Biosimulation Market Size, Share, Industry, Forecast and outlook (2024-2031)

Biosimulation Market is Segmented By Product (Software, Molecular Modeling and Simulation Software, PK/PD Modeling and Simulation Software, PBPK Modeling and Simulation Software, Trial Design Software, Toxicity Prediction Software, Others, In-house Services, Contract Services), By Application(Preclinical and Clinical Drug Development, Drug Discovery, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030.

Biosimulation Market is expected to reach  at a CAGR 15.9% during the forecast period (2023-2030). Biosimulation is the simulation of biological processes using a computer program. Biosimulation technology has a wide range of applications in drug discovery and development. It is a predictive tool used in the discovery stage to predict the outcomes of current experimental trials.

Biosimulation Market Scope

To Know More: Download Sample

Biosimulation Market Dynamics

Due to their cost-effectiveness, rising incidence of various diseases, an increasing number of off-patented drugs, positive outcomes in ongoing clinical trials, and rising demand for biosimilars in different therapeutic applications such as rheumatoid arthritis and blood disorders are all driving growth in the global biosimilars market. Pharmaceutical companies are attempting to identify new applications for their existing pharmaceuticals due to the lack of success in the R&D of novel chemical entities. Biosimulation technologies are used to confirm the notion of employing the pharmaceuticals for a novel indication or disease, as toxicity and other critical characteristics of drug safety have already been verified.

Increasing  global healthcare expenditure is supporting the growth of the market

Over the projected period, the biosimulation market is expected to benefit from increasing global healthcare spending. Increased healthcare expenditures are projected to increase spending on drug discovery, which will drive revenue earned by biosimulation solutions. Drugs to mimic diseases are currently being developed using biosimulation software. Virtual clinical trials for new pharmaceutical medications can be undertaken using computers running illness simulations with the help of biosimulation software. According to the US Centers for Medicare & Medicaid Services, healthcare spending in the United States climbed 4.6 percent in 2019 to $3.8 trillion, or $11,582 per person, accounting for 17.7% of the country's GDP. As a result, the rise in healthcare spending propels the biosimulation industry forward.A new drug's development necessitates a significant quantity of study and resources. Every stage of the medication development process, from clinical trials through approval, has a significant risk of failure. Biosimulation can considerably lower these odds. Biosimulation not only aids in the prediction of medication failure throughout the development phase, but it also lowers the expense of any other potential failures by reducing the number of clinical trials required.

Furthermore, a new drug's development necessitates a significant quantity of study and resources. Every stage of the medication development process, from clinical trials through approval, has a significant risk of failure. Biosimulation can considerably lower these odds. Biosimulation not only aids in the prediction of medication failure throughout the development phase, but it also lowers the expense of any other potential failures by reducing the number of clinical trials required. Pharmaceutical companies (such as Pfizer, Merck, Novartis, and Johnson Pharmaceutical Research & Development) and research firms (such as Johnson Pharmaceutical Research & Development) have been using biosimulation software and service providers to reduce the length of trials and the high costs associated with failures. The high cost of development and drug discovery is expected to drive this market's rapid growth in the coming years.This contributes to the growth of the global biosimulation  market.

Lack of standardization is likely to hamper the market growth

Biosimulation captures and processes various aspects of biological processes using various models, tools, and languages. Current modeling methods fail to capture the fundamental semantics of biosimulation models, making it difficult to construct, reuse, compose, and merge diverse, complicated biosimulation models. In silico or biosimulation technology in the drug research or development process has yet to be standardized by regulatory agencies. Biomedical researchers' computing power for constructing and operating sophisticated biosimulation systems has increased due to recent technology developments. On the other hand, researchers are finding it more difficult to communicate, manage, and change their models as their models and simulations become more complicated. The lack of scalable standards for the model representation and reuse exacerbates the challenge of sharing sophisticated biomedical models. As a result, many model developers cannot exchange and construct new models based on existing models. This weakness of biosimulation can only be addressed by developing a systematic, standards-based representation model that can unambiguously express biosimulation data in both human and machine-readable formats. As a result, the biosimulation community desperately needs tools to help them construct, manage, and reuse their models more efficiently.

COVID-19 Impact Analysis On Biosimulation Market

The global biosimulation market is predicted to be unaffected by the onset of the novel COVID-19 pandemic. Despite the COVID-19 issue, research and development operations are set to continue apace as researchers and medical specialists investigate the potential of biosimulation to stop the spread of the novel coronavirus. As a result, the need for biosimulation solutions and platforms is expected to continue to rise.

Biosimulation Market Segmentation Analysis

The software segment is expected to grow at the fastest CAGR during the forecast period (2021-2028)     

Biosimulation market is segmented into services and software based on the product. The rising usage of biosimulation software by pharmaceutical and research organizations and increased R&D spending for pharmaceutical research are attributable to the segment's rapid rise. Over 6,000 scientists in 60 countries use Phoenix, Certara's industry-leading modeling and simulation software, at nearly 2,000 institutions, including the top 50 global pharmaceutical corporations, university institutes, and research foundations. The program is particularly useful for determining how the body reacts to the medicine. As a result, the market is likely to be driven by increased demand for innovative technologies to minimize the cost of drug discovery and development. Emerging biosimulation applications in nutraceuticals, defense, industrial bioprocessing,  and agri-food production presents significant opportunities for the global biosimulation market to grow. To broaden the applications of their biosimulation software and services, various biosimulation companies are pursuing inorganic and organic growth strategies. In May 2017, Swansea University's Institute of Life Science delivered an in silico drug discovery software platform to the UK Ministry of Defense to develop antimicrobials to meet the country's defense and security needs. Certara also formed a partnership with the Australian Department of Defense in April 2017. Certara's d3 medicine company was chosen to conduct a national audit of Australia's medical countermeasures (MCM) product's research and development capabilities and capacity.

Biosimulation Market Geographical Analysis

North America region holds the largest market share of global biosimulation market

North America accounted for the largest market share in the biosimulation market. The United States is one the largest contributor in this region as patient pool in several disease category is high for pharmaceutical companies to conduct clinical trials for a new drug in this country. Furthermore, companies that provide biosimulation software and services are broadening their drug discovery and development scope by utilizing advanced tools and improved software optimization. As a result of these factors, the biosimulation market is expected to expand during the forecast period.

On the other hand, the Asia Pacific regional segment is expected to see promising growth opportunities in the coming years of the forecast period spanning from 2020 to 2030. The region's expansion can be attributed to increased investments in developing the healthcare sector. Furthermore, increased activities and funding for research and development activities are likely to aid in developing the Asia Pacific biosimulation market.

Biosimulation Market Competitive Landscape

The biosimulation market is highly competitive with presence of local as well as global companies.  Some of the key players which are contributing to the growth of the market include Certara, Simulations Plus Inc, Rhenovia Pharma, In Silico biosciences Inc, Genedata AG. As the interest in biosimulation grows, several companies in the present biosimulation market are focusing on extending their operations and services to obtain a competitive advantage. For instance in April 2020, Lixoft was purchased for $16.5 million by Simulations Plus Inc., a US-based company that provides simulation and modeling tools for pharmaceutical development and discovery. Simulations Plus expands its modeling software solutions and expects to grow its position in Europe with the acquisition of Lixoft. Lixoft is a software firm established in France specializing in modeling and simulation software for sophisticated model-based drug development. Further, Switchback Medical, a top-tier medical device contract design and manufacturing company, has stated that it would likely expand its services by launching Switchback BioSim Innovations. The company hopes to strengthen its market position by providing dynamic biosimulation model creation, physical training, and cell culture services as part of the expansion.

 Key Developments

• In Jan 2021, The Insilico Selector is a new software developed by Insilico Biotechnology AG, a firm based in Germany that provides predictive solutions for the Bioeconomy. Micro-scale data can be used to create an accurate selection of high-performing cell clones with the help of the Insilico Selector.
• In August 2020, Certara, a major player in the market, cooperated with several pharmaceutical businesses. The goal of this collaboration was to help build a new biosimulation tool that would enable researching vaccine candidates for a variety of patient groups easier by employing virtual patients and trials. It was also meant to provide insight before any real-world research was conducted.
• In Jan 2017, Certara has established a Quantitative Systems Pharmacology Consortium. This brought together leading biopharma companies in a pre-competitive environment to collaborate on developing a Simulator that will predict the immunogenicity of biologics and their impact on efficacy, pharmacokinetics, and safety in diverse patient populations.
• In June 2020,Certara has released an improved version of their Phoenix biosimulation program, widely regarded as the gold standard in PK/PD and toxicokinetic modeling and simulation tools. The new edition adds features that improve the efficiency, quality, and time savings needed to execute trials. The biosimulation market is expected to increase as a result of this.
• In April 2020,OnScale and LEXMA have formed cooperation in which both firms will use AI and cloud simulation to develop effective biosimulation solutions that will improve patient outcomes.

Certara

Overview: Certara provides translational solutions from discovery to patient access across all therapeutic domains and new medicines, including immuno-oncology, rare illness, CNS, respiratory disease, gene therapy, and global health.

Product Portfolio:

Phoenix WinNonlin:  Over 6,000 researchers from biopharmaceutical companies, academic institutions, and 11 global regulatory agencies, including the US FDA, EMA, PMDA, and others, use Phoenix WinNonlin for non-compartmental analysis (NCA), toxicokinetic modelling, and pharmacokinetic and pharmacodynamic (PK/PD) modelling.