A survey of global pharmaceutical companies shows broad use of non-animal methods in early drug development, with limited adoption in later stages and regulatory approval. 

Before moving to human clinical trials, drugs are evaluated via cell cultures, computer models and animal studies. About 90% of candidates fail in clinical trials—a statistic sometimes used to question animal research—but it does not identify which methods failed to predict outcomes. Understanding how each method selects drugs is essential for interpreting these rates. 

A study from the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) surveyed 45 pharmaceutical companies across the US, Europe and Asia about their use of new approach methodologies (NAMs), defined in this study as non-animal methods. They found that  98% of companies used laboratory-based cell models and 84% used computer models.  

Early drug development relied heavily on these methods: 73% of companies used them to validate targets and 58% to assess candidate efficacy. This indicates that progression to human trials depends on multiple approaches, not just animal studies. 

Despite broad use, companies face major barriers to advancing NAMs: 84% cited regulatory uncertainty and 80% questioned human-response reliability.  

The study, published in Regulatory Toxicology and Pharmacology, calls for stronger evidence of NAM reliability, clearer regulatory processes and shared databases, noting that expanded use requires purpose-specific validation.  

Read EARA’s statement about the study here.