Number of pages: 100 | Report Format: PDF | Published date: March 23, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
According to the deep-dive market assessment study by Growth Plus Reports, the global genetic toxicology testing market was valued at US$ 1.45 billion in 2022 and is expected to register a revenue CAGR of 11.69% to reach US$ 3.93 billion by 2031.
Genetic Toxicology Testing Market Fundamentals
Genetic toxicology testing is a fundamental aspect of genetics that evaluates the genetic damage caused by various environmental agents. Genetic damage results from changes in the DNA sequence, which can lead to mutations and ultimately develop diseases, including cancer. This type of testing is essential to ensure the safety of chemicals, drugs, and other substances used in various industries, including pharmaceuticals, cosmetics, and food. The most commonly used techniques are the bacterial mutation assay, the in vitro mammalian chromosomal aberration assay, and the in vitro mammalian gene mutation assay. These tests use living cells or microorganisms to assess a chemical’s potential mutagenic and carcinogenic effects. The results of these tests can provide insights into the potential health risks associated with exposure to a particular chemical. The bacterial mutation assay is one of the most commonly used tests in genetic toxicology. It is based on the principle that certain mutations in bacterial DNA can lead to resistance to specific antibiotics. The in vitro mammalian chromosomal aberration assay evaluates the ability of a chemical to cause chromosomal damage and uses living cells that have been treated with the test substance.
The in vitro mammalian gene mutation assay evaluates the potential of a chemical to cause mutations in genes that control cell growth and division. These tests typically use mice, rats, or other small animals to assess the potential for genetic damage and carcinogenicity. These tests provide a more comprehensive evaluation of the potential health risks associated with exposure to a particular chemical.
Genetic Toxicology Testing Market Dynamics
Genetic toxicology testing is essential to drug development to ensure the drug’s safety and metabolites. The increasing demand for new and innovative drugs is driving the revenue growth of the genetic toxicology testing market. The growing need for tailored medication to treat various ailments will likely drive market expansion over the forecast period. The progress of molecular medicine has given rise to the unique idea of pharmacogenomics, in which customized medications can enable improved pharmaceutical selection and personalized therapy. It also helps to reduce negative effects while improving patient experience. Increased R&D spending in the early phases of drug development is also predicted to expand the usage of in-vivo toxicology approaches before the medicine reaches the high-cost clinical stages. The need for genetic toxicology services rises as a result.
Governments and regulatory agencies worldwide are imposing stringent regulations for the safety assessment of chemicals used in various industries. Governments of some economies demand toxicity testing as a prerequisite for importing and exporting multiple genetically modified foods, pharmaceuticals, chemicals, insecticides, and vaccines. Genetic toxicology testing is a crucial component of safety assessment, driving the market revenue growth. Consumers are becoming more aware of the harmful effects of chemicals in various industries, including cosmetics and food. This is driving the demand for genetic toxicology testing to ensure the safety of products before they are released into the market. Developing new and advanced technologies for genetic toxicology testing is driving market revenue growth. These technologies offer faster, more accurate, with an enhancement in the sensitive testing methods essential for the safety assessment of chemicals and drugs.
Conversely, genetic toxicology testing can be complex and time-consuming, requiring specialized equipment and expertise. This can make it challenging for smaller laboratories to offer such tests. Furthermore, this type of testing can identify genotoxic substances; however, there is a limitation in understanding the underlying mechanisms of genotoxicity. This can make it difficult to predict a substance’s potential genotoxicity accurately. There is currently no standardized testing protocol for genetic toxicology testing, which can lead to inconsistent results between laboratories. This can create challenges for regulatory agencies while evaluating the safety of chemicals. Moreover, it can be expensive, limiting the accessibility of these tests to smaller companies and laboratories. Genetic toxicology testing often involves the usage of animals, which raises ethical concerns. There is increasing pressure to develop alternative testing methods that do not rely on animal testing.
Genetic Toxicology Testing Market Ecosystem
The global genetic toxicology testing market has been analyzed from four perspectives: type, product, application, and region.
Genetic Toxicology Testing Market by Type
Based on type, the global genetic toxicology testing market can be segmented into in vitro and in vivo.
The in vitro segment dominates the global market with the largest revenue share and is expected to retain its dominance during the projected timeframe. The in vitro method is less expensive and time-consuming than in vivo. In vitro tests can be performed on cell cultures that are easier to handle and manipulate and do not require extensive animal testing. This reduces the cost and time required for testing, making it more cost-effective and efficient. In vitro methods are more ethically acceptable as they do not involve animal testing. Using animals in scientific testing has been debated and criticized for decades. In vitro methods eliminate the need for animal testing, making them a more ethical alternative. This method offers a higher degree of accuracy and reliability. The results obtained from in vitro testing are more consistent and reproducible, which helps reduce errors and uncertainties associated with in vivo testing.
