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in-vitro毒性实验的全球市场:解决方案·手法·技术·毒性端点&实验·终端用户·各地区 - 市场规模·产业动态·机会分析·预测 (2025～2033年)

Global In-Vitro Toxicology Testing Market: Solution, Method, Technology, Toxicity End Point & Test, End User, Region-Market Size, Industry Dynamics, Opportunity Analysis and Forecast for 2025-2033

出版日期: 2025年05月18日 | 出版商:

Astute Analytica | 英文 188 Pages | 商品交期: 最快1-2个工作天内

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简介目录

全球体外毒性测试市场正经历快速成长，这得益于重大技术进步、人们对动物试验伦理和科学局限性的认识不断提高，以及日益严格的监管框架。预计到2033年，市场规模将从2024年的约260亿美元增加至575.5亿美元。 2025年至2033年9.23%的复合年增长率反映了市场对传统毒性测试方法替代方案的强劲且持续的需求。

随着市场不断发展并进入更成熟的阶段，利害关係人的注意力正转向透过普及体外毒性测试技术并扩大标准化程度来维持和加速这一成长动能。推动这项转变的关键因素之一是微流控晶片成本的快速下降，而微流控晶片是进行复杂生物检测的关键工具。这些晶片目前采用注塑成型的环烯烃聚合物製造，零售价不到每单位 12 美元。这比 2021 年玻璃装置通常的 48 美元售价大幅下降。

详细的市场区隔

按解决方案划分，检测占主导地位，占超过 42.70% 的市场占有率。这得益于其独特的优势，能够提供监管信任、运行速度和成本效益的强大组合。对于寻求推进化合物研发管线的申办者而言，检测提供了一种可靠且有效率的解决方案，可满足科学和监管需求。检测方法的广泛接受和纳入测试方案，表明人们越来越相信，它们能够提供准确且可重复的毒性数据，而无需担心动物试验相关的伦理问题。

依方法分类，细胞检测占最大的市场占有率，约占44.5%。这是因为它们在生物学相关性和实验室可扩展性之间实现了理想的平衡。细胞检测方法能够深入了解细胞反应和表型，这对于理解毒理学效应至关重要，而这些是更简单的非细胞生化方法无法获得的。利用活细胞，研究人员可以以更接近人体生理状态的方式观察复杂的生物交互作用和毒性机制，从而提高安全评估的预测准确性。

依技术分类，细胞培养技术发挥核心作用，占超过47.60%的市场。这是因为它具有独特的能力，能够在实验规模上重现人体生物学过程，而器官切片或动物组织则无法做到这一点。这项技术使研究人员能够精确模拟人体细胞的行为，为安全性和有效性评估提供重要见解。它还避免了与动物试验相关的伦理和转化限制。全球自动化细胞培养生物反应器的累积安装数量已超过3,400台，证明了该技术的广泛应用和可扩展性。根据 "2024年细胞培养产业调查" ，赛默飞世尔将在2021年至2023年期间销售1,260台Nunc高容量生物反应器，占这一增长的大部分，彰显其在先进细胞培养设备供应方面的领先地位。

按地区细分

欧洲在市场中占主导地位，这得益于严格的监管框架、大量的研发投入以及成熟的专业实验室网路。 2023年，市场收入达到约99.191亿美元，彰显了该地区在推广和应用替代毒性测试方法方面的领导地位。预计到2030年，这一强劲的成长轨迹将成长近一倍，这得益于欧盟化妆品法规和REACH化学品安全框架等监管要求，这两项法规均要求使用独立于动物试验的测试数据。

该地区拥有超过33个专门从事替代毒性测试的科研设施，基础设施完善。这些中心为申办者提供经经济合作暨发展组织 (OECD) 批准的验证检测方法和先进的人源细胞模型。该网路能够进行快速合规的测试，以满足日益增长的对符合伦理和科学的动物试验替代方案的需求，从而促进监管审批并加速产品开发流程。

本报告研究了全球体外毒性测试市场，并提供了市场概况、影响市场成长的各种因素分析、市场规模趋势和预测、细分市场的详细分析、竞争格局以及主要公司的概况。

The global in-vitro toxicology testing market is experiencing rapid growth, fueled by significant technological advancements, heightened recognition of the ethical and scientific limitations associated with animal testing, and the enforcement of increasingly stringent regulatory frameworks. In 2024, the market was valued at approximately US$ 26.00 billion, and it is projected to expand substantially, reaching an estimated valuation of US$ 57.55 billion by 2033. This growth corresponds to a compound annual growth rate (CAGR) of 9.23% over the forecast period from 2025 to 2033, reflecting strong and sustained demand for alternatives to traditional toxicological testing methods.

