The global genetic toxicology testing Market size was estimated to be USD 1.83 billion in 2023 and is expected to reach USD 6.16 billion by 2034 with a CAGR of 11.66% during the forecast period 2024-2034. The market is expected to rise due to rising genetic disease incidence, advancements in genetic toxicology testing technologies, increased R&D activities, strategic collaborations, and a focus on personalized therapy.
Strategic collaborations are a significant driver in the global genetic toxicology testing market, as they enhance access to advanced testing technologies and improve patient outcomes. A notable example of this is the partnership formed in May 2023 between Thermo Fisher Scientific, Inc. and Pfizer. This collaboration aims to enhance local access to next-generation sequencing for lung and breast cancer. By providing faster and more precise testing, the partnership seeks to facilitate tailored treatments in regions where advanced diagnostics were previously limited. Such initiatives not only boost the availability of genetic toxicology testing but also foster innovation and improve the overall quality of healthcare, ultimately contributing to the growth of the market.
By product, the service segment accounted for the highest revenue-grossing segment in the global genetic toxicology testing market in 2023 owing to the increasing demand for specialized testing services, technological advancements, and the growing emphasis on regulatory compliance in pharmaceutical and environmental sectors. For instance, in April 2023, Nelson Labs gained Accreditation Scheme for Conformity Assessment (ASCA) Accreditation from the United States Food and Drug Administration, bolstering the company's confidence in providing safe genotoxicity testing. Additionally, the reagents & consumables segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising demand for high-quality testing materials, advancements in diagnostic technologies, and the increasing focus on research and development activities in genetic toxicology.
By type, the in vitro segment accounted for the highest revenue-grossing segment in the global genetic toxicology testing market in 2023 owing to the advantages of reduced costs, improved accuracy, and the ability to provide rapid results compared to traditional in vivo testing methods. For instance, in July 2023, Toxys announced a training workshop for the ToxTracker® genotoxicity assay. The workshop will take place in October 2023 in Oegstgeest, the Netherlands. Additionally, the in vivo segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing focus on comprehensive safety assessments and the growing demand for testing in real biological systems to better evaluate the effects of substances on living organisms.
By assay, the comet assay segment accounted for the highest revenue-grossing segment in the global genetic toxicology testing market in 2023 owing to the its sensitivity in detecting DNA damage, ease of use, and widespread acceptance in regulatory testing protocols. For instance, MilliporeSigma, a subsidiary of Merck KGaA, has created a first-of-its-kind "all-in-one" CHO genetic stability assay, according to an April 16 announcement. According to the company, the Aptegra platform reduces biosafety testing time by two-thirds, speeding up the commercialization process for biotech and pharma companies. Additionally, the genetic mutation test segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing prevalence of genetic disorders, advancements in genetic testing technologies, and the rising demand for personalized medicine.
By end-user, the pharmaceutical and biotechnology segment accounted for the highest revenue-grossing segment in the global genetic toxicology testing market in 2023 owing to the robust investment in drug development, stringent regulatory requirements, and the need for comprehensive safety evaluations of new therapeutics. For instance, in June 2023, the National Cancer Institute (NCI) initiated a significant precision medicine cancer effort to investigate the efficacy of treating adults and children with new medication combinations that target specific tumor changes. The Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH) is the largest program of its type to explore cancer medication combinations based on tumor biology. Additionally, the food industry segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing demand for food safety, rising consumer awareness of genetically modified organisms (GMOs), and stringent regulatory standards for food testing.
North American region is anticipated to have the highest revenue share during the forecast period owing to the presence of leading pharmaceutical companies, advanced healthcare infrastructure, and stringent regulatory frameworks for genetic toxicology testing. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to increasing investment in biotechnology and pharmaceuticals, a growing emphasis on research and development, and rising awareness of genetic toxicology among regulatory bodies and consumers. In April 2023, Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) approved QALSODY™ (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults with a mutation in the superoxide dismutase 1 gene. This indication has been granted accelerated approval based on a reduction in plasma neurofilament light chain (NfL) levels reported in patients treated with QALSODY. Continued approval for this indication may be predicated on clinical benefit being demonstrated in confirmatory trials.1 Tofersen's Phase 3 ATLAS study in persons with presymptomatic SOD1-ALS will serve as the confirmatory trial.
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
Strategic collaborations are a significant driver in the global genetic toxicology testing market, as they enhance access to advanced testing technologies and improve patient outcomes. A notable example of this is the partnership formed in May 2023 between Thermo Fisher Scientific, Inc. and Pfizer. This collaboration aims to enhance local access to next-generation sequencing for lung and breast cancer. By providing faster and more precise testing, the partnership seeks to facilitate tailored treatments in regions where advanced diagnostics were previously limited. Such initiatives not only boost the availability of genetic toxicology testing but also foster innovation and improve the overall quality of healthcare, ultimately contributing to the growth of the market.
By product, the service segment accounted for the highest revenue-grossing segment in the global genetic toxicology testing market in 2023 owing to the increasing demand for specialized testing services, technological advancements, and the growing emphasis on regulatory compliance in pharmaceutical and environmental sectors. For instance, in April 2023, Nelson Labs gained Accreditation Scheme for Conformity Assessment (ASCA) Accreditation from the United States Food and Drug Administration, bolstering the company's confidence in providing safe genotoxicity testing. Additionally, the reagents & consumables segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising demand for high-quality testing materials, advancements in diagnostic technologies, and the increasing focus on research and development activities in genetic toxicology.
