The global biosimulation market is projected to reach USD 9.18 billion by 2029 from USD 4.24 billion in 2024, at a CAGR of 16.7% from 2024 to 2029. The major factors driving the growth of the biosimulation market include the high rate of clinical trial failures, the growing necessity of being able to predict drug pharmacokinetics and pharmacodynamics, as well as toxicity management. According to a research article published by the National Library of Medicine in February 2022, the drug discovery and development process takes about 10-15 years for a new drug to be approved for clinical use. And 90% of the drug candidates fail during the phases I, II, and III of clinical trials and drug approvals. The possible reasons stated for the failure include lack of clinical efficacy, unmanageable toxicity, poor drug-like properties, lack of commercial needs, and poor strategic planning. The use of biosimulation helps address these challenges to increase the chances of drug approval and facilitate swift trial processes.

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By application, the drug discovery segment is expected to capture the largest share of the biosimulation market. This large share is attributed to the rising burden of chronic and infectious diseases, coupled with technological advancements that enhance understanding of disease mechanisms. Some other drivers for the drug discovery segment include the emphasis on personalized medicine, increased investment in drug discovery, and supportive regulatory frameworks.

Pharmaceutical and biotechnology companies are expected to hold a major share of the biosimulation market by end users. Companies have been putting in much effort in new drug discovery and development, having strong candidate drugs in their pipelines. With stringent regulatory requirements, pharma and biotech companies heavily rely on biosimulation tools to support clinical trial designs and optimize therapeutic dosing. In 2023, the US FDA approved 55 novel drug therapies, while as of 2024, 36 novel drug therapies have been approved so far, reflecting the scope of the segment and its substantial large market share.

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The major players in the biosimulation market with a significant global presence are Certara USA. (US), Simulations Plus. (US), Dassault Systèmes (France), Schrödinger, Inc. (US), Advanced Chemistry Development, Inc. (Canada), Chemical Computing Group ULC. (Canada), Rosa & Co. LLC. (US), Genedata AG (US), Physiomics Plc (United Kingdom), In Silico Biosciences. (US), Allucent. (US), OpenEye, Cadence Molecular Sciences. (US), Cellworks Group, Inc. (US), VeriSIM Life. (US), Netabolics SRL (Italy), Charnwood Discovery (United Kingdom), The MathWorks, Inc. (US), ANSYS, Inc (US), Instem Group of Companies (United Kingdom), Insilico Medicine (US), SCM – Software Chemistry & Materials (Netherlands), BioSymetrics, Inc. (Canada), Atomwise Inc. (US), insitro. US), and Clinithink. (US). The market players have adopted strategies such as acquisitions, collaborations, partnerships, mergers, product/service launches & enhancements, and approvals to strengthen their position in the biosimulation market. The product and technology innovations have helped the market players expand globally by providing biosimulation and modeling solutions.

Certara USA.:

As a global leader in manufacturing software and services for drug discovery and development, Certara provides Model-informed Drug Development (MIDD) software solutions to support all stages of drug development, from preclinical through clinical and commercial. Its proprietary, end-to-end platform integrates generative AI technology with biosimulation, regulatory science, and market access solutions. The company boasts a strong presence in North America, Europe, and Asia Pacific. The customer base includes more than 2,400 biopharmaceutical companies, academic institutes, and regulatory agencies from 66 countries.

Dassault Systèmes:

Dassault Systèmes is a multinational software company that develops and sells 3D design software and intelligence products for modeling and simulation. The company offers a number of products and services - 3DEXCITE, 3DEXPERIENCE, 3DVIA, BIOVIA, DraftSight, CATIA, DELMIA, ENOVIA, EXALEAD, GEOVIA, NETVIBES, SIMULIA, for multiple industries, including aerospace & defence, architecture, engineering & construction, consumer goods & retail, consumer packaged goods & retail, energy, process & utilities, financial and business services, high-tech, industrial equipment, life sciences, marine & offshore, natural resources, and transportation & mobility. Dassault Systèmes operates in 140 countries with more than 194 offices across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa, serving more than 270,000 customers.

Schrödinger:

Schrödinger is a scientific leader in developing state-of-the-art chemical simulation software for pharmaceutical and biotechnology research. It operates through two business segments: software and drug discovery. The company provides products ranging from general molecular modeling programs to a full-featured drug design software suite using ligand—and structure-based methods. Schrödinger has a geographical presence in the US, Europe, the Middle East, Africa, and Asia-Pacific.

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Recent Developments of Biosimulation Market

·         In October 2024, Certara acquired Chemaxon to combine its expertise in biosimulation with Chemaxon's cheminformatics expertise. This acquisition will help Certara expand its capabilities to help life science companies enhance their productivity and boost scientific innovation success rates.

·         In September 2024, Advanced Chemistry Development (ACD/Labs) launched the version 2024 of its flagship Percepta platform, offering enhanced prediction accuracy for logP, logD, and pKa, and a range of ADME and toxicity endpoints, making the platform more robust and efficient.

·         In June 2024, Simulations Plus acquired Pro-ficiency, LLC, in a USD 100 million deal to expand its market reach. This acquisition tends to double Simulations Plus’s total addressable market to USD 8 billion by utilizing Pro-ficiency's AI-driven software and services.

·         In March 2024, Dassault Systèmes collaborated with CDR-Life Inc. to enhance the development of highly tumor-selective immunotherapies using CDR-Life’s M-gager platform. This collaboration allowed the contract research team of Dassault to perform virtual “what if” experiments on antibody-based biologics utilizing the BIOVIA software and CDR-Life’s experimental data.

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