In-vitro Toxicology Testing Market

  • In-vitro toxicology holds ~30 percent share in the overall toxicology testing market (rest being in-vivo testing)
  • The global market value for in-vitro toxicity testing was $3.5 billion in 2017. That value is anticipated to reach $5.1 billion in 2020, as it increases at a five-year CAGR of 15.4 percent
  • North America accounted for the largest share of over 40 percent revenue in 2016, followed by Europe with 30 percent market share


  • Demand for genetic toxicity testing is on the rise, largely due to the upcoming 2018 deadline for the registration of small-volume substances, as required by the REACH regulation and the need for additional testing for previously registered substances
  • Cosmetics & parmaceutical industry segment accounted for the largest share of the global in Vitro toxicology testing market in 2017
  • There is particular concern about capacity for complex Genotoxicity studies, such as the Extended One-generation Reproductive Toxicity Study (EOGRTS) and higher-tier Ecotoxicity testing, as there are a limited number of CROs capable of performing them

In-vitro Toxicology Tests at Pharma Companies

  • Around 99 percent of usage is seen in the three main areas, namely ADME, safety pharmacology, and genotoxicity
  • Overall, a large and steady increase in the use of in-vitro tests was observed for both pharmaceutical companies and CROs since 2000
  • There was a large difference in the total number of compounds between pharmaceutical companies and CROs, with pharmaceutical companies peaking at over 180,000 and CROs peaking at over 500 tests per annum

Growth Drivers and Constraints


  • Opposition to animal testing in drug development
  • Increasing R&D to detect toxicity at early stages. Investigative toxicology group that de-risks findings observed in non-clinical studies
  • Novel and promising technologies in analytical laboratories
  • Rapid up gradation of databases that serve information for toxicity profiling and lethal dose determination of different compounds
  • Multiple regulatory endpoint verifications
  • Increase in demand for in-vitro models as compared to in-vivo models
  • Increased global illicit drug abusers
  • Enhanced efficiency of IVTT in cancer diagnosis


  • Predictive ability of the tests, stringent regulatory framework, and the inability of in-vitro models to detect certain anomalies are the major challenges faced by the market
  • Inability of in-vitro models to detect autoimmunity and immunostimulation
  • Despite the growing popularity of outsourcing, in-house ADME-Toxicology testing still accounts for four-fifth of the industry’s total expenditure
  • There are also some in-vivo tests, for which, no in-vitro alternatives have yet been developed that exhibit acceptable predictability, such as for complex toxicological endpoints

Pricing Models

  • The pricing model adoption rate for in-vitro services varies with the geographies, due to the variation in engagement terms, as well as the type and duration of the project outsourced
  • The pricing model adoption rate for discovery research biology services remains similar across the geographies, as the outsourcing of services in this category is still in nascent stages
  • Presently, FFS is the preferred model, but with increased outsourcing penetration and greater volume of work, it would shift to FTE, as it offers more flexibility, visibility of spend, and cost savings