In Silico Clinical Trials Market Size, Share & Trends Analysis Report By Industry (Medical Devices, Pharmaceutical), By Therapeutic Area (Oncology, Infectious Disease, Hematology), By Phase (Phase I, Phase II, Phase III, Phase IV), By Region, And Segment Forecasts, 2025 - 2030

In Silico Clinical Trials Market Size & Trends

The global in silico clinical trials market size was valued at USD 3.60 billion in 2024 and is projected to grow at a CAGR of 7.74% from 2025 to 2030. In-silico technologies are revolutionizing the development and evaluation of pharmaceuticals, medical devices, & digital health technologies. By leveraging computational power, these technologies offer an efficient, cost-effective, and highly predictive tool for innovation and safety assessment. Furthermore, the in-silico trials offer less expensive drug/ device development approaches, further de-risking trials for patients.

Moreover, technological innovations in in-silico clinical trials are expected to drive the market. Traditional clinical trials are expensive as compared to in-silico trials. In addition, human and animal testing in clinical trials ideally have higher than more chances of side effects, which further creates demand for in-silico clinical trials to reduce the chances of adverse reactions during trials, thus enhancing the efficacy & safety of research activities. Hence, the high cost associated with traditional clinical trials is one of the major factors supporting the adoption of computer-based trials.

Moreover, in-silico trials provide a better understanding of the safety and efficacy of a drug or a device and also reduce the chances of termination of clinical trials, thus reducing the expenditure involved in the trials. There has been a significant rise in R&D expenditure for drug development in recent years.  The growth in R&D spending is likely to impact the market growth positively.

Industry Insights

On the basis of industry segment, the market includes medical devices and pharmaceuticals. In 2024, the medical devices segment dominated the market, accounting for a revenue share of 57.88%. This growth can be attributed to factors such as growing advanced in MedTech industries, emerging use of advanced computer modeling & growing simulations in developing or regulatory evaluation of a product. In addition, the simulations for medical devices are considered more accurate than pharmaceuticals, which is the key reason fueling the demand for the in-silico trials market. In addition, it acts as a useful tool to minimize risk throughout a life cycle of product through multiple design iterations at a fraction of the cost. These clinical trials support reducing cost with the flexibility to test different designs & minimize the risk throughout the design by identifying failure modes, testing under extreme conditions, and identifying worst scenarios.

For instance, in February 2024, the UK University of Leeds mentioned that Adsilico had raised £3.5m (USD 4.4 million) in seed funding to develop an in-silico trial solution. The company received £2m (USD 2.56 million) investment from Northern Gritstone, a company launched by the Universities of Manchester, Sheffield & Leeds. The remaining £1.5m (USD 1.92 million) was invested in Parkwalk Advisors, a UK-based investment management firm.

The pharmaceutical segment is anticipated to register the fastest CAGR of 8.14% during the forecast period. The segment is driven by increasing trends for using silico methods in drug development & clinical trials, growing advances in artificial intelligence and machine learning in pharmaceutical clinical trials & revolutionizing the landscape of clinical trials & regulatory science. Furthermore, real-world evidence & big data integration into in silico models will propel their capability to simulate biological systems that are complex and predict long-term outcomes, further fueling pharmaceutical clinical trials segment growth. Such factors are expected to drive the segment growth over the estimated period.

Therapeutic Area Insights

On the basis of the therapeutic area segment, the market is segregated into oncology, infectious disease, hematology, cardiology, dermatology, neurology, diabetes, and others. In 2024, the oncology segment dominated the market, accounting for a revenue share of 26.19%. The high segment growth is due to revolutionizing the landscape of oncology drug development by enabling faster, safer, and precise development of oncology treatments. 

Furthermore, traditional clinical trials for cancer are considered expensive and also have high chances of incurring harmful effects on humans. These factors are primarily contributing to the demand for oncology in silico clinical trials. Furthermore, technological advances such as the incorporation of Artificial Intelligence (AI) in cancer computer simulation trials for better understanding, safety, and efficacy of drugs are further contributing to the segment growth.

