The global in-vitro toxicology testing market size was estimated at USD 15.3 billion in 2019 and is expected to register a CAGR of 9.2% over the forecast period. The evolution of 3D cell culture systems that mimic host physiology has enabled safe testing of new compounds in the in-vitro environment, thus limiting the use of animal testing models. This has increased the acceptance of in-vitro toxicology and computational methods, consequently driving the market growth.
Growing ethical concerns regarding animal testing procedures and efforts taken by several animal welfare organizations have paved the way for the replacement or reduction of animal testing with in-vitro toxicology testing. For instance, in April 2018, the U.S. Environmental Protection Agency (EPA) introduced a draft policy that prescribes the use of in-vitro methods to minimize animal use in testing chemicals causing skin inflammation or sensitization.
The broadening horizon of high-throughput screening (HTS) techniques has encouraged drug manufacturers to adopt these cost-effective and time-efficient techniques for toxicological evaluation. For instance, in October 2019, the HTS data from the ToxCast program, initiated by the U.S. EPA to evaluate the toxic potential of chemicals, has been utilized for the risk assessment of food contact materials by employing an assessment framework called RISK 21.
In-vitro toxicology assays enable rapid assessment of safety and offer cost-saving as well as time-saving advantages. Drug developers prefer in-vitro toxicology screening of their candidate drugs, further driving the adoption of these assays. Integration of systems biology, toxicogenomics, computational toxicology, and epigenetics in in-vitro methodology also positively impact the adoption rate.
Major players focus on the expansion of their in-vitro toxicology testing offerings, thus providing lucrative avenues for market growth. For instance, in October 2018, SGS SA introduced in-vitro toxicology services at its laboratory located in Mississauga, Canada. This allowed SGS’s clients in Canada to establish toxicological profiles of drugs, chemicals, and medical devices.
Cell culture technology dominated the market in 2019 as it serves as an excellent model for examining toxic effects since it provides consistent samples and reproducible results, which enables early-stage detection of toxicity in the drug development process. Moreover, cell cultures are increasingly replacing animal testing, leading to its extensive application. In recent years, 3D cell culture models have gained significant traction due to the advantages it offers. For instance, it supports tissue-specific function, differentiation, and increases cell proliferation.
On the other hand, OMICS technology is estimated to register the highest CAGR over the forecast period as it offers personalized toxicology data, thereby providing better insights and reducing variability in the procured data. OMICS technologies largely contribute to a deeper understanding of the toxicity of nano-sized materials such as metal, carbon, and metal oxide nanoparticles. This technology led to the identification of new targets and markers in nanotoxicology as well as the detection of adverse effects of low particle concentrations on cells. Moreover, lower interference with nanoparticles is an added benefit offered by the technology.
Cellular assay dominated the market in 2019 owing to the wider availability of this technique for pharmacokinetic profiling of drug products. Moreover, several pharmaceutical and biotechnological companies are essentially dependent on cellular assays for toxicity screening in the early stages of drug development. In-vitro cell viability assays offer several advantages, such as minimal cost, speed, and potential for automation. However, these assays pose several technical challenges and are yet to completely replace animal testing, thus posing challenges to their growth. On the other hand, the ex-vivo segment is expected to grow at a considerable rate over the forecast period.
Ex-vivo or small explant cultures enable drug screening experiments to be conducted in a sterile, controlled, and dynamic environment by maintaining the native architecture of the tissues. A major advantage of using the ex-vivo model is that it performs tests or detections outside the organism and hence does not raise ethical concerns of performing tests on living subjects.
Systemic toxicology dominated the in-vitro toxicology testing market in 2019. The development of multiple organ plate with simulated blood flow for assessing systemic toxicity drives the segment growth. Moreover, several public and private organizations are taking initiatives for replacing animal testing with in-vitro techniques for acute systemic toxicity testing.
Dermal toxicity is estimated to witness significant growth over the forecast period. Toxicology assays for dermal toxicology have proven to be a simple, reliable, and cost-effective choice. Advancements pertaining to the tools for dermal toxicity and risk assessment are anticipated to drive the segment growth.
The presence of regulatory guidelines for cosmetic toxicity testing drives the demand for in-vitro testing methodologies. The availability of toxicity assays adhering to government guidelines further fuels the segment growth. For instance, the 3T3 Neutral Red Uptake Phototoxicity Assay—as described under OECD Test Guideline 432—is used to assess phototoxicity of test materials that are either topically applied to the skin or are systemically administered within the body.
