Introduction

Drug development from initial discovery of a promising target to the final medication, is characterized by a high degree of scientific, regulatory and economic risk. Colossal amounts of time, effort, and money are invested in the research and development process to bring a new medicine to the market. In fact, it takes an average of 10 to 15 years to bring a drug from discovery to approval, and for every 5,000-10,000 compounds investigated; only one is approved and marketed.

Figure 1: Current time-scale of drug approval processes.

Studies have estimated that the cost of bringing a single new drug to market is in excess of US $800million., Other health economists estimate that the current cost of drug development is now between US$1.3 billion to $1.7 billion., However, an updated cost per NCE (New chemical entity) has been recently calculated taking annual inflation, toughening regulatory demands and the decline in success rates into account. It has been proposed that the earlier cost estimate of drug development of $802M has risen to the astronomical level of $3.9Bn after adjustment. In addition, it is important to note that this does not represent the entire cost as the expenditure for marketing is omitted from these figures. However, the costs have been questioned as it is claimed it is in the best interests of drug companies to overstate costs since they often lobby governments to loosen price regulations and increase patent protection. The surging costs of clinical trials can be attributed to a variety of factors. Firstly, for diseases for which society is facing a high degree of unmet medical need, the industry face a large amount of challenge and pressure to find efficient treatments. The increasing focus on complex deceases, (Alzheimer’s, obesity, diabetes) has led to the design of highly sophisticated and costly clinical trials.