Ottawa, Dec. 10, 2024 (GLOBE NEWSWIRE) -- The global in-vitro toxicology testing market size is predicted to increase from USD 12.99 billion in 2025 to approximately USD 30.06 billion by 2033, According to Precedence Research. The North America in-vitro toxicology testing market size was estimated at USD 5.18 billion in 2023.
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Tissues or cells that have been extracted and cultivated or preserved under controlled circumstances are used in in vitro toxicological investigations. Since living things are incredibly intricate functional systems, the main benefit of this method is that it makes it possible to examine both the basic biological processes in cells and the particular parts of this intricate system. The purpose of the In Vitro Toxicology Lecture series is to highlight significant studies that employ in vitro and alternative methodologies to investigate fundamental mechanisms and to create test procedures that, if possible, aim to replace the use of animals. Reliable and precise in vitro toxicity testing is essential in the medication development process.
In-Vitro Toxicology Testing Market Key Highlights:
- North America accounted for the maximum market share of 47.12% in 2023.
- By technology, the cell culture technology segment accounted for the largest market share of 43.28% in 2023.
- By method, the cellular assay segment generated the biggest market share of 39.11% of in 2023.
- By application, the genotoxicity segment recorded the highest market share of 20.99% in 2023.
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In-Vitro Toxicology Testing Market Revenue (USD Million), By Technology, 2021 to 2023
| Technology | 2021 | 2022 | 2023 |
| Cell Culture Tech | 4,118.3 | 4,416.5 | 4,756.6 |
| High Throughput Tech | 2,440.3 | 2,637.4 | 2,863.5 |
| Cellular Imaging | 1,927.7 | 2,077.7 | 2,249.3 |
| OMICS Tech | 978.2 | 1,044.7 | 1,120.3 |
In-Vitro Toxicology Testing Market Revenue (USD Million), By Application, 2021 to 2023
| Application | 2021 | 2022 | 2023 |
| Genotoxicity | 2,004.0 | 2,145.5 | 2,307.2 |
| Cytotoxicity | 1,708.7 | 1,835.7 | 1,980.7 |
| Phototoxicity | 534.5 | 574.7 | 620.5 |
| Carcinogenicity | 1,454.3 | 1,570.3 | 1,703.0 |
| Neurotoxicity | 963.5 | 1,029.7 | 1,105.2 |
| Dermal Toxicity | 829.2 | 905.9 | 993.9 |
| Endocrine Disruption | 882.1 | 944.0 | 1,014.8 |
| Ocular Toxicity | 697.0 | 754.1 | 819.5 |
| Others | 391.4 | 416.4 | 444.9 |
In-Vitro Toxicology Testing Market Trends:
- Cytotoxicity assay: Drug development relies heavily on cytotoxicity tests, which are an essential part of in vitro toxicology services. The influence of chemical substances on cell viability and health after exposure is determined in large part by these tests.
- Prevents animal cruelty: In recent years, the contentious topic of animal experimentation has taken on an emotional significance. Consequently, it's critical to acknowledge the increasing significance of substitutes for animal testing, such as in vitro toxicity testing.
- Provides better assessment: Methods based on organoids and human-induced pluripotent stem cells (iPSCs) hold considerable promise for evaluating the heterogeneity of human population responses and customizing tailored treatments.
- Low cost than animal testing: The relative affordability of cell-based in vitro techniques in comparison to animal research and their increased throughput are two of their most significant benefits. Industry and authorities are very interested in the development of high-throughput in vitro techniques.
Opportunities in the In-Vitro Toxicology Testing Market
- In September 2024, a 2.5 million GBP funding campaign was successfully concluded, according to ILC Therapeutics, a specialized developer of hybrid interferons, a novel medication class designed for enhanced therapeutic characteristics across numerous indications.
- In August 2024, international scientific software provider Schrödinger stated that the Bill & Melinda Gates Foundation has awarded a $10 million grant to begin a project that will increase the use of computational methods to anticipate toxicological risk at an early stage of drug research.
In-Vitro Toxicology Testing Market Regional Analysis
U.S. In-Vitro Toxicology Testing Market Size and Forecast 2024 to 2033
The U.S. in-vitro toxicology testing market size accounted for USD 4.99 billion in 2024 and is estimated to hit around USD 12.25 billion by 2033 with a remarkable CAGR of 10.48% from 2024 to 2033.
