Genotoxicity Testing Market

Genotoxicity Testing and Mutagenicity Testing Services Market: Distribution by Type of Assay, Assay / Test Offered, End User Industry and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

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Mutagenicity Testing And Genotoxicity Testing Market Overview 

The global genotoxicity testing market size is estimated to grow from USD 1.3 billion in 2023 to USD 2.7 billion by 2035, representing a CAGR of 7.0% during the forecast period. 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 image provides context of genotoxicity testing services market. Genotoxicity and mutagenicity testing techniques have the potential to transform the overall safety assessment process of compounds, by overcoming several challenges currently faced by healthcare sector as well as end-users This image provides list of genotoxicity / mutagenicity testing service providers.Presently, over 80 industry and non-industry players are providing genotoxicity and mutagenicity testing services across the globe; majority of these firms are based in Asia-Pacific The infographic looks at the genotoxicity / mutagenicity testing service providers clandscape. Leveraging their expertise, over 70% players use in vitro and in vivo assays to provide genotoxicity / mutagenicity testing services to a range of end users, primarily those engaged in the healthcare sector

Key Market Insights

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.

Genotoxicity Testing and Mutagenicity Testing to Ensure Safety and Regulatory Compliance during Drug Development

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.

Types of Genotoxicity Testing and Mutagenicity Testing Services

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.

Need for Outsourcing Mutagenicity Testing / Genotoxicity Testing to Contract Service Providers

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.

Service Providers Landscape: Players Offering Genotoxicity Testing and Mutagenicity Testing Service

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.

Grants Analysis: More than 280 Grants Awarded to Various Organizations Focused on Mutagenicity Testing / Genotoxicity Testing, since 2018

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. 

Publications Analysis: The Growing Scientific Literature Indicates the Active R&D Efforts by Stakeholders for Mutagenicity / Genotoxicity Testing 

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

Key Industries Catered by Mutagenicity / Genotoxicity Testing Service Providers

Genotoxicity / mutagenicity testing is employed across various industries, such as healthcare industry (pharmaceutical / biotechnology), chemical industry, cosmetic industry, agriculture industry and food industry.

Key Drivers of Mutagenicity and Genotoxicity Testing Market Growth: Stringent Regulatory Mandates, Consumer Heath Concerns and Advancements in Genetic Toxicology Testing Technology

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.

Leading Mutagenicity Testing and Genotoxicity Testing Service Providers

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.

The image looks at the competitive landscape across various genotoxicity / mutagenicity testing service providers. In pursuit of building a competitive edge, service providers in this domain are steadily expanding their capabilities in order to cater to the customized requests of their clients This infographic looks at the various partnership deals inked by stakeholders in genotoxicity / mutagenicity testing domain. The growing interest in this field is also evident from the rise in partnership activity; specifically, a large share of deals were acquisitions, highlighting the significant consolidation efforts currently ongoing in this market This image looks at the benchmarking of various publications released related to genotoxicity / mutagenicity testing domain. More than 360 studies related to genotoxicity and mutagenicity have been published since 2018, indicating the growing interest of stakeholders in this domain

Recent Developments in Genotoxicity Testing Market

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.

  • In July 2023, Toxys announced a training workshop for the ToxTracker® genotoxicity assay. The workshop is going to take place in October 2023, at Oegstgeest, The Netherlands. 
  • In April 2023, Nelson Labs received Accreditation Scheme for Conformity Assessment (ASCA) Accreditation from the FDA, adding on to the credibility of the company to offer safe genotoxicity testing assays.

