Biosimilar drug revenues will reach $2,445m worldwide in 2013

Tuesday 4 June 2013, Amsterdam

A new report predicts the world market for biosimilar drugs will be worth $2,445m in 2013, growing by more than 20% from 2012. In 2013 it will account for around 2% of the overall biologics (biological drugs) market. That study forecasts rapid growth to 2023 for the global biosimilars market. The launch of more biosimilars worldwide, but particularly in the US and EU, will drive that sales growth. These predictions and other forecasts appear in Biosimilars and Follow-On Biologics: World Market 2013-2023, published in April 2013.

Fastest growth will be in the biosimilar monoclonal antibodies and insulin submarkets. Two companies – Celltrion and Hospira – submitted biosimilar antibody approval applications to the European Medicines Agency (EMA) in 2012. Those products will be launched in the EU in 2014. From 2014, many companies will try to launch monoclonal antibody biosimilars, with most targeting Roche’s Rituxan (rituximab) and Herceptin (trastuzumab), and Remicade (infliximab, J&J/Merck & Co./Mitsubishi Tanabe) for competition.  By 2023, biosimilar monoclonal antibodies (mAbs) and insulin products will account for 57% of the global biosimilars market, the study also predicts.

This report forecasts steady growth to 2023 for other segments of the biosimilars market. Biosimilar erythropoietins and filgrastim products are already available in the EU, Japan and other developed markets and achieve limited revenues compared with their reference biologics. The launch of these biosimilars in the US will drive growth from 2014, as will the launch worldwide of second generation filgrastim (pegfilgrastim) and epoetin alpha (darbepoetin alpha) biosimilars. The biosimilar human growth hormone submarket will be the slowest-growing of the leading market sectors. Sandoz’s growth hormone biosimilar, Omnitrope (somatropin) was the first biosimilar launched in many major markets, from 2004 onwards. That drug has achieved limited market penetration, though.

Richard Lang, a pharmaceutical market analyst, said: “Many companies are interested in entering the biosimilars market. These drugs offer a simpler way to launch biopharmaceuticals, compared with developing novel biologics. Big pharma companies, such as Pfizer, Merck & Co. and Boehringer Ingelheim, have invested in this area in recent years. Many of these companies are focusing on biosimilar monoclonal antibody development – those three companies have clinical-stage candidates in that sector.

“Not all biosimilar development programmes will be successful, though. Biologics and biosimilars are large, complex molecules requiring long and expensive development and manufacturing. The recent release of development guidelines by regulatory agencies in markets worldwide will increase the success rate of biosimilar development. However, commercialising biosimilars is as challenging as developing them. Companies will need to brand and market their biosimilars in a similar way to novel drugs, engaging key stakeholders such as doctors, healthcare payers and patients, to achieve high market penetration.”