In addition, it accelerates the development process and enhances the precision of targeting specific diseases, further optimizing drug interactions and effects before they are tested in real-world clinical trials. It further helps to assess the efficacy and safety of anti-cancer treatment, optimizing the dose-exposure-response relationship.  For instance, GNS Healthcare mentioned its plans to develop & launch Gemini, the in-silico patient for prostate cancer. The company’s collaboration with Tempus, this in silico patient is fueled due to rich clinical-genomic data, whole exome sequencing, patient treatment history, RNAseq, current treatments such as Enzalutamide, Abiraterone, Cabazitaxel, Docetaxel, Sipuleucel-T & Pembrolizumab and associated lines of therapy & mortality. Such factors are anticipated to drive the segment growth.

The infectious disease segment is expected to register a CAGR of 9.45% during the forecast period. The growth is due to the increasing spread of infectious diseases globally, which is the major reason for the segment’s growth. Moreover, increasing funding for in silico infectious disease trials is likely to impact the segment’s growth positively. For instance, in March 2023, Premier Research & InSilicoTrials mentioned accelerating the development of new therapies & medical devices that have partnered to create faster, safer, and more efficient pathways to regulatory approval for rare disease treatments. Such factors are anticipated to drive the segment.

Phase Insights

On the basis of phase segment, the market is segregated into phase I, phase II, phase III, and phase IV. In 2024, the Phase II segment dominated the market, accounting for a revenue share of 44.60%. The high segment growth is due to a rise in R&D activities for advanced therapeutics and medical devices, contributing to the growth of the segment. Moreover, the growing focus on series funding to expand clinical research facilities is one of the considerable factors supporting market growth. In addition, an increasing number of pharmaceutical companies are focusing on the development of generic drugs on account of patent expiration. This has further increased the number of clinical trials conducted across the globe, thereby supporting the segment growth.

The phase III segment is expected to register a CAGR of 8.54% during the forecast period. The growth is due to rising demand for biologics and personalized medicines globally and increasing awareness among the population to eliminate animal studies are a few factors the growth of the phase III segment. Such factors are anticipated to drive the segment.

Regional Insights

North America in-silico clinical trials market dominated the global market in 2024 with the largest share of 44.68%. This can be attributed to the growing demand for pharmaceutical drugs & medical devices, the increasing number of in silico trials, growing innovations in patient-centric solutions, rising remote or site-less clinical trials, and the increasing number of cost-efficient clinical trials expected to drive the market. In addition, established market players such as GNS Healthcare Inc., Insilico Medicine, Inc., Immunetrics Inc., and others, as well as developed healthcare infrastructure, are significant factors supporting the region’s growth. Furthermore, an expanding number of in-silico clinical trials are expected to stimulate clinical trials. Thus, the market offers to minimize potential risks and failure associated with clinical trials.

U.S. In Silico Clinical Trials Market Trends

The U.S. accounts for the highest share of the North America in-silico clinical trials market owing to the growing focus on the safety and effectiveness of medical devices/pharmaceutical drugs and the presence of several market players in the country. Besides, the demand for in-silico clinical trials is growing in the U.S. due to the robust clinical trials scenarios and the well-developed pharmaceutical/medical devices R&D infrastructure, stringent regulatory system, and rising investments in drug discovery are expected to drive the market. Moreover, regulatory agencies in the U.S., such as the FDA, also promote the use of in silico clinical trials to improve regulatory evaluations. Such factors are expected to drive the market.

The in-silico clinical trials market in Canada is driven by the growing use of in-silico clinical trials among researchers and healthcare providers and the rising continuous approval for clinical trials. Furthermore, in-silico clinical development plans to support health technology assessment for the development of innovative therapies and medical devices. Such factors are expected to drive the country’s growth. For instance, the Government of Canada mentioned that it is investing more than USD 43 million in supporting 14 clinical trials focused on preparing the country for health emergencies and advancing the country’s life sciences sector.

Europe In Silico Clinical Trials Market Trends

Europe's in-silico clinical trials market is driven by growing advancements in technology, an increasing number of clinical trials, and the presence of key players offering in-silico clinical trial services. In addition, the market is driven by the growing drug discovery, rising in-silico screening, and profiling of compounds for medical devices/ pharmaceutical drugs.  In addition, the presence of a well-established market, the growing prevalence of diseases, increasing innovation of products, and the expansion of new facilities are expected to drive the market.

