The in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market is projected to reach US$ 6,830.99 million in 2028 from US$ 2,957.65 million in 2021; it is estimated to grow at a CAGR of 12.7% from 2021 to 2028.

The in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market growth is mainly attributed to the benefits associated with in silico trials, such as low cost and rapid process, which saves time. In silico trials refers to the development of patient-specific models to form virtual cohorts for testing the safety or efficacy of new drugs and medical devices. Also, with the development of computational modelling and simulation, entire imaging, including source, object, detection, and image interpretation components intended for R&D, optimization, technology assessment, and regulatory evaluation, have been achieved.

Developing an in silico trial method was to benefit animal and human trials. Numerous benefits are associated with in silico clinical trials, such as cost-effectiveness in pharmaceutical and therapeutic research, the ability to assess without significant delays, and additional resources, thereby increasing scalability and ensuring animal safety. Additionally, the in silico clinical trials manage the ethical issues, thereby substantiating the growth of in silico clinical trials market. In silico trial method is financially economical and affordable compared to the conventional clinical trial method. The cost of any adverse effect of the trial on humans is nullified as the in silico clinical trial does not include human test subjects. Thus, saving humans from various adverse drug reactions (ADRs) is the most significant benefit derived from in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market.

Imaging clinical trials aim at answering specific scientific queries or concerns regarding the value of imaging technologies and procedures for detecting, diagnosing, guiding, or monitoring the treatment of disease. Imaging clinical trials can be burdensome for industry and regulators, often delaying patient access to novel, high-quality medical devices and access to drug discoveries. The evaluation of new imaging technologies typically requires a substantial clinical study to demonstrate benefits compared to the standard of care. While computational models are sometimes used in the regulatory evaluation of medical devices, their use in support of imaging products has been uncommon. However, tools for in silico imaging trials have significantly improved in sophistication and availability since the late 1980s and particularly since 2000, with refined and efficient freely available tools increasingly being used in research and development. Such a factor is expected to drive the in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market growth over the forecast period.

Furthermore, in silico clinical trials can supplement phase II drug trials to explore the safety and efficacy in the more infrequent phenotypes that usually appear only in phase III and predict the dose-effect relationship. Computational study in natural drug discovery is used to determine the metabolic pathways of active molecules and find the new targets and new molecules with high affinity to those targets. Moreover, unlike conventional clinical trials, in silico clinical trials are readily approved and authorized by the food and drug administration (FDA). Incrementally but inevitably, the in silico clinical trial approach is expected to become the most significant evidence for regulatory evaluations. These factors indicate that the benefits mentioned above are substantially driving the growth of in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market.

Organization Size Insights

Based on organization size, the global in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market is bifurcated into small & medium organizations and large organizations. In 2021, the large organizations segment held a larger in silico trials market share. Moreover, the small and medium organization segment is expected to register a higher CAGR in the market during 2021-2028, owing to the fact that the high usage of the in silico trial methods is more in large research organizations and institutes than the latter one. For instance, the VICTRE study consisted of an in silico replication of a comparative human trial demonstrating the potential of this approach to encourage widespread use of in silico trials for regulatory evaluation. The VICTRE project's primary goal was to demonstrate the present maturity of the in silico tools and provide evidence that similar regulatory decisions could be made based on in silico evidence at a fraction of the cost of a clinical trial, the latter involving imaging of hundreds of patients collected in several clinical sites and across many years. This mainly aims to reduce both time and cost, thus being cost-efficient in nature and hence, the techniques are used by small and medium-sized organizations. Although VICTRE's conclusions were promising, barriers to the widespread adoption of in silico techniques for clinical trials remain.

Offering Insights

Based on offering, the global in in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market is segmented into products, platforms, and services. In 2021, the products segment held the largest in silico trials market share. Moreover, the services segment is expected to register the highest CAGR in the market during 2021-2028. This growth is owing to the low-risk, cost-effective, and virtual environment in in silico trials computational modelling and simulation technology.

Application Insights

Based on application, the global in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market is segmented into product design and discovery, product development, pre-clinical targeting, assessment of drugs and other biomedical products, and others. In 2021, the product design and discovery segment held the largest in silico trials market share. Moreover, the pre-clinical targeting segment is expected to register the highest CAGR in the market during 2021-2028. The factor attributing to the growth of this segment is the incorporation of advanced technologies such as artificial intelligence (AI) is applied for drug discovery applications.

Clinical Indication Insights

Based on clinical indication, the global in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market is segmented into cardiovascular diseases, neurodegenerative diseases, oncology, rare diseases, metabolic diseases, immune-based diseases, infectious diseases, and others. In 2021, the cardiovascular diseases segment held the largest in silico trials market share. Moreover, the infectious diseases segment is expected to register the highest CAGR in the market during 2021-2028. The factor attributing to the growth of this segment is increasing types of infectious diseases like COVID-19 and strong involvement of the immune system modelling to cure the disease.

End-User Insights

Based on end-users, the global in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market is segmented into pharmaceutical and biopharmaceutical companies, medical technology companies, contract research organizations, and others. In 2021, the pharmaceutical and biopharmaceutical companies segment held the largest in silico trials market share. Moreover, the contract research organization segment is expected to register the highest CAGR in the market during 2021-2028.

A few major primary and secondary sources referred to while preparing the report includes the World Bank Data, Biotechnology Ministerial Coordinating Committee, Contract Research Organization, and Medical Research Council Laboratory of Molecular Biology.