In Vitro Toxicology Testing Market, by Product & Service (Assays (ELISA & Western Blot), Equipment, Consumable, Software), Toxicity Endpoints (ADME, Genotoxicity, Cytotoxicity), Technology, Method, Industry (Pharma, Cosmetics) - Global Forecast to 2028", is projected to reach USD 17.1 billion by 2028 from an estimated USD 10.8 billion in 2023, at a CAGR of 9.5% during the forecast period. Technological advancements taking place in assays and equipment being used for such studies, along with the increasing R&D expenditure to undertake toxicity studies during the early stages of drug development, are also aiding the adoption of in vitro testing. Stringent regulations have also been implemented across large parts of the globe to minimize animal testing, which has prompted the pharmaceutical and cosmetics industries to shift to in vitro methods for product testing. However, authorities are still reluctant to fully accept safety and efficacy data generated from non-animal methods, which is a major restraint to market growth.
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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:
- Lack of data availability and validation
- Complexity in data analysis and management
The consumables segment accounted for the largest share by product & service in the In vitro toxicology testing market in 2022.
By product and service, the In vitro toxicology testing market has been further categorized as consumables, assays, equipment, software, and services. Consumables accounted for the largest share of the in vitro toxicology testing market in 2022. The large share of this segment can be attributed to the increasing demand for high-quality reagents and the repeated use of media and reagents in in vitro toxicology studies. Additionally, the growing R&D activities in the pharmaceutical industry and the increased initiatives by governments in various countries to strengthen their product safety assessment capabilities are supporting the growth of this market.
The organ toxicity segment is expected to grow at a higher rate during the forecast period.
Based on the toxicity endpoints and tests, the in vitro toxicology testing market has been segmented into absorption, distribution, metabolism, and excretion (ADME), skin irritation, corrosion, and sensitization, genotoxicity, cytotoxicity, ocular toxicity, organ toxicity, phototoxicity, dermal toxicity, and other toxicity endpoints & tests. In 2022, the ADME segment accounted for the largest share of the in vitro toxicology testing market. However, the organ toxicity segment is expected to grow at a higher growth rate during the forecast period of 2023-2028. This can be attributed to increasing regulatory demands for safety assessment and reducing animal testing, continuous advancements in cell culture and tissue engineering technologies, and increasing drug development needs.
The pharmaceutical & biopharmaceutical segment accounted for the largest share of the industry segment in the in vitro toxicology testing market in 2022.
Based on industry, the in vitro toxicology testing market has been segmented into pharmaceutical & biopharmaceutical, consumer care, food, and other industries (including chemical and medical device industries). In 2022, the pharmaceutical & biopharmaceutical industry segment accounted for the largest share of the in vitro toxicology testing market. One of the major factors driving the growth of this segment is the mandate of preclinical safety assessment for the marketing approval of pharmaceutical products. Additionally, the rising investments in discovering new ways to construct molecules to study genetics and proteins and the increasing focus on reducing economic losses due to drug failures in the late stage are expected to increase the demand for in vitro tests to screen potentially toxic molecules during drug development.
The cell culture technologies segment accounted for the largest share of the technologies segment in the in vitro toxicology testing market in 2022.
Based on the technologies, the in vitro toxicology testing market has been segmented into cell culture, high-throughput screening, and toxicogenomics. In 2022, cell culture technologies accounted for the largest share. This can be attributed to the fact that it is the most preferred technique for toxicity testing owing to its capability of mimicking in vivo conditions. Cell and tissue-based technologies are commonly employed for in vitro toxicology testing in pharmacology. Cell cultures, either bacterial or mammalian, can express the same genes and proteins as their in vivo counterparts. Their ability to produce similar testing environments is one of the major factors driving the growth of this segment.
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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In Vitro Toxicology Testing Market Advantages:
- Ethical Considerations: In vitro testing methods are more humane and align with ethical concerns by reducing or eliminating the need for animal testing, thereby reducing harm to animals.
- Cost Efficiency: In vitro testing is often more cost-effective than in vivo testing, as it requires fewer resources, less time, and lower maintenance expenses.
- Rapid Results: In vitro tests can deliver results more quickly, allowing for faster decision-making in drug development, chemical safety assessments, and other applications.
- High Throughput: In vitro testing methods can be automated and conducted at a high throughput, making them suitable for screening large numbers of compounds or chemicals efficiently.
- Reduced Variability: In vitro tests offer greater control over experimental conditions, minimizing the variability often associated with in vivo tests.
- Human-Relevant Data: In vitro models can be designed to mimic human biology more closely, providing more relevant data for predicting human responses to drugs and chemicals.
- Reduced Safety Risks: In vitro testing reduces the potential risks associated with handling and testing in live animals, improving laboratory safety.
- Regulatory Acceptance: Regulatory agencies increasingly accept and encourage in vitro toxicology testing data for safety assessments, streamlining the approval process for pharmaceuticals and chemicals.
- Environmental Benefits: Reduced animal testing leads to fewer ecological impacts, such as reduced use of laboratory animals and fewer waste disposal concerns.
- Adaptability: In vitro testing can be tailored to specific research needs, enabling customization for different applications and industries.
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