遗传毒理学检测市场－全球产业规模、份额、趋势、机会和预测（按组件、类型、应用、地区和竞争细分，2020-2030 年）

2024 年全球遗传毒理学检测市场价值为 18.8 亿美元，预计到 2030 年将达到 30.2 亿美元，预测期内的复合年增长率为 8.34%。全球遗传毒理学检测市场正经历着巨大的发展势头，这得益于技术进步、监管框架不断发展以及对药物开发和环境监测安全性的日益重视。遗传毒理学检测在评估物质引起基因突变或染色体损伤的可能性方面起着关键作用，这些突变或损伤可能导致严重的健康问题，如癌症、发育障碍和遗传疾病。该市场的主要成长动力之一是对更安全的药品的需求不断增长。全球各地的监管机构都要求在药品审批过程中进行全面的毒理学评估。这促使製药和生物技术公司采用更先进的遗传毒理学测试方法来符合安全标准并避免后期失败。例如，2022年7月，Inotiv Inc.宣布计划扩展其在遗传毒理学研究方面的能力，重点关注体外细胞遗传学和细菌检测。此次扩展旨在透过提升检测能力并支持药物开发过程中更全面的安全性评估，来满足日益增长的新疗法需求。从动物试验转向替代性体外方法的趋势已获得显着发展。这些方法在成本、速度和伦理方面均具有优势，使其在商业和研究应用方面都越来越具有吸引力。微核试验、彗星试验和Ames试验等技术通常用于检测DNA损伤和基因突变，而无需进行活体动物试验。

关键市场驱动因素

药物研发活动不断增加

主要市场挑战

测试技术成本高昂

主要市场趋势

个人化和预测毒理学的扩展

目录

第 1 章：产品概述

第二章：研究方法

第三章：执行摘要

第四章：顾客之声

第五章：全球遗传毒理学检测市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 依组件（试剂及耗材、检测、服务）
  • 依类型（体外和体内）
  • 按应用（製药和生物技术、化妆品、食品、其他）
  • 按地区
  • 按公司分类（2024）
• 市场地图

第六章：北美遗传毒理学检测市场展望

• 市场规模和预测
• 市场占有率和预测
• 北美：国家分析
  • 美国
  • 加拿大
  • 墨西哥

第七章：欧洲遗传毒理学检测市场展望

• 市场规模和预测
• 市场占有率和预测
• 欧洲：国家分析
  • 法国
  • 德国
  • 英国
  • 义大利
  • 西班牙

第八章：亚太地区遗传毒理学检测市场展望

• 市场规模和预测
• 市场占有率和预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第九章：南美洲遗传毒理学检测市场展望

• 市场规模和预测
• 市场占有率和预测
• 南美洲：国家分析
  • 巴西
  • 阿根廷
  • 哥伦比亚

第十章：中东和非洲遗传毒理学检测市场展望

• 市场规模和预测
• 市场占有率和预测
• MEA：国家分析
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第 11 章：市场动态

• 驱动程式
• 挑战

第 12 章：市场趋势与发展

• 最新动态
• 併购
• 产品发布

第 13 章：竞争格局

• Thermo Fisher Scientific, Inc.
• Eurofins Scientific SE
• Jubilant Life Sciences Limited
• Syngene International Limited
• Gentronix Ltd.
• Inotiv Inc.
• Charles River Laboratories International, Inc.
• Merck KGaA
• Toxikon Corporation
• Gentronix Limited

第 14 章：策略建议

第15章调查会社について・免责事项

Global Genetic Toxicology Testing Market was valued at USD 1.88 billion in 2024 and is expected to reach USD 3.02 billion by 2030 with a CAGR of 8.34% during the forecast period. The global genetic toxicology testing market is witnessing significant momentum, driven by a confluence of technological advancements, evolving regulatory frameworks, and increasing focus on safety in drug development and environmental monitoring. Genetic toxicology testing plays a critical role in evaluating the potential of substances to cause genetic mutations or chromosomal damage, which can lead to serious health issues such as cancer, developmental disorders, and inherited diseases. One of the primary growth drivers for this market is the growing demand for safer pharmaceutical products. Regulatory agencies across the globe require comprehensive toxicology assessments as part of drug approval processes. This has pushed pharmaceutical and biotechnology companies to adopt more advanced genetic toxicology testing methodologies to comply with safety standards and avoid late-stage failures. For instance, in July 2022, Inotiv Inc. announced plans to expand its capabilities in genetic toxicology studies, focusing on in vitro cytogenetics and bacterial assays. This expansion aims to address the growing demand for new treatments by enhancing testing capacity and supporting more comprehensive safety evaluations in drug development. The shift from animal-based testing to alternative in vitro methods has gained substantial traction. These methods offer advantages in terms of cost, speed, and ethical considerations, making them increasingly attractive for both commercial and research applications. Techniques such as the micronucleus test, comet assay, and Ames test are commonly used to detect DNA damage and genetic mutations without the need for live animal testing.

