Certara (US) and Dassault Systèmes (France) are the leading key players in the Biosimulation Market
The biosimulation market is projected to reach USD 9.24 billion by 2031 from USD 4.27 billion in 2026, at a CAGR of 16.7% from 2026 to 2031. The increasing complexity of drug discovery and development, rising R&D costs, and growing focus on improving clinical success rates are driving the adoption of biosimulation solutions across pharmaceutical and biotechnology companies, CROs, and academic research institutions. Organizations are increasingly utilizing technologies such as physiologically based pharmacokinetic (PBPK) modeling, quantitative systems pharmacology (QSP), population PK/PD modeling, and model-informed drug development (MIDD) to optimize candidate selection, predict drug behavior, support dose selection, and improve clinical trial design. Regulatory agencies are also increasingly recognizing the value of biosimulation in decision-making. For instance, the US FDA has highlighted the extensive use of PBPK modeling in regulatory submissions to predict drug-drug interactions and support dosing recommendations. Furthermore, the International Council for Harmonisation (ICH) introduced the M15 guideline on Model-Informed Drug Development, promoting greater adoption and harmonization of modeling approaches globally. Such developments are creating a growing need for advanced biosimulation platforms capable of integrating biological, pharmacological, and clinical data to accelerate drug development and improve decision-making. However, market growth may be constrained by high implementation costs, limited availability of skilled modeling professionals, challenges related to model validation and regulatory acceptance, data integration complexities, and lower awareness among smaller pharmaceutical and biotechnology organizations.
Prominent players in the eClinical solutions market include Certara (US), Dassault Systèmes (France), Schrödinger, Inc. (US), Simulations Plus (US), and Advanced Chemistry Development, Inc. (Revvity) (Canada), among others. These companies adopted strategies such as product launches, expansions, agreements, partnerships, collaborations, and acquisitions to strengthen their presence in the biosimulation market.
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In May 2026, Certara and Altasciences announced a strategic partnership to accelerate early drug development by integrating Certara's biosimulation and regulatory science expertise with Altasciences' preclinical and clinical development capabilities, enabling sponsors to optimize decision-making, reduce development risks, and advance drug candidates more efficiently.
In March 2026, Simulations Plus announced strategic collaboration programs for AI-enabled modeling, aimed at integrating artificial intelligence with biosimulation workflows to enhance model development, improve predictive accuracy, and accelerate decision-making across drug discovery and development processes.
Certara has built up a solid hold on the biosimulation industry by offering a wide-ranging repertoire of model-based development programmes (MDT), physiology-based pharmacokinetics (PBPK), quantitative systems pharmacology, and regulatory components. Certara provides support to pharmaceutical and biotech companies and regulatory bodies by optimizing drug discovery & development efforts, selecting doses, predicting safety/toxicity and efficacy, and speeding regulatory submissions. Certara continues to solidify its place in the market by adding new technology into its work processes, with an emphasis on the incorporation of artificial intelligence into its biosimulation workflows. For instance, in October 2025, Certara added an AI-based QSP system to its existing portfolio of models to automate the process of developing models, enhance the ability to predict, and allow researchers to analyze complex biological systems more effectively and quickly. This platform will enable companies developing drugs to make quicker decisions during the drug discovery and development processes and will provide more scalable and accessible ways to model QSP. In addition to developing new products, Certara is also expanding its capabilities by establishing strategic alliances and partnerships throughout the entire life science ecosystem.
Dassault Systèmes offers biosimulation solutions for modeling and simulating biological systems, running virtual experiments, improving drug development, and better informed decision making across the product lifecycle using advanced modeling, simulation and digital twin technology from its 3DEXPERIENCE platform and its Life Sciences Solutions Portfolio. As a result of using biosimulation, pharmaceutical, biotechnology and healthcare companies are able to better understand disease processes, better predict drug therapy outcomes and reduce drug development risk. At the same time, biosimulation will enable faster innovation. In addition, Dassault Systèmes continues to solidify its leadership position in the Life Sciences ecosystem by enhancing its existing and new solution offerings with features such as artificial intelligence, cloud-based collaboration, and virtual twin technology. To expand its marketplace presence beyond technology leadership, Dassault Systèmes has been aggressively pursuing new opportunities to expand its market reach through strategic partnerships, acquisitions and collaborations throughout the Life Sciences ecosystem.
Schrödinger, Inc. has built a strong position in the biosimulation market with its computational physical based platform, which combines molecular modeling, machine learning, and predictive simulation technologies to aid in the discovery and development of drugs. Through this platform, pharmaceutical and biotech companies can increase the speed of identifying targets, optimizing leads, and selecting final candidates while at the same time increasing their chances of successfully completing clinical trials. The company continues to build upon the platform through innovative advances in computational chemistry, artificial intelligence, and predictive modeling. In January ‘26, Schrödinger entered into a partnership with Eli Lilly to provide access to its TuneLab platform within the LiveDesign environment, allowing researchers to utilize advanced protein engineering and molecular design within one digital space. The objective of the partnership is to streamline workflows involved in developing therapeutics while enhancing collaboration between laboratories that are developing them and ultimately speeding up the discovery process for new medicines, such as drugs or vaccines, by accelerating the optimization process for each one discovered. In addition to product innovation, these partnerships and collaborations are an integral part of the company's strategy to expand its capabilities as well as establish itself in the life sciences sector globally.
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Related Reports:
Biosimulation Market by Phase (Drug Discovery, Preclinical, Regulatory), Modality (Antibody, Peptide), Application (Molecular Design, PK/PD, QSP, Trial Simulation, Disease Modeling), Indication (Cardio, Onco), End User (CRO, Pharma) – Global Forecast to 2031
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