Biosimulation Market Demand is Set to Grow a CAGR of 14.50% By 2032

The global biosimulation market size is estimated to garner around USD 10.80 billion by 2032 and is expanding at a healthy CAGR of 14.50% from 2023 to 2032.

Key Insights:

• By Product, the software segment has held the largest market share of 66% in 2022.
• By Application, the drug development segment captured the biggest revenue share of 56% in 2022.
• By End User, the Pharmaceutical & biotechnology segment generated over 51% of revenue share in 2022.

The biosimulation market size was valued at USD 2.8 billion in 2022, grew to USD 3.19 billion in 2023. North America led the global market with the major market share of 41% in 2022.

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Biosimulation, a scientific approach, employs computer-based mathematical simulations to replicate and model biological processes, dynamics, and systems. This method enables researchers to make model-based predictions, offering valuable insights into the behavior of biological systems. Through biosimulation, researchers can gather crucial data on natural processes without requiring invasive tests on living organisms, encompassing humans and animals.

Biosimulation predicts drug development failures and trims costs by reducing the need for extensive clinical trials. Pharmaceutical giants like Merck, Pfizer, Novartis, and research firms such as Johnson Pharmaceutical Research & Development use biosimulation services to expedite trials and minimize the financial impact of failures. The rising costs of drug discovery are expected to drive the growth of this market in the coming years.

The biosimulation market holds a significant share in North America, particularly in the United States, driven by a well-established healthcare industry, broad use of advanced technologies in pharmaceutical research and development, and the presence of key industry players. Notably, as of August 8, 2022, the United States was involved in 32% of the global clinical trials, with approximately 134,116 ongoing trials, indicating its vital role in advancing medical research worldwide.

Growth Factors:

• The global biosimulation market is on the rise, driven by a surge in drug relapse cases caused by the resistance of diseases like Tuberculosis, cancer, and bacterial infections. This growth is boosted by increased research and development investments by pharmaceutical companies, a rising need to control drug discovery costs, and an adoption of biosimilars and biologics.
• Regulatory authorities globally are increasingly embracing biosimulation software. However, the upswing in drug discovery investments has also resulted in a higher volume of clinical trials, heightening the risk of failures at various phases.

• The rise in global healthcare spending is set to boost investment in drug development, consequently enhancing revenue for biosimulation. Biosimulation is vital in developing drugs that mimic diseases, using computer-operated simulations to conduct virtual clinical trials for new pharmaceutical treatments. Given the considerable research involved in creating a new medicine, each stage, from clinical trials to drug approval, carries a significant risk of failure. Biosimulation lessens these risks by predicting potential failures during the development process. Moreover, it contributes to cost reduction for pharmaceutical companies by minimizing the need for extensive clinical trials.

• Innovative technologies introduced by leading companies are driving the biosimulation market forward. For instance, in 2022, Certara introduced innovative technology to address challenges in understanding drug discovery and development, especially with complex biologics. Furthermore, the widespread use of biosimulation in healthcare research and development is a significant factor in market growth.

• Biosimulation is advancing across defense, agri-food production, nutraceuticals, and industrial bioprocessing. In defense, it aids in strategic decision-making, while in agri-food production, it optimizes crop yields and resource management. For nutraceuticals, it ensures product efficacy and safety during research and development.
• In industrial bioprocessing, bio-simulation contributes to process optimization. Companies in this sector are strategically expanding their software and services to cater to these diverse applications, utilizing organic growth and strategic partnerships.

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Regional Stance:

In 2022, North America dominated the worldwide biosimulation market and had the most revenue share—more than 41%. The main factors driving the growth of the North American biosimulation market are the rising prevalence of various chronic diseases in the area, rising investments in the adoption of digital and automation technologies, and supportive government policies that encourage the expansion of the pharmaceutical industries. The use of in-silico models is becoming more widespread in the enforcement of regulations that promote patient safety and treatment standardisation.

The U.S. biosimulation market size was valued at USD 0.97 billion in 2022 and is expected to reach USD 3.79 billion by 2032, growing at a CAGR of 14.70% from 2023 to 2032.

