首页 > 市场调查报告书 > 製药

药物开发

市场调查报告书

商品编码

1623521

全球体外毒理学测试市场：依技术、产品、应用、最终用户、地区划分，2024-2031

Global In vitro Toxicology Testing Market By Technology, Product, Application, End-User, & Region for 2024-2031

出版日期: 2024年09月06日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3个工作天内

价格

简介目录

体外毒性测试市场评估，2024-2031

毒理学研究和技术开发的进步以及对新定製药物开发的日益关注推动了市场扩张。化学品和药品安全评估的监管要求不断提高，需要采用体外测试方法，预计2024年价值将超过134.3亿美元，2031年约为295亿美元，预计将达到1美元。

除此之外，人们越来越认识到传统毒理学筛检技术的缺点和困难。因此，体外测试已被广泛认为是确定化合物安全性和有效性的有用方法，并预计在 2024 年至 2031 年期间以 11.40% 的复合年增长率增长其利基市场。

体外毒性测试全球市场定义/概述

体外毒性试验是指利用实验技术来评估物质对体外生物细胞或组织的毒性。这些测试是在受控环境中进行的，可以进行精确测量和特定生物过程的研究。体外毒性测试广泛用于在对动物或人体进行测试之前评估化学物质、药物和其他物质的安全性。

体外毒性测试是评估各种物质的安全性和有效性的重要工具。其应用范围广泛，包括药物开发、化学品安全评估、风险评估和法规遵循。透过采用实验室技术评估物质对生物细胞和组织的毒性，体外测试提供了对潜在风险的宝贵见解，并有助于开发更安全、更有效的产品。

更复杂的体外模型的开发，例如器官晶片系统，可能会提高毒性评估的预测准确性。此外，人工智慧和机器学习的整合可以实现更有效率的数据分析和建模，从而实现更快、更准确的毒性预测。

对动物测试日益增长的道德担忧如何推动全球体外毒性测试市场的发展？

全球体外毒性测试市场主要是由不断上升的伦理问题和有关动物测试的严格监管指南推动的。根据美国环保署 (EPA) 的数据，截至 2023 年，超过 10,000 种化学物质受有毒物质控制法管辖，并需要进行广泛的安全测试。例如，2024年3月15日，Thermo Fisher Scientific宣布推出新的体外毒理学高通量筛选平台，旨在加速药物发现过程。

製药和生物技术领域不断增加的研发投资正在推动市场成长。美国国立卫生研究院 (NIH) 报告 2024 财政年度生物医学研究预算为 451 亿美元，其中大部分专门用于开发替代测试方法。例如，2024 年 4 月 2 日，Charles River Laboratories 宣布推出新的 3D 细胞培养系统，以更准确地预测候选药物的毒性。

细胞培养技术与人工智慧相结合的技术进步正在提高体外毒性测试的效率。美国食品药物管理局（FDA）在2023年核准了55种新药，其中80%以上在开发过程中使用体外方法。例如，2024 年 2 月 20 日，领先的 CRO Cyprotex 推出了一个人工智慧驱动的平台，利用体外检测来预测药物引起的肝损伤，这可能会降低临床试验中的药物损耗率。

与体内测试相比，预测准确性的限制如何影响全球体外毒性测试市场的成长？

儘管成长，全球体外毒性测试市场仍面临重大课题。与体内测试相比，体外模型的预测准确性有限仍然是一个问题。FDA表示，进入临床试验的药物最终只有11%获得批准，这凸显了对更可靠的临床前测试方法的需求。2024 年 3 月，Charles River Laboratories 宣布与 Instem 建立合作关係，以增强其毒理学资料管理能力。

不同地区的监管障碍和缺乏标准化正在阻碍市场扩张。2023 年，欧洲化学品管理局报告称，只有 32% 的 REACH 申请完全符合资讯要求，凸显了协调测试协议的必要性。例如，2024 年 1 月，Thermo Fisher Scientific 宣布推出一个新平台，旨在简化多个市场体外毒性测试的监管合规性。

