Biosimulation Market, By Product and Services (Software (Molecular Modeling and Simulation Software, PBPK Modeling and Simulation Software, PK/PD Modeling and Simulation Software, Trial Prediction Software, and Toxicity Prediction Software), and Services (In-house Services and Contract Services)), By Application (Drug Discovery (Target Identification and Validation and Lead Identification and Optimization),and Drug Development (Preclinical Testing (PK/PD and ADME/TOX) and Clinical Trials)), By End User (Pharmaceutical and Biotechnology Organizations, Contract Research Organization, and Academic Research Institutions), and By Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa) - Trends, Analysis and Forecast till 2034

Biosimulation Market was valued at US$ 3.8 billion in 2024 and is projected to grow at a CAGR of 17% to reach US$ 15.9 billion by 2034.

A significant amount of research and funding go into the creation of a new medication. There is a very high probability of failure at every level of the drug development process, from clinical trials to approval. Through biosimulation, these alterations can be greatly minimized. Because it minimizes the number of clinical trials required, biosimulation not only assists in forecasting the likelihood that a medicine would fail during its development phase but also lowers the expense of any additional failures.

The objective of developing and using computer models that mimic and predict biological processes is driving the rapidly growing subject of biosimulation.

Disclaimer: This data is only a representation. Actual data may vary and will be available in the report.

Biosimulation Market Key Drivers:

• Technological advancements

Biosimulation is becoming more accurate and efficient due to ongoing improvements in modelling methods and processing capacity. Because of this, its use in drug development and other life sciences fields has increased. The creation of more complex and precise biosimulation models is being fueled by the quick advances in artificial intelligence, data storage, and processing capacity. These developments provide us with the previously overlooked research directions by enabling the simulation of intricate biological systems with increased precision and prediction capability. In addition, the increased adoption of biosimulation software by regulatory bodies and the increased financial support by government to promote the adoption of these solutions is significantly fueling the biosimulation market growth.

• Growing expenditures for healthcare

The enormous expense of healthcare is a serious issue for the entire world. In order to reduce total costs, pharmaceutical corporations and research institutions are in a desperate quest for methods to optimize and streamline the drug development process. Biosimulation presents a strong case for cost savings by substituting virtual models for costly animal research and clinical trials.

• Increased demand for biosimilars and biologics

The growing demand for biosimilars in various therapeutic applications like rheumatoid arthritis and blood disorders are the main factors driving growth in the biosimilar market. Also, since there has been little development in the R&D of novel chemical entities, pharmaceutical companies are trying to find new applications for the drugs they already manufacture. Because toxicity and other important aspects of drug safety have been examined earlier, the notion of using pharmaceuticals for a novel indication or condition is confirmed by using biosimulation technology.

Biosimulation Market Restrains:

• Lack of Standardization

Standardization plays a crucial role in the growth and widespread adoption of Biosimulation solutions. It becomes challenging to evaluate and interpret the results of biosimulation when there are no defined criteria for model construction, validation, and reporting. Potential consumers become confused and skeptical as a result, doubting the validity and applicability of the results. Also, the absence of scalable standards for model representation and reuse inhibits the sharing of complex biomedical models problem. The only approach to address this flaw in biosimulation is to provide a standards-based, principled representation model that can accurately and clearly express biosimulation data in a way that is comprehensible to both humans and machines.

• Lack of Regulatory Frameworks

Since biosimulation is a relatively new topic, standards and legal frameworks have not yet been fully developed. The absence of lucidity in the regulatory landscape and its consequences for research or commercial applications may deter prospective users.

Recent Development:

• In July 2023, Simulations Plus, Inc. a leading supplier of modeling and simulation solutions for the pharmaceutical and biotechnology industries, has introduced the development of ADMET Predictor 11, its principal machine learning modeling platform.
• In March 2023, Certara, Inc. announced the launch of Simcyp simulator Version 22, it offers updated features and additional capabilities to the company's population-based modelling and simulation platform. Drug development has demonstrated applications for the Simcyp Simulator, such as first-in-human dosing, extrapolation to specific populations, bio equivalency testing, clinical study design optimization, and drug-drug interactions (DDIs).

