In-vitro Toxicology Testing Market Size, Share & Trends Analysis Report By Technology (Cell Culture, High Throughput), By Method, By Application, By End-user, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global in-vitro toxicology testing market size was valued at USD 28,014.0 million in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 11.10% from 2023 to 2030. The major factor boosting the growth of in-vitro toxicology testing market is the developments in toxicology research such as use of 3D in-vitro models. In addition, the higher cost of animal testing to evaluate the toxicity along with the ethical & social concerns for these conventional tests is anticipated to further fuel the market’s growth. The COVID-19 pandemic resulted in limitation of movement and restriction due to which the market observed a short term decline in growth. However, as there were multiple drug discovery processes, various drug development programs & high research activities, the market demand for in-vitro toxicology testing accelerated eventually. The significant contributing reason for this was to minimize the last stage drug failure risk by in-vitro toxicology assays. As per US FDA Coronavirus Treatment Acceleration Program (CTAP), there are more than 700 drug development programs in various stages for COVID-19.This high number of programs is estimated to further increase the demand for in-vitro toxicology testing services.

Increase in government initiatives that are focused on banning animal testing can be attributed to the rise in adoption of in-vitro toxicology testing. Several government bodies’ as well private agencies are involved in offering funding opportunities & programs to research communities for development of in-vitro test approaches. Funding programs are primarily aimed to protect the human health, animal health, and the environment through reducing the reliance on animal models for the safety assessment of new chemical compound and formulations. 

The increase in need of in-vitro assays and toxicology testing is coupled with the developments in these assays to evaluate safety of drugs, cosmetics, diagnostics, and other products. This has led several companies to broaden their portfolio of offerings to increase revenue generation and meet the market demand. Moreover, presence of various advanced methods such as in-silico simulated models alongside databases for analysis of vast compounds to understand & study the toxicity is anticipated to attribute to the market growth in the forecasted period.   

Technology Insights

The cell culture technology segment held the highest market share of 43.8% in 2022. As cell cultures provide reproducible results to consistent samples, they serve as excellent models for toxicology assays. This further enables early stage drug toxicity testing due to which this technology is gaining popularity & extensive application. Moreover, cell culturing technology is adopted in comparison to animal testing by healthcare academic institutions, biotechnology industries, and pharmaceutical manufacturers across the globe.  

There has been rising adoption of high throughput technologies (HTTs) in the pharmaceutical industry and this can be attributed for the highest growth rate of this segment. The increase in need for reducing toxicity failure burden along with multiple drugs in product pipeline will contribute to the growth during the forecast.as the attrition rate for the drugs due to toxicity in clinics have not declined.Furthermore, incorporation of HTT in vitro models aids in examining varied dose levels, chemicals, and their effects. Researchers are keen on making use of such data to carry out predictive analysis. 

Application Insights

The systemic toxicology segment captured the largest market share of 67.1% in 2022 and anticipated to witness the fastest growth during 2023 - 2030. Owing to the understanding of adverse reactions that occurs in relatively short time after drug administration will drive the adoption of this segment in the market.There are various types of systemic toxicology studies which includes acute systemic toxicity, sub-acute systemic toxicity, sub-chronic systemic toxicity and chronic systemic toxicity. Hence, the goal is to generate a precise data points like- minimum dose that results in toxicity, maximum tolerated dose, plasma concentration which leads to toxicity and margin of safety which is used to make decisions. 

Similarly, the dermal toxicity segment will also witness significant CAGR during the forecasted years. In-vitro toxicology assays for assessing dermal toxicity are much simple, cost-reliable and effective rather than animal testing. The regulatory framework for toxicity tests of cosmetics is also driving the demand for in-vitro dermal toxicity testing. In the current scenario many countries like Israel, Norway, Brazil and India are following the suit with the ban which was been introduced in Europe. Government which could ban testing of cosmetics on animals can also ban the sale of cosmetics that are tested on animals. Besides, the advancements in in-vitro tools for risk assessment during dermal toxicity will also fuel growth in the market. 

Method Insights

The cellular assay segment captured the largest market share of 44.5% in 2022. As cell cultures are excellent models and are available widely for analyzing the pharmacokinetic profile of drugs, cellular assays attribute to the high revenue in in-vitro toxicology testing market. Furthermore, early stage drug toxicity profiling also contributes to this segment’s revenue and drives its growth. 

