Genetic Toxicology Testing Market

Global Genetic Toxicology Testing Market Size (2023 to 2028)

The global genetic toxicology testing market size is estimated to be worth USD 2.74 billion by 2028 from USD 1.58 billion in 2023, growing at a CAGR of 11.6% between 2023 to 2028.

Genetics Toxicology testing based on In vitro, bacterial, and in vivo testing systems is used to assess a test's potential to cause gene mutations or chromosome damage in mammalian cells. The term "genotoxic" refers to physical or chemical agents that cause such effects by interacting with genetic material and altering its structure. Because genetic damage can cause an increase in the incidence of heritable diseases and cancer in human populations, this information is critical and must be included in preclinical studies. Thus, genetic toxicology testing is widespread, and accurate interpretation of the results is critical to avoid data compromise and potential program failure. Using cutting-edge science enables a more effective and efficient testing and assessment paradigm for chemical risk management. It is also to reduce the number of animals used in testing while still producing reliable chemical safety assessments. A significant challenge for the field of toxicology in general and genetic toxicology is to embrace computational toxicology, new assay technologies capable of screening thousands of chemicals efficiently and structure-based and in-silico prediction approaches. Given its unique position in toxicology and these new technologies, facilitating and leading the transition to 21st-century toxicology. There have been some recent advances in genetic toxicology testing that would reduce the use of animals while still providing the necessary information.

MARKET DRIVERS:

Increased pharmaceutical research activities across the world are expected to boost the global genetic toxicology testing market growth.

In 2019, the pharmaceutical industry spent about 186 billion US dollars on R & R&D. Pharmaceutical R&D encompasses all stages of disease process research, compound testing, pre-clinical testing, and clinical trial stages. Pharmaceutical research and development (R&D) funding is derived from a complex mix of private and public sources. Governments primarily fund basic and early-stage research. Major advances in pharmaceutical research and development have begun to alter the R&D landscape in recent years. A growing number of drug manufacturers are outsourcing large portions of R&D, primarily to clinical research organizations (CROs), to cut costs. In 2019, Eli Lilly and AstraZeneca spent around 23 and 28% of their prescription drug revenue on R&D, respectively. Around 17,700 prescription drugs were in the 2020 R&D pipeline, a global figure increasing year after year. Since 2006, the drug count has more than doubled, and it is expected to rise even further in the future.

Growing innovations in personalized medicine are expected to accelerate the growth rate of the global genetic toxicology testing market.

Personalized medicine (PM) is a particularly novel and exciting topic in the medical and healthcare industries. Several challenges are associated with personalized medicines, particularly obtaining approval for routine use from various regulatory agencies. Healthcare is transforming, and it is critical to use new technologies to generate new data and support precision medicine (PM). The advanced commercialization of molecular medicine has resulted in the novel concept of pharmacogenetics, whose application is now recognized as PM. PM can provide better medication selection and targeted therapy, reduce side effects, and improve patient compliance.

The increasing use of the In-vitro toxicology method by the healthcare industry is predicted to favor the global genetic toxicology testing market.

In vitro toxicology studies the toxic properties of compounds and mixtures using cells or tissues maintained or grown in a controlled laboratory environment. The entire process of in vitro toxicology risk assessment, including current and future developments, focuses on cytotoxicity, toxicokinetics, cellular responses, metabolism, modeling, cancer-related endpoints, allergenicity prediction, developmental toxicity, and finally, biomarker development and application. In Vitro Toxicology Systems brings together critical issues and considerations required to develop a reliable, workable, integrated testing strategy for animal replacement in toxicity testing regimes. Scientists, Students, and regulators working in chemical safety assessment and a broader scientific audience will benefit from In Vitro Toxicology Systems. In vitro toxicology studies can help reduce the risks of late-stage failure in the drug development process. Toxicity is a common reason for drug withdrawal in late-stage drug development and aftermarket approval, with hepatotoxicity and cardiotoxicity being the most common reasons. Early in the drug discovery process, determine the toxic potential of compounds.

