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
The mutagenicity testing and genotoxicity testing market is expected to reach USD 1.01 billion in 2023 anticipated to grow at a CAGR of 7% during the forecast period 2023-2035.
Genotoxicity signifies the potential of harmful agents across physical, chemical, and biological domains to inflict damage upon the genetic information housed within cells. This damage can lead to mutations, untimely cellular events, and direct DNA harm. Notably, these induced mutations have been linked to a range of disease indications, including oncological and genetic disorders. Moreover, alterations in genetic material can be passed on to successive cell generations. Similarly, mutagenicity refers to the induction of transmissible changes in an organism's genetic material, resulting in irreversible mutations. Consequently, conducting assessments for mutagenicity and genotoxicity stands as a critical element in assessing the safety of products, aiming to prevent adverse effects on human health due to hazardous chemicals.
The importance of conducting mutagenicity and genotoxicity tests during the early stages of product scaling cannot be overstated. These evaluations serve as essential indicators for process engineers, guiding potential modifications to prevent the synthesis of intermediates carrying significant genetic damage potential. Presently, genotoxicity assays are widely used across various industries, including healthcare, chemicals, cosmetics, food, and agriculture. Their purpose lies in determining whether specific compounds induce harmful effects. However, due to the absence of a single test encompassing all relevant genotoxic endpoints, a range of in vivo and in vitro techniques is employed for safety assessments in the healthcare domain.Short-term tests (STTs) represent an initial step in genotoxicity testing. These assays, such as the Ames assay (conducted in different Salmonella typhimurium strains and Escherichia coli) and the micronucleus assay, are cost-effective, rapid, and capable of screening numerous substances. Their application extends to evaluating environmental chemicals, consumer products, and exploring the mechanisms of suspected carcinogens.
The rapid advancement of next-generation sequencing technologies has introduced new methods for genotoxicity testing, enabling direct analysis of genetic materials. However, due to limited chemistry capabilities and expertise, stakeholders increasingly rely on testing service providers to assess the safety of their compounds. These providers offer tailored genotoxicity testing services for toxicity evaluations in drug and medical device development, aligning with regulatory agency recommendations worldwide.
In summary, the growing demand for healthcare product testing, coupled with stringent safety requirements mandated by global regulatory bodies for mutagenicity and genotoxicity testing of substances intended for human use, has led to the emergence of lucrative opportunities for genotoxicity and mutagenicity testing service providers.
Report Coverage
Genotoxicity signifies the potential of harmful agents across physical, chemical, and biological domains to inflict damage upon the genetic information housed within cells. This damage can lead to mutations, untimely cellular events, and direct DNA harm. Notably, these induced mutations have been linked to a range of disease indications, including oncological and genetic disorders. Moreover, alterations in genetic material can be passed on to successive cell generations. Similarly, mutagenicity refers to the induction of transmissible changes in an organism's genetic material, resulting in irreversible mutations. Consequently, conducting assessments for mutagenicity and genotoxicity stands as a critical element in assessing the safety of products, aiming to prevent adverse effects on human health due to hazardous chemicals.
The importance of conducting mutagenicity and genotoxicity tests during the early stages of product scaling cannot be overstated. These evaluations serve as essential indicators for process engineers, guiding potential modifications to prevent the synthesis of intermediates carrying significant genetic damage potential. Presently, genotoxicity assays are widely used across various industries, including healthcare, chemicals, cosmetics, food, and agriculture. Their purpose lies in determining whether specific compounds induce harmful effects. However, due to the absence of a single test encompassing all relevant genotoxic endpoints, a range of in vivo and in vitro techniques is employed for safety assessments in the healthcare domain.Short-term tests (STTs) represent an initial step in genotoxicity testing. These assays, such as the Ames assay (conducted in different Salmonella typhimurium strains and Escherichia coli) and the micronucleus assay, are cost-effective, rapid, and capable of screening numerous substances. Their application extends to evaluating environmental chemicals, consumer products, and exploring the mechanisms of suspected carcinogens.
