Genetic Toxicology Testing Market Segmentation by In Vitro and In Vivo Type
Industry: Healthcare
Published Date: November-2022
Format: PPT*, PDF, EXCEL
Delivery Timelines: Contact Sales
Number of Pages: 289
Report ID: PMRREP33213
The global genetic toxicology testing market garnered a market value of US$ 1.34 Billion in 2022 and is expected to accumulate a market value of US$ 4.56 Billion by registering a CAGR of 13% in the forecast period 2022-2032. Growth of the genetic toxicology testing market can be attributed to increasing drug development and discovery, along with the rising use of pharmacogenomics. The market for genetic toxicology testing registered a CAGR of 9% in the historical period 2016-2021
“Genetic toxicology testing finds various applications in sectors including food, cosmetics, pharmaceutical, and biotech. The is anticipated to boost the demand for genetic toxicology data.”
Since it can assess the compounds that can induce genetic mutations or chromosomal damages. Additionally, the expansion of facilities and accessibility of funding across the globe is also a considerable growth determinant in the genetic toxicology testing industry.
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Attributes |
Details |
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Genetic toxicology Testing Market CAGR (2022-2032) |
13% |
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Genetic toxicology testing Market Size (2022) |
US$ 1.34 Billion |
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Genetic toxicology testing Market (2032) |
US$ 4.56 Billion |
Increasing import of novel foods and investments by key manufacturers driving market growth
The global genetic toxicology testing market is booming as a result of the rising demand for imports of novel food. Increasing imports of foods are compelling regulatory bodies to tighten the testing and other safety evaluation. According to the European Food Safety Authority (EFSA), ethnic diversity, rising globalization, and innovative sources of nutrients are the contributing factors to novel food imports. Novel foods include food that is produced with the assistance of technology, food with the addition of new ingredients/substances, and food through new sources. The list of novel food applications increased from four in 2010 to 39 in 2019. As a result, the requirement for genetics toxicology is anticipated to grow in the coming years.
The genetic toxicology testing market is witnessing increasing investments by key players for the expansion of lab facilities. This strategy accelerates the accessibility and availability of the service in the market.
COVID-19 and need for reduction of animal employment creating lucrative opportunities
An increasing focus on the reduction of animal employment for evaluation of the genotoxic potential of substances is anticipated to impact the costs and time required for genetic toxicology testing. Such changes in market dynamics are expected to open new opportunities for in-vitro testing and can expect a significant boost in market actions.
The COVID-19 pandemic is considered to have a devastating impact on society, the public healthcare system, and economies across the globe. However, the roles of genetic toxicology testing were neutral in the development of vaccines for COVID-19. Since it wasn't a mandatory requirement by the regulatory bodies from the companies. Toxicity studies were being done to understand the mutation of the virus. Similarly, 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.
Expensive nature of testing along with time duration restraining market growth
The average cost of genetic testing ranges from under USD 100 to over USD 2,000, depending on the complexity and nature of the test. The cost accelerates with the number of testing or requires a sample from multiple family members to draw a meaningful test result. The results could take weeks to receive. In some cases, health insurance plans cover the genetic testing cost, when recommended by professionals. However, health insurance providers have different policies and coverage. Hence, genetic toxicology testing lacks uniformity in terms of insurance coverage and payout.
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Attributes |
Genetic Toxicology Testing Market |
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CAGR (2022-2032) |
14% |
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Market Value (2032) |
US$ 4.56 Billion |
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Growth Factor |
Increasing regulatory bodies to test novel foods is expected to drive the market in the forecast period. |
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Opportunity |
Integration of technological advancements along with development of pharmaceutical sectors is expected to offer lucrative opportunities to the market. |
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Attributes |
Genetic Testing Market |
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CAGR (2022-2032) |
12% |
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Market Value (2032) |
US$ 25,500 Million |
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Growth Factor |
Popularity of genetic testing is increasing due to various advantages offered by this procedure such as detection of genetic abnormalities in early gestation period of about 8 to 10 weeks. |
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Opportunity |
Various factors such as advancements in genetic testing technologies, increasing prevalence of genetic diseases and growing awareness are driving the global genetic testing market. This, in turn, is expected to offer lucrative opportunities to the market. |
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Attributes |
Glucose Testing Market |
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CAGR (2022-2032) |
4.5% |
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Market Value (2032) |
US$ 4.9 Billion |
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Growth Factor |
The growing geriatric population, the ability of point-of-care (POC) diagnostic tests and rising market penetration of Electronic Medical Records (EMRs) are among the high-impact rendering drivers of this market. |
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Opportunity |
The shortage of skilled staff, especially in the field of diagnostics, is also expected to increase the market penetration of glucose POC diagnostic products. |
Limitations of Vivo Tests Increasing Preference Towards Vitro Tests?
Safety evaluation of food ingredients spurring adoption of vitro tests
Ethical, scientific, and financial concerns about the use of animals in toxicology testing, have accelerated the interest in the mechanistic in vitro testing approach. For instance, in November 2021, a group of researchers assessed testing strategy with in vitro technique for genotoxicity. Employing in vitro approach resulted in low cost and was less time-consuming.
