Most drugs fail to make it to market no matter what
Adrian Rubinstein ’23, November 29, CEO of Ax3.Bio, “Redefining drug development: the trailblazing evolution of the pharmaceutical industry,” LABIOTECH, accessed July 16, 2024, https://www.labiotech.eu/opinion/evolution-drug-discovery-through-innovation/
Drug discovery and development is a long, costly, and high-risk process that takes over 10 to 15 years with an average cost of over $1 to $2 billion for each new drug to be approved for clinical use.
For any pharmaceutical company or academic institution, it is a big achievement to advance a drug candidate to phase 1 clinical trials after drug candidates are rigorously optimized at the preclinical stage. However, nine out of ten drug candidates would fail during phase 1, 2, 3 clinical trials and drug approval.
It is also worth noting that the 90% failure rate is for the drug candidates that are already advanced to phase 1 clinical trials, which does not include the drug candidates in the preclinical stages. If drug candidates in the preclinical stage are also counted, the failure rate of drug discovery/development is even higher than 90%. The concept we use for this low efficiency in drug development is called Eroom´s Law.