Early Toxicity Testing Market by Technique, Assay, Application, and End User - Global Industry Analysis and Forecast to 2025

Report Code : HC06109

Toxicology testing is assessment of degree by which toxic substances can damage living organisms. Toxicological studies are conducted to determine toxicity of final product such as pesticides, certain food additives, cosmetics and other chemical substances. Toxicological studies are necessary to provide basis for regulation of substances that humans and other living things may come in contact intentionally or unintentionally. Toxicological studies are conducted either in vitro or in vivo. Cell, tissue and organ cultures are used in highly controlled toxicity tests which are often less expensive than traditional tests. These cell and tissue cultures provide a good screening mechanism and can reduce number of animals used for toxicology screening. In vitro toxicity testing is analysis of effect of toxic chemical substances on cultured mammalian cells or bacteria whereas in vivo toxicological studies involve use of laboratory animals for safety assessment of drugs or chemicals.

Early toxicity testing is employed for broad range of testing application such as dermal toxicity to highly complex genotoxicity. Genetic toxicity assessment is used to identify alterations in genes, chromosomes and DNA sequencing by using either whole plant and animals or cultured bacterial cells. Comet assays is one of the widely used test for genotoxicity due to ability to detect low levels of DNA damage, requires small sample and display quick results. The technique involves lysing of cells by use of highly concentrated detergents or salts thereby releasing DNA, which is then electrophoresed under neutral pH conditions. In addition, early toxicity testing is also employed in carcinogenicity, neurotoxicity and organ toxicity to screen large number of harmful chemicals.

Increase in demand for early toxicity testing, technological advancements and increasing investment in research and developments activities to develop new cell assays methods is expected to propel growth of the market. In addition, advancements in biotechnology and bioinformatics techniques for developing toxicology database for cell based analysis will drive the market. Furthermore, increasing government focus towards biotech sector coupled with availability of advanced automated laboratories is expected to play significant role in growth of the market. However, dearth of awareness about importance of early toxicology testing and stringent government regulations and guidelines regarding use of live cell cultures and animals for testing will hamper growth of the market.

The major players operating in this industry include Agilent Technologies Inc., Quest Diagnostics Incorporation, Charles River Laboratories International Incorporation, Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., Becton, Dickinson and Company, Danaher Corporation and The Jackson Laboratory. These players are focusing on developing new enhanced cell based assays and animal models to gain strategic edge over other players by acquiring larger market share. For instance in April 2016, The Jackson Laboratory had launched innovative and cost effective Humanized NSG- SGM3 mice to stimulate trials, evaluate drugs and to produce predictive data. This mice allow superior development of myeloid and CD4-T cells thereby enabling more accurate representation of human immune system.

Recent years have witnessed shift from animal based testing to in silico method of toxicology screening. Innovations such as automated assays to screen large number of substances having similar properties to assess toxic effect of substances and rapid advancements in biotechnology and pharmaceutical industry will provide ample growth opportunities for market players. For instance in April 2017, Emulate, Inc., has developed organ-on-chips technology for toxicology testing for wide range of products. In silico studies performed via computer stimulation will open up new avenues for predicting toxicity of substances. Furthermore, development of 3D human cells and artificial organs resembling close in vivo function will revolutionize early toxicology testing market.

Early Toxicity Testing Market Segmentation:

By Technique:

  • In vitro
  • In vivo

By Assay

  • Receptor Binding Assays
  • Bacterial Toxicity Assays
  • Tissues Culture Assays
  • Enzyme Toxicity Assays
  • Cell-Based ELISA and Western Blots
  • Other Assays

By Application

  • Systemic Toxicity
  • Ocular Toxicity
  • Dermal Toxicity
  • Genotoxicity
  • Carcinogenicity
  • Organ Toxicity
  • Skin Sensitization and Irritation
  • Neurotoxicity
  • In silico
  • Other Toxicity Endpoints and Tests

By End User

  • Diagnostics industry
  • Chemicals industry
  • Food industry
  • Cosmetics industry
  • Pharmaceuticals industry
  • Other industries

