The globalization of industry-sponsored clinical trials over the past 17 years is not unexpected. The cost and competition faced when conducting trials in the US and EU has become overwhelming, and many biopharmaceutical companies are seeking new destinations for trial studies that offer opportunities to shorten clinical trial duration and reduce the cost per clinical trial subject.
Emerging market destinations are also attractive because of the opportunity to collect data from patients with diverse ethnic backgrounds, as well as the availability of qualified investigators – all without the competition or cost they face in more developed nations.
As a result, the balance of clinical trial investment around the globe is shifting. In a recent report on clinical trial trends from 2007-2012, we ranked nations based on their clinical trial market share and found that while developed nations still lead the world for pure number of biopharmaceutical-sponsored clinical trial (BPCT) sites, emerging markets are slowly gaining a competitive advantage.
In the developed nations, our research shows:
- Japan captured 1.2% of global market share during this period (representing relative market growth of 33.6%). The growth of the Japanese market does not come as a total surprise to us since we identified Japan as a country with one of the largest gaps between share of global BPCT sites and biopharma significance indicator in a previous study.
- North America saw a continued loss of global market share of BPCT Phase II-III sites. At 2.6% it lost the largest market share among global regions over the period. However, with 43.8% of total global market share, North America still remains the global market leader by a wide margin.
- Germany lost 0.4% of global market share with a relative market decline of 6.6%. But with 5.5% of global market share it still ranks #2 behind the US.
- France lost 0.6% of global market share with a relative market decline of 16.5%. With just 3.2% of the global market share its rank fell two places to #5.
- Spain gained 0.1% of global market share with a relative market growth of 4.9%. With 2.9% of global market share it maintained its #6 ranking.
- UK was a top gainer in Western Europe and one of the fastest growing countries globally. It gained 0.4% of global market share on a strong 15.4% relative market growth and jumped global ranks from #10 to #7.
- Italy traded global ranks with the UK, falling from #7 to #10 globally (behind Russia) on 0.1% loss of global market share and a relative market decline of 5.3%.
- Belgium was the only other Western European country in the global top 20. With a 1.4% loss of the market share, it fell from #13 to #15 globally, overtaken by a more rapidly growing China and Hungary.
- Australia & New Zealand gained 0.3% of the global BPCT Phase II-III market share to a total of 2.1%, with a strong relative market growth of 15%. Next to Japan, Australia and New Zealand were top gainers among developed BPCT countries.
Among emerging regions the following trends were observed:
- China gained 0.6% to reach 1.6% of global market share, with a 61.5% market growth. With this growth China jumped eight spots in global market share, from #20 to #12, becoming the second country after Japan with the strongest market share gain.
- India lost 0.4% of global market share, to rest at 1.5%, with a relative market decline of 22.3%. The decline first became visible in 2011 with a 31% decline versus 2010 level, and continued in 2012. With this decline, India became the third country (after US and France) to lose significant global market share, falling from #11 to #14. We assume that the decline of the previously buoyant Indian BPCT market is related to domestic concerns over adequate protection of participating human subjects, increased regulatory scrutiny and difficult to predict start-up timelines.
- South Korea remained one of the top growing countries. It’s 0.3% global market share gain was the 5th largest gain globally (after Japan, China, UK and Hungary) on the back of a strong 32.4% relative local market growth. With 1.4% global market share South Korea has moved up one spot to #17 .
- Central and Eastern Europe gained 1.5% of global BPCT Phase II-III market share to a total of 13.6%, with strong relative market growth of 12.2%, thus maintaining by a wide margin its top destination position among emerging markets. Six countries in this region made it to the top 20 list in terms of global market share: Poland, Russia, Hungary, Czech Republic, Ukraine and, for the first time, Romania.
- Brazil lost 0.04%, falling to a 1.2% global market share, with relative market decline of 3%. With this performance Brazil moved down four ranks to #20.
- Argentina lost its position among top 20 global countries but maintained 1% of global market share with a small relative market decline of 0.1%. With this performance Argentina descended two spots to #21.
- Mexico is the third largest market in Latin America after Brazil and Argentina. With a relative market decline of 0.4% maintained 0.9% of global market share, and replaced the Netherlands as the 22nd largest market globally.
- Sub-Saharan Africa and TMENA stay at the bottom. The two emerging regions with lowest market share during 2007-09 period -- sub-Saharan Africa and TMENA (Turkey, Middle East and North Africa (excluding Israel) -- not only remained at the bottom of the global market share list, but their gap versus other emerging regions further widened during 2010-12 period, with their regional markets in relative terms contracting 9.1% and 2.5% respectively.
These numbers should be a wakeup call for biopharma companies as they consider where to locate their next trial. Shifting regulations, stabilizing economies and a growing global talent pool has opened the door to new markets. When biopharma companies are willing to reassess their decision-making processes about clinical trials will be held, they can gain dramatic cost-savings while facing less competition for patients and investigators as they launch their next round of clinical trials.