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

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.

In silico clinical trials refer to developing patient-specific models to form virtual cohorts for testing the safety and efficacy of new drugs and medical devices. Companies use sophisticated computational modeling and simulation techniques to test their drug candidates in virtual patients before trying them in humans. In silico modeling, also known as computer modeling, allows researchers to simulate behaviors on a computer screen.

The in silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market is segmented on the basis of organization size, offering, application, clinical indication, end user, and geography. The market, based on geography, is broadly segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. The report offers insights and a comprehensive analysis of the market, emphasizing parameters such as in silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market size, technological advancements, and market dynamics, along with the analysis of the competitive landscape of the globally leading market players.  

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In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market: Strategic Insights

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Market Insights

Rising Concerns Over Animal Welfare to Drive In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market Growth during Forecast Period

The rapid use of animals in clinical trials is mainly due to the biological similarities between animals and humans. Animals provide adequate human biology and diseases models to yield relevant information, and consequently, animal models offers significant human health benefits. However, using animals for clinical studies is not the only way of drug and devices discovery, as almost every clinical study causes harm to the animal and its progeny in any manner. For instance, in January 2020, the U.S. Department of Agriculture had reported that approximately 300,000 animals were involved in pain-causing experimental activities in just one year.

Moreover, as mentioned by People for the Ethical Treatment of Animals (PETA), each year, more than 100 million animals, including mice, frogs, rabbits, hamsters, and guinea pigs, are killed in US laboratories. The purpose of sacrificing these animals is biology lessons, medical training, curiosity-driven experimentation, and chemical, drug, food, and cosmetics testing. In silico clinical trials offer an effective way of replacing animal anatomies for conducting various experiments and research & development activities, thus, supporting the growth of the in silico trials market. Additionally, rapidly increasing concerns over animal welfare and consistent efforts of human and animal rights and welfare organizations are boosting the global in silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market growth.

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 market share. Moreover, the small and medium organization segment is expected to register the highest CAGR in the market during 2021–2028 due to the high usage of the in silico trial methods in large research organizations and institutes. However, in the recent era, medium-sized pharmaceutical and biopharmaceutical companies are adopting the in silico model processes to reach their trial processes and increase their efficacy in creating new products.

Offering Insights

Based on offering, the global 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 market share. Moreover, the services segment is expected to register the highest CAGR in the market during 2021–2028. The factor attributing to the growth of this segment is 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 & other biomedical products, and others. In 2021, the product design and discovery segment held the largest market share. Moreover, the pre-clinical targeting segment is expected to register the highest CAGR in the market during 2021–2028. The factor attributing the growth of this segment is the incorporation of advanced technologies such as machine learning, and artificial intelligence is applied for drug discovery and design 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 the rising COVID-19 cases across the globe 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.

Product launches, mergers & acquisitions, and collaborations are highly adopted strategies by the global market players. A few of the recent key market developments are listed below:

• In September 2021, Sensyne Health announced that it had launched SENSIGHT, an AI-enabled global data analytics platform for the healthcare and life sciences sectors.
• In February 2022, In SilicoTrials announced that it partnered with IonsGate Preclinical Services Inc (IonsGate) to leverage innovative technology like Modeling and Simulation.

Though the COVID-19 pandemic crisis had a devastating effect on several industries, the in-silico trial market experienced significant growth during this period due to the computer-aided drug discovery method. The demand for in silico trials with the help of computational modeling has witnessed a higher growth rate due to increased R&D activities among researchers and biotechnological and biopharmaceutical companies to limit the spread of the coronavirus disease. The increasing mutation rate of the COVID-19 pandemic has encouraged scientists to discover an effective treatment against the disease. Thus, the significance of research and drug discovery was raised, thereby driving the in silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market growth. The above-stated factors show that the pandemic generated substantial investment opportunities in the market.

In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market Segmentation

The global In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance market is segmented on the basis of organization size, offering, application, clinical indication, end user, and geography. Based on organization size, the In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance market is bifurcated into small & medium organizations and large organizations. Based on offering, the In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance market is segmented into products, platforms, and services.

Based on application, the 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.

Based on clinical indication, the 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.

Based on end-users, the 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.

The In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance market, based on geography, is broadly segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and South and Central America.  The market in North America is further segmented into the US, Canada, and Mexico. The European market is segmented into France, Germany, the UK, Spain, Italy, and the Rest of Europe.

In Silico Clinical Trials

In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market Regional Insights

The regional trends and factors influencing the In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market throughout the forecast period have been thoroughly explained by the analysts at Insight Partners. This section also discusses In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market Report Scope

In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market Players Density: Understanding Its Impact on Business Dynamics

The In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Market players density refers to the distribution of firms or companies operating within a particular market or industry. It indicates how many competitors (market players) are present in a given market space relative to its size or total market value.

Major Companies operating in the In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market are:

1. InSilico Trials Technologies
2. Feops
3. CADFEM Medical GmbH
4. Dassault Systèmes
5. Virtonomy GmbH

Disclaimer: The companies listed above are not ranked in any particular order.

The market in Asia Pacific is segmented into China, India, Japan, Australia, South Korea, and the Rest of APAC. The market in the MEA is further segmented into Saudi Arabia, the UAE, South Africa, and the Rest of the MEA. The market in South and Central America is segmented into Brazil, Argentina, and the Rest of South and Central America. InSilico Trials Technologies; FEops; CADFEM Medical GmbH; Dassault Systemes SE; Virtonomy GmbH; Certara Inc.; Computational Life; Novadiscovery; TwInsight Medical; Ansys, Inc.; Synopsys, Inc.; Sensyne Health plc; Phesi; Tempus; and Cerner Corporation are among the leading companies operating in the global market during the forecast period of 2021 to 2028. In May 2020, UK-based Exscientia raised US$60 million in a series C financing round led by Novo Holdings, the wholly-owned holding company of Danish diabetes medicine maker Novo Nordisk, along with German drug development company Evotec, US pharmaceutical company Bristol Myers Squibb, and Asian-based private investment partnership GT Healthcare Capital. This brought the company’s total funding to just over US$100 million. The new capital will be used in part to expand the company’s AI capabilities in biology.