In Silico Clinical Trials
In Silico Clinical Trials Market Forecasts to 2030 - Global Analysis By Type (Preclinical Trials, Clinical Trials, Post-Market Trials, Regulatory Compliance Trials, Disease Modeling Trials and Other Types), Simulation Type, Therapeutic, Technology, Application, End User and By Geography
According to Stratistics MRC, the Global In Silico Clinical Trials Market is accounted for $3.6 billion in 2024 and is expected to reach $5.8 billion by 200 growing at a CAGR of 8.4% during the forecast period. In silico clinical trials are the use of computer simulations and modeling to replicate human biology and predict the effects of medical interventions. These virtual trials use vast amounts of patient data, biological models, and computational algorithms to simulate how drugs, therapies, or devices would perform in real-world clinical settings. By replacing or reducing the need for traditional in vivo trials, in silico trials offer a faster, cost-effective, and ethical alternative for evaluating the safety and efficacy of treatments before clinical implementation.
According to the European Medicines Agency - European Union, in the EU / EEA, more than 4,000 clinical trials are authorised each year, of which 60% of clinical trials are sponsored by the pharma industry and 40% by non-commercial sponsors. As per the Clinical Trials Registry India (CTRI), India approved over 100 global clinical trials in 2021, the highest since 2013.
Market Dynamics:
Driver:
Growing demand for safer drugs
The growing demand for safer drugs in the market is driven by the need for more efficient, cost-effective, and ethical drug development processes. In silico trials, using advanced computational models, offer a safer alternative to traditional clinical trials by predicting drug efficacy, toxicity, and patient responses before real-world testing. This approach accelerates drug approval, reduces risks, and minimizes the reliance on animal and human testing, aligning with regulatory and public health goals.
Restraint:
Limited availability of high-quality data
The limited availability of high-quality data in the market hampers the accuracy and reliability of predictive models. Inadequate or biased data can lead to flawed simulations, resulting in incorrect predictions about drug efficacy, safety, or patient responses. This undermines the potential of in silico trials to replace traditional methods, slowing down drug development, increasing risks, and potentially leading to delayed or failed regulatory approvals for new treatments.
Opportunity:
Advances in computational modeling and AI
Advances in computational modeling and AI are revolutionizing market by enhancing the accuracy and efficiency of drug development. AI algorithms analyze vast datasets to predict drug interactions, patient responses, and potential side effects. Improved computational models simulate complex biological systems, reducing reliance on traditional trials. These innovations enable faster, more precise drug testing, optimizing clinical outcomes and safety while lowering costs and accelerating time-to-market for new treatments.
Threat:
Regulatory and ethical uncertainty
Regulatory and ethical uncertainty in the market poses a significant challenge to widespread adoption. The lack of clear guidelines on the use of computational models in drug testing can delay approval processes and increase compliance risks. Additionally, ethical concerns about data privacy, patient consent, and model transparency may hinder trust in these technologies, slowing progress and limiting their potential to replace traditional clinical trial methods effectively.
Covid-19 Impact:
The COVID-19 pandemic accelerated the adoption of In Silico Clinical Trials by highlighting the need for faster, more efficient drug development methods. With traditional trials facing disruptions, computational models became crucial for rapid drug testing and vaccine development. The pandemic emphasized the benefits of virtual simulations in reducing trial timelines, costs, and reliance on physical interactions, driving further investment and innovation in the market.
The preclinical trials segment is expected to be the largest during the forecast period
The preclinical trials segment is expected to account for the largest market share during the projection period. These virtual trials enable researchers to predict drug efficacy, safety, and pharmacokinetics, helping to identify potential risks, side effects, and optimal dosages. By utilizing AI, machine learning, and other predictive technologies, in silico preclinical trials reduce the cost, time, and ethical concerns associated with traditional animal and human studies, accelerating drug development and improving success rates.
The machine learning segment is expected to have the highest CAGR during the forecast period
The machine learning segment is expected to have the highest CAGR during the extrapolated period. These algorithms process vast datasets to predict patient responses, identify optimal dosing strategies, and simulate trial outcomes, significantly reducing the time. This technology also enhances decision-making, improves trial accuracy, and supports personalized medicine. As a result, ML is becoming a crucial tool in accelerating drug development and advancing more efficient, data-driven clinical research methodologies.
Region with largest share:
North America region is projected to account for the largest market share during the forecast period driven by advancements in computational modeling, artificial intelligence, and big data analytics. These virtual simulations are revolutionizing drug development by enhancing efficiency, reducing costs, and minimizing risks. Key factors such as increasing regulatory acceptance, a rising demand for personalized medicine, and a growing focus on precision healthcare contribute to the market's expansion in the region.
