Global Genotoxicity Testing Market
- An Outline of the Global Genotoxicity Testing Market
- Market Definition & Segmentation
- Assumptions and Abbreviations
- Research Methodology & Approach
- Primary Research
- Secondary Research
- Data Triangulation
- SPSS Methodology
- Executive Summary
- Market Overview
- Market Dynamics
- Growth Drivers
- Major Roadblocks
- Opportunities
- Prevalent Trends
- Government Regulation
8. Technological Advancements
8.1 Market Definition & Segmentation
9. Growth Outlook
10. Risk Overview
11. Regional Demand
12. Recent Development News
13. Environmental Impact and Sustainability
14. Industry-wise Case Study Analysis
15. Detailed Assay Type Analysis
16. Comparative Analysis of Chromosomal Aberration, Micronucleus and Comet assays for Global Genotoxicity Testing
17. Application Analysis
18. Test Type Analysis
19. Root Cause Analysis (RCA) for Discovering Problems in the Industry
20. Porter Five Forces
21. PESTLE
22. Competitor SWOT Analysis
23. Strategic Developments by Competitors in the Industry
24. Comparative Positioning
25. Top Market Players Analysis in Japan
26. Competitive Landscape: Key Players
27. Competitive Model
27.1 Market Share of Company, 2024
- Company Profile
- Agilent Technologies, Inc.
- Anthem Bio Sciences
- biotoxicity.com
- Cell Biolabs, Inc
- Creative Bioarray
- Creative Diagnostics
- Enzo Biochem Inc.
- Frontage Labs
- Inotiv
- IPHASE Biosciences Inc.
- Litron Laboratories
- Merck KGaA
- Pharmaron
- Thermo Fisher Scientific Inc.
- Toxys
- WuXi AppTec
- XENOMETRIX AG
28. Global Genotoxicity Testing Market Outlook
- Market Overview
- Market Revenue by Value (USD Thousand) and Compound Annual Growth Rate (CAGR)
- Genotoxicity Testing Market Segmentation Analysis (2025-2038)
28.3.1 By Test Type
- In Vitro Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- In Vivo Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
28.3.2 By Assay Type
- Ames Test, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chromosomal Aberration Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Micronucleus Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Comet Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- By End use Industry
- Pharmaceutical & Biotechnology, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Food Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Cosmetics Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chemical Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
28.3.4 By Region
- North America, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- Europe, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- Asia Pacific Excluding Japan, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- Japan, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- Latin America, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- Middle East and Africa, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
29. North America Genotoxicity Testing Market Outlook
- Market Overview
- Market Revenue by Value (USD Thousand) and Compound Annual Growth Rate (CAGR)
- Genotoxicity Testing Market Segmentation Analysis (2025-2038)
29.3.1 By Test Type
- In Vitro Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- In Vivo Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
29.3.2 By Assay Type
- Ames Test, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chromosomal Aberration Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Micronucleus Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Comet Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
29.3.3By End use Industry
- Pharmaceutical & Biotechnology, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Food Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Cosmetics Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chemical Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- By Country
- US, Market Value (USD Thousand) and CAGR, 2025-2038F
- Canada, Market Value (USD Thousand) and CAGR, 2025-2038F
30. Europe Genotoxicity Testing Market Outlook
- Market Overview
- Market Revenue by Value (USD Thousand) and Compound Annual Growth Rate (CAGR)
- Genotoxicity Testing Market Segmentation Analysis (2025-2038)
30.3.1 By Test Type
- In Vitro Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- In Vivo Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
30.3.2 By Assay Type
- Ames Test, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chromosomal Aberration Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Micronucleus Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Comet Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
30.3.3 By End user Industry
- Pharmaceutical & Biotechnology, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Food Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Cosmetics Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chemical Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
30.3.4 By Country
- UK, Market Value (USD Thousand) and CAGR, 2025-2038F
- Germany, Market Value (USD Thousand) and CAGR, 2025-2038F
- France, Market Value (USD Thousand) and CAGR, 2025-2038F
- Italy, Market Value (USD Thousand) and CAGR, 2025-2038F
- Spain, Market Value (USD Thousand) and CAGR, 2025-2038F
- BENELUX, Market Value (USD Thousand) and CAGR, 2025-2038F
- Poland, Market Value (USD Thousand) and CAGR, 2025-2038F
- Russia, Market Value (USD Thousand) and CAGR, 2025-2038F
- Rest of Europe, Market Value (USD Thousand) and CAGR, 2025-2038F
31. Asia Pacific Excluding Japan Genotoxicity Testing Market Outlook
- Market Overview
- Market Revenue by Value (USD Thousand) and Compound Annual Growth Rate (CAGR)
31.3 Genotoxicity Testing Market Segmentation Analysis (2025-2038)
31.3.1 By Test Type
- In Vitro Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- In Vivo Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
31.3.2 By Assay Type
- Ames Test, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chromosomal Aberration Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Micronucleus Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Comet Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- By End user Industry
- Pharmaceutical & Biotechnology, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Food Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Cosmetics Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chemical Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
31.3.4 By Country
- China, Market Value (USD Thousand) and CAGR, 2025-2038F
- India, Market Value (USD Thousand) and CAGR, 2025-2038F
- Indonesia, Market Value (USD Thousand) and CAGR, 2025-2038F
- South Korea, Market Value (USD Thousand) and CAGR, 2025-2038F
- Malaysia, Market Value (USD Thousand) and CAGR, 2025-2038F
- Australia, Market Value (USD Thousand) and CAGR, 2025-2038F
- Singapore, Market Value (USD Thousand) and CAGR, 2025-2038F
- Vietnam, Market Value (USD Thousand) and CAGR, 2025-2038F
- Thailand, Market Value (USD Thousand) and CAGR, 2025-2038F
- New Zealand, Market Value (USD Thousand) and CAGR, 2025-2038F
- Rest of Asia Pacific Excluding Japan, Market Value (USD Thousand) and CAGR, 2025-2038F
32. Japan Genotoxicity Testing Market Outlook
- Market Overview
- Market Revenue by Value (USD Thousand) and Compound Annual Growth Rate (CAGR)
- Genotoxicity Testing Market Segmentation Analysis (2025-2038)
32.3.1 By Test Type
- In Vitro Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- In Vivo Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
32.3.2 By Assay Type
- Ames Test, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chromosomal Aberration Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Micronucleus Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Comet Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
32.3.3 By End use Industry
- Pharmaceutical & Biotechnology, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Food Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Cosmetics Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chemical Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
33. Latin America Genotoxicity Testing Market Outlook
- Market Overview
- Market Revenue by Value (USD Thousand) and Compound Annual Growth Rate (CAGR)
- Genotoxicity Testing Market Segmentation Analysis (2025-2038)
33.3.1 By Test Type
- In Vitro Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- In Vivo Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
33.3.2 By Assay Type
- Ames Test, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chromosomal Aberration Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Micronucleus Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Comet Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
33.3.3 By End use Industry
- Pharmaceutical & Biotechnology, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Food Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Cosmetics Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chemical Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
33.3.4 By Country
- Brazil, Market Value (USD Thousand) and CAGR, 2025-2038F
- Argentina, Market Value (USD Thousand) and CAGR, 2025-2038F
- Mexico, Market Value (USD Thousand) and CAGR, 2025-2038F
- Rest of Latin America, Market Value (USD Thousand) and CAGR, 2025-2038F
34. Middle East & Africa Genotoxicity Testing Market Outlook
- Market Overview
- Market Revenue by Value (USD Thousand) and Compound Annual Growth Rate (CAGR)
- Genotoxicity Testing Market Segmentation Analysis (2025-2038)
34.3.1 By Test Type
- In Vitro Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
- In Vivo Tests, Market Value (USD Thousand) and CAGR & Y-o-Y Growth Trend, 2025-2038F
34.3.2 By Assay Type
- Ames Test, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chromosomal Aberration Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Micronucleus Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Comet Assays, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- By End use Industry
- Pharmaceutical & Biotechnology, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Food Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Cosmetics Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Chemical Industry, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
- Others, Market Value (USD Thousand), CAGR & Y-o-Y Growth Trend, 2025-2038F
34.3.4 By Country
- GCC, Market Value (USD Thousand) and CAGR, 2025-2038F
- Israel, Market Value (USD Thousand) and CAGR, 2025-2038F
- South Africa, Market Value (USD Thousand) and CAGR, 2025-2038F
- Rest of Middle East & Africa, Market Value (USD Thousand) and CAGR, 2025-2038F
Genotoxicity Testing Market Outlook:
Genotoxicity Testing Market size is valued at USD 254.8 million in 2025 and is expected to reach USD 913.8 million by the end of 2038, registering a CAGR of 8.7% during the forecast period, i.e., between 2026-2038. In 2026, the industry size of genotoxicity is estimated at USD 335.1 million.
