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
Market Size Value in US$ 2,957.65 Million in 2021 Market Size Value by US$ 6,830.99 Million in 2028 Growth rate CAGR of 12.7% from 2021 to 2028 Forecast Period 2021-2028 Base Year 2021
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In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market: Strategic Insights
| Market Size Value in | US$ 2,957.65 Million in 2021 |
| Market Size Value by | US$ 6,830.99 Million in 2028 |
| Growth rate | CAGR of 12.7% from 2021 to 2028 |
| Forecast Period | 2021-2028 |
| Base Year | 2021 |
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Lucrative Regions for in silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market
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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.
In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market, by Organization Size – 2021 and 2028
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
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. 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.
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Organization Size, Offerings, Application, Clinical Indication, and End User
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
In-silico trials refers to the development of patient-specific models to form virtual cohorts for testing the safety and/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 can be achieved.
Rising concerns over animal welfare and benefits and benefits associated with in-silico trials are the most significant factors responsible for the overall market growth.
Based on organization size, large organizations segment took the forefront lead in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.
The pharmaceutical and biopharmaceutical companies segment dominated the global in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market and accounted for the largest market share in 2021.
InSilico Trials Technologies, Feops, CADFEM Medical GmbH, Dassault Systèmes, Virtonomy GmbH, Certara Inc., Computational Life, NOVA, TwInsight Medical, Ansys, Inc.; Synopsys, Inc; Sensyne Health plc, Phesi, Tempus, Cerner Corporation are among the leading companies operating in the global in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market.
Global in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. In North America, the U.S. is the largest market for in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market. The US is estimated to hold the largest share in the in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance market during the forecast period. The presence of top players and favorable regulations related to product approvals coupled with commercializing new products are the contributing factors for the regional growth. Additionally, the increasing number of R&D activities is the key factor responsible for the Asia-Pacific regional growth for in-silico trials: computational modelling and simulation for medical product innovation and regulatory clearance accounting fastest growth of the region during the coming years.
The List of Companies - In Silico Trials: Computational Modelling and Simulation for Medical Product Innovation and Regulatory Clearance Market
- InSilico Trials Technologies
- Feops
- CADFEM Medical GmbH
- Dassault Systèmes
- Virtonomy GmbH
- Certara Inc.
- Computational Life
- NOVA
- TwInsight Medical
- Ansys, Inc.
- Synopsys, Inc
- Sensyne Health plc
- Phesi
- Tempus
- Cerner Corporation
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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