与先进体外技术相关的高昂初始成本是采用的障碍，特别是对于小型实验室而言。美国国立卫生研究院已在 2024 财政年度拨款 12 亿美元用于毒理学研究，但资金竞争依然激烈。为了解决这个问题，Lonza 于 2023 年 11 月宣布推出一种经济高效的高通量筛选系统，旨在让更广泛的实验室更容易进行先进的体外毒性测试。

The market expansion is ascribed to the ongoing advancements in the toxicological research and technological developments coupled with the increasing focus on the novel development of tailored medications. Increasing regulatory requirements for the safety assessment of chemicals and drugs are necessitating the adoption of in-vitro testing methodologies, surpassing USD 13.43 Billion valued in 2024 to reach a valuation of aroundUSD 29.5 Billion by 2031.

In addition to this, there has been an increase in the awareness of the drawbacks and difficulties of conventional toxicological screening techniques. As a result, in-vitro testing is now more widely recognized as a useful method for determining a compound's safety and effectiveness, thus enabling the niche market grow at aCAGR of 11.40% from 2024 to 2031.

Global In vitro Toxicology Testing Market: Definition/ Overview

In-vitro toxicology testing refers to the use of laboratory techniques to assess the toxicity of substances on biological cells or tissues outside of a living organism. These tests are conducted in a controlled environment, allowing for precise measurements and the study of specific biological processes. In-vitro toxicology testing is widely used to evaluate the safety of chemicals, drugs, and other substances before they are tested in animals or humans.

In-vitro toxicology testing serves as a valuable tool for assessing the safety and efficacy of various substances. Its applications extend across drug development, chemical safety evaluation, risk assessment, and regulatory compliance. By employing laboratory techniques to evaluate the toxicity of substances on biological cells or tissues, in-vitro testing offers valuable insights into potential risks and facilitates the development of safer and more effective products.

The development of more sophisticated in-vitro models, such as organ-on-a-chip systems, will improve the predictive accuracy of toxicity assessments. Additionally, the integration of artificial intelligence and machine learning will enable more efficient data analysis and modeling, leading to faster and more accurate toxicity predictions.

What's inside a VMR industry report?

Our reports include actionable data and forward-looking analysis that help you craft pitches, create business plans, build presentations and write proposals.

How are the Increasing Ethical Concerns Regarding the Animal Testing Fueling the Development of Global In vitro Toxicology Testing Market?

The Global In vitro Toxicology Testing Market is primarily driven by increasing ethical concerns regarding animal testing and stringent regulatory guidelines. According to the U.S. Environmental Protection Agency (EPA), as of 2023, over 10,000 chemicals are subject to the Toxic Substances Control Act, necessitating extensive safety testing. For instance, in March 15, 2024, Thermo Fisher Scientific announced a new high-throughput screening platform for in-vitro toxicology, aiming to accelerate drug discovery processes.

Rising R&D investments in pharmaceutical and biotechnology sectors are fueling market growth. The National Institutes of Health (NIH) reported a budget of $45.1 billion for biomedical research in fiscal year 2024, a significant portion allocated to developing alternative testing methods. for instance, in April 2, 2024, Charles River Laboratories unveiled a novel 3D cell culture system for more accurate toxicity predictions in drug candidates.

Technological advancements in cell culture techniques and the integration of artificial intelligence are enhancing the efficiency of in-vitro toxicology testing. The U.S. Food and Drug Administration (FDA) approved 55 novel drugs in 2023, with over 80% utilizing in-vitro methods during development. For instance, in February 20, 2024, Cyprotex, a leading CRO, launched an AI-powered platform for predicting drug-induced liver injury using in-vitro assays, potentially reducing drug attrition rates in clinical trials.

How are the Limited Predictive Accuracy Compared to In-Vivo Testing Impacting of the Global In vitro Toxicology Testing Market Growth?

