DescriptionReport Scope:The scope of the report encompasses the major types of traditional toxicity testing that have been used, and the in vitro techniques that are being developed by industry, government agencies and nonprofits. It analyzes current market status, examines drivers on future markets and presents forecasts of growth over the next five years.Technology developments, including the latest trends, are discussed. Other influential factors such as validation and testing strategies for pharmaceuticals, cosmetics, and chemicals also have been included.
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Regulatory drivers play a large role in toxicology, determining the specific parameters of tests that have been explicitly required. They also heavily influence the testing that is performed by companies in earlier stages of research. The report examines the regulatory role and the different federal and international agencies that play an active role in in vitro toxicology research, development and adoption.
Report Includes:- 52 data table and 18 additional tables- An overview of the global markets and technologies for the in vitro toxicity testing techniques within the pharmaceutical industry- Analyses of global market trends with data from 2017, 2018, and projections of compound annual growth rates (CAGRs) through 2023- Information on latest trends, technological developments and government regulations that influence the growth of the market- A breakdown of influential factors, such as validation of the alternative measures for toxicity and toxicity testing strategies for chemicals, pesticides, and food additives- Evaluation covering equipment, assays, cells, reagents, and services used in toxicity testing- Profiles of major players in the toxicology market, including Abbott Laboratories, Inc., Agilent Technologies, Inc., Evotec AG, GE Healthcare Life Sciences and Thermo Fisher Scientific, Inc.SummaryThe global in vitro toxicity market should grow at a compound annual growth rate (CAGR) of REDACTED during the forecast period (20182023). Every year more chemicals are synthesized and are brought into the market. The cost of animal testing is high, with some substances costing more than several million dollars. Along with the high cost of toxicity testing, animal welfare is another key concern that calls for alternative testing methods. In vitro model systems, like cell-based models, can significantly reduce costs and the use of animals in toxicity testing. The increasing need for non-animal tests in toxicity testing is driving demand in the in vitro toxicity market.
In vitro models are used to gain a betterunderstanding of chemical-induced toxicity in animals and humans. The in vitro test model primarily serves as a rapid screening system for the toxicologic evaluation of chemicals. These models may complement in vivo toxicity tests or may replace some in vivo models if scientifically validated and accepted by regulatory agencies.
The most common in vitro models are isolated tissue preparations, perfused organ preparations, singlecell suspensions, and cell-culture systems (like primary cell cultures) and mammalian cell lines. Cellculture systems often are used because they are reliable, reproducible, and relatively inexpensive testing methods that assess chemical toxicity at the cellular level. Further, non-animal toxicity test methods have been used for determining cellular toxicity by manufacturers to support decisions for conducting conventional animal testing.
The growing demand for in vitro toxicity testing during the drug discovery process and increasing number of contract research organizations (CRO) are major drivers of the global in vitro toxicity market. The Developmental Therapeutics Program at the National Cancer Institute (DTP 2005) developed an in vitro cell-line screen to support its drug-discovery program. For potential anticancer activity, the in vitro cell-line screen test can screen up to 20,000 compounds per year. The in vitro cell-line screen test uses 60 human tumor cell lines, representing various cancers such as skin cancer, breast cancer, colon cancer, brain cancer, prostate cancer, blood cancer, and kidney cancer.
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Charles River, GVK Biosciences Private Ltd., Sekisui XenoTech LLC and Merck KGaA are among a large number of CROs that offer in vitro toxicity services. The increasing demand for animal-free toxicity tests driving growth of the global in vitro toxicity market. In vitro toxicity tests are reliable, cost-effective and do not use animals, unlike in vivo tests. The rising global prevalence of chronic diseases has significantly increased demand for the discovery of novel drugs. The toxicity study of drugs and compounds is performed by the regulatory bodies, in order to facilitate approval of drugs and devices.
High cost of toxicology equipment, inadequate infrastructure and funding for RandD in emerging countries are expected to hinder growth of the global in vitro toxicity market. High-throughput screening (HTS) equipment is expensive, particularly for small and emerging countries that wish to purchase multiple instruments. Their high cost may hinder market growth in these countries. However, governments, companies and research institutes are extensively funding for toxicology research, which should overcome the cost challenges and drive market growth during the forecast period. Also, regulatory programs such as TOX21, ToxCast program and NTP (National Toxicology Program) are creatingenormous opportunities for companies in the in vitro toxicity global market.
Companies Mentioned:ABBOTT LABORATORIES, INC.ACEA BIOSCIENCES, INC.AGILENT TECHNOLOGIES, INC.ALBANY MOLECULAR RESEARCH, INC.APTUIT, INC.BIOGNOSYS AGBIORELIANCEBIOVIABUSINESS OVERVIEWCELLULAR DYNAMICS INTERNATIONAL, INC.CHANTESTCHARLES RIVER LABORATORIESCOVANCE, INC.CYPROTEX PLCDRIK LLCENZO LIFE SCIENCES, INC.ESSEN BIOSCIENCE, INC.EUROFINS SCIENTIFIC SEEVOTEC AGGE HEALTHCARE LIFE SCIENCESGENEDATAGENTRONIX LTD.HUREL CORP.IMQUEST BIOSCIENCES, INC.IMSTAR SAINSPHERO AGKIYATEC, INC.LONZA GROUP LTD.METABOLON, INC.MOLECULAR DEVICES LLCPERKINELMER, INC.PROMEGA CORP.QIAGEN NVSGS-SASTEMINA BIOMARKER DISCOVERY, INC.SYNVIVO, INC.THERMO FISHER SCIENTIFIC, INC.VALA SCIENCES, INC.VISTAGEN THERAPEUTICS, INC.XENOMETRIX AG
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Table of ContentsChapter 1 IntroductionStudy Goals and ObjectivesReasons for Doing This StudyIntended AudienceScope of ReportInformation SourcesMethodologyGeographic BreakdownAnalyst’s CredentialsBCC Custom ResearchRelated BCC Research ReportsChapter 2 Summary and HighlightsChapter 3 Market and Technology BackgroundIntroductionRegulatory Framework and ProgramsEuropean UnionIndiaRegulatory ProgramsKey Market Growth FactorsReplacement of In Vivo Models, by In Vitro ModelsIn Vitro Toxicity in the Drug Discovery ProcessCROs Gaining PopularityApplication of High-Throughput Screening in ToxicologyOpportunitiesExtensive Funding, by Research Institutes on ToxicologyParadigm Shift in Toxicity Testing in the 21st CenturyLimitations and ChallengesExpensive Equipment Used in ToxicologyChapter 4 Market Breakdown by Toxicity Endpoints and TestsADMEIn Vitro Metabolism OfferingsMetabolism Reaction Phenotyping for Genetic PolymorphismsSkin Irritation, Corrosion and SensitizationGenotoxicity TestingIn Vitro Micronucleus Test (MNT)Cytotoxicity TestingUse of Cytotoxicity Assays for Acute Toxicity TestingExample of Commercially Available Cytotoxicity Assay KitOcular ToxicityOrgan ToxicityPhototoxicity TestingDermal ToxicityCarcinogenicityThe AMES TestNeurotoxicityDevelopment and Reproductive Toxicity (DART)Other Toxicity Endpoints and TestsChapter 5 Market Breakdown by End-User IndustryPharmaceutical and Biotechnology CompaniesHealthcare (Diagnosis)Food and Beverage IndustryChemical InduContinued….
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