Humanized Liver Mice Model Market: Introduction and Current Market Status

The global humanized liver mice model market is expected to grow significantly, reaching an estimated USD 178 million by 2033, up from USD 104 million recorded in 2024. This represents a compound annual growth rate (CAGR) of 5.6% during the forecast period from 2024 to 2033.

Introduction

The global market for humanized liver mice models is witnessing rapid growth, driven by the increasing demand for advanced preclinical models in drug development and disease research. As a promising alternative to traditional animal models, humanized liver mice offer a more accurate representation of human liver functions, making them invaluable in studying liver diseases and evaluating therapeutic interventions.

Market Insights and Developments

Humanized liver mice models have emerged as crucial tools in biomedical research, particularly in understanding liver diseases and developing new treatments. The human liver is a critical organ, harboring pathogens responsible for millions of infections and fatalities annually. As such, the need for reliable models that can mimic human liver physiology has never been more pressing.

Traditionally, liver mouse models were created by transplanting human liver cells or hepatic cancer cells into immunocompromised mice. However, the results were often inconsistent and unreliable. To address these challenges, researchers developed mice with weakened immune systems that naturally destroy their own livers, allowing human liver cells to grow and replace the original liver. This innovation has led to the creation of stable humanized liver models that closely resemble human liver functions.

The growing utilization of these models in drug discovery research, particularly in oncology, is a key driver of market growth. The increasing demand for personalized medicine and the rising research and development activities in the pharmaceutical and biotechnology sectors further fuel this expansion.

Comparative Analysis: Past and Future Outlook

Before 2023, the humanized liver mice model market experienced moderate growth, primarily driven by research on liver diseases, advancements in genetic engineering, and the rising prevalence of liver disorders such as hepatitis and liver cancer. North America dominated the market, benefiting from substantial investments in biomedical research and a robust healthcare infrastructure.

Looking ahead, the market is expected to witness accelerated growth post-2024. Technological advancements will play a crucial role in this surge, leading to the development of more reliable and consistent models. Enhanced capabilities in genetic modifications and the creation of better immunodeficient mouse strains that naturally replace their liver with human cells are significant factors contributing to this growth. The increasing number of FDA approvals for hepatitis and other liver disease drugs, which rely heavily on these models, further highlights their essential role in drug development.

Key Growth Determinants

Technological Advancements

The humanized liver mice model market is experiencing substantial growth driven by technological advancements. These advancements have led to the development of more sophisticated and reliable models that better mimic human liver physiology. Newer models, such as PPARalpha and AFC8-based mice, demonstrate improved consistency and stability in liver function. The evolution from simple immunodeficient mice implanted with human liver cells to more advanced models that naturally replace their liver with human cells has dramatically enhanced research outcomes. These innovations facilitate more accurate studies in drug metabolism, liver disease mechanisms, and therapeutic testing, boosting the market's growth potential.

Rising Prevalence of Liver Diseases

The global prevalence of liver diseases, including hepatitis B and C, liver cirrhosis, and liver cancer, is a critical growth driver for the humanized liver mice model market. These conditions have seen a surge, necessitating extensive research and the development of new treatments. Humanized liver mice models play a crucial role in understanding disease mechanisms and testing potential therapies in a preclinical setting. The global burden of liver diseases, particularly in regions with high endemic rates like Asia and Africa, underscores the demand for these models. The increased need for effective preclinical testing models is propelling market growth as researchers and pharmaceutical companies invest more in developing and utilizing humanized liver mice models.

Increasing FDA Approvals for Hepatitis Drugs

The rising number of FDA approvals for hepatitis drugs is a significant growth driver for the humanized liver mice model market. The approval process for new drugs requires extensive preclinical testing to ensure safety and efficacy, for which humanized liver mice models are invaluable. The trend of increasing drug approvals, particularly in the treatment of hepatitis, underscores the critical role of these models in drug development. The noticeable increase in approved hepatitis treatments reflects the intensified research and validation efforts using humanized liver mice models over the last decade. This trend not only highlights the importance of these models in pharmaceutical research but also stimulates further investment and innovation in this market segment.

