Genetic Toxicology Testing Market Size, Share & Trends Analysis Report By Type (In-vitro, In-vivo), By Product (Reagents & Consumables, Assays, Services), By Application, By Region- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2023-2032

The global genetic toxicology testing market size was exhibited at USD 12.8 billion in 2022 and is projected to hit around USD 4.48 billion by 2032, growing at a CAGR of 12.8% during the forecast period 2023 to 2032.

Key Pointers:

• By type, the in vitro is expected to be the fastest growing segment with the largest share of the Genetic Toxicology Testing Market in 2021. Owing to the rising requirement by regulatory agencies for genotoxicity in the food industry
• By application, the pharmaceutical & biotechnology segment is estimated to become a major market contributor. This is attributed to an increase in the development of cell and gene therapy, coupled with increasing use of pharmacogenomics and personalized medicines
• The Asia Pacific region is projected to grow substantially over the forecasted period owing to the increasing imports of novel food and tightening test regulations for the same, especially in Australia
• By product, the service segment captured a significant proportion of the share in 2021, owing to the increasing demand by pharmaceutical and biotechnology companies for nonclinical works. Also, increasing strategic initiatives by contract research organizations is a major growth determinant
• North America was a major regional market for genetic toxicology in 2022 owing to the availability of efficient players in the region to match the demand by pharma and biotech companies. The increasing R&D in personalized medicines is also a significant factor

Genetic Toxicology Testing Market Report Scope

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.

The North America region led the industry with a revenue share of 40.90% in 2021. The regional dominance can be attributed to increasing drug development with strong investments in pipelines. Along with that, the existence of key players in the regions eases the accessibility of genotoxicology testing for pharma and biotech companies in the region.

Asia Pacific is projected to expand at a CAGR of 14.7% over the forecast period, due to considerable developments by India and Japan in tightening the regulations on drug development and testing of novel food. Moreover, the development of laboratory facilities, coupled with increasing government funding for R&D and clinical development frameworks of emerging economies such as Australia and India have been the key growth determinants for regional growth.

Genetic Toxicology Testing Market Segmentation