Biosimulation Market - Research Report- Market size, Industry outlook, Market Forecast, Demand Analysis, Market Share, Market Report 2024-2030

Report Code: HCR 1127 Report Format: PDF + Excel

Biosimulation Market Overview: 

Biosimulation Market size is estimated to reach $49.2 billion by 2030, growing at a CAGR of 9.4% during the forecast period 2024-2030. Biosimulation is the application of computational modeling and simulation techniques to understand and predict the behavior of biological systems. In the pharmaceutical and biotechnology industries, it is used to optimize drug development, reduce costs and accelerate time-to-market. The biosimulation market is rapidly expanding driven by factors such as increased R&D investment in pharmaceuticals, growing adoption by regulatory bodies and the need to reduce drug development costs. Advancements in technology like AI and QSP systems are further accelerating market growth. Biosimulation is increasingly used in drug discovery, development and pharmacogenomics, with a particular focus on addressing drug resistance challenges.

Biosimulations are quickly becoming indispensable tools in the drug development process by speeding up timelines and bringing down costs. A major trend in the market is the integration of AI and machine learning to boost the predictive capabilities of Biosimulations which leads to better accuracy. Increasing regulatory acceptance of biosimulation is fostering its wider adoption in the industry. For example, in Q1 2024, COFEPRIS proposed new regulations to update and harmonize the framework for biosimilars, focusing on bioequivalence, biocomparability and aligning with international standards to enhance safety and quality. This represents the biosimulation industry outlook. 

Market Snapshot: 


Biosimulation Market - Report Coverage:

The “Biosimulation Market Report - Forecast (2024-2030)” by IndustryARC, covers an in-depth analysis of the following segments in the Biosimulation Market.
By Type: Software, Services
By Application: Preclinical and Clinical Development, Drug Discovery

By End Users: Academic and Government Research Institutes, Pharmaceuticals and Biotechnological Companies, Contract Research Organizations, Regulatory Authorities
By Geography: North America (U.S., Canada, and Mexico), Europe (Germany, UK, France, Italy, Spain, Netherlands and Rest of Europe), Asia-Pacific (China, India, Japan, South Korea, Australia, New Zealand, and Rest of Asia-Pacific), South America (Brazil, Argentina, Colombia, Chile and Rest of South America) and Rest of World (the Middle East and Africa)

Key Takeaways:

  • Dominance of North America

Geographically, North America held the largest share with 35% of the overall market in 2023 and it is poised to dominate the market over the period 2024-2030. North America, particularly the United States, holds the largest share of the biosimulation market. The region boasts a mature and extensive pharmaceutical industry with substantial R&D investments. North American companies are pioneers in adopting advanced technologies, including biosimulation, to enhance drug development processes. According to Federal data, healthcare spending in the U.S. is projected to have risen 7.5% in 2023 to $4.8 trillion. Spending on Medicaid and private health insurance drove the growth, with the insured share of the population surging to 93%, as per data from the U.S. Centers for Medicare and Medicaid Services (CMS). Substantial healthcare spending creates a lucrative market for cost-effective alternatives like biosimilars. FDA's increasing acceptance of biosimulation as a tool for drug development has encouraged its wider adoption. 

  • Drug Discovery is the largest market 

Biosimulation offers a powerful tool for drug discovery by increasing efficiency, reducing costs, improving safety, and accelerating the development of new therapies. As the complexity of drug discovery challenges grows, the demand for biosimulation is expected to continue rising. Biosimulation helps in predicting drug behavior, optimizing drug candidates, and identifying potential safety issues early in the development process. This significantly reduces the overall drug development timeline. By simulating drug interactions with biological systems, biosimulation helps in selecting drug candidates with higher probability of success, thereby improving clinical trial success rates. Biosimulation can help identify potential safety issues before clinical trials, reducing the risk of adverse drug reactions. In 2023,  the US Food and Drug Administration (FDA) approved 55 novel drugs– the second-highest figure in the last 30 years. This is almost a 50% increase compared to 2022, which saw 37 new approvals among them. Cancer, neurology, infectious disease and hematology drugs gained the newest approvals.

  • Pharma and Biotech are the primary users of Biosimulation

The pharmaceutical and biotechnology industries are the primary consumers of biosimulation for several compelling reasons. Biosimulation enables researchers to predict how a drug will behave in the human body, reducing the time and cost associated with clinical trials, by simulating drug interactions with biological systems, companies can identify the most promising drug candidates early in the development process. Biosimulation can help identify potential safety issues before clinical trials, reducing the risk of adverse drug reactions. By simulating drug pharmacokinetics and pharmacodynamics, companies can optimize drug dosing regimens for maximum efficacy and safety.  In June 2024, Dr. Reddy’s announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the launch of its proposed biosimilar rituximab candidate in the European markets. Ituxredi/DRL_RI is a proposed biosimilar to MabThera and the intended indications are for non–Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis and other conditions where MabThera is indicated for use.

  • Cost and Time efficiency in Clinical Trial

Biosimulation has emerged as a powerful tool in optimizing clinical trial design, execution and analysis. Its application can significantly enhance both cost and time efficiency in the drug development process. Biosimulation helps in determining optimal dosing regimens, patient populations and endpoints, leading to more efficient trial design and reduced costs. By accurately predicting drug responses, biosimulation can help determine the minimum sample size required for a trial, leading to cost savings. Biosimulation can identify potential drug failures early in the development process, preventing costly late-stage failures. By prioritizing promising drug candidates, biosimulation helps optimize resource allocation and reduce overall development costs.

