Biocon, Dr Reddy’s, Reliance Life, Intas to dominate $19.4 bn global biosimilars market by 2014

Biosimilars market will grow at CAGR of 89.1% from 2009; Erythropoetin to emerge key biogeneric with $6.2 b sales: Report

Indian biotech companies are set to dominate the global biogeneric business even as the worth of biosimilar market is estimated to reach $19.4 billion by 2014.

Biocon, Dr. Reddy’s, Intas, Ranbaxy, Reliance LifeSciences and Wockhardt along with LG Life Sciences, Sandoz and Teva will emerge as the key players in the sector, says the report titled Biosimilars (2009-2014) from Markets and Markets.

The global biosimilars market is forecasted to be worth $19.4bn (€13.6bn) by 2014, by which time the US will have overtaken Asia as the dominant market, according to a report.

The global biosimilar market will grow at compound annual growth rate (CAGR) of 89.1 per cent from 2009 to 2014.

The fast-track growth in the biosimilars market is majorly attributed to the ongoing efforts to establish a regulatory pathway in the US. Opening up of the US market will drive growth in the biosimilar sector.

“What this [regulatory path-way] essentially means is that it will now be possible for companies to use innovator data to conduct abbreviated (shorter) clinical trials in order to enter the [U.S.] market. This is likely to see the advent of biogenerics over the next 12-24 months,” stated Dr Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd.

The Bangalore-based Biocon, which sees its recombinant insulin reaching the U.S. market by 2011, has insulin analogs, GCSF and monoclonals in pipeline.

Currently Asia is the primary market for biosimilars, accounting for 34.1 per cent of sales. However, US will reclaim the market once legislation on biosimilars is enacted.

The fact that biologics with sales totalling $25bn will go off patent by 2016 is also contributing to the higher growth rate of biosimilars.
Biosimilar versions of recombinant erythropoietins are predicted to emerge as the dominant product with sales of $6.1 bn by 2014.

Among the product categories recombinant non glycosylated protein products account for 61 per cent of the biosimilars market. Recombinant non glycosylated protein products are forecasted to touch $11.5 billion growing at a CAGR of 87.9 per cent from 2009 to 2014.

Recombinant non glycosylated protein products such as interferon, human growth hormone-Somatropin, insulin and G-CSF will spur the demand in this sector.

Besides, Biocon, Relaince Life Sciences, Dr Reddy’s Wockhardt, Intas Bio, Ranbaxy etc have also developed capacities and technological capabilities to produce biosimilars.

Reliance Life Sciences (RLS) is offering a range of services including cloning and expression of proteins and antibodies, clinical lot manufacturing and bioassay development is currently conducting clinical studies for erythropoetin and granulocyte colony stimulating factor (GCSF).

Intas Bio of Ahmedabad, western India is reportedly investing $32 million on a monoclonal antibodies (MAb) facility for in Gujarat, which is expected to go on stream by 2011. Intas Bio offers contract services in microbial as well as mammalian platforms. In January, Intas Bio extended a pact with Apotex Inc. to market its recombinant pegylated GCSF in Northern America and Europe.

Wockhardt also built up huge capacities and brought out erythropoetin, hepatitis vaccine, recombinant insulin and insulin glaritus —an analogue of Sanofi- Aventis’ Lantus — which Wockhardt claims to be the first of its kind in the world.

Dr Reddy’s, which has already launched filgrastim and rituximab in emerging market, also view generic biopharmaceuticals as an integral part of its mid to long term growth strategy and believe that building depth in development and manufacturing capabilities will be critical in accessing this opportunity. Dr Reddy’s has a pipeline of 8 generic biopharmaceuticals in various stages of development with two in clinical development stage.