The biotechnology has changed the outlook of pharmaceutical market. Pharmaceutical in combination with biotechnology has evolved a new branch called biopharmaceutical. Presently biopharmaceutical contributes 15% of entire pharmaceutical market. The expiration of patents of a number of blockbuster biopharmaceutical drugs; increasing pressure from patients, insurers and Government to reduce the expenditure has created a large number of opportunities for biosimilar products; imparting challenges for innovative drug manufacturers.
Currently the biosimilar market is highly fragmented and huge opportunities available in the market, are attractive new players. Favorable regulatory developments in the biosimilar sector are expected to increase the market share, profit margins and reduce the medical expenditure, in turn from an important developing pharmaceutical market.

Biosimilar market is getting boost from increasing user acceptance and emerging Indian and Chinese markets. The major challenge for the biosimilar market is risk involved with the high investment and possible failure of the drug during development stages. However, opportunities for biosimilar market is immense, as biologics worth $25 billion are going to be off patent by 2016 and an anticipated approval pathway in U.S. will open up potentially largest market.

The global biosimilar market is expected to be worth $19.4 billion by 2014, growing at an expected CAGR of 89.1% from 2009 to 2014. The biosimilar market is segmented into peptides, Recombinant glycosylated proteins, Recombinant non-glycosylated proteins and others. Among all the products, Biosimilar erythropoietins are expected to emerge as the best product with a market worth $6.1 billion by 2014.
While America and Asia hold a major share of the global biosimilar market, Europe is also gaining momentum after the approval of its first biosimilar Omnitrope in 2006. Moreover, U.S. market is expected to open up in 2010 which will give a major thrust to the growth of biosimilar market.

Global Biosimilar Market by Products, 2009
biosimilars
 
Source: MarketsandMarkets

In 2009, biosimilar recombinant non glycosylated protein products form the largest market segment; and are expected to reach $11.5 billion by 2014 at a CAGR of 87.9% from the year 2009 to 2014. This is mainly because most of the branded blockbuster biopharmaceutical drug such as interferon, human growth hormone-Somatropin, insulin and G-CSF; belong to this class and have wide range of applications.
The key players in biosimilar market include Biocon, Dr. Reddy’s lab, Intas, LG Life Sciences, Ranbaxy, Reliance LifeSciences, Sandoz, Teva, and Wockhardt, etc.

Our analysis indicates that companies taking the first mover advantage by quick commercialization with extensive R&D will have an edge over their competitors. Agreements and collaborations as well as new product launches are some of the most popular strategies adopted by market players to stay ahead of the competition and to expand into new geographies.

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