Drug Development: Historical Influences, Recent Trends and Emerging Areas within the Pharmaceutical IndustryIntroductionIn recent years, the cost of drug development has increased to a level unprecedented. The cost of developing a new drug target was estimated at $802 million in 2003, compared to $138 million in 1979 and $318 million in 1991 [1] [2] [3]. These numbers are industry averages for the “average drug.” There is variation within the industry, with cost estimates ranging from $521 million to $2.1 billion [4]. While this cost continues to rise, levels of innovation within the industry have remained largely constant. On average, five or six first-in-class new molecular entities (NMEs) have been approved each year, but the percentage of these, called “blockbusters,” has been declining [5]. This alarming trend has raised several questions about the sustainability of the current research and development (R&D) model used by today's pharmaceutical companies. Due to this sustainability issue, alternative methods have been suggested to help improve R&D efficiency and productivity. The general consensus within the industry is that, without a redevelopment of the current model, it could eventually have long-lasting and far-reaching effects. These include the reduction of effective drug compounds, which could potentially lead to a decreased life expectancy rate [5]. By examining the historical factors that affect industry regulation, the reasons for rising costs and declining productivity can be determined. Recent trends and emerging areas that have contributed to increasing drug development costs, as well as improving efficiency and reducing costs, within the drug industry..... . middle of paper ...... , which include steadily rising drug development costs, a large number of patent expirations, and declining R&D spending for antimicrobial agents. All of this could potentially have negative impacts, not only on the pharmaceutical and biological industries, but also on society. Although there have been many pessimistic views within the industry, several positive trends have developed in recent years. These developments appear to signal the industry’s shift towards a more sustainable model. The cost of developing the average drug and NME continues to rise, and new advances in R&D technology and processes have shown promise in helping to reduce this cost by increasing the likelihood of approval. These methods include the development of early-stage proof-of-concept tests, increased use of genomics within industry.,