Simulations Plus Announces Collaboration with Lonza and U.S. FDA to Advance Predictive Frameworks for Complex Oral Drug Products 

Simulations Plus, Inc., a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, announced a funded research collaboration with Lonza Group AG (“Lonza”), a leading contract development and manufacturing organisation (CDMO) dedicated to serving the healthcare industry. 

The U.S. Food and Drug Administration (FDA) is to develop and validate a mechanistic, predictive framework for assessing the in vivo performance of amorphous solid dispersion (ASD) drug products. 

According to Towards Healthcare, the Drug Delivery CDMO Services market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 268.39 billion in 2026 to approximately USD 587.74 billion by 2035, representing a compound annual growth rate (CAGR) of 9.1% from 2026 to 2035. Growth is driven by the increasing experience of rapid growth due to increasing demand for outsourcing services, cost-effective manufacturing solutions, and a growing focus on research and development in the pharmaceutical and biotechnology sectors. 

Head of R&D, Lonza Advanced Synthesis, Francois Ricard said, this collaboration reflects Lonza’s commitment to advancing more predictive, science-driven approaches as the leader in the field of bioavailability enhancement and aims to strengthen the scientific foundation that underpins regulatory decision-making for complex oral drug products. 

Advancing Mechanistic, Model-Informed Approaches for Complex Products 

Regulatory approaches often require multiple clinical bioequivalence (BE) studies, which can be resource-intensive while still carrying uncertainty. ASDs are among the most powerful yet complex oral drug delivery systems, with performance influenced by factors such as food intake, gastric pH, formulation composition, and manufacturing processes.  

The collaboration evaluates whether advanced in vitro dissolution systems, particularly those incorporating dynamic gastrointestinal physiology combined with mechanistic physiologically based biopharmaceutics modelling (PBBM), can reliably predict key in vivo outcomes, including food effects and the impact of elevated gastric pH conditions. 

This collaboration aims to provide a scientific foundation for reducing reliance on certain clinical BE studies while maintaining the rigor and transparency required by regulators. 

A recent report by Towards Healthcare highlights that the Drug Delivery CDMO Services market is witnessing growth primarily fueled by the increasing complexity of drug molecules, particularly in the macromolecule and biologic segments, which necessitate specialised delivery solutions and advanced manufacturing capabilities. 

North America is leading the market share, and Asia Pacific is emerging as the fastest-growing region, driven by the rising demand for specialised, high-potency manufacturing and the transition towards complex biologics. The Asia Pacific region is leveraging labour-cost advantages and government subsidies to differentiate its offerings and pressure incumbents to enhance quality metrics and integrated regulatory consulting.