In the upcoming years, Asia Pacific is anticipated to grow at the fastest rate. The region is anticipated to witness a swift increase in investments aimed at advancing the healthcare and pharmaceutical sectors. The top pharmaceutical MNCs' increasing FDIs in the region, coupled with the existence of several premier contract research organisations, is propelling the biosimulation market's expansion in the Asia Pacific region. The region's pharmaceutical and healthcare sectors are expanding thanks to the availability of inexpensive production inputs and supportive government regulations, which is anticipated to fuel the expansion of the Asia Pacific biosimulation market.

Biosimulation Market Scope

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Market Potential:

The significant growth in the software segment is driven by the rising use of biosimulation software in pharmaceutical and research organizations, coupled with increased investments in pharmaceutical research and development. For instance, Entelos is a notable provider of simulation software specializing in predictive biosimulation for drug discovery and development. The company offers advanced predictive technologies that reduce the risks, time, and costs associated with healthcare product development. The presence of such companies in the biosimulation software sector is fueling the demand for diverse software, thereby fostering overall market growth.

The increasing investment by various governments in drug research and development is creating a promising opportunity for the biosimulation market. Governments allocate funds to research and development sectors for discovering and evaluating new drugs, mainly due to the rising prevalence of chronic diseases and increased mortality rates, prompting heightened public concern. This heightened concern leads to increased government funding for developing innovative drugs. This substantial government investment presents a lucrative prospect for the biosimulation market in the coming years.

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Industry Spotlight:

• In January 2023, Cellworks, a personalized therapy simulation company, announced the launch of two business units using an in-silico approach to test potential precision oncology drugs in pre-clinical and clinical stages. These services accelerate therapy development and reassess previously studied but unapproved candidates.

• In June 2022, Certara unveiled an updated version of its Immunogenicity, Immuno-Oncology, and Vaccine Simulators. These tools are designed to predict how drugs function, offering insights and solutions for developing innovative biological therapies.

• In June 2022, Genedata AG shared that Syros Pharmaceuticals opted for Genedata AG's Genedata Profiler as its data integration and investigation platform. This choice aims to expedite Syros Pharmaceuticals' pharmaceuticals' translational research strategy.

• In March 2022, Simulation Plus, Inc. introduced Membrane Plus 3.0 software, featuring enhanced data handling and simulation performance. This upgrade benefits in vitro-in vivo extrapolation (IVIVE) for permeability, skin penetration, and release assay systems.

Market Key Players:

• Biovia
• Certara
• Compugen Inc.
• Genedata
• In Silico Biosciences, Inc.
• Leadscope Inc.
• Pharmaceutical Product Development, LLC.
• Schrödinger, LLC.
• Simulations Plus, Inc.
• DassaultSystemes
• Advanced Chemistry Development

Company Synopsis:

Compugen Inc.

Founded in 1981, Compugen Inc. develops and modifies computer software and packaging. In June 2023, Compugen marked a significant milestone by administering the first patient in a proof-of-concept clinical trial. The trial focuses on testing a triple immunotherapy combination of COM701, COM902, and pembrolizumab for the treatment of platinum-resistant ovarian cancer.

Schrodinger Inc.

Schrodinger Inc. is a technology company specialising in software solutions for drug discovery. The company provides a computational platform with predictive modelling, data analytics, and collaboration features tailored for molecular discovery. On July 25, 2023, investment firm Baillie Gifford & Co. increased its stake in Schrödinger, Inc., a prominent developer of a physics-based computational platform for drug development. According to their recent filing with the Securities and Exchange Commission, Baillie Gifford now owns around 3.21% of Schrödinger'sSchrödinger's stock, following the acquisition of 462,993 shares in the first quarter of this year, valued at $60,160,000.

Market Segmentation

By Product

• Software
• Services
  • Contract Services
  • In-House Services

By Application

• Drug Discovery
  • Lead Identification
  • Lead Optimization
  • Target Identification
  • Target Validation
• Drug Development
  • Preclinical Testing and Clinical Trials
  • In Patient Validation
• Others

By End User

• Regulatory Authorities
• Pharmaceutical & Biotechnology Companies
• Contract Research Organizations (CROs)
• Academic Research Institutes

By Delivery Model

• Subscription Models
• Ownership Models

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)

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