Modeling and simulation (M&S) in the drug development process is a scientific approach used in crucial drug development decisions. In order to avoid issues in discovery and development of new drug, biosimulation offers a promising tool, along with saving both time, money, and improving the predictability in early stage of drug development. Biosimulation refers to simulation of biological systems.
FDA also utilizes M&S in the drug development process. FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms. Biosimulation is important for drug development, as it provides information regarding dose precision, drug-drug interaction on a molecular level, as well as physiologically-based pharmacokinetic (PBPK) modelling using sophisticated pharmacodynamics models of the heart, liver, and other systems. In addition to this, according to the US FDA’s Office of Clinical Pharmacology (OCP), 2014 data, PBPK modelling: a mathematical predictions of drug interactions with other drugs is increasingly used by FDA in drug discovery and early development process. Moreover, growing adoption of biosimulation tools in various stages of drug development help to increase growth of the biosimulation market
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The global biosimulation market size was valued at US$ 1,323.1 Mn in 2017 and is expected to witness a CAGR of 15.4% over the forecast period (2018 – 2026).
Accelerated drug discovery development process by key players to favor market growth
Pharmaceutical companies, non-profit organizations, and healthcare regularity organizations are majorly investing in research and development of drug discovery process. Market players are engaged in exploiting biosimulation techniques for enhancing efficacy of drug discovery and development process, which is expected to drive growth of the biosimulation market. Government of various economies are funding initiatives such as Innovate UK and Horizon 2020 provide businesses and research organizations with grants to drive scientific research. Innovate UK is the UK’s innovation agency and part of UK Research and Innovation, which supported two companies, Adorial Pharma Limited and C4X Discovery, in enabling the development of a novel mathematical-based system of drug discovery. Moreover, in March 2016, C4X Discovery Holdings plc., an innovative drug discovery and development organization announced acquisition of Adorial Limited. Combining these two business, along with support by Innovative UK will accelerate commercial and clinical success of biosimulation.
Strategic collaborations among market players offers lucrative growth opportunities during the forecast period
Major players in biosimulation market are expanding their product offering with strategic acquisition. For instance, in December 2015, Certara, a biosimulation technology-enabled drug development company, acquired XenologiQ, a UK-based quantitative systems pharmacology (QSP) consultancy. This acquisition strengthened Certara’s modeling and simulation capabilities, and supports company’s precision medicine vision. Furthermore, in February 2018, Certara acquired BaseCase Management GmbH, a data visualization software as a service (SaaS) company. This acquisition strengthened Certara’s data visualization and communication capabilities.
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Advancement in Biosimulation Technology
In July 2018, team of scientist from Indian Institute of Science (IISc) developed EndoMimyk: an endoscopy simulator. EndoMimyk excels by using the technology of haptics. EndoMimyk combines haptics technology with advanced simulation and instrumented tools to offer high-fidelity, realistic, and immersive training in gastrointestinal and bronchoscopy procedures. Furthermore, in March 2017, Certara developed a new licensing approach, which provides smaller organizations to access their physiologically-based pharmacokinetic (PBPK) modeling and simulation platform, Simcyp. Simcyp Access is a cloud-based licensing approach, which helps to predict pharmacokinetic outcomes in virtual patient populations.
Key players operating in biosimulation market include Certara, L.P., Simulations Plus, Inc., Dassault Systèmes (Accelrys), Genedata AG, LeadScope, Inc., Compugen Inc., Schrödinger, LLC, In Silico Biosciences, Inc., Advanced Chemistry Development, Inc., Chemical Computing Group ULC, Physiomics PLC, and Pharmaceutical Product Development, LLC (Evidera).
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