Genetic Toxicology Testing Market Size, Share & Trends Analysis Report By Type (In Vitro, In Vivo), By Product (Reagents & Consumables, Assays Kit, Services), By Assay, By Application, By Region, And Segment Forecasts, 2024 - 2030

Genetic Toxicology Testing Market Trends

The global genetic toxicology testing market size was valued at USD 1.60 billion in 2023 and is projected to grow at a CAGR of 11.6% from 2024 to 2030. Genetic toxicology testing has applications in various industries including biotechnology, food and cosmetics. Rising incidence rate of cancer, technological advancements in genomics, R&D activities in pharmaceuticals, biotechnology, and chemical industries, the shift towards personalized medicine and precision healthcare, and increasing awareness about health hazards associated with exposure to genotoxic agents are driving the market growth.

The increasing research and development activities in the pharmaceutical, biotechnology, and chemical industries are driving the demand for genetic toxicology testing. As new consumer products, drugs, and chemicals are developed, there is a growing need to assess their potential risks to human health and the environment through genetic toxicology testing. Stringent regulations by global health organizations are driving the adoption of genetic toxicology testing. Regulatory bodies require thorough assessments of genotoxic substances in pharmaceuticals, cosmetics, and other products before they can be approved for use or sale. Advances in testing methods, such as in silico modeling, in vitro micronucleus assays, and high-throughput screening techniques, are enhancing the efficiency and accuracy of genetic toxicology testing. These technological innovations are making testing processes faster, more cost-effective, and more reliable, thereby contributing to market growth and growing awareness of health risks associated with genotoxic substances is driving the market growth.

There is a growing market for genetic toxicology testing worldwide due to the increasing need for new food imports. The rise in food imports is causing regulatory agencies to increase scrutiny on testing and safety evaluations. As per the European Food Safety Authority (EFSA), new food imports are influenced by factors such as ethnic diversity, increasing globalization, and the emergence of innovative nutrient sources.

Novel foods encompass food created with technological help, food incorporating new ingredients/substances, and food from innovative sources. The number of novel food applications received by EFSA were maximum 10 between 2003 and 2017 it grew to 40 in 2018 and 39 in 2019 because of new regulations. Therefore, the demand for genetic toxicology is expected to increase in the future.

Shifts in market dynamics are likely to create fresh possibilities for in-vitro testing and generate a notable increase in market activities. For instance, in July 2022, Inotiv Inc. revealed plans to further increase its ability to perform genetic toxicology studies for in vitro cytogenetics and bacterial assays to meet the increasing demand for new treatments. Accordingly, anticipated changes in emphasis towards reducing the use of animals in assessing the genotoxicity of substances are expected to affect the expenses and time needed for genetic toxicology testing.

Product Insights

The service segment captured the largest revenue share of 52.1% in 2023. This is attributed to several factors such as the increasing demand for outsourced services, the complexity of testing procedures, and the need for specialized expertise. Service providers offer a range of genetic toxicology testing services, including in vitro and in vivo testing, genotoxicity assays, and regulatory consulting services. This segment’s dominance can be attributed to its ability to provide comprehensive solutions to clients, ensuring compliance with regulatory requirements and delivering accurate and reliable results.

The reagents & consumables segment is expected to grow at the fastest CAGR of 12.3% over the forecast period. This growth is attributed to several factors such as the increasing demand for genetic toxicology testing, advancements in technology leading to the development of more sophisticated reagents and consumables, and the rising focus on research and development activities in the field of genetic toxicology.

Type Insights

The in vitro segment held the largest revenue share of 65.1% in 2023 and is estimated to have similar momentum during the forecast period. This is attributed to advantages which include cost-effectiveness, faster results, reduced animal usage, ethical considerations, regulatory acceptance advancements in technology, and increasing awareness of genetic toxicology testing in various products. These advantages make it a preferred choice for many researchers and companies involved in toxicology studies. In addition, advancements in cell culture techniques, high-throughput screening technologies, and computational modeling have enhanced the reliability and relevance of in vitro tests, further boosting their popularity.

The in vivo segment is expected to witness rapid growth of CAGR 10.8% in the coming years. This is owing to the increasing demand for accurate and reliable testing methods, advancements in technology, and rising awareness about genetic toxicology testing’s importance in assessing potential risks associated with chemicals and pharmaceuticals. In vivo testing methods are considered more accurate and reliable due to their ability to simulate real biological conditions within living organisms. Regulatory bodies are emphasizing the importance of genetic toxicology testing in pharmaceuticals and other products which is driving the demand for in vivo testing services.

