시장 확대의 배경에는 독물학적 연구와 기술 개발이 진전하고 주문제의약품의 신규개발에 대한 주목이 높아지고 있는 경우가 있습니다. 요구사항이 증가함에 따라 시험관 내 시험 방법을 채택해야 하며, 2024년 평가액은 134억 3,000만 달러를 초과하고 2031년에는 약 295억 달러에 이를 전망입니다.
이외에도 기존의 독성 스크리닝 기술의 단점과 어려움에 대한 인식이 높아지고 있습니다. 2024년부터 2031년에 걸쳐 CAGR 11.40%로 틈새 시장을 성장시킬 수 있게 되었습니다.
세계의 In vitro 독성 시험 시장 정의/개요
In vitro 독성 시험은 생체외 생물학적 세포 또는 조직에 대한 물질의 독성을 평가하기 위한 실험 기술의 사용을 말합니다. 특정 생물학적 과정에 대한 연구가 가능합니다. 체외 독성 시험은 동물과 인간에서 시험하기 전에 화학 물질, 의약품 및 기타 물질의 안전성을 평가하는 데 널리 사용됩니다.
체외독성시험은 다양한 물질의 안전성과 효능을 평가하기 위한 귀중한 툴로서 도움이 되고 있습니다. 생물학적 세포 및 조직에 대한 물질의 독성을 평가하기 위해 실험실 기술을 채택함으로써, 시험관 내 시험은 잠재적 위험에 대한 귀중한 통찰력을 제공하여 보다 안전하고 효과적인 제품 개발을 촉진합니다.
장기 온칩 시스템과 같은 보다 정교한 시험관 내 모델의 개발은 독성 평가의 예측 정확도를 향상시킬 것으로 보입니다. 가능하고 더 빠르고 정확한 독성 예측으로 이어집니다.
세계의 In vitro 독성 시험 시장은 주로 동물실험에 대한 윤리적 우려 증가와 엄격한 규제 가이드라인에 의해 견인되고 있습니다. 규제법의 대상이며, 광범위한 안전성 시험이 필요합니다.
제약·바이오테크놀러지 분야에서의 R&D 투자 증가가 시장 성장을 뒷받침하고 있습니다. 그 대부분은 대안 검사 방법의 개발에 할당되었습니다.
세포 배양 기술과 인공지능의 통합에 있어서 기술적 진보는 체외독성 시험의 효율을 높여주고 있습니다. 도중에 시험관 내 방법을 이용하고 있습니다. 2024년 2월 20일, 주요 CRO의 Cyprotex는 시험관 내 분석을 사용하여 약물 유발 간 장애를 예측하기 위한 인공지능이 탑재된 플랫폼을 출시하여 임상시험에서 약물 감소율을 감소시킵니다.
세계의 In vitro 독성 시험 시장은 성장에도 불구하고 큰 과제에 직면하고 있습니다. FDA에 따르면 임상시험에 참여한 의약품 중 최종적으로 승인된 것은 11%로 보다 신뢰성이 높은 전임상시험법의 필요성이 부각되고 있습니다. 2024년 3월, Charles River Laboratories는 독성 데이터 관리 역량을 강화하기 위해 Instem사와의 제휴를 발표했습니다.
규제상의 장애물과 다른 지역 간의 표준화 부족은 시장 확대에 방해를 받고 있습니다.
첨단 시험관 내 기술과 관련된 고액의 초기 비용은 특히 소규모 검사 시설의 경우 도입 장벽이 됩니다. 이 문제를 해결하기 위해 Lonza는 2023년 11월 첨단 시험관 독성 시험을 보다 광범위한 연구시설에서 쉽게 사용할 수 있도록 설계된 비용 효율적인 고처리량 스크리닝 시스템을 발표했습니다.
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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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.
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.
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.
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.
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.
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.
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
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.