Cellular assays as in-vitro models offer several benefits such as speed of analysis, minimum cost, and even potential technological advances such as automation. In addition, key efforts laid down by manufacturers for the development of novel cellular assays will also boost the market progression during the forecast. For instance, Enzo Life Sciences provides a board range of fluorescence-based live cell assays, CELLESTIAL, that are capable of investing cell biology and its interconnection with disease pathology. 

In-silico analysis for toxicology testing will also expand at a significant CAGR during the 2023 -2030 period. Implementation of analysis strategy via computational tools for safety assessment in an informed and efficient manner will propel the product development during all stages. This technological development will create new market opportunities & result in higher demand in the toxicology testing industry. 

End-user Insights

In 2022, the pharmaceutical industry segment held the highest share of 42.9% in the market. It is attributed to the high use of toxicology testing for analyzing the pharmacokinetic properties of pharmaceutical drugs. Both novel and generic drugs require assays for toxicology testing. Areas such as absorption, distribution, metabolism, and excretion (ADME), genotoxicity, safety pharmacology necessitate the use of toxicity assays. Additionally, the continuous development and research for new drugs coupled with candidate drug pipeline will propel the demand for in-vitro testing methods.

The diagnostics segment is estimated to witness the fastest growth rate during the forecast due to rising number of diagnostic devices. The COVID-19 pandemic also pushed the diagnostic segment to develop innovative solutions for virus detection. Moreover, companies provide a comprehensive diagnostics product line for detection of therapeutic drug monitoring, long-term alcohol abuse, and point-of-care drug testing, thereby boosting the segment growth.

Regional Insights

North America held the largest revenue share of 47.8% in market during 2022. Owing to the rising government funding for research of therapeutics, increased healthcare expenditure, advanced infrastructure & processes for drug discovery and strong regulatory framework for approval has increased the demand as well as adoption on in-vitro testing methods in this region’s market. 

Furthermore, launch of biologics by biopharmaceutical players in North America, particularly the U.S. has driven the adoption of toxicology testing and will contribute to future revenue generation. Presence of multiple government & private agencies for funding programs will also contribute to the fastest growth rate in 2023-2030. 

On the other hand, Asia Pacific will also register significant CAGR during the forecast period due to development of health care settings, increased geriatric population in need of medicines, and various government incentives for enhancing technology and development.   

Key Companies & Market Share Insights

The in-vitro toxicology testing market has multiple market players and thus demonstrates intensive market competition. Various products and services are offered by the participants to generate revenue and occupy the market share. For example, in January 2021, Charles River had announced a partnership with Cypre, Inc., for expansion of services of 3D in-vitro models for immunotherapy treatment of cancer as well as targeted therapy drug screening. This partnership enabled the company to access Cypre’s patented 3D hydrogel technology or Falcon-X to expand Charles River’s services. Some of the prominent players 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 Technolgies, Inc.

• Catalent, Inc.

• Danaher Corporation

• Bio-Rad Laboratories, Inc.

• BioIVT

• Gentronix 

Recent Development

• In September 2022, BioIVT disclosed the successful acquisition of XenoTech, showcasing their dedication to offering extensive research models and services to biopharmaceutical customers for improved drug development and diagnostic research. By integrating XenoTech's specialized expertise and product lines, such as microsomes and other in vitro models, BioIVT is set to bolster its in-vitro toxicology testing and drug research capabilities, further enhancing its value proposition in the industry

In-vitro Toxicology Market Report Scope 

Global In-vitro Toxicology Testing Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the global in-vitro toxicology testing market report on the basis of technology, application, method, end-user, and region:

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Cell Culture Technology

  • High Throughput Technology

  • Molecular Imaging

  • OMICS Technology

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Systemic Toxicology

  • Dermal Toxicity

  • Endocrine Disruption

  • Occular Toxicity

  • Others

• Method Outlook (Revenue, USD Million, 2018 - 2030)

  • Cellular Assay

    • Live Cells

      • High Throughput / High Content Screening

      • Molecular Imaging

        • Confocal Microscopy

        • Others

      • Others

    • Fixed Cells

  • Biochemical Assay

  • In-silico

  • Ex-vivo

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical Industry

  • Cosmetics & Household Products

  • Academic Institutes & Research Laboratories

  • Diagnostics

  • Chemicals Industry

  • Food Industry

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait