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    US ADME Toxicology Testing Market

    ID: MRFR/LS/17738-HCR
    100 Pages
    Rahul Gotadki
    September 2025

    US ADME Toxicology Testing Market Research Report By Method (Cellular Assay, Biochemical Assay, In Silica, Ex-vivo), By Technology (Cell Culture, High Throughput, Molecular Imaging, OMICS Technology), By Application (Systemic Toxicity, Renal Toxicity, Hepatotoxicity, Neurotoxicity, Others) and By End-Users (Hospitals and clinics, Diagnostic centers, Pathological Labs, Others) - Forecast to 2035

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    US ADME Toxicology Testing Market Infographic
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    US ADME Toxicology Testing Market Summary

    The US ADME Toxicology Testing market is projected to experience substantial growth from 166.7 million USD in 2024 to 893.4 million USD by 2035.

    Key Market Trends & Highlights

    US ADME Toxicology Testing Key Trends and Highlights

    • The market is expected to grow at a compound annual growth rate of 16.49 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 893.4 million USD, indicating robust expansion.
    • In 2024, the market is valued at 166.7 million USD, reflecting a strong foundation for future growth.
    • Growing adoption of advanced testing technologies due to increasing regulatory requirements is a major market driver.

    Market Size & Forecast

    2024 Market Size 166.7 (USD Million)
    2035 Market Size 893.4 (USD Million)
    CAGR (2025-2035) 16.49%

    Major Players

    Intertek, Laboratory Corporation of America, Invivo Therapeutics, Syngene International, MilliporeSigma, PerkinElmer, Thermo Fisher Scientific, Wuxi Apptec, Agilent Technologies, BioAgilytix, Eurofins Scientific, Covance, Charles River Laboratories, ICON plc, Life Technologies

    US ADME Toxicology Testing Market Trends

    The US ADME Toxicology Testing Market is experiencing significant growth driven by several key market drivers. An increasing emphasis on drug safety and the need for regulatory compliance play major roles in shaping this market. The US Food and Drug Administration (FDA) and other regulatory bodies are setting stringent guidelines that require comprehensive toxicology testing as part of the drug development process. This regulatory landscape is compelling pharmaceutical companies to invest more in toxicology testing services to align with safety standards, thus driving market demand.

    Opportunities abound for innovation in this sector, especially with the advancement of in vitro technologies and computational toxicology, which can provide more accurate and reliable results while saving time and costs in drug development. Furthermore, the ongoing shift towards personalized medicine opens new avenues for ADME toxicology testing services that cater specifically to individualized patient responses to medications. Trends in recent times have also highlighted the adoption of high-throughput screening technologies, which allow for faster testing and better risk assessment in early drug development stages.

    Additionally, there is a growing interest in using biomarkers for toxicity testing, improving the relevance and predictive power of toxicological assessments. These developments are indicative of an industry that is rapidly evolving, with more focus on reducing the reliance on animal testing and utilizing alternative methods that align with ethical considerations. Overall, the US market reflects a blend of regulatory compliance demands, evolving technologies, and a strong commitment to improving drug safety, making it a dynamic landscape for ADME toxicology testing.

    Market Segment Insights

    ADME Toxicology Testing Market Method Insights

    The Method segment of the US ADME Toxicology Testing Market encompasses various innovative approaches essential for evaluating the absorption, distribution, metabolism, and excretion of substances, playing a crucial role in drug development and safety assessment. Among these methods, Cellular Assay techniques are significantly prevalent as they provide valuable information on cell viability, cytotoxicity, and the biochemical interactions of compounds at the cellular level. This method allows for a robust understanding of how drugs interact with living cells, thereby assisting in the early detection of toxic effects.

    Biochemical Assays contribute substantially by measuring the biochemical activity of compounds and their effects on biological systems, offering crucial insights needed for risk assessment and regulatory compliance. In Silica approaches have gained prominence as they utilize computer-based simulations to predict the behavior of compounds, significantly reducing the time and resources required for experimental testing while enhancing the predictive accuracy of toxicological data. Meanwhile, Ex-vivo testing involves studying the effects of substances on biological samples extracted from living organisms, providing a realistic view of how these substances would behave in a living system.

    Each of these methodologies presents unique advantages and is essential for a comprehensive understanding of toxicological profiles, contributing to more informed decision-making in Research and Development settings. With the growing emphasis on efficient drug testing and regulatory requirements in the US, these methodologies are becoming increasingly vital, reflecting the evolving nature of the US ADME Toxicology Testing Market. Notably, the integration of these methods with advanced technologies also creates opportunities for improved accuracy and reduced animal testing, which is becoming an important consideration in both regulatory frameworks and ethical practices within the industry.

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    ADME Toxicology Testing Market Technology Insights

    The Technology segment of the US ADME Toxicology Testing Market encompasses several key areas that are crucial for drug development and safety assessment. Cell Culture technologies are integral as they provide a controlled environment for studying cell behavior and the efficacy of compounds. High Throughput technologies dominate the landscape due to their ability to process large volumes of samples quickly and efficiently, significantly speeding up the screening process in pharmaceutical research. Molecular Imaging plays a vital role by enabling real-time visualization of biological processes, thus enhancing understanding of drug action and toxic effects.

