Global Market Outlook on In-Vivo Toxicology Testing 

The global pre-clinical toxicology market size is estimated at $4.4-4.5 billion in 2017, with a CAGR of about 6.5-7% percent. The current outsourcing penetration for toxicology services is over 50 percent, and will increase by ~2–3 percent annually, over the next five years. The market is dominated by a few service providers like Charles River Laboratories, Covance, Envigo, MPI research, etc

in-vivo-toxicology-testing-market-size

Pre-clinical Toxicology Industry Trends

Increased protest against animals used in pharma research have led to numerous technologies offering alternatives to animal  testing. Also, regulatory compliances mandate that service providers restrict the number of in-vivo models, through the  application of the 3R principle

3R Principle

  • CROs are now embedding the 3R (Replace, Refine and Reduce) principle, in order to reduce the number of animals used for toxicology studies
  • On an average, large pharma companies have reduced 20–30 percent of the animals used for research between 2013 and 2016

Agrochemical Industry Demand

  • Toxicology testing demand is expected to grow at 4–5 percent for the next five years. This growth will be driven by demand for chemicals, in order to increase crop yields; prompted by the growing global population and limited land for agriculture
  • The recurring need for testing services, due to the regulatory requirement for re-registration every 10 years, for agro-chemicals is already on the market
  • REACH initiative testing backlog, and an anticipated future testing is expected to create significant demand through 2025

Pricing

  • Pricing for safety testing has improved in 2016–2017 by 2-3 percent, compared to 2012–2015, when the pricing remained stagnant
  • Prices are not expected to improve further in 2017, as capacity utilization has not reached the optimal level (85 percent)

Alternatives

  • Organovo concluded collaboration agreements with L’Oréal, USA; and Merck in 2015, and launched the world’s first commercially available 3D printed human tissue that has the potential to replace anima testing 
  • Similarly, BASF and Sumitomo have teamed up to develop an in-vitro alternative to animal based chemical testing in 2015
  • Cyprotex (the largest in-vitro and in-silico tox CRO in the world) launched its new in-silico modelling solution, ChemTox, which predicts genotoxicity and rat LD50 directly from the chemical structure. LD50 is a commonly determined parameter in pre-clinical toxicity studies, representing the dose that causes death in 50 percent of the test group. Using models such as those in ChemTox, to predict this parameter, will have obvious ethical benefits in reducing animal toxicity testing
  • Canadian Centre for Alternatives to Animal Methods (CCAAM) opened in October 2017. The centre will carry out multidisciplinary basic research making use of human biological samples rather than conducting in vivo or in vitro tests using animals or animal cell

Engagement Model: Adoption Rate

Strategic deals involving lift-out in preclinical toxicology services by the pharmaceutical companies would increase, in contrast to the current scenario, where the widely adopted (45 percent) engagement model is project by project, as it would help in reducing their fixed cost by shutting down or transferring the toxicology facilities that are under-utilized

Engagement Model Adoption: 2016 

  • Majority of the suppliers (small Biotech) were adopting the project by project model, as the volume of work is not large and this helps to establish a relationship before engaging into a strategic partnership
  •  Adoption of strategic partnerships have increased from 17 percent in 2012 to over 30 percent in 2015–2016
  • Currently, Charles River earns more than 30 percent of its revenues from strategic relationships (25 percent in 2014)