Syamala Ariyanchira
Accepted Abstracts: J Bioequiv Availab
While biosimilars have triggered a major regulatory debate in regulated markets, emerging markets are embracing the opportunity. The governments in the emerging markets such as China, Russia, Korea, and India are trying to improve access to expensive biologic drugs in their countries by designing suitable regulatory frameworks and promoting local companies to invest in biosimilar product development. The worldwide biosimilar market in 2011 was around $2.5 billion (excluding vaccines and blood products except LMWH). Emerging markets accounted for 39% of the market. The market is expected to grow at a CAGR of 9% in the next five years. These markets are highly price sensitive as a large proportion of the population pay for healthcare out of their own pockets. Hence, market share by value tend to be much lower in comparison to the demand by volume. Some of the emerging markets have even commercialized complex biologic drugs such as monoclonal antibodies. Many companies in these markets have a rich pipeline of biosimilar products. The quality of biologic drugs developed and marketed in these countries is often debated since they are not subjected to stringent regulatory processes before commercialization. However, this scenario is changing slowly driven by the returning scientists trained in regulated markets, who are influencing the governments to pay attention to safety standards and IP protection. A deeper look into countries such as China, Korea, India, and Russia indicates critical trends evolving in these countries, which will play crucial roles in shaping the global biosimilar market during the forecast period and beyond.
Syamala Ariyanchira did her PhD from Indian Institute of Science, Bangalore, India. She worked in R&D for 10 years in various organizations including academia and multinational corporations. In 2004 she moved to industry analysis and consulting. Currently she is an independent consultant based in Malaysia. Her clients include manufacturing firms, consulting firms and Government agencies based in India, SE Asia and USA. She regularly publishes global industry analysis reports and writes for popular trade journals such as GEN in addition to reputed scientific journals.