How long can the discovery and development of a new drug take?

The discovery and development of a new drug is a complex, multi-stage process that can take 10 to 15 years from initial discovery to marketing.1

This extensive timeline is due to the rigorous scientific and regulatory requirements necessary to ensure patient safety and drug efficacy. The process generally involves the following stages:

• Laboratory Screening: Researchers must screen 5,000 to 10,000 chemical compounds to identify potential candidates.1
• Preclinical Testing: Approximately 250 of those compounds typically enter preclinical testing.1
• Clinical Trials: Only about 5 compounds reach the stage of clinical trials in humans. These trials are conducted in sequential phases (Phase 1, 2, and 3) to evaluate safety, dosage, and effectiveness before a drug can be approved for general use by regulatory agencies like the FDA.123

Because this process is so lengthy and resource-intensive, governments grant patents to pharmaceutical firms, allowing them to market the drug exclusively for a period to recover development costs.4