글로벌 생체 내 독성학 시장 – 2024-2031

Overview
Global In Vivo Toxicology Market reached US$ XX million in 2023 and is expected to reach US$XXmillion by 2031, growing at a CAGR of XX% during the forecast period 2024-2031.
In vivo toxicology is a branch of toxicology that involves the study of the toxic effects of substances on living organisms. The term "in vivo" is Latin for "within the living," and in this context, it refers to experiments or studies conducted within a living organism, typically animals. The goal of in vivo toxicology is to understand how exposure to certain substances affects the whole organism, including its organs, tissues, and systems.
In vivo toxicology plays a key role in assessing the safety of a wide range of products, including pharmaceutical drugs, chemicals, food additives, cosmetics, and pesticides. It helps identify potential hazards, set safe exposure limits, and establish guidelines for safe use. In the pharmaceutical industry, in vivo toxicology studies are integral to drug development. They help identify potential toxic effects, determine safe dosage levels, and contribute to the decision-making process during preclinical and clinical development phases.
Market Dynamics: Drivers
Rising the technological advancements
The ongoing advancements in technology and methodologies for in vivo toxicology studies enhance the efficiency and accuracy of assessments. Innovations such as improved imaging techniques, molecular biology tools, and data analysis methods contribute to the growth of the market. For instance, in December 2022, Emulate, Inc., the leading provider of next-generation in vitro models, stated the emulate publishes landmark study validating Organ-on-a-Chip technology for predictive toxicology in preclinical development.
Pharmaceutical companies can encounter many challenges in developing human drugs. Often, compounds showing promise in preclinical efforts face high attrition during human trials due to poor predictive validity of preclinical models, especially for biologics. Therefore, the researchers also modeled the potential economic impact that routine use of the Emulate human Liver-Chip could have on drug development productivity.
Additionally, according to NIH 2022, machine learning and artificial intelligence approaches have revolutionized multiple disciplines, including toxicology. By leveraging machine learning and artificial intelligence approaches, now it is possible to develop PBPK models for hundreds of chemicals efficiently, to create in silico models to predict toxicity for a large number of chemicals with similar accuracies compared with in vivo animal experiments, and to analyze a large amount of different types of data (toxicogenomics, high-content image data, etc.) to generate new insights into toxicity mechanisms rapidly, which was impossible by manual approaches in the past. Thus above factors helps to accelerates the market growth.
Market Dynamics: Restraints
The stringent regulations releated to use animal models
Stringent regulations can pose challenges to the in vivo toxicology market in several ways. While regulations are implemented to ensure the safety and efficacy of products, their stringency can sometimes have unintended consequences that impact the cost, time, and feasibility of conducting in vivo toxicology studies. Stringent regulations often require comprehensive and rigorous testing protocols, increasing the overall cost of conducting in vivo toxicology studies.
Companies may need to allocate significant financial resources to meet the demanding regulatory requirements, which can be a barrier for smaller companies or those with limited budgets. For instance, regulation 1107/2009 came into force on 14 June 2011 and lays down a number of requirements aimed at avoiding unnecessary testing on vertebrate animals, where alternative methods are available, avoiding duplicate testing and prescribing sharing of tests and studies involving vertebrate animals. Thus above factors restrain the market growth.
Segment Analysis
The global In Vivo toxicology market is segmented based on product type, test type, technology, end user, and region.
The kits segment from the product type segment accounted for approximately 39.7% of In Vivo Toxicology type share
In vivo toxicology kits play a crucial role in advancing and streamlining toxicology studies, providing researchers with standardized tools and assays for evaluating the effects of substances in living organisms. The importance of in vivo toxicology kits lies in their ability to enhance efficiency, reproducibility, and data quality in toxicological assessments.
For instance, in vivo toxicology kits offer standardized assays and protocols for assessing various toxicological parameters. This standardization helps ensure consistency across experiments, making it easier to compare results between studies and laboratories. Kits provide pre-packaged reagents and protocols, reducing the time and effort required for assay optimization and preparation. This enhances the overall efficiency of in vivo toxicology studies and allows researchers to focus on data interpretation and analysis.
