Genotoxicity / Mutagenicity Testing Services Market, 2023-2035

Genotoxicity / Mutagenicity Testing Services Market, 2023-2035

INTRODUCTION

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.

KEY MARKET INSIGHTS

The Genotoxicity / Mutagenicity Testing Services 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 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.

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 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 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 / 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 / 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 / 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 / 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 / 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.



SCOPE OF THE REPORT

The study features an in-depth analysis of various firms / organizations that are engaged in this domain, across different segments as defined in the below table:

Genotoxicity / Mutagenicity Testing Service Market:

Report Attribute / Market Segmentations

Report Attribute Details

Forecast Period 2023 – 2035

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

Key Geographical Regions North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa

Key Companies Profiled Aurigene Pharmaceutical Services, Charles River Laboratories, GLR Laboratories, LabCorp, LSIM Safety Institute, Sai Life Sciences, Syngene

(Full list of 80+ companies captured in the market landscape analysis of the report)

Customization Scope 15% Free Customization Option (equivalent to 5

Analyst’s 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

Source: Roots Analysis

The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different geographies. Amongst other elements, the report includes:

An executive summary of the insights captured during our research, offering a high-level view on the current state of the genotoxicity and mutagenicity testing service markets 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 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 service providers segregated into three peer groups, based on location of their headquarters (North America, Europe, and Asia Pacific), highlighting the top players in this domain, in terms of their respective capabilities.

Elaborate profiles of genotoxicity and mutagenicity service providers. Each profile includes a brief overview of the company, details related to its financial information (if available), service 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 domain, 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 this domain.

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 report was to estimate the current opportunity and future growth potential of genotoxicity and mutagenicity testing services market over the coming years. We have provided informed estimates on the likely evolution of the market for the 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 report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in this domain (academia, industry, medical practice, and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent views on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research, and understanding of the relevant market gathered from various secondary and primary sources of information.

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.

CHAPTER OUTLINES

Chapter 1 is a preface providing an introduction to the full report, Genotoxicity / Mutagenicity Testing Service Market, 2023-2035.

Chapter 2 is an executive summary of the key insights captured in our report. It offers a high-level view of the current scenario of genotoxicity and mutagenicity testing service market and its likely evolution in the short term to mid-term and long term.

Chapter 3 provides a general overview of genotoxicity and mutagenicity, along with information on its detrimental effects. mechanism and testing techniques employed. Further, the chapter features a discussion on key applications, recent developments in the market and future perspectives for this market.

Chapter 4 provides a detailed review of the overall market landscape of genotoxicity and mutagenicity testing service, 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)

Chapter 5 provides an insightful benchmark analysis of various service providers segregated into three peer groups, based on location of their headquarters (North America, Europe, and Asia Pacific), highlighting the top players in this domain, based on their respective capabilities.

Chapter 6 provides elaborate profiles of genotoxicity and mutagenicity service providers. Each profile includes a brief overview of the company, details related to its financial information (if available), service portfolio, recent developments, and an informed future outlook.

Chapter 7 provides 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 highlights a publication timeline analysis (by article type and journal impact factor), along with the benchmarking of the publications to develop more insightful opinions on the recent trends related to research and development in this area.

Chapter 8 provides 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 and popular NIH departments (in terms of number of grants). Further, the chapter also highlights the prominent program officers (in terms of number of grants) and popular recipient organizations (in terms of number of grants).

Chapter 9 provides an in-depth analysis of the various collaborations and partnership agreements that have been inked by stakeholders engaged in this domain, during the period 2018-2022. It includes a brief description of the partnership models (including acquisitions, platform licensing, service alliances, mergers and platform development and commercialization) adopted by stakeholders in this domain. Further, the partnership activity in this domain has been analyzed based on various parameters, such as year of partnership, type of partnership, analysis on most active players and regional analysis. Further, the chapter includes a world map representation of all the deals inked in this field in the period 2018-2022, highlighting both intercontinental and intracontinental agreements.

Chapter 10 features 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. In addition, the chapter includes a detailed patent benchmarking and an insightful valuation analysis, highlighting the leading patents (in terms of number of citations).

Chapter 11 presents an insightful market forecast analysis, highlighting the likely growth of the genotoxicity and mutagenicity testing service market till the year 2035. In order to provide details on the future opportunity. Further, our projections have 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).

Chapter 12 is an appendix, which contains tabulated data and numbers for all the figures provided in the report.

Chapter 13 is an appendix, which contains a list of companies and organizations mentioned in this report.