The Global In vitro Toxicology Testing Market faces significant challenges despite its growth. Limited predictive accuracy of in-vitro models compared to in-vivo testing remains a concern. According to the FDA, only 11% of drugs that enter clinical trials ultimately receive approval, highlighting the need for more reliable preclinical testing methods. In March 2024, Charles River Laboratories announced a partnership with Instem to enhance their toxicology data management capabilities.

Regulatory hurdles and lack of standardization across different regions hinder market expansion. The European Chemicals Agency reported in 2023 that only 32% of REACH dossiers fully complied with information requirements, emphasizing the need for harmonized testing protocols. For instance, in January 2024, Thermo Fisher Scientific launched a new platform aimed at streamlining regulatory compliance for in-vitro toxicology testing across multiple markets.

High initial costs associated with advanced in-vitro technologies pose a barrier to adoption, especially for smaller laboratories. The National Institutes of Health allocated $1.2 billion for toxicology research in fiscal year 2024, but funding remains competitive. To combat this, Lonza introduced a cost-effective, high-throughput screening system in November 2023, designed to make advanced in-vitro toxicology testing more accessible to a broader range of research facilities.

Category-Wise Acumens

What are the Features Bolstering the Demand of Cell Culture Technology Segment?

The cell culture technology segment dominates the Global In vitro Toxicology Testing Market due to its ability to mimic human physiology accurately. According to the National Center for Advancing Translational Sciences (NCATS), as of 2023, over 30% of promising medications fail in human trials due to toxicity undetected in animal studies.

Advancements in 3D cell culture models and organ-on-a-chip technologies are driving the segment's growth. The U.S. FDA reported that in 2023, approximately 25% of drug submissions included data from advanced cell culture models. In a significant development, on March 5, 2024, InSphero AG announced a partnership with a major pharmaceutical company to develop liver-on-a-chip models for high-throughput toxicity screening, potentially revolutionizing drug safety assessment procedures.

What Factors are Responsible to Project the Market Growth of Cellular Assay Segment?

The cellular assay segment has maintained a dominant position in the Global In vitro Toxicology Testing Market, driven by its ability to provide detailed insights into cellular responses to potential toxicants. According to the National Toxicology Program (NTP) of the U.S. Department of Health and Human Services, as of 2023, over 60% of toxicity screenings utilize cellular assays. For instance, in January 10, 2024, Lonza Group announced the expansion of its cellular assay portfolio with the launch of a new high-throughput 3D spheroid platform, enhancing the predictability of in-vitro toxicity assessments.

Advancements in cell culture technologies and the development of organ-on-a-chip models have further bolstered the cellular assay segment's market share. The European Chemicals Agency (ECHA) reported in 2023 that cellular assays accounted for 70% of all in-vitro methods used for REACH compliance. For instance, in March 5, 2024, InSphero AG unveiled a novel liver-on-a-chip platform integrating multiple cell types for comprehensive hepatotoxicity testing, potentially revolutionizing drug safety assessments in preclinical stages.

Country/Region-wise Acumens

How are the Increased Adoption of In-Vitro Methods in Toxicology Studies Fueling the Demand in the North America region?

North America maintains a dominant position in the Global In vitro Toxicology Testing Market, driven by robust research infrastructure and stringent regulatory frameworks. The U.S. National Toxicology Program (NTP) reported in 2023 that over 65% of toxicology studies now incorporate in-vitro methods. For instance, in January 12, 2024, PerkinElmer announced the expansion of its Massachusetts-based in-vitro toxicology testing facility, doubling its capacity to meet growing demand in the region.

The region's leadership is further bolstered by substantial funding and collaborative initiatives between industry and academia. The Canadian Institutes of Health Research (CIHR) allocated CAD 25 million for alternatives to animal testing in fiscal year 2023-2024. For instance, in March 28, 2024, Eurofins Scientific partnered with the University of California, San Diego to establish a center of excellence for advanced in-vitro toxicology methods, focusing on organ-on-chip technologies.

How are the Increasing R&D Investments and Biotechnology Growth Fueling the Asia Pacific In-vitro Toxicology Testing Growth?