Strong Presence of Pharma & Biotech: North America to Sustain the Lead
North America held the dominant share of the in-vitro toxicology testing market in 2023. mostly because of several variables. Significant expenditures have been made in medication research and safety testing by the region's thriving biotechnology and pharmaceutical industries. Furthermore, there is a strong need for thorough toxicity assessment due to strict regulatory frameworks like those established by the FDA. Furthermore, the existence of prominent companies in the in vitro toxicology market and ongoing technical developments reinforce North America's dominance as the industry's major market stakeholder.
The pharmaceutical business in the United States creates a wide range of novel medications with significant health advantages each year. Many of those medications are costly and drive up healthcare expenditures for both the federal government and the private sector. Legislators have thought about measures that would cut government drug spending and prescription prices. Such regulations would most likely lessen the industry's motivation to create novel medications.
In March 2024, the Food and Drug Administration (FDA) of the United States revealed that it is seeking $7.2 billion as part of the proposed budget for the President's fiscal year (FY) 2025. The FDA will be able to improve food safety and nutrition, progress the safety of medicinal products, boost supply chain resilience, bolster the agency's ability to serve its mission, promote public health, and update its facilities and infrastructure thanks to this money.
The $495 million increase in the proposal is 7.4% higher than the budget level for FY 2023. The FDA's main goals in critical areas that are crucial for the health of humans and animals are reflected in the request.
Increasing Investments in Healthcare Sector: Asian Countries to Boom
Asia Pacific is estimated to host a significantly growing in-vitro toxicology testing market during the forecast period. The region's need for toxicity testing services is being driven by rapid industrialization, economic expansion, and rising investments in healthcare infrastructure. The market's expansion is further fueled by a growing emphasis on pharmaceutical research and development, as well as by encouraging government efforts. The Asia Pacific region's rapid expansion in this market may be attributed to its vast population as well as the growing biotechnology and pharmaceutical sectors. Additionally, the market for in vitro toxicology testing was developing at the quickest rate in the Asia-Pacific region, with China holding the highest market share.
Indian In-vitro Toxicology Market Trends:
- India's pharmaceutical industry is worth over $50 billion and is the third largest in the world by volume. This country accounts for 3.5% of global pharmaceutical and medicine exports to more than 200 countries.
- Approximately 8% of the global API industry is made up of 500 API manufacturers. The largest supplier of generic medications worldwide is India. It manufactures more than 60,000 different generic medications across 60 therapeutic categories and accounts for 20% of the global generic drug supply.
- About 60% of the world's vaccine needs are met by India, a significant supplier of DPT, BCG, and measles vaccines. The WHO imports 70% of its immunizations from India, according to the Essential Immunization Schedule.
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In-Vitro Toxicology Testing Market Report Coverage
| Report Attribute | Key Statistics |
| Market Size in 2023 | USD 10.99 Billion |
| Market Size in 2024 | USD 11.92 Billion |
| Market Size by 2033 | USD 30.06 Billion |
| Growth Rate from 2024 to 2033 | CAGR of 10.82% |
| Largest Market | North America |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | By Technology, By Application, By Method, and By End-user |
| Regions Covered | North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
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In-Vitro Toxicology Testing Market Segments Outlook
By Technology Outlook
The cell culture technology segment dominated the in-vitro toxicology testing market in 2023. The reader is introduced to a variety of methods used in in vitro cell culture in toxicological investigations in Cell Culture Methods for in vitro Toxicology. It covers the main cell types that are investigated in toxicology and will be helpful to anybody who wants to learn more about in vitro cell models or who wants to begin working with animal cell cultures. The primary tool for preclinical medication development and research is increasingly human cell cultures. The number of animals utilized has significantly decreased despite the fact that the number of researchers is always growing.
By Method Outlook
The cellular assay segment held the largest share of the in-vitro toxicology testing market in 2023. The primary usage of human cells is in toxicological testing. Cells have many origins, including embryonic cells, induced pluripotent cells, cancer cells, and stem cells, among others. The use of cell culture systems in toxicological studies has been greatly expanded in the past ten years due to technology breakthroughs and significant biomedical research outcomes. Advanced analytical methods for mechanistic investigations, growth factors, and substrates that can promote cell division and/or the expression of certain highly specialized activities, as well as automated processes, have all been crucial.
By Application Outlook
The genotoxicity segment remained dominant in the in-vitro toxicology testing market in 2023. In vitro, genotoxicity testing is essential to identify possible carcinogenic or mutagenic substances that might alter the genetic makeup of somatic or germ cells. This information is then utilized in regulatory decision-making. Genotoxicity is assessed using a variety of in vitro tests, such as the Ames test, comet assay, micronucleus assay, and chromosomal aberration assays. Different facets of genetic damage are the focus of each approach. The accuracy and effectiveness of genotoxicity evaluations are continuously being improved by developments in vitro testing techniques and technology, which help to achieve the overarching objective of guaranteeing the safety of goods introduced into diverse sectors.
