体外毒性試験市場 - 世界の産業規模、シェア、動向、機会、予測：技術別、用途別、方法別、エンドユーザー別、地域別、競合別、2020年～2030年

体外毒性試験の世界市場は、2024年に182億3,000万米ドルと評価され、2030年までのCAGRは10.29%で、予測期間には328億8,000万米ドルに達すると予測されています。

体外毒性試験in vitroとは、様々な物質が生体外の生物システムに及ぼす潜在的な毒性影響を評価する科学的プロセスであり、通常は実験室で行われます。「in vitro」はラテン語で「ガラスの中」を意味し、生体全体（in vivo）ではなく、試験管、培養皿、その他の人工的なシステムなどの制御された環境で行われる実験を意味します。動物やヒトに有害な影響を与えることなく、化学物質、医薬品、化粧品、消費者製品、その他の物質の安全性を評価するために利用されます。これらの試験は、細胞レベル、分子レベル、生化学レベルでの物質の潜在的リスクと影響について貴重な洞察を提供します。また、動物モデルや臨床試験でさらに試験を行う物質を選別し、優先順位をつけるために、体外試験が用いられることも多いです。体外毒性試験には、倫理的配慮、コストと時間の削減、ハイスループット・スクリーニングの可能性など、従来の動物試験にはない利点がいくつかあります。しかし、全生物の複雑さを完全に再現することができないことや、in-vitroシステムと生体との反応の違いの可能性などの限界もあります。体外毒性試験は、細胞培養アッセイ、酵素アッセイ、遺伝毒性アッセイ、細胞毒性アッセイ、ハイスループットスクリーニング（HTS）の体外毒性試験に基づいて分類することができます。

市場促進要因

新薬や化学物質の安全性評価に対する需要の高まり

主な市場課題

生体システムの複雑性

主な市場動向

個別化医療への応用

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 世界の体外毒性試験市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • 技術別（細胞培養技術、ハイスループット技術、分子イメージング、オミックス技術）
  • 用途別（全身毒性、経皮毒性、内分泌かく乱、眼毒性、その他）
  • 方法別（細胞アッセイ、生化学アッセイ、in-silico、ex-vivo）
  • エンドユーザー別（製薬業界、化粧品・家庭用品、学術機関・調査機関、診断、化学業界、食品業界）
  • 企業別（2024）
  • 地域別
• 市場マップ

第6章 北米の体外毒性試験市場展望

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

第7章 欧州の体外毒性試験市場展望

• 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 アジア太平洋地域の体外毒性試験市場展望

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

第9章 南米の体外毒性試験市場展望

• 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・アフリカの体外毒性試験市場展望

• 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
• 製品上市
• 合併と買収

第13章 PESTEL分析

第14章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第15章 競合情勢

• Charles River Laboratories International, Inc.
• SGS S.A.
• Merck KGaA
• Eurofins Scientific
• Abbott Laboratories
• Laboratory Corporation of America Holdings
• Evotec S.E.
• Thermo Fisher Scientific, Inc.
• Quest Diagnostics Incorporated
• Agilent Technolgies, Inc.

第16章 戦略的提言

第17章 調査会社について・免責事項

Global In-vitro Toxicology Testing Market was valued at USD 18.23 billion in 2024 and is expected to reach USD 32.88 billion in the forecast period with a CAGR of 10.29% through 2030. In-vitro Toxicology Testing are the scientific process of evaluating the potential toxic effects of various substances on biological systems outside of a living organism, typically in a laboratory setting. The term "in vitro" is Latin for "in glass," and it signifies experiments conducted in a controlled environment such as test tubes, culture dishes, or other artificial systems rather than in a whole living organism (in vivo). They are utilized to assess the safety of chemicals, drugs, cosmetics, consumer products, and other substances without subjecting animals or humans to potentially harmful effects. These tests provide valuable insights into the potential risks and effects of substances on cellular, molecular, and biochemical levels. In-vitro testing is also often used to screen and prioritize substances for further testing in animal models or clinical trials. In-vitro toxicology testing has several advantages over traditional animal testing, including ethical considerations, reduced cost and time, and potential for high-throughput screening. However, it also has limitations, such as the inability to fully replicate the complexity of whole organisms and potential differences in responses between in-vitro systems and living organisms. In-vitro Toxicology Testing can be categorized based on cell culture assays, Enzyme Assays, Genotoxicity Assays, Cytotoxicity Assays and High-Throughput Screening (HTS) In-vitro Toxicology Testing.

