San Francisco, 01 February 2024: The Report In-vitro Toxicology Testing Market Size, Share & Trends Analysis Report By Technology (Cell Culture, High Throughput), By End-use, By Application, By Method (Cellular Assay), By Product, By Region, And Segment Forecasts, 2024 - 2030

The global in-vitro toxicology testing market size is expected to reach USD 64.81 billion by 2030, registering a CAGR of 11.17% from 2024 to 2030, according to a new report by Grand View Research, Inc. Over the years, acceptance of in-vitro toxicology testing methods by regulatory authorities is increasing at a faster pace & thus validation of these tests methods opposed to conventional testing is even rising. Also, development of technologies to substitute animal use for toxicology tests has fueled the usage of in-vitro models such as in-silico simulation, assays, 3D cell cultures and many more, thereby boosting market growth.

Screening of a new drug candidate involves the use of animals for preclinical studies which is very tedious and expensive. However, in recent times, several jurisdictions are promoting ban for animal-based chemical testing. For example, for several years, the EU has been promoting the reduction, replacement, and refinement of animal tests. The Regulation on cosmetic products (1223/2009), REACH (2007/2006), the Directive on the protection of animals used for scientific purposes (2010/63), and Classification, Labelling and Packaging (CLP) (1272/2008) are some examples of EU legislation that are engaged in strongly encouraging the replacement of animal toxicology testing. Furthermore, in June 2018, the Cruelty-Free Cosmetics Act was passed in California to ban the selling of animal-tested products after 2020.

Many governments and private organization are taking actions to minimize conventional testing models, providing funds to support & develop in-vitro toxicology assays and form conducive government policies. Thus, increase in government initiatives that are focused on banning animal testing can be attributed to the rise in adoption of in-vitro toxicological models and creates many opportunities within the market. For instance, approximately USD 3.2 million were contributed by People for the Ethical Treatment of Animals (PETA) and its international associates to promote the development of non-animal test methods.

The advancements in computational and screening methods such as biological, high throughput, and chemical coupled with the vast number of public databases for toxicity analysis has expanded largely. This has allowed researchers to access information for drug discovery studies, toxicology profiling, and drug development programs. For instance, the MetaTox HS project by Agilent Technologies, Inc. brings advanced solutions for toxicity assays & high sensitivity metabolism during drug development procedures.

The growth of the market is attributed to continuous developments in toxicology research and advancement of technologies. In addition, rising emphasis on development of personalized medicines is further expected to boost the market during the forecast period. Awareness regarding the limitations and challenges associated with traditional toxicology screening methods has been growing. This has led to a broader acceptance of in-vitro testing as a valuable tool for assessing the safety and efficacy of compounds.

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In recent times, validation, and acceptance of in vitro and alternative testing methods by regulatory authorities is increasing at a lucrative rate. In addition, ongoing technological advancements to replace the use of animals for toxicology testing purposes have increased the use of in vitro screening and monitoring models. The advent of 3D cell culture is recognized as one of the most significant advancements, which enables safety testing of new compounds in the in vitro environment that mirrors the host physiology. As a result, researchers are engaged in developing and adapting novel in vitro test methods based on 3D human tissue constructs, co-culture systems, and kinetic tissue culture methods to address the various issues related to animal testing. Various examples of nonanimal technologies that are developed against animal testing are direct peptide reactivity assay, ARE-Nrf2 Luciferase assay, and Human Cell Line Activation Test (h-CLAT). Furthermore, the development of an integrated approach is recognized as a key to capitalizing on market opportunities. Another development that is anticipated to greatly influence the growth of this market is the growing trend of outsourcing toxicology assessment services.

In-vitro Toxicology Testing Market Report Highlights

• Based on technology, Cell culture technology segment held a dominant market share of 43.88% in the global market in 2023, owing to the increased demand for accurate & cost-effective analysis. Moreover, the adoption of 3D cell culture is also propelling the growth of this segment
• On the basis of application, the systemic toxicology application segment dominated the market in 2023. Generation of toxicology data points such as minimum dose, tolerated dose, risk assessment and many more will contribute to the revenue generation
• The cellular assay accounted for the largest share in terms of revenue and is expected to grow over the forecasted period, owing to the developments in cell-based imaging assays, high throughput screening & label-free detection
• The pharmaceutical industry end-use segment held a major share in the market in 2023. The importance of toxicology testing during drug development stages coupled with high number of product pipeline attributes to the revenue generation
• North America dominated the market and accounted for a 47.73% share in 2023 due to prevalence of animal testing bans & supportive government initiatives for toxicology research. In addition, aggregation of players in this regions to provide in-vitro testing product and services will continue the revenue generation during the forecast 

The usage of new food additives along with innovations in food contact substance development has propelled manufacturers and researchers to explore the use of high-throughput chemical toxicity testing. Moreover, limited resources with respect to budget and time for examining chemicals have fomented the product manufacturers to adopt new cost-effective methods for animal-free (in vitro) High-Throughput Screening (HTS). One such method is the quantitative HTS (qHTS) program, which is considered a cost- and time-efficient method for toxicological evaluation. Furthermore, ongoing development in these programs is anticipated to expand the application scope of in vitro testing market. For example, the development of Collaborative Programs Tox21, a multi-agency, automated qHTS program, for efficient safety testing of chemicals by enhancing efficiency along with reduction of overall testing costs. However, such a program exhibits certain challenges such as extrapolation of such data to decide in vivo doses. Moreover, the data required to implement the use of information acquired from in vitro testing assay to estimate and validate the dosage of a drug product in the target organ or disease site are often unavailable.

Furthermore, several academic centers have taken in vitro toxicology initiatives to expand on the use of in vitro models across various applications, such as skin toxicity and genotoxicity. Development and implementation of suitable in vitro models that deliver highly relevant biological data across several therapeutic areas are aiding segment growth; for example, the use of Reinnervate’s Alvetex, a synthetic scaffold, to design 3D culture assays for routine assessment of cancer cell cytotoxicity. Moreover, a group of researchers from the University of CESPU Health Sciences Department, Portugal, and Albert Labs International Corp. announced a collaboration to conduct toxicology testing on KRN-101, a candidate for mental health.

In-vitro Toxicology Testing Market Report Scope

Additionally, in-vitro toxicological testing has seen substantial success in different areas like genetic toxicology, skin absorption, and reproductive toxicology. The “EpiSkin test” is an example of in-vitro toxicology testing as it uses the human epidermis instead of rabbit skin to perform an irritation study. The major players present in the market include Agilent Technologies, Covance, Bio-Rad Laboratories, General Electric Company, Eurofins Scientific SE, BioReliance, Charles River Laboratories International, Thermo Fisher Scientific, Catalent, and Cyprotex. For instance, in January 2023, AmplifyBio raised USD 50 million to improve its business plans. In March 2022, Toxys BV opened a new office in the U.S. to expand its business processes and operations in the international market. The company provides in vitro toxicology services in a wide range of areas.

List of Key Players in the In-vitro Toxicology Testing Market

• Charles River Laboratories International, Inc.
• SGS S.A.
• Merck KGaA
• Eurofins Scientific
• Abbott Laboratories
• Laboratory Corporation of America Holdings
• Evotec S.E.
• Thermo Fisher Scientific, Inc.
• Quest Diagnostics Incorporated
• Agilent Technologies, Inc.
• Catalent, Inc.
• Danaher Corporation
• Bio-Rad Laboratories, Inc.
• BioIVT
• Gentronix