In vitro毒性試験の世界市場：技術、製品、用途、エンドユーザー、地域別、2024年～2031年

In vitro毒性試験市場の評価、2024年～2031年

市場拡大の背景には、毒物学的研究の進展や技術開発の進展に加え、オーダーメイド医薬品の新規開発への注目が高まっていることがあります。化学物質や医薬品の安全性評価に関する規制要件の増加により、in-vitro試験手法の採用が必要となっており、2024年の評価額は134億3,000万米ドルを超え、2031年には約295億米ドルに達する見込みです。

これに加えて、従来の毒性学的スクリーニング技術の欠点や困難さに対する認識が高まっています。その結果、in vitro試験は化合物の安全性と有効性を判断する有用な方法として広く認知されるようになり、2024年から2031年にかけてCAGR 11.40%でニッチ市場を成長させることができるようになった。

In vitro毒性試験の世界市場定義/概要

In vitro毒性試験は、生体外の生物学的細胞または組織に対する物質の毒性を評価するための実験技術の使用を指します。これらの試験は制御された環境で実施されるため、正確な測定と特定の生物学的プロセスの研究が可能です。体外毒性試験は、動物やヒトで試験する前に、化学物質、医薬品、その他の物質の安全性を評価するために広く利用されています。

体外毒性試験は、様々な物質の安全性と有効性を評価するための貴重なツールとして役立っています。その用途は、医薬品開発、化学物質の安全性評価、リスク評価、規制遵守など多岐にわたります。生物学的細胞や組織に対する物質の毒性を評価するために実験室技術を採用することにより、試験管内試験は潜在的リスクに関する貴重な洞察を提供し、より安全で効果的な製品の開発を促進します。

臓器オンチップ・システムなど、より洗練された試験管内モデルの開発は、毒性評価の予測精度を向上させると思われます。さらに、人工知能と機械学習の統合により、より効率的なデータ分析とモデリングが可能になり、より迅速で正確な毒性予測につながります。

動物実験に関する倫理的懸念の高まりは、世界のIn vitro毒性試験市場開拓をどのように促進しているか？

In vitro毒性試験の世界市場は、主に動物実験に関する倫理的懸念の高まりと厳しい規制ガイドラインによって牽引されています。米国環境保護庁（EPA）によると、2023年現在、10,000を超える化学物質が有害物質規制法の対象となっており、広範な安全性試験が必要とされています。例えば、2024年3月15日、サーモフィッシャーサイエンティフィックは、創薬プロセスの加速を目指し、in-vitro毒性学のための新しいハイスループットスクリーニングプラットフォームを発表しました。

製薬・バイオテクノロジー分野での研究開発投資の増加が市場成長を後押ししています。国立衛生研究所（NIH）は、2024年度の生物医学研究予算として451億ドルを計上したと報告しており、その大部分は代替検査方法の開発に割り当てられています。例えば、2024年4月2日、チャールズ・リバー・ラボラトリーズは、医薬品候補化合物のより正確な毒性予測のための新しい3D細胞培養システムを発表しました。

細胞培養技術と人工知能の統合における技術的進歩は、体外毒性試験の効率を高めています。米国食品医薬品局（FDA）は2023年に55の新薬を承認しており、その80％以上が開発中に試験管内手法を利用しています。例えば、2024年2月20日、大手CROのCyprotexは、in-vitroアッセイを使用して薬剤誘発性肝障害を予測するためのAIを搭載したプラットフォームを立ち上げ、臨床試験における薬剤の減少率を減少させる可能性があります。

生体内試験と比較した予測精度の限界は、世界のIn vitro毒性試験市場の成長にどのような影響を与えているか？

世界のIn vitro毒性試験市場は、その成長にもかかわらず、大きな課題に直面しています。in-vitroモデルの予測精度がin-vivo試験と比較して限定的であることは、依然として懸念事項です。FDAによると、臨床試験に参加した医薬品のうち最終的に承認されたのはわずか11%であり、より信頼性の高い前臨床試験法の必要性が浮き彫りになっています。2024年3月、チャールズ・リバー・ラボラトリーズは、毒性データ管理能力を強化するため、Instem社との提携を発表しました。

規制上のハードルと異なる地域間での標準化の欠如が市場拡大の妨げとなっています。欧州化学物質庁は2023年、REACH申請書類の32%しか情報要件に完全に準拠していないと報告し、試験プロトコルの調和の必要性を強調しました。例えば、サーモフィッシャーサイエンティフィックは2024年1月、複数の市場における体外毒性試験の規制遵守を合理化することを目的とした新しいプラットフォームを発表しました。

高度な試験管内技術に関連する高額な初期費用は、特に小規模な検査施設にとっては、導入の障壁となります。米国国立衛生研究所は、2024会計年度に毒物学研究に12億米ドルを割り当てているが、資金調達は依然として競合が多いです。これに対処するため、ロンザは2023年11月、高度なin-vitro毒性試験をより幅広い研究施設で利用しやすくするよう設計された、費用対効果の高いハイスループットスクリーニングシステムを発表しました。

目次

第1章 In vitro毒性試験の世界市場：イントロダクション

• 市場のイントロダクション
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 In vitro毒性試験の世界市場展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析
• 規制の枠組み

第5章 In vitro毒性試験の世界市場：製品別

• 概要
• アッセイ
• ソフトウェア
• 消耗品
• サービス
• 装置

第6章 In vitro毒性試験の世界市場：技術別

• 概要
• OMICS技術
• 細胞培養技術
• ハイスループット技術
• 分子イメージング技術

第7章 In vitro毒性試験の世界市場：試験法別

• 概要
• インシリコ
• 生化学アッセイ
• 細胞アッセイ
• 生体外

第8章 In vitro毒性試験の世界市場：用途別

• 概要
• 内分泌かく乱作用
• 経皮毒性
• 全身毒性
• 眼毒性
• その他

第9章 In vitro毒性試験の世界市場：最終用途別

• 概要
• 化粧品・家庭用品
• 製薬産業
• 診断薬
• 学術機関・研究所
• 食品産業
• 化学産業

第10章 In vitro毒性試験の世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • アルゼンチン
• 世界のその他の地域
  • ラテンアメリカ
  • 中東・アフリカ

第11章 世界のIn vitro毒性試験市場：競合情勢

• 概要
• 企業市場シェア
• ベンダー情勢
• 主な発展戦略

第12章 企業プロファイル

• Abbott Laboratories
• Agilent Technologies
• Bio-Rad Laboratories
• Charles River Laboratories
• Covance
• Eurofins Scientific
• GE Healthcare
• Labcorp
• Lonza
• Merck KGaA

第13章 付録

• 関連調査

In vitro Toxicology Testing Market Valuation - 2024-2031

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.

TABLE OF CONTENTS

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