The genetic toxicology testing market size is estimated to be USD 1,276.2 million in 2022 and is expected to witness a CAGR of 12.85% during the forecast period 2023-2033. The rising medication research and discovery, development of facilities and the availability of funding globally and expanding usage of pharmacogenomics are factors contributing to the market growth. Additionally, surging pharmaceutical R&D activities and rising investments from major players for the growth of lab facilities is also expected to propel the market. However, inability to establish the complexities of in vivo conditions, the lack of in vitro models to study complex endpoints, and the regulatory authorities’ unwillingness to consider alternate methods for demonstrating safety and efficacy is expected to hinder the growth.

Surging pharmaceutical R&D activities is expected to propel the market. By expanding the acceptability of compounds in the preclinical phases, R&D initiatives primarily aim to raise the high – levels of approval of Phase I therapeutic candidates. In the early stages of medication development, intense R&D activities are carried out to accomplish this. The demand for genetic toxicology services is consequently increased. Before a medicine enters the expensive clinical stages, increased R&D investments in the early phases of drug development are also anticipated to enhance the usage of in vivo toxicity techniques. Additionally, this causes a rise in demand for genetic toxicology services, which further supports the market’s expansion.

Rising investments from major players for the growth of lab facilities is predicted to fuel the market growth. This strategy helps to facilitate the service’s market accessibility and availability. For instance, in November 2021, Gentronix, a contract research business based in the UK, announced that it would raise USD 854,000 in order to expand its lab space and increase its ability to conduct ocular, genetic, and skin toxicological tests.

Segmentation

By Product

The market is categorized into assays, reagents & consumables, and services. In 2022, the accounted for the highest revenue share due to the Contract Research Organizations’ (CROs’) growing key objectives through investment in this sector. For instance, Inotiv Inc. stated in January 2022 that it would purchase the Integrated Laboratory System (ILS) for USD 56 million in order to expand the study of toxicology. ILS is anticipated to provide more capacity in addition to prospects for Inotiv’s growth as well as an expansion of its in vitro and in vivo toxicology services. Conversely, during the projected period, the reagents & consumables category is anticipated to increase at the fastest rate. The segment’s expansion can be ascribed to the widening range of applications and subsequent rise in regulatory agency demands.

By Application

The market is divided into food industry, cosmetics industry, pharmaceutical & biotechnology, and others. In the global market, the segment accounted for the largest revenue share in 2022 owing to extensive use of genotoxicity testing in drug research and development. Over 20,000 medicines were in active development as of May 2022, an increase of about 8.22% from 2021. While Takeda, Pfizer, Roche, and BMS collectively account under 1,000 products, Novartis AG reported 213 products. Testing for genetic toxicity is done at the preclinical stage. Several medications in the preclinical stage reportedly had outstanding growth of 11%, going from 10,223 in 2021 to 11,351 in 2022, according to a research by Pharma Intelligence UK Limited.

By Type

Based on type, the market is segmented into in vivo and in vitro. In 2022, the segment accounted for the largest revenue share owing to ethical, scientific, and budgetary issues with the use of animals in toxicological research. For instance, in November 2021, a team of researchers evaluated a testing strategy for genotoxicity using an in vitro technique. Utilizing the in vitro method was less expensive and time-consuming. The U.S. FDA also published recommendations for assessing the safety of food components. The agency’s approved genetic toxicity test comprises tests for gene alterations in bacteria and chromosomal damage in human hematopoietic cells performed in-vivo.

Regional Markets

In 2022, North America region accounted for the highest revenue in the genetic toxicology testing market and is expected to maintain its dominance during the forecast period. This is attributed to the rising product development and significant pipeline spending. Additionally, the presence of important players in the region makes genotoxicology testing more accessible for local pharmaceutical and biotech firms. Asia Pacific is predicted to grow at a significant CAGR over the projection period, owing to significant improvements by India and Japan in tightening the rules on drug research and testing of innovative foods. Additionally, improving government financing for R&D and clinical development frameworks in growing countries like Australia and India, and the expansion of laboratory facilities, have been the main drivers of regional growth.

Competitor Insights

Some of the key players operating in the genetic toxicology testing market are Charles River Laboratories International, Creative Bioarray, Jubilant Life Sciences Limited, Syngene International Limited, Thermo Fisher Scientific, Inc., Gentronix Ltd., Inotiv Inc., Eurofins Scientific, Laboratory Corp of America Holdings, and MB Research Laboratories.

• Major players are creating and implementing a number of strategies, including as expanding their geographic reach through mergers and acquisitions, taking advantage of economies of scale when producing new products, and forming strategic collaborationto enhance their market position.
• For instance, Millipore Sigma’s BioReliance’s significant genetic toxicology assets, including historical control data, standard operating procedures, customer lists, and stock cultures, were completed acquired by Inotiv Inc. in July 2021. The contract research company thinks that this acquisition will help them provide their clients with comprehensive solutions for human clinical studies.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including product, application, and type from 2023 to 2033.

Report Scope:

Segmentation: Genetic Toxicology Testing Market Report 2022 – 2033

Product (Revenue, USD Million), 2022 – 2033

• Assays
• Reagents & Consumables
• Services

Application (Revenue, USD Million), 2022 – 2033

• Food Industry
• Cosmetics Industry
• Pharmaceutical & Biotechnology
• Others

Type (Revenue, USD Million), 2022 – 2033

• In Vivo
• In Vitro

By Region (Revenue, USD Million), 2022 – 2033

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of LATAM
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of MEA