In Silico Clinical Trials Market- Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The in silico clinical trials market is segmented by Therapeutic Area (Oncology, Infectious Disease, Cardiology, Neurology, Diabetes, Others), Industry (Medical Devices, Pharmaceutical), Phase (Phase I, Phase II, Phase III, Phase IV), Geography (North America, Europe, Asia-Pacific, South America, Middle East, and Africa). The report offers the value (in USD million) for the above segments.

Market Snapshot

Global In Silico Clinical Trials Market
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia-Pacific
Largest Market: North America
CAGR: 7.75 %

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Market Overview

The in silico clinical trials market is expected to register a CAGR of 7.75% over the forecast period 2022-2027.

The unanticipated spread of COVID-19 has a significant influence on the in silico clinical trials market. Even though the news article “Why 2020 Saw The Steady Rise Of In Silico Trials”, published in January 2021, explains that as COVID-19-related constraints continue to cause chaos in the clinical research environment, big pharma companies are increasingly turning to in silico or virtual clinical trials to help companies continue their product development efforts. Before evaluating their drug prospects in humans, companies can use advanced computational modelling and simulation tools to test them in "virtual patients." Additionally, since the in silico studies are based on computer simulations, they are unaffected by the ongoing COVID-19-related travel and social distancing restrictions that have hampered many traditional trials.

Further, the proper understanding of drug efficacy and safety, the growing prevalence of numerous diseases, and the cost-effectiveness of in silico clinical trials make the in silico marketgrow. The article “In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable” published in the Trial journal in 2021, reveals the tremendous advantages offered by in silico clinical trials such as adjustable variability, unlimited samples, no patient risk, and less burden. These advantages in turn lead to the point of high demand for in silico clinical trial market.

Furthermore, market players are engaged in marketing tactics such as mergers and acquisitions, as well as product launches for instance in July 2021, Kiromic Biopharma, Inc., a pioneer in Immuno oncology cellular therapy for solid tumors, has acquired InSilico Solutions. Kiromic will integrate a team of bioinformatics and AI professionals in-house as part of this deal, extending its lead in the race for AI technology that can identify the best biomarkers for cutting-edge immunotherapeutics like CAR-T cell treatment.

Increased understanding of the benefits of insilico clinical trial leads the market to develop exponentially over the ages. The webcast published by United States Food and Drug Administration under the title “ The VICTRE trial: an in-silico replica of a clinical trial for evaluating digital breast tomosynthesis as a replacement for full-field digital mammography” on March 2021, explains the simulated Virtual Imaging Clinical Trial for Regulatory Evaluation (VICTRE trial) compared digital mammography and digital breast tomosynthesis using computer-simulated imaging of 2,986 in silico patients (an advanced type of mammography that generates three-dimensional images of the breasts using a low-dose x-ray system and computer reconstructions). For all breast sizes and lesion types, it showed an improved lesion detection performance favoring tomosynthesis. The improved tomosynthesis performance was in line with findings from a comparison trial including real patients and radiologists.

As a result of the reasons outlined, the explored market is anticipated to grow throughout the analysis period. However, since human subjects are not involved, the results are based on approximation which can restrain in silico clinical trials market growth.

Scope of the Report

As per the scope of the report, in silico clinical trials refers to the development of patient-specific models to form virtual cohorts for testing the safety and/or efficacy of new drugs and of new medical devices. The in silico clinical trials market is segmented by Therapeutic Area (Oncology, Infectious Disease, Cardiology, Neurology, Diabetes, Others), Industry (Medical Devices, Pharmaceutical), Phase (Phase I, Phase II, Phase III, Phase IV) Geography (North America, Europe, Asia-Pacific, South America, Middle East, and Africa). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Therapeutic Area
Infectious Disease
By Industry
Medical Devices
By Phase
Phase I
Phase II
Phase III
Phase IV
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle East and Africa
South Africa
Rest of Middle East and Africa
South America
Rest of South America

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Key Market Trends

Oncology Therapeutic Area is Expected to Witness a Significant Growth Over the Forecast Period

Regular cancer clinical trials are mostly at a high cost, and they also have a significant risk of causing harm to patients. The demand for cancer in silico clinical trials is mostly driven by these considerations. Also, technological advancements such as the use of Artificial Intelligence (AI) in cancer computer simulation studies to improve medication knowledge, safety, and efficacy are boosting the growth of the market.

As per the news published in In silico Medicine in 2022, announces they had completed experimental validation of AI-designed compounds with the requisite features and have nominated a preclinical candidate (PCC) for anti-cancer therapeutics targeting ubiquitin-specific protease 1 (USP1), a known synthetic lethality target. Synthetic lethality, a well-established genetic technique to exploit vulnerabilities in tumor cells to trigger tumor cell death while sparing normal cells, is a potential field of cancer therapy. When used against a wide spectrum of tumor lineages, Insilico's preclinical candidate molecule showed promising results. In vitro studies revealed that the chemical has a substantial antiproliferative effect in breast cancer gene mutant (BRCA) tumor cells with high selectivity.