The Asia Pacific region is poised for substantial growth in the in-vitro toxicology testing market, driven by increasing R&D investments and a rapidly expanding biotechnology sector. According to the Indian Ministry of Science and Technology, the country's biotechnology industry reached a market size of $92 billion in 2023, with a significant portion dedicated to drug discovery and toxicology research.

Stringent regulations and growing awareness about animal welfare are further propelling market growth in the region. China's National Medical Products Administration (NMPA) reported in 2023 that over 40% of toxicology studies for drug approvals now include in-vitro methods. for instance, in April 10, 2024, South Korean CRO Samsung Biologics unveiled a state-of-the-art in-vitro toxicology testing facility in Incheon, featuring advanced organ-on-chip platforms and AI-driven data analysis capabilities.

Competitive Landscape

The Global In vitro Toxicology Testing Market is a dynamic and competitive landscape, with a mix of established players and emerging challengers vying for market share. These players are actively working to strengthen their presence by implementing strategic plans such as collaborations, mergers, acquisitions, and political support. The organizations are dedicated to continuously improving their product line to meet the needs of a wide range of customers in different regions.

Some of the key players operating in the Global In vitro Toxicology Testing Market include:

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.

Catalent, Inc.

Danaher Corporation

Bio-Rad Laboratories, Inc.

BioIVT

Gentronix

Latest Developments

In February 2023, Cyprotex US, LLC, an Evotec subsidiary, has moved from Watertown to Framingham, U.S., according to an announcement made by Evotec. "Expanding the new facility for faster turnaround time" was the motto of this migration.

In March 2022, WuXi AppTec added a new plant in Chengdu broadening their toxicological footprint capabilities. They were able to guarantee improved service and quicker clinical study initiation thanks to this expansion.

In January 2021, Charles River announced a collaboration with Cypre, Inc. to extend its 3D in vitro services for targeted therapy drug screening and cancer immunotherapy. Through this collaboration, the business was able to increase the scope of its in vitro testing services by utilizing Cypre's patented Falcon-X 3D hydrogel patterning technology.

1 INTRODUCTION OF GLOBAL IN VITRO TOXICOLOGY TESTING MARKET

1.1 Introduction of the Market
1.2 Scope of Report
1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

3.1 Data Mining
3.2 Validation
3.3 Primary Interviews
3.4 List of Data Sources

4 GLOBAL IN VITRO TOXICOLOGY TESTING MARKET OUTLOOK

4.1 Overview
4.2 Market Dynamics
- 4.2.1 Drivers
- 4.2.2 Restraints
- 4.2.3 Opportunities
4.3 Porters Five Force Model
4.4 Value Chain Analysis
4.5 Regulatory Framework

5 GLOBAL IN VITRO TOXICOLOGY TESTING MARKET, BY PRODUCT

5.1 Overview
5.2 Assays
5.3 Software
5.4 Consumables
5.5 Services
5.6 Instruments

6 GLOBAL IN VITRO TOXICOLOGY TESTING MARKET, BY TECHNOLOGY

6.1 Overview
6.2 OMICS Technology
6.3 Cell Culture Technology
6.4 High Throughput Technology
6.5 Molecular Imaging Technology

7 GLOBAL IN VITRO TOXICOLOGY TESTING MARKET, BY METHOD

7.1 Overview
7.2 In Silico
7.3 Biochemical Assay
7.4 Cellular Assay
7.5 Ex-vivo

8 GLOBAL IN VITRO TOXICOLOGY TESTING MARKET, BY APPLICATION

8.1 Overview
8.2 Endocrine Disruption
8.3 Dermal Toxicity
8.4 Systemic Toxicology
8.5 Ocular Toxicity
8.6 Others

9 GLOBAL IN VITRO TOXICOLOGY TESTING MARKET, BY END-USE

9.1 Overview
9.2 Cosmetics & Household Products
9.3 Pharmaceutical Industry
9.4 Diagnostics
9.5 Academic Institutes & Research Laboratories
9.6 Food Industry
9.7 Chemicals Industry