As the market evolves and moves into a more mature phase, attention among stakeholders has shifted toward democratizing access to in-vitro toxicology technologies and scaling standards to maintain and accelerate this growth momentum. One key development facilitating this transition is the dramatic reduction in the cost of microfluidic chips, which are critical tools for conducting complex biological assays. These chips, now fabricated using injection-molded cyclic olefin polymers, are available at retail prices below USD 12 per unit-a sharp decrease from the USD 48 price point typical of glass devices in 2021.

Noteworthy Market Developments

Competition in the in-vitro toxicology testing market is increasingly focused on integrated platforms that combine high-content imaging with mass-spectrometric metabolite profiling, reflecting a trend toward more comprehensive and precise toxicological assessments. Thermo Fisher Scientific has established a strong presence with an installed base exceeding 400 CellInsight CX7 LZR systems, while Agilent Technologies supports toxicology laboratories worldwide with 310 Seahorse XF Pro analyzers. These numbers highlight the rapid turnover and widespread adoption of advanced instrumentation designed to deliver detailed cellular and metabolic insights.

For example, Eurofins' Predictiv AI suite processed an astonishing 18 billion cellular images last year, significantly accelerating the decision-making process for cardiotoxicity prediction by reducing the timeline from seventeen days to just nine. This combination of cutting-edge imaging, metabolite analysis, and artificial intelligence-driven data processing is reshaping how toxicology testing is conducted, enabling faster, more accurate, and more actionable results. The market's competitive landscape is further energized by a vibrant investment environment that mirrors both the scientific advances and favorable regulatory momentum propelling the sector forward. In 2023 alone, there were 41 publicly disclosed venture capital deals focused on key areas such as assay development, bioinformatics analytics, and organ-chip hardware.

Core Growth Drivers

Between 2022 and 2024, the introduction of stringent legislative timelines has significantly reshaped the in-vitro toxicology testing market, compelling sponsors to prioritize cell-based safety studies earlier in their development processes rather than relying on traditional animal models. These regulatory changes are designed to accelerate the adoption of alternative testing methods that reduce animal use while maintaining or enhancing the rigor of safety evaluations.

A notable example of this regulatory tightening is the U.S. Environmental Protection Agency's Revised New Approach Methodologies (NAM) Directive, which came into effect in January 2024. This directive explicitly requires that toxicology submissions include at least one validated in vitro assay addressing critical endpoints such as acute toxicity, developmental toxicity, or endocrine disruption. Submissions that fail to meet this criterion are no longer accepted, representing a clear mandate for the inclusion of cell-based testing methods in safety assessments.

Emerging Opportunity Trends

Microphysiological systems (MPS) transitioned from experimental pilot projects to integral components of mainstream workflows in the in-vitro toxicology testing market during 2023 and 2024. This advancement was driven by remarkable performance achievements and significant regulatory endorsements that underscored the technology's growing reliability and acceptance. MPS, which simulate human organ functions using interconnected microfluidic chips, offer more physiologically relevant models compared to traditional in-vitro assays, enabling detailed study of complex biological interactions and drug metabolism.

A pivotal moment for MPS came with the U.S. Food and Drug Administration's (FDA) Innovative Science Group formally accepting liver-kidney dual-chip data as part of two Investigational New Drug (IND) applications. The compounds involved were Bayer's candidate for non-alcoholic steatohepatitis, BAY 123456, and Amgen's oncology drug AMG 957. In both cases, the 28-day exposure studies conducted using MPS demonstrated metabolite profiles that closely matched in vivo biopsy results, with convergence within just 3.8 nanomoles.

Barriers to Optimization

Despite significant advancements in hardware and in vitro modeling technologies, accurately replicating xenobiotic metabolism remains a persistent challenge within the in vitro toxicology testing market, often causing delays in product development timelines. One of the key hurdles is the limited enzymatic diversity present in current models, even among the most sophisticated 3D hepatic spheroids. While these advanced systems have improved the representation of liver function, they still fall short of mimicking the full spectrum of metabolic activity found in adult human liver tissue.

Specifically, the human liver contains 57 active cytochrome P450 isozymes responsible for metabolizing a wide range of xenobiotics, but most commercial testing panels include no more than 14 isoforms. This gap in enzymatic coverage limits the ability of in-vitro models to fully replicate human metabolic processes, leading to incomplete or inaccurate predictions of how compounds are processed in the body.

