Genetic Toxicology Testing Market To Reach $3.57 Billion By 2030

Genetic Toxicology Testing Market Growth & Trends

The global genetic toxicology testing market size is anticipated to reach USD 3.57 billion by 2030, registering to grow at a CAGR of 11.6% from 2024 to 2030, according to a new report by Grand View Research, Inc. The rising usage of personalized medicines, combined with the development of cell and gene therapy across the globe is enhancing the demand for genotoxicity. For instance, the U.S. FDA has designed guidance documents for the manufacturers of cell and gene therapy. According to the guidance, information on the identification of toxicities and physiologic parameters in preclinical studies can assist in guiding clinical monitoring for the investigational product.

Increasing implementation of pharmacogenomics to support personalized medicine usage and reduced risk of adverse drug toxicity is considered to have a significant impact on the growth of the industry. Moreover, organizations, such as the Dutch Pharmacogenetics Working Group (DPWG), Clinical Pharmacogenetics Implementation Consortium (CPIC), the French National Network of Pharmacogenetics, and the Canadian Pharmacogenomics Network for Drug Safety (CPNDS), have issued clinical guidelines with a primary focus on the pharmacogenomics testing interpretation and recommendation on therapeutic specific drug-gene pairs.

Similarly, the market players are indulging in various strategies to expand their footprint in multiple segments. For instance, in November 2021, Labcorp announced the acquisition of Toxikon, a Contract Research Organization (CRO) with offerings in nonclinical testing services. Through this acquisition, Labcorp is anticipated to strengthen its toxicology business and Toxikon’s location enables Labcorp to engage with known biotech and pharmaceutical companies in the region for non-clinical work.

The COVID-19 pandemic is anticipated to have a neutral impact on the genetic toxicology testing market growth. Numerous researchers employed genotoxic to assess the effects of drugs against the COVID-19 virus. For instance, in September 2020, a team of researchers evaluated the impact of Chloroquine (CQ) and Hydroxychloroquine (HCQ) as prophylactic drugs against the virus. The genetic toxicology of various drugs and chemicals was assessed. Such studies using genetic toxicology testing as a tool of assessment are anticipated to support stable growth during the peak of COVID-19.

The rising demand for novel food and its imports is expected to be a contributor to market growth. Charles River Laboratories is one of the major players offering toxicology assessments on novel foods. They offer novel food analysis including genotoxicity, which consist of in vivo micronucleus test, Ames study, In Vitro Mammalian Cell Micronucleus, and in the vivo comet assay. Similarly, in January 2021, EFSA published its evaluation of insect-derived food. It is the first kind of assessment conducted by the institution on the insect product as a novel food. Every year, EFSA receives a large number of applications, consisting of herbal products based on algae foods, plants, and non-indigenous fruits.

On the other hand, the ability to retrieve information through genetic toxicology is limited. According to the Pathology Tests Explained organization, genetic tests offer information regarding the specific diseases/gene that is being tested. It does not cover information about other genetic diseases that might be present but have not been tested. Similarly, it cannot identify all the variations of genes that cause the diseases, and also it does not showcase the severity of the diseases. Hence, these limitations are anticipated to hamper the growth of the genetic toxicology industry.

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Genetic Toxicology Testing Market Report Highlights

• By type, 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.

• By application,the pharmaceutical and biotechnology segment held the largest revenue share of 44.9% in 2023.

• By product, 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.

• By Assay,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.  

• 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.

• 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.

Genetic Toxicology Testing Market Segmentation

Grand View Research has segmented global genetic toxicology testing market report based on product, type, assay, application, and region:

Genetic Toxicology Testing Product Outlook (Revenue, USD Million, 2018 - 2030)

• Reagents & Consumables

• Assays Kit

• Services

Genetic Toxicology Testing Type Outlook (Revenue, USD Million, 2018 - 2030)

• In Vitro

• In Vivo

Genetic Toxicology Testing Assay Outlook (Revenue, USD Million, 2018 - 2030)

• Comet Assay 

• Micronucleus Assay 

• Chromosomal Aberration Test 

• Genetic Mutation Test

• Others

Genetic Toxicology Testing Application Outlook (Revenue, USD Million, 2018 - 2030)

• Pharmaceutical & Biotechnology

• Food Industry

• Cosmetics Industry

• Other

Genetic Toxicology Testing 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

List of Key Players of Genetic Toxicology Testing Market

• Laboratory Corporation of America Holdings

• Eurofins Scientific

• Thermo Fisher Scientific, Inc.

• Charles River Laboratories

• Jubilant Ingrevia Limited

• Syngene International Limited

• Gentronix, Inotiv

• Creative Bioarray

• MB Research Laboratories.