The global In Vitro Toxicology Testing Market valued at US$10.1 billion in 2022, is forecasted to grow at a robust CAGR of 9.5%, reaching US$10.8 billion in 2023 and an impressive US$17.1 billion by 2028. This remarkable expansion is fueled by the advent of cutting-edge toxicology testing technologies and heightened investment in research and development for early toxicity detection. The market's growth trajectory is further propelled by its alignment with stringent regulations banning animal testing, leading to significant industry expansion over the past decade.
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Key Market Players of In Vitro Toxicology Testing Industry:
Key players in the in vitro toxicology testing market include Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Eurofins Scientific (Luxembourg), Laboratory Corporation of America Holdings (US), Charles River Laboratories (US), SGS SA (Switzerland), Bio-Rad Laboratories, Inc. (US), Evotec SE (Germany), Promega Corporation (US), Catalent, Inc. (US), Agilent Technologies, Inc. (US), Intertek Group plc (UK), Revvity (US), Inotiv (US), BioIVT (US), Lonza (Switzerland), Creative Biolabs (US), Shanghai Medicilon Inc. (China), Creative Bioarray (US), Aragen Life Sciences Ltd. (India), Enzo Biochem Inc. (US), Microbac Laboratories, Inc. (US), Vimta Labs Ltd. (India), Pacific BioLabs Inc. (US), and MB Research Laboratories (US).
In Vitro Toxicology Testing Market Dynamics:
DRIVER: Growing public resistance against animal testing
The increasing resistance of the public towards animal testing has been a significant driving force for the growth of the in vitro toxicology testing market. This shift in public sentiment is driven by various factors, including ethical concerns, awareness of animal rights, and a growing understanding of the limitations and ethical dilemmas associated with traditional animal testing methods. As a result, there has been a notable impetus to find alternative approaches to assess the safety and toxicity of products and substances without relying on animal experimentation. Animal testing is a highly time-consuming process and involves high costs and immense safety risks for the animals involved. Working with rodent and rabbit models also increases the risk of zoonotic diseases. The European Animal Research Association, 7th Amendment to EU Directive 76/768/EEC, passed in 2003, introduced a gradual prohibition on animal testing for cosmetics, culminating in a deadline of 2013. On March 11, 2013, the complete ban took effect, making it unlawful to market or sell cosmetics within the EU if either the finished product or its constituent ingredients had undergone testing on animals.
RESTRAINT: Failure to establish intricacies of in vivo conditions
With regulatory authorities introducing bans on animal testing in several countries for testing drugs or substances with potential hazards, in vitro toxicity testing is gaining wide recognition. However, compared to in vivo tests, in vitro toxicology testing methods still need to demonstrate their validity. In vitro tests can determine only the mechanism of action of test substances and not their outcomes after being metabolized. A chemical substance may not be harmful, but its metabolites can prove to be detrimental. One such example is a polycyclic aromatic hydrocarbon (PAH), benzo[a]pyrene, a metabolite of a chemical that is mutagenic and carcinogenic. In vivo methods are still practiced in the pharmaceuticals, food, and chemical industries to ensure the safety of substances. Research in the workings of in vivo environments is still lacking; as a result, while efforts are being made to develop in vitro techniques to simulate in vivo conditions, there are no tangible results yet. Hence, the use of in vivo methods is the major restraint of this market.
OPPORTUNITY: Increasing focus on predictive toxicology
Predictive toxicology relies on structure-activity relationship (SAR) modeling to predict biological activities in chemical structures. Such approaches have proven capabilities when applied to well-defined toxicity endpoints or regions of chemical space. Computational approaches continue to increase in capability and applicability to predictive toxicology. These advanced methodologies are utilized in various stages of the development of substances by predicting properties that correlate with toxicity endpoints, structure-activity relationship models for new chemical formulations, and building/retrieving information on chemical databases. In the field of drug design, one primary need is the early recognition of potentially toxic molecules. In fact, attrition due to nonclinical safety represents a major issue for the productivity of pharmaceutical R&D. To this end, the development of predictive toxicology assays and models has become a primary concern for drugmakers.
CHALLENGE: Complexity in data analysis and management
Complexity in data analysis and management has emerged as a major limitation to the growth of the in vitro toxicology testing market. One key factor is the sheer volume of data generated during in vitro toxicology experiments. With the advent of high-throughput screening technologies, researchers can assess thousands of compounds simultaneously, leading to massive datasets. Managing and analyzing this data requires advanced computational tools and expertise, which can be expensive and timeconsuming to develop and maintain. For example, a pharmaceutical company conducting toxicity screening for a new drug candidate may generate terabytes of data from various assays, making it challenging to extract meaningful insights efficiently. Moreover, the diversity of data types in in vitro toxicology adds to the complexity. Researchers integrate information from genomics, proteomics, metabolomics, and other omics disciplines to gain a comprehensive understanding of toxicity mechanisms. This multidimensional data landscape demands sophisticated data integration and analysis approaches, which can be a barrier for smaller companies and research institutes with limited resources.
Insights on In Vitro Toxicology Testing Market Size and Share:
Industry Insights
- Market Growth: The In Vitro Toxicology Testing Market size is experiencing substantial growth due to the increasing demand for alternative testing methods that reduce animal testing. The market is projected to expand at a robust CAGR, driven by advancements in biotechnology and the growing awareness of ethical testing practices.
- Technological Advancements: Innovations in cell culture technology, high-throughput screening (HTS), and 3D cell culture are significantly enhancing the capabilities of in vitro toxicology testing. These advancements are enabling more accurate and efficient testing, contributing to the growth of the In Vitro Toxicology Testing Market size.
- Regulatory Support: Regulatory bodies like the FDA and European Medicines Agency (EMA) are promoting the use of in vitro testing methods to ensure safety and efficacy in drug development. This regulatory support is boosting the In Vitro Toxicology Testing Market share, as more companies adopt these methods to comply with stringent regulations.
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The Europe region catered for the largest share of the in vitro toxicology testing market in 2022.
The in vitro toxicology testing market is segmented into North America, Europe, the Asia Pacific (APAC), Latin America (LATAM), and the Middle East and Africa (MEA). The European region is witnessing increasing investments to develop biologics and advanced dosage forms, with the impending patent expiration of several blockbuster drugs. The need to reduce the time and cost incurred to bring a drug to market—roughly 10 to 12 years, has contributed to the demand for in vitro toxicology testing of drugs.
Recent Developments:
- In March 2023, Agilent Technologies, Inc. (US) acquired e-MSion (US). Through this acquisition, Agilent will integrate the e-MSion's ExD cell into its portfolio of advanced workflows, instruments, and analytical solutions for biotherapeutic characterization and development.
- In January 2023, Eurofins Scientific expanded its presence in India with the establishment of a new, fully equipped, state-of-the-art laboratory campus in Genome Valley, Hyderabad. The lab will support pharma and biotech companies in the areas of synthetic organic chemistry, analytical R&D, bioanalytical services, in vivo pharmacology, safety toxicology, and formulation R&D.
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