• In March 2023, Simulations Plus Inc. and the Sino-American Cancer Foundation (SACF) have formed a strategic research collaboration. This partnership enables the ADMET Predictor software platform's Artificial Intelligence-driven Drug Design (AIDD) technology and Simulations Plus personnel to assist in the identification and creation of new inhibitors for MTHFD2, an emerging cancer target.
• In June 2022, Certara unveiled a new version of biosimulation software, which was revealed for the betterment and advancement of Novel Biologics. The updated version incorporates Immunogenicity (IG), Immuno-Oncology (IO), and Vaccine simulators to help comprehend and forecast drug interactions as well as identify critical issues in the creation of innovative biologic treatments.
• In March 2022, Simulation Plus, Inc. launched its Membrane Plus 3.0 software. The new software offers enhanced data handling and simulation performance for in vitro-in vivo extrapolation (IVIVE) for permeability, skin penetration, and release test devices.

Biosimulation Market is segmented based on Products and services, Application, End user, and region.

Products and Services Insights

• Software: The software segment is a dominating factor in the biosimulation market. The rising use of biosimulation software by pharmaceutical and research organizations, along with the rise in R&D spending in pharmaceutical research, are the main reasons for the software segment's strong growth.
  • Molecular Modeling and Simulation Software: It is used in drug designing to visualise, comprehend, and predict the behaviour of molecules such as proteins and DNA.
  • PBPK Modeling and Simulation Software: PBPK modeling is a computational approach which is described mathematically and helps with dose optimisation and toxicity evaluation by simulating the body's processes for drug and chemical absorption, distribution, metabolism, and excretion (ADME).
  • PK/PD Modeling and Simulation Software: PK/PD Modeling is involved in determination of dosage scheduling and improving clinical trials by forecasting the pharmacokinetic (PK) and pharmacodynamics (PD) profiles of pharmaceuticals.
  • Trial Prediction Software: This software is responsible to reduce costs and failure rates by analysing preclinical data to forecast the clinical trial success of potential drug candidates.
  • Toxicity Prediction Software: This software has the ability to identify potential harmful effects of chemicals and pharmaceuticals before they are tested on humans, thereby increasing safety.
• Services: The services segment is poised to register high growth rate during the forecast period. The segment's rise might be credited to drug development systems that are becoming more intricate and multi-layered, where biosimulation services might become essential. More targeted combination medicines are anticipated to be developed in order to accomplish the previously outlined goals.
  • In-house Services: In-house Services are carried out by research and pharmaceutical companies who have their own software infrastructure and biosimulation experience.
  • Contract Services: Contract services are provided by specialized businesses that charge clients for biosimulation software and expertise. This lowers the initial cost of accessing biosimulation technologies for smaller organizations.

Application Insights

• Drug Discovery: Drug discovery segment is expected to register continuous growth throughout the forecast period. The segment is developing in addition to the growing use of biosimulation in fields like pharmacogenomics and pharmacogenetics. 

• Target Identification and Validation: This involves identification of promising therapeutic targets and the evaluation of their potential efficacy before funding in research projects.
• Lead Identification and Optimization: It involves techniques for virtual screening and simulation to speed up the process of finding and enhancing promising lead drug candidates for further research.

• Drug Development: Drug development is a dominating segment and is growing as a result of an increasing number of government programmes encouraging the use of cutting-edge software.

• Preclinical Testing: Preclinical testing helps in anticipating drug behaviour and possible safety issues. Also, biosimulation streamlines and ethically enhances preclinical development, hence reducing reliance on animal testing.
  • PK/PD:  PK/PD involves the computer models to simulate and forecast a drug's Pharmacokinetics (PK) and Pharmacodynamics (PD) behaviour inside the body.
  • ADME/TOX: ADME/TOX involves the use of biosimulation models to anticipate ADME/TOX features beforehand, which helps them detect possible problems before investing time and money on costly in vitro or in vivo trials.
• Clinical Trials: It involves prediction of possible adverse effects, optimizes dosage schedules, and informs clinical trial design. Simulation models also enhances patient safety and efficiency.

