The process of developing new drugs is complex and long-term. On average it takes up to 12-15 years from identification of a potential drug candidate to obtaining regulatory approval and its launching on the market. During that period basic, preclinical and clinical trials are conducted.
New drug research and development requires science base, technology, planning and organization of subsequent steps of that process as well as a major investment of capital increasing every year. Currently it costs more than 1 billion USD to launch a new drug.
The main reasons of continuously increasing costs are as follows:
- Increasing regulatory requirements
- Increasing number of subjects that need to be enrolled into clinical trials
- Necessity to conduct numerous research and diagnostic procedures
- Increasing costs of subconstructors’ services
- Development of drugs used for treatment of chronic and degenerative diseases
- Low efficacy of research and development process
Only a few evaluated compounds go through a difficult process of tests and trials in order to finally achieve the status of a drug.