Outlook on the Genotoxicity Testing and Mutagenicity Testing Services Global Market to 2035: In Vivo Assays Dominate the Industry


Dublin, March 06, 2023 (GLOBE NEWSWIRE) -- The "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" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study of the current market landscape and future potential of genotoxicity and mutagenicity testing services.

The report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. It also answers many key questions related to this domain; some of these have been mentioned below.

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 perpetual transmissible changes in the genomic structure of organisms, enabling mutations in cells.

Therefore, testing of genotoxicity / mutagenicity is an essential component of the safety assessment of products, with the objective of preventing certain particles from negatively impacting the human health. At present, genotoxicity tests 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. For instance, short-term tests (STTs), such as Ames test and micronucleus assay, determine the genotoxic potential of hazardous chemicals.

These tests 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. Overall, the growing demand for testing of healthcare products and the stringent safety requirements established by several regulatory bodies across the globe, has created lucrative opportunities for genotoxicity / mutagenicity testing service providers.

What is genotoxicity and mutagenicity?

The ability of certain substances to damage genetic information is referred to as genotoxicity. It is worth mentioning that exposure to such harmful substances can lead to epigenetic alteration and genomic instability, thereby, resulting in various disease indications, such as different types of cancer.

Mutagenicity is defined as introduction of permanent transmissible changes in the structure of genetic material. These changes can affect a single gene, a group of genes, or an entire chromosome, and are linked with increasing the frequency of mutations.

What are the key advantages offered by genotoxicity testing and mutagenicity testing?

Genotoxicity and mutagenicity testing can prove beneficial in detection of potential long-term effects of substances that are introduced into the market. As a result, these tests are considered to be crucial tools for the enhancement of safety assessment of the compounds.

Which companies offer genotoxicity testing and mutagenicity testing services?

At present, more than 80 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. It is worth highlighting that genotoxicity / mutagenicity testing service providers primarily cater to the needs of healthcare, chemical, agriculture, cosmetic and food industries. Notable examples of the players (which have also been captured in this report) include (in alphabetic order) BioReliance, Charles River Laboratories, Eurofins Scientific, Jai Research Foundation, MB Biosciences, Syngene and Toxys.

What is the need for outsourcing genotoxicity and mutagenicity testing to contract service providers?

A number of companies currently lack the expertise related to conduct of a biological study of a compound, along with limited in-house capabilities and inadequate availability of resources, which are essential to conduct the safety assessment of products. These limitations have encouraged several organizations to outsource their genotoxicity / mutagenicity needs, in order to leverage the relevant experience and expertise of contract service providers.

How many grants have been offered for genotoxicity and mutagenicity testing?

More than 280 grants have been awarded to various organizations focused on genotoxicity / mutagenicity testing. Interestingly, majority of the grants offered in this domain are administered by National Institute of Environmental Health Sciences (NIEHS) and National Institute of Allergy and Infectious Diseases (NIAID).

What is the trend of publications related to genotoxicity and mutagenicity testing?

Over 360 articles focused on genotoxicity / mutagenicity testing have been published in high-impact journals, in the past five years. This is indicative of the substantial efforts made by researchers engaged in this domain. 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.

Across which key industries can genotoxicity and mutagenicity testing be utilized?

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

What is the market size of genotoxicity and mutagenicity testing services?

Driven by the continuous efforts of industry stakeholders and considerable investment for exploring genetic toxicology, the genotoxicity / mutagenicity testing services market is anticipated to witness substantial growth in the foreseen future.

Frequently Asked Questions

Question 1: What is the growth rate of genotoxicity and mutagenicity testing services market?

Answer: The global market for genotoxicity and mutagenicity testing service market is expected to grow at a growth rate of 5% - 9% from 2023 to 2035.

Question 2: Which region will lead the genotoxicity and mutagenicity testing service market?

Answer: North America is anticipated to drive 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 3: Which segment, in terms of type of assay offered, dominates the genotoxicity and mutagenicity testing service market?