Germany accounts for the highest share of the European in-silico clinical trials market owing to technological advancements, enhanced clinical team expertise, and growing usage of computational models and AI technology, accelerating the development of new drugs and further accelerating the development of medical devices/drugs further improving the safety of medical products and significantly cutting the R&D costs. Such factors are anticipated to drive the market.

The in-silico clinical trials market in the UK is driven by the increasing trend of in-silico clinical trials among pharmaceutical/medical devices companies, increasing requirements for in-silico clinical trials to improve & tackle diseases with more effective treatments. For instance, the InSilicoUK network launch mentioned that it had launched a new UK-wide network, ‘InSilicoUK,’ bringing the community together to deliver innovation and regulatory science of medical products that parallel the UK’s ambition to be a “science superpower.” Such factors are anticipated to drive the market.

Asia Pacific In Silico Clinical Trials Market Trends

Asia Pacific is expected to grow at a CAGR of 8.38% during the forecast period owing to the changing market dynamics, rising healthcare expenditure, and increasing adoption of in-silico technology yields immediate benefits such as streamlined workflows, improved data management, and enhanced decision-making processes. Furthermore, various companies in this region are adopting the use of in-silico trials to reduce the overall cost of clinical studies. In addition, in-silico trials further support improving the market requirement for both pharmaceutical and medical devices, targeting the development of products, reducing reliance on animal clinical trials, and providing support to bolster regulatory submissions.

Japan's demand for in-silico clinical trials is steadily increasing, driven by automated AI-powered robotics laboratories performing target discovery, significant progress in drug development, and increased pipeline medical devices/drug development. In addition, the clinical trials further support the acceleration of end-to-end medical devices/drug discovery, optimizing the success rate of drug development. Such factors are anticipated to drive the market.

The in-silico clinical trials market in China is driven by a growing number of clinical trials and emerging in the development of the country as a hub for outsourcing drug discovery activities due to the availability of skilled manpower, cost-effectiveness, favorable regulatory environment, and quality data. Such factors are anticipated to drive the market.

The increasing presence of the medical device and pharmaceutical companies are anticipated to drive the in silico clinical trials market. The country has become one of the preferred sites for clinical trials due to its increasing patient pool, cost competitiveness, and developing healthcare sector. In addition, growing investment in R&D is expected to support market growth over the projected period.

Key In Silico Clinical Trials Company Insights

The market players operating across the insilico clinical trials are seeking to enhance their production capacities, and market presence with the adoption of in-organic strategic initiatives such as partnerships & agreements, service launches, expansions, mergers & acquisitions, and others to increase market presence & revenue and gain a competitive edge drives the market growth. Therefore, growing strategic initiatives are expected to boost the market share of prominent players operating across the market. For instance, in September 2024, Insilico Medicine mentioned drug candidate successfully met its safety & secondary efficacy endpoints. The INS018_055 drug is a small molecule targeting TRAF2- & NCK-interacting kinase. TNIK inhibitors are studied for anticancer properties; they are being explored for anti-fibrotic capabilities, benefiting lung diseases like idiopathic pulmonary fibrosis.

Recent Developments

• In November 2024, Debiopharm's Novadiscovery announced that it had demonstrated the power of its technology by forecasting the MARIPOSA Phase III clinical study finding. The company's latest achievement crystallizes the predictive simulation platforms in clinical trials. Additionally, Novadiscovery and Janssen's collaboration sets the stage for a transformative approach to drug development, leading to global patient benefits.

• In July 2024, Exscientia plc expanded work with Amazon Web Services to use the cloud provider's AI & ML to power its drug discovery & automation platform.

• In June 2023, Insilico Medicine mentioned first dose completion in Phase II clinical trial patients of INS018_055. It marks as the first world's anti-fibrotic small molecule inhibitor discovered & is designed using artificial intelligence, initiating phase II clinical trials for evaluation.

In Silico Clinical Trials Market Report Scope

Global In Silico Clinical Trials Market Report Segmentation

This report forecasts revenue growth at the regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the in silico clinical trials market report on the basis of industry, therapeutic area, phase and region:

• Industry Outlook (Revenue, USD Million, 2018 - 2030)

  • Medical Devices

  • Pharmaceutical

• Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Infectious Disease

  • Hematology

  • Cardiology

  • Dermatology

  • Neurology

  • Diabetes

  • Others

• Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Thailand

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait