IN SILICO CLINICAL TRIALS MARKET ANALYSIS

The global in silico clinical trials market was valued at US$ 3,173.1 Mn in 2022 and is forecast to reach a value of US$ 5,824.6 Million by 2030 at a CAGR of 7.95% between 2023 and 2030. The global in silico clinical trials market is experiencing strong growth due to the rise in prevalence of chronic, infectious, and neurological diseases and outbreak of COVID-19 worldwide. Moreover, increasing use of in silico models to test medical devices and increase in number of in silico clinical trials is expected to boost growth of the market. However, factors such as unavailability of complex testing centers and low awareness about in silico trials are expected to hamper the growth of the global in silico clinical trials market.

Global In Silico Clinical Trials Market: Regional Insights

Based on geography, the global in silico clinical trials market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period owing to the increasing prevalence of chronic, infectious, and neurological diseases, rise in number of clinical trials, and rise in drug discovery and development in the region. For instance, with the rise in burden of chronic, infectious, and neurological diseases, the demand for safe and effective drugs and medical device is also increasing. According to the Centers for Disease Control and Prevention (CDC), chronic diseases, such as heart disease, cancer, and diabetes, are the leading causes of death and disability in the United States.

Europe and Asia Pacific are also expected to witness robust growth in the global in silico clinical trials market due to the rise in burden of chronic, infectious, and neurological diseases, rise in drug discovery and development, and increase in number of clinical trials in these regions. For instance, 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.

Figure 1. Global In Silico Clinical Trials Market Share (%), by Region, 2023

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Global In Silico Clinical Trials Market Drivers:

Rise in disease burden to augment market growth

One of the key factors expected to augment the growth of the global in silico clinical trials market during the forecast period is the rise in prevalence of chronic, infectious, and neurological diseases worldwide. With the rise in burden of chronic, infectious, and neurological diseases, the demand for safe and effective drugs and medical device is also increasing. In July 2022, Amazon started developing cancer vaccines in collaboration with the Fred Hutchinson Cancer Research Center, and launched an FDA-approved clinical trial. Amazon and Fred Hutchinson planned to recruit 20 participants over the age of 18 for early stage, or phase 1 trial, to develop “personalized vaccines” that can treat breast cancer and melanoma, a form of skin cancer.

The outbreak of COVID-19 to underpin market growth

Another factor which is driving the growth of the in silico clinical trials market is the outbreak of COVID-19 across the globe. For instance, in November 2020, Pfizer and BioNTech SE announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based  candidate, BNT162b2, met all of the study’s primary efficacy endpoints. The efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%. Moreover, according to CTRI, even in 2020, the year the COVID pandemic struck, India registered 87 global clinical trials.

Global In Silico Clinical Trials Market Opportunities:

Increasing use of in silico models to test medical devices is expected to provide significant growth opportunities for players in the in silico clinical trials market. For instance, in silico models allow manufacturers to shorten product development cycle for new medical devices and pharmaceuticals without compromising quality or safety. In April 2021, InSilicoTrials Technologies, Italian startup, received funding for its 3 Horizon 2020 project by the EU to support the development of advanced medical devices through in silico trials. InSilicoTrials will work with over 140 esteemed European scientists until 2024. This in turn is driving the market growth.

Increase in number of in silico clinical trials across the globe is expected to offer lucrative growth opportunities for players in the global in silico clinical trials market. For instance, in silico models allow researchers to test new drugs on virtual patients for pharmaceutical trials. In November 2021, Japanese preclinical CRO, DSTC, partnered with InSilicoTrials, to innovate the drug development process with the adoption of in silico clinical trials, following the recommendations of regulatory bodies, such as FDA, EMA and PMDA, to significantly cut the cost and time-to-market of drug development, increasing the safety new drugs and reducing animal and human testing.

Global In Silico Clinical Trials Market Trends:

Growing geriatric population is a recent trend

The ageing population tends to have a higher prevalence of chronic diseases worldwide. With the growing geriatric population coupled with minor to severe chronic diseases, such as cardiovascular  diseases, cancer, diabetes, and respiratory diseases, the demand for safe and effective therapeutics and medical devices is increasing, and for rigorous development of the therapeutics and medical devices, in silico clinical trials (ISCTs) are increasing worldwide. This trend is expected continue during the forecast period, driving the growth of the market.