Region with highest CAGR:
Asia Pacific is expected to register the highest growth rate over the forecast period driven by advancements in computational models. Artificial Intelligence (AI), Machine Learning (ML), and Big Data are being increasingly integrated into the in silico clinical trials market. These technologies enable better prediction models, improve trial accuracy, and reduce development costs. Additionally, the rise in biotech startups, along with government support for digital transformation in healthcare, is helping the market grow.
Key players in the market
Some of the key players in In Silico Clinical Trials market include Novadiscovery, Dassault Systemes, GNS Healthcare, Clarivate, Evotec, Abzena Ltd., PerkinElmer Inc., Schrödinger, Inc., Selvita, Tracxn Technologies, WuXi AppTec, Hoffmann- La Roche, Mars, PYC Therapeutics and Immatics.
Key Developments:
In October 2024, Dassault Systèmes announced the availability of the world’s first guide for the medical device industry that outlines how to use virtual twins to accelerate clinical trials. The in silico clinical trial “ENRICHMENT Playbook” marks a significant advancement in the integration of virtual twins into the regulatory process in response to needs for improved patient safety, regulatory compliance, and pace of innovation.
In July 2024, Clarivate Plc announced the launch of its new OFF-X platform. It delivers critical drug and target safety information to proactively identify risks. Integrated with Cortellis Drug Discovery Intelligence™, OFF-X™ provides a comprehensive, one-stop resource for drug safety information, streamlining processes, increasing efficiencies and delivering a competitive advantage.
Types Covered:
• Preclinical Trials
• Clinical Trials
• Post-Market Trials
• Regulatory Compliance Trials
• Disease Modeling Trials
• Other Types
Simulation Types Covered:
• Physiological Simulations
• Toxicology Simulations
• Disease Models
• Population-Based Simulations
• Virtual Patient Simulations
Therapeutics Covered:
• Oncology
• Infectious Disease
• Cardiology
• Neurology
• Diabetes
• Other Therapeutics
Technologies Covered:
• Computational Biology
• Artificial Intelligence
• Machine Learning
• Systems Biology
• Other Technologies
Applications Covered:
• Drug Discovery and Development
• Medical Device Development
• Digital Health Technologies
• Personalized Medicine
• Other Applications
End Users Covered:
• Pharmaceutical and Biotechnology Companies
• Academic Institutions
• Contract Research Organizations (CROs)
• Regulatory Authorities
• Other End Users
Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan
o China
o India
o Australia
o New Zealand
o South Korea
o Rest of Asia Pacific
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa
o Saudi Arabia
o UAE
o Qatar
o South Africa
o Rest of Middle East & Africa
What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2022, 2023, 2024, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements
Free Customization Offerings:
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
o Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances
Table of Contents
1 Executive Summary
2 Preface
2.1 Abstract
2.2 Stake Holders
2.3 Research Scope
2.4 Research Methodology
2.4.1 Data Mining
2.4.2 Data Analysis
2.4.3 Data Validation
2.4.4 Research Approach
2.5 Research Sources
2.5.1 Primary Research Sources
2.5.2 Secondary Research Sources
2.5.3 Assumptions
3 Market Trend Analysis
3.1 Introduction
3.2 Drivers
3.3 Restraints
3.4 Opportunities
3.5 Threats
3.6 Technology Analysis
3.7 Application Analysis
3.8 End User Analysis
3.9 Emerging Markets
3.10 Impact of Covid-19
4 Porters Five Force Analysis
4.1 Bargaining power of suppliers
4.2 Bargaining power of buyers
4.3 Threat of substitutes
4.4 Threat of new entrants
4.5 Competitive rivalry
5 Global In Silico Clinical Trials Market, By Type
5.1 Introduction
5.2 Preclinical Trials
5.3 Clinical Trials
5.4 Post-Market Trials
5.5 Regulatory Compliance Trials
5.6 Disease Modeling Trials
5.7 Other Types
6 Global In Silico Clinical Trials Market, By Simulation Type
6.1 Introduction
6.2 Physiological Simulations
6.3 Toxicology Simulations
6.4 Disease Models
6.5 Population-Based Simulations
6.6 Virtual Patient Simulations
7 Global In Silico Clinical Trials Market, By Therapeutic
7.1 Introduction
7.2 Oncology
7.3 Infectious Disease
7.4 Cardiology
7.5 Neurology
7.6 Diabetes
7.7 Other Therapeutics
8 Global In Silico Clinical Trials Market, By Technology
