Early Toxicology: Markets and Approaches

Abstract

Toxicity is a crucial parameter that is measured throughout the drug development process. Toxic side-effects are one of the most common reasons drug candidates fail. Toxicity can be a factor of dose, the form in which the drug is administered, and the time of exposure before elimination. Patient responses also differ widely, depending on their age and metabolism and other products in the patient' s system may augment the effect of the drug.

Just twenty years ago, toxicology was something that was measured after a drug was developed. Traditional studies were performed in-vivo with animals, and required 20 to 100 grams of the candidate compound for a single set of evaluations. Intake of the compound was measured, and a series of toxicity tests were performed, including LD 50 and histological examinations of target organs. These tox tests were expensive, time-consuming and were only performed on drug candidates that had already passed all other criteria to become successful drugs. These studies were high information, but low throughput estimates of a candidate drug' s toxicology. Failures were common, and expensive. The goal was to find approaches that would predict toxicology at an earlier stage, and with less cost.

Various in vivo, in vitro, and in silico approaches have been evolving ever since. The objective of this report is to focus the reader' s attention on the issues and opportunities related to early tox testing in drug discovery, including:

• quantification of the current and future markets for various segments and subsegments,
• discussion of various big pharma approaches to early toxicology testing,
• review of the emerging tools and techniques,
• the views of interviewed experts in the field, and
• a landscape of competitors and their product and service offerings.

The report begins with an overview of drug discovery, ADMET, and early tox testing. It continues with some of the ways big pharmas deal with early tox. The next four chapters deal with the markets for in-silico, in-vitro, and in-vivo early tox products, and with the suppliers of early tox services. Product, company and market information are provided in each of these chapters. Opinions of the experts on basic issues are provided in Chapter Seven. The report concludes with profiles of 30 representative suppliers, the products they provide and their approach to the market.

For the purposes of reporting market size and growth forecasts, the report segments the market into the following:

• In Silico Approaches
  • Databases
  • Data Mining Tools
  • Modeling
• In Vitro Assays and Platforms
  • Biochemical Assays
  • Cellular Assays
  • Instruments & Platforms
• In Vivo Testing
  • Mice & Traditional Animals
  • Zebrafish Models
  • Other Animals
  • Human Microdosing
• Early Tox Services
  • In Silico Services
  • In Vitro Services
  • In Vivo Services