Key Growth Barriers

High Costs of Humanized Liver Mice Models

Despite the advantages, the high cost of humanized liver mice models presents a significant restraint to market growth. These models, involving complex genetic modifications and requiring specialized care, can be prohibitively expensive. Immunodeficient mice used for liver studies can cost between $140 and $500 each, while more sophisticated chimeric humanized liver mice models can range from $2,500 to $3,500 per mouse. The financial burden limits the accessibility of these models, particularly for smaller research institutions and companies with limited budgets, hindering wider adoption and market expansion.

Stringent Regulatory Requirements

Stringent regulatory requirements are another major restraint affecting the market for humanized liver mice models. The use of animal models in research is subject to rigorous ethical and regulatory scrutiny, aimed at ensuring humane treatment and justifiable scientific use. Regulatory frameworks, such as the 3Rs principle (replace, reduce, and refine), are enforced to minimize the use of animals and encourage the adoption of alternative methods wherever possible. These regulations necessitate extensive documentation and compliance efforts, which can delay research timelines and increase operational costs. The approval process for using humanized liver mice models in specific studies can be cumbersome and time-consuming, posing significant challenges to researchers and companies.

Market Trends and Opportunities

Integration of Advanced Genetic Editing Techniques

The integration of advanced genetic editing techniques, such as CRISPR-Cas9, is a significant trend in the humanized liver mice model market. This technology allows for precise modifications of the mouse genome to create more accurate and reliable humanized liver models. CRISPR-Cas9 has facilitated the development of models with specific human gene expressions and liver functions closely mimicking human physiology. The precision and efficiency of CRISPR-Cas9 reduce the time and cost associated with developing humanized models, making them more accessible to a broader range of researchers.

Expansion in Emerging Markets

An exciting opportunity for the humanized liver mice model market lies in the expansion into emerging markets, particularly in regions such as Asia Pacific and Latin America. Governments and private sectors in these regions are investing heavily in healthcare infrastructure and research capabilities, providing a robust foundation for market growth. The high prevalence of hepatitis B and C in these regions underscores the need for effective preclinical models to facilitate the development of new treatments.

How Does Regulatory Scenario Shape the Humanized Liver Mice Model Market?

Regulatory agencies like the FDA and EMA are increasingly focused on the safety and efficacy of preclinical models used in drug development. Humanized liver mice, models must meet stringent safety standards, ensuring their reliability and accuracy in mimicking human liver function.

Regulatory bodies emphasize ethical considerations and animal welfare in research, promoting the use of humanized liver mice models as they can reduce the number of animals needed by providing more relevant human-like data.

Governments and regulatory bodies often provide funding and grants for research involving advanced preclinical models, including humanized liver mice. Further, efforts are underway to harmonize regulatory standards globally, ensuring that data from humanized liver mice models are accepted across different jurisdictions.

Key Market Companies

• Ingenious Targeting Laboratory

• Axenis S.A.S

• Trans Genic Inc.

• Horizon Discovery Group PLC

• HuMurine Technologies

• Champions Oncology Inc.

• Genoway S.A.

• Crown Bioscience Inc.

• Taconic Biosciences Inc.

• The Jackson Laboratory

• Vitalstar Biotechnology Co. Ltd.

Recent Industry Developments

• In January 2022, Taconic Biosciences, Inc. (US) introduced the huNOG-EXL EA (early access) humanized immune system (HIS) mouse.

• In October 2021, The Jackson Laboratory (US) acquired the Research Models & Services (RMS) business of Charles River Laboratories Japan, Inc. (Japan) as a wholly-owned subsidiary.

An Expert’s Eye

• Increasing utilization of humanized liver mice models for accurate human liver function studies creates opportunities in biomedical research.

• The growing prevalence of liver diseases, such as hepatitis, cirrhosis, and liver cancer, caters to the scope of research and development activities.

• Enhanced ability to predict human responses to therapies, improving drug development outcomes.

• The humanized liver mice model market is set for significant expansion with broad applications in biomedical research.

Global Humanized Liver Mice Model Market is Segmented as -

By Model Type

• Genetic

• Cell-based

 By Application

• Oncology

• Immunology

• Neuroscience

By End User

• Research Institutes

• Biotech Companies

• Hospitals

By Region

• North America

• Europe

• Asia Pacific

• Latin America

• The Middle East & Africa