인실리코 임상시험 시장 예측(-2030년) : 치료 분야, 단계, 용도, 최종사용자, 지역별 세계 분석

According to Stratistics MRC, the Global In Silico Clinical Trials Market is accounted for $3.23 billion in 2023 and is expected to reach $6.06 billion by 2030 growing at a CAGR of 9.4% during the forecast period. In silico clinical trials, also known as virtual or computational clinical trials, are a form of computer-based modeling and simulation used in the pharmaceutical and healthcare industries. They involve the use of computational techniques and mathematical models to simulate various aspects of clinical trials, drug development, and patient responses to medications. In silico clinical trials aim to reduce the need for extensive and costly physical trials, accelerate drug development, optimize treatment strategies, and enhance patient safety by providing valuable insights before advancing to human or animal testing.

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.

Market Dynamics:

Driver:

Improved patient safety

In silico trials offer a transformative approach to drug development by replacing or supplementing traditional human trials with computer simulations. This method significantly reduces the risks associated with experimental drug testing on human subjects. In silico studies improve the safety profile of novel drug candidates by enabling the evaluation of possible side effects, drug interactions, and patient-specific responses through the use of virtual patient models. Furthermore, these trials enable pharmaceutical companies to refine drug formulations and optimise dosages to minimise side effects and ensure a higher level of safety for patients. As patient safety is a paramount concern in the pharmaceutical industry, in silico clinical trials provide a powerful avenue for enhancing the overall safety of drug development processes, making them a pivotal driver in the market's growth and adoption.

Restraint:

Interdisciplinary challenges

Interdisciplinary challenges serve as a significant restraint in the in silico clinical trial market. In silico trials require collaboration between experts from diverse fields, including biology, chemistry, pharmacology, data science, and computer engineering. Effective communication and integration of knowledge from these disciplines can be complex, potentially leading to misinterpretations, data incompatibility, or misunderstandings. These interdisciplinary challenges may slow down research and development efforts, hinder the adoption of in silico methods, and necessitate enhanced coordination and standardisation to unlock the full potential of this innovative approach in drug development.

Opportunity:

Advancements in artificial intelligence and machine learning technologies

Advancements in artificial intelligence (AI) and machine learning (ML) technologies present a significant opportunity in the in silico clinical trials market. These technologies enhance the precision of in silico clinical trials by predicting patient responses, optimising drug candidates, and identifying potential adverse effects. Furthermore, AI and machine learning empower the discovery of new therapeutic targets and the repurposing of existing drugs, reducing the time and cost required for research. As these technologies continue to evolve, the in silico clinical trials market stands to benefit from increased efficiency, improved success rates in drug development, and the potential for more tailored and effective treatments, ultimately revolutionising the pharmaceutical industry.

Threat:

Lack of standardized protocols and regulatory frameworks

In silico trials rely on computational models and simulations, and the absence of universally accepted standards can lead to variability and inconsistency in the results. Moreover, regulatory bodies may struggle to establish clear guidelines for evaluating and approving in silico trials, potentially delaying their adoption. The lack of standardised protocols and regulations raises concerns about the credibility and reliability of in silico trial outcomes, hindering trust and acceptance within the pharmaceutical and healthcare industries.

COVID-19 Impact

The COVID-19 pandemic crisis had a devastating effect on several industries. The use of computers to aid in drug development during this time led to a notable increase in the in-silico trial market. Because academics and biotechnological and biopharmaceutical businesses are working intensively on R&D for preventing the coronavirus disease from spreading, there is a greater need for in silico trials that use computational modelling. Furthermore, Scientists are working hard to find a cure for the COVID-19 pandemic as a result of the virus' rising mutation rate. As a result, the importance of research and drug discovery was increased, which in turn fueled the rise of the in silico computational modelling and simulation trials for medical product innovation and regulatory clearance.

The Oncology segment is expected to be the largest during the forecast period

The Oncology segment is estimated to hold the largest share. In silico clinical trials offer a groundbreaking approach to oncology research by utilising computer simulations and modelling to accelerate the development of cancer treatments. These simulations help assess drug candidates' efficacy, predict patient responses, and optimise treatment strategies. Given the complexity of cancer and the urgency for innovative therapies, in silico clinical trials in oncology offer significant advantages in terms of cost and time savings, as well as reduced risks associated with traditional clinical trials. This segment plays a pivotal role in advancing precision medicine and personalised cancer treatments, offering hope for improved outcomes for cancer patients.

The Pharmaceutical and Biotechnology Companies segment is expected to have the highest CAGR during the forecast period

The Pharmaceutical and Biotechnology Companies segment is anticipated to have lucrative growth during the forecast period. Pharmaceutical and biotechnology companies utilise in silico methods to streamline drug discovery and development processes. In silico trials employ computer simulations and modelling to predict drug behaviour, optimise formulations, and assess safety and efficacy. This approach significantly reduces research and development costs and expedites the time it takes to bring new drugs to market. It also enables a more efficient exploration of drug candidates, minimising the need for costly and time-consuming physical trials. Moreover, Pharmaceutical and biotechnology companies leverage in silico clinical trials to enhance their research pipelines, increase innovation, and ultimately deliver safer and more effective therapies to patients.

