Certara Expands the Simcyp™ Simulator Platform Advancing Biopharmaceutics, Drug-Drug Interaction & Biologic Capabilities
Rhea-AI Summary
Certara (Nasdaq: CERT) has released Version 24 of its Simcyp™ Simulator, enhancing its physiologically-based pharmacokinetic (PBPK) modeling platform. The update includes significant improvements in biopharmaceutics, drug-drug interactions, and biologics capabilities.
Key updates include enhanced food effect predictions in the Virtual Bioequivalence module, expanded drug-drug interaction libraries, improved biologics modeling, and enhanced trial design support. The platform also features modernized UI, cloud computing capabilities, and AI-enabled assistance.
The Simcyp Simulator, guided by a consortium of over 30 pharmaceutical companies, has contributed to more than 120 FDA-approved novel drugs. Notably, 4 out of 5 drugs using PBPK for FDA approval in recent years utilized the Simcyp Simulator.
Positive
- Dominant market position with 80% of recent FDA PBPK approvals using Simcyp
- Strong track record with contribution to over 120 FDA-approved drugs
- Collaboration with 30+ leading pharmaceutical companies
- Expansion of product capabilities including cloud computing and AI features
Negative
- None.
Insights
Certara's Simcyp Simulator V24 release represents a significant advancement in physiologically-based pharmacokinetic (PBPK) modeling capabilities that could strengthen the company's market position. PBPK modeling is increasingly critical in drug development as it allows companies to predict drug behavior in different tissues before conducting expensive clinical trials.
The validation statistic that 4 out of 5 drugs leveraging PBPK for FDA approval used Certara's simulator indicates dominant market share in this niche. This new version expands capabilities in three strategically important areas: biopharmaceutics, drug-drug interactions, and biologics modeling.
Most valuable are the enhancements to the Virtual Bioequivalence module for food effect predictions and expanded drug-drug interaction libraries. These directly address regulatory requirements that often delay drug approvals. The ability to potentially waive certain clinical trials through simulation represents substantial cost and time savings for pharmaceutical clients.
The consortium model with 30+ pharmaceutical companies provides Certara with both revenue stability and continuous feedback for product improvement, creating a powerful competitive moat. The integration of AI-enabled help features and cloud computing capabilities shows Certara is modernizing its platform infrastructure while maintaining its scientific expertise.
With over 120 FDA-approved drugs supported by their simulator, Certara has established itself as the standard in regulatory-grade PBPK modeling, a position this update further cements.
This product update strengthens Certara's position in its core business of model-informed drug development software. The Simcyp Simulator is clearly a flagship product with substantial market penetration, evidenced by its use in 4 of 5 drugs that leveraged PBPK modeling for FDA approval.
The announcement reveals multiple vectors for potential revenue growth. First, the expanded capabilities across biopharmaceutics, drug-drug interactions, and biologics modeling broaden the platform's applicability across more drug development programs. Second, the new cloud computing add-on suggests a potential shift toward SaaS-based revenue streams that could improve margins and predictability.
Certara's consortium approach with 30+ pharmaceutical companies creates a virtuous cycle: clients fund development, provide requirements, validate results, and become invested users. This model likely drives high customer retention rates while creating significant barriers to entry for competitors.
The enhanced capabilities for predicting food effects and simulating clinical trials directly target expensive pain points in drug development. Each clinical trial waiver secured through simulation represents millions in cost savings for clients, creating strong ROI justification for Certara's software.
While no specific financial projections are provided, this release represents an iterative strengthening of Certara's specialized market position rather than a transformative change. The continued regulatory acceptance of PBPK modeling creates a favorable long-term growth environment for this business segment.
Updates strengthen Certara’s position as a leader of PBPK modeling in drug development to advance regulatory decision-making
RADNOR, Pa., April 01, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, has released a new version of the Simcyp™ Simulator for physiologically-based pharmacokinetic (PBPK) modeling. Simcyp PBPK models describe and predict the behavior of drugs in different body tissues. The latest version includes numerous advancements to further support data-driven decision-making at every stage of development.
“We’re advancing the Simcyp Simulator to address the evolving needs of our pharmaceutical collaborators and regulators,” Rob Aspbury, President, Certara Predictive Technologies said. “Simcyp Version 24 supports the growing adoption of PBPK in drug development and regulatory decision-making, as well as the broader applications of PBPK from discovery through clinical development.”
A consortium of more than 30 leading pharmaceutical companies guides the development of the Simcyp Simulator. Version 24 incorporates their feedback, which enhances and expands existing capabilities and databases. Masoud Jamei, Ph.D., Senior Vice President of Simcyp R&D at Certara added, “We’re proud of the Simulator’s continuous advancement of innovative technology. Currently, 4 out of 5 drugs leveraging PBPK for FDA approval in recent years used the Simcyp Simulator.”
Simcyp Simulator V24 features numerous updates, including:
- Biopharmaceutical capabilities and the Virtual Bioequivalence (VBE) module now include features for predicting food effects that improve the simulation of drug absorption under various meal conditions.
- Expanded library for drug-drug interactions (DDI): New and upgraded compound files for enzymes and transporters cover a broader range of DDI capabilities. These capabilities provide qualification evidence for transporter-mediated DDIs in the gut, liver, and kidney.
- More precise characterization of the behavior of membrane-bound targets across various tissues and plasma in biologics models. These include soluble target movement and drug-target complex dynamics throughout the body, and refinements to the target shedding model. Further, nonlinear protein and plasma binding, and target-mediated drug disposition are incorporated for small molecules.
- Expanded Trial Design support: Enhanced speed and ease of use for designing and simulating clinical trials.
- Special Populations modeling: Enhanced and expanded capabilities for pediatric, pregnancy, and lactation populations.
- Performance and Usability: Modernized UI, cloud computing add-on, ‘Ask Simcyp’ AI-enabled help chat, and chemical structure-based parameter predictors.
- Routes of Administration: Improved functionality for long-acting injectables, inhalation, and ocular routes.
The Simcyp Simulator has contributed to over 120 FDA-approved novel drugs. It has also supported clinical trial waivers in many areas, including DDI and pediatric trials.
For more insights on the latest developments, register for the Simcyp V24 release webinar.
About Certara
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries. Learn more at certara.com.
Certara Contact:
Sheila Rocchio
sheila.rocchio@certara.com
Media Contact:
Alyssa Horowitz
certara@pancomm.com
FAQ
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