End User Insights

• Pharmaceutical & Biotechnology Organizations: Pharmaceutical and biotechnology companies have the largest market share due to factors like, increased use of computer modelling approaches, increase in research and development activities and rise in demand for personalized medicines.
• Contract Research Organizations (CROs): CROs segment is anticipated to grow at the fastest rate during the forecast period. The usage of biosimulation in CROs will also be influenced by elements like improved productivity and the capacity to concentrate on key business development areas. The increasing tendency of businesses to cut overall expenditure is expected to accelerate the segment's growth.
• Academic Research Institutions: Academic Research Institutions use biosimulation models to promote personalized treatment, disease modelling, and fundamental research.

Regional Insights:

Disclaimer: This data is only a representation. Actual data may vary and will be available in the report.

Biosimulation Market Regional Insights

• North America market is estimated to witness a significantly high revenue share over the forecast period, owing to the presence of important players, the escalation of healthcare digitization, and the rise in the frequency of long-term health problems. Additionally, the regional market has grown as a result of the use of in-silico models during the implementation of regulations to guarantee high patient safety and treatment standards.
• Asia Pacific market is estimated to witness fastest revenue share due to increase in CROs, a notable rise in healthcare IT expenditure, and the expansion of developing nations' healthcare infrastructure. Additionally, continuous advancements in healthcare infrastructure and a rise in R&D endeavors in emerging nations are anticipated to propel the biosimulation market.
• Europe market is expected to show growth due to increased frequency of chronic illnesses, which has sparked research, development, and drug discovery efforts in the region. The region's rising cancer incidences also fuel the market's expansion, since biosimulation software is needed to produce new medications.
• Latin America market is expected to hold immense potential for development in the region due to increase in healthcare costs, rise in government initiatives, and growing pharmaceutical industries.
• Middle East & Africa market is predicted to have positive growth for the target market and has the potential to have a big impact on drug development, healthcare, and other industries in the area with continuing efforts to solve problems and seize possibilities.

Report Scope:

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2024 to 2034. For the purpose of this study, has segmented the Biosimulation Market report based on Product and services, Application, End User and Region:

Biosimulation Market, By Product and Services:

• Software

• Molecular Modeling and Simulation Software
• PBPK Modeling and Simulation Software
• PK/PD Modeling and Simulation Software
• Trial Prediction Software
• Toxicity Prediction Software

• Services

• In-house Services
• Contract Services

Biosimulation Market, By Application:

• Drug Discovery

• Target Identification and Validation
• Lead Identification and Optimization

• Drug Development

• Preclinical Testing
  • PK/PD 
  • ADME/TOX
• Clinical Trials

Biosimulation Market, By End User:

• Pharmaceutical and Biotechnology Organizations
• Contract Research Organization
• Academic Research Institutions

Biosimulation Market, By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Russia
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The key players operating the Biosimulation  Market includes, Simulations Plus, Inc., Certara L.P., Genedata AG, Compugen Inc., ACD/Labs, Chemical Computing Group, In Silico Biosciences, Dassault Systemes (Accelrys), LeadScope Inc., and Schrödinger, Inc.

• Simulations Plus, Inc.
  • Company Overview
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Business Strategies

• Certara, L.P.
• Genedata AG
• Compugen Inc.
• ACD/Labs
• Chemical Computing Group
• In Silico Biosciences
• Dassault Systemes (Accelrys)
• LeadScope Inc.
• Schrödinger, Inc.

“*” marked represents similar segmentation in other categories in the respective section

Research Objective and Assumption

• Preface
• Research Objectives
• Study Scope
• Years Considered for the study
• Assumptions
• Abbreviations

Research Methodology

• Research data
• Primary Data
  • Primary Interviews
  • Primary Breakdown
  • Key data from Primary Sources
  • Key Thickness Insights
• Secondary Data
  • Major Secondary Sources
  • Secondary Sources
• Market Estimation
• Top-Down Approach
  • Approach for estimating Market Share by Top-Down Analysis (Supply Side)
• Bottom-Up Approach
  • Approach for estimating market share by Bottom-up Analysis (Demand Side)
• Market Breakdown and Data Triangulation
• Research Assumptions

