遺傳毒理學檢測市場－全球產業規模、佔有率、趨勢、機會和預測（按組件、類型、應用、地區和競爭細分，2020-2030 年）

2024 年全球遺傳毒理學檢測市場價值為 18.8 億美元，預計到 2030 年將達到 30.2 億美元，預測期內的複合年成長率為 8.34%。全球遺傳毒理學檢測市場正經歷著巨大的發展勢頭，這得益於技術進步、監管框架不斷發展以及對藥物開發和環境監測安全性的日益重視。遺傳毒理學檢測在評估物質引起基因突變或染色體損傷的可能性方面起著關鍵作用，這些突變或損傷可能導致嚴重的健康問題，如癌症、發育障礙和遺傳疾病。該市場的主要成長動力之一是對更安全的藥品的需求不斷成長。全球各地的監管機構都要求在藥品核准過程中進行全面的毒理學評估。這促使製藥和生物技術公司採用更先進的遺傳毒理學測試方法來符合安全標準並避免後期失敗。例如，2022年7月，Inotiv Inc.宣布計劃擴展其在遺傳毒理學研究方面的能力，重點關注體外細胞遺傳學和細菌檢測。此次擴展旨在透過提升檢測能力並支持藥物開發過程中更全面的安全性評估，來滿足日益成長的新療法需求。從動物試驗轉向替代性體外方法的趨勢已獲得顯著發展。這些方法在成本、速度和倫理方面均具有優勢，使其在商業和研究應用方面都越來越具有吸引力。微核試驗、彗星試驗和Ames試驗等技術通常用於檢測DNA損傷和基因突變，而無需進行活體動物試驗。

關鍵市場促進因素

藥物研發活動不斷增加

主要市場挑戰

測試技術成本高昂

主要市場趨勢

個人化和預測毒理學的擴展

目錄

第 1 章：產品概述

第2章：研究方法

第3章：執行摘要

第4章：顧客之聲

第5章：全球遺傳毒理學檢測市場展望

• 市場規模和預測
  • 按價值
• 市場佔有率和預測
  • 依組件（試劑及耗材、檢測、服務）
  • 依類型（體外和體內）
  • 按應用（製藥和生物技術、化妝品、食品、其他）
  • 按地區
  • 按公司分類（2024）
• 市場地圖

第6章：北美遺傳毒理學檢測市場展望

• 市場規模和預測
• 市場佔有率和預測
• 北美：國家分析
  • 美國
  • 加拿大
  • 墨西哥

第7章：歐洲遺傳毒理學檢測市場展望

• 市場規模和預測
• 市場佔有率和預測
• 歐洲：國家分析
  • 法國
  • 德國
  • 英國
  • 義大利
  • 西班牙

第8章：亞太地區遺傳毒理學檢測市場展望

• 市場規模和預測
• 市場佔有率和預測
• 亞太地區：國家分析
  • 中國
  • 印度
  • 日本
  • 韓國
  • 澳洲

第9章：南美洲遺傳毒理學檢測市場展望

• 市場規模和預測
• 市場佔有率和預測
• 南美洲：國家分析
  • 巴西
  • 阿根廷
  • 哥倫比亞

第10章：中東和非洲遺傳毒理學檢測市場展望

• 市場規模和預測
• 市場佔有率和預測
• MEA：國家分析
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第 11 章：市場動態

• 驅動程式
• 挑戰

第 12 章：市場趨勢與發展

• 最新動態
• 併購
• 產品發布

第 13 章：競爭格局

• 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：策略建議

第15章調查會社について,免責事項

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