The clinical trials sector remains dominated by North America and Europe, collectively accounting for over 80% of active commercial clinical trial sites in 2016. However, increasing need for globalisation has led to clinical trials being conducted in a wider number of countries, in particular emerging regions. In 2006, commercial clinical trials were conducted in 92 countries. To date this number has increased to 140; growth of over 50%.
The emerging regions of South America, Middle East and Asia (excluding Japan) currently account for just under 10% of all commercial clinical trial sites globally. Although they remain regions of interest due to treatment naïve patient pools, faster recruitment rates and lower costs, conducting trials in these markets are not without their challenges.
Focusing on the core BRIC (Brazil, Russia, India and China) markets, this article highlights some of the key challenges in conducting clinical trials in emerging markets.
Regulatory barriers present a significant challenge for conducting clinical trials in Brazil. The National Health Surveillance Agency (ANVISA) process is lengthy, costing pharmaceutical companies valuable time and money, which has deterred companies from conducting trials in the country. In response to this, the ANVISA reviewed the process to take into account previous approval from other regulatory bodies in an effort to streamline the process for multinational sponsors. Currently, there is estimated to be just under 4,000 active clinical trial sites in Brazil, ranking it 3rd out of BRIC markets, behind Russia and China. Further growth is anticipated as regulatory processes are improved allowing increased return of investment for clinical trials conducted in Brazil.
As part of Russia’s 2020 strategy there has been an increased focus on the local manufacture of pharmaceuticals to reduce reliance on imports. In addition to other industries, the pharmaceutical market has been impacted by this with multinational sponsors looking to partner with local suppliers and invest in local production in order to remain competitive in the market. Russia is currently ranked 10th globally based on the number of clinical trials sites with just under 7,000 in 2016. Forecasts for the Russian clinical trials market are mixed. Increased investment in healthcare and regulations has improved clinical trial quality. However, changing regulations and corruption remain concerns for multinational suppliers.
According to the World Bank, approximately 67% of the Indian population live in rural areas. Healthcare provision in rural areas remains poor and as a result a high proportion of the population have to travel long distances to receive basic medical services and partake in clinical trials. Despite efforts by the Central Drugs Standard Control Organization (CDSCO) a recent analysis by the World Health Organisation highlighted the numerous regulatory and ethical concerns regarding the conduct of clinical trials in India. As a result, the number of active clinical trial sites in India has decreased over the last 5 years, estimated at 1,884 in 2016.
Research by IMS Health estimates that within the next 2 years China will become the second largest pharmaceutical market globally; surpassed only by the United States. With a population of over 1.3 billion and rising incidence of cancer and infectious diseases, China has a high volume of treatment naïve patients, presenting large potential patient pools for pharmaceutical companies. As of June 2016, China was ranked 13th globally with an estimated 5,628 commercial clinical trial sites. However, the 2014 GSK corruption case which saw the drug maker heavily fined for bribery has resulted in stricter regulations for the pharmaceutical and medical device industries as part of the government’s anti-corruption campaign. This is projected to create a more stringent and challenging regulatory environment for pharmaceutical companies which could slow growth.
Economic uncertainty, regulatory barriers and clinical trial quality are key concerns for the conduct of trials in emerging markets. Expansion of clinical trials into emerging regions requires detailed understanding of country specific dynamics in order to maximise the benefits. However, in a sector which is already conscious of escalating costs and focused on minimising risk, expansion into emerging regions may be a chance many sponsors are currently unwilling to take. If so, this will put increased pressure on developed markets to increase efficiencies by reducing costs and increasing recruitment and retention rates.