The rapid advancement of next-generation sequencing technologies has introduced new methods for genotoxicity testing, enabling direct analysis of genetic materials. However, due to limited chemistry capabilities and expertise, stakeholders increasingly rely on testing service providers to assess the safety of their compounds. These providers offer tailored genotoxicity testing services for toxicity evaluations in drug and medical device development, aligning with regulatory agency recommendations worldwide.
In summary, the growing demand for healthcare product testing, coupled with stringent safety requirements mandated by global regulatory bodies for mutagenicity and genotoxicity testing of substances intended for human use, has led to the emergence of lucrative opportunities for genotoxicity and mutagenicity testing service providers.
Report Coverage
- Analyzing the mutagenicity and genotoxicity market based on assay types, test offerings, industry users, and key geographical regions.
- Examining factors impacting market growth, including drivers, restraints, opportunities, and challenges.
- Assessing market advantages, challenges, and competitive landscapes for key players.
- Forecasting revenue for market segments across five major regions.
- Providing an executive summary of current and future states of genotoxicity and mutagenicity testing services, spanning short, mid, and long-term evolutions.
- Offering an overview of genotoxicity and mutagenicity, covering negative impacts, testing methods, applications, market advancements, and future prospects.
- Evaluating genotoxicity testing service providers based on establishment year, size, location, services, assays, industries served, and testing systems.
- Conducting a comparative analysis of providers across North America, Europe, and Asia Pacific, highlighting leading companies by capabilities.
- Creating detailed profiles of genotoxicity and mutagenicity testing service providers, encompassing company summaries, service portfolios, recent advancements, and future outlooks.
- Analyzing publications on genotoxicity and mutagenicity, exploring publication years, types, popular publishers, journals, impact factors, and R&D trends.
- Reviewing academic grants awarded for research since 2018, considering grant details, funding institutes, recipient organizations, and other relevant factors.
- Examining recent partnerships in the testing market, focusing on partnership types, active players, and regional distributions.
- Conducting an in-depth analysis of patents filed/granted since 2018, including types, publication years, regions, leading players, applicant types, and patent valuation based on citations.
- Aurigene Pharmaceutical Services
- Charles River Laboratories
- GLR Laboratories
- LabCorp
- LSIM Safety Institute Sai LifeSciences
- Syngene
1. PREFACE
1.1. Scope of the Report
1.2. Market Segmentation
1.3. Research Methodology
1.4. Key Questions Answered
1.5. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Detrimental Effects of Genotoxins / Mutagens
3.3. Mechanism of Genotoxicity / Mutagenicity
3.4. Techniques Employed for Genotoxicity Testing / Mutagenicity Testing
3.5. Applications of Genotoxicity / Mutagenicity
3.6. Recent Developments and Future Perspectives
4. MARKET LANDSCAPE
4.1. Genotoxicity Testing / 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 End User Industry
4.1.7. Analysis by Type of Testing System(s)
4.1.8. Analysis by Custom Testing Services Offered
4.1.9. Analysis by Company Size and Type of Assay
4.1.10. Analysis by Assay / Test Offered and Type of Organization
