Moving Beyond Animal Models with iPSC-based Models: Shifts and New Challenges

October 31, 2025

For decades, animal models have served as the foundation of biomedical research and drug development. However, growing ethical concerns, high costs, and limited ability to mirror human biology are driving a shift toward more predictive, human-specific systems.^1,2

Two of the most promising options are the induced pluripotent stem cells (iPSC) derived from disease and phenotypically-normal models, which offer a reproducible and ethically sound platform for drug discovery by enabling the in vitro production of almost any human cell type.

This article examines the shift beyond animal models, the unique advantages of iPSC-based models, the current challenges, and how Fujifilm is leading innovation in this area.

The Limitations of Animal Models

Animal models have long been central to evaluating the safety and efficacy of new drugs. However, their limitations are increasingly under scrutiny:

• Low predictive accuracy: Animal physiology often diverges significantly from human biology, contributing to high attrition rates in clinical trials.¹
• High cost and complexity: Maintaining animal colonies is expensive and time-consuming, often requiring specialized facilities and long development timelines.¹
• Ethical concerns: Societal and institutional pressures are pushing for the reduction/elimination of animals in research.²
• Regulatory change: Recent legislative updates are accelerating the shift by permitting validated non-animal methods for safety and efficacy assessments.^3,4

In response, the field is transitioning towards human-based platforms, with iPSC-derived disease and phenotypically-normal models standing as leading alternatives.

What Makes iPSC-Derived Disease Models so Promising?

iPSCs are generated by reprogramming adult somatic cells into a pluripotent state. These cells can then be differentiated into various cell types, including neurons, cardiomyocytes, and hepatocytes, for use in disease modeling and drug testing.

Some of the key advantages of iPSC-derived models include an accurate representation of human disease mechanisms and drug responses compared to traditional animal models.⁵ They can be derived from individuals with specific diseases or genetic backgrounds, enabling personalized or population-specific drug screening and development.⁶ iPSCs offer a sustainable, long-term source of human cells for drug screening.⁵

Overcoming Barriers to Widespread Adoption

Despite their advantages, iPSC-based models still face practical challenges in early discovery. One of the most important is consistency. Differentiation protocols can be sensitive to small changes, causing variability in how cells develop and behave. Reliable methods are key for reproducible results across experiments. Biological variation also plays a role. Differences in donor genetics or reprogramming techniques can impact cell performance; therefore, it’s crucial to use high-quality tools that can help reduce variability and improve reliability.

Another key factor is efficiency. Researchers benefit from reagents and protocols that integrate smoothly into existing workflows. Models that are easy to use and deliver consistent results support faster, more confident decision-making.^4,5 As the technology continues to evolve, overcoming these barriers will be key to making iPSC models a standard tool in human-relevant research. At Fujifilm, we are focused on helping scientists overcome these new challenges.

Consistency Through High-Quality Reagents for Building iPSC-Based Models From FUJIFILM Biosciences

FUJIFILM Biosciences supports academic and early discovery researchers who build their own iPSC models by providing rigorously tested specialized culture media, Shenandoah Recombinant Proteins, and small molecules such as the CultureSure CEPT Cocktail. With a strong focus on quality assurance, our solutions are designed to improve cell survival, stability, and reproducibility during model development.

Consistency Through Off-the-Shelf Models From FUJIFILM Cellular Dynamics

FUJIFILM Cellular Dynamics offers high-quality iPSC-based tools and therapies at scale to serve biopharma, CROs, and industry labs. These validated, off-the-shelf iPSC-derived cells enable applications in drug discovery, toxicology screening, and release testing, while eliminating variability from in-house cell generation. The iCell catalog of cell models provides both phenotypically normal and disease models for a wide range of cell types including neural, cardiac, and vascular, with a broader offering in intestinal and immune cells in development.

Partners for Life: A Fujifilm Ecosystem of Collaboration and Expertise

Fujifilm offers a single source of partnership in advancing the creation of therapies from discovery, development, and commercialization. In addition to the solutions offered by FUJIFILM Biosciences and FUJIFILM Cellular Dynamics, Fujifilm also supports neuropharmacology research through hiPSC-derived neural cells with co/tri-culture and cellular aging technologies. Helping to establish appropriate neurodegenerative disease models and neuroinflammation models for your drug discovery.

Looking Ahead: iPSC Models Shaping the Future of Early Discovery

The transition from animal models to iPSC-based platforms signifies a broader move toward human-relevant, ethically responsible research. For early-stage drug discovery, iPSC models provide a valuable opportunity to study both disease biology and tissue biology in general more precisely, and identify promising therapeutic candidates earlier in development.

With ongoing innovations in reagents, workflows, and quality assurance, such as those provided by Fujifilm, researchers are better prepared to adopt iPSC models with increased confidence and consistency. As these models become more accessible and dependable, they are poised to play a central role in the future of early discovery.

Stay tuned for upcoming articles in this series, where we’ll explore more trending topics in disease modeling.

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References:

1. Van Norman, G. A. (2020). Limitations of animal studies for predicting toxicity in clinical trials. JACC Basic to Translational Science, 5(4),387-397.
2. Stanford Medicine. (n.d.). What are the 3Rs? Beyond 3Rs: Promoting alternatives to animal research. Stanford University School of Medicine.
3. FDA (2023). FDA announces plan to phase out animal testing requirement for monoclonal antibodies and other drugs. https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs
4. Zushin, P. H., Mukherjee, S., & Wu, J. C. (2023). FDA Modernization Act 2.0: transitioning beyond animal models with human cells, organoids, and AI/ML-based approaches. Journal of Clinical Investigation. 133(21).
5. Loewa, A., Feng, J. J., & Hedtrich, S. (2023). Human disease models in drug development. Nature Reviews Bioengineering, 1(8), 545-559.
6. Kim, E et al. (2025). Exploring Potential Applications of iPSC-Derived Cell Models for Drug Screening of Specific Diseases. Cytotherapy 2025, 27(5),S235.