Key Market Drivers

Rising Demand For Safety Assessment Of New Drugs And Chemicals

The rising demand for safety assessment of new drugs and chemicals is significantly accelerating the adoption of in-vitro toxicology testing across various sectors. According to the U.S. FDA, nearly 70% of investigational new drug (IND) applications rely on non-animal methods, including in-vitro assays, during early screening phases. This underscores a growing trust in laboratory-based models for initial safety profiling. Additionally, a 2023 study published in Nature Reviews Drug Discovery highlighted that over 60% of pharmaceutical companies are now incorporating high-throughput in-vitro assays as part of their standard safety assessment protocols, reflecting a broader industry shift toward more predictive, cost-efficient, and ethically sound testing methodologies.

Beyond regulatory mandates, the ability of in-vitro toxicology testing to screen large chemical libraries in parallel using techniques such as high-content imaging and omics technologies has streamlined the early decision-making process in drug development. These tests reduce time-to-market and improve the success rate by identifying cytotoxic, genotoxic, or hepatotoxic risks before clinical trials. Moreover, the integration of human-relevant cell lines and organotypic cultures provides more accurate data on human biological responses, thereby improving the reliability of risk assessments. As precision medicine and chemical safety continue to be prioritized, in-vitro testing is becoming indispensable for safer and more efficient innovation.

The growing complexity and volume of new chemical entities (NCEs) entering research pipelines have also bolstered the importance of in-vitro toxicology testing. As chemical and pharmaceutical industries aim to bring safer products to market faster, in-vitro models help narrow down potential leads by providing critical toxicological profiles early in the development stage. Technologies such as microfluidic "organ-on-chip" platforms are being increasingly integrated to mimic human physiological responses more accurately, allowing researchers to predict organ-specific toxicity with higher precision. This technological advancement has empowered companies to make go/no-go decisions much earlier, saving significant R&D resources and improving product safety outcomes.

Key Market Challenges

Complexity of Biological Systems

The complexity of biological systems poses significant challenges to the global in-vitro toxicity testing market. While in-vitro methods offer numerous advantages, accurately replicating the intricate interactions and dynamic processes that occur within living organisms is a complex endeavor. The challenges arising from biological complexity impact the predictive accuracy, relevance, and applicability of in-vitro toxicity testing. In-vitro models often focus on individual cell types or simplified tissues, which fail to capture the interactions between different organs, tissues, and cell types that occur in the whole organism. This limitation reduces the ability to predict systemic effects and complex physiological responses. Cells in the body interact within a specific microenvironment, including extracellular matrix, signaling molecules, and neighboring cells. Replicating these interactions in in-vitro models is challenging, potentially leading to altered cellular behavior and responses.

Additionally, the metabolic capacity of in-vitro systems often falls short compared to that of an entire organism. Many toxic effects arise from metabolites generated during the body's metabolic processes, particularly in the liver. Standard in-vitro models may not accurately reproduce these metabolic transformations, leading to an underestimation or misinterpretation of a substance's toxicity. For instance, hepatocyte cultures may not fully reflect the enzymatic activity of a functioning liver, which is crucial for assessing the safety of drugs and chemicals.

Another layer of complexity is introduced by individual genetic variability. Humans exhibit differences in gene expression, metabolism, and immune responses, all of which influence how substances are processed in the body. Most in-vitro systems use standardized cell lines that do not capture this inter-individual variability. This presents a limitation in predicting population-wide safety outcomes and personalizing risk assessments. As a result, despite advances in 3D cultures and organ-on-chip technologies, translating in-vitro findings to real-world human scenarios remains a significant hurdle for researchers and regulatory bodies alike.

