Genetic Toxicology Testing Market

Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2023-2030 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

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Industry: Medical Devices

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Genetic Toxicology Testing Market: Overview

The market size for Genetic Toxicology Testing was USD 1.3 billion in 2021, and it is projected to grow at a CAGR of 10.5 percent during the forecast period. Testing for genetic toxicity is intended to assess the substances that cause chromosomal damage or genetic abnormalities. Screening techniques help determine compounds with potential human risk because DNA reactive substances can trigger carcinogenic processes. The market can be divided into in-vitro and in-vivo categories depending on the test type. In this case, the in-vitro type has uses in drug discovery and customized therapy, while humanized models for in-vivo research are also gaining popularity. Important companies are developing new animal models to satisfy the enormous potential for in-vivo testing. For instance, Creative Biogene introduced its Zebrafish illness model in July 2022 to aid medication development and toxicological testing. The rise aids the rapid expansion of the market in the frequency of chronic diseases and the creation of specialized testing kits for specialized therapeutic fields.

In a report released by the World Health Organization in October 2021, One in six individuals on the earth will be 60 or older by 2030. By 2050, there will be 1.4 billion persons in this age group, up from 1 billion in 2020. The number of persons over 60 will double worldwide by 2050. (2.1 billion). The number of people 80 and older is projected to treble between 2020 and 2050, reaching 426 million. The aging population makes people more susceptible to chronic illnesses, which increases the need for preventive diagnostics, particularly genetic testing. However, depending on the complexity and type of the test, the average cost of genetic testing can range from around $100 to over USD 2,000. A valid test result requires a sample from several family members, which increases the expense as the number of tests increases. It can take weeks to get the findings. When advised by experts, health insurance plans occasionally pay for genetic testing. The policies and coverage offered by various health insurance companies vary, though. As a result, there is a lack of consistency in insurance coverage and payout for genetic toxicology tests.

Genetic Toxicology Testing Market: COVID-19 Impact

The research indicates that over the next two years, the market for genetic toxicology testing is anticipated to expand at a CAGR of roughly 10–11%. The following elements would be crucial in determining how the world market will develop: The need for genetic toxicology services has expanded along with the demand for fast COVID-19 testing, particularly for diagnostic assays and toxicology services. Different in vitro kits have received FDA approval, including in vitro toxicological assays and consumables for COVID-19 testing and diagnostics. Regular patient visits to hospitals and clinics have decreased due to the virus' exponential growth in the U.S. Additionally, and it has led to a decline in the quantity of profiling research carried out. These elements are anticipated to restrict the market's expansion for genetic toxicology services. Due to brief global lockdowns that have halted manufacturing operations and enforced travel restrictions, affecting the transit of shipments, the rapid spread of COVID-19 has resulted in a lack of medical supplies and equipment. COVID-19 has not severely affected the availability of raw materials used in genetic toxicology, except for transportation-related delays brought on by travel restrictions and driver scarcity difficulties.

Genetic Toxicology Testing Market: Drivers

Increased R&D Activity In The Pharmaceutical Industry to Drive Market Growth

By raising the acceptance of compounds in the preclinical phases, R&D operations primarily aim to raise the overall likelihood 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 pricey 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 propels the market's expansion.

Increasing Demand For Humanised Animal Models Globally Driving Market Growth

More and more biomedical research applications use humanized mice as test subjects. Professors at Yale University and the Jackson Laboratory (U.S.) were awarded a three-year grant for US$1.5 million in September 2017 to conduct advanced research on humanized MISTRG models for understanding the biology of human melanoma and identifying therapeutic targets. The Connecticut Bioscience Innovation Fund awarded the Jackson Laboratory and Yale University (U.S.) a grant for USD 700,000 in November 2018. (CBIF). This award supported scientific collaboration to create humanized mouse models that correctly reflect how people react to disease and cancer treatments. During the forecast period, the usage and creation of humanized animal models will increase due to the necessity of determining the actual effects of medications on humans and investigating human-specific illnesses, therapies, and immune responses.

Genetic Toxicology Testing Market: Restraints

Insufficient Verified in Vitro Models for Complex Endpoint Research to Hamper Market Growth

Given that human proteins and antibodies make over half of the novel medications created, autoimmune disease and immunological activation are crucial endpoints for drug development. These medicinal compounds can only yet be tested in animal models. Using in vitro genetic testing techniques does not permit the assessment of the memory response induced within a body following secondary infection. These techniques can't assess how well a body recovers in response to short-term versus long-term immunosuppression. Additionally, they cannot assess the therapeutic compounds' harmful effects on lymphoid architecture, such as lymph nodes, which may result in faulty cellular interactions that impair immune response. Contrary to T-dependent antibody sheep red blood cells (SRBC) in animals, there aren't any efficient methods for producing antibodies in vitro using human cells. Researchers currently rely on animal experiments to identify autoimmunity and immune stimulation brought on by recently produced medications because there aren't any reliable in vitro human models available.