Scope of the Report

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: 

Report Attribute Details

Forecast Period

2023 – 2035

Market Size 2023 $ 1.01 Billion
CAGR 7%

Type of Assay

  • In vivo
  • In vitro
  • 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
  • Other Industries

Key Geographical Regions

  • North America 
  • Europe 
  • Asia-Pacific 
  • Latin America 
  • Middle East and North Africa

Key Companies Profiled

  • Aurigene Pharmaceutical Services 
  • Charles River Laboratories 
  • GLR Laboratories 
  • LabCorp 
  • LSIM Safety Institute Sai LifeSciences 
  • Syngene
(Full list of 80+ companies captured available in the report)
Customization Scope

15% Free Customization Option (equivalent to 5 analysts working days)

Excel Data Packs (Complimentary)

  • Market Landscape Analysis 
  • Benchmarking Analysis 
  • Publication Analysis 
  • Academic Grant Analysis 
  • Partnerships and Collaborations Analysis 
  • Patent Analysis 
  • Market Forecast and Opportunity Analysis

 

This image looks at the details of grants related to genotoxicity / mutagenicity testing domain. Several government organizations have also extended considerable financial support to aid the ongoing research efforts focused on genotoxicity / mutagenicity testing This image looks at the details of patents related to genotoxicity / mutagenicity testing domain. Close to 450 patents related to genotoxicity and mutagenicity have been filed / granted to various industry and non-industry players The image provides segmentaion of genotoxicity / mutagenicity testing services market. The genotoxicity / mutagenicity testing services market is anticipated to grow at a healthy pace in the coming decade; the opportunity is likely to be well distributed across different assays, end users and key regions

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:

  • An executive summary of the insights captured during our research, offering a high-level view on the current state of the genotoxicity testing and mutagenicity testing services market and its likely evolution in the short to mid and long term.
  • A general overview of genotoxicity and mutagenicity, along with information on its detrimental effects, mechanism and testing techniques employed, key applications, recent developments in the market and future perspectives.
  • A detailed assessment of the overall market landscape of genotoxicity testing and mutagenicity testing service providers, based on several relevant parameters, including year of establishment, company size (in terms of number of employees), location of headquarters, type of organization, location of the facility, type of operation (genotoxicity and mutagenicity), type of offering (service, and reagents and consumables), type of assay(s) (in vitro, in vivo and Non-GLP / Screening), assay(s) / test(s) offered (ames test, micronucleus test, chromosomal aberration test, genetic mutation assay, comet assay and others), end user industry (healthcare industry, chemical  industry, agriculture industry, cosmetic industry, food industry and other industries) and type of testing system(s) (bacteria, animals and novel technology)  
  • An insightful benchmark analysis of various genotoxicity testing and mutagenicity testing service providers segregated into three peer groups, based on location of their headquarters (North America, Europe, and Asia Pacific), highlighting the top companies in this industry, in terms of their respective capabilities.
  • Elaborate profiles of genotoxicity testing and mutagenicity testing service providers. Each profile includes a brief overview of the company, details related to its financial information (if available), testing services portfolio, recent developments and an informed future outlook.
  • An in-depth analysis of various publications related to genotoxicity and mutagenicity, based on several relevant parameters, such as year of publication, type of article, popular publishers (in terms of number of publications), popular journals (in terms of number of number of publications), journal impact factor and popular journals (in terms of journal impact factor). It also includes a publication timeline analysis (by article type and journal impact factor), along with benchmarking of publications to develop more insightful opinions on the recent trends related to research and development in this area.
  • A detailed review of academic grants that have been awarded to various research institutes for projects focused on genotoxicity and mutagenicity, since 2018, based on several parameters, such as year of grant award, amount awarded, funding institute centre, administering institute centre, support period, purpose of grant, activity code, type of recipient organization, location  of recipient organization, study section involved, type of grant application, popular NIH departments (in terms of number of grants), prominent program officers (in terms of number of grants) and popular recipient organizations (in terms of number of grants).
  • A detailed analysis of recent partnerships inked between stakeholders engaged in this industry, since 2018, based on several relevant parameters, such as year of partnership, type of partnership, most active players (in terms of number of partnerships) and regional distribution of partnership activity in genotoxicity testing and mutagenicity testing market.
  • An in-depth analysis of various patents that have been filed / granted related to genotoxicity and mutagenicity, since 2018, taking into consideration parameters, such as type of patent, publication year, geographical region, CPC symbols, leading players (in terms of number of patents filled / granted) and type of applicant, along with a detailed patent benchmarking analysis and an insightful valuation analysis, highlighting the leading patents (in terms of number of citations).