For instance, EpiDerm, normal human epidermal keratinocytes and cultured on a permeable polycarbonate membrane. Furthermore, in vivo toxicology kits are subject to rigorous quality control measures during production. This ensures the consistency and reliability of the reagents, reducing the risk of experimental errors and enhancing the overall quality of data generated. Thus above factors helps to boost the segment growth.
Geographical Analysis
North America accounted for approximately 32.4% of the market share in 2022
The region benefits from the presence of major players operating in the US, growing biomedical research in the US, rising preclinical activities by CROs and pharmaceutical companies in the region, significant government support, mandatory toxicology testing rules, and simplified toxicology guidelines, resulting in a higher number of studies.
Partnerships play a significant role in fostering growth and innovation in the in vivo toxicology market in the U.S. Collaborative efforts between different stakeholders, such as pharmaceutical companies, contract research organizations (CROs), academic institutions, and technology providers, can contribute to advancements in research methodologies, expanded service offerings, and improved capabilities. For instance, in November 2023, Cyprotex had signed an 18-month partnered with U.S. drug giant Pfizer focused on predictive in-vitro toxicology in preclinical development.
Furthermore, the U.S. regulatory landscape, governed by agencies such as the U.S. Food and Drug Administration (FDA), mandates the submission of comprehensive in vivo toxicology data as part of regulatory submissions for drug approvals, environmental assessments, and other product registrations. Thus above factors help to boost the region growth.
COVID-19 Impact Analysis
The COVID-19 pandemic has had various impacts on scientific research and the broader life sciences industry, including in vivo toxicology studies. Many research laboratories, including those conducting in vivo toxicology studies, experienced temporary closures or disruptions due to lockdowns, social distancing measures, and workforce limitations. This led to delays in ongoing studies and the postponement of planned experiments.
The pandemic had implications for studies involving animals, as maintaining animal colonies and conducting experiments were affected by staffing shortages and operational challenges. Researchers faced difficulties in ensuring the welfare of research animals and maintaining study timelines. Delays in completing in vivo toxicology studies contributed to postponed regulatory submissions for new drugs and other products. This, in turn, could impact the timelines for regulatory approvals and product launches.
The pandemic increased the demand for specific types of in vivo studies related to COVID-19, such as studies on the safety and efficacy of potential treatments and vaccines. This demand, while addressing critical needs, could create resource competition and impact the broader spectrum of toxicology research
Market Segmentation
By Product Type
• Kits
• Reagents
• Equipments
By Test Type
• Subchronic Toxicity Tests
• Chronic Toxicity Tests
• Carcinogenicity Tests
• Others
By Technology
• In vivo Imaging
• In Silico Models
• Omics Technologies
By End User
• Pharmaceutical and Biotechnology Companies
• Contract Research Organizations (CROs)
• Academic and Research Institutions
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o UK
o France
o Italy
o Spain
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o Rest of Asia-Pacific
• Middle East and Africa
Competitive Landscape
The major global players in the market include MATTEK CORPORATION, Vimta Labs Ltd, Merck KGaA, NUVISAN GmbH, Charles River Laboratories, Eurofins Scientific, Nagi Bioscience, Labcorp Drug Development, PerkinElmer Inc, Taconic Biosciences among others.
Key Developments
• In September 2023, Quris-AI, an artificial intelligence (AI) company in the pharmaceutical space, extended its collaboration with Merck KGaA Darmstadt, Germany. This follows the successful initial collaboration, a preclinical study to assess Quris-AI’s ability to predict drug toxicity in comparison to traditional in vitro and in vivo approaches.
• On January 10, 2022, Inotiv, Inc had completed the acquisition of Integrated Laboratory Systems, LLC (“ILS”), a portfolio company of Sier Capital Partners (“Sier Capital”). ILS is a contract research organization, located in Morrisville, North Carolina, specializing in genetic toxicology, in vivo and in vitro toxicology, pathology, molecular biology, bioinformatics and computational toxicology services
Why Purchase the Report?
• To visualize the global In Vivo toxicology market segmentation based on product type, test type, technology, end user, and regionas well as understandkey commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of In Vivo toxicology market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.
The global In Vivo Toxicology Market report would provide approximately 64tables, 61figures and 186pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies