PUBLISHER: The Business Research Company | PRODUCT CODE: 1877843
PUBLISHER: The Business Research Company | PRODUCT CODE: 1877843
Pharmaceutical safety assessment is the systematic evaluation of drugs and pharmaceutical products to ensure their safety and minimize potential risks to patients. It involves the analysis of preclinical and clinical data, monitoring of adverse effects, and adherence to regulatory standards. This process supports informed decision-making regarding the approval, labeling, and safe use of medications.
The major types in the pharmaceutical safety assessment market include in-vitro safety assessment, in-vivo safety assessment, and computational safety assessment. In-vitro safety assessment refers to the evaluation of the safety and toxicity of drugs, chemicals, or other substances through controlled laboratory tests conducted outside a living organism. The types of drugs assessed include biological drugs and chemical drugs. The process covers multiple phases, including preclinical, clinical (phase I, II, III), and post-market surveillance (phase IV). The key end users are pharmaceutical companies, biotechnology firms, medical device manufacturers, academic and research institutions, and contract research organizations.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.
The pharmaceutical safety assessment market research report is one of a series of new reports from The Business Research Company that provides pharmaceutical safety assessment market statistics, including pharmaceutical safety assessment industry global market size, regional shares, competitors with a pharmaceutical safety assessment market share, detailed pharmaceutical safety assessment market segments, market trends and opportunities, and any further data you may need to thrive in the pharmaceutical safety assessment industry. This pharmaceutical safety assessment market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The pharmaceutical safety assessment market size has grown strongly in recent years. It will grow from $10.47 billion in 2024 to $11.32 billion in 2025 at a compound annual growth rate (CAGR) of 8.1%. The growth in the historic period is driven by increasing demand for preclinical research, stricter regulatory requirements for drug safety, expansion of outsourcing to contract research organizations, advancements in animal model studies, and early adoption of cell-based assays.
The pharmaceutical safety assessment market size is expected to see strong growth in the next few years. It will grow to $15.64 billion in 2029 at a compound annual growth rate (CAGR) of 8.4%. The growth in the forecast period can be connected to expansion of biologics and biosimilars development, increasing adoption of in silico toxicology platforms, rising investment in personalized medicine, regulatory shift toward alternative testing methods, growing demand for high throughput screening technologies. Major trends in the forecast period include integration of artificial intelligence in toxicity prediction, shift from animal testing to organ on chip systems, expansion of computational modeling for safety profiling, rising collaborations between pharma and tech firms, focus on predictive biomarkers for safety assessment.
The expansion of clinical trials is expected to support the growth of the pharmaceutical safety assessment market going forward. Clinical trials refer to research studies conducted in humans to evaluate the safety, effectiveness, and side effects of new medical treatments, drugs, or interventions. The number of clinical trials is increasing due to the growing need for new and effective treatments, as researchers and healthcare providers work to develop therapies that can better prevent, manage, or cure diseases. Clinical trials strengthen pharmaceutical safety assessment by systematically evaluating a drug's effects on humans through carefully controlled studies, monitoring adverse reactions, determining safe dosage ranges, and generating essential data that regulatory authorities use to confirm that medications are both effective and safe for public use. For instance, in September 2025, according to the National Library of Medicine, a United States-based biomedical library, as of September 26, 2025, a total of 554,798 studies were registered on ClinicalTrials.gov. Therefore, the expansion of clinical trials is supporting the growth of the pharmaceutical safety assessment market.
Leading companies in the pharmaceutical safety assessment market are emphasizing advanced strategies such as the lifecycle-wide approach to risk management, which incorporates safety evaluation throughout all phases of drug development, from discovery to post-marketing surveillance, ensuring continuous patient protection and adherence to regulatory standards. The lifecycle-wide approach involves the ongoing assessment and management of pharmaceutical safety across the entire lifespan of a drug, covering development, manufacturing, and real-world use. For example, in October 2024, the International Society for Pharmaceutical Engineering (ISPE), a US-based organization dedicated to advancing pharmaceutical science and technology, introduced the initiative *Enabling Global Pharma Innovation Delivering for Patients* to promote innovation across the sector. Earlier, in late 2022, ISPE assembled a team of industry specialists experienced in developing emerging technologies and navigating complex regulatory frameworks. This team conducted a comprehensive survey to identify the root causes, scale, and impact of barriers that impede technological advancement and adoption in the pharmaceutical field. The initiative ultimately aims to accelerate the integration of advanced technologies within the industry while effectively addressing regulatory and operational challenges.
In January 2025, Groupe ProductLife S.A.S., a France-based life sciences services company, acquired Stragen Services SAS for an undisclosed amount. Through this acquisition, ProductLife Group aims to strengthen its pharmacovigilance and clinical safety expertise, expand its footprint across Europe, and deliver more integrated regulatory and safety solutions to pharmaceutical and biotechnology clients. Stragen Services SAS is a France-based company specializing in pharmaceutical safety assessment, also known as pharmacovigilance.
Major players operating in the pharmaceutical safety assessment market are IQVIA Holding Inc., LabCorp (formerly Covance), Thermo Fisher Scientific (PPD), Charles River Laboratories, ICON plc, Parexel International Corp., Syneos Health, Eurofins Scientific SE, Wuxi Biologics Inc., SGS SA, Medpace Holdings Inc., Fujifilm Wako (Fujifilm Corp.), Pharmaron Beijing Co. Ltd., Inotiv (incl. Envigo), Evotec (Cyprotex), Intertek Group, Altasciences Inc., Aragen Life Sciences Ltd., CTI Clinical Trial and Consulting Inc., ChemDiv Inc., Frontage Laboratories, Medicilon Inc., Biotoxtech Co. Ltd., BioIVT, Accelera Srl.
North America was the largest region in the pharmaceutical safety assessment market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the pharmaceutical safety assessment market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the pharmaceutical safety assessment market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The pharmaceutical safety assessment market includes revenues earned by entities by providing services such as post-marketing surveillance, safety pharmacology, regulatory consulting and compliance, bioanalytics and biomarker services, and in silico and computational toxicology. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Pharmaceutical Safety Assessment Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on pharmaceutical safety assessment market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for pharmaceutical safety assessment ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The pharmaceutical safety assessment market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.