Technological advancements is another trend

Technological advances such as the incorporation of  (AI) in cancer trials for better understanding, safety, and efficacy of drugs are further contributing to the market growth. The demand for cancer in silico clinical trials is has also increased over the years. In 2022, Insilico Medicine completed experimental validation of AI-designed compounds with requisite features and have nominated a preclinical candidate (PCC) for anti-cancer therapeutics targeting ubiquitin-specific protease 1 (USP1), a known synthetic lethality target. This trend is also expected continue over the forecast period, driving the market growth.

Global In Silico Clinical Trials Market Restraints:

Unavailability of complex testing centers to market growth

One of the key factors expected to hamper the growth of the global in silico clinical trials market is unavailability of complex testing centers and results based on approximation. Most of the trials require solutions that are developed to use 5G technology and hybrid laboratories with advanced technology which require substantial cost and significantly new infrastructure. Several developing and underdeveloped countries are not economically stable for developments and high investments to fulfill the surge in demand for the advancement in the complex testing centers and are facing challenges related to the limited availability of infrastructure and technical resources. This in turn is expected to restrain the growth of the market.

Low awareness about in silico trials to hamper market growth

Another factor which is hampering the growth of the global in silico clinical trials market is the low awareness about in silico trials in developing countries. For instance, the use of Computational Modelling and Simulation to support regulatory filings is hampered by a lack of or contradictory information on their reliability. Low awareness about in silico trials in the developing economies and issues related to protein flexibility, molecule conformation, and promiscuity led to inaccurate prediction may hinder the demand for computer simulation trials. This in turn is also expected to hamper the growth of the market.

Figure 2. Global In Silico Clinical Trials Market Share (%), by Therapeutic Area, 2023

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Global In Silico Clinical Trials Market Segmentation:

The global in silico clinical trials market report is segmented into Therapeutic Area, Industry, Phase, and Geography.

Based on Therapeutic Area, the global in silico clinical trials market is segmented into Oncology, Infectious Disease, Cardiology, Neurology, Diabetes, and Other Therapeutic Areas. Out of which, Oncology Segment is expected to dominate the in silico clinical trials market during the forecast period and this is attributed to the rise in burden of cancer across the globe.

Cardiology Segment is also expected to witness significant growth in the near future and this is owing to the increase in prevalence of cardiovascular diseases worldwide.

Based on Industry, the market is segmented into Medical Devices and Pharmaceutical. Out of which, Medical Devices Segment is expected to dominate the market over the forecast period and this is attributed to the increase in demand for technologically advanced medical devices.

Pharmaceutical Segment is also expected to witness significant growth in the near future and this is owing to the increase in demand for safe and effective pharmaceuticals.

Based on Phase, the market is segmented into Phase I, Phase II, Phase III, and Phase IV. Out of which, Phase II Segment is expected to dominate the market over the forecast period and this is attributed to the rise in R&D activities for advanced therapeutics and medical devices.

Phase III Segment is also expected to witness significant growth in the near future and this is owing to the rising demand for biologics and personalized medicines across the globe and rise in awareness among the population.

Global In Silico Clinical Trials Market: Key Developments

In July 2022,  announced that the company has identified multiple unreported potential therapeutic targets for amyotrophic lateral sclerosis (ALS), using its proprietary Artificial Intelligence (AI) driven target discovery engine, PandaOmics. The findings were published in the June 28 issue of Frontiers in Aging Neuroscience.

In June 2022,  announced ten highly innovative organizations joined its ground breaking Sensor Cloud Network, bringing high-quality data and data science together to help speed faster discovery and better treatments for patients.

In May 2022, GNS Healthcare announced a collaboration with Arvinas Inc., creating a new class of drugs based on targeted protein degradation to generate insights to help accelerate drug development for neurodegenerative diseases.

In December 2021, Novadiscovery (NOVA), expanded its collaboration with Janssen, to apply its collaborative clinical trial simulation platform, JINKO, to expand the existing lung cancer model to support Janssen’s market access and global medical affairs strategies.

Global In Silico Clinical Trials Market: Key Companies Insights

The global in silico clinical trials market is highly competitive. This is attributed to the increase in demand for safe and effective therapeutics and medical devices, as a result, players in the market are focusing on launching novel products in the market.

Some of the key players in the global in silico clinical trials market are Abzena Ltd., Clarivate, Immunetrics Inc., GNS Healthcare, Dassault Systemes, Evotec, Novadiscovery, Insilico Medicine Inc., and InSilicoTrials Technologies, among others.

*Definition: In silico clinical trials refers to the development of a patient-specific models to form virtual cohorts for testing the safety and efficacy of new drugs and of new medical devices. In silico clinical trials play an important role in the evaluation of new drugs and medical devices.