10 GLOBAL IN VITRO TOXICOLOGY TESTING MARKET, BY GEOGRAPHY

10.1 Overview
10.2 North America
- 10.2.1 U.S.
- 10.2.2 Canada
- 10.2.3 Mexico
10.3 Europe
- 10.3.1 Germany
- 10.3.2 U.K.
- 10.3.3 France
- 10.3.4 Rest of Europe
10.4 Asia Pacific
- 10.4.1 China
- 10.4.2 Japan
- 10.4.3 India
- 10.4.4 Rest of Asia Pacific
10.5 Latin America
- 10.5.1 Brazil
- 10.5.2 Argentina
10.6 Rest of the World
- 10.6.1 Latin America
- 10.6.2 Middle East and Africa

11 GLOBAL IN VITRO TOXICOLOGY TESTING MARKET COMPETITIVE LANDSCAPE

11.1 Overview
11.2 Company Market Share
11.3 Vendor Landscape
11.4 Key Development Strategies

12 COMPANY PROFILES

12.1 Abbott Laboratories
- 12.1.1 Overview
- 12.1.2 Financial Performance
- 12.1.3 Product Outlook
- 12.1.4 Key Developments
12.2 Agilent Technologies
- 12.2.1 Overview
- 12.2.2 Financial Performance
- 12.2.3 Product Outlook
- 12.2.4 Key Developments
12.3 Bio-Rad Laboratories
- 12.3.1 Overview
- 12.3.2 Financial Performance
- 12.3.3 Product Outlook
- 12.3.4 Key Developments
12.4 Charles River Laboratories
- 12.4.1 Overview
- 12.4.2 Financial Performance
- 12.4.3 Product Outlook
- 12.4.4 Key Developments
12.5 Covance
- 12.5.1 Overview
- 12.5.2 Financial Performance
- 12.5.3 Product Outlook
- 12.5.4 Key Developments
12.6 Eurofins Scientific
- 12.6.1 Overview
- 12.6.2 Financial Performance
- 12.6.3 Product Outlook
- 12.6.4 Key Developments
12.7 GE Healthcare
- 12.7.1 Overview
- 12.7.2 Financial Performance
- 12.7.3 Product Outlook
- 12.7.4 Key Developments
12.8 Labcorp
- 12.8.1 Overview
- 12.8.2 Financial Performance
- 12.8.3 Product Outlook
- 12.8.4 Key Developments
12.9 Lonza
- 12.9.1 Overview
- 12.9.2 Financial Performance
- 12.9.3 Product Outlook
- 12.9.4 Key Developments
12.10 Merck KGaA
- 12.10.1 Overview
- 12.10.2 Financial Performance
- 12.10.3 Product Outlook
- 12.10.4 Key Developments

13 Appendix

13.1 Related Research

02-2729-4219

+886-2-2729-4219

License/价格

全球体外毒理学测试市场：依技术、产品、应用、最终用户、地区划分，2024-2031

Global In vitro Toxicology Testing Market By Technology, Product, Application, End-User, & Region for 2024-2031

体外毒性测试市场评估，2024-2031

对动物测试日益增长的道德担忧如何推动全球体外毒性测试市场的发展？

与体内测试相比，预测准确性的限制如何影响全球体外毒性测试市场的成长？

目录

第 1 章：体外毒理学测试的全球市场：简介

第 2 章执行摘要

第3章 验证市场研究研究方法

第4章 全球体外毒性测试市场前景

第5章全球体外毒理学测试市场：按产品

第6章全球体外毒理学测试市场：依技术分类

第7章全球体外毒理学测试市场：依测试方法

第8章全球体外毒理学测试市场：依应用分类

第9章全球体外毒理学测试市场：依最终用途分类

第10章全球体外毒理学测试市场：按地区

第11章全球体外毒理学测试市场：竞争格局

第12章 公司简介

第13章附录

In vitro Toxicology Testing Market Valuation - 2024-2031