Abstract:

The relevance of the study is due to the fact that there is a tendency to increase the cost of developing new drugs substances in the pharmaceutical industry. Major players of the global pharmaceutical market, such as “Pfizer”, “Bristol-Myers Squibb”, “Eli Lilly”, etc., direct millions of dollars to find innovative drug substances. Many of the original drugs substances, which brought huge profits to manufacturers, have lost or will lose patent protection in the coming years. At the same time, the state rules for registration of medicines are being tightened, and the efficiency of R & D is decreasing in the pharmaceutical industry.  The purpose of the study is to identify the challenges faced by pharmaceutical companies involved in pharmaceutical development. The authors used the following scientific methods: content analysis method, inductive and deductive methods, system approach, syncretic method, complex approach. The study analyzed the global R & D costs in the pharmaceutical industry, the structure of drug substance development costs, identified the role of pharmaceutical development in the life cycle of the drug product, analyzed the methodology for pharmaceutical development and approaches to it.  As a result, the challenges faced by pharmaceutical companies engaged in pharmaceutical development have been identified.