Biosimulation is a computer-aided mathematical simulation of biological
processes and systems. It is aimed at the model-based prediction of the
behavior and dynamics of biological systems.
The broad
range of applications of modeling and Biosimulation throughout the development of generic drugs will further aid in
global harmonization of making critical regulatory decisions, engaging global
stakeholders to gain a better understanding on using quantitative approaches in
the process of generic drug development, and exploring next-generation
quantitative methods and modeling tools. For instance,
Simulation Plus is offering GastroPlus software for the development of generic drugs and has been
encouraged by various regulatory agencies.
Similarly,
in October 2016, Certara was awarded a multi-year research grant to create and
validate a PBPK modeling and simulation framework by the Office of Generic
Drugs and the FDA using the Simcyp population-based
simulators. Overall, as a result of the looming patent cliff and the
cost-effective nature of generics, the pharmaceutical market is witnessing an
increase in the adoption of generic drugs in the US and across the world.
Hence, the leveraging mathematical modeling and simulation to improve generic
drugs will propel the growth of the global biosimulation market at a CAGR of 14.20% during the forecast period.
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The biosimulation market is concentrated, and the degree of concentration will
decrease during the forecast period. To survive in this competitive market,
manufacturers are focusing on adopting taking strategic initiatives and indulge
in M&A activities. Certara L.P., Dassault Systèmes SE, and Physiomics Plc are some of the major market participants. Though the
accelerating growth momentum will offer immense growth opportunities, the
difficulties involved in understanding complex biosimulation will challenge the growth of market participants. To make the
most of the opportunities, market vendors should focus more on the growth
prospects in the fast-growing segments, while maintaining their positions in
the slow-growing segments.