The growing Evolution of 3D cell culture systems is expected to favor the global genetic toxicology testing market.

3D cell cultures have been used as a model in several experimental therapy studies involving radiotherapy, chemotherapy, and cell- and antibody-based immunotherapy. As a result, the behavior of 3D-cultured cells is more similar to in vivo cellular responses. In addition, the physical and spatial aspects of 3D cultures influence signal transduction from the outside to the inside of cells, influencing gene expression and cellular behavior. By bridging the traditional 2D monolayer cell culture to animal models, 3D culture systems hold great promise for applications in drug discovery, cancer cell biology, stem cell research, and many other cell-based analyses and devices. Recent advances clearly show that the transition from 2D to 3D cell cultures for industrial applications is promising.

Government initiatives aimed at increasing funding for new drug development support the global genetic toxicology testing market.

Governments worldwide are currently offering significant incentives to encourage the discovery and development of orphan drugs to treat these diseases. However, there are still significant scientific, clinical, and regulatory hurdles to overcome. Furthermore, drug regulatory authorities in some countries have established designations that allow for the expedited development and review of select medications used for life-threatening diseases with an unmet medical need that demonstrates significant benefit over existing therapies early in their clinical development.

Increased R&D for drug discovery and rising demand for drug discovery is further expected to support the global genetic toxicology testing market.

According to the NIH, only a small percentage of the 6800 rare diseases have approved treatments, so new drugs are desperately needed. Only 500 orphan drugs have been approved, with more than a hundred more tested in clinical trials.  It also paved the way for more personalized medicine by allowing researchers to look into how frequently their genetic profile influences a patient's response to medication. In the coming years, genomic research will enable the identification of new disease genes and modifier alleles, as well as valuable insights into disease pathobiology. There is no doubt that newer technologies, such as high-throughput DNA sequencing. Knowing a person's genome sequence in the future may aid in determining susceptibility to diseases such as cancer, heart disease, and type 2 diabetes, potentially paving the way for better preventative care.

Additionally, the rising prevalence of chronic diseases and gene therapy is advancing worldwide. The market for genetic toxicology testing market has been driven by the demand for robust and predictive models of cellular pathways.

MARKET RESTRAINTS:

Drug development is a time-consuming and costly process that includes several stages such as lead discovery, target identification and optimization, preclinical validation, and clinical trials, culminating in clinical approval. In addition, 3D models continue to lack vasculature, which is essential for tumor growth/survival and drug delivery. The aforementioned factors are expected to restrain the global genetic toxicology testing market. Additionally, the shortage of trained professionals, high costs associated with the R&D, lack of in-vitro models to study complex endpoints, stringent regulatory authorities, and approval of the drug discovery process limit factors for the genetic toxicology testing market.

Impact of COVID-19 on the global genetic toxicology testing market:

The Coronavirus disease 2019 (COVID-19) outbreak has evolved into an emerging global pandemic. Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 coronavirus, has now been confirmed worldwide. COVID-19 morbidity and mortality rates rise dramatically with age and co-occurring health conditions such as cancer and cardiovascular disease. Many drugs with unknown efficacy are being used to treat COVID-19 patients, either off-label/compassionately or in clinical trials. The first step toward identifying and prioritizing potential safe COVID-19 therapeutics is in vitro drug screening. SARS-CoV-2, the causative agent of COVID-19, is a novel coronavirus that has disrupted the global clinical trial landscape in just a few months. For the COVID-19 pandemic, the SARS-CoV-2 virus mutated, resulting in genetic variation in the population of circulating viral strains.

The WHO has urged countries to expand sequencing studies to address unknown coronavirus strains. It stated that the coronavirus mutation was discovered in the United Kingdom for the first time. Plant shutdowns, and Lockdown also impacted flight cancellations, export and import of raw materials, and approval regulatory processes such as IND, NDA, ANDA, and FDA approval, and the R&D process. Due to the early stages of the clinical trials investigating treatments, data for pharmacogenomics on COVID-19 is limited.

