In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market Research Report and Outlook by 2028

The market for in-silico trials, which encompasses computational modeling and simulation for the innovation of medical products and regulatory approval, is anticipated to grow significantly, reaching approximately US$ 6,830.99 million by 2028, up from US$ 2,957.65 million in 2021. This growth represents a compound annual growth rate (CAGR) of 12.7% from 2021 to 2028.

The expansion of the in-silico trials market is primarily driven by the numerous advantages these trials offer, including reduced costs and expedited processes that save valuable time. In-silico trials involve the creation of patient-specific models that allow for the formation of virtual cohorts, which are utilized to assess the safety and efficacy of new pharmaceuticals and medical devices. Furthermore, advancements in computational modeling and simulation have enabled comprehensive imaging processes, covering aspects such as source, object, detection, and image interpretation, all aimed at research and development, optimization, technology assessment, and regulatory evaluation.

The development of in-silico trial methodologies aims to enhance both animal and human trials. These trials present various benefits, including cost-effectiveness in pharmaceutical and therapeutic research, the ability to conduct assessments without significant delays, and the provision of additional resources, which enhances scalability and ensures the safety of animal subjects. Moreover, in-silico clinical trials address ethical concerns, contributing to the market's growth. Compared to traditional clinical trials, in-silico methods are more financially viable and accessible. The absence of human test subjects in these trials eliminates the risk of adverse effects on individuals, thus protecting them from potential adverse drug reactions (ADRs), which is a major advantage of the in-silico trials market.

Imaging clinical trials are designed to address specific scientific questions regarding the effectiveness of imaging technologies and procedures in detecting, diagnosing, guiding, or monitoring disease treatment. However, these trials can impose significant burdens on both the industry and regulatory bodies, often delaying patient access to innovative medical devices and new drug discoveries. The assessment of new imaging technologies typically necessitates extensive clinical studies to demonstrate their advantages over standard care. Although computational models have occasionally been employed in the regulatory evaluation of medical devices, their application in imaging product assessments has been limited. Nevertheless, the sophistication and availability of tools for in-silico imaging trials have markedly improved since the late 1980s, particularly after 2000, with increasingly refined and accessible tools being utilized in research and development. This trend is expected to further propel the growth of the in-silico trials market for medical product innovation and regulatory clearance in the coming years.

Additionally, in-silico clinical trials can complement phase II drug trials by exploring safety and efficacy in rarer phenotypes that typically emerge only in phase III trials, as well as predicting dose-effect relationships. Computational studies in natural drug discovery are employed to identify the metabolic pathways of active molecules and to discover new targets and compounds with high affinity for those targets. Unlike traditional clinical trials, in-silico trials are more readily approved and authorized by the Food and Drug Administration (FDA). Gradually, the in-silico trial approach is expected to become a primary source of evidence for regulatory evaluations, indicating that the aforementioned benefits are significantly driving the growth of this market.

Organization Size Insights

The global in-silico trials market is categorized based on organization size into small & medium organizations and large organizations. In 2021, large organizations held a more substantial share of the in-silico trials market. However, the small and medium organization segment is projected to experience a higher CAGR during the period from 2021 to 2028. This is largely due to the prevalent use of in-silico trial methods in larger research organizations and institutes. For example, the VICTRE study involved an in-silico replication of a comparative human trial, showcasing the potential of this approach to promote the widespread adoption of in-silico trials for regulatory evaluations. The primary objective of the VICTRE project was to demonstrate the current maturity of in-silico tools and to provide evidence that regulatory decisions could be made based on in-silico evidence at a fraction of the cost of traditional clinical trials, which often require imaging hundreds of patients over several years. This focus on reducing both time and costs makes these techniques appealing to small and medium-sized organizations. Despite the promising findings from VICTRE, challenges to the widespread adoption of in-silico techniques for clinical trials still exist.

Offering Insights

The global in-silico trials market is segmented based on offerings into products, platforms, and services. In 2021, the products segment accounted for the largest share of the in-silico trials market. However, the services segment is expected to exhibit the highest CAGR from 2021 to 2028, driven by the low-risk, cost-effective, and virtual environment provided by in-silico trials and computational modeling technologies.

Application Insights

In terms of application, the in-silico trials market is divided into product design and discovery, product development, pre-clinical targeting, drug assessment, and other applications. In 2021, the product design and discovery segment held the largest market share, while the pre-clinical targeting segment is anticipated to register the highest CAGR during the forecast period, attributed to the integration of advanced technologies such as artificial intelligence (AI) in drug discovery processes.

Clinical Indication Insights

Based on clinical indications, the in-silico trials 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 market share, while the infectious diseases segment is expected to achieve the highest CAGR from 2021 to 2028, driven by the increasing prevalence of infectious diseases like COVID-19 and the significant role of immune system modeling in treatment strategies.

End-User Insights

Regarding end-users, the in-silico trials market is categorized into pharmaceutical and biopharmaceutical companies, medical technology firms, contract research organizations, and others. In 2021, the pharmaceutical and biopharmaceutical companies segment dominated the market, while the contract research organization segment is projected to experience the highest CAGR during the forecast period.

Key sources referenced in the preparation of this report include the World Bank Data, the Biotechnology Ministerial Coordinating Committee, Contract Research Organizations, and the Medical Research Council Laboratory of Molecular Biology.