GENETIC TOXICOLOGY TESTING MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024 - 2031)

High capital investments required for setting up genetic toxicology testing facilities is posing a major challenge for the growth of the global genetic toxicology testing market. Establishing a dedicated genetic toxicology testing laboratory mandates significant capital investments ranging anywhere between US$5 and US$10 million dollars. This is a substantial amount for biotech and pharmaceutical companies, especially small and medium enterprises. Setting up such labs involves high costs associated with sourcing and installation of specialized equipment such as cell culture systems, genetic analyzers, bioinformatics solutions and other auxiliary infrastructure. Moreover, requisite qualified personnel with expert knowledge on genetic toxicology must be hired to efficiently operate and maintain such advanced testing facilities. This further adds to the operational expenses. The costs rise progressively with increasing scope and scale of operations. For instance, conducting in vivo animal testing on a large sample size requires dedicated animal housing with specialized care and handling facilities in accordance with global quality standards. This amplifies the initial setup costs substantially. Additional operational costs are also incurred on a continual basis for consumables, reagents, procurement, and feeding of the test subject animals as well as their veterinary care. Periodic equipment upgrades and customization as per evolving industry guidelines also demand recurring capital investments. Consequently, smaller companies and start-ups dealing with limited capital budgets find it extremely challenging to bear such heavy capital expenditures for instituting internal genetic toxicology testing capabilities.

Market Opportunities: Combination of genetic toxicology tests with alternative methods

The combination of genetic toxicology tests with alternative methods is significantly restraining the growth of the global genetic toxicology testing market. Advancements in alternative testing approaches such as in silico and in vitro techniques have allowed the reduction and replacement of animal testing. These alternative methods are providing faster, cost-effective, and more reliable results as compared to traditional animal-based assays. They are also ethical and minimize animal suffering. The adoption of alternative methods is increasing across industries as well as regulatory agencies. For example, the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) promotes alternative methods for evaluation of chemicals under the REACH and cosmetics legislation. They have recommended 15 alternative methods for replacing animal testing until now. Similarly, in the U.S., the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) encourages implementing alternative methods for chemicals, biomedical devices and research purposes.