Toxicology Testing Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Canada, UK, Germany, China - Size and Forecast 2024-2028

Toxicology Testing Market Forecast 2024-2028

The global toxicology testing market size is estimated to grow by USD 32.58 billion at a CAGR of 15.61% between 2023 and 2028. 

The surge in pharmaceutical and biotechnology firms is driven by the escalating incidence of diseases like cancer, necessitating novel drug development. Metabolites produced during Phase I reactions in drug metabolism demand rigorous safety evaluation due to their chemical reactivity. A successful drug is characterized by a balance of potency, efficacy, safety, and favorable pharmacokinetics, ensuring optimal concentration at the target site without toxicity. To avert late-stage failures, toxicology testing, and ADMET studies are now conducted early in the discovery process. Biotechnology products derived from rDNA technology undergo stringent safety assessments, contributing to the rigorous scrutiny of bio-based products. The proliferation of pharmaceutical and biotech companies drives the demand for toxicology testing, fostering the growth of the market.

What will be the Size of the Market During the Forecast Period?

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The market witnesses a surge in demand driven by evolving regulatory adjustments, buying behavior and policy shifts. Key stakeholders, including academic institutes and research organizations, rely on advanced technologies like high-throughput screening and proteomics for comprehensive data analysis. With rising concerns over public sentiment and animal rights, in vitro and ex vivo models play a pivotal role. Collaborative networks between instrument suppliers, data management providers, and testing facilities enhance testing patterns. The healthcare landscape benefits from digital platforms and innovative testing methodologies, ensuring workplace safety and facilitating forensic investigations, sports, and addiction treatment.

Market Segmentation

The market encompasses a wide array of approaches, from traditional animal studies to cutting-edge in vitro testing methods. Within this market, 3D cell culture techniques offer enhanced physiological relevance, while nonanimal technologies like the Direct Peptide Reactivity Assay and ARE-Nrf2 Luciferase Assay provide ethical alternatives. Outsourcing toxicology assessment services is increasingly popular, allowing companies to access specialized expertise. In the treatment segment, antidotes such as activated charcoal are crucial for addressing acute poisonings, while medications target specific toxic effects on vital bodily functions. Diagnosis focuses on identifying exposure through biomonitoring, critical for addressing risks from toxic substances in food items and environmental pollution.

By End-user  

The market share growth by the pharmaceutical industry segment will be significant during the forecast period. This is fundamental for the growth of a pharmaceutical company as a drug or biologic can only be launched and sold commercially once it goes through a successful process. It involves the study of the safety and biological effects of drugs and chemical agents on a living organism. 

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The pharmaceutical industry segment was the largest and was valued at USD 5.92 billion in 2018. The pharmaceutical industry continuously develops new drug candidates to address unmet medical needs and expand therapeutic options. The rise in chronic diseases and conditions, such as cancer, has increased the demand for new drugs and personalized medicines. Overall, the demand in the pharmaceutical industry is driven by regulatory requirements, risk mitigation objectives, quality assurance needs, and the imperative to develop safe and effective drugs that address unmet medical needs while maintaining compliance with regulatory standards and ensuring patient safety, which is leading to the demand for this process in the pharmaceutical industry which in turn will boost the growth of the market during the forecast period.

By Technology  

Cell culture technology is used for screening toxicity both by estimation of the basal functions of the cell or by tests on specialized cell functions. Numerous cell types are used in general toxicity tests, which primarily aim to assess the biological activity of test chemicals (e.g., fibroblasts, HeLa, and hepatoma cells). Endpoints used to quantify toxicity include vital staining, cytosolic enzyme release, cell proliferation, and cloning effectiveness. Further, when a chemicals in-vivo toxicity is well known and in-vitro studies employing specialist cell cultures have been employed to elucidate the mechanisms of harmful action on the target tissue, cytotoxicity testing using specialized cells has proven to be most helpful. Additionally, these tests have helped shed light on the pathogenesis of a few human diseases. Cell culture technology holds a major share in the market in 2023, which is expected to boost the growth of the market during the forecast period.

In the context of toxicology testing, high throughput technology allows for the screening and analysis of numerous samples efficiently, which is particularly valuable in applications where large-scale testing is required such as drug discovery, environmental monitoring, and clinical diagnostics. Continuous advancements in automation and robotics have enhanced the capabilities of high throughput technology, enabled the automation of complex laboratory workflows, and reduced manual labor and human error. This has resulted in increased throughput, improved reproducibility, and higher efficiency in sample processing and analysis. The pharmaceutical industry is increasingly relying on (HTS) and other high throughput technologies to accelerate drug discovery and development processes. Thus, the need for rapid, accurate, and cost-effective analysis across various industries and disciplines will lead to the growth of the segment as well as the market during the forecast period.

Regional Analysis

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North America is estimated to contribute 43% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional market trends and drivers will shape the market during the forecast period. The market in North America is led by the US and Canada. The reason for their high contribution is the increasing adoption of these techniques by the pharmaceutical and biotechnology industries in these countries. The industries are growing in number due to the need for drug discovery due to the emergence of new diseases and the prevalence of chronic diseases. In addition to easy access and an adequate amount of government funding and investments, government programs such as the National Toxicology Program (NTP) and Environmental Protection Agency (EPA) Office of Pesticide Programs have increased the adoption rate of toxicology testing products.

For instance, the EPA Office of Pesticide Programs regulates the use of pesticides under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Through FIFRA, the EPA mandates toxicity tests of conventional chemical pesticides. Further, the rise in the number of collaborations and acquisitions between companies that deal with products will boost the market growth during the forecast period.

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Key Market Players 

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:

 Abbott Laboratories - The company offers toxicology testing solutions such as iCup Drug Screen, which is an all-inclusive, on site urine drug screening device. The device simplifies the collection process and tests for up to 17 drugs.

Agilent Technologies Inc., Danaher Corp., BioIVT LLC, Bio Rad Laboratories Inc., Catalent Inc., CompuDrug Ltd., Charles River Laboratories International Inc., Eurofins Scientific SE, Evotec SE, LABORATORY CORPORATION OF AMERICA HOLDINGS, Merck KGaA, PerkinElmer Inc, Quest Diagnostics Incorporated, Thermo Fisher Scientific Inc., SGS SA, Aragen Life Sciences Pvt. Ltd., BICO Group AB, Ingenza Ltd, and Randox Laboratories Ltd.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Dynamics and Customer Landscape

The market is driven by a shift towards ethical and efficient nonanimal technologies such as in vitro testing methods and advanced assays like the ARE-Nrf2 Luciferase assay. Emerging trends include the adoption of 3D cell culture for more accurate assessments and the outsourcing of toxicology assessment services for specialized expertise. Challenges persist in ensuring the reliability and regulatory acceptance of alternative methods, as well as addressing the complexities of assessing the effects of new compounds on vital bodily functions in the context of environmental pollution and food safety. Our researchers analyzed the market research and growth data with 2023  as the base year, along with the key market growth analysis, trends, and challenges. A holistic analysis of drivers, trends, and challenges will help companies refine their marketing strategies to gain a competitive advantage. 

Key Market Drivers

Increasing use of in-vitro tests as an alternative to animal testing is notably driving market growth. The traditional approach to toxicology testing relies on animal experimentation, but increasing concerns over animal welfare and the high costs associated with such methods have spurred a shift towards alternatives. Global animal welfare organizations like PETA advocate for ethical treatment and seek to minimize animal use in research. This has led to the promotion of the 3Rs principle such as replacement, refinement, and reduction of animal testing.

In-vitro tests offer a viable solution, mimicking human reactions to chemical compounds without the need for animal subjects. They provide high-throughput capabilities, enabling rapid testing of numerous compounds. For example, biochip technology allows the testing of ten thousand compounds within days. In-vitro testing is not only economically feasible but also ethically sound, driving growth in the market as it aligns with societal values and regulatory pressures. Such factors will propel the growth of the market during the forecast period.

Significant Market Trends

Increased use of toxicology testing in forensics is an emerging trend shaping market growth. Forensic toxicology deals with the investigation of toxic substances, environmental chemicals, and poisonous or hazardous products. Currently, the field of forensics has evolved to mean the study of legal and illegal drugs, including alcohol. It involves the study and identification of the chemical makeup of each substance from various sources, such as hair or urine. It studies the way the substances are absorbed, metabolized, distributed, or eliminated in the body. When studying drugs and how they react in the body, forensic toxicology helps to find out where the drug has affected the body and how this occurs. It is also being used to assess people who drive with a blood alcohol concentration over the accepted legal limit.

Further, another application of forensic toxicology relates to sexual assault, which involves the use of drugs. These days drugs are being used to unconscious the victim, who is then sexually assaulted. Through toxicology testing, it is found out what drug was given to the victim, who can then be treated accordingly. Thus, with an increase in crime scenes and awareness about technologies related to forensic toxicology, there will be an increase in demand for products for solving issues related to forensics, which will fuel the growth of the market during the forecast period.

Major Market Challenges

The lack of skilled professionals is a significant challenge hindering market growth. A major challenge in these scientific fields is the lack of technically skilled and trained staff, i.e., toxicologists. A shortage of skilled professionals means that toxicology laboratories may have limited capacity to conduct testing. This can result in longer wait times for testing services, which may discourage organizations from seeking out these services. The often complex and requires sophisticated techniques and instruments for various analysis procedures. The most important component in biopharmaceutical, university, and forensic science is the professional and scientific staff. The minimum required skills are usually gained through formal education, training, and operational (on-the-job) experience.

Toxicology testing requires a lot of prior knowledge of chemical components and their metabolizing process in the living system, as certain concentrations of chemicals can be lethal for cells or alter the genetic system (change in gene sequence, i.e., mutation). Extensive training and experience are required to operate all stages for accurate toxicology testing. A lack of skilled professionals could lead to errors or inconsistencies in testing procedures, raising concerns about the quality of the results provided by testing laboratories. The limited number of such trained professionals will act as a challenge to the growth of the market during the forecast period.

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Market Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth and forecasting strategies.

 Customer Landscape

Segment Overview

The market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2018 to 2028. 

•  End-user Outlook
  • Pharmaceutical industry
  • Food industry
  • Chemicals and others

• Technology Outlook
  • Cell culture technology
  • High throughput technology
  • Molecular imaging
  • OMICS technology

• Region Outlook
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • Rest of World (ROW)
    • Brazil
    • Argentina 
    • Australia 

Market Analyst Overview 

The market in the pharmaceutical/biotechnology sector is driven by advancements in preclinical evaluation and pharmacokinetic profiles, focusing on ADME properties. Technologies like combinatorial chemistry and high throughput screening enhance drug discovery. The market sees consolidation in ADME services with key providers. Regulatory guidelines and ethical concerns shape in vitro ADME testing. Stakeholders include pharmaceutical & biotechnology companies, research institutes, and regulatory authorities. Predictive toxicology and computational approaches aid in drug design. The market also caters to consumer care and the chemical industry, emphasizing safety measures and quality check products for comprehensive drug testing.

Moreover, the market in the pharmaceutical/biotechnology sector is witnessing significant growth, driven by technological advancements in ADME services. Key providers offer in vitro ADME toxicology testing, aligning with regulatory guidelines. The market includes stakeholders like consumer care companies, research institutes, and technology providers. With a focus on precision toxicology and safety pharmacology, this market addresses healthcare priorities and substance use issues. Advancements in high-throughput screening and toxicogenomics enhance toxicology drug testing, crucial for pharmaceutical research and manufacturers. Regulatory-approved therapies and advanced models like PhysioMimix drive the market's expansion, addressing prevalent drug abuse and clinical drug monitoring needs.

Further, the market in the pharmaceutical/biotechnology sector is witnessing consolidation with key service providers focusing on ADME. Market reports highlight the competitive landscape and regulatory guidelines for in vitro ADME testing. Stakeholders, including academic institutes and instrument suppliers, are key players in advancing high-throughput screening and omics disciplines. The market is driven by  rise  in  demand for safer pharmaceuticals and mental health testing, with a shift towards remote testing and telemedicine. Policy adjustments and technological advancements are shaping the landscape, emphasizing the need for safe workplace and clinical drug monitoring.

Market Scope
Report Coverage	Details
Page number	178
Base year	2023
Historic period	2018-2022
Forecast period	2024-2028
Growth momentum & CAGR	Accelerate at a CAGR of 15.61%
Market Growth 2024-2028	USD 32.58 billion
Market structure	Fragmented
YoY growth 2023-2024(%)	15.18
Regional analysis	North America, Europe, Asia, and Rest of World (ROW)
Performing market contribution	North America at 43%
Key countries	US, Canada, UK, Germany, and China
Competitive landscape	Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks
Key companies profiled	Abbott Laboratories, Agilent Technologies Inc., Danaher Corp., BioIVT LLC, Bio Rad Laboratories Inc., Catalent Inc., CompuDrug Ltd., Charles River Laboratories International Inc., Eurofins Scientific SE, Evotec SE, LABORATORY CORPORATION OF AMERICA HOLDINGS, Merck KGaA, PerkinElmer Inc, Quest Diagnostics Incorporated, Thermo Fisher Scientific Inc., SGS SA, Aragen Life Sciences Pvt. Ltd., BICO Group AB, Ingenza Ltd, and Randox Laboratories Ltd.
Market dynamics	Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the forecast period.
Customization purview	If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the growth of the between 2024 and 2028
• Precise estimation of the size and its contribution of the market in focus to the parent market
• Detailed analysis of customer landscape covering Diver of price sensitivity, Adoption of the lifecycle, and key purchase criteria 
• Companies landscape comparing criticality of inputs and factors of differentiation
• Exclusive Matrix on companies position and classification
• Accurate predictions about upcoming trends and changes in consumer behavior
• Growth of the market across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of companies

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