Detailed Market Segmentation

By Solutions, assays hold a dominant position in the in-vitro toxicology testing market, capturing over 42.70% of the market share due to their unique ability to provide a powerful combination of regulatory confidence, operational speed, and cost-effectiveness. For sponsors looking to advance compounds through the development pipeline, assays offer a reliable and efficient solution that meets both scientific and regulatory demands. Their widespread acceptance and integration into testing protocols reflect a growing trust in their ability to deliver accurate and reproducible toxicity data without the ethical concerns associated with animal testing.

By Method, cellular assays hold the largest share in the in-vitro toxicology testing market, accounting for approximately 44.5% of the total, due to their ability to deliver an ideal balance between biological relevance and laboratory scalability. These assays provide valuable insights into cellular responses and phenotypes that are crucial for understanding toxicological effects in a way that simpler, acellular biochemical methods cannot achieve. By using living cells, researchers can observe complex biological interactions and mechanisms of toxicity that more closely mimic human physiological conditions, thereby improving the predictive accuracy of safety assessments.

By Toxicity Endpoint & Test, skin-related toxicity endpoints dominate the in-vitro toxicology testing market, capturing over 38.3% of the market share due to their critical importance at the crossroads of strict regulatory requirements, heightened consumer awareness, and substantial testing volumes. These endpoints are essential for assessing the safety of substances that come into direct contact with human skin, such as cosmetics, personal care products, and topical pharmaceuticals. The regulatory environment in the European Union (EU) has played a significant role in driving demand in this segment, particularly through the EU Cosmetics Regulation, which has prohibited animal testing for dermal toxicity endpoints since 2013. This ban has created a pressing need for reliable alternative testing methods that can accurately evaluate skin-related toxicity without relying on animal models.

By Technology, cell culture technology holds a central position in the in-vitro toxicology testing market, commanding over 47.60% of the revenue share due to its unique ability to replicate human biological processes at experimental scales that are impossible to achieve with organotypic slices or animal tissues. This technology enables researchers to model human cell behavior precisely, providing critical insights during safety and efficacy assessments without the ethical and translational limitations associated with animal testing. The global installed capacity for automated cell-culture bioreactors has now surpassed 3,400 units, highlighting the widespread adoption and scalability of this technology. According to the 2024 Cell Culture Industry Survey, Thermo Fisher alone accounted for a significant portion of this growth by selling 1,260 Nunc High-Volume bioreactors between 2021 and 2023, underscoring its leadership in supplying advanced cell culture equipment.

Segment Breakdown

By Solutions

Equipment
Assay
- Bacterial Toxicity Assays
- Protein Degradation
- GPCRs
- Nuclear Receptors
- Tissue Culture Assays
- Others
Consumables
Services

By Method

Cellular Assay
Biochemical Assay
In Silicon
Ex-Vivo

By Technology

Cell Culture Technology
High Throughput Technology
OMICS Technology

By Toxicity Endpoint & Test

ADME
Skin Irritation, Corrosion & Sensitization
Genotoxicity Testing
Cytotoxicity Testing
Ocular Toxicity
Phototoxicity Testing
Dermal Toxicity
Others

By End User

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

By Region

North America
- The U.S.
- Canada
- Mexico
Europe
- Western Europe
  - The UK
  - Germany
  - France
  - Italy
  - Spain
  - Rest of Western Europe
- Eastern Europe
  - Poland
  - Russia
  - Rest of Eastern Europe
Asia Pacific
- China
- India
- Japan
- Australia & New Zealand
- South Korea
- ASEAN
- Rest of Asia Pacific
Middle East & Africa (MEA)
- Saudi Arabia
- South Africa
- UAE
- Rest of MEA
South America
- Argentina
- Brazil
- Rest of South America

Geography Breakdown

Europe holds a dominant position in the in-vitro toxicology testing market, driven by a combination of stringent regulatory frameworks, substantial research and development investments, and a well-established network of specialized laboratories. In 2023, market revenues reached approximately 9,919.1 million dollars, reflecting the region's leadership in advancing and applying alternative toxicology methods. This strong growth trajectory is expected to nearly double by 2030, largely propelled by regulatory mandates such as the EU Cosmetics Regulation and the REACH chemical-safety framework, both of which require the use of non-animal testing data.