The article published in MedRxiv journal under the heading “In silico cancer immunotherapy trials uncover the consequences of therapy-specific response patterns for clinical trial design and outcome” in 2021, explains the advantages of cancer immunotherapy coupled with in silico trials. In the study they point out that, for immuno-oncology, in silico studies have major implications such as they offer a cost-effective way to check the validity of the biological assumptions that underpin immunotherapy trials and aid in their design. Along with that, it can be used as a teaching tool that can help scientists in training understand design principles, resulting in better designs and higher success rates in future immunotherapy studies.

As a result of the stated factors, the oncology therapeutic area segment is predicted to develop significantly throughout the forecast period.

Percentage of Recruiting Studies by Location (as of June 09, 2022)

North America is Expected to Grow the In Silico Clinical Trials Market

North America had the majority of share in the in silico clinical trials market in 2021. The emergence of this region can be attributed to an increase in understanding of the benefits of in silico trials and reduced side effects that have been raised from human trials.

Key product releases, cost-effectiveness, and the presence of manufacturers in the country are all factors that have contributed to the growth of the in silico clinical trials market. According to the press release on May 2021, Massachusetts-based GNS Healthcare, an artificial intelligence organization that produces in silico patients that simulate therapeutic intervention on a patient-by-patient basis announced that they are planning to develop and launch Gemini, which is an in silico Patient for Prostate Cancer. This in silico patient was created in collaboration with Tempus and is powered by a clinico-genomic data, including whole-exome sequencing (tumor/normal match), RNAseq, patient treatment history, current treatments like Enzalutamide, Abiraterone, Docetaxel, Cabazitaxel, Sipuleucel-T, and Pembrolizumab, as well as related lines of treatment and mortality.

Moreover, according to the report published by the United States Food and Drug Administration on January 2022, describe that In silico clinical trials employing Computational Modeling and Simulation (CM&S), in which a device is evaluated on a cohort of virtual patients, are encouraged by the United States Food and Drug Administration and are expected to replace or augment clinical studies. However, the use of Computational Modeling and Simulation to support regulatory filings is now hampered by a lack of or contradictory information on their reliability. The analyzed market is predicted to grow in the North American region as a result of the aforementioned factors.

Global In Silico Clinical Trials Market

Competitive Landscape

The In silico clinical trial market is moderately competitive and consists of several major players. The competitive landscape includes an analysis of a few international as well as local companies which hold the market shares and are well known. Include Novadiscovery, Insilico Medicine, Inc., GNS Healthcare, InSilicoTrials Technologies, and Immunetrics Inc. among others.

Recent Development

  • In March 2022, QuantHealth partnered with 4P-Pharma to conduct AI-based in-Silico clinical trial simulations. The partnership will perform in silico clinical trials of their lead therapeutic candidates in collaboration. The in-silico simulation of the phase II clinical trial of 4P004, a first-in-class disease-modifying osteoarthritis medication (DMOAD) being developed by 4PPharma’s spin-off, will kick off this comprehensive alliance.
  • In February 2022 IonsGate Preclinical Services and InSilicoTrials have teamed up to revolutionize drug development. To digitalize IonsGate's drug development methods, InSilicoTrials will deliver a sophisticated technology known as Modeling and Simulation. This will reduce the cost and duration of preclinical testing while also improving the safety of novel compounds.

Table of Contents


    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Better Understanding of the Safety and Efficacy of a Drug

      2. 4.2.2 Cost-effectiveness and Less Chances of Termination of the Trial

    3. 4.3 Market Restraints

      1. 4.3.1 Unavailability of Complex Testing Centers and Results Based on Approximation

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 5.1 By Therapeutic Area

      1. 5.1.1 Oncology

      2. 5.1.2 Infectious Disease

      3. 5.1.3 Cardiology

      4. 5.1.4 Neurology

      5. 5.1.5 Diabetes

      6. 5.1.6 Others

    2. 5.2 By Industry

      1. 5.2.1 Medical Devices

      2. 5.2.2 Pharmaceutical

    3. 5.3 By Phase

      1. 5.3.1 Phase I

      2. 5.3.2 Phase II

      3. 5.3.3 Phase III

      4. 5.3.4 Phase IV

    4. 5.4 Geography

      1. 5.4.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.4.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle East and Africa

      5. 5.4.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Novadiscovery

      2. 6.1.2 Insilico Medicine, Inc.

      3. 6.1.3 Dassault Systemes

      4. 6.1.4 GNS Healthcare

      5. 6.1.5 Immunetrics Inc.

      6. 6.1.6 InSilicoTrials Technologies

      7. 6.1.7 Clarivate

      8. 6.1.8 Evotec

      9. 6.1.9 Abzena Ltd

    2. *List Not Exhaustive

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The Global In Silico Clinical Trials Market market is studied from 2019 - 2027.

The Global In Silico Clinical Trials Market is growing at a CAGR of 7.75% over the next 5 years.

The Global In Silico Clinical Trials Market is valued at 2962 Million USD in 2019.

The Global In Silico Clinical Trials Market is valued at 4607 Million USD in 2027.

Asia-Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Novadiscovery, Insilico Medicine, Inc., GNS Healthcare , Immunetrics Inc., InSilicoTrials Technologies are the major companies operating in Global In Silico Clinical Trials Market.

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