4.2. Genotoxicity Testing / 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 Location of Headquarters
4.2.4. Analysis by Type of Organization
4.2.5. Analysis by Location of Facility
5. BENCHMARKING ANALYSIS
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. COMPANY PROFILES
6.1. Aurigene Pharmaceutical Services
6.1.1. Company Overview
6.1.2. Service Portfolio
6.1.3. Recent Developments and Future Outlook
6.2. Charles River Laboratories
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. GLR Laboratories
6.3.1. Company Overview
6.3.2. Service Portfolio
6.3.3. Recent Developments and Future Outlook
6.4. LabCorp
6.4.1. Company Overview
6.4.2. Financial Information
6.4.3. Service Portfolio
6.4.4. Recent Developments and Future Outlook
6.5. LSIM Safety Institute
6.5.1. Company Overview
6.5.2. Service Portfolio
6.5.3. Future Outlook
6.6. Sai Life Sciences
6.6.1. Company Overview
6.6.2. Financial Information
6.6.3. Service Portfolio
6.6.4. Recent Developments and Future Outlook
6.7. Syngene
6.7.1. Company Overview
6.7.2. Financial Information
6.7.3. Service Portfolio
6.7.4. Recent Developments and Future Outlook
7. PUBLICATION BENCHMARKING ANALYSIS
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. GRANTS ANALYSIS
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. PARTNERSHIPS AND COLLABORATIONS
9.1. Partnership Models
9.2. Assumptions and Key Parameters
9.3. Genotoxicity Testing / Mutagenicity Testing: List of Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Analysis by Year and Type of Partnership
9.3.4. Analysis by Type of Partnership and Type of Partner
9.3.5. Analysis by Year of Partnership and Type of Partner
9.3.6. Most Active Players: Analysis by Number of Partnerships
9.3.7. Analysis by Region
9.3.7.1. Intercontinental and Intracontinental Deals
9.3.8. Word Cloud Analysis: Emerging Focus Areas
10. PATENT ANALYSIS
10.1. Scope and Methodology
10.2. Assumptions and Key Parameters
10.3. Genotoxicity Testing and Mutagenicity Testing: List of Patents
10.4. Analysis by Type of Patent
10.5. Analysis by Patent Publication Year
10.6. Analysis by Annual Number of Granted Patents
10.7. Analysis by Geographical Location
10.8. Analysis by Jurisdiction
10.9. Analysis by CPC Symbols
10.10. Analysis by Type of Applicant
10.11. Analysis by Patent Age
10.12. Word Cloud: Emerging Focus Areas
10.13. Leading Industry Players: Analysis by Number of Patents
10.14. Leading Non-Industry Players: Analysis by Number of Patents
10.15. Leading Individual Assignees: Analysis by Number of Patents
10.16. Leading Players: Benchmarking by Patent Characterization (CPC Symbols)
10.17. Patent Valuation: Analysis Methodology and Parameters
10.17.1. Analysis by Relative Patent Valuation
11. MARKET SIZING AND OPPORTUNITY ANALYSIS
11.1. Forecast Methodology and Key Assumptions
11.2. Global Genotoxicity Testing / Mutagenicity Testing Market, 2023-2035
11.2.1. Genotoxicity Testing / Mutagenicity Testing Market: Analysis by Type of Assay, 2023 and 2035
11.2.1.1. Genotoxicity Testing / Mutagenicity Testing Market for In vivo Assays, 2023-2035
11.2.1.2. Genotoxicity Testing / Mutagenicity Testing Market for In vitro Assays, 2023-2035
11.2.1.3. Genotoxicity Testing / Mutagenicity Testing Market for Non-GLP / Screening Assays, 2023-2035
11.2.2. Genotoxicity Testing / Mutagenicity Testing Market: Analysis by Assay / Test Offered, 2023 and 2035
11.2.2.1. Genotoxicity Testing / Mutagenicity Testing Market for Comet Assays, 2023-2035
11.2.2.2. Genotoxicity Testing / Mutagenicity Testing Market for Micronucleus Assays, 2023-2035
11.2.2.3. Genotoxicity Testing / Mutagenicity Testing Market for Chromosomal Aberration Tests, 2023-2035