Key Market Drivers

Rising Drug Development Activities

Rising drug development activities are playing a pivotal role in driving the growth of the global genetic toxicology testing market. With increasing investment in pharmaceutical research and development, there is a growing emphasis on identifying and eliminating potentially genotoxic compounds at early stages of the drug discovery process. For instance, in March 2025, the FDA approved a new drug for a rare genetic disorder, offering hope to affected families. This milestone was the result of pioneering research and clinical trials led by Oregon Health & Science University (OHSU). Their efforts improved testing methods and advanced understanding of cerebrotendinous xanthomatosis (CTX) disease, paving the way for this important treatment breakthrough. As new drugs become more complex-ranging from small molecules to biologics, gene therapies, and cell-based treatments-the need for comprehensive genetic toxicology testing becomes more critical. These tests help in detecting genetic mutations, chromosomal damage, and other hereditary effects that may arise from drug exposure, ensuring patient safety and compliance with regulatory standards. Genetic toxicology is an integral component of preclinical safety assessment. Regulatory authorities require a robust set of genotoxicity data before a drug can advance to clinical trials. As a result, pharmaceutical and biotech companies rely on a range of in vitro and in vivo tests, such as the Ames test, micronucleus assay, and comet assay, to assess the genetic safety profile of drug candidates. The increasing use of high-throughput screening and advanced cell-based assays is further accelerating the pace of toxicological evaluations. The global focus on developing targeted therapies and personalized medicine has expanded the scope of drug development, which in turn amplifies the demand for genetic toxicology testing. As more drugs are tailored to individual genetic profiles, thorough testing becomes essential to ensure both efficacy and long-term safety.

Key Market Challenges

High Cost of Testing Technologies

The high cost of testing technologies remains one of the most significant challenges in the global genetic toxicology testing market. Advanced toxicology testing involves sophisticated equipment, complex assay systems, and highly sensitive detection tools. Methods such as high-throughput screening, next-generation sequencing, and automated in vitro platforms require substantial capital investment. These systems are not only expensive to purchase but also incur high operational and maintenance costs, which can be a barrier for small and medium-sized enterprises or research institutions with limited funding. Laboratory infrastructure needs to meet strict regulatory and quality standards, adding to the financial burden. Specialized facilities, temperature-controlled environments, and contamination-free zones are essential to ensure the accuracy and reliability of test results. This infrastructure investment often comes before any financial return, making it difficult for smaller players to compete or innovate within the space. The costs extend beyond equipment and facilities. Reagents, consumables, and biological materials used in assays also contribute significantly to recurring expenses. Training staff to operate advanced equipment and interpret complex data adds to the operational expenditure. Companies must also invest in software tools and data management systems to handle the large volumes of information generated during genetic toxicology assessments.

For organizations working under tight R&D budgets or located in developing regions, these high costs can limit their ability to conduct thorough genotoxicity testing. As a result, many rely on outsourcing or face delays in research timelines. Reducing the cost burden through scalable, efficient technologies will be crucial for broader adoption across the market.

Key Market Trends

Expansion of Personalized and Predictive Toxicology

The expansion of personalized and predictive toxicology is reshaping the global genetic toxicology testing market by introducing more tailored and precise approaches to safety assessment. Personalized toxicology focuses on understanding how individual genetic variations influence responses to chemicals and drugs, allowing for more accurate predictions of adverse effects. This approach aligns closely with the growing field of personalized medicine, where treatments and preventive strategies are customized based on a person's genetic makeup. Genetic toxicology testing now increasingly incorporates genomic data to assess susceptibility to genotoxic agents, providing insights that can guide safer drug development and environmental exposure evaluations. Predictive toxicology uses advanced computational models and biological data to forecast the likelihood of genetic damage caused by new compounds before extensive laboratory testing. These models integrate data from various sources, such as high-throughput screening, molecular profiling, and existing toxicology databases, to simulate biological responses. This reduces the reliance on traditional in vivo testing and accelerates decision-making in drug discovery and regulatory review processes. Predictive tools can identify potential hazards early, saving time and resources while improving the accuracy of toxicity predictions. The convergence of personalized and predictive toxicology supports the development of safer pharmaceuticals and consumer products by enabling risk assessments tailored to specific populations or individual profiles. This approach helps minimize adverse effects and enhances therapeutic efficacy. As technologies such as genomics, bioinformatics, and machine learning continue to advance, the integration of personalized and predictive toxicology will play an increasingly important role in the genetic toxicology testing market, driving innovation and improving public health outcomes.

Key Market Players

• Thermo Fisher Scientific, Inc.
• Eurofins Scientific SE
• Jubilant Life Sciences Limited
• Syngene International Limited
• Gentronix Ltd.
• Inotiv Inc.
• Charles River Laboratories International, Inc.
• Merck KGaA
• Toxikon Corporation
• Gentronix Limited

Report Scope:

In this report, the Global Genetic Toxicology Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Genetic Toxicology Testing Market, By Component:

• Reagents & Consumables
• Assays
• Services

Genetic Toxicology Testing Market, By Type:

• In Vitro
• In Vivo

Genetic Toxicology Testing Market, By Application:

• Pharmaceutical & Biotechnology
• Cosmetics
• Food
• Others

Genetic Toxicology Testing Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Genetic Toxicology Testing Market.

