In-vitro Toxicology Testing Market Size, Share & Trends Analysis Report By Technology (Cell Culture, High Throughput), By Method, By Application, By End-use (Diagnostics, Chemical Industry, Food Industry), By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global in-vitro toxicology testing market size was estimated at USD 22.7 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 10.7% from 2021 to 2028. Significant advancements in toxicology science are one of the primary factors driving the market. Also, high costs associated with conventional animal tests and socio-ethical concerns associated with animal tests are anticipated to boost the growth of the market for in-vitro toxicology testing.

As in-vitro toxicology studies can help in minimizing liabilities related to late-stage failure in the drug discovery process, a high number of research studies and drug development programs for COVID-19 are expected to accelerate the market for in-vitro toxicology testing. More than 590 drugs for COVID-19 are in the development program as of November 2020. Such a high number of drug development programs is anticipated to boost the demand for in vitro toxicology testing services.

Significant advancements in in-vitro toxicology assays to evaluate drug product safety along with the assessment of the potential effect of pharmaceuticals on cells and tissues are anticipated to bolster revenue generation in the market. With an increase in the need for such assays, companies have broadened their portfolio to serve demand in the market for in-vitro toxicology testing.

Availability of different methods in biotechnology and bioinformatics division to carry out in-silico simulation on animal models is also attributive for influencing industry growth through to 2028. Moreover, the development of toxicology databases for in-silico analysis of different compounds is anticipated to fuel demand for in-vitro techniques thereby leading to sector progress.

Considerable government funding for research coupled with definite reimbursement policies to develop automated and technologically advanced equipment for laboratory analysis and ex-vivo studies is expected to enhance market stability. On the contrary, unavailability of immunity testing and immune stimulation in current in-vitro tests is expected to hamper the growth of this industry.

Technology Insights

The cell culture technology dominated the market for in-vitro toxicology testing in 2020 with a revenue share of over 47.0%. It serves as an excellent model for examining toxic effects since it provides consistent samples and reproducible results, which enables early-stage detection of toxicity in the drug development process. Moreover, cell cultures are increasingly replacing animal testing, leading to its extensive application.

In recent years, 3D cell culture models have gained significant traction due to the advantages it offers. For instance, it supports tissue-specific function, differentiation, and increases cell proliferation. Moreover, researchers are keen to incorporate mammalian cell culturing for designing novel therapeutic approaches as they aid in effective cell function investigation along with the screening of new compounds

On the other hand, the OMICS technology segment is estimated to register the highest CAGR over the forecast period as it offers personalized toxicology data, thereby providing better insights and reducing variability in the procured data. OMICS technologies largely contribute to a deeper understanding of the toxicity of nano-sized materials such as metal, carbon, and metal oxide nanoparticles. This technology led to the identification of new targets and markers in nanotoxicology as well as the detection of adverse effects of low particle concentrations on cells.

Application Insights

The systemic toxicology segment dominated the market for in-vitro toxicology testing and accounted for the largest revenue share of over 68.0% in 2020. The development of multiple organ plates with simulated blood flow for assessing systemic toxicity drives the segment growth. Moreover, public and private organizations are taking initiatives for replacing animal testing with in-vitro techniques for acute systemic toxicity testing.

The dermal toxicity segment is estimated to witness significant growth over the forecast period. Toxicology assays for dermal toxicology have proven to be a simple, reliable, and cost-effective choice. Advancements pertaining to the tools for dermal toxicity and risk assessment are anticipated to drive the segment.

The presence of regulatory guidelines for cosmetic toxicity testing drives the demand for in-vitro testing methodologies. The availability of toxicity assays adhering to government guidelines further fuels the segment growth. For instance, the 3T3 Neutral Red Uptake Phototoxicity Assay-as described under OECD Test Guideline 432-is used to assess phototoxicity of test materials that are either topically applied to the skin or are systemically administered within the body.

Method Insights

The cellular assay segment dominated the market for in-vitro toxicology testing and accounted for the largest revenue share of 43.8% in 2020. This can be attributed to the wider availability of this technique for pharmacokinetic profiling of drug products. Moreover, several pharmaceutical and biotechnological companies are essentially dependent on cellular assays for toxicity screening in the early stages of drug development.

In-vitro cell viability assays offer several advantages, such as minimal cost, speed, and potential for automation. However, these assays pose several technical challenges and are yet to completely replace animal testing, thus posing challenges to their growth. On the other hand, the ex-vivo segment is expected to grow at a considerable rate over the forecast period.

Ex-vivo or small explant cultures enable drug screening experiments to be conducted in a sterile, controlled, and dynamic environment by maintaining the native architecture of the tissues. A major advantage of using the ex-vivo model is that it performs tests or detections outside the organism and hence does not raise ethical concerns of performing tests on living subjects.

