遺伝子毒性検査市場- 世界の産業規模、シェア、動向、機会、予測、コンポーネント別、タイプ別、用途別、地域別、競合別、2020年～2030年

遺伝子毒性検査の世界市場規模は2024年に18億8,000万米ドルで、予測期間中のCAGRは8.34%で2030年には30億2,000万米ドルに達すると予測されています。

遺伝子毒性検査の世界市場は、技術の進歩、規制枠組みの新興国市場、医薬品開発や環境モニタリングにおける安全性への注目の高まりが重なり、大きな勢いを見せています。遺伝子毒性検査は、がん、発達障害、遺伝性疾患などの深刻な健康問題を引き起こす可能性のある遺伝的変異や染色体損傷を引き起こす物質の可能性を評価する上で重要な役割を果たしています。この市場の主な成長促進要因の一つは、より安全な医薬品に対する需要の高まりです。世界中の規制機関は、医薬品承認プロセスの一環として包括的な毒性学的評価を要求しています。このため、製薬企業やバイオテクノロジー企業は、安全基準を遵守し、後期段階での失敗を回避するため、より高度な調査手法を採用するようになっています。例えば、2022年7月、Inotiv Inc.は、in vitro細胞遺伝学と細菌アッセイを中心とした遺伝毒性試験の能力を拡大する計画を発表しました。この拡張は、試験能力を強化し、医薬品開発におけるより包括的な安全性評価をサポートすることで、増大する新規治療への需要に対応することを目的としています。動物実験から代替のin vitro試験法への移行は、大きな支持を得ています。これらの方法は、コスト、スピード、倫理的配慮の面で利点があり、商業的にも研究的にもますます魅力的なものとなっています。小核試験、コメットアッセイ、エームス試験などの技術は、生きた動物実験を必要とせずにDNA損傷や遺伝子変異を検出するために一般的に用いられています。

市場促進要因

医薬品開発活動の活発化

主な市場課題

検査技術の高コスト

主な市場動向

個別化および予測毒性学の拡大

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界の遺伝子毒性検査市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • コンポーネント別（試薬・消耗品、アッセイ、サービス）
  • タイプ別（体外vs.生体内）
  • 用途別（医薬品・バイオテクノロジー、化粧品、食品、その他）
  • 地域別
  • 企業別（2024年）
• 市場マップ

第6章 北米の遺伝子毒性検査市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • カナダ
  • メキシコ

第7章 欧州の遺伝子毒性検査市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • 英国
  • イタリア
  • スペイン

第8章 アジア太平洋の遺伝子毒性検査市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋：国別分析
  • 中国
  • インド
  • 日本
  • 韓国
  • オーストラリア

第9章 南米の遺伝子毒性検査市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの遺伝子毒性検査市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 最近の動向
• 合併と買収
• 製品上市

第13章 競合情勢

• 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 戦略的提言

第15章 調査会社について・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