Region with largest share:

Asia Pacific commanded the largest market share during the extrapolated period. Factors driving this growth include a robust pharmaceutical and biotechnology industry, a large and diverse patient population, and a supportive regulatory environment. In silico clinical trials, which utilise computer simulations and modelling to assess drug efficacy and safety, offer cost-effective and efficient alternatives to traditional clinical trials. This approach not only accelerates the drug development process but also reduces costs and the ethical concerns associated with human trials. The Asia-Pacific region's increasing investment in this technology highlights its potential to become a key hub for in silico clinical trials, contributing to faster drug development and improved healthcare outcomes.

Region with highest CAGR:

North America is expected to witness profitable growth over the projection period. North America is a prominent hub in the in silico clinical trials market. The region boasts a well-established pharmaceutical and biotechnology sector, which continually seeks innovative solutions to expedite drug development. In silico clinical trials, which utilise computer-based simulations to assess drug safety and efficacy, are gaining traction due to their cost-efficiency and speed. The presence of major pharmaceutical companies and cutting-edge research institutions further drives the adoption of this technology. Additionally, North America's regulatory framework and healthcare infrastructure support the growth of in silico clinical trials, positioning the region as a leader in advancing drug discovery and development through computational modelling and simulations.

Key players in the market

Some of the key players in the In Silico Clinical Trials Market include: Certara, Inc., Insilico Medicine, Inc., Novadiscovery Sas, Dassault Systemes SE, The AnyLogic Company, GNS Healthcare Inc., InSilicoTrials, Nuventra Pharma Sciences, Immunetrics Inc., Abzena Ltd., Clarivate, Evotec, Aitia, Allucent and Acellera Ltd.

Key Developments:

In March 2022, QuantHealth partnered with 4P-Pharma to conduct AI-based in-Silico clinical trial simulations. In collaboration, the partnership would perform in silico clinical trials of their lead therapeutic candidates. The in-silico simulation of the phase II clinical trial of 4P004, a first-in-class disease-modifying osteoarthritis medication (DMOAD) developed by 4PPharma's spin-off, would kick off this comprehensive alliance.

In February 2022, IonsGate Preclinical Services and InSilicoTrials teamed up to revolutionize drug development. To digitalize IonsGate's drug development methods, InSilicoTrials would deliver a sophisticated modeling and simulation technology. This would reduce the cost and duration of preclinical testing while improving the safety of novel compounds.

Therapeutic Areas Covered:

• Oncology
• Cardiology
• Diabetes
• Infectious Disease
• Neurology
• Hematology
• Dermatology
• Other Therapeutic Areas

Phases Covered:

• Phase I
• Phase II
• Phase III
• Phase IV

Applications Covered:

• Drug Development
• Treatment Optimization
• Medical Devices
• Regulatory Approval

End Users Covered:

• Pharmaceutical and Biotechnology Companies
• Contract Research Organizations
• Academic and Research Institutes
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • 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 2021, 2022, 2023, 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
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • 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 Application Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 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 Therapeutic Area

• 5.1 Introduction
• 5.2 Oncology
• 5.3 Cardiology
• 5.4 Diabetes
• 5.5 Infectious Disease
• 5.6 Neurology
• 5.7 Hematology
• 5.8 Dermatology
• 5.9 Other Therapeutic Areas

6 Global In Silico Clinical Trials Market, By Phase

• 6.1 Introduction
• 6.2 Phase I
• 6.3 Phase II
• 6.4 Phase III
• 6.5 Phase IV

7 Global In Silico Clinical Trials Market, By Application

• 7.1 Introduction
• 7.2 Drug Development
• 7.3 Treatment Optimization
• 7.4 Medical Devices
• 7.5 Regulatory Approval

8 Global In Silico Clinical Trials Market, By End User

• 8.1 Introduction
• 8.2 Pharmaceutical and Biotechnology Companies
• 8.3 Contract Research Organizations
• 8.4 Academic and Research Institutes
• 8.5 Other End Users

9 Global In Silico Clinical Trials Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Certara, Inc.
• 11.2 Insilico Medicine, Inc.
• 11.3 Novadiscovery Sas
• 11.4 Dassault Systemes SE
• 11.5 The AnyLogic Company
• 11.6 GNS Healthcare Inc.
• 11.7 InSilicoTrials
• 11.8 Nuventra Pharma Sciences
• 11.9 Immunetrics Inc.
• 11.10 Abzena Ltd.
• 11.11 Clarivate
• 11.12 Evotec
• 11.13 Aitia
• 11.14 Allucent
• 11.15 Acellera Ltd.