  • Specific Applications

Simulating drug absorption, distribution, metabolism, and elimination (ADME) can optimize dosing regimens and reduce the number of clinical trials needed. Analyzing drug data from multiple patients to identify factors influencing drug response can help in patient selection and dose individualization. It also plays an important role in Physiologically Based Pharmacokinetic (PBPK) Modeling by simulating drug behavior at the organ and tissue level can improve drug design and reduce animal testing. Along with that simulating disease progression can help identify patient populations for clinical trials and optimize trial design. By leveraging biosimulation, pharmaceutical companies can significantly improve the efficiency and success rate of their clinical trials, ultimately leading to faster drug development and improved patient outcomes.

                               Biosimulation Market Share (%) by Geography, 2023


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Key Market Players: 

Product/Service launches, approvals, patents and events, acquisitions, partnerships and collaborations are key strategies adopted by players in the Biosimulation Market. The top 10 companies in the Biosimulation Market are:
1.    Novartis AG
2.    Pfizer Inc.
3.    Amgen Inc.
4.    Biogen Inc.
5.    Eli Lilly and Company 
6.    Dr. Reddy's Laboratories
7.    F Hoffman-La Roche Ltd.
8.    Sandoz International GmbH
9.    AbbVie Inc.
10.  Celltrion Healthcare 
 

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  1. Biosimulation Market- Market Overview
      1.1 Definitions and Scope
  2. Biosimulation Market - Executive Summary
      2.1 Key Trends by Product Type
      2.2 Key Trends by Application
      2.3 Key Trends by End Use Industry
      2.4 Key Trends by Geography
  3. Biosimulation Market – Comparative analysis
      3.1 Market Share Analysis- Major Companies
      3.2 Product Benchmarking- Major Companies
      3.3 Top 5 Financials Analysis
      3.4 Patent Analysis- Major Companies
      3.5 Pricing Analysis (ASPs will be provided)
  4. Biosimulation Market - Startup companies Scenario Premium 
      4.1 Major startup company analysis:
            4.1.1 Investment
            4.1.2 Revenue
            4.1.3 Product portfolio
            4.1.4 Venture Capital and Funding Scenario
  5. Biosimulation Market – Industry Market Entry Scenario Premium 
      5.1 Regulatory Framework Overview
      5.2 New Business and Ease of Doing Business Index
      5.3 Successful Venture Profiles
      5.4 Customer Analysis – Major companies
  6. Biosimulation Market - Market Forces
      6.1 Market Drivers
      6.2 Market Constraints
      6.3 Porters Five Force Model
            6.3.1 Bargaining Power of Suppliers
            6.3.2 Bargaining Powers of Buyers
            6.3.3 Threat of New Entrants
            6.3.4 Competitive Rivalry
            6.3.5 Threat of Substitutes
  7. Biosimulation Market – Strategic Analysis
      7.1 Value/Supply Chain Analysis
      7.2 Opportunity Analysis
      7.3 Product/Market Life Cycle
      7.4 Distributor Analysis – Major Companies
  8. Biosimulation Market – By Type (Market Size –$Million/$Billion
      8.1 Software
      8.2 Services
  9. Biosimulation Market – By Application (Market Size –$Million/$Billion)
      9.2 Drug Discovery
  10. Biosimulation Market – By End Use Industry (Market Size –$Million/$Billion)
      10.1 Academic and Government Research Institutes
      10.2 Pharmaceuticals and Biotechnological Companies
      10.3 Contract Research Organisations
      10.4 Regulatory Authorities
      10.5 Others
  11. Biosimulation Market - By Geography (Market Size -$Million/Billion)
      11.1 North America
            11.1.1 USA
            11.1.2 Canada
            11.1.3 Mexico
      11.2 Europe
            11.2.1 UK
            11.2.2 Germany
            11.2.3 France
            11.2.4 Italy
            11.2.5 Netherlands
            11.2.6 Spain
            11.2.7 Belgium
            11.2.8 Rest of Europe
      11.3 Asia-Pacific
            11.3.1 China
            11.3.2 Japan
            11.3.3 India
            11.3.4 South Korea
            11.3.5 Australia
            11.3.6 Indonesia
            11.3.7 Thailand
            11.3.8 Malaysia
            11.3.9 Rest of APAC
      11.4 South America
            11.4.1 Brazil
            11.4.2 Argentina
            11.4.3 Colombia
            11.4.4 Chile
            11.4.5 Rest of South America
      11.5 Rest of the World
            11.5.1 Middle East
            11.5.2 Africa
  12. Biosimulation Market – Entropy
      12.1 New Product Launches
      12.2 M&As, Collaborations, JVs and Partnerships
  13. Biosimulation Market – Industry/Segment Competition Analysis 
      13.1 Company Benchmarking Matrix – Major Companies
      13.2 Market Share at Global Level - Major companies
      13.3 Market Share by Key Region - Major companies
      13.4 Market Share by Key Country - Major companies
      13.5 Market Share by Key Application - Major companies
      13.6 Market Share by Key Product Type/Product category - Major companies
  14. Biosimulation Market – Key Company List by Country Premium 
  15. Biosimulation Market Company Analysis - Business Overview, Product Portfolio, Financials, and Developments
      15.1 Novartis AG
      15.2 Pfizer Inc.
      15.3 Amgen Inc.
      15.4 Biogen Inc.
      15.5 Eli Lilly and Company 
      15.6 Dr. Reddy's Laboratories
      15.7 F Hoffman-La Roche Ltd.
      15.8 Sandoz International GmbH
      15.9 AbbVie Inc.
      15.10 Celltrion Healthcare
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