and short breeding cycles. These advantages make them ideal for disease modeling, drug testing, and genetic research. Moreover, their role in oncology and immunology studies continues to drive demand.

Another leading technology driving growth is CRISPR, which is projected to account for over 56% of the market revenue by 2025. This gene-editing technology facilitates the development of transgenic and knockout mouse models, enabling more precise and effective research in areas like cancer, genetic disorders, and immunotherapy.

In terms of application, the research and development (R&D) segment is anticipated to dominate, contributing to nearly 40% of the total market revenue by 2025. This sector benefits from substantial investments in drug discovery and the increasing complexity of diseases being researched. The demand for new therapeutics, particularly for chronic conditions such as cancer and autoimmune diseases, underscores the importance of animal models in preclinical trials.

Market Outlook: Opportunities and Challenges

Despite the positive market outlook, several challenges could restrain growth. Ethical concerns surrounding animal testing have led to a growing emphasis on the reduction, refinement, and replacement of animal models with alternative methods where possible. However, for many therapeutic areas, particularly in oncology and neurology, animal models remain an irreplaceable tool in understanding human diseases.

Moreover, the lengthy and costly nature of animal trials, such as the multi-year duration of cancer studies, poses financial and regulatory hurdles for the industry. The development of more efficient models and the continued push toward humanized models are expected to mitigate some of these challenges.

Opportunities for Key Players

The USA animal model market presents significant growth opportunities for companies that are focusing on next-generation genetic tools and disease-specific models. For example, Charles River Laboratories' development of specialized mouse models, such as the hACE2-NCG mouse for COVID-19 research, highlights the importance of customized solutions in meeting market demands. Collaborations, such as the partnership between Ingenious Targeting Labs and SMOC to distribute off-the-shelf validated mouse models, are also likely to increase as companies strive to meet the evolving needs of researchers.

Additionally, the market benefits from substantial government funding and policy reforms aimed at advancing biomedical research. This has spurred innovations and encouraged more investments in preclinical testing, which will ultimately support market growth.

Competitive Landscape: Key Players and Innovations

The USA animal model market is highly competitive, with a mix of established players and emerging companies vying for market share. Key players include Charles River Laboratories, The Jackson Laboratory, Taconic Biosciences, Inc., Genoway, and Envigo, among others. These companies are focused on expanding their product portfolios through acquisitions, collaborations, and product innovations.

For instance, Taconic Biosciences launched the huNOG-EXL EA humanized immune system mice in January 2025, offering new opportunities for immunological and oncological research. Similarly, Harbour BioMed's collaboration with Dana-Farber Cancer Institute in June 2024 aims to advance cancer therapies, particularly CAR-T cell products and bi-specific antibodies, through the use of animal models.

As the demand for more personalized and genetically accurate models increases, these companies are expected to lead the way in providing cutting-edge solutions to researchers.

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