Global Biosimulation Market- By Component (Software and Services), By Application (Drug Development, Drug Discovery, and Other Applications), By Delivery Mode (Ownership Models and Subscription Models), By End-User (Contract Research Organizations (CROs), Regulatory Authorities, Biotech Companies, Pharma Companies, and Other End Users), By Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends, and Forecast 2023-2032

Report Overview

In 2022, the Global Biosimulation Market was valued at USD 2.9 Billion and expected to grow USD 10.1 Billion in 2032. Between 2023 and 2032, this market is estimated to register a CAGR of 13.7%.

Biosimulation is a technique in which computer programs simulate biological processes. In drug discovery and new drug development, biosimulation has numerous uses. Biosimulation is a tool for prediction, and it is used to predict the future outcomes of current drug discovery and development experiments.

Drug discovery and development is costly, and a drug molecule failure in the late stages of development results in a significant waste of time, money, and other resources. As a result, a predictive tool that can simulate the biological processes involved in drug development to help predict future outcomes is needed. This is the most significant driver of the global biosimulation market. The biosimulation market is also supported by the creation of cutting-edge software, rising healthcare costs, and improved simulation-related technology.

*Actual Numbers Might Vary In The Final Report

Key Takeaways

• Revolutionizing Drug Development: Biosimulation Market has taken on an immense role in revolutionizing drug development by using computer models to simulate biological and physiological processes that speed up drug discovery and development processes.
• Biosimulation in Personalized Medicine: Biosimulation is an integral component of personalized medicine, permitting physicians to simulate individual patient responses to drugs for more personalized treatments plans and more effective therapies.
• Reducing R&D Costs: One of the major impacts of biosimulation market is to lower research and development costs by conducting virtual trials and experiments instead of costly, time-consuming physical ones.
• Enhancing Drug Safety: Biosimulation assists drug development teams by accurately anticipating adverse drug reactions and safety concerns in early development stages, thus increasing patient safety while decreasing postmarket withdrawal risks. This ensures optimal patient protection with reduced withdrawal risks post market.
• Optimizing Clinical Trial Designs: Biosimulation can enhance clinical trial designs by selecting promising drug candidates and treatment regimens; thus resulting in more successful trials overall.

Driving Factors

A Rise in R&D Investments, Reduction in Development Costs, and Other factors are Responsible for Driving the Market.

The biosimulation market is anticipated to expand during the forecast period due to increased R&D investments in the pharmaceutical and biotechnology industries, regulatory bodies’ increased use of biosimulation software, and technologically advanced QSP systems.

The biosimulation market is estimated to be driven by the need to reduce drug discovery and development costs and the expansion of the biologics and biosimilar markets.

The market has been further influenced by the increased funding provided by the federal government to encourage the use of these solutions. The biosimulation market also benefits from advancements in healthcare infrastructure, rising healthcare spending, and strong demand for expanded care delivery.

Restraining Factors

The Lack of Standardization

Due to the lack of standardization in the field of biosimulation, it was becoming difficult to compare the results from different studies. Thus, it is challenging to interpret and validate the simulation results. This will hindered the growth of the market as it will limit its use and adoption. Additionally, The high cost of biosimulation process mainly in the advanced computational methods or software will limit the adoption of biosimulation specially by acoademic institutions or small companies with limited fund.

Growth Opportunities

The Expanding Applications and Increased Use of Personalized Medicine

The biosimulation market will have additional opportunities to expand in the coming years due to the growing use of biosimulation solutions and personalized medicine for the development of pediatric drugs. The expanding fields of defense, nutraceuticals, agri-food production, industrial bioprocessing, and biosimulation present significant growth opportunities for the global biosimulation market.

To develop the applications of their biosimulation software & services, a number of biosimulation companies are utilizing both organic and inorganic growth strategies. Certara collaborated with the Australian Department of Defense. The Certara d3 medicine company was chosen to carry out a national audit to examine the capabilities of Australian medical countermeasures (MCM) products in terms of R&D.

Component Analysis

The Software Segment Dominated the Market with The Largest Revenue Share

With the highest revenue share, the software sector dominated the market. This is because there are a lot of application-specific software products on the market that meet specific needs for R&D. Software developed by Rhenovia Pharma, for instance, simulates the mechanism of CNS-specific drugs. Software and services constitute the product segment.

The services sector is expected to experience the highest CAGR during the forecast period. Biosimulation services may prove crucial in increasingly multilayered and complex drug development systems responsible for the segment’s expansion. It is anticipated that new, more precise combination therapies will be developed to accomplish the abovementioned factors.

A wide range of services that simplify the entire drug discovery and development process is provided by key players. Phoenix Technology Services, a collection of biosimulation services used to make data transfer easier, improve R&D productivity, and create protocols for regulatory submission, was launched by Certara.

Application Analysis

Drug Development Segment Held the Largest Market Share

The market’s highest revenue share belonged to drug development. The segment is expanding due to increasing government initiatives encouraging the use of advanced software. The FDA’s critical path initiative report suggests that this strategy can be incorporated as an effective predictive tool and emphasizes its significance for drug development. The application segment comprises drug development, drug discovery, and other activities.

