Global Biosimulation Market – Global Industry Insights
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
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).
Global Biosimulation Market, By Region: 2018
Source: Coherent Market Insights Analysis (2018)
Increasing focus of various key players to accelerate drug discovery and development process is expected to aid in the market growth
Pharmaceutical companies, non-profit organizations, and healthcare regularity organizations are increasingly utilizing funds and their capabilities in drug discovery and development process. Growing engagement by these players in exploiting biosimulation techniques in increasing the effectiveness in drug discovery and development process will help to augment growth of the biosimulation market.
Various government funding initiatives such as Innovate UK and Horizon 2020 provide businesses and research organizations with grants to help drive their scientific research. Innovate UK is the UK’s innovation agency and part of UK Research and Innovation. It has supported two companies, Adorial Pharma Limited and C4X Discovery, 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.
Furthermore, various non-profit organizations, such as the Wellcome Trust and the National Institute of Health are also funding for various drug discovery programs. The Wellcome Trust fund supports over 14,000 people in over 70 countries, and aims to invest upto US$ 7.04 billion (£5 billion) in population health, medical innovation, vaccine development such as the development of a new Ebola vaccine, public health interventions, among others.
Additionally, increasing burden of genetic diseases and growing need to detect early sign of disease, will lead to increase in research and development funding in gene therapy and diagnosis of genetic disease, thereby increasing adoption of biosimulation products and services, over the forecast period. For instance, according to the Research, Condition, and Disease Categories (RCDC) July 2017 data findings, National Institute of Health (NIH) has incurred funding in various disease categories through grants, contracts, and other funding mechanisms. According to the RCDC -2017 annual funding data, NIH spend US$ 422 million, US$ 462 million, and US$ 486 million on gene therapy, genetic clinical trials, and genetic testing, in 2015, 2016, and 2017, respectively.
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.
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).
Biosimulation plays important role in research and development process. Biosimulation is widely used in consumer personalized medicine, owing to increasing demand for personalized medicine in offering tailored solutions for various treatment areas such as drug discovery, oncology, cardiology, infectious disease, and psychiatry. Predictive biosimulation offers effective platform to use biological data and mathematical modeling to create a virtual version of patient to test simulated treatments.
Moreover, continuous research is being conducted to create a low-priced or open source version of predictive biosimulation platforms for self-tracking and modeling using patient’s data and to speed up the adoption by software development communities to generate future health scenarios using patient’s medication data.
Market players are engaged in developing novel biosimulation platform, in order to offer tailored solution in each therapeutic area. This is expected to aid in growth of the market. For instance, in October 2013, Rhenovia Pharma: a biotechnology firm specialized in biosimulation has developed the first simulator for biological mechanism of epilepsy. Moreover, development of new simulator opens new possibilities for research in epilepsy treatment. Rhenovia’ new simulator replicates the basic biological mechanisms of signal transmission between brain cells and simulates its defects leading to epileptic patterns, thereby leading to prevent epileptic seizures.
Furthermore, growing support from heathcare regulatory organizations in the adoption of biosimulation based software and services will, augment future growth of biosimulation market. Current FDA and EMA guidelines recommends the use of biosimulation in pediatric drug development studies, thereby minimizing the impact on children that must enroll in clinical trials. For instance, in Novembr 2017, Certara stated that U.S. Food and Drug Administration (FDA), expanded its use of Certara’s PBPK Simcyp Population-based Simulator and its Pediatric and Cardiac Safety Simulators. In addition, under the new agreement, FDA has tripled its number of licenses, equipping its Modeling and Simulation (M&S) review team with almost 60 PBPK licenses.
Key features of the study:
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