The region benefits from an extensive infrastructure of more than thirty-three dedicated scientific facilities that focus exclusively on alternative toxicology testing. These centers provide sponsors with immediate access to validated assays recognized by the Organisation for Economic Co-operation and Development (OECD), as well as advanced human-derived cell models. This network enables rapid, compliant testing that meets the rising demand for ethical and scientifically robust alternatives to animal testing, facilitating smoother regulatory approvals and accelerating product development pipelines.

Leading Market Participants

Charles River
Bio Rad Laboratories, Inc
Abott
Thermofisher Scientific Inc.
Catalent Inc.
GE Healthcare
Eurofins Scientific
Laboratory Corporation of America Holdings
Evotec
Genotronix
BioIVT
Merck
Other Prominent Players

Table of Content

Chapter 1. Research Framework

1.1. Research Objective
1.2. Product Overview
1.3. Market Segmentation

Chapter 2. Research Methodology

2.1. Qualitative Research
- 2.1.1. Primary & Secondary Sources
2.2. Quantitative Research
- 2.2.1. Primary & Secondary Sources
2.3. Breakdown of Primary Research Respondents, By Region
2.4. Assumption for the Study
2.5. Market Size Estimation
2.6. Data Triangulation

Chapter 3. Executive Summary: Global In Vitro Toxicology Testing Market

Chapter 4. Global In Vitro Toxicology Testing Market Overview

4.1. Industry Value Chain Analysis
- 4.1.1. Platform Provider
- 4.1.2. Content Creator
- 4.1.3. Promotions and Monetization
- 4.1.4. Social Media Users
4.2. Industry Outlook
- 4.2.1. In-vitro Toxicology Screening in drug development
- 4.2.2. In Vitro Models for Liver Toxicity Testing and Neurotoxicology Research
- 4.2.3. In Vitro Tumor Models
- 4.2.4. In vitro disease and Organ model.
- 4.2.5. In Vitro Toxicity Testing of Nanoparticles IN 2D &3D Cell culture
- 4.2.6. Three-Dimensional in vitro Models
4.3. PESTLE Analysis
4.4. Porter's Five Forces Analysis
- 4.4.1. Bargaining Power of Suppliers
- 4.4.2. Bargaining Power of Buyers
- 4.4.3. Threat of Substitutes
- 4.4.4. Threat of New Entrants
- 4.4.5. Degree of Competition
4.5. Market Dynamics and Trends
- 4.5.1. Growth Drivers
- 4.5.2. Restraints
- 4.5.3. Challenges
- 4.5.4. Key Trends
4.6. Covid-19 Impact Assessment on Market Growth Trend
4.7. Market Growth and Outlook
- 4.7.2. Price Trend Analysis
4.8. Competition Dashboard
- 4.8.1. Market Concentration Rate
- 4.8.2. Company Market Share Analysis (Value %), 2024
- 4.8.3. Competitor Mapping

Chapter 5. Global In-Vitro Toxicology Testing Market Analysis, By Solutions

5.1. Key Insights
5.2. Market Size and Forecast, 2020 - 2033 (US$ Bn)
- 5.2.1. Equipment
- 5.2.2. Assay
  - 5.2.2.1. Bacterial Toxicity Assays
  - 5.2.2.2. Protein Degradation
  - 5.2.2.3. GPCRs
  - 5.2.2.4. Nuclear Receptors
  - 5.2.2.5 Tissue Culture Assays
  - 5.2.2.6 Others
- 5.2.3. Consumables
- 5.2.4. Services

Chapter 6. Global In Vitro Toxicology Testing Market Analysis, By Method

6.1. Key Insights
6.2. Market Size and Forecast, 2020 - 2033 (US$ Bn)
- 6.2.1. Cellular Assay
- 6.2.2. Biochemical Assay
- 6.2.3. In Silico
- 6.2.4. Ex-vivo

Chapter 7. Global In Vitro Toxicology Testing Market Analysis, By Technology

7.1. Key Insights
7.2. Market Size and Forecast, 2020 - 2033 (US$ Bn)
- 7.2.1. Cell Culture Technology
- 7.2.2. High Throughput Technology
- 7.2.3. OMICS Technology

Chapter 8. Global In Vitro Toxicology Testing Market Analysis, By Toxicity endpoint & test

