Britannica
Sources used in this answer
- pharmaceutical industry - Drug development process
- translational medicine
- pharmaceutical industry - Drug approval processes
- pharmaceutical industry - Pharmacokinetic investigation
- pharmaceutical industry - Research and discovery
- Prescription drug costs - Con 1: Regulation of drug prices reduces the revenue needed for the research and development of new drugs
- pharmaceutical industry - Drug patents
Why can drug discovery and development take 10 to 15 years?
Created from Britannica articles
using AI.
AI can make mistakes, so verify using Britannica articles.
drug
Docking of the anticancer drug Gleevec (imatinib) in the abl domain of the bcr-abl tyrosine kinase. Abnormalities in bcr-abl stimulate the continuous proliferation of bone marrow stem cells, causing an increase in myelogenous cells (granulocytes and macrophages) in the body and leading to chronic myelogenous leukemia (CML).
The drug discovery and development process is a lengthy, complex, and costly endeavor that typically spans 10 to 15 years from initial discovery to market approval. This extended timeline is driven by several rigorous requirements:1
- Extensive Screening: Scientists must screen between 5,000 and 10,000 chemical compounds to identify a single drug that is safe and effective for human use.1
- Rigorous Testing: Only a small fraction of these compounds proceed to preclinical and clinical testing. These trials are essential to evaluate safety, efficacy, and pharmacokinetics—the study of how a drug is absorbed, distributed, metabolized, and excreted by the body.12
- Regulatory Hurdles: Regulatory agencies require comprehensive premarketing studies to ensure a favorable risk-to-benefit ratio. Because every new drug is unique, unforeseen safety or efficacy issues often arise, necessitating additional studies that further prolong the process.3
- Complexity of Modern Agents: The development of sophisticated biotechnology products, such as those involving genetic modification, adds layers of complexity to safety and efficacy evaluations, making standardization difficult.4
Ultimately, this process is designed to ensure that only safe and effective medications reach the public.3