BRIC Nations: Divergent Patterns in the Clinical Trials Landscape

By Beth Nuskey, pharmaceutical research analyst, Thomson Reuters

The clinical trial landscape in BRIC countries is changing. Long heralded as a low-cost alternative to Western markets, Brazil, Russia, India and China are experiencing a shift in trial initiation by global sponsors. In examining the number of clinical trials initiated in BRIC countries in the past five years, only China exhibits growth. According to Cortellis Clinical Trials Intelligence, clinical research in India peaked in 2010 with a steady decrease from 598 trials to 326 in 2013. This is in contrast to China’s increase from 691 trials in 2010 to 1018 trials in 2013. Brazil and Russia have experienced a slower decline since their peak, from 295 in 2011 to 211 in 2013 and 822 in 2012 to 724 in 2013, respectively (Fig 1).

Fig 1.  Source: Thomson Reuters Cortellis Clinical Trials Intelligence 

The rapidly changing drug development climate is perceived as a major cause of clinical trial decline in recent years. Healthcare reforms provide wider public access to hospitals and research centers, resulting in an increased number of trained professionals. Government agencies are strengthening regulations by promoting greater transparency and accountability, leading to higher quality trials and patient protection. Although these improvements are necessary to meet rising clinical trial standards worldwide, some sponsors indicate that regulatory changes are being enacted faster than they can keep up. For instance, several trials in India have been suspended to await stabilization of the climate, while some global sponsors have pulled back or out completely.

However, several global sponsors continue to invest in BRIC countries. Novartis has maintained a presence in the top ten sponsors initiating trials in BRIC and has seen little variation in number since 2009. Approximately half of Novartis’ trials each year were started in Russia, followed by India with a total of 92, Brazil with 87 and China with 72. They have maintained a strong focus on chronic obstructive pulmonary disease from 2009 to 2013, initiating six trials in 2009, three in 2010, three in 2011, five in 2012 and five in 2013. Other areas of high-interest for Novartis were non-insulin dependent diabetes, hypertension, metastatic breast cancer and multiple sclerosis (Fig 2).

Fig 2. Source: Thomson Reuters Cortellis Clinical Trials Intelligence

With the exception of China, early phase trials comprise a small amount of total trials initiated in the BRIC nations. Out of those trials with phase reported, Brazil saw 6 percent phase 1 and phase 1/phase 2 trials from 2009 to 2013, while Russia had 8 percent and India had 11 percent. China’s relatively high number of early phase trials – 22 percent – may be due to the fact that the country sees a higher investment in clinical research by local companies than any other BRIC country. In fact, the top ten sponsors in China from 2009 to 2013 are comprised entirely of local institutions with the exception of Novartis at the number four spot and GlaxoSmithKline plc at number eight (Fig 3). This may result from the CFDA’s requirement that phase 1 trials be conducted in China on Chinese patients for trial and market approval. Regulatory red tape also continues to hinder cost-effective global trials, as the requirements are complex and best navigated by those with an on-the-ground presence. In this respect, local offices of foreign sponsors, contract research organizations (CROs) and central laboratories have helped to ease the process.

Fig 3. Source: Thomson Reuters Cortellis Clinical Trials Intelligence

Although foreign investment in BRIC countries is dwindling, India has seen the greatest decline in the number of trials initiated in its clinical research sites. Figure 1 shows a decrease by almost half since peaking in 2010. Sponsors indicate that rapid regulatory changes, ethical issues and patent protection losses have contributed to the decline.

Despite a decline in foreign-sponsor investment, BRIC markets are ripe for opportunity. The decrease in clinical trial initiation and increase in healthcare expenditure opens research sites, untapped patient pools and qualified investigators. Will global developers decide that the risks outweigh the benefits? That depends on whether they are willing to partner or establish a local presence to take full advantage of BRIC’s cost-efficiency. To learn more, download Overcoming Clinical Challenges in BRIC Markets, a Thomson Reuters report that further explores the benefits and challenges of conducting clinical trials in the pharmaceutical markets of the BRIC nations.