Abstract

Latest trends based upon analysis of biopharmaceutical-sponsored clinical trial (BPCT) sites added to the ClinicalTrials.gov database during the period 2007–12 have been analyzed. When comparing global market share of BPCT sites in regions/countries for the 2007-09 versus 2010-12 period, our data confirm the previously observed trend of loss of share in developed markets (-2.1%), with simultaneous growth in several emerging markets. During this period North America lost 2.6% of global BPCT sites market share and Western Europe lost 1.1% market share. These market share losses among developed bio-pharmaceutical markets were partially offset by the rapid growth of BPCT sites in Japan (1.2%), and Australia and New Zealand (0.3%). During the same period, emerging markets gained 2.1% global market share. Among emerging markets, CEE continues to dominate, demonstrating highest market share gain (1.5%), followed by emerging Asia (0.7%). Latin America experienced flat growth, while sub-Saharan Africa and TMENA (Turkey, Middle East & North Africa) lost 0.08% and 0.02% of global market share respectively from very low starting levels. Despite the observed market share decline, developed markets contribute more than 74% of global BPCT sites. Although all four BRIC countries (Brazil, Russia, India, and China) remained among top 20 countries by BPCT sites market share, only China demonstrated market share growth and global ranking improvement. Similarly, majority of the top 17 pharmemerging markets by biopharmaceutical sales declined both in relative and absolute terms over the two periods, demonstrating that industry product development growth does not necessarily follow product sales growth.

Keywords: Access to clinical research, Biopharma-sponsored clinical trials, Clinical trials in developed markets, Clinical trials in emerging markets, Ethics in clinical research, Globalization of clinical research, Industry-sponsored clinical research, Productivity in clinical research, Quality in clinical research, Regional trends in movement of clinical trials, Societal values of industry- sponsored clinical trials.