Driven by the high demand for biopharmaceuticals, the usage of in-vitro toxicology testing is highest in the pharmaceutical industry. The high usage of toxicology testing in pharmacokinetic analysis of novel and generic modified pharmaceutical products results in the revenue growth of these toxicity testing assays. Moreover, the presence of several drug candidates in the pipeline is expected to drive the demand for in-vitro toxicology testing.
In order to comply with the changing regulatory guidelines for drug development, these assays are mainly used in three areas—ADME, safety pharmacology, and genotoxicity testing of drug candidates. In addition, the development of biologics and biosimilars have resulted in a higher penetration of toxicity tests based on in-vitro models.
The chemical industry is expected to register lucrative growth over the forecast period owing to ongoing advancements associated with toxicity profiling in this sector. Strategic implementation of these tools for informed and efficient safety assessment at all stages of product development is expected to drive the demand for in-vitro toxicology testing in the industry.
Several government bodies and animal welfare organizations such as the U.S. EPA, People for the Ethical Treatment of Animals, the Animal Welfare Information Center, are working toward reducing the need for animal testing. Ongoing launches of biologics and biosimilar products by biopharmaceutical manufacturers in the U.S. further drives the demand for in-vitro toxicology testing.
In addition, government agencies are involved in investment and funding initiatives for drug discovery. National Institutes of Health and Defense Advanced Research Projects Agency are among some of the agencies actively involved in generating funds for basic drug discovery research and improving the adoption of alternative modes of toxicology testing in the U.S.
The Asia Pacific region is estimated to witness the highest growth rate owing to the increasing focus of government organizations to promote toxicology testing by in-vitro methods. Moreover, conducting clinical trials in Asian countries is relatively cost-effective when compared to western nations, owing to which several biopharmaceutical companies perform their drug development procedures in this region.
Key players operating in the market include Merck KGaA; Charles River; Bio-Rad Laboratories, Inc.; Abbott; Thermo Fisher Scientific Inc.; Catalent, Inc.; GE Healthcare; Quest Diagnostics Incorporated; Eurofins Scientific; Laboratory Corporation of America Holdings; Evotec; Creative Bioarray; Gentronix; BioIVT; SGS SA; and Agilent Technologies.
Market participants are engaged in the development of software solutions to improve the in-silico simulation methods for toxicological profiling of different compounds. Market entities are also engaged in expanding their market presence by entering untapped regions and collaborating with other smaller manufacturers that offer in-vitro assays. For instance, in August 2019, Abbott signed an agreement with Intoximeters, which gave Intoximeters exclusive distribution rights to Abbott's SoToxa Mobile Test System, a handheld oral fluid solution for drug and alcohol testing in the U.S. The product enables the testing of methamphetamine, benzodiazepines, amphetamine, cocaine, cannabis (THC), and opiates.
Base year for estimation
Actual estimates/Historical data
2016 - 2018
2020 - 2027
Revenue in USD Million and CAGR from 2020 to 2027
North America, Europe, Asia Pacific, Latin America, MEA
U.S., Canada, Germany, U.K., China, Japan, Brazil, and South Africa
Revenue forecast, company share, competitive landscape, growth factors and trends
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global in-vitro toxicology testing market report on the basis of technology, method, application, end use, and region:
Technology Outlook (Revenue, USD Million, 2016 - 2027)
Cell Culture Technology
High Throughput Technology
Method Outlook (Revenue, USD Million, 2016 - 2027)
Application Outlook (Revenue, USD Million, 2016 - 2027)
End-use Outlook (Revenue, USD Million, 2016 - 2027)
Cosmetics & Household Products
Regional Outlook (Revenue, USD Million, 2016 - 2027)
Middle East and Africa (MEA)
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Biopharmaceutical innovators are at the forefront of the human response to the coronavirus pandemic. A significant number of major biotech firms are in the midst of a race to investigate the Sars-Cov-2 genome and prepare a viable vaccine for the same. As compared to the speed of response to SARS/MERs etc, the biotech entities are investigating SARs-Cov-2 at an unprecedented rate and a considerable amount of funds are being put into the R&D. With multiple candidates in trial, the public and private sectors are anticipated to work in unison for the foreseeable period, until a vaccine is developed for Covid-19. The report will account for Covid19 as a key market contributor.