The initiation of different anti-doping programs by several organizations, including the International Testing Agency (ITA) and World Anti-Doping Agency (WADA), fuels the market growth. For example, in October 2023, after years of planning, the ITA launched the pre-Games programme, an anti-doping initiative for the Olympics 2024 to ensure the subjectivity of athletes to the testing regime. The anti-doping experts associated with the International Federation (IF) and the National Anti-Doping Organisation (NADO) also collaborated with ITA in succeeding the initiative. Genotoxicity testing plays a crucial role in anti-doping initiatives by assisting in finding substances in the human body that can damage the genome or alter the expression of genes.
In addition, investments by companies for the development of genotoxicity testing drive the growth of the market. For example, in April 2025, Eurofins acquired the clinical diagnostic operations of Synlab in Spain. The diagnostic operations acquired by Eurofins comprise services of clinical diagnostic testing, including anatomical a pathology and genetics services. Involvement in performing clinical diagnostic testing provides companies with insights into ways DNA damage and repair take place. As a result, a deeper understanding is gained by companies about the approaches suitable for refining and expanding genotoxicity testing methods, which can lead to innovation.
Genotoxicity Testing Market - Growth Drivers and Challenges
Growth Drivers
-
Increase in pharmaceutical R&D: The growth of the global genotoxicity testing market is significantly driven by the rising research and development in the pharmaceutical industry globally, focused on the development of the potential effects of drug molecules. For instance, as reported by the Philanthropy News Digest (PND) in May 2024, the Access to Medicine Foundation is involved in tracking five research and development projects across the pipelines of companies that include F2G, GSK, Pfizer, and Venatorx for their recently approved aztreonam-avibactam. With the rise of research and development in the pharmaceutical industry, the need to find and remove genotoxic compounds during the early stage of the process of drug discovery increases.
-
Rising consumer awareness of product safety: Rising awareness of product safety among consumers, concerned about the health impacts of the presence of genotoxic substances in the products, is encouraging companies in the pharmaceutical, personal care, and other industries to develop safety assessments and invest more in testing. One such example is the collaboration and investment of AstraZeneca with Cellectis in November 2023, for the acceleration of progress for genomic medicine and cell therapy. AstraZeneca decided to invest USD 105 million in the collaboration with Cellectis. By imposing the requirement to assess the genotoxic effects in the manipulation of the genetic materials in the use of cells, the process of developing cell therapy and genomic medicine drives the growth of the genotoxicity market.
-
Technological advancements in the testing methods: The growth of the genotoxicity testing market is significantly fuelled by the latest technological advancements in the testing methods, including the development of Omics technologies that encompass transcriptomics and genomics. One such example is the launch of MGI Tech launched CycloneSEQ-WT02* and CycloneSEQ-WY01* in September 2024. These are technology platforms based on nanopore sequencing, and the utilization of such technologies can be proven effective to assist in meeting the diverse requirements for sequencing across different applications. In applications such as microbial metagenomes, microbial genome research, targeted disease testing, amplicon-based microbial detection, and others, the advanced testing methods can be used.
Challenges
-
Ethical concerns over animal testing: Ethical concerns emerge in the process of genotoxicity testing on animals, which hinders market growth. The use of animals for genotoxicity testing is an ethical and moral challenge. As reported by The Regulatory Review in January 2024, deaths of more than 110 million animals take place in laboratories in the U.S due to the evaluation of medications, cosmetics, food additives, and others through animal testing.
Genotoxicity Testing Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2025 |
|
Forecast Year |
2026-2038 |
|
CAGR |
8.7% |
|
Base Year Market Size (2025) |
USD 254.8 million |
|
Forecast Year Market Size (2038) |
USD 913.8 million |
|
Regional Scope |
|
Genotoxicity Testing Market Segmentation:
Test Type Segment Analysis
The in vitro test segment is anticipated to command a dominant revenue of 65.4% by the end of 2038, as stringent regulations on in vivo testing are fueling the adoption of in vitro methods. Technological developments, including the emergence of 3D cell, to enhance the accuracy of in vitro genotoxicity testing, are expected to fuel segment growth in the coming year. In March 2023, the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) reported its progress in its transition towards methods for testing that exclude the use of animals. The organization has been progressive in integrating animal alternatives for testing using in vitro methods, for example, omics technologies.
Assay Type Segment Analysis
The Ames test segment is set to acquire a market share of 34.1% by the end of 2038 due to its capacity to detect both point mutations and frameshift mutations. A relatively quick turnaround time in relation to other assay types also influences the domination of the Ames test segment. Considering these factors, organizations have started to promote the use of the Ames test in drug development. In April 2025, Santox, a pharmacology and toxicology contract research organisation, hosted a webinar on the navigation of the Ames-positive results in small molecule drug development. Increased awareness of the assay type can lead to increased use of the same due to its advantages in genotoxicity testing.