Drug discovery is expected to exhibit the highest CAGR during the forecast period. The segment’s expansion is supplemented by the growing use of biosimulation in fields like pharmacogenetics and pharmacogenomics.

Delivery Mode Analysis

The Ownership Models Segment Is Expected to Dominate the Market During the Forecast Period

The biosimulation market is segmented into subscription models and ownership models. During the forecast period, the market is expected to be dominated by ownership models. The primary factor responsible for the segment’s expansion is that buyers primarily select these delivery models for their security advantages.

End-User Analysis

Pharmaceutical and Biotechnology Companies Accounted for A Revenue Share

Pharmaceutical and biotechnology companies had the largest revenue share of the market. The constant efforts of key companies to extend the lifecycles of discovering drug variants and off-patent drugs through computer modeling can be credited with the strong demand for biosimulation in these businesses. The end-user segment comprises contract research organizations, regulatory authorities, biotech companies, and pharma companies.

During the forecast period, the CROs sector is anticipated to expand at the fastest rate. The market is expected to grow quicker as businesses tend to reduce overall spending. Other factors include increased flexibility and productivity to concentrate on core development areas essential to a company’s growth.

Key Market Segments

Based on Component

• Software
• Molecular Modeling and Simulation
• PBPK Modeling and Simulation
• PK/PD Modeling and Simulation
• Toxicity Prediction
• Other Software
• Services
• In-house Services
• Contract Services

Based on Application

• Drug Development
• Drug Discovery
• Other Applications

Based on The Delivery Mode

• Ownership Models
• Subscription Models

Based on End-User

• Contract Research Organizations (CROs)
• Regulatory Authorities
• Biotech Companies
• Pharma Companies
• Other End Users

Regional Analysis

North America Dominates the Global Biosimulation Market During the Forecast Period

In 2022, North America held the largest revenue share of over 46.0%. The growing digitization in the healthcare industry, the presence of key players, and rising rates of chronic health conditions are all responsible for this expansion. In addition, the regional market is expanding as in-silico models enforce regulatory policies to guarantee high patient treatment and safety standards.

Due to increasing initiatives by the private and public sectors and consistent improvement of healthcare infrastructure, Asia Pacific is expected to experience exponential growth over the forecast period. Additionally, the region benefits greatly from the burgeoning R&D activities in emerging economies. Certara opened a new office in Shanghai, China. As a result of this, the business was able to strengthen its relationship with customers in the rapidly expanding Chinese biopharmaceutical market.

Key Regions

• North America
  • The US
  • Canada
  • Mexico
• Western Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Portugal
  • Ireland
  • Austria
  • Switzerland
  • Benelux
  • Nordic
  • Rest of Western Europe
• Eastern Europe
  • Russia
  • Poland
  • The Czech Republic
  • Greece
  • Rest of Eastern Europe
• APAC
  • China
  • Japan
  • South Korea
  • India
  • Australia & New Zealand
  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Colombia
  • Chile
  • Argentina
  • Costa Rica
  • Rest of Latin America
• Middle East & Africa
  • Algeria
  • Egypt
  • Israel
  • Kuwait
  • Nigeria
  • Saudi Arabia
  • South Africa
  • Turkey
  • United Arab Emirates
  • Rest of MEA

Key Players Analysis

Simulation Plus Partnered with A Pharmaceutical Company to modify the GastroPlus Advanced Compartmental Absorption and Transit (ACAT) Model

Significant players used competitive sustainability strategies to increase their market share, like expanding their geographical presence and product development. Market leaders also focus on satisfying unmet needs and creating economic value through regular product enhancements. In support of ongoing programs for treating gastrointestinal diseases, Simulation Plus, for instance, modified the GastroPlus Advanced Compartmental Absorption and Transit (ACAT) model in collaboration with a pharmaceutical company.

A few prominent players in the market are Compugen Inc., Silico Biosciences, Inc., Insilico Biotechnology AG, Leadinvent Technologies, Cellworks Group Inc., Leadscope Inc., Schrodinger Inc., Simulation Plus Inc., LeadScope, Inc., and others.

Listed below are some of the most prominent global biosimulation market players.

Market Key Players

• Simulation Plus, Inc.
• Physiomics Plc
• Rosa & Co. LLC
• Dassault Systèmes SE
• Instem Group of Companies
• Schrödinger, Inc.
• Genedata AG
• BioSimulation Consulting Inc.
• Other Key Players.

Key Industry developments

• In June 2022– Certara released a new version of its Biosimulation software to advance novel biologics. Immuno-Oncology, Immunogenicity, and Vaccine Simulators are included in the latest version to help people predict and comprehend how drugs work and identify the most important questions regarding the creation of novel biologic therapies.
• In March 2022– Simulation Plus, Inc. released the software known as Membrane Plus 3.0 for skin penetration, permeability, and release assay systems; the new software has improved simulation performance and data handling for in vitro-in vivo extrapolation (IVIVE).

Report Scope