    Spatial OMICS Technology, which includes genomics, proteomics, and metabolomics, is important for its comprehensive approach to analyzing biological molecules, offering insights into the complex pathways affected by drug substances. These advancements are driving innovations in the industry, addressing the need for more effective testing methodologies to ensure safety and efficacy in drug development, which is particularly relevant given the regulatory pressures and the growing demand for personalized medicine in the US market.

    ADME Toxicology Testing Market Application Insights

    The US ADME Toxicology Testing Market, particularly in the Application segment, is experiencing notable evolution as it encompasses critical areas such as Systemic Toxicity, Renal Toxicity, Hepatotoxicity, Neurotoxicity, and others. Systemic Toxicity testing plays a fundamental role in drug development, ensuring that compounds are safe when taking into account the overall physiological effects on the body. Renal Toxicity is garnering increased attention due to the high prevalence of kidney-related issues in patients, highlighting the need for detailed evaluations of drug impacts on renal function.

    Hepatotoxicity assessments are paramount, as liver damage from pharmaceutical agents is a common concern in medication toxicity, necessitating thorough testing. Likewise, Neurotoxicity evaluations are crucial given the significant number of drugs affecting the nervous system, which can lead to long-term health implications if not adequately assessed. Collectively, these areas reflect a comprehensive approach to toxicity testing in the US, emphasizing patient safety and optimizing the drug development pipeline. Understanding the intricacies of these applications aids in improving drug design while aligning with regulatory requirements, enhancing the overall US ADME Toxicology Testing Market industry.

    ADME Toxicology Testing Market End-Users Insights

    The US ADME Toxicology Testing Market accounted for a significant share, highlighting the essential role played by End-Users in ensuring drug safety and efficacy. Hospitals and clinics are crucial in this segment, as they often require comprehensive toxicology testing to support their patient care processes and clinical trials. Diagnostic centers also contribute considerably, providing specialized testing services that help identify potential drug interactions and toxic effects. Pathological Labs are vital for conducting detailed analyses that inform both treatment decisions and regulatory submissions.

    Additionally, the 'Others' category includes various research institutions and pharmaceutical companies that utilize toxicology testing to support their Research and Development initiatives. This segmentation reflects the growing adoption of advanced testing methodologies within the US healthcare system, driven by stricter regulatory requirements and an increasing focus on personalized medicine. Collaboration between these end-users promotes innovation and efficiency in toxicology testing, enhancing drug development processes and patient outcomes. Overall, the segment continues to evolve in response to the expanding demand for stringent testing protocols that ensure drug safety and efficacy in real-world applications.

    Get more detailed insights about US ADME Toxicology Testing Market

    Key Players and Competitive Insights

    The US ADME Toxicology Testing Market is characterized by a dynamic and highly competitive landscape where numerous players vie for market share. This market has witnessed significant growth, driven by the increasing demand for drug discovery and development processes, coupled with stringent regulatory requirements necessitating thorough safety assessments of pharmaceutical compounds. The competitive insights reveal that companies are focusing on innovation, technological advancements, and strategic collaborations to enhance their service offerings and improve operational efficiency.

    By leveraging cutting-edge technologies, regulatory compliance, and a strong emphasis on customer-centric solutions, these organizations are carving out a strong presence in a market that continues to expand as new therapies and drugs are developed. The rise in biopharmaceuticals also adds impetus to the need for robust ADME (Absorption, Distribution, Metabolism, and Excretion) testing services, positioning players to effectively navigate market trends and capitalize on emerging opportunities.

    Intertek has established a formidable presence in the US ADME Toxicology Testing Market, leveraging its extensive experience and expertise in the field to deliver high-quality testing services. Known for its commitment to maintaining rigorous quality standards, Intertek is widely recognized for its ability to adapt to the complex regulatory landscape, ensuring compliance with FDA and other regulatory bodies. The company's strengths lie in its comprehensive testing capabilities, which include in vitro and in vivo studies that provide critical insights into the pharmacokinetics of drug candidates.

    Furthermore, Intertek's global network facilitates seamless access to a variety of specialized technologies and methodologies, ensuring that its clients benefit from the latest scientific advancements. Their strategic emphasis on client relationships and customized solutions effectively positions them to meet the diverse needs of sponsors and researchers in the rapidly evolving ADME toxicology space.

    Laboratory Corporation of America has solidified its role as a key player in the US ADME Toxicology Testing Market by offering a broad range of testing services that cater specifically to the needs of pharmaceutical and biotechnology companies. With a strong focus on providing accurate and timely results, Laboratory Corporation of America's services include comprehensive toxicology testing, which is instrumental in assessing the safety and efficacy of drug candidates. The company's strengths are further demonstrated through its extensive laboratory network, allowing for streamlined operations and efficient service delivery across the United States.

    Additionally, Laboratory Corporation of America is known for strategic mergers and acquisitions that bolster its capabilities and enhance its market position. By integrating advanced technologies and methodologies, the company maintains its competitive edge, ensuring that it addresses the evolving needs of clients while adhering to regulatory guidelines. Their commitment to innovation and operational excellence continues to sustain their prominence in the competitive landscape of ADME toxicology testing.

    Key Companies in the US ADME Toxicology Testing Market market include

    Industry Developments

    Recent developments in the US ADME Toxicology Testing Market indicate a dynamic landscape with significant growth driven by increasing demand for drug safety and efficacy assessments. Companies such as Intertek and Laboratory Corporation of America have been enhancing their testing capabilities to meet regulatory needs and consumer safety standards. Additionally, a noteworthy acquisition occurred in June 2023 when Charles River Laboratories acquired the biopharmaceutical services segment of WuXi AppTec, expanding its portfolio and strategic offerings in the toxicology space.

    Moreover, investment in innovation remains high, particularly with companies like Thermo Fisher Scientific and Agilent Technologies focusing on advanced technologies to enhance testing efficiency and accuracy.

    The ongoing developments in the biopharmaceutical and biotechnology sectors continue to stimulate growth in the ADME toxicology testing market, as stakeholders emphasize the importance of comprehensive assessments in drug development. Over the past few years, notable changes have included the adoption of AI and automation within testing processes, which began to gain traction around early 2021, reflecting a broader trend of technological integration across the industry. As regulatory landscapes evolve, the emphasis on reliable toxicology testing is anticipated to rise further, influencing market dynamics significantly.

    Market Segmentation

    ADME Toxicology Testing Market Method Outlook

    • Cellular Assay
    • Biochemical Assay
    • In Silica
    • Ex-vivo

    ADME Toxicology Testing Market End-Users Outlook

    • Hospitals and clinics
    • Diagnostic centers
    • Pathological Labs
    • Others

    ADME Toxicology Testing Market Technology Outlook

    • Cell Culture
    • High Throughput
    • Molecular Imaging
    • OMICS Technology

    ADME Toxicology Testing Market Application Outlook

    • Systemic Toxicity
    • Renal Toxicity
    • Hepatotoxicity
    • Neurotoxicity
    • Others

    Report Scope

    Report Attribute/Metric Source: Details
    MARKET SIZE 2018 148.74(USD Million)
    MARKET SIZE 2024 166.74(USD Million)
    MARKET SIZE 2035 893.39(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 16.486% (2025 - 2035)
    REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR 2024
    MARKET FORECAST PERIOD 2025 - 2035
    HISTORICAL DATA 2019 - 2024
    MARKET FORECAST UNITS USD Million
    KEY COMPANIES PROFILED Intertek, Laboratory Corporation of America, Invivo Therapeutics, Syngene International, MilliporeSigma, PerkinElmer, Thermo Fisher Scientific, Wuxi Apptec, Agilent Technologies, BioAgilytix, Eurofins Scientific, Covance, Charles River Laboratories, ICON plc, Life Technologies
    SEGMENTS COVERED Method, Technology, Application, End-Users
    KEY MARKET OPPORTUNITIES Increased drug development, Advanced in vitro testing, Integration of AI technologies, Regulatory compliance demands, Rise in personalized medicine
    KEY MARKET DYNAMICS Increasing regulatory requirements, Advancements in testing technologies, Rising drug development costs, Growing demand for personalized medicine, Emphasis on alternative testing methods
    COUNTRIES COVERED US

    FAQs

    What is the expected market size of the US ADME Toxicology Testing Market in 2024?

    The US ADME Toxicology Testing Market is expected to be valued at 166.74 USD Million in 2024.

    What is the projected market size of the US ADME Toxicology Testing Market by 2035?

    By 2035, the US ADME Toxicology Testing Market is estimated to reach 893.39 USD Million.

    What is the expected compound annual growth rate (CAGR) for the US ADME Toxicology Testing Market between 2025 and 2035?

    The expected CAGR for the US ADME Toxicology Testing Market from 2025 to 2035 is 16.486%.

    Which sub-segment of the US ADME Toxicology Testing Market is expected to have the highest value in 2035?

    The Cellular Assay sub-segment is expected to have the highest value, projected at 260.0 USD Million in 2035.

    Which major players are currently dominating the US ADME Toxicology Testing Market?

    Some key players in the market include Intertek, Laboratory Corporation of America, and Charles River Laboratories.

    What is the market value of the Biochemical Assay sub-segment in 2024?

    The Biochemical Assay sub-segment is valued at 40.0 USD Million in 2024.

    What market value is expected for the In Silica method by 2035?

    The In Silica method is expected to reach a market value of 180.0 USD Million by 2035.

    How much value is the Ex-vivo method projected to hold in 2035?

    The Ex-vivo method is projected to have a market value of 243.39 USD Million in 2035.

    What opportunities exist in the US ADME Toxicology Testing Market?

    The market presents opportunities driven by technological advancements and increasing demand for toxicity testing.

    What are the anticipated challenges facing the US ADME Toxicology Testing Market?

    Challenges may include regulatory hurdles and the need for continuous innovation in testing methodologies.

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