End use Segment Analysis
The pharmaceutical and biotechnology segment is anticipated to witness a steady expansion during the forecast period. Rising R&D activities and the adoption of advanced testing technologies in the pharmaceutical and biotechnology industry fuel the segment growth. Companies associated with the pharmaceutical and biotechnology industries in the early phase of drug development are involved in performing screening of chemicals using toxicology studies so that early genotoxic concerns can be detected. For example, as reported by the Innovative Genomics Institute in July 2025, the organization got approval for CRISPR-based medicine, Casgevy for the treatment of transfusion-dependent beta thalassemia (TBT) and sickle cell disease (SCD).
Our in-depth analysis of the global market includes the following segments:
|
Segment |
Subsegments |
|
Test Type |
|
|
Assay Type |
|
|
End use |
|
Vishnu Nair
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Genotoxicity Testing Market - Regional Analysis
North America Market Insights
North America genotoxicity market is anticipated to dominate, acquiring a market share of 36.2% by 2038, due to the rectifications in relevant regulatory needs for genotoxicity testing. In June 2023, revisions were initiated in the Toxic Substances Control Act (TSCA) to make it more transparent, predictable, and rigorous. The mandates as per the guidelines by the U.S Federal and International Chemical Regulatory Policy increase the demand for genotoxicity testing and impose the requirement to adopt new testing approaches, enhance data sharing, and innovation. The development of new assays also boosts the market growth in North America, expanding the scope of applying novel genotoxicity testing methods.
The U.S genotoxicity market is set to retain its dominance, expanding at a CAGR of 8.7% during the forecast period due to rising demand for accurate and reliable methods for testing. The adoption of novel genotoxicity testing methodologies also fuels the market growth significantly. In June 2024, the United States Environmental Protection Agency (EPA) revealed that it planned to implement high-throughput computational models and assays for the evaluation of chemicals to a significant extent and ensure effective screening of chemicals. The scope for applying high-throughput assays and computational models influences the opportunity to increase efficiency in genotoxicity assessments.
The genotoxicity market in Canada is likely to grow steadily, expanding at a rate of 9.3% owing to rising awareness of genotoxicity substances affecting the population. Additionally, the market growth is fuelled by the emergence of Contract Research Organizations (CROs) and their constant innovation in genotoxicity testing. For instance, in February 2025, the Clinical Data Interchange Standards Consortium (CDISC) reported on its collaboration with Lindus Health for the acceleration of the generation of biomedical concepts using AI technology.
Asia Pacific Market Insights
The Asia Pacific genotoxicity market is expected to expand at a CAGR of 9.1% during the forecast period due to a surge in pharmaceutical and biotechnological industrial activity. For instance, in October 2023, ClavystBio, a Temasek-supported investor in the biotechnology sector, unveiled the inauguration of its new research and collaboration centre in Singapore. The advancement of the manufacturing standards also fuels the market growth. In September 2023, a revision was initiated in Korea to enforce the rules of the Occupational Safety and Health Act (OSHA). Through the revision, the manufacturers and importers were allowed to utilize alternative names of chemicals and the content range directly for CBI substances, so that MSDS could be prepared for the mixture containing them. This is likely to help the manufacturers and importers of the pharma and biotechnology sectors to keep the users informed. The expansion of research and collaboration centres indicates an increase in the likelihood of more drug discovery and development efforts. This, along with MSDS preparation, fuels the demand for genotoxicity testing.
By 2038, the genotoxicity market in China is expected to grow rapidly during the forecast period due to the development of in-house genotoxicity testing kits. For instance, in April 2023, Elveflow introduced a microfluidic-chip-compatible genotoxicity testing process, which is faster and requires less space and material to be performed. With the launch of in-house testing kits, genotoxicity testing becomes more convenient. The obligation for the optimization of the process of reviewing and approving clinical trials of innovative drugs also influences the penetration of genotoxicity testing rates.
The genotoxicity testing market in India is poised to achieve significant growth during the forecast period, due to the initiatives of the government to promote genomics. One such example is the announcement by the Union Agriculture Minister of India about the allocation of funding of USD 57.1 million for the editing of genomes in crops. The use of technologies for genome editing raises concerns for genotoxicity, fuelling the demand for genotoxicity testing. Rising initiatives related to pharmaceutical research can lead to more innovation in genotoxicity testing.