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.

Frequently Asked Questions

Question 1: What is the test for genotoxicity?

Answer: Genotoxicity assays are laboratory tests designed to identify substances that can cause DNA damage or interfere with the cell's genetic material leading to chromosomal aberrations. These assays are essential for evaluating the potential hazards of various chemicals that have the potential to cause cancer, birth defects, or other adverse health effects. The type of genotoxic assays performed vary depending on the substance being tested and the intended use of the test results.

Question 2: What is an example of genotoxicity?

Answer: A genotoxin is a chemical agent capable of causing DNA or chromosomal damage. Thalidomide is a well-known example of a drug that could have been prevented from causing severe birth defects if it had been properly tested for genotoxicity. Thalidomide was a sedative drug that was prescribed to pregnant women in the 1950s to relieve nausea. However, it caused severe fetal abnormalities, including limb defects and the absence of normal openings of the gastrointestinal tract, in thousands of children worldwide. The thalidomide tragedy led to the adoption of more rigorous testing procedures and regulations for the pharmaceutical industry.

Question 3: What is a genotoxicity test for medical devices?

Answer: Genotoxicity testing is crucial for the risk assessment of medical devices. To evaluate the genotoxic risk of medical devices, manufacturing additives as well as the residual components of the devices are evaluated for their potential to damage DNA. This is followed by extractable and leachable (E&L) studies to understand the clinical exposures to the constituent chemicals.

Question 4: What is the importance of mutagenicity testing?

Answer: Mutagenicity testing aids in identification as well as quantification of natural or man-made mutagens from samples. The data gathered from mutagenicity testing is widely accepted as a means of predicting long-term risks associated with cancer in somatic cells or heritable mutations in germ cells.

Question 5: What is an example of mutagenicity?

Answer: Examples of chemical mutagens include alkylating agents and azides, which induce point mutations in the DNA. Biological mutagens often consist of viruses as well as different bacterial strains that can lead to gene mutations. Apart from the aforementioned hazardous agents that cause unintended adverse effects, there are several drugs which present therapeutic mutagenic action. For instance, streptomycin is mutagenic for the tubercle bacillus.

Question 6: What is the anticipated market growth rate of mutagenicity testing and genotoxicity testing market?

Answer: The mutagenicity testing and genotoxicity testing market is expected to grow at a CAGR of 7%, during the forecast period from 2023 to 2035.

Question 7: Which region will lead the mutagenicity testing and genotoxicity testing market?

Answer: North America is anticipated to drive majority of the market revenues, by 2035. In addition, the market in Asia-Pacific is likely to grow at a relatively faster pace, in the long term.

Question 8: Which segment, in terms of type of assay offered, dominates the mutagenicity testing and genotoxicity testing market?

Answer: Currently, in vivo assays dominate the mutagenicity testing and genotoxicity testing market. However, in the foreseen future, in vitro assays are expected to influence the market growth with a higher share in 2035.

Question 9: Which segment, in terms of type of end user, accounts for the largest market share in the mutagenicity testing and genotoxicity testing market?

Answer: Chemical industries are anticipated to capture over 65% of the market share by 2035. In addition, the market for healthcare industries is likely to grow at a relatively faster pace, in the long term.

Question 10: What type of partnership models are most commonly being adopted by stakeholders engaged in mutagenicity testing and genotoxicity testing market?

Answer: Acquisitions emerged as the most popular type of partnership model adopted by companies engaged in offering genotoxicity and mutagenicity testing services. This is followed by platform licensing agreements and service alliances.

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