End-use Insights

The pharmaceutical industry segment dominated the market for in-vitro toxicology testing and accounted for the largest revenue share of over 40.0% in 2020. The high usage of toxicology testing in pharmacokinetic analysis of novel and generic modified pharmaceutical products results in the revenue growth of these toxicity testing assays. Moreover, the presence of several drug candidates in the pipeline is expected to drive the demand for in-vitro toxicology testing.

To comply with the changing regulatory guidelines for drug development, these assays are mainly used in three areas-ADME, safety pharmacology, and genotoxicity testing of drug candidates. In addition, the development of biologics and biosimilars has resulted in a higher penetration of toxicity tests based on in-vitro models.

The chemical industry is expected to register lucrative growth over the forecast period owing to ongoing advancements associated with toxicity profiling in this sector. Strategic implementation of these tools for informed and efficient safety assessment at all stages of product development is expected to drive the demand for in-vitro toxicology testing in the industry.

Regional Insights

North America dominated the in-vitro toxicology testing market and accounted for the largest revenue share of over 47.0% in 2020 owing to an increased focus of government bodies for drug discovery, rise in healthcare expenditure, and presence of adequate infrastructure for growth and development of drug discovery technologies. Furthermore, strong regulatory guidelines pertaining to drug development and approval have boosted the adoption of services in the regional market for in-vitro toxicology testing.

Ongoing launches of biologics and biosimilar products by biopharmaceutical manufacturers in the U.S. further drive the demand for in-vitro toxicology testing. In addition, government agencies are involved in investment and funding initiatives for drug discovery. National Institutes of Health and Defense Advanced Research Projects Agency are among some of the agencies actively involved in generating funds for basic drug discovery research and improving the adoption of alternative modes of toxicology testing in the U.S

However, in Asia Pacific, the market for in-vitro toxicology testing is estimated to register relatively faster gains over the next seven years due to enhancement in health care infrastructure and rise in government incentives for research in academic and private organizations in order to aid enhancement in technology.

Key Companies & Market Share Insights

This industry shows the presence of a number of sector participants due to which there is an intense internal rivalry to occupy revenue share. Market participants are involved in the development of software solutions in order to enhance in-silico simulation methods for toxicological profiling of different compounds.

Market entities are also engaged in expanding their presence by entering untapped regions and collaborating with smaller clinical research organizations operating in this market. For instance, in August 2019, Abbott signed an agreement with Intoximeters, which gave Intoximeters exclusive distribution rights to Abbott's SoToxa Mobile Test System, a handheld oral fluid solution for drugs and alcohol testing in the U.S. The product enables the testing of methamphetamine, benzodiazepines, amphetamine, cocaine, cannabis (THC), and opiates. Some of the prominent players in the in-vitro toxicology testing market include:

• Merck KGaA

• Charles River

• Bio-Rad Laboratories, Inc.

• Abbott

• Thermo Fisher Scientific Inc.

• Catalent, Inc.

• GE Healthcare

• Quest Diagnostics Incorporated

• Eurofins Scientific

• Laboratory Corporation of America Holdings

• Evotec

• Creative Bioarray

• Gentronix

• BioIVT

• SGS SA

• Agilent Technologies

In-vitro Toxicology Testing Market Report Scope 

Segments Covered in the Report 

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 2028. For the purpose of this study, Grand View Research has segmented the global in-vitro toxicology testing market report on the basis of technology, method, application, end use, and region:

• End-use Outlook (Revenue, USD Million, 2018 - 2028)

  • Pharmaceutical Industry

  • Cosmetics & Household Products

  • Academic Institutes and Research Laboratories

  • Diagnostics

  • Chemical Industry

  • Food Industry

• Technology Outlook (Revenue, USD Million, 2018 - 2028)

  • Cell Culture Technology

  • High Throughput Technology

  • Molecular Imaging

  • OMICS Technology

• Application Outlook (Revenue, USD Million, 2018 - 2028)

  • Systemic Toxicology

  • Dermal Toxicity

  • Endocrine Disruption

  • Occular Toxicity

  • Others

• Method Outlook (Revenue, USD Million, 2018 - 2028)

  • Cellular Assay

    • Live Cells

      • High Throughput / High Content Screening

      • Molecular Imaging

        • Confocal Microscopy

        • Others

      • Others

    • Fixed Cells

  • Biochemical Assay

  • In-Silico

  • Ex-vivo

• Regional Outlook (Revenue, USD Million, 2018 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

  • Middle East Africa (MEA)

    • South Africa