Pharma industry is racing for off shore venues to combat escalating Research & Development costs and lengthy clinical trial timelines by outsourcing it to developing countries like China, Latin America and India. A Country Attractiveness Index for clinical trial developed by A.T. Kearney’ stated that India is at the third position with the rating of 5.58, China grabs the second highest rating at 6.10 and United states earns the highest at 6.68. By analyzing this data, China India and Brazil, emerges to be the most attractive countries, with China taking the top slot followed by India and Brazil. India faces near edge competition from Latin America and China from being the most attractive market for performing the clinical trials. Latin America is unquestionably emerging to be one of the most attractive markets for clinical trials as it offers appealing population and easy to follow regulations. Next to Latin America, China is emerging as one of the fastest growing pharmaceutical market with large urban population in the world.It is estimated that China alone accounts two-third of the researchers present in the developing countries. In contrast to these two countries, India is also emerging as a country with a genetically diverse population and cheap labour, as the Indian patent law is weak and doesn’t permit foreign companies to conduct phase1 clinical trial, it is facing tough competition from China and America. Hence, to conclude Government of India and pharmaceutical companies need to put an urgent and concerted effort to overcome the competition and move ahead in the clinical trials industry.
As the pharma industry race for off shore venues to combat escalating Research & Development costs and lengthy clinical trial timelines by gaining access to largely untapped patient pool. The Asian and South American continent market is resilient, offering many replete potential as in the clinical research realm. A hot bed of clinical trial activity is underway among the “BRIC” nations, i.e. Brazil, India, Russia and China. The constancy of the quality and growth will determine who will be the leader in global pharmaceutical industry.
The increasing financial pressure and growing demand of the clinical trials are leading to outsourcing of clinical trials to emerging countries like India, China and Latin America who provide potential advantages of lower labour cost and promising population concentration consisting of treatment naïve patient. According to a recent data available on website www.clinicaltrials.gov, there are 105,670 trials being conducted in 174 countries, of which 2201 studies being conducted in Brazil, 2104 in china and 1552 studies in India.
Country attractiveness Index: A Country Attractiveness Index for clinical trial was developed by A.T. Kearney’ which compares the performances of countries in clinical trials, According to this study country attractiveness index for India is at the third position with the rating of 5.58, China grabs the second highest rating at 6.10 and United states earns the highest at 6.68. By analyzing this data, China India and Brazil, emerges to be the most attractive countries, with China taking the top slot followed by India and Brazil.
India in a Rat Race with China and Latin America:
India faces near edge competition from Latin America and China from being the most attractive market for performing the clinical trials. Every country has its attractions. China and Latin America have their own advantages compared with India and vice versa.
Latin America: Latin America is unquestionably emerging to be one of the most attractive markets for clinical trials offering appealing population. The new regulations now allows starting clinical trials faster and reduces the set up time as the clinical trial application submission to the ethics committee and competent authority can be done in parallel fashion. The population and ethnic diversity which includes large Hispanic population gives Latin America real edge over India and China.Moreover recent acquisitions by Sanofi-Aventis in Latin America reflects the growing trend of pharma companies intending to expand away from their traditional locations in the US and EU. Various other driving forces are not only helping the pharma companies to conduct clinical trials but also helping in product sales. With population of 600 million, most of whom are treatment naïve, Latin America is undoubtedly turns to be the best choice.
China:China is emerging as one of the fastest growing pharmaceutical market with large urban population in the world. The government of china is adopting new structural and technological changes in order to suit the expertise of foreign sponsored clinical trials. With the IP laws being stringent in China, it has gained the confidence of the clinical trials industry; much of the comfort is also available from the number of researchers present in China.It is estimated that China alone accounts two-third of the researchers present in the developing countries. In the year 2007, China was almost close to its counterpart countries like US and EU in terms of the number of researchers. The great number of scientific publications done by China in the recent times has increased their share in the market which is ultimately attracting the foreign companies to perform clinical trials in China. It is quite evident to see that China is the only country that provides both good infrastructure and also cost effective resources with good quality, when compared to like US, EU, India, Latin America and Eastern Europe where proper regulatory practices are hard to see. With this it quite clear that variety of options are available globally to meet the expectations of the growing and demanding clinical trials, with China being the best choice for outsourcing. Moreover the shift of number of clinical trials from India to China is also quite evident through the list of trials available on web posted by various international pharmaceutical companies. Chain has its own barriers, the country endures from the cultural and language difference makes it costly and slows down the process of clinical trial. The biggest challenge faced by China is the risk posed by the strict government regulations for companies and the use of Chinese traditional medicines which might not be reported by the researchers and might affect the results.
India:India is emerging as a country with a genetically diverse population with a large pool of different acute and chronic diseases and cheap labour, India has a more advanced arena of chemistry and drug discovery activity and is expected to be 10th largest pharmaceutical market by 2013. Large English speaking population helps international companies to have a smooth and continuous relation with companies in India, leading to overall strong economic growth. India gives China a strong competition by catering over 20% of global requirements for generic pharmaceutical. But the major drawback is the Indian patent law which has been weak and did not permit foreign companies to conduct phase – I clinical trials. As per the World Health Organization report the consumption of modern medicines in China is 85 % whereas in India it is hardly 35 %. Also adding to this, when compared to China, the healthcare infrastructure and the delivery system in India is not adequate and is poor.
Conclusion: recent data made available on website www.clinicaltrials.gov, showed that there are 105,670 trials being conducted in 174 countries, of which 2201 studies being conducted in Brazil, 2104 in china and 1552 studies in India, this shows that Latin America is emerging to be the favorite choice of many, next to China. The latest report given by (Frost andOverall results show that clinical trials in China including Latin America are growing tremendously. This is quite evident from the fact that China’s pharmaceutical advancements and infrastructure is better than India.
It is also clearly witnessed in many literatures, publications, journals and reports that the government of China is showing commitment by reforming many of its regulations to gain maximum benefits of globalization. Also theand Sullivan, et al) stated that there is an expected growth in the outsourcing business in India of about $7 billion by 2013. Hence, an urgent and concerted effort is needed by the Government of India, stake holders and pharmaceutical companies to enhance its existing potential to overcome the competition and move ahead in the clinical trials industry.