Key Market Trends

Personalized Medicine Applications

Personalized medicine applications represent a significant trend in the global in-vitro toxicity testing market. Personalized medicine aims to tailor medical treatment to the individual characteristics of each patient, including their genetic makeup, lifestyle, and environmental factors. In the context of in-vitro toxicity testing, personalized medicine applications involve assessing how an individual's unique genetic and physiological characteristics influence their response to potential toxicants. In-vitro toxicity testing can be used to evaluate how a patient's specific genetic and molecular profile influences their susceptibility to adverse effects from chemicals and drugs. This approach enables more accurate and personalized risk assessments, helping to identify individuals who may be particularly sensitive to certain substances. By using patient-derived cells or tissues, researchers can conduct in-vitro toxicity testing to predict how an individual's body might respond to a particular compound. This information can guide treatment decisions and drug choices to maximize efficacy and minimize risks for each patient. In-vitro toxicity testing can help identify biomarkers or specific molecular indicators that signal potential toxic responses in certain individuals. These biomarkers can be used to monitor and predict toxicity in real-time during treatment. In-vitro toxicity testing can play a crucial role in identifying compounds that may lead to adverse reactions in specific patient populations. By selecting safer alternatives based on personalized testing, the risk of adverse effects can be significantly reduced.

Key Market Players

• Charles River Laboratories International, Inc.
• SGS S.A.
• Merck KGaA
• Eurofins Scientific
• Abbott Laboratories
• Laboratory Corporation of America Holdings
• Evotec S.E.
• Thermo Fisher Scientific, Inc.
• Quest Diagnostics Incorporated
• Agilent Technologies, Inc.

Report Scope:

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

In-vitro Toxicology Testing Market, By Technology:

• Cell Culture Technology
• High Throughput Technology
• Molecular Imaging
• OMICS Technology

In-vitro Toxicology Testing Market, By Application:

• Systemic Toxicology
• Dermal Toxicity
• Endocrine Disruption
• Occular Toxicity
• Others

In-vitro Toxicology Testing Market, By Method:

• Cellular Assay
• Biochemical Assay
• In-silico
• Ex-vivo

In-vitro Toxicology Testing Market, By End User:

• Pharmaceutical Industry
• Cosmetics & Household Products
• Academic Institutes & Research Laboratories
• Diagnostics
• Chemicals Industry
• Food Industry

In-vitro Toxicology Testing Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Asia-Pacific
  • China
  • India
  • South Korea
  • Australia
  • Japan
• Europe
  • Germany
  • France
  • United Kingdom
  • Spain
  • Italy
• 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 In-vitro Toxicology Testing Market.

Available Customizations:

Global In-vitro 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 In-vitro Toxicology Testing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Technology (Cell Culture Technology, High Throughput Technology, Molecular Imaging, OMICS Technology)
  • 5.2.2. By Application (Systemic Toxicology, Dermal Toxicity, Endocrine Disruption, Occular Toxicity, Others)
  • 5.2.3. By Method (Cellular Assay, Biochemical Assay, In-Silico, Ex-Vivo)
  • 5.2.4. By End-User (Pharmaceutical Industry, Cosmetics & Household Products, Academic Institutes & Research Laboratories, Diagnostics, Chemicals Industry, Food Industry)
  • 5.2.5. By Company (2024)
  • 5.2.6. By Region
• 5.3. Market Map

6. North America In-vitro Toxicology Testing Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Technology
  • 6.2.2. By Application
  • 6.2.3. By Method
  • 6.2.4. By End-User
  • 6.2.5. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States In-vitro 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 Technology
      • 6.3.1.2.2. By Application
      • 6.3.1.2.3. By Method
      • 6.3.1.2.4. By End-User
  • 6.3.2. Mexico In-vitro 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 Technology
      • 6.3.2.2.2. By Application
      • 6.3.2.2.3. By Method
      • 6.3.2.2.4. By End-User
  • 6.3.3. Canada In-vitro 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 Technology
      • 6.3.3.2.2. By Application
      • 6.3.3.2.3. By Method
      • 6.3.3.2.4. By End-User