Europe Market Insights
The genotoxicity market in Europe is anticipated to expand at a CAGR of 8.5% throughout the forecast period due to growing preference for in vitro methods for genotoxicity testing. Considering this factor, the regulatory bodies in Europe are putting efforts into mitigating the shortage of in vitro tests in the market. For instance, in January 2023, EPSCO Council initiated amendments in (EU) 2017/746 (In Vitro Diagnostics Regulation – IVDR) regarding the provision of in vitro tests to the public. The promotion of in vitro tests fuels the growth of the genotoxicity market in Europe, especially when this segment type is already forecasted to dominate.
Germany is expected to witness a steady growth in the genotoxicity testing market, experiencing an expansion at a CAGR of 9.1%, owing to the growing demand for genetically modified drugs. Companies in Germany are investing in the development of genetically modified drugs. In April 2024, Boehringer Ingelheim announced its plan to focus on therapeutic areas of research, including renal and metabolic disease, cardiovascular disease, immunology, mental health, retinal disease, and others. In the development of drugs for the mentioned therapeutic areas, drug safety evaluation through genotoxicity testing is integral.
The UK genotoxicity testing market is expected to expand at a CAGR of 9.4% during the forecast period, driven by rising focus on ethical and sustainable testing practices. Local government is focusing on the promotion of ethical and sustainable genotoxicity testing. One such example is the guidance of the Committee on Mutagenicity of Chemicals in Food, Consumer Products, and the Environment (COM) for genotoxicity testing announced in July 2024. The guidance is about the implementation of a staged approach for genotoxicity testing by making preliminary considerations, providing information on 3 types of genetic damage, detecting chemical genotoxins, and addressing genotoxic endpoints on a case-by-case basis.
Key Genotoxicity Testing Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The global genotoxicity testing market is highly competitive, comprising key players operating at global and regional levels. Charles River Laboratories, Aurigene Pharmaceutical Services, LabCorp, Syngene, Merck KGaA, and Eurofins Scientific are the key genotoxicity testing market players globally. Research and development are prioritized by these key players to the utmost. Companies involved in genotoxicity testing and development are also supporting one another in the development of testing methodologies to make the process increasingly ethical and sustainable.
Here is a list of key players in the global market:
|
Company |
Country of Origin |
Approx. Market Share % |
|
Charles River Laboratories |
U.S. |
7.6 |
|
Aurigene Pharmaceutical Services |
India |
6.2 |
|
LabCorp |
U.S. |
5.5 |
|
Merck KGaA |
Germany |
3.2 |
|
Eurofins Scientific |
France |
xx |
|
SGS |
France |
xx |
|
TÜV SÜD |
Germany |
xx |
|
Aurigene Pharmaceutical Services |
India |
xx |
|
Miltenyi Biotec |
Germany |
xx |
|
Amerigo Scientific |
U.S. |
xx |
|
Syngene |
India |
xx |
|
Adgyl Lifesciences |
India |
xx |
|
Syngene |
India |
xx |
|
Thermo Fisher Scientific |
U.S. |
xx |
|
Covance |
U.S. |
xx |
Below are the areas covered for each company in the market:
Recent Developments
- In February 2025, Creative Bioarray launched Bacterial Reverse Mutation Test (OECD TG 471), In Vitro Mammalian Chromosome Aberration Test (OECD TG 473), In Vitro Mammalian Cell Gene Mutation Tests (OECD TG 476 and TG 490), and In Vitro Mammalian Cell Micronucleus Test (OECD TG 487). These are some comprehensive in vitro test panels that serve as pivotal genotoxicity tests under the guidelines of the Economic Co-operation and Development (OECD).
- In September 2024, Toxys collaborated with Mutagentech to develop MutaTracker, a genotoxicity and mutagenicity assay based on cells and capable of combining the reliable readout for the ToxTracker, a stem cell-based genotoxicity detection assay..
- In April 2024, Charles River Laboratories announced the launch of the Alternative Methods Advancement Project (AMAP), focused on the development of alternatives to animal testing, driving new drug discovery standards and investment in the same.
- In March 2024, Cyprotex revealed its research on a high-content screening approach that comprises robust data analysis at the Society of Toxicology (SOT) conference. To de-risk food additives, the research is effective to be followed as an early-stage package for genotoxicity screening guidance.
- Report ID: 8018
- Published Date: Aug 27, 2025
- Report Format: PDF, PPT
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Genotoxicity Testing Market Report Scope
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