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- In-Vitro Fertilization Market: The global in-vitro fertilization market was valued at USD 25 billion in 2022 and is expected to reach over USD 59.45 billion by 2032, poised to grow at a noteworthy CAGR of 9.10% from 2023 to 2032.
- In-vitro Diagnostics Enzymes Market: The global in-vitro diagnostics enzymes market size was valued at USD 2.20 billion in 2023 and is anticipated to reach around USD 4.10 billion by 2033, growing at a CAGR of 6.42% from 2024 to 2033.
- Infectious Disease In-Vitro Diagnostics Market: The global infectious disease in-vitro diagnostics market size accounted for USD 84.63 billion in 2022 and it is anticipated to reach around USD 28.62 billion by 2032, with a CAGR of -10.31% during the forecast period 2023 to 2032.
- In Vitro Diagnostics Market: In-Vitro Toxicology Testing Market The global in vitro diagnostics (IVD) market size was accounted for USD 107.77 billion in 2023 and it is expected to hit around USD 128.33 billion by 2033 with a registered CAGR of 2.6% from 2024 to 2033.
- Pharmaceutical Analytical Testing Market: The global pharmaceutical analytical testing market size surpassed USD 8.37 billion in 2023 and is estimated to increase from USD 9.10 billion in 2024 to approximately USD 21 billion by 2034. It is projected to grow at a CAGR of 8.72% from 2024 to 2034.
- Enzyme-Linked Immunosorbent Assay Testing Market: The global enzyme-linked immunosorbent assay (ELISA) testing market size was USD 2.13 billion in 2023, estimated at USD 2.27 billion in 2024 and is anticipated to reach around USD 4.19 billion by 2034, expanding at a CAGR of 6.32% from 2024 to 2034.
- Preterm Birth and PROM Testing Market: The preterm birth and PROM testing market size was valued at USD 180 billion in 2022 and is expected to hit over USD 2.21 billion by 2030 with a registered CAGR of 3.2% from 2022 to 2030.
- Microbiology Testing Market: The global microbiology testing market size reached USD 5.33 billion in 2023 and is projected to be worth around USD 12.72 billion by 2033, expanding at a CAGR of 9.12% during the forecast period from 2024 to 2033.
- Drug of Abuse Testing Market: The global drug of abuse testing market size was estimated at US$ 4.90 billion in 2022 and is expected to hit US$ 9.15 billion by 2032, poised to grow at a noteworthy compound annual growth rate (CAGR) of 6.5% from 2023 to 2032.
In-Vitro Toxicology Testing Market Top Companies
- 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 Technolgies, Inc.
- Catalent, Inc.
- Danaher Corporation
- Bio-Rad Laboratories, Inc.
- BioIVT
- Gentronix
- Labcorp Drug Development
- Acea Biosciences Inc.
- Cyprotex Plc
- Ge Healthcare
- Perkinelmer Inc.
- Qiagen Nv
- Biognosys Ag
- Imquest Biosciences Inc.
- Lonza Group Ltd.
- Promega Corporation
- Stemina Biomarker Discovery Inc.
- Vistagen Therapeutics Inc.
- Xenometrix Ag
- MB Research Laboratories
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What is Going Around the Globe?
- In October 2024, Kingston University partnered with a specialized laboratory service to provide a high-specification toxicity testing facility to assist coroners and pathologists throughout England and Wales.
- In September 2024, MutaTracker® is a mammalian cell-based mutagenicity and genotoxicity test that was developed by Mutagentech and Toxys. It combines error-corrected single-molecule mutation sequencing (SMM-seq) with the dependable output from ToxTracker.
Segments Covered in the Report
By Technology
- Cell Culture Technology
- High Throughput Technology
- Cellular Imaging
- OMICS Technology
By Application
- Genotoxicity
- Cytotoxicity
- Phototoxicity
- Carcinogenicity
- Neurotoxicity
- Dermal Toxicity
- Endocrine Disruption
- Ocular Toxicity
- Others
By Method
- Cellular Assay
- Live Cells
- High Throughput / High Content Screening
- Molecular Imaging
- Others
- Fixed Cells
- Live Cells
- Biochemical Assay
- In-silico
- Ex-vivo
By Region
- North America
- Asia Pacific
- Europe
- Latin America
- Middle East and Africa (MEA)
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