The Global biosimulation market was valued at $1.3 billion in 2022 and is projected to reach $4.9 billion by 2030, growing at a CAGR of 20.1% during the forecast period.

The increasing adoption of biosimulation in drug development, growing demand for personalized medicine, and rising R&D spending in the pharmaceutical and biotechnology industries are some of the key factors driving the market growth.

The global biosimulation market is a rapidly growing sector that involves the use of computational tools and techniques to simulate biological and physiological processes. Biosimulation is widely used in the pharmaceutical and biotechnology industries to accelerate drug discovery and development, reduce costs, and minimize the risks associated with clinical trials.

North America is currently the largest market for biosimulation, followed by Europe and Asia-Pacific. The presence of a well-established healthcare infrastructure, favorable government initiatives, and a high level of awareness about the benefits of biosimulation are some of the factors driving the growth of the biosimulation market in these regions.

The major players operating in the global biosimulation market include Certara, Dassault Systèmes SA, Simulations Plus, Inc., Schrödinger, LLC, Genedata AG, Physiomics PLC, InSilico Biotechnology AG, and Evidera, Inc. These companies are focusing on strategic collaborations and partnerships to expand their product offerings and increase their market share.

Market Dynamics

Driving Factors

There are several driving factors that are contributing to the growth of the global biosimulation market. These include:

Advancements in technology: The continuous advancements in technology have led to the development of more sophisticated and accurate biosimulation tools and techniques. This has made it easier for researchers and scientists to simulate complex biological processes, which is driving the growth of the market.

Increasing prevalence of chronic diseases: The rising prevalence of chronic diseases such as cancer, diabetes, and cardiovascular diseases is driving the demand for new and effective treatments. Biosimulation offers a faster and more efficient way to identify potential drug candidates, which is driving its adoption in the pharmaceutical and biotechnology industries.

Restraining Factors

The global biosimulation market is expected to grow significantly in the coming years, driven by the increasing demand for efficient drug development and personalized medicine. However, there are several restraining factors that could limit the growth of the biosimulation market. Some of these factors include:

Lack of standardization: There is currently no standardization of biosimulation methodologies, which can lead to inconsistencies in simulation results. This can be a major concern for regulatory agencies, as well as for companies that rely on biosimulation for drug development.

Data availability and quality: Biosimulation requires large amounts of high-quality data, which can be difficult to obtain. This can limit the accuracy and reliability of simulation results, which can in turn limit the adoption of biosimulation technology.

Ethical concerns: Biosimulation involves the use of biological data and models, which can raise ethical concerns related to privacy, data ownership, and consent. These concerns can limit the availability and use of biological data for biosimulation.

Challenges

The global biosimulation market faces a number of challenges that could impact its growth and development. Some of these challenges include:

Regulatory and ethical challenges: Biosimulation models are subject to regulatory and ethical constraints, which can limit their development and use. For example, the use of biosimulation in drug development requires validation and verification of the models, which can be time-consuming and expensive.

Business challenges: The biosimulation market is highly competitive, with many companies offering similar products and services. Companies need to differentiate themselves and demonstrate the value of their products and services to attract customers.

Education and training challenges: Biosimulation requires specialized knowledge and skills, which can be difficult to acquire. There is a need for education and training programs to develop a skilled workforce capable of developing and using biosimulation models effectively.

Opportunity Factors

The global biosimulation market presents a number of opportunities for growth and development. Some of these opportunities include:

Emerging markets: Emerging markets such as Asia Pacific and Latin America present significant opportunities for growth in the biosimulation market. The increasing demand for healthcare, rising investments in research and development, and improving infrastructure are driving the growth of the biosimulation market in these regions.

Regulatory support: Regulatory bodies such as the FDA and EMA are recognizing the potential of biosimulation technology and are supporting its adoption in drug development. This regulatory support is helping to validate the use of biosimulation technology and increasing its acceptance among industry stakeholders.

Segmentation Analysis

Product Outlook

Software is a key product category in the biosimulation market. It includes a range of software tools and platforms that enable the development, simulation, and analysis of biological models. Examples of biosimulation software products include Simcyp, GastroPlus, and Dassault Systèmes BIOVIA.

In-house vs. outsourcing can be developed and used in-house by pharmaceutical companies and research organizations, or they can be outsourced to specialized service providers. In-house biosimulation products typically require significant investments in software, hardware, and personnel, while outsourcing allows companies to access biosimulation expertise and resources without the need for significant upfront investments.

Biosimulation products require ongoing support and maintenance to ensure that they remain up-to-date and functional. Support and maintenance services may include technical support, software updates, and hardware repairs.

Application Outlook

Drug development is the largest user of biosimulation technology, where it is used to develop and optimize drug candidates. Biosimulation can help predict drug efficacy, toxicity, and pharmacokinetics in humans, thereby reducing the time and cost of drug development. This segment includes applications such as pharmacokinetic modeling, pharmacodynamic modeling, and toxicity prediction.

Food science is used in food science to optimize food processing and preservation methods, as well as to predict the impact of changes in ingredients, processing conditions, and packaging on the quality and safety of food products.

Other applications is also used in other application areas such as cosmetics, consumer goods, and biomanufacturing.

Drug development is the largest and most established application segment in the biosimulation market, accounting for a significant portion of the total market revenue. However, other application segments such as agriculture and environmental science are growing in importance as the use of biosimulation technology expands. The choice of application segment depends on the specific needs and priorities of the organization, as well as the availability of data and expertise in the relevant area.

Regional Analysis

North America is the largest market for biosimulation, with the US being the dominant country in the region. The growth of the biosimulation market in North America is driven by the high demand for drug development and the presence of leading pharmaceutical companies in the region.

Europe is a significant market for biosimulation, with countries such as Germany, France, and the UK being major contributors to the growth of the market. The growth of the biosimulation market in Europe is driven by the increasing investments in research and development and the high adoption of biosimulation technology in drug development.

Asia Pacific is the fastest-growing market for biosimulation, with countries such as China, India, and Japan being major contributors to the growth of the market. The growth of the biosimulation market in Asia Pacific is driven by the increasing demand for personalized medicine, rising investments in research and development, and the increasing adoption of biosimulation technology in drug development.

The Global Biosimulation Market has been segmented into:

By Product

• Software
• Services
• In-house Services
• Contract Services

By Application

• Drug Development
• Drug Discovery
• Others

By Delivery Model

• Subscription Models
• Ownership Models

By End-use

• Pharmaceutical & Biotechnology Companies
• CRO
• Regulatory Authorities
• Academic Research Institutions

Market Players 

The global Biosimulation market is highly competitive and fragmented, with numerous players vying for market share. Some of the key companies in the market are:

• Certara, USA
• Dassault Systems
• Advanced Chemistry Development
• Simulation Plus
• Schrodinger, Inc.
• Chemical Computing Group ULC
• Physiomics Plc
• Rosa & Co. LLC
• BioSimulation Consulting Inc.
• Genedata AG
• Instem Group of Companies
• PPD, Inc.
• Yokogawa Insilico Biotechnology GmbH
• Immunetric

Certara is a leading provider of biosimulation software and services for drug development, with a comprehensive suite of modeling and simulation tools. Simulations Plus is a leading provider of modeling and simulation software for pharmaceutical and biotechnology companies.

Dassault Systemes is a leading provider of 3D modeling and simulation software, including biosimulation software for drug development. Schrodinger is a leading provider of computational chemistry software and services, including biosimulation software for drug discovery and development.

Genedata is a leading provider of data management and analysis software for the life sciences industry, including biosimulation software for drug development. Physiomics is a specialist provider of biosimulation software and services for the pharmaceutical and biotechnology industries.

InSilico Biotechnology is a leading provider of biosimulation software and services for the biotechnology industry. Evidera is a leading provider of real-world evidence and biosimulation services for the life sciences industry.

Strategic Developments

In February 2021, Certara acquired the biosimulation company, XenologiQ, to expand its capabilities in rare disease drug development.

In September 2020, Schrodinger raised $346.5 million in an initial public offering (IPO) to fund its growth and development of its biosimulation software and services.

In May 2020, the French company, Dassault Systemes, acquired Medidata, a clinical software company, for $5.8 billion to expand its offerings in the life sciences industry.

In November 2019, Simulations Plus acquired Lixoft, a provider of biosimulation software for the pharmaceutical industry, to expand its capabilities in pharmacometrics.

In August 2019, the UK-based biotechnology company, Optibrium, raised $2.9 million in funding to further develop its biosimulation software for drug discovery and development.

In March 2019, Certara acquired the biosimulation company, Analytica Laser, to expand its capabilities in personalized medicine and drug development.