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

One of the most promising options is the induced pluripotent stem cell (iPSC) derived disease model, which offers 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 Biosciences 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 models standing as a leading alternative.

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.

FUJIFILM Biosciences: Enabling reliable iPSC-based research

At FUJIFILM Biosciences, we are focused on supporting researchers in early drug discovery with tools designed for consistency, efficiency, and quality. Our differentiation reagents, including specialized culture media, Shenandoah Recombinant Proteins, and small molecules are developed to promote reliable, reproducible outcomes across a variety of human cell types.

A key feature of our offering is the CultureSure CEPT Cocktail, a proprietary blend that enhances cell survival, cloning efficiency, and genome stability. Each batch is rigorously tested for endotoxins and certified mycoplasma-negative, ensuring cleaner, safer cultures from the beginning.

This strong focus on quality assurance supports more reliable cell performance and helps researchers overcome common challenges in early-stage iPSC applications. FUJIFILM Biosciences empowers researchers to harness the full potential of iPSC-derived platforms for predictive, ethical, and efficient 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 disease biology 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 Biosciences, 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.