REPORT COVERAGE:

This research report on the global genetic toxicology testing market has been segmented and sub-segmented based on the product, application, and region.

Genetic Toxicology Testing Market – By Product:

• Services
• Reagents and Consumables
• Assays

Based on the product, the services segment had the largest market share in 2022 and is predicted to continue the lead throughout the forecast period. Factors contributing to the segment's larger share include increased R&D activities in the pharmaceutical industry, increased government investments in life sciences research, and increased research conducted with integrated omics studies, leading to increased outsourcing of services to contracting research organizations (CROs).

Genetic Toxicology Testing Market – By Application:

• Healthcare Industry
• Food Industry
• Cosmetics Industry
• Other Industries

Based on the application, during the forecast period, the cosmetics industry segment is expected to grow significantly. The increasing popularity of cosmetics, owing to increased disposable incomes and widespread availability, has prompted the industry to invest in breakthrough product development and research.

In 2022, the Healthcare industry segment held the greatest share of the market. The required preclinical safety review for drug registration, together with increased investments in the study of novel compounds to tackle present and future healthcare concerns, is one of the primary drivers driving this segment's rise. Furthermore, late-stage drug failures, which result in significant economic losses, are predicted to drive up demand for in vitro testing to screen potentially toxic molecules throughout drug development.

Genetic Toxicology Testing Market – By Region:

• North America
• Europe
• Asia-Pacific
• Latin America
• The Middle East and Africa

Based on the region, the North American genetic toxicology testing market had the highest share of the global in 2022. The growing development of structure-based drug designs, growing academic and government investments in genomics and proteomics research, high biopharmaceutical R&D expenditure, and the emerging adoption of advanced technologies in North America contribute to this market segment's size. Another important reason contributing to this market segment's significant share in the presence of a high number of global companies in this region. In addition, as the virus has spread at an exponential rate in the United States, frequent patient visits to hospitals and clinics have decreased. Furthermore, it has resulted in a decrease in the number of profiling studies carried out. To some extent, all of these challenges are projected to limit the growth of the genetic toxicology services market.

Next to North America, the Asia Pacific genetic toxicology testing market is expected to develop faster. During the forecast period, factors such as rising regional government and industry investments, growing gene-based research, and expanding awareness regarding customized medicines are expected to drive the expansion of this regional market. Moreover, manufacturers should anticipate profit from the increased focus on Asia Pacific countries due to their low-cost production.

KEY MARKET PARTICIPANTS:

Some of the major companies leading the global genetic toxicology testing market profiled in this report are Charles River Laboratories International, Inc., Creative Bioarray, Creative Biolabs, Cyprotex plc, Environmental Bio-Detection Products Inc. (EBPI), Eurofins Scientific, Gentronix Limited, Jubilant Life Sciences Limited, Laboratory Corp of America Holdings, MB Research Laboratories, Merck KGaA (Millipore Sigma), Shanghai Medicilon Inc., Sotera Health LLC, Thermo Fisher Scientific Inc., and Toxikon Corporation.

RECENT MARKET DEVELOPMENTS:

• Evotec developed a specialized site for the research and development of gene therapy-based initiatives in 2020. Evotec GT's fully operating location will allow the company to provide dedicated gene therapy services to its clients in the pharmaceutical and biotech industries, foundations, and academia.
• Merck will invest € 18 million in a new life science lab in Switzerland in 2020. Merck's reference materials are used every day by researchers in testing laboratories all around the globe to help create accurate, dependable analytical results in pharmaceutical, environmental, and food and beverage analysis.
• LabCorp launched a new R&D center in Shanghai in 2019. (China). The R&D Center is 12,000 square meters in size and is located in Shanghai's Pudong District's Zhangjiang Hi-Tech Park. It more than doubles Covance's capability to provide clinical development and commercialization solutions, as well as bioanalytical and central laboratory services to customers.