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

Question 4: Which segment, in terms of type of end users, accounts for the largest share in the genotoxicity and mutagenicity testing service 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 5: What type of partnership models are most commonly being adopted by stakeholders engaged in this domain?

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

Key Topics Covered:




4.1. Genotoxicity / Mutagenicity Testing Service Providers: Overall Market Landscape
4.1.1. Analysis by Type of Operation
4.1.2. Analysis by Type of Offering
4.1.3. Analysis by Regulatory Compliance
4.1.4. Analysis by Type of Assay(s)
4.1.5. Analysis by Assay(s) / Test(s) Offered
4.1.6. Analysis by Type of Testing System(s)
4.1.7. Analysis by Custom Testing Services Offered
4.1.8. Analysis by End User Industry
4.2. Genotoxicity / Mutagenicity Testing: Service Provider Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Company Size and Type of Assay
4.2.4. Analysis by Location of Headquarters
4.2.5. Analysis by Type of Organization
4.2.6. Analysis by Type of Organization and Type of Assay
4.2.7. Analysis by Location of Facility

5.1. Scope and Methodology
5.2. Assumptions and Key Parameters
5.3. Parameters Scoring
5.4. Benchmarking Analysis: Players based in North America
5.5. Benchmarking Analysis: Players based in Europe
5.6. Benchmarking Analysis: Players based in Asia-Pacific

6.1. Charles River Laboratories
6.1.1. Company Overview
6.1.2. Financial Information
6.1.3. Service Portfolio
6.1.4. Recent Developments and Future Outlook
6.2. LabCorp
6.2.1. Company Overview
6.2.2. Financial Information
6.2.3. Service Portfolio
6.2.4. Recent Developments and Future Outlook
6.3. Syngene
6.3.1. Company Overview
6.3.2. Financial Information
6.3.3. Service Portfolio
6.3.4. Recent Developments and Future Outlook
6.4. Aurigene Pharmaceutical Services
6.4.1. Company Overview
6.4.2. Service Portfolio
6.4.3. Recent Developments and Future Outlook
6.5. Sai Life Sciences
6.5.1. Company Overview
6.5.2. Financial Information
6.5.3. Service Portfolio
6.5.4. Recent Developments and Future Outlook
6.6. LSIM Safety Institute
6.6.1. Company Overview
6.6.2. Service Portfolio
6.6.3. Future Outlook
6.7. GLR Laboratories
6.7.1. Company Overview
6.7.2. Service Portfolio
6.7.3. Recent Developments and Future Outlook

7.1. Scope and Methodology
7.2. Assumptions and Key Parameters
7.3. Analysis by Year of Publication
7.4. Analysis by Type of Article
7.5. Popular Journals: Analysis by Number of Publications
7.6. Popular Publishers: Analysis by Number of Publications
7.7. Analysis by Journal Impact Factor
7.8. Popular Journals: Analysis by Journal Impact Factor
7.9. Publication Timeline Analysis
7.10. Publication Benchmarking Methodology
7.11. Publication Benchmarking Analysis
7.12. List of Top 10 Publications

8.1. Scope and Methodology
8.2. Assumptions and Key Parameters
8.3. Analysis by Year of Grant Award
8.4. Analysis by Amount Awarded
8.5. Analysis by Funding Institute Center
8.6. Analysis by Administering Institute Center
8.7. Analysis by Support Period
8.8. Popular Recipient Organizations: Analysis by Number of Grants
8.9. Analysis by Type of Recipient Organization
8.10. Analysis by Purpose of Grant
8.11. Analysis by Study Section
8.12. Popular NIH Departments: Analysis by Number of Grants
8.13. Analysis by Administering Institute Center and Support Period
8.14. Analysis by Type of Grant Application
8.15. Analysis by Grant Activity Code
8.16. Prominent Program Officers: Analysis by Number of Grants
8.17. Analysis by Location of Recipient Organization

9.1. Partnership Models
9.2. Assumptions and Key Parameters
9.3. Genotoxicity / Mutagenicity Testing: List of Partnerships and Collaborations





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