In Silico Clinical Trials Market growth is driven by rising use of ai-based modeling, regulatory support, and accelerated drug development strategies.
Austin, Nov. 28, 2025 (GLOBE NEWSWIRE) — In Silico Clinical Trials Market Size & Growth Analysis:
According to SNS Insider, the global In Silico Clinical Trials Market was valued at $3.42 billion in 2023 and is projected to reach $6.68 billion by 2032, growing at a CAGR of 7.75% over the forecast period of 2024 to 2032. The U.S. in silico trials market was valued at $1.11 billion in 2023 and is expected to reach $1.98 billion by 2032, growing at a CAGR of 6.66%.
This increased momentum is driven by the growing need for faster and more cost-efficient drug development, stronger adoption of AI and advanced computational models, and expanding regulatory support for digital clinical trial methods. The rising integration of predictive analytics, virtual patient modeling, and machine learning tools is streamlining trial workflows and reducing development risks for pharmaceutical and biotech companies.
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Regulatory bodies, including the FDA, continue to encourage digital trial approaches, which further supports the growth of computational simulation tools. Venture capital activity, research collaborations, and public-private partnerships are injecting capital into the sector, accelerating innovation and strengthening the global in silico clinical trials ecosystem.
Major Players Analysis Listed in the In Silico Clinical Trials Market Report Are:
- Certara, Inc.
- Novadiscovery SAS
- Insilico Medicine, Inc.
- Dassault Systèmes SE
- GNS Healthcare Inc.
- The AnyLogic Company
- InSilicoTrials
- Immunetrics Inc.
- Nuventra Pharma Sciences
- Abzena Ltd.
- Other players
In Silico Clinical Trials Market Segmentation Analysis:
By Phase
In 2023, the Phase II segment captured the largest market share with a revenue share of 40.6% as Phase II trials play a vital role in determining whether new treatments work and are safe in a wider population of patients. The Phase III segment will be the fastest growing in the market. Phase III trials are the last stage before a drug’s introduction into the market, where there is large-scale testing to verify the drug’s effectiveness and safety.
By Industry
In 2023, the medical devices segment captured the highest revenue share of 54.6%, indicating its well-established position in clinical trials. The pharmaceutical sector is expected to record the highest growth in the forecast period. Increased demand for advanced treatments such as biologics, personalized medicine, and gene therapies will fuel pharmaceutical trials’ growth.
By Therapeutic Area
In 2023, the oncology segment represented 22.9% of the overall market revenue, and it was the largest therapeutic area for clinical trials. The infectious disease segment is anticipated to be the most rapidly growing over the forecast period. Due to the growth of emerging diseases and global health threats, the demand for novel therapeutic products in this segment is anticipated to grow, thus driving segment growth.
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In Silico Clinical Trials Market Regional Insights:
North America led the in silico clinical trials market in 2023, capturing the highest share of global revenue. North America’s leadership is largely driven by the strong presence of leading pharmaceutical firms, superior healthcare infrastructure, and high investment in research and development (R&D).
Asia Pacific is likely to be the most rapidly growing region through the forecast period. This rapid growth can be attributed to the rising number of clinical trials carried out in countries, such as China, Japan, and India, where there is heavy investment in healthcare innovation.
Recent Developments:
- In Oct 2024, Dassault Systèmes unveiled the world’s first guide for the medical device industry on using virtual twins to expedite clinical trials. This guide, developed in collaboration with the U.S. Food and Drug Administration over five years, introduces the ENRICHMENT Playbook, advancing the integration of virtual twins into the regulatory process to enhance patient safety, compliance, and innovation speed.
- In Feb 2024, U.K.-based AdSilico secured USD 4.4 million in funding to advance its virtual trial solution. The platform leverages AI to generate synthetic populations, enabling more time-efficient trials for medical devices. This development aims to streamline the trial process and accelerate product testing.
Exclusive Sections of the Report (The USPs):
- REGULATORY & APPROVAL TRENDS – helps you understand how evolving FDA, EMA, and international regulatory frameworks are accelerating or limiting the adoption of in silico clinical models.
- TECHNOLOGY ADOPTION & INTEGRATION METRICS – helps you evaluate the penetration of AI, machine learning, HPC, and virtual patient modelling across pharma and biotech companies.
- TRIAL SIMULATION PERFORMANCE INDEX – helps you assess accuracy, prediction reliability, validation rates, and efficiency improvements achieved through virtual trials over traditional models.
- INVESTMENT TRENDS & FUNDING FLOW – helps you track where capital is moving, key investors supporting in silico platforms, and financial opportunities for market entrants.
- COLLABORATION & BIOTECH PARTNERSHIP SCORE – helps you identify the intensity of collaboration between pharmaceutical companies, biotech startups, research institutes, and simulation technology providers.
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In Silico Clinical Trials Market Report Scope
| Report Attributes | Details |
| Market Size in 2023 | $3.42 billion |
| Market Size by 2032 | $6.68 billion |
| CAGR | CAGR of 7.75% From 2024 to 2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Data | 2020-2022 |
| Key Segments | • By Phase [Phase I, Phase II, Phase III, Phase IV] • By Industry [Medical Devices, Pharmaceutical] • By Therapeutic Area [Oncology, Infectious Disease, Hematology, Cardiology, Dermatology, Neurology, Diabetes, Others] |
| Regional Analysis/Coverage | North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America). |
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