InFocus: Changing Landscape in Product Development
Posted 01 December 2008 | By
With 2008 coming to an end, this final issue of Regulatory Focus addresses the changing landscape in product development. Product development has always been an innovative process, adapting to new and changing environments. This is especially true in the life sciences industry, where changes in legislation can profoundly affect the development process. The pharmaceutical and medical device sectors have been characterized by rapid growth that generates strong sales and revenue.1 Typical models include growth through the development of pharmaceutical blockbusters and, more recently, via mergers and acquisitions. However, this sector is showing the signs of a maturing industry. Product portfolios are aging as New Chemical Entity (NCE) output has continued to decline, while increased regulation has led to escalating costs. The landscape is shifting from a predominantly blockbuster strategy to narrower product portfolios aligned against chronic disease markets, smaller numbers of innovative compounds and a proliferation of drugs offering only incremental improvements.1 New and emerging technologies such as advanced therapies, genotyping, biomarkers and molecular-level disease understanding offer new business opportunities in the quest to improve the availability of treatment for the patient population. New and improved approaches will play a major role in determining the future landscape in product development.