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1623521

全球體外毒理學測試市場：依技術、產品、應用、最終用戶、地區劃分，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個工作天內

價格

簡介目錄

體外毒性測試市場評估，2024-2031

毒理學研究和技術開發的進步以及對新定製藥物開發的日益關注推動了市場擴張。化學品和藥品安全評估的監管要求不斷提高，需要採用體外測試方法，預計2024年價值將超過134.3億美元，2031年約為295億美元，預計將達到1美元。

除此之外，人們越來越認識到傳統毒理學篩檢技術的缺點和困難。因此，體外測試已被廣泛認為是確定化合物安全性和有效性的有用方法，並預計在 2024 年至 2031 年期間以 11.40% 的複合年增長率增長其利基市場。

體外毒性測試全球市場定義/概述

體外毒性試驗是指利用實驗技術來評估物質對體外生物細胞或組織的毒性。這些測試是在受控環境中進行的，可以進行精確測量和特定生物過程的研究。體外毒性測試廣泛用於在對動物或人體進行測試之前評估化學物質、藥物和其他物質的安全性。

體外毒性測試是評估各種物質的安全性和有效性的重要工具。其應用範圍廣泛，包括藥物開發、化學品安全評估、風險評估和法規遵循。透過採用實驗室技術評估物質對生物細胞和組織的毒性，體外測試提供了對潛在風險的寶貴見解，並有助於開發更安全、更有效的產品。

更複雜的體外模型的開發，例如器官晶片系統，可能會提高毒性評估的預測準確性。此外，人工智慧和機器學習的整合可以實現更有效率的數據分析和建模，從而實現更快、更準確的毒性預測。

對動物測試日益增長的道德擔憂如何推動全球體外毒性測試市場的發展？

全球體外毒性測試市場主要是由不斷上升的倫理問題和有關動物測試的嚴格監管指南推動的。根據美國環保署 (EPA) 的數據，截至 2023 年，超過 10,000 種化學物質受有毒物質控制法管轄，並需要進行廣泛的安全測試。例如，2024年3月15日，Thermo Fisher Scientific宣佈推出新的體外毒理學高通量篩選平台，旨在加速藥物發現過程。

製藥和生物技術領域不斷增加的研發投資正在推動市場成長。美國國立衛生研究院 (NIH) 報告 2024 財政年度生物醫學研究預算為 451 億美元，其中大部分專門用於開發替代測試方法。例如，2024 年 4 月 2 日，Charles River Laboratories 宣佈推出新的 3D 細胞培養系統，以更準確地預測候選藥物的毒性。

細胞培養技術與人工智慧相結合的技術進步正在提高體外毒性測試的效率。美國食品藥物管理局（FDA）在2023年核准了55種新藥，其中80%以上在開發過程中使用體外方法。例如，2024 年 2 月 20 日，領先的 CRO Cyprotex 推出了一個人工智慧驅動的平台，利用體外檢測來預測藥物引起的肝損傷，這可能會降低臨床試驗中的藥物損耗率。

與體內測試相比，預測準確性的限制如何影響全球體外毒性測試市場的成長？

儘管成長，全球體外毒性測試市場仍面臨重大課題。與體內測試相比，體外模型的預測準確性有限仍然是一個問題。FDA表示，進入臨床試驗的藥物最終只有11%獲得批准，這凸顯了對更可靠的臨床前測試方法的需求。2024 年 3 月，Charles River Laboratories 宣佈與 Instem 建立合作關係，以增強其毒理學資料管理能力。

不同地區的監管障礙和缺乏標準化正在阻礙市場擴張。2023 年，歐洲化學品管理局報告稱，只有 32% 的 REACH 申請完全符合資訊要求，凸顯了協調測試協議的必要性。例如，2024 年 1 月，Thermo Fisher Scientific 宣佈推出一個新平台，旨在簡化多個市場體外毒性測試的監管合規性。

與先進體外技術相關的高昂初始成本是採用的障礙，特別是對於小型實驗室而言。美國國立衛生研究院已在 2024 財政年度撥款 12 億美元用於毒理學研究，但資金競爭依然激烈。為了解決這個問題，Lonza 於 2023 年 11 月宣佈推出一種經濟高效的高通量篩選系統，旨在讓更廣泛的實驗室更容易進行先進的體外毒性測試。

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.

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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