In vivo segment is also predicted to show steady revenue growth during the forecast period. The in vivo method is an important tool in genetic toxicology testing, which studies the effects of chemicals and other agents on genetic material. In vivo studies involving the usage of live animals to evaluate the potential genotoxicity of a substance. The main advantage of in vivo studies is that they provide a more realistic representation of the effects of a substance on living organisms than in vitro studies, which are conducted outside of living organisms. In vivo studies can also provide information on the absorption, distribution, metabolism, and excretion of a substance in the body, which can be important in assessing its potentially toxic effects. In genetic toxicology testing, in vivo studies can be used to evaluate the ability of a substance to cause mutations in DNA, chromosome damage, and other genetic changes. These studies can be conducted using animal models, such as rodents or non-human primates. They can involve different routes of exposure, such as inhalation, ingestion, or injection.
Genetic Toxicology Testing Market by Product
Based on product, the global genetic toxicology testing market can be segmented into reagents & consumables, assays, and services.
The services segment accounted for the largest revenue share in the global market in 2022. The revenue growth of this segment can be primarily attributed to the increasing demand for outsourced genetic toxicology testing services from pharmaceutical and biotechnology companies. Genetic toxicology testing is an important part of the drug development process. It is used to identify potential genotoxicity, which can lead to cancer and other genetic diseases. Many pharmaceutical and biotechnology companies lack the necessary expertise, equipment, and infrastructure to perform genetic toxicology testing in-house, and therefore outsource this service to specialized contract research organizations that offer genetic toxicology testing services. The increasing outsourcing of genetic toxicology testing services by pharmaceutical and biotechnology companies to CROs is one of the major factors driving the revenue growth of the services segment in the global genetic toxicology testing market. Moreover, the increasing demand for personalized medicine and the development of new drugs and therapies specific to individual patients also require genetic toxicology testing services, further fueling the revenue growth of the services segment. In addition, the services segment of the genetic toxicology testing market is characterized by high competition. Many CROs offer a wide range of genetic toxicology testing services, including in vitro and in vivo testing, to meet the diverse needs of their clients. This competition is also driving innovation and the development of new genetic toxicology testing methods and technologies, supporting the revenue growth of the services segment in the global genetic toxicology testing market.
Genetic Toxicology Testing Market by Application
Based on the application, the global genetic toxicology testing market can be segmented into pharmaceutical & biotechnology, the food industry, the cosmetic industry, and others.
The pharmaceutical & biotechnology segment dominates the global market with the largest revenue share. This can be attributed to the rapidly growing demand for novel and enhanced drugs, thus, increasing the usage of genotoxicity testing in drug development and research.
The cosmetic industry segment is illustrating significant revenue growth in the global market. The rapid revenue growth of this segment can be attributed to the high demand for cosmetics due to its increasing popularity among the people. Additionally, growing disposable incomes and increasing demand prompt the industry to engage in cutting-edge product research and development.
Genetic Toxicology Testing Market by Region
Based on the region, the global genetic toxicology testing market can be further segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America dominates the global market with the largest revenue share. This could be attributed to the increased development of structure-based drug designs, genomics, and proteomics research investments, a high biopharmaceutical R&D expenditure, and the emerging adoption of advanced technologies in North America. Similarly, Asia Pacific is estimated to show significant revenue growth during the projected timeline due to rapidly evolving and enhancing economies.
Genetic Toxicology Testing Market Competitive Landscape
The prominent players operating in the global genetic toxicology testing market are:
Genetic Toxicology Testing Market Strategic Developments
Thermo Fisher Scientific Inc., Charles River Laboratories International, Laboratory Corp of America Holdings, and Eurofins Scientific SE are among the key players in the global genetic toxicology testing market.
The pharmaceutical & biotechnology segment dominates the global genetic toxicology testing market.
Asia Pacific is expected to register the highest revenue growth in the global genetic toxicology testing market during the forecast period.
The lack of standardized testing protocol for genetic toxicology testing is one of the major restraining factors to the revenue growth of the global market.
Genetic toxicology testing is a fundamental aspect of genetics that evaluates the genetic damage caused by various environmental agents.
*Insights on financial performance are subject to the availability of information in the public domain