(MENAFN- GlobeNewsWire - Nasdaq) Opportunities span AI toxicity prediction, in-silico models, automated testing, real-time pharmacovigilance, CRO expansion and regulatory analytics amid rising clinical trials.Dublin, Sept. 16, 2026 (GLOBE NEWSWIRE) -- "Pharmaceutical Safety Assessment Market Report 2026" has been added to ResearchAndMarkets.com's offering.
Pharmaceutical Safety Assessment Market to Reach $16.97 Billion by 2030 as AI Adoption and Clinical Trials Accelerate
The global pharmaceutical safety assessment market is experiencing strong growth as pharmaceutical and biotechnology companies expand research and development pipelines, strengthen drug safety programs, and respond to increasingly rigorous regulatory requirements. The market is projected to grow from $11.32 billion in 2025 to $12.24 billion in 2026, representing a compound annual growth rate (CAGR) of 8.2%.
Historical market growth has been supported by rising pharmaceutical research and development activity, greater regulatory scrutiny of drug safety, and increasing volumes of preclinical and clinical testing. Wider adoption of in-vitro safety assessment methods and growing reliance on contract research organizations (CROs) for specialized safety studies have also contributed to market expansion.
The pharmaceutical safety assessment market is forecast to reach $16.97 billion by 2030, advancing at a CAGR of 8.5% from 2026. Growth during the forecast period is expected to be driven by increased use of computational safety assessment, continued development of personalized medicines, demand for faster regulatory approvals, and the integration of artificial intelligence into drug safety workflows. More extensive post-market surveillance requirements are also expected to generate sustained demand for pharmaceutical safety assessment services and technologies.
Key pharmaceutical safety assessment market trends include the increasing use of AI-based toxicity prediction tools, broader adoption of in-silico safety assessment models, and integration of real-time pharmacovigilance systems. Automated preclinical testing platforms and regulatory-compliant safety analytics are also gaining importance as drug developers seek to improve efficiency, data consistency, and risk detection throughout the product lifecycle.
The expansion of clinical trials is a major factor supporting market growth. Rising demand for novel and effective therapies is encouraging researchers, healthcare providers, and drug developers to increase clinical research activity across multiple therapeutic areas. Pharmaceutical safety assessments help identify adverse effects, establish appropriate dosage ranges, and generate evidence required by regulatory authorities to evaluate the safety and efficacy of new medicines. As of September 26, 2025, the US National Library of Medicine reported that 554,798 studies were registered on ClinicalTrials.gov, highlighting the scale of global clinical research activity and its importance to drug safety assessment.
Companies active in the market are increasingly investing in AI-powered decision support technologies to improve toxicity prediction and safety profiling. In April 2024, Charles River Laboratories collaborated with Deciphex to launch the Patholytix Foresight platform for toxicologic pathology applications. The platform applies artificial intelligence to complex preclinical pathology data, supporting earlier identification of potential safety risks while reducing subjectivity. Its capabilities include tissue abnormality detection, cloud-based collaboration, scalable slide review, and tools designed to improve the accuracy and consistency of safety data.
Merger and acquisition activity is also strengthening pharmaceutical safety and pharmacovigilance capabilities. In January 2025, France-based Groupe ProductLife S.A.S. acquired Stragen Services SAS for an undisclosed amount. The transaction is intended to enhance ProductLife Group's clinical safety and pharmacovigilance services, expand its European presence, and provide broader regulatory and safety support to pharmaceutical and biotechnology clients.
North America was the largest region in the pharmaceutical safety assessment market in 2025, supported by its established pharmaceutical sector, extensive clinical research infrastructure, and strong regulatory framework. Asia-Pacific is expected to be the fastest-growing region during the forecast period as drug development, outsourced research, and investment in testing capabilities increase. Regions covered by the market include Asia-Pacific, Southeast Asia, Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa. Countries covered include Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, the United Kingdom, the United States, Canada, Italy, and Spain.
Markets Covered:
1) By Type: In-Vitro Safety Assessment; In-Vivo Safety Assessment; Computational Safety Assessment
2) By Drug Type: Biological Drugs; Chemical Drugs
3) By Phase: Preclinical; Clinical (Phase I, II, III); Post-Market Surveillance (Phase IV)
4) By End User: Pharmaceutical Companies; Biotechnology Companies; Medical Device Companies; Academic And Research Institutions; Contract Research Organizations (CROs)
Subsegments:
1) By In-Vitro Safety Assessment: Cell-Based Assays; Organotypic Models; Tissue Culture Models; High-Throughput Screening
2) By In-Vivo Safety Assessment: Rodent Studies; Non-Rodent Studies; Toxicokinetic Studies; Carcinogenicity Studies
3) By Computational Safety Assessment: Quantitative Structure-Activity Relationship (QSAR) Modeling; Physiologically Based Pharmacokinetic (PBPK) Modeling; Toxicity Prediction Software; In Silico Simulation Studies
Time Series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.
Data Segmentation: Country and regional historic and forecast data, market share of competitors, market segments.
Key Attributes:
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