Press release
Bioequivalence Studies Market to Reach US$1.35 Billion by 2033, Growing at a 7.5% CAGR | Key Players: Simulations Plus, Certara & SGS
Bioequivalence Studies Market
United States: Recent Industry Developments
✅ In October 2024, Simulations Plus, Inc., in collaboration with the University of Strathclyde and InnoGI Technologies, received an FDA grant to enhance understanding of amorphous solid dispersions and predict food and pH-dependent drug-drug interactions using mechanistic modeling and simulation, advancing bioequivalence predictions.
✅ Ongoing regulatory support from the FDA for model-informed drug development (MIDD), including grants and qualifications promoting biosimulation tools for virtual bioequivalence assessments and reduced in vivo studies.
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Japan: Recent Industry Developments
Japan-focused developments highlighted; however, the Asia-Pacific region, including Japan, benefits from growing adoption of AI-driven biosimulation and government support for digital health and pharmaceutical R&D in generic drug development.
Asia-Pacific: Recent Industry Developments
✅ Rapid expansion in biosimulation adoption and infrastructure improvements in countries like China, India, South Korea, and Japan, driven by government initiatives for cost-effective drug development, generic manufacturing hubs (e.g., India and China), and increasing clinical research facilities for bioequivalence testing.
Mergers & Acquisitions
recent M&A detailed in the report; growth primarily driven by strategic partnerships, collaborations, and technology integrations among biosimulation providers and CROs.
Technological Partnerships
✅ In March 2025, Certara, Inc. formed a strategic partnership with Biowaived to combine Certara's advanced simulation tools with Biowaived's experimental expertise, delivering integrated biopharmaceutics, formulation, and bioequivalence solutions to streamline drug development.
✅ Ongoing collaborations, such as Simulations Plus with academic institutions (e.g., University of Strathclyde, Polish Academy of Sciences), for advancing PBPK/PBBM modeling, AI-driven predictions, and regulatory-compliant biosimulation.
New Product/Service Launch
✅ In May 2024, Simulations Plus, Inc. launched GastroPlus X (GPX), the next-generation PBPK/PBBM modeling and simulation software with advanced algorithms, integrated machine learning, enhanced user interface, faster processing, and improved accuracy for bioequivalence studies.
✅ In April 2025, Certara, Inc. released an enhanced version of its Simcyp Simulator, advancing capabilities in biopharmaceutics, drug-drug interaction prediction, and biologic modeling to support data-driven regulatory decisions.
Technological Advancements in the Market
✅ 2025 trends: Rapid integration of AI, machine learning, and advanced computing in PBPK (Physiologically Based Pharmacokinetic) and PBBM (Physiologically Based Biopharmaceutics Modeling) for virtual bioequivalence assessments; shift toward in vitro and in silico methods reducing in vivo trials; EMA qualification of tools like Simcyp Simulator (August 2025) as the first PBPK platform for regulatory submissions; validation of AI-driven ADMET Predictor models (July 2025 publication).
Funding Raised by Companies
✅ In October 2024, Simulations Plus, Inc. secured an FDA grant (in collaboration with partners) for mechanistic modeling research in amorphous solid dispersions and drug interactions, supporting bioequivalence innovation.
Market Dynamics & Key Insights
✅ Drivers: Technical advances in PBPK/PBBM and computing; strong regulatory support from FDA/EMA for MIDD; digital transformation with AI/ML in pharma R&D; biosimulation growth enabling virtual assessments and cost/time reductions in generic/biosimilar development.
✅ Key focus: Oncology dominates applications (48.3% share in 2024) due to complex formulations, narrow therapeutic indices, rising cancer incidence, and generic oncology demand. In vivo studies lead (70.3% share in 2024) as gold standard.
✅ Restraints: Stringent model validation, data quality needs, time-intensive/expensive processes, limited expertise in smaller firms, and regulatory hurdles for unvalidated models.
✅ North America dominates; Asia-Pacific fastest-growing with improving facilities and generic hubs.
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Segmentation
☛ By Study Type
In Vivo dominates with 70.3% share in 2024 (gold standard for therapeutic equivalence and regulatory approvals); In Vitro (growing with simulation advancements).
☛ By Application
Oncology dominates with 48.3% share in 2024 (driven by complex generics, rising incidence, R&D investments); Cardiovascular Disease; Central Nervous System (CNS) Disorders; Infectious Diseases; Others.
☛ By End User
Pharmaceutical Companies; Contract Research Organizations (CROs); Research Institutes; Research Laboratories.
Regional Analysis
» North America leads the global bioequivalence studies market with the largest revenue share of 43.5% in 2024; driven by advanced infrastructure, R&D, early AI/biosimulation adoption, FDA support for MIDD, and strong pharmaceutical presence in the U.S.
» Asia-Pacific exhibits the fastest growth at a CAGR of 7.4% over the forecast period, supported by generic manufacturing hubs (India/China), government digital initiatives, improved research facilities, and cost-efficient simulation adoption in China, India, Japan, and South Korea.
» Europe holds a significant share of 34.5% in 2024, fueled by EMA qualifications (e.g., Simcyp in 2025), advanced computing, collaborations, and regulatory backing in Germany, UK, and France.
» The Middle East and Africa, along with South America, hold emerging potential with increasing access to biosimulation and generic development.
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