Markets and Markets’ report, titled Biosimilars (2009-2014), states that the sector is currently highly fragmented and this, coupled to the shift in regulations, means there are opportunities for growth.
In particular the opening up of the US market will drive growth in the sector. Currently Asia is the primary market for biosimilars, accounting for 34.1 per cent of sales, but the US market is predicted to rise to the top spot once legislation is passed.
Compound annual growth rate (CAGR) is predicted to be 89.1 per cent from 2009 to 2014, in part because of the expected establishment of a regulatory pathway in the US. The other aspect is that biologics with sales totalling $25bn will be off patent by 2016.
Recombinant non glycosylated protein products account for a sizeable proportion of this. The group currently accounts for 61 per cent of the biosimilars market and is predicted to have a CAGR of 87.9 per cent from 2009 to 2014, which will see the sector grow to $11.5bn.
Interferon, human growth hormone-Somatropin, insulin and G-CSF all belong to this sector of biologics and demand for these products will underpin the 87.9 per cent CAGR.
Biosimilar erythropoietins are predicted to emerge as the dominant product and achieve sales of $6.1bn by 2014.
Barriers to entry
To achieve sales in the biosimilars sector companies will have to invest significant capital and risk their product failing in development stages. These barriers distinguish the biosimilars market from small molecule generics, which is a relatively affordable sector for companies to enter.
Facing these challenges some generics manufacturers have entered into joint ventures, such as the deal between Teva and Lonza, to ensure they have the necessary expertise to produce biosimilars.
The report predicts that collaborations will be a common strategy to help perform extensive R&D, quicken commercialisation and expand into new geographies.
Biocon, Dr. Reddy’s, Intas, LG Life Sciences, Ranbaxy, Reliance LifeSciences, Sandoz, Teva, and Wockhardt are listed as the key players in the sector.