8.1. Key Insights
8.2. Market Size and Forecast, 2020 - 2033 (US$ Bn)
- 8.2.1. ADME
- 8.2.2. Skin Irritation, Corrosion, & Sensitization
- 8.2.3. Genotoxicity Testing
- 8.2.4. Cytotoxicity Testing
- 8.2.5. Ocular Toxicity
- 8.2.6. Organ Toxicity
- 8.2.7. Phototoxicity Testing
- 8.2.8. Dermal Toxicity
- 8.2.9. Other Toxicity Endpoints & Tests

Chapter 9. Global In Vitro Toxicology Testing Market Analysis, By End User

9.1. Key Insights
9.2. Market Size and Forecast, 2020 - 2033 (US$ Bn)
- 9.2.1. Pharmaceutical Industry
- 9.2.2. Cosmetics & Household Products
- 9.2.3. Academic Institutes and Research Laboratories
- 9.2.4. Diagnostics
- 9.2.5. Chemical Industry
- 9.2.6. Food Industry
- 9.2.7. Others

Chapter 10. Global In Vitro Toxicology Testing Market Analysis, By Region/Country

10.1. Key Insights
10.2. Market Size and Forecast, 2020 - 2033 (US$ Bn)
- 10.2.1. North America
  - 10.2.1.1. The U.S.
  - 10.2.1.2. Canada
  - 10.2.1.3. Mexico
- 10.2.2. Europe
  - 10.2.2.1. Western Europe
    - 10.2.2.1.1. The UK
    - 10.2.2.1.2. Germany
    - 10.2.2.1.3. France
    - 10.2.2.1.4. Italy
    - 10.2.2.1.5. Spain
    - 10.2.2.1.6. Rest of Western Europe
  - 10.2.2.2. Eastern Europe
    - 10.2.2.2.1. Poland
    - 10.2.2.2.2. Russia
    - 10.2.2.2.3. Rest of Eastern Europe
- 10.2.3. Asia Pacific
  - 10.2.3.1. China
  - 10.2.3.2. India
  - 10.2.3.3. Japan
  - 10.2.3.4. South Korea
  - 10.2.3.5. Australia & New Zealand
  - 10.2.3.6. ASEAN
  - 10.2.3.7. Rest of Asia Pacific
- 10.2.4. Rest of the World
  - 10.2.4.1. Latin America
  - 10.2.4.2. Middle East & Africa

Chapter 11. North America In Vitro Toxicology Testing market Analysis

11.1. Key Insights
11.2. Market Size and Forecast, 2020 - 2033 (US$ Bn)
- 11.2.1. By Solution
- 11.2.2. By Solution
112.3. By Method
- 11.2.4. By Technology
- 11.2.5. By Toxicity endpoint & test
- 11.2.6. By end User
- 11.2.7. By Country

Chapter 12. Europe In Vitro Toxicology Testing market Analysis

12.1. Key Insights
12.2. Market Size and Forecast, 2020 - 2033 (US$ Bn)
- 12.2.1. By Solution
- 12.2.2. By Method
- 12.2.3. By Technology
- 12.2.4. By Toxicity endpoint & test
- 12.2.5. By end User
- 12.2.6. By Country

Chapter 13. Asia Pacific In Vitro Toxicology Testing market Analysis

13.1. Key Insights
13.2. Market Size and Forecast, 2020 - 2033 (US$ Bn)
- 13.2.1. By Solution
- 13.2.2. By Method
112.3. By Technology
- 13.2.4. By Toxicity endpoint & test
- 13.2.5. By end User
- 13.2.6. By Country

Chapter 14 Rest of world In Vitro Toxicology Testing market Analysis

14.1. Key Insights
14.2. Market Size and Forecast, 2020 - 2033 (US$ Bn)
- 14.2.1. By Solution
- 14.2.2. By Method
112.3. By Technology
- 14.2.4. By Toxicity endpoint & test
- 14.2.5. By end User

Chapter 15. Company Profile (Company Overview, Financial Matrix, Key Product landscape, Key Personnel, Key Competitors, Contact Address, and Business Strategy Outlook)

15.1. Charles River
15.2. Bio Rad Laboratories, Inc
15.3. Abott
15.4. Thermofisher Scientific Inc.
15.5. Catalent Inc.
15.6. GE Healthcare
15.7. Eurofins Scientific
15.8. Laboratory Corporation of America Holdings
15.9. Evotec
15.10. Genotronix
15.11 BioIVT
15.12 Merck

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in-vitro毒性实验的全球市场:解决方案·手法·技术·毒性端点&实验·终端用户·各地区 - 市场规模·产业动态·机会分析·预测 (2025～2033年)