8.1 Introduction
8.2 Computational Biology
8.3 Artificial Intelligence
8.4 Machine Learning
8.5 Systems Biology
8.6 Other Technologies
9 Global In Silico Clinical Trials Market, By Application
9.1 Introduction
9.2 Drug Discovery and Development
9.3 Medical Device Development
9.4 Digital Health Technologies
9.5 Personalized Medicine
9.6 Other Applications
10 Global In Silico Clinical Trials Market, By End User
10.1 Introduction
10.2 Pharmaceutical and Biotechnology Companies
10.3 Academic Institutions
10.4 Contract Research Organizations (CROs)
10.5 Regulatory Authorities
10.6 Other End Users
11 Global In Silico Clinical Trials Market, By Geography
11.1 Introduction
11.2 North America
11.2.1 US
11.2.2 Canada
11.2.3 Mexico
11.3 Europe
11.3.1 Germany
11.3.2 UK
11.3.3 Italy
11.3.4 France
11.3.5 Spain
11.3.6 Rest of Europe
11.4 Asia Pacific
11.4.1 Japan
11.4.2 China
11.4.3 India
11.4.4 Australia
11.4.5 New Zealand
11.4.6 South Korea
11.4.7 Rest of Asia Pacific
11.5 South America
11.5.1 Argentina
11.5.2 Brazil
11.5.3 Chile
11.5.4 Rest of South America
11.6 Middle East & Africa
11.6.1 Saudi Arabia
11.6.2 UAE
11.6.3 Qatar
11.6.4 South Africa
11.6.5 Rest of Middle East & Africa
12 Key Developments
12.1 Agreements, Partnerships, Collaborations and Joint Ventures
12.2 Acquisitions & Mergers
12.3 New Product Launch
12.4 Expansions
12.5 Other Key Strategies
13 Company Profiling
13.1 Novadiscovery
13.2 Dassault Systemes
13.3 GNS Healthcare
13.4 Clarivate
13.5 Evotec
13.6 Abzena Ltd.
13.7 PerkinElmer Inc.
13.8 Schrödinger, Inc.
13.9 Selvita
13.10 Tracxn Technologies
13.11 WuXi AppTec
13.12 Hoffmann- La Roche
13.13 Mars
13.14 PYC Therapeutics
13.15 Immatics
List of Tables
1 Global In Silico Clinical Trials Market Outlook, By Region (2022-2030) ($MN)
2 Global In Silico Clinical Trials Market Outlook, By Type (2022-2030) ($MN)
3 Global In Silico Clinical Trials Market Outlook, By Preclinical Trials (2022-2030) ($MN)
4 Global In Silico Clinical Trials Market Outlook, By Clinical Trials (2022-2030) ($MN)
5 Global In Silico Clinical Trials Market Outlook, By Post-Market Trials (2022-2030) ($MN)
6 Global In Silico Clinical Trials Market Outlook, By Regulatory Compliance Trials (2022-2030) ($MN)
7 Global In Silico Clinical Trials Market Outlook, By Disease Modeling Trials (2022-2030) ($MN)
8 Global In Silico Clinical Trials Market Outlook, By Other Types (2022-2030) ($MN)
9 Global In Silico Clinical Trials Market Outlook, By Simulation Type (2022-2030) ($MN)
10 Global In Silico Clinical Trials Market Outlook, By Physiological Simulations (2022-2030) ($MN)
11 Global In Silico Clinical Trials Market Outlook, By Toxicology Simulations (2022-2030) ($MN)
12 Global In Silico Clinical Trials Market Outlook, By Disease Models (2022-2030) ($MN)
13 Global In Silico Clinical Trials Market Outlook, By Population-Based Simulations (2022-2030) ($MN)
14 Global In Silico Clinical Trials Market Outlook, By Virtual Patient Simulations (2022-2030) ($MN)
15 Global In Silico Clinical Trials Market Outlook, By Therapeutic (2022-2030) ($MN)
16 Global In Silico Clinical Trials Market Outlook, By Oncology (2022-2030) ($MN)
17 Global In Silico Clinical Trials Market Outlook, By Infectious Disease (2022-2030) ($MN)
18 Global In Silico Clinical Trials Market Outlook, By Cardiology (2022-2030) ($MN)
19 Global In Silico Clinical Trials Market Outlook, By Neurology (2022-2030) ($MN)
20 Global In Silico Clinical Trials Market Outlook, By Diabetes (2022-2030) ($MN)
21 Global In Silico Clinical Trials Market Outlook, By Other Therapeutics (2022-2030) ($MN)
22 Global In Silico Clinical Trials Market Outlook, By Technology (2022-2030) ($MN)
23 Global In Silico Clinical Trials Market Outlook, By Computational Biology (2022-2030) ($MN)
24 Global In Silico Clinical Trials Market Outlook, By Artificial Intelligence (2022-2030) ($MN)
25 Global In Silico Clinical Trials Market Outlook, By Machine Learning (2022-2030) ($MN)
26 Global In Silico Clinical Trials Market Outlook, By Systems Biology (2022-2030) ($MN)
27 Global In Silico Clinical Trials Market Outlook, By Other Technologies (2022-2030) ($MN)
28 Global In Silico Clinical Trials Market Outlook, By Application (2022-2030) ($MN)
29 Global In Silico Clinical Trials Market Outlook, By Drug Discovery and Development (2022-2030) ($MN)
30 Global In Silico Clinical Trials Market Outlook, By Medical Device Development (2022-2030) ($MN)
31 Global In Silico Clinical Trials Market Outlook, By Digital Health Technologies (2022-2030) ($MN)