By type, the in vitro segment accounted for the highest revenue-grossing segment in the global genetic toxicology testing market in 2023 owing to the advantages of reduced costs, improved accuracy, and the ability to provide rapid results compared to traditional in vivo testing methods. For instance, in July 2023, Toxys announced a training workshop for the ToxTracker® genotoxicity assay. The workshop will take place in October 2023 in Oegstgeest, the Netherlands. Additionally, the in vivo segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing focus on comprehensive safety assessments and the growing demand for testing in real biological systems to better evaluate the effects of substances on living organisms.
By assay, the comet assay segment accounted for the highest revenue-grossing segment in the global genetic toxicology testing market in 2023 owing to the its sensitivity in detecting DNA damage, ease of use, and widespread acceptance in regulatory testing protocols. For instance, MilliporeSigma, a subsidiary of Merck KGaA, has created a first-of-its-kind "all-in-one" CHO genetic stability assay, according to an April 16 announcement. According to the company, the Aptegra platform reduces biosafety testing time by two-thirds, speeding up the commercialization process for biotech and pharma companies. Additionally, the genetic mutation test segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing prevalence of genetic disorders, advancements in genetic testing technologies, and the rising demand for personalized medicine.
By end-user, the pharmaceutical and biotechnology segment accounted for the highest revenue-grossing segment in the global genetic toxicology testing market in 2023 owing to the robust investment in drug development, stringent regulatory requirements, and the need for comprehensive safety evaluations of new therapeutics. For instance, in June 2023, the National Cancer Institute (NCI) initiated a significant precision medicine cancer effort to investigate the efficacy of treating adults and children with new medication combinations that target specific tumor changes. The Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH) is the largest program of its type to explore cancer medication combinations based on tumor biology. Additionally, the food industry segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing demand for food safety, rising consumer awareness of genetically modified organisms (GMOs), and stringent regulatory standards for food testing.
North American region is anticipated to have the highest revenue share during the forecast period owing to the presence of leading pharmaceutical companies, advanced healthcare infrastructure, and stringent regulatory frameworks for genetic toxicology testing. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to increasing investment in biotechnology and pharmaceuticals, a growing emphasis on research and development, and rising awareness of genetic toxicology among regulatory bodies and consumers. In April 2023, Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) approved QALSODY™ (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults with a mutation in the superoxide dismutase 1 gene. This indication has been granted accelerated approval based on a reduction in plasma neurofilament light chain (NfL) levels reported in patients treated with QALSODY. Continued approval for this indication may be predicated on clinical benefit being demonstrated in confirmatory trials.1 Tofersen's Phase 3 ATLAS study in persons with presymptomatic SOD1-ALS will serve as the confirmatory trial.
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
Report Scope:
- Base Year: 2023
- Forecast Period: 2024-2034
- Study Coverage
- Market Forecast by Product, Type, Assay, and End-User
- Market Forecast for 5 Regions and 17+ Countries
- North America (U.S. and Canada)
- Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
- Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
- Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
- MEA (South Africa, GCC, Rest of MEA)
- Exhaustive Company Profiles of the Top 10+ Major Market Players
- 20% Free Customization Available to Meet Your Exact Requirement.
Segmentation: Genetic Toxicology Testing Market Report 2023 - 2034
Genetic Toxicology Testing Market Analysis & Forecast by Product 2023 - 2034 (Revenue USD Bn)
- Reagents & Consumables
- Assays Kit
- Services
Genetic Toxicology Testing Market Analysis & Forecast by Type 2023 - 2034 (Revenue USD Bn)
- In Vitro
- In Vivo
Genetic Toxicology Testing Market Analysis & Forecast by Assay 2023 - 2034 (Revenue USD Bn)
- Comet Assay
- Micronucleus Assay
- Chromosomal Aberration Test
- Genetic Mutation Test
- Others
Genetic Toxicology Testing Market Analysis & Forecast by End-User 2023 - 2034 (Revenue USD Bn)
- Pharmaceutical & Biotechnology
- Food Industry
- Cosmetics Industry
- Other
Genetic Toxicology Testing Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Genetic Toxicology Testing Market: Product Estimates & Trend Analysis
8. Genetic Toxicology Testing Market: Type Estimates & Trend Analysis
9. Genetic Toxicology Testing Market: Assay Estimates & Trend Analysis
10. Genetic Toxicology Testing Market: End-User Estimates & Trend Analysis
11. Regional Market Analysis
12. North America Genetic Toxicology Testing Market
13. Europe Global Genetic Toxicology Testing Market
14. Asia Pacific Global Genetic Toxicology Testing Market
15. Latin America Global Genetic Toxicology Testing Market
16. MEA Global Genetic Toxicology Testing Market
17. Competitor Analysis
18. Company Profiles
Companies Mentioned
- Thermo Fisher Scientific Inc.
- Covance Inc. (LabCorp)
- Charles River Laboratories
- Eurofins Scientific
- SGS S.A.
- Pacific BioLabs
- BioReliance (Merck KGaA)
- Genetic Toxicology Testing Services (GTT)
- Intertek Group plc
- Q2 Solutions
- BioAgilytix Labs
- Envigo
- WuXi AppTec
- Molecular Toxicology Inc.
- Nutritional Research Institute.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | December 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 1.83 Billion |
| Forecasted Market Value ( USD | $ 6.16 Billion |
| Compound Annual Growth Rate | 11.6% |
| Regions Covered | Global |
| No. of Companies Mentioned | 15 |
