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Global Toxicity Studies Outsourcing Market $7.5 Billion by 2031

The global market for toxicity studies outsourcing estimated to reach $7.5 billion by 2031, expanding at a CAGR of 8.6% over the forecast period, driven by increasing trend of outsourcing product testing among the biopharma companies, growing number of potential preclinical and clinical pipeline molecules, and continuous financial support for R&D activities.

  • Other factors driving the market growth includes increasing attrition rate in preclinical studies, high cost of R&D and toxicological testing services in developed economies, ethical concerns surrounding the use of animals, and complex drug development environment.
Global Toxicity Studies Outsourcing Market

Toxicity testing plays a key role in the regulatory decisions of agencies and governments that aim to protect the public and the environment from the potentially harmful or adverse effects of these multitudinous chemicals. There are many requirements that are needed for preclinical development that require a great deal of time and capital expenditure. Outsourcing is becoming a trend in preclinical development and is projected to increase from the current 20-25% to 30-50% of R&D expenditures in the next few years.

  • Toxicity is a measure of any undesirable or adverse effect of chemicals. Specific types of these adverse effects are called toxicity endpoints, such as carcinogenicity or genotoxicity, and can be quantitative (e.g., LD50: lethal dose to 50% of tested individuals) or qualitative, such as binary (e.g., toxic or non‐toxic) or ordinary (e.g., low, moderate, or high toxicity).
    • In addition to reduce the cost associated with expensive infrastructure required for preclinical toxicological studies, many pharmaceutical and biotechnology companies are using outsourcing to support their discovery and development process to increased available capital, preserved R&D focus, wider range of available expertise, and increased flexibility within these activities in light of overall risk-assessment and risk-management needs.
      • The ever-increasing population and the constant demand for new and improved technologies have set a huge challenge for regulatory toxicology (RT), as many of these innovations are based upon chemical substances.

The global toxicity testing outsourcing market research report provides market size ($million 2021 to 2031), market share analysis, growth trends and forecast (CAGR%, 2024 to 2031).

The global market for toxicity studies outsourcing segmented by method (in vitro, in vivo), GLP type [good laboratory practice (GLP), non-GLP], end user (academic and research institutes, pharmaceutical and biopharmaceutical companies, others), and geography.

  • Based on the methods, the in vitro toxicological testing segment accounted for the largest share of the total toxicity studies outsourcing market. In the last 10 years or so, delineation of the pathway of toxicity and development of new reliable in vitro and in silico screening methods have provided useful tools for screening molecules at an early stage.
    • The advantages of in vitro toxicity testing include use human cells, cost and time effectiveness, fewer ethical issues, wide availability of human cell types, requires less test substance, reduced waste and hazardous materials.
      • In addition, the animal models have been used for a long time for toxicity testing. However, in vivo animal tests are constrained by time, ethical considerations, and financial burden. Therefore, in vitro methods for estimating the toxicity of chemicals are considered useful. In vitro methods are common and widely used for screening and ranking chemicals and have also been taken into account sporadically for risk assessment purposes.
  • Among the laboratory practices, the good laboratory practices (GLP) segment held the majority revenue share of the total market for toxicity testing. In order for toxicity tests to qualify for regulatory submission, the tests must be conducted per GLP which also takes additional resources.
    • Essentially, good laboratory practices (GLPs) are a system of management controls for nonclinical research studies involving animals to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of data collected as part of chemical (including pharmaceuticals) tests, from in vitro through acute to chronic toxicity tests. The GLP supports the protection of public health in the areas of pesticides, chemicals, and drug investigations in response to allegations of inaccurate data acquisition.
      • Although the establishment of infrastructure for GLPs compliance is labor-intensive and time-consuming, achievement and maintenance of GLP compliance ensures the accuracy of the data collected from each study, which is critical for defending results, advancing science, and protecting human and animal health.
        • The use of standardized test guidelines and GLP promotes consistency, reliability, comparability, and harmonization of various types of studies used by regulatory agencies worldwide.
  • Out of the end users, the pharmaceutical and biopharmaceutical companies segment led the global market for toxicity testing outsourcing, attributed to increasing shift in outsourcing end-to-end services.
    • The aim of the toxicological regulations of pharmaceuticals is the research, development and production of new and effective therapeutics for the market, while protecting consumers from unsafe products.
      • However, regulation may seem an obstacle in drug development, as it requires high levels of evidence of safety and efficiency of the product before approval for use.

The global market for toxicity studies outsourcing research report is further segmented by geography into North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), Latin America (Brazil, Mexico, Rest of LA), and Rest of the World.

  • In terms of geographic distribution, the North America region dominated the global toxicity studies market, owing to availability of sophisticated healthcare infrastructure, presence of large multinational companies, and increasing spending on R&D activities, and established regulatory environments.
    • The U.S. FDA’s drug and food-additive testing programs and U.S. Environmental Protection Agency’s pesticide testing program represent strategies designed to support safety evaluations of chemicals before specified uses. Other testing can occur in response to regulatory concerns regarding environmental agents.
  • On the other hand, the Asia Pacific region expected to witness the fastest double-digit growth rate in the coming years, due to the continuous increase of drug-development costs and risk-management strategies provided by numerous contract research organizations (CROs) in countries Like China, India and Brazil.

In addition, the global market for toxicity testing outsourcing report provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis, and market profitability analysis by key products and regions or countries. The report also tracks the major competitors operating in the global market by company overview, financial snapshot, major products, technologies, services offered and recent developments.

Major competitors operating in the global market for toxicity studies outsourcing and profiled in this report include Catalent, Inc., Charles River Laboratories International, Inc., Eurofins Scientific SE, ICON plc, Intertek Group plc, LabCorp Drug Development, Medpace Holdings, Inc., SGS S.A., Thermo Fisher Scientific, Inc., and Wuxi AppTec.

  • Method
    • In Vitro Testing
    • In Vivo Testing
  • GLP Type
    • Good Laboratory Practice (GLP)
    • Non-GLP
  • End User
    • Academic and Research Institutes
    • Pharmaceutical and Biopharmaceutical Companies
    • Others
  • Geography
    • North America (U.S., Canada)
    • Europe (U.K., Germany, France, Italy, Spain, Rest of EU)
    • Asia Pacific (Japan, China, India, Rest of APAC)
    • Latin America (Brazil, Mexico, Rest of LA)
    • Rest of the World
  • Company Profiles
    • Catalent, Inc.
    • Charles River Laboratories International, Inc.
    • Eurofins Scientific SE
    • ICON plc
    • Intertek Group plc
    • LabCorp Drug Development
    • Medpace Holdings, Inc.
    • SGS S.A.
    • Thermo Fisher Scientific, Inc.
    • Wuxi AppTec

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