Similarly, the U.S. FDA released guidelines for the safety evaluation of food ingredients. The recommended genetic toxicity test by the agency includes, and a test employed in bacteria for gene mutations, and an in-vivo test using mammalian hematopoietic cells for chromosomal damage.
While the agency provides alternative options between in vitro mouse lymphoma thymidine kinase+/- gene mutation assay or an in vitro test along with the cytogenetic assessment of chromosomal damage via mammalian cells. The agency stated that there are compounds, wherein in vivo tests do not offer relevant insights. In such cases, in vitro testing is considered to be appropriate. Hence, the limitations of in vivo tests increase the preference for in vitro tests amongst researchers. Owing to the aforementioned reasons, the in vitro segment is expected to hold 53% market share for genetic toxicology testing market in 2022 and is estimated to have similar momentum during the forecasted period.
Initiatives and Investments by CRO Propelling Growth of Service Segment?
Expanding range of skin services boosting growth of service segment
The increasing strategic initiatives by Contract Research Organizations (CRO) through investment in this segment is propelling the market growth. The growth of the service segment is also propelled by the expanding range of services in skin and genetic toxicology testing. For instance, in December 2020, Gentronix announced the growth of its scope of services in the area of dermal toxicology to support the rising global demand. The company has projected an increase of 20% in revenue from new services throughout the year. Thus, the service segment is expected to possess 53% market share in 2022.
On the other hand, the reagents & consumables segment is expected to showcase the fastest growth during the forecasted period. The growth of the segment can be attributed to the expanding scope of applications followed by increasing requirements by regulatory agencies.
Preclinical Testing of Medicines Increasing Adoption of Genetic Toxicology Testing in Pharmaceutical and Biotechnology Segment?
Drug discovery and development leading to extensive use of genetic toxicology testing
The widespread use of genotoxicity testing in drug discovery and development is anticipated to be a contributing factor to the growth. As of May 2022, over 20,000 drugs are under active development, which is approximately an 8.22% increase from 2021.
Novartis AG reports for 213 products, while Takeda, Pfizer, Roche, and BMS, accumulatively account for around 1,000 products. Genetic toxicology testing is employed during the preclinical stage. According to the report of Pharma Intelligence UK Limited, several drugs in the preclinical stage experienced exceptional growth of 11%, that is from 10,223 in 2021 to 11,351 in 2022.
Furthermore, the pharmaceutical and biotechnology segment is reported to witness the fastest growth during the forecast period. Since the testing is a requirement for all levels of drugs and chemicals. Also, the strategy of testing is needed to be customized based on the applicable regulatory guidelines and outcomes observed in vitro. Thus, the pharmaceutical and biotechnology segment is expected to possess 45% market share for genetic toxicology testing.
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Regions |
CAGR |
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United States |
10% |
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Canada |
8% |
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China |
11% |
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Japan |
7.5% |
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India |
9% |
Presence of Pharmaceutical and Biotechnological Sectors Favoring Growth of Genetic Toxicology Testing Market in North America?
Drug development in pharmaceutical companies maximizing use of genetic toxicology testing
The growth of 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.
In addition, integration of technological advancements in the testing sector along with the accuracy of results is shaping the landscape for genetic toxicology testing market in North America. Thus, North America is expected to possess 40% market share in 2022.
Regulation of Food Safety Increasing Demand for Genetic Toxicology Testing in Asia Pacific?
Mandatory testing of novel foods spurring growth for genetic toxicology testing in Asia Pacific
Government of countries in Asia Pacific such as India and China are particular regarding food safety. This has led to a demand for testing the launch of novel foods. 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. Thus, Asia Pacific is projected to expand at a CAGR of 15% over the forecast period
Major players are designing and executing several strategies including increasing geographical footprint through mergers and acquisitions, leveraging economies of scale for developing products, and strategic collaborations to inflate their market presence. Some prominent players in the global genetic toxicology testing market include Thermo Fisher Scientific, Inc, Charles River Laboratories International, Laboratory Corp of America Holdings, Eurofins Scientific, Jubilant Life Sciences Limited, Syngene International Limited, Gentronix Ltd., Inotiv Inc., Creative Bioarray and MB Research Laboratories
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Attributes |
Details |
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Forecast Period |
2022-2032 |
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Historical Data Available For |
2015-2021 |
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Market Analysis |
US$ Mn for Value |
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Key Countries Covered |
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By Market Segments |
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Key Companies Profiled |
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Pricing |
Available Upon Request |
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The global genetic toxicology testing market is estimated at a 13% growth rate during the forecast period of 2022-2032.
The global genetic toxicology testing market is expected to garner US$ 4.56 Billion by 2032.
U.S is projected to register a CAGR of 10% for genetic toxicology testing market in the forecast period 2022-2032.
India is expected to register a CAGR of 7.5% for genetic toxicology testing market in the forecast period 2022-2032.
The Global genetic toxicology testing market was estimated at US$ 1.19 Billion in 2021.
The pharmaceutical and biotechnology segment is expected to possess 45% market share for genetic toxicology testing.