Assay Insights

The comet assay segment dominated the market in 2023. The comet assay, also known as single-cell gel electrophoresis assay, is widely used for assessing DNA damage, it can detect a broad range of DNA damage, including single-strand breaks, double-strand breaks and incomplete repair sites. It is a relatively simple and versatile technique making it adaptable to various types of samples and testing methods. Also, its adoption has increased due to its cost-effectiveness in the genetic toxicology testing.

The genetic mutation test is expected to witness rapid growth with the fastest CAGR during the forecast period. The growth is due to factors including awareness of genetic disorders, demand for personalized medicine, advancement in genomics and biotechnology, regulatory compliance, and the growing prevalence of diseases such as cancer and genetic disorders. Also, the increase in the use of genetic testing in different sectors such as pharmaceutical, agriculture, and environmental sectors contributes to the market growth.

Application Insights

The pharmaceutical and biotechnology segment held the largest revenue share of 44.9% in 2023. The pharmaceutical and biotechnology industries are heavily regulated, requiring extensive genetic toxicology assessment to ensure the safety and efficacy of new drugs and biologics before they can be introduced to market. This regulatory environment drives the demand for genetic toxicology testing services in these sectors. The widespread use of genetic toxicology testing in drug discovery and development is anticipated to contribute to the growth.

The food industry segment is expected to grow at a CAGR of 11.6% during the forecast period. This growth can be attributed to several factors such as increasing consumer awareness about food safety, increasing global food supply chain, stringent regulations governing food quality and safety, advancements in genetic toxicology testing technologies, and the rising demand for genetically modified organisms in the food industry.

Regional Insights

The North America genetic toxicology testing market dominated the global market with a revenue share of 40.1% in 2023. The regional dominance can be attributed to increasing drug development with strong investments in pipelines. Additionally, the existence of key players in the region eases the accessibility of genetic toxicology testing for pharma and biotech companies in the region.

U.S. Genetic Toxicology Testing Market Trends

The genetic toxicology testing market in the U.S. dominated the North America market in 2023. The stringent regulatory environment in the U.S., particularly from agencies such as the Food and Drug Administration, plays a crucial role in driving the demand for genetic toxicology testing. Regulatory bodies require toxicology assessment before approving a new drug, food ingredients, cosmetics, and other products for human use such as lotions, nose drops, eye drops, and many more.

Asia Pacific Genetic Toxicology Testing Market Trends

Asia Pacific is projected to expand at the fastest CAGR over the forecast period, due to developments by countries such as Japan and India in tightening the regulations on testing of novel food and drug development.

The Japan genetic toxicology testing market is expected to grow significantly in the coming years due to increased research and development activities on early toxicity detection,augmented funding by governments in the life sciences research field.

Genetic toxicology testing market in China is expected to grow significantly in the coming years due to increasing research and development activities within the pharmaceutical and biotechnology sector. In addition, increasing public health awareness and stricter regulations around product safety are promoting companies across various industries like food and cosmetics 

Key Genetic Toxicology Testing Company Insights

Organizations are focusing on increasing customer base to gain a competitive edge in the industry. Therefore, key players are taking several strategic initiatives, such as mergers and acquisitions, and partnerships with other major companies.

• Thermo Fisher Scientific, Inc. is an internationally recognized provider of analytical instruments, solutions for life sciences, specialized diagnostics, as well as laboratory, pharmaceutical, and biotechnology services.

• Charles River Laboratories offers a wide range of solutions for drug development, chemicals, and medical devices on a global scale. Its products and services cater to clients throughout the entire process, from basic research and discovery to safety assessment, manufacturing, and commercialization.

Recent Developments

• In May 2023, Thermo Fisher Scientific, Inc. partnered with Pfizer to enhance local access to next-generation sequencing for lung and breast cancer. This collaboration aims to provide faster, more precise testing, leading to tailored treatments and improved patient outcomes in regions where such advanced diagnostics were previously limited.

• In January 2022, Inotiv, Inc. acquired Integrated Laboratory Systems, LLC to extend Inotiv's capabilities into genomics, bioinformatics, and computational toxicology. The acquisition further aimed at adding significant pathology and toxicology expertise.

Genetic Toxicology Testing Market Report Scope

Global Genetic Toxicology Testing Market Report Segmentation

This report forecasts revenue growth at the 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 this report, Grand View Research has segmented the global genetic toxicology testing market report based on product, type, assay, application, and region:

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

  • Reagents & Consumables

  • Assays Kit

  • Services

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

  • In Vitro

  • In Vivo

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

  • Comet Assay 

  • Micronucleus Assay 

  • Chromosomal Aberration Test 

  • Genetic Mutation Test

  • Others

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

  • Pharmaceutical & Biotechnology

  • Food Industry

  • Cosmetics Industry

  • Other

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

  • North America

    • U.S.

    • Mexico

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait