Current Market Scenario:
The global personalized therapy biosimulation market size reached USD 1,061.7 Million in 2020 and is expected to register a significant revenue CAGR during the forecast period, according to latest analysis by Emergen Research.
Increasing need to reduce R&D costs and high failure rates in clinical trials and increasing focus on implementing personalized cancer therapy are some key factors expected to continue to drive global personalized therapy biosimulation market revenue growth over the forecast period. High failure rate in clinical trials results in low United States Food and Drug Administration (FDA) approval rates and consequently high R&D costs which lead to significant wastage of resources and time of pharmaceutical companies.
The biopharmaceutical companies and Contract Research Organizations (CROs) face the challenge of drug attrition in phase 1 and phase 2 clinical trials, whereby 95% of the drug tested does not reach marketing authorization, thereby making the whole drug development process ineffective and costly. In recent years, drug attrition in phase 2 clinical trial is the highest as most of the investigation drugs tested on humans fail in this phase due to suboptimal dosing, targeting wrong mechanism or patient population.
Hence, most biopharmaceutical companies are focusing on implementing modeling and simulation approaches in drug development process to potentially reduce time and cost, enable dose individualization based on measured biomarkers, optimize doses, optimize clinical trial design, and to bring sustainability in drug development, which are factors expected to drive global personalized therapy biosimulation market revenue growth. In recent years, personalized cancer therapy has been gaining traction as an effective treatment approach for cancer, which utilizes tumor biomarkers and patient’s genetic factor to analyze drug metabolism, drug response, drug toxicity, and to predict individual patient’s response to specific cancer therapies, thereby significantly improving outcomes and clinical efficacy.
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Furthermore, recommendation by FDA for implementing biosimulation technique in drug development process is expected to support revenue growth of the market. For instance, Certara USA Inc., has received 90% of novel drugs and biologics approval by the U.S. Food & Drug Administration (FDA). This will provide impetus for other market players to use biosimulation technique in development of new generation of drugs.
Lack of standardization in biosimulation is a key factor expected to hamper growth of the market to a certain extent during forecast period. Biosimulation involves the usage of variety of tools, models, and languages in order to capture and process different aspects involved in a biological process. The governing bodies have yet not established any standardization for using biosimulation or in silico models in the process of drug discovery and drug development. Lack of scalable standards for model reuse and representation are posing challenges to researchers for sharing complex biomedical models. Thus, lack of standardization in biosimulation is a key factor expected to hamper growth of the market to a certain extent during forecast period.
The global personalized therapy biosimulation market is expected to expand at a CAGR of 14.6% from USD 1,061.7 Million in 2020 to USD 3,164.1 Million by 2028. Rising focus on building standard-based biosimulation representation model and expanding the application of personalized therapy biosimulation in other therapeutic areas is expected to fuel revenue growth of global personalized therapy biosimulation market over the forecast period.
COVID-19 Impact Analysis:
- The virus outbreak and social distancing norms and restrictions severely disrupted the overall business landscape and operations worldwide.
- COVID-19 pandemic and lockdowns have resulted in several countries shutting down airports, ports, and commercial and domestic transportation. This had impacted manufacturing activities and operations globally and took a toll on the economy of various countries.
- Sudden and drastic downturn in economic activity caused a slowdown in manufacturing, production, agriculture, fisheries, dairy, and other sectors and also resulted in employment loss to a major extent.
- Supply impacts were further compounded due to challenges on the demand-side owing to reduced disposable income, depleting savings, and increased concerns and uncertainties.
- Emergence of variants of the virus and rise in infection rates during the initial waves and subsequent lockdowns has severely impacted operations and disrupted supply chains.
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Current Trends and Innovations:
Rising focus to implement biosimulation in pediatric drug development is expected to further drive revenue growth of the global personalized therapy biosimulation market. Modeling and Simulation (M/S) in pediatric drug development offers various advantages such as reduced trial duration, increased likelihood of success, and minimizing blood draws, which is expected to increase demand for biosimulation solutions.
- Asia Pacific market revenue is expected to expand at a relatively rapid CAGR over the forecast period due to increasing spending on healthcare IT, increasing expenditure on R&D activities, rising focus in precision oncology, rising awareness about the benefits of using biosimulation software in clinical trials, and robust presence of pharmaceutical and biotechnology companies and CROs in countries in the region.
Some major companies operating in the global market include Cellworks Group Inc., Certara USA Inc., Simulation Plus Inc., Schrodinger Inc., In Silico Biosciences Inc., Genedata AG, Physiomics plc, Insilico Biotechology AG, Chemical Computing Group ULC (CCG), and Evidera Inc.
- In August 2020, Certara L.P. announced the launch of a new biosimulation platform for COVID-19 vaccines and up-gradation in its immunogenicity and immuno-oncology QSP platforms. The new vaccine platform will facilitate dosing strategies for a range of patients impacted by COVID-19 and speed up the drug discovery and development process.
Emergen Research has segmented the global personalized therapy biosimulation market on the basis of product, therapeutic area, application end-use, and region:
- Product Outlook (Revenue, USD Billion; 2018–2028)
- Therapeutic Area Outlook (Revenue, USD Billion; 2018–2028)
- Application Outlook (Revenue, USD Billion; 2018–2028)
- Drug Development
- Drug Discovery
- End-use Outlook (Revenue, USD Billion; 2018–2028)
- Pharmaceutical & Biotechnology Companies
- Contract Research Organizations (CROs)
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- Regional Outlook (Revenue, USD Billion; 2018–2028)
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