Global Biosimulation Market Reaches $5.6 Billion in 2025, Growing at a CAGR of 21.1%

Global biosimulation market was valued at $5.6 billion in 2025 and is growing at a CAGR of 21.1% during the forecast period (2026-2035). Recent FDA initiatives aim to streamline biosimilarity studies by reducing the need for extensive clinical testing, thereby supporting the adoption of biosimulation tools. These tools facilitate modeling of pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and comparability, which in turn reduces development time and costs, driving market growth. For instance,

Browse the full report description of “Global Biosimulation Market Size, Share & Trends Analysis Report, By Application (Drug Discovery and Drug Development), By Product (Software and Services), By End-User (Biotechnology and Pharmaceutical Companies, Contract Research Organizations (CROs), Regulatory Authorities, and Others) and Forecast, (2026-2035).” At https://www.omrglobal.com/industry-reports/biosimulation-market-share

• In October 2025, FDA has announced actions to expedite the development of biosimilar medicines, aimed at reducing costs associated with these lower-cost alternatives to biologic drugs. A new draft guidance proposes updates to simplify biosimilarity studies and minimize clinical testing. Additionally, the FDA aims to facilitate the development of interchangeable biosimilars, thereby assisting patients and pharmacists in selecting cost-effective options. Despite biologics representing a small percentage of prescriptions, they account for a significant portion of drug spending. Currently, only 76 biosimilars are approved, capturing less than 20% of the market, in stark contrast to over 30,000 approved generic drugs.
• In April 2025, Biocon Biologics Ltd announced FDA approval of Jobevne (bevacizumab-nwgd), a biosimilar to Avastin for intravenous cancer treatment. Jobevne, a recombinant humanized monoclonal antibody, acts as a VEGF inhibitor to prevent angiogenesis by blocking VEGF-receptor interaction. This approval enhances Biocon's biosimilar oncology portfolio in the US, including OGIVRI and FULPHILA.

Key Innovators Driving Biosimulation Transformation

The key players in the biosimulation market include Certara, Inc., Dassault Systèmes SE, Genedata AG, Schrödinger, Inc., Simulations Plus, Inc., among others. These companies are driving innovation in digital health solutions such as telemedicine, electronic health records, remote patient monitoring, and AI-powered clinical tools, shaping the future of healthcare delivery globally.

• In October 2024, Simulations Plus, Inc. received a grant from the FDA, in partnership with the University of Strathclyde and InnoGI Technologies, to enhance the validation of in vitro-in vivo extrapolation methods for amorphous solid dispersion (ASD) formulations. The project will analyze ASD drug products under different conditions, including dietary influences and pH levels on drug-drug interactions, using advanced in vitro testing and mechanistic modeling. Professor Hannah Batchelor's lab will investigate formulation variants, while InnoGI Technologies will test these variants in an in vitro system. The approach includes utilizing physiologically based pharmacokinetic models in the GastroPlus platform to link in vitro dissolution with in vivo data, leading to virtual bioequivalence simulations aimed at improving formulation processes, lowering costs, and speeding up the market entry of ASD products.

Market Coverage

• The market number available for – 2025-2035
• Base year- 2025
• Forecast period- 2026-2035
• Segment Covered-
  • By Application
  • By Product
  • By End-User
• Regions Covered-
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
• Competitive Landscape - Certara, Inc., Dassault Systèmes SE, Genedata AG, Schrödinger, Inc., Simulations Plus, Inc., among others.

Key questions addressed by the report.

• What is the market growth rate?
• Which segment and region dominate the market in the base year?
• Which segment and region will project the fastest growth in the market?
• Who is the leader in the market?
• How are players addressing challenges to sustain growth?
• Where is the investment opportunity?

Global Biosimulation Market Report Segment

By Application

• Drug Discovery
• Drug Development
• Preclinical Testing
• Clinical Trials

By Product

• Software
  • Molecular Modeling & Simulation Software
  • Clinical Trial Design Software
  • PK/PD Modeling and Simulation Software
  • Pbpk Modeling and Simulation Software
  • Toxicity Prediction Software
  • Other Software
• Services
  • Contract Services
  • Consulting
  • Others (Implementation, Training, & Support)

By End User

• Biotechnology and Pharmaceutical Companies
• Contract Research Organizations (CROs)
• Regulatory Authorities
• Others

Global Biosimulation Market Report Segment by Region

North America

• United States
• Canada

Europe

• UK
• Germany
• Italy
• Spain
• France
• Russia
• Rest of Europe

Asia-Pacific

• China
• India
• Japan
• South Korea
• Australia and New Zealand
• ASEAN Economies
• Rest of Asia-Pacific

Rest of the World

• Latin America
• Middle East & Africa

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