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Mutagenicity testing and genotoxicity testing market is estimated to be $1.01 billion in 2023 and is anticipated to grow at a CAGR of 7% during the forecast period 2023-2035. Genotoxicity refers to the property of hazardous (physical, chemical and biological) agents to cause damage to genetic information present within a cell. It is worth mentioning that this damage can lead to formation of mutations, activation of mistimed event and direct DNA damage. Further, researchers have been able to link the mutations caused by genetic toxicology to various disease indications, including several oncological and genetic disorders. In addition, it is believed that the changes introduced in the genetic material can be passed down to future cell generations. Similarly, mutagenicity refers to the introduction of transmissible changes to the amount and structure of genetic material of organisms, leading to irreversible changes, known as mutations. Therefore, it is crucial to conduct the mutagenicity testing and genotoxicity testing for the safety assessment of products, with the objective of preventing hazardous chemicals from negatively impacting the human health. In addition, mutagenicity and genotoxicity assays conducted during an early stage of product scale-up, can notify process engineers to consider process modifications in order to prevent the synthesis of an intermediate with significant potential for causing genetic damage. At present, genotoxicity assays are frequently employed across several industries, such as healthcare, chemical, cosmetic, food and agriculture, in order to determine whether a particular compound induces damage. However, since there is no particular test available for identifying all relevant genotoxic endpoints, a series of in vivo and in vitro genotoxicity testing techniques are employed to assess the safety of healthcare compounds. Short-term tests (STTs) are often used as the first step in genotoxicity testing. These tests are relatively inexpensive and quick to perform, and they can be used to screen a large number of substances. Some common STTs include the Ames assay (performed in different strains of Salmonella typhimurium and in Escherichia coli) and the micronucleus assay. These genotoxicity assays usually assess the safety of environmental chemicals and consumer products, as well as investigate the mode of action of suspected carcinogens. Additionally, with the rapid development of next-generation sequencing technology, several new methods for genotoxicity testing have been introduced that can enable players to directly analyze the genetic materials. However, owing to the lack of required chemistry capabilities and limited in-house expertise, the stakeholders have started relying on testing service providers for assessing the safety of their compounds. The service providers offer a range of customized genotoxicity testing services for the toxicity evaluation for drug as well as medical device development as recommended by regulatory agencies in most countries. Overall, the growing demand for testing of healthcare products and the stringent safety requirements established by several regulatory bodies across the globe for the mutagenicity testing and genotoxicity testing of human-use substances, has created lucrative opportunities for genotoxicity testing / mutagenicity testing service providers.
The Mutagenicity Testing and Genotoxicity Testing Market by Type of Assay (In vivo, In vitro and Non-GLP / Screening), Assay / Test Offered (Comet Assay, Micronucleus Assay, Chromosomal Aberration Test, Genetic Mutation Test and Others), End User Industry (Chemical Industry, Healthcare Industry, Agriculture Industry, Cosmetic Industry and Other Industries) and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa): Industry Trends and Global Forecasts, 2023-2035 market report features an extensive study of the current market landscape, market size and future opportunities for the companies offering genotoxicity testing services and / or mutagenicity testing services, during the given forecast period. Further, the market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the industry. Key takeaways of the mutagenicity testing and genotoxicity testing market are briefly discussed below.
Mutagenicity and genotoxicity assays are considered to be crucial in ensuring the safety of substances intended for human consumption. Specifically in the case of pharmaceuticals, potential sources of endotoxins include water, packaging components, equipment, and chemical / raw materials used during the development and manufacturing of a drug product. As a result, genetic toxicology testing is a necessary regulatory requirement for approving new drugs. In fact, mutagenicity testing and genotoxicity testing have been integrated into early-stage drug discovery, allowing the identification of compounds with genotoxic liabilities prior to further drug development. This helps avoid costly setbacks and delays in project timelines.
In order to test mutagenicity and carcinogenicity properties, several standard assays are currently in use. These tests can broadly be divided into two main categories, namely in vitro assays and in vivo assays. In vitro assays are conducted using cells and microorganisms, and they are relatively quick to perform. Some common in vitro genotoxic assays include the Ames assay, micronucleus assay, chromosomal aberration assay, genetic mutation assay, and the comet assay. After the in vitro study, if there is any positive response, a follow-up in vivo study of the same endpoint is usually recommended. In vivo assays are conducted in live animals such as mice or rats, and they are more expensive and time-consuming than in vitro assays. However, these genotoxic assays provide more information about the mechanism of action of test compounds. In addition to the standard genotoxicity assays, there are a number of advanced assays, such as ToxTracker® assay, 3D cell culture assay and high-throughput screening assay that are being developed to improve understanding of the mechanisms of genotoxicity and mutagenicity.