11.2.2.4. Genotoxicity Testing / Mutagenicity Testing Market for Genetic Mutation Tests, 2023-2035
11.2.2.5. Genotoxicity Testing / Mutagenicity Testing Market for Other Tests, 2023-2035
11.2.3. Genotoxicity Testing / Mutagenicity Testing Market: Analysis by End User Industry, 2023 and 2035
11.2.3.1. Genotoxicity Testing / Mutagenicity Testing Market for Chemical Industry 2023-2035
11.2.3.2. Genotoxicity Testing / Mutagenicity Testing Market for Healthcare Industry, 2023-2035
11.2.3.3. Genotoxicity Testing / Mutagenicity Testing Market for Agriculture Industry, 2023-2035
11.2.3.4. Genotoxicity Testing / Mutagenicity Testing Market for Cosmetic Industry, 2023-2035
11.2.3.5. Genotoxicity Testing / Mutagenicity Testing Market for Other Industries, 2023-2035
11.2.4. Genotoxicity Testing / Mutagenicity Testing Market: Analysis by Geographical Region, 2023 and 2035
11.2.4.1. Genotoxicity Testing / Mutagenicity Testing Market in North America, 2023-2035
11.2.4.2. Genotoxicity Testing / Mutagenicity Testing Market in Europe, 2023-2035
11.2.4.3. Genotoxicity Testing / Mutagenicity Testing Market in Asia-Pacific, 2023-2035
11.2.4.4. Genotoxicity Testing / Mutagenicity Testing Market in Latin America, 2023-2035
11.2.4.5. Genotoxicity Testing / Mutagenicity Testing Market in Middle East and North Africa, 2023-2035
12. APPENDIX 1: TABULATED DATA
13. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
1.1. Scope of the Report
1.2. Market Segmentation
1.3. Research Methodology
1.4. Key Questions Answered
1.5. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Detrimental Effects of Genotoxins / Mutagens
3.3. Mechanism of Genotoxicity / Mutagenicity
3.4. Techniques Employed for Genotoxicity Testing / Mutagenicity Testing
3.5. Applications of Genotoxicity / Mutagenicity
3.6. Recent Developments and Future Perspectives
4. MARKET LANDSCAPE
4.1. Genotoxicity Testing / 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 End User Industry
4.1.7. Analysis by Type of Testing System(s)
4.1.8. Analysis by Custom Testing Services Offered
4.1.9. Analysis by Company Size and Type of Assay
4.1.10. Analysis by Assay / Test Offered and Type of Organization
4.2. Genotoxicity Testing / 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 Location of Headquarters
4.2.4. Analysis by Type of Organization
4.2.5. Analysis by Location of Facility
5. BENCHMARKING ANALYSIS
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. COMPANY PROFILES
6.1. Aurigene Pharmaceutical Services
6.1.1. Company Overview
6.1.2. Service Portfolio
6.1.3. Recent Developments and Future Outlook
6.2. Charles River Laboratories
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. GLR Laboratories
6.3.1. Company Overview
6.3.2. Service Portfolio
6.3.3. Recent Developments and Future Outlook
6.4. LabCorp
6.4.1. Company Overview
6.4.2. Financial Information
6.4.3. Service Portfolio
6.4.4. Recent Developments and Future Outlook
6.5. LSIM Safety Institute
6.5.1. Company Overview
6.5.2. Service Portfolio
6.5.3. Future Outlook
6.6. Sai Life Sciences
6.6.1. Company Overview
6.6.2. Financial Information
6.6.3. Service Portfolio
6.6.4. Recent Developments and Future Outlook
6.7. Syngene
6.7.1. Company Overview
6.7.2. Financial Information
6.7.3. Service Portfolio
6.7.4. Recent Developments and Future Outlook
7. PUBLICATION BENCHMARKING ANALYSIS
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. GRANTS ANALYSIS
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. PARTNERSHIPS AND COLLABORATIONS
9.1. Partnership Models
9.2. Assumptions and Key Parameters