Market Preview

• Executive Summary
• Key Findings—Global Outlook for medical carts Strategies
  • Key Questions this Study will Answer
  • Market Snippet, By Product and services
  • Market Snippet, By Application
  • Market Snippet, By End User
  • Market Snippet, By Region
• Opportunity Map Analysis
• Executive Summary—3 Big Predictions

Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Drivers
  • Restrains
  • Market Opportunities
  • Market Trends
• DR Impact Analysis
• PEST Analysis
• Porter’s Five Forces Analysis
• Opportunity Orbit
• Market Investment Feasibility Index
• Macroeconomic Factor Analysis

Biosimulation Market, By Product and services, Forecast Period up to 10 Years, (US$ Mn)

• Overview
  • Market Value and Forecast (US$ Mn), and Share Analysis (%), Forecast Period up to 10 Years
  • Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
  • Segment Trends
• Software (Molecular Modeling and Simulation Software, PBPK Modeling and Simulation Software, PK/PD Modeling and Simulation Software, Trial Prediction Software, and Toxicity Prediction Software)
  • Overview
  • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Services (In-house Services and Contract Services)
  • Overview
  • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), Forecast Period up to 10 Years

Biosimulation Market, By Application, Forecast Period up to 10 Years, (US$ Mn)

• Overview
  • Market Value and Forecast (US$ Mn), and Share Analysis (%), Forecast Period up to 10 Years
  • Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
  • Segment Trends
• Drug Discovery (Target Identification and Validation and Lead Identification and Optimization)
  • Overview
  • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Drug Development (Preclinical Testing (PK/PD and ADME/TOX) and Clinical Trials)
  • Overview
  • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), Forecast Period up to 10 Years

Biosimulation Market, By End User, Forecast Period up to 10 Years, (US$ Mn)

• Overview
  • Market Value and Forecast (US$ Mn), and Share Analysis (%), Forecast Period up to 10 Years
  • Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
  • Segment Trends
• Pharmaceutical
  • Overview
  • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Biotechnology Organizations
  • Overview
  • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Contract Research Organization
  • Overview
  • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Academic Research Institutions
  • Overview
  • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), Forecast Period up to 10 Years

Biosimulation Market, By Region, Forecast Period up to 10 Years, (US$ Mn)

• Overview
  • Market Value and Forecast (US$ Mn), and Share Analysis (%), Forecast Period up to 10 Years
  • Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
  • Regional Trends
• North America
  • Market Size and Forecast (US$ Mn), By Product and services, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Application, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By End User, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Country, Forecast Period up to 10 Years
    • U.S.
    • Canada
• Europe
  • Market Size and Forecast (US$ Mn), By Product and services, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Application, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By End User, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Country, Forecast Period up to 10 Years
    • UK
    • France
    • Germany
    • Russia
    • Italy
    • Rest of Europe
• Asia Pacific
  • Market Size and Forecast (US$ Mn), By Product and services, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Application, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By End User, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Country, Forecast Period up to 10 Years
    • India
    • Japan
    • South Korea
    • China
    • Rest of Asia Pacific
• Latin America
  • Market Size and Forecast (US$ Mn), By Product and services, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Application, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Distribution Channel, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Country, Forecast Period up to 10 Years
• Brazil
• Mexico
• Rest of Latin America

• Middle East & Africa
  • Market Size and Forecast (US$ Mn), By Product and services, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Application, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By End User, Forecast Period up to 10 Years
  • Market Size and Forecast (US$ Mn), By Country, Forecast Period up to 10 Years
• GCC
• Israel
• South Africa
• Rest of Middle East

Competitive Landscape

• Heat Map Analysis
• Market Presence and Specificity Analysis

Company Profiles

• Simulations Plus, Inc.
  • Company Overview
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Business Strategies
• Certara, L.P.
  • Company Overview
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Business Strategies

• Genedata AG
  • Company Overview
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Business Strategies

• Compugen Inc
  • Company Overview
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Business Strategies
• ACD/Labs
  • Company Overview
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Business Strategies
• Chemical Computing Group
  • Company Overview
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Business Strategies
• In Silico Biosciences
  • Company Overview
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Business Strategies
• LeadScope Inc
  • Company Overview
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Business Strategies

The Last Word

• Future Impact
• About Us
• Contact