United States Biosimulation Market Size, Share, and COVID-19 Impact Analysis, By Product (Software and Services), By Application (Drug Discovery & Development, Disease Modeling, and Other), and United States Biosimulation Market Insights, Industry Trend, Forecasts to 2035

United States Biosimulation Market Insights Forecasts to 2035

• The US Biosimulation Market Size Was Estimated at USD 1765.7 Million in 2024
• The Market Size is Expected to Grow at a CAGR of around 16.39% from 2025 to 2035
• The US Biosimulation Market Size is Expected to Reach USD 9376.5 Million by 2035

According to a research report published by Spherical Insights & Consulting, the United States Biosimulation Market is anticipated to reach USD 9376.5 million by 2035, growing at a CAGR of 16.39% from 2025 to 2035. The expansion of the United States biosimulation market is propelled by the rising number of cases of drug relapse brought on by treatment resistance in conditions including cancer, TB, and other bacterial illnesses.

Market Overview

Biosimulation, also known as model-based or in silico simulation, is the computer-assisted mathematical modelling of biological systems and processes, encompassing whole-organism physiology as well as molecular, cellular, and organ-level dynamics. The market has the potential to grow rapidly due to renewed interest in personalising treatment. There is an increasing demand for tools to model patient-specific responses to medicines as system-wide healthcare processes strive towards more individualised treatment approaches. Biosimulation can be used to build complex models for individual genetic diversities so that researchers can predict how various patients will respond to specific medications or treatment regimens. The ability to customise medicines to an individual patient's profile improves therapeutic efficacy and decreases side effects. Technological advancements create opportunities for virtual clinical trials, which offer pharmaceutical companies a faster and less expensive alternative to traditional ways of conducting clinical trials. 

In the United States, several government agencies have advocated for the use of biosimulation, or in-silico modelling, to expedite medication development and regulation. With the Model-Informed Drug Development (MIDD) pilot program (2018–2022) and more recent efforts under PDUFA VI, the FDA is integrating biosimulation into choices about dose, safety, and trial design.

Report Coverage

This research report categorizes the market for the United States biosimulation market based on various segments and regions and forecasts revenue growth and analyses trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the United States biosimulation market. Recent market developments and competitive strategies such as expansion, product launch, development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the United States biosimulation market.

Driving Factors

The growth of the United States biosimulation market is boosted by helping researchers to evaluate numerous parameters and estimate physiological responses to therapeutics without having to rely on human studies. This may enable the identification of safer and more effective drugs and may create opportunities for entirely new therapies. It is increasingly being employed by the pharmaceutical industry to improve our understanding of human body complexity, improve clinical outcomes, and mitigate the risks and costs of developing medicines. Biosimulation is another important element in improving the efficiency and speed of the drug discovery process by providing information regarding drug interactions, to spur on the enormous growth in the drug discovery landscape.

Restraining Factors

The United States biosimulation market faces obstacles like limited knowledge regarding disease pathophysiology. In addition, there is significant concern regarding the variation both within and between patient populations of the disease. Those challenges may inhibit the universal use and success of biomimetic models in drug research because they complicate the ability for them to accurately replicate human diseases.

Market Segmentation

The United States biosimulation market share is classified into product and application.

• The software segment held the largest market share in 2024 and is expected to grow at a remarkable CAGR during the forecast period.

The United States biosimulation market is segmented by product into software and Services. Among these, the software segment held the largest market share in 2024 and is expected to grow at a remarkable CAGR during the forecast period. The segment is driven by the proliferation of software designed for specific applications addressing specific R&D needs. Rhenovia Pharma is one business in the drug development industry that specialises in simulating the mechanism of CNS-specific drugs.

• The drug discovery & development segment held the highest revenue share in 2024 and is expected to grow at a significant CAGR during the forecast period.

Based on the application, the United States biosimulation market is segmented into drug discovery & development, disease modeling, and other. Among these, the drug discovery & development segment held the highest revenue share in 2024 and is expected to grow at a significant CAGR during the forecast period. The segmental growth is propelled by the increase in the number of approaches to developing medications. Currently, there are more than 8,000 medications under development. Drug development relies on the use of biosimulation software to allow scientists to develop complex models of biological systems.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the United States biosimulation market, along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborate analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Immunetrics
• Rosa & Co
• Schrodinger Inc Ordinary Shares
• Simulations Plus Inc
• Certara Inc Ordinary Shares
• Simulations Plus, Inc.
• Evidera
• In Silico Biosciences, Inc. 
• Dassault Systèmes
• Advanced Chemistry Development
• Others

Recent Development

• In October 2024, Certara acquired ChemAxon, a leading provider of cheminformatics software. This acquisition helped Certara enhance its drug discovery and development capabilities by integrating ChemAxon's advanced molecular modeling and data analysis tools.

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Market Segment

This study forecasts revenue at the United States, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the United States biosimulation market based on the following segments:

United States Biosimulation Market, By Product

• Software
• Services

United States Biosimulation Market, By Application

• Drug Discovery & Development
• Disease Modeling
• Other