By Region

  • North America
  • U.S
  • Canada
  • Mexico
  • Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe
  • Asia-Pacific
  • Japan
  • China
  • Australia
  • India
  • South Korea
  • Rest of Asia-Pacific
  • Rest of the World
  • Brazil
  • South Africa
  • Saudi Arabia
  • Turkey
  • United Arab Emirates
  • Others

Research Methodology

We use both primary as well as secondary research for our market surveys, estimates and for developing forecast. Our research process commence by analyzing the problem which enable us to design the scope for our research study. Our research process is uniquely designed with enough flexibility to adjust according to changing nature of products and markets, while retaining core element to ensure reliability and accuracy in research findings. We understand both macro and micro-economic factors to evaluate and forecast different market segments.

Data Mining

Data is extensively collected through various secondary sources such as annual reports, investor presentations, SEC filings, and other corporate publications. We also refer trade magazines, technical journals, paid databases such as Factiva and Bloomberg, industry trade journals, scientific journals, and social media data to understand market dynamics and industry trends. Further, we also conduct primary research to understand market drivers, restraints, opportunities, challenges, and competitive scenario to build our analysis.

Data Collection Matrix

Data Collection Matrix

Supply Side

Demand Side

Primary Data Sources

  • Manufacturers
  • Distributors & Wholesalers
  • GPOs
  • Physicians/Specialist
  • Healthcare Providers
  • Consumers

Secondary Data Sources

  • Annual Reports/SEC Filings/ Investor Presentations/ Press Releases
  • Government/Associations Publications
  • Case Studies
  • Reference Customers


Market Modeling and Forecasting

We use epidemiology and capital equipment-based models to forecast market size of different segments at country and regional level.

  • Epidemiology-based Forecasting Model: This method uses epidemiology data gathered through various publications and from physicians to estimate population of patients, flow of treatment of individual disease and therapies. The data collected through this method includes statics on incidence of disease, population suffering from disease, and treatment population. This method is used to understand:
  • Number of patients for particular device or medical procedure and
  • Repeated use of particular device depending on health and condition of patient
  • Capital-based Forecasting Model: This method of forecasting is based on number of replacements, installed-based and new sales of capital equipment used in various healthcare and diagnostic centers. These three parameters are calculated and forecast is developed. Installation base is calculated as average number of units per facility; while sales for particular year is calculated from number of new and replace units. Secondary data is collected through various supply chain intermediaries and opinion leaders to arrive at installation and sales rate. These techniques help our analysts in validating market and developed market estimates and forecast.

We do forecast on basis of several parameters such as market drivers, market opportunities, industry trends government regulations, raw materials supply and trade dynamics to ensure relevance of forecast with market scenario. With increasing need to granulized information, we used bottom-up methodology for forecasting where we evaluate each regional segment differently and combined all forecast to develop final market forecast.

Data Validation

We believe primary research is a very important tool in analyzing and forecasting different markets. In order to make sure accuracy of our findings, our team conducts primary interviews at every stage of research to gain deep insights into current business environment and future trends and key developments in market. This includes use of various methods such as telephonic interviews, focus groups, face to face interviews and questionnaires to validate our research from all aspects. We validate our data through primary research from key industry leaders such as CEO, product managers, marketing managers, suppliers, distributors, and consumers are frequently interviewed. These interviews provide valuable insights which help us to have better market understanding besides validating our estimates and forecast.

Data Triangulation

Industry Analysis

Qualitative Data

Quantitative Data (2017-2025)

  • Market Dynamics (Drivers, Restraints, and Challenges)
  • Industry Trend Analysis
  • Market Opportunities
  • Government Policies and Regulations, Patent Analysis, and Reimbursement Policies
  • Porter’s Five Forces and PESTLE Analysis
  • Key Developments and Competitive Landscape
  • Market Assessment and Forecast
  • Market Assessment and Forecast, By Product
  • Market Assessment and Forecast, By Technology
  • Market Assessment and Forecast, By Application
  • Market Assessment and Forecast, By End User
  • Market Assessment and Forecast, By Region/Country

License Type

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