Genetic Toxicology Testing Market: Segment Overview

In Vitro dominates market due to its increasing Use of Animals in Toxicology Testing

The in vitro category had the largest revenue share, and it is anticipated that it will continue to grow steadily over the expected period. The interest in the mechanical in vitro testing approach has increased due to ethical, scientific, and budgetary issues with using animals in toxicological research. For instance, in November 2021, a research team evaluated a genotoxicity testing strategy 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. At the same time, the organization offers alternate methods such as an in vitro test coupled with the cytogenetic assessment of chromosomal damage using mammalian cells or an in vitro test along with the mouse lymphoma thymidine kinase+/- gene mutation assay. According to the organization, some substances for which in vivo studies do not provide useful information. In these circumstances, in vitro testing is seen as appropriate. Therefore, in vitro tests are increasingly preferred by researchers due to the drawbacks of in vivo tests.

With Increased Extensive Use of Genotoxicity Testing, Pharmaceutical & Biotechnology Category Dominated Market

The pharmaceutical and biotechnology sector accounted for the biggest revenue share. One of the driving forces behind the rise is the extensive use of genotoxicity testing in drug research and development. While Takeda, Pfizer, Roche, and BMS collectively account for just 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 research by Pharma Intelligence U.K. Limited.

Genetic Toxicology Testing Market: Regional Landscape

North America to Dominate market due to Growing Rising Medication Development

Over the forecast period, it is anticipated that the North American market will account for the largest revenue share. The significant market share of this industry sector can be due to the growth of structure-based drug designs, rising financing for life sciences research, high R&D costs in the biopharmaceutical industry, and the burgeoning uptake of cutting-edge technologies in North America. The dominance in the region can be due to rising medication development and significant pipeline spending. Additionally, important regional actors make genotoxicology testing more accessible for local pharmaceutical and biotech firms. Another important aspect of the substantial share of this market segment is the existence of numerous international competitors in this area. Most clinics and hospitals have restricted in-person delivery of optional medical services, such as genetic counseling, to reduce the spread of coronavirus, according to the Centers for Disease Control and Prevention (CDC). Delaying genetic counseling, however, might provide challenges because delaying genetic testing could impact decisions made regarding cancer treatment or during pregnancy. As a result, even though the ongoing epidemic has slowed the market under study, things should eventually get better.

Global Genetic Toxicology Testing Market: Competitive Landscape

In July 2022, Inotiv Inc. increased its ability to carry out the in-vitro cytogenetics and bacterial assays of genetic toxicity investigations necessary to create innovative treatments. Moreover, in July 2021, Inotiv Inc. announced the completion of the acquisition of MilliporeSigma's BioReliance's key assets for genetic toxicology, including stock cultures, client lists, operational manuals, and historical control data. The contract research company thinks this acquisition will help them provide their clients with comprehensive solutions for human clinical studies.

Few of the Genetic Toxicology Testing Market players include Gentronix Ltd.; Inotiv Inc.; Thermo Fisher Scientific, Inc.; Laboratory Corp of America Holdings; Charles River Laboratories International; Jubilant Life Sciences Limited; Eurofins Scientific; Syngene International Limited; Creative Bioarray; M.B. Research Laboratories.

Regional Classification of the Global Genetic Toxicology Testing Market is Described Below:

North America

  • U.S.
  • Canada


  • Germany
  • France
  • Spain
  • U.K.
  • Italy
  • Russia
  • Rest of Europe

Asia Pacific

  • China
  • Japan
  • India
  • Southeast Asia
  • Rest of Asia Pacific

Latin America

  • Brazil
  • Mexico
  • Rest of Latin America

Middle East and Africa

  • GCC
  • South Africa
  • Rest of Middle East and Africa

*Regions and countries are subject to change based on data availability

Key Elements Included In The Study: Global Genetic Toxicology Testing Market

  • Genetic Toxicology Testing Market by Product/Technology/Grade, Application/End-user, and Region
  • Executive Summary (Opportunity Analysis and Key Trends)
  • Historical Market Size and Estimates, Value, 2018 - 2022
  • Market Value at Regional and Country Level, 2023 - 2030
  • Market Dynamics and Economic Overview
  • Market Size in Value, Growth Rates, and Forecast Figures, 2023 - 2030
  • Competitive Intelligence with Financials, Key Developments, and Portfolio of Leading Companies 
  • Regional and Product/Grade/Application/End-user Price Trends Analysis
  • Value Chain and Five Force’s Analysis
  • Regional/Sub-region/Country Market Size and Trend Analysis
  • Company Market Share Analysis and Key Player Profiles

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