9.3. Genotoxicity Testing / Mutagenicity Testing: List of Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Analysis by Year and Type of Partnership
9.3.4. Analysis by Type of Partnership and Type of Partner
9.3.5. Analysis by Year of Partnership and Type of Partner
9.3.6. Most Active Players: Analysis by Number of Partnerships
9.3.7. Analysis by Region
9.3.7.1. Intercontinental and Intracontinental Deals
9.3.8. Word Cloud Analysis: Emerging Focus Areas
10. PATENT ANALYSIS
10.1. Scope and Methodology
10.2. Assumptions and Key Parameters
10.3. Genotoxicity Testing and Mutagenicity Testing: List of Patents
10.4. Analysis by Type of Patent
10.5. Analysis by Patent Publication Year
10.6. Analysis by Annual Number of Granted Patents
10.7. Analysis by Geographical Location
10.8. Analysis by Jurisdiction
10.9. Analysis by CPC Symbols
10.10. Analysis by Type of Applicant
10.11. Analysis by Patent Age
10.12. Word Cloud: Emerging Focus Areas
10.13. Leading Industry Players: Analysis by Number of Patents
10.14. Leading Non-Industry Players: Analysis by Number of Patents
10.15. Leading Individual Assignees: Analysis by Number of Patents
10.16. Leading Players: Benchmarking by Patent Characterization (CPC Symbols)
10.17. Patent Valuation: Analysis Methodology and Parameters
10.17.1. Analysis by Relative Patent Valuation
11. MARKET SIZING AND OPPORTUNITY ANALYSIS
11.1. Forecast Methodology and Key Assumptions
11.2. Global Genotoxicity Testing / Mutagenicity Testing Market, 2023-2035
11.2.1. Genotoxicity Testing / Mutagenicity Testing Market: Analysis by Type of Assay, 2023 and 2035
11.2.1.1. Genotoxicity Testing / Mutagenicity Testing Market for In vivo Assays, 2023-2035
11.2.1.2. Genotoxicity Testing / Mutagenicity Testing Market for In vitro Assays, 2023-2035
11.2.1.3. Genotoxicity Testing / Mutagenicity Testing Market for Non-GLP / Screening Assays, 2023-2035
11.2.2. Genotoxicity Testing / Mutagenicity Testing Market: Analysis by Assay / Test Offered, 2023 and 2035
11.2.2.1. Genotoxicity Testing / Mutagenicity Testing Market for Comet Assays, 2023-2035
11.2.2.2. Genotoxicity Testing / Mutagenicity Testing Market for Micronucleus Assays, 2023-2035
11.2.2.3. Genotoxicity Testing / Mutagenicity Testing Market for Chromosomal Aberration Tests, 2023-2035
11.2.2.4. Genotoxicity Testing / Mutagenicity Testing Market for Genetic Mutation Tests, 2023-2035
11.2.2.5. Genotoxicity Testing / Mutagenicity Testing Market for Other Tests, 2023-2035
11.2.3. Genotoxicity Testing / Mutagenicity Testing Market: Analysis by End User Industry, 2023 and 2035
11.2.3.1. Genotoxicity Testing / Mutagenicity Testing Market for Chemical Industry 2023-2035
11.2.3.2. Genotoxicity Testing / Mutagenicity Testing Market for Healthcare Industry, 2023-2035
11.2.3.3. Genotoxicity Testing / Mutagenicity Testing Market for Agriculture Industry, 2023-2035
11.2.3.4. Genotoxicity Testing / Mutagenicity Testing Market for Cosmetic Industry, 2023-2035
11.2.3.5. Genotoxicity Testing / Mutagenicity Testing Market for Other Industries, 2023-2035
11.2.4. Genotoxicity Testing / Mutagenicity Testing Market: Analysis by Geographical Region, 2023 and 2035
11.2.4.1. Genotoxicity Testing / Mutagenicity Testing Market in North America, 2023-2035
11.2.4.2. Genotoxicity Testing / Mutagenicity Testing Market in Europe, 2023-2035
11.2.4.3. Genotoxicity Testing / Mutagenicity Testing Market in Asia-Pacific, 2023-2035
11.2.4.4. Genotoxicity Testing / Mutagenicity Testing Market in Latin America, 2023-2035
11.2.4.5. Genotoxicity Testing / Mutagenicity Testing Market in Middle East and North Africa, 2023-2035
12. APPENDIX 1: TABULATED DATA
13. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
