세계의 체외 독성 시험 시장 - 산업 규모, 점유율, 동향, 기회, 예측 : 기술별, 용도별, 방법별, 최종 사용자별, 지역별, 경쟁별(2020-2030년)
In-vitro Toxicology Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Technology, By Application, By Method, By End-User, By Region and Competition, 2020-2030F
상품코드 : 1785151
리서치사 : TechSci Research
발행일 : 2025년 08월
페이지 정보 : 영문 182 Pages
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한글목차

세계의 체외 독성 시험 시장은 2024년에 182억 3,000만 달러로 평가되었으며, 2030년까지의 CAGR은 10.29%를 나타내 예측 기간에는 328억 8,000만 달러에 달할 것으로 예상되고 있습니다.

체외 독성 시험은 다양한 물질이 생체 외 생물 시스템에 미치는 잠재적 독성 영향을 평가하는 과학적 과정이며, 일반적으로 실험실에서 수행됩니다. 'in vitro'는 라틴어로 '유리 안'을 의미하며 생체 전체(in vivo)가 아닌 시험관, 배양 접시, 기타 인공 시스템 등의 제어된 환경에서 수행되는 실험을 의미합니다. 동물과 인간에 해로운 영향을 미치지 않고 화학 물질, 의약품, 화장품, 소비자 제품 및 기타 물질의 안전성을 평가하는 데 사용됩니다. 이러한 시험은 세포 수준, 분자 수준 및 생화학 수준에서 물질의 잠재적 위험과 영향에 대한 귀중한 인사이트를 제공합니다. 또, 동물 모델이나 임상시험으로 한층 더 시험을 실시하는 물질을 선별해, 우선 순위를 붙이기 위해서, 체외 시험이 이용되는 일도 많습니다. 체외 독성 시험은 윤리적 고려, 비용 및 시간 절감, 높은 처리량 스크리닝 가능성 등 전통적인 동물 시험에는 없는 장점이 있습니다. 그러나 전생물의 복잡성을 완전히 재현할 수 없거나 생체외 시스템과 생체 간의 반응 차이의 가능성 등의 한계도 있습니다. 체외 독성 시험은 세포 배양 검정, 효소 검정, 유전 독성 검정, 세포 독성 검정, 고처리량 스크리닝(HTS)의 체외 독성 시험에 기초하여 분류될 수 있습니다.

시장 개요
예측 기간 2026-2030년
시장 규모 : 2024년 182억 3,000만 달러
시장 규모 : 2030년 328억 8,000만 달러
CAGR : 2025-2030년 10.29%
급성장 부문 세포 배양 기술
최대 시장 북미

시장 성장 촉진요인

신약 및 화학물질의 안전성 평가에 대한 수요 증가

주요 시장 과제

생체 시스템의 복잡성

주요 시장 동향

맞춤형 의료에의 응용

목차

제1장 개요

제2장 조사 방법

제3장 주요 요약

제4장 고객의 목소리

제5장 세계의 체외 독성 시험 시장 전망

제6장 북미의 체외 독성 시험 시장 전망

제7장 유럽의 체외 독성 시험 시장 전망

제8장 아시아태평양의 체외 독성 시험 시장 전망

제9장 남미의 체외 독성 시험 시장 전망

제10장 중동 및 아프리카의 체외 독성 시험 시장 전망

제11장 시장 역학

제12장 시장 동향과 발전

제13장 PESTEL 분석

제14장 Porter's Five Forces 분석

제15장 경쟁 구도

제16장 전략적 제안

제17장 기업 소개와 면책사항

KTH
영문 목차

영문목차

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.

Market Overview
Forecast Period2026-2030
Market Size 2024USD 18.23 Billion
Market Size 2030USD 32.88 Billion
CAGR 2025-203010.29%
Fastest Growing SegmentCell Culture Technology
Largest MarketNorth America

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

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:

In-vitro Toxicology Testing Market, By Application:

In-vitro Toxicology Testing Market, By Method:

In-vitro Toxicology Testing Market, By End User:

In-vitro Toxicology Testing Market, By Region:

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

Table of Contents

1. Product Overview

2. Research Methodology

3. Executive Summary

4. Voice of Customer

5. Global In-vitro Toxicology Testing Market Outlook

6. North America In-vitro Toxicology Testing Market Outlook

7. Europe In-vitro Toxicology Testing Market Outlook

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

9. South America In-vitro Toxicology Testing Market Outlook

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

11. Market Dynamics

12. Market Trends & Developments

13. PESTLE Analysis

14. Porter's Five Forces Analysis

15. Competitive Landscape

16. Strategic Recommendations

17. About Us & Disclaimer

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