A number of companies currently lack the expertise to conduct the biological study of a compound due to limited in-house capabilities and inadequate availability of resources. These limitations have encouraged several organizations to outsource the genotoxicity testing / mutagenicity testing, in order to leverage the relevant experience and expertise of contract service providers. Businesses can capitalize on the experience and advanced technologies offered by the contract service providers, thereby streamlining the testing process and expediating the time-to-market products. Further, outsourcing mutagenicity testing and genotoxicity testing optimizes in-house resource allocation, allowing stakeholders to focus on core research and development efforts.
At present, more than 80 industry and non-industry players offer a variety of assays, such as Ames assay, micronucleus assay, chromosomal aberration test, genetic mutation assay and comet assay, which can be used to evaluate the genetic toxicity of a substance. These services are offered across more than 115 facilities across the world. It is worth highlighting that Asia-Pacific is the current hub for providing genotoxicity testing and mutagenicity testing services, featuring the presence of nearly 40% of the total service facilities.
Over the past few years, various non-profit organizations have extended financial support to aid research related to genotoxicity and mutagenicity. Interestingly, the majority of the grants offered in this market segment are administered by National Institute of Environmental Health Sciences (NIEHS) and National Institute of Allergy and Infectious Diseases (NIAID). Over 90% of the grants have been awarded for a time period of less than 5 years for projects in this sector.
Over 360 articles focused on genotoxicity / mutagenicity testing have been published in high-impact journals, since 2018. It is worth noting that, a considerably high share of these publications are research articles focused on evaluating the use of genetic toxicity testing in different types of compounds. Further, MDPI emerged as the most popular publisher with more than 80 publications focused on in vitro and in vivo genetic toxicology assessment
Genotoxicity / mutagenicity testing is employed across various industries, such as healthcare industry (pharmaceutical / biotechnology), chemical industry, cosmetic industry, agriculture industry and food industry.
The genotoxicity testing and mutagenicity testing market is growing rapidly in response to the increasing demand for safe and effective healthcare products and the growing awareness of the public about the risks of genotoxic substances. Further, increased environmental impact of chemicals is driving companies to assess the genotoxic potential of their products in order to protect the ecosystem. Driven by the continuous efforts of industry stakeholders and considerable investments for exploring genetic toxicology, the mutagenicity testing and genotoxicity testing market is anticipated to witness substantial market growth during the forecast period.
Market Analysis: Mutagenicity and Genotoxicity Testing Services Market Size
The mutagenicity and genotoxicity testing services market is estimated to be worth USD 1,011 million in 2023. This value is projected to grow at a CAGR of 7%, during the forecast period 2023-2035. Specifically, in terms of the type of test, the market is anticipated to be driven by in-vitro tests. However, non-GLP / screening is estimated to grow at a significant pace over the coming years. Additionally, it is worth highlighting that the majority of the current market share is captured by companies based in North America.
Examples of the key service providers in this industry (the complete list of companies is available in the full market report) include BioReliance, Charles River Laboratories, Eurofins Scientific, Jai Research Foundation, MB Biosciences, Syngene and Toxys. This market report includes an easily searchable excel database of all the companies providing mutagenicity testing and genotoxicity testing services worldwide.
Several recent developments have taken place in the field of genotoxicity testing. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.
The market report presents an in-depth analysis of the various firms / organizations that are engaged in the mutagenicity testing and genotoxicity testing market, across different segments, as defined in the below table:
2023 – 2035
|Market Size 2023
|$ 1.01 Billion
Type of Assay
Assay / Test Offered
End User Industry
Key Geographical Regions
Key Companies Profiled
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The market research report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market report includes:
One of the key objectives of the market report was to estimate the current market size, opportunity and the future growth potential of genotoxicity and mutagenicity testing services market in the forecast period. We have provided informed estimates on the likely evolution of the market in the mid-term to long-term for the forecast period, 2023-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as type of assay (in vivo, in vitro and non-GLP / screening), assay / test offered (comet assay, micronucleus assay, chromosomal aberration test, genetic mutation test and others), end user industry (chemical industry, healthcare industry, agriculture industry, cosmetic industry and other industries) and key geographical regions (North America, Europe, Asia- Pacific, Latin America, and Middle East and North Africa). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution.
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.