Clinical research is an increasingly global endeavour. With clinical trials conducted in over 140 countries worldwide, there are a complicated network of legal and ethical bodies involved in the design, oversight and conduct of studies. However, globalisation of clinical trials is vital for a number of reasons:
- Increasing competition for patient populations
- The need to access limited numbers of rare disease patients
- The global expansion of clinical trial networks
The below describes the current clinical trials landscape based on the number of active commercial clinical trial sites. 60% of active commercial clinical trial sites are in the 5 countries listed below, with the remaining 40% of active sites spread over the remaining 135 countries.
1. United States
With over 39% (134,000) of active commercial clinical trial sites in 2016, and more than 80,000 clinical trials registered in the US as of June 2016, the US is the largest market for clinical trials. Information from clinicaltrials.gov demonstrates that over 37% of studies are registered only in the US, whilst over 40% of recruiting studies are currently active in the US.
The pharmaceutical market in Germany was worth over $58 billion in 2014, and is expected to grow to over $65 billion by 2020. With the largest population in Europe (over 80 million as of July 2015) Germany is a huge potential market for clinical trials. It is ranked second in the world and first in Europe for the number of active clinical trial sites, with over 22,000 active clinical trial sites.
Japan has a population of 126 million, and the second largest pharmaceutical market in the world, representing 9.7% of the world pharmaceutical market in 2013, based on revenue. There have been a number of initiatives in Japan to improve clinical research, ranking it third with approximately 20,000 active clinical trial sites.
The French pharmaceutical market was worth $46.2 billion in 2014, making it the second largest market in Europe behind Germany. Although the fatal clinical trial that occurred in January 2015made headlines globally and raised questions on safety of clinical trials, , France is ranked 4th with just under 15,000 active clinical trial sites.
Spain has recently passed new regulations on clinical trials to increase transparency and simplify procedures in order to increase the number of trials conducted in areas that aren’t necessarily a priority for the pharmaceutical industry. It currently has just under 13,000 active clinical trial sites.
With a population of over 65million, and pharmaceutical research and development spend close to $5.6 billion in 2014, the UK is ranked sixth, with only 3% of all active clinical trials sites (10,566), followed by Italy (9,944), Canada (9,722), Poland (7,136) and Russia (6,994).
Over the next 5 to 10 years, MRN anticipates globalisation of clinical trials with continue with the increasing involvement of emerging countries. We have recently increased our coverage into 38 countries worldwide, with activities in place to expand into a further 12 countries over the next 12 months based on analysis of the clinical trials landscape and discussion with sponsors.