7. Europe In-vitro Toxicology Testing Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Technology
  • 7.2.2. By Application
  • 7.2.3. By Method
  • 7.2.4. By End-User
  • 7.2.5. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France In-vitro 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 Technology
      • 7.3.1.2.2. By Application
      • 7.3.1.2.3. By Method
      • 7.3.1.2.4. By End-User
  • 7.3.2. Germany In-vitro 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 Technology
      • 7.3.2.2.2. By Application
      • 7.3.2.2.3. By Method
      • 7.3.2.2.4. By End-User
  • 7.3.3. United Kingdom In-vitro 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 Technology
      • 7.3.3.2.2. By Application
      • 7.3.3.2.3. By Method
      • 7.3.3.2.4. By End-User
  • 7.3.4. Italy In-vitro 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 Technology
      • 7.3.4.2.2. By Application
      • 7.3.4.2.3. By Method
      • 7.3.4.2.4. By End-User
  • 7.3.5. Spain In-vitro 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 Technology
      • 7.3.5.2.2. By Application
      • 7.3.5.2.3. By Method
      • 7.3.5.2.4. By End-User

8. Asia-Pacific In-vitro Toxicology Testing Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Technology
  • 8.2.2. By Application
  • 8.2.3. By Method
  • 8.2.4. By End-User
  • 8.2.5. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China In-vitro 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 Technology
      • 8.3.1.2.2. By Application
      • 8.3.1.2.3. By Method
      • 8.3.1.2.4. By End-User
  • 8.3.2. India In-vitro 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 Technology
      • 8.3.2.2.2. By Application
      • 8.3.2.2.3. By Method
      • 8.3.2.2.4. By End-User
  • 8.3.3. South Korea In-vitro 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 Technology
      • 8.3.3.2.2. By Application
      • 8.3.3.2.3. By Method
      • 8.3.3.2.4. By End-User
  • 8.3.4. Japan In-vitro 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 Technology
      • 8.3.4.2.2. By Application
      • 8.3.4.2.3. By Method
      • 8.3.4.2.4. By End-User
  • 8.3.5. Australia In-vitro 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 Technology
      • 8.3.5.2.2. By Application
      • 8.3.5.2.3. By Method
      • 8.3.5.2.4. By End-User

9. South America In-vitro Toxicology Testing Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Technology
  • 9.2.2. By Application
  • 9.2.3. By Method
  • 9.2.4. By End-User
  • 9.2.5. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil In-vitro 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 Technology
      • 9.3.1.2.2. By Application
      • 9.3.1.2.3. By Method
      • 9.3.1.2.4. By End-User
  • 9.3.2. Argentina In-vitro 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 Technology
      • 9.3.2.2.2. By Application
      • 9.3.2.2.3. By Method
      • 9.3.2.2.4. By End-User
  • 9.3.3. Colombia In-vitro 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 Technology
      • 9.3.3.2.2. By Application
      • 9.3.3.2.3. By Method
      • 9.3.3.2.4. By End-User

10. Middle East and Africa In-vitro Toxicology Testing Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Technology
  • 10.2.2. By Application
  • 10.2.3. By Method
  • 10.2.4. By End-User
  • 10.2.5. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa In-vitro 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 Technology
      • 10.3.1.2.2. By Application
      • 10.3.1.2.3. By Method
      • 10.3.1.2.4. By End-User
  • 10.3.2. Saudi Arabia In-vitro 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 Technology
      • 10.3.2.2.2. By Application
      • 10.3.2.2.3. By Method
      • 10.3.2.2.4. By End-User
  • 10.3.3. UAE In-vitro 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 Technology
      • 10.3.3.2.2. By Application
      • 10.3.3.2.3. By Method
      • 10.3.3.2.4. By End-User

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

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

13. PESTLE Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Product

15. Competitive Landscape

• 15.1. Charles River Laboratories International, Inc.
  • 15.1.1. Business Overview
  • 15.1.2. Company Snapshot
  • 15.1.3. Products & Services
  • 15.1.4. Financials (As Reported)
  • 15.1.5. Recent Developments
  • 15.1.6. Key Personnel Details
  • 15.1.7. SWOT Analysis
• 15.2. SGS S.A.
• 15.3. Merck KGaA
• 15.4. Eurofins Scientific
• 15.5. Abbott Laboratories
• 15.6. Laboratory Corporation of America Holdings
• 15.7. Evotec S.E.
• 15.8. Thermo Fisher Scientific, Inc.
• 15.9. Quest Diagnostics Incorporated
• 15.10. Agilent Technolgies, Inc.

16. Strategic Recommendations

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