Available Customizations:

Global Genetic Toxicology Testing Market report with the given market data, TechSci Research, offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Genetic Toxicology Testing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Component (Reagents & Consumables, Assays, Services)
  • 5.2.2. By Type (In Vitro v/s In Vivo)
  • 5.2.3. By Application (Pharmaceutical & Biotechnology, Cosmetics, Food, Others)
  • 5.2.4. By Region
  • 5.2.5. By Company (2024)
• 5.3. Market Map

6. North America Genetic Toxicology Testing Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Component
  • 6.2.2. By Type
  • 6.2.3. By Application
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Genetic Toxicology Testing Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Component
      • 6.3.1.2.2. By Type
      • 6.3.1.2.3. By Application
  • 6.3.2. Canada Genetic Toxicology Testing Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Component
      • 6.3.2.2.2. By Type
      • 6.3.2.2.3. By Application
  • 6.3.3. Mexico Genetic Toxicology Testing Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Component
      • 6.3.3.2.2. By Type
      • 6.3.3.2.3. By Application

7. Europe Genetic Toxicology Testing Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Component
  • 7.2.2. By Type
  • 7.2.3. By Application
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Genetic Toxicology Testing Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Component
      • 7.3.1.2.2. By Type
      • 7.3.1.2.3. By Application
  • 7.3.2. Germany Genetic Toxicology Testing Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Component
      • 7.3.2.2.2. By Type
      • 7.3.2.2.3. By Application
  • 7.3.3. United Kingdom Genetic Toxicology Testing Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Component
      • 7.3.3.2.2. By Type
      • 7.3.3.2.3. By Application
  • 7.3.4. Italy Genetic Toxicology Testing Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Component
      • 7.3.4.2.2. By Type
      • 7.3.4.2.3. By Application
  • 7.3.5. Spain Genetic Toxicology Testing Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Component
      • 7.3.5.2.2. By Type
      • 7.3.5.2.3. By Application

8. Asia-Pacific Genetic Toxicology Testing Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Component
  • 8.2.2. By Type
  • 8.2.3. By Application
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Genetic Toxicology Testing Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Component
      • 8.3.1.2.2. By Type
      • 8.3.1.2.3. By Application
  • 8.3.2. India Genetic Toxicology Testing Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Component
      • 8.3.2.2.2. By Type
      • 8.3.2.2.3. By Application
  • 8.3.3. Japan Genetic Toxicology Testing Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Component
      • 8.3.3.2.2. By Type
      • 8.3.3.2.3. By Application
  • 8.3.4. South Korea Genetic Toxicology Testing Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Component
      • 8.3.4.2.2. By Type
      • 8.3.4.2.3. By Application
  • 8.3.5. Australia Genetic Toxicology Testing Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Component
      • 8.3.5.2.2. By Type
      • 8.3.5.2.3. By Application

9. South America Genetic Toxicology Testing Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Component
  • 9.2.2. By Type
  • 9.2.3. By Application
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Genetic Toxicology Testing Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Component
      • 9.3.1.2.2. By Type
      • 9.3.1.2.3. By Application
  • 9.3.2. Argentina Genetic Toxicology Testing Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Component
      • 9.3.2.2.2. By Type
      • 9.3.2.2.3. By Application
  • 9.3.3. Colombia Genetic Toxicology Testing Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Component
      • 9.3.3.2.2. By Type
      • 9.3.3.2.3. By Application

10. Middle East and Africa Genetic Toxicology Testing Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Component
  • 10.2.2. By Type
  • 10.2.3. By Application
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Genetic Toxicology Testing Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Component
      • 10.3.1.2.2. By Type
      • 10.3.1.2.3. By Application
  • 10.3.2. Saudi Arabia Genetic Toxicology Testing Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Component
      • 10.3.2.2.2. By Type
      • 10.3.2.2.3. By Application
  • 10.3.3. UAE Genetic Toxicology Testing Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Component
      • 10.3.3.2.2. By Type
      • 10.3.3.2.3. By Application

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Developments
• 12.2. Mergers & Acquisitions
• 12.3. Product Launches

13. Competitive Landscape

• 13.1. Thermo Fisher Scientific, Inc.
  • 13.1.1. Business Overview
  • 13.1.2. Product Offerings
  • 13.1.3. Recent Developments
  • 13.1.4. Financials (As Reported)
  • 13.1.5. Key Personnel
  • 13.1.6. SWOT Analysis
• 13.2. Eurofins Scientific SE
• 13.3. Jubilant Life Sciences Limited
• 13.4. Syngene International Limited
• 13.5. Gentronix Ltd.
• 13.6. Inotiv Inc.
• 13.7. Charles River Laboratories International, Inc.
• 13.8. Merck KGaA
• 13.9. Toxikon Corporation
• 13.10. Gentronix Limited

14. Strategic Recommendations

15. About Us & Disclaimer