32 Global In Silico Clinical Trials Market Outlook, By Personalized Medicine (2022-2030) ($MN)
33 Global In Silico Clinical Trials Market Outlook, By Other Applications (2022-2030) ($MN)
34 Global In Silico Clinical Trials Market Outlook, By End User (2022-2030) ($MN)
35 Global In Silico Clinical Trials Market Outlook, By Pharmaceutical and Biotechnology Companies (2022-2030) ($MN)
36 Global In Silico Clinical Trials Market Outlook, By Academic Institutions (2022-2030) ($MN)
37 Global In Silico Clinical Trials Market Outlook, By Contract Research Organizations (CROs) (2022-2030) ($MN)
38 Global In Silico Clinical Trials Market Outlook, By Regulatory Authorities (2022-2030) ($MN)
39 Global In Silico Clinical Trials Market Outlook, By Other End Users (2022-2030) ($MN)
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.
List of Figures
RESEARCH METHODOLOGY
We at ‘Stratistics’ opt for an extensive research approach which involves data mining, data validation, and data analysis. The various research sources include in-house repository, secondary research, competitor’s sources, social media research, client internal data, and primary research.
Our team of analysts prefers the most reliable and authenticated data sources in order to perform the comprehensive literature search. With access to most of the authenticated data bases our team highly considers the best mix of information through various sources to obtain extensive and accurate analysis.
Each report takes an average time of a month and a team of 4 industry analysts. The time may vary depending on the scope and data availability of the desired market report. The various parameters used in the market assessment are standardized in order to enhance the data accuracy.
Data Mining
The data is collected from several authenticated, reliable, paid and unpaid sources and is filtered depending on the scope & objective of the research. Our reports repository acts as an added advantage in this procedure. Data gathering from the raw material suppliers, distributors and the manufacturers is performed on a regular basis, this helps in the comprehensive understanding of the products value chain. Apart from the above mentioned sources the data is also collected from the industry consultants to ensure the objective of the study is in the right direction.
Market trends such as technological advancements, regulatory affairs, market dynamics (Drivers, Restraints, Opportunities and Challenges) are obtained from scientific journals, market related national & international associations and organizations.
Data Analysis
From the data that is collected depending on the scope & objective of the research the data is subjected for the analysis. The critical steps that we follow for the data analysis include:
- Product Lifecycle Analysis
- Competitor analysis
- Risk analysis
- Porters Analysis
- PESTEL Analysis
- SWOT Analysis
The data engineering is performed by the core industry experts considering both the Marketing Mix Modeling and the Demand Forecasting. The marketing mix modeling makes use of multiple-regression techniques to predict the optimal mix of marketing variables. Regression factor is based on a number of variables and how they relate to an outcome such as sales or profits.
Data Validation
The data validation is performed by the exhaustive primary research from the expert interviews. This includes telephonic interviews, focus groups, face to face interviews, and questionnaires to validate our research from all aspects. The industry experts we approach come from the leading firms, involved in the supply chain ranging from the suppliers, distributors to the manufacturers and consumers so as to ensure an unbiased analysis.
We are in touch with more than 15,000 industry experts with the right mix of consultants, CEO's, presidents, vice presidents, managers, experts from both supply side and demand side, executives and so on.
The data validation involves the primary research from the industry experts belonging to:
- Leading Companies
- Suppliers & Distributors
- Manufacturers
- Consumers
- Industry/Strategic Consultants
Apart from the data validation the primary research also helps in performing the fill gap research, i.e. providing solutions for the unmet needs of the research which helps in enhancing the reports quality.
For more details about research methodology, kindly write to us at info@strategymrc.com
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