The world market for biosimilar drugs will reach a value of $2.44 billion for the whole of 2013, representing growth of more than 20% from 2012 and accounting for around 2% of the overall biological drugs market, according to a new study.The global biosimilars market will experience fast growth to 2023, driven by the launches of more such products worldwide but particularly in the US and the European Union (EU), according to the study, from Visiongain.
The fastest growth will be experienced within the submarkets for biosimilar monoclonal antibodies (mAbs) and insulins, the study forecasts. Last year, two companies - Celltrion and Hospira - submitted biosimilar mAb applications to the European Medicines Agency (EMA), and those products will be launched in the EU next year, it says.
From 2014, many companies will be trying to launch mAb biosimilar products, and the majority will be targeting Roche's Rituxan (rituximab) and Herceptin (trastuzumab), and Johnson & Johnson/Merck & Co/Mitsubishi Tanabe’s Remicade (inflximab) for competition. By 2023, biosimilar mAbs and insulin products will account for 57% of the global biosimilars market, the study also predicts.
In addition, it is expecting steady growth in 2023 for other segments of the market. Biosimilar erythropoietins and filgrastim products are already available in the EU, Japan and other developed markets, but are achieving limited revenues compared with their reference biologics, it says. However, the launches of these biosimilar products in the US are set to drive growth starting in 2014, as will the introduction worldwide of second-generation filgrastim (pegfilgrastim) and epoetin alpha (darbepoetin alpha) biosimilars.
The study also forecasts that the market for biosimilar human growth hormone (HGH) will be the slowest-growing of all the leading market sectors. Sandoz' HGH biosmilar Omnitrope (somatropin) was the first biosimilar to be launched in many markets, from 2004 onwards, but has achieved only limited market penetration, it notes.
Many companies are interested in entering the biosimilars market, comments Richard Lang, a pharmaceutical market analyst at Visiongain, and he points out that 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, and many such companies are focusing on biosimilar mAb development - these three firms currently have clinical-stage candidates in that sector, he notes.
However, not all biosimilar development programmes will be successful, Mr Lang cautions."Biologics and biosimilars are large, complex molecules requiring long and expensive development and manufacturing," he says. "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 stakeholder such as doctors, healthcare payers and patients, to achieve high market penetration," Mr Lang advises.
The market's seven leading segments currently are: mAbs; insulins; interferons; erythropoetins; filgrastim; somatropin; and follicle stimulating hormone (FSH).
In 2012, emerging markets accounted for the majority of global revenues for biosimilars; the products were first launched in these markets more than two decades ago. Hundreds of biosimilars are marketed in China, which was the leading national market and where - in common with other leading emerging countries such as India - the market is fragmented, with few companies achieving revenues over $10 million.
Growth in the developed markets will be much faster than in the emerging markets during 2012-23, according to Visiongain. In 2012, the US, EU and Japan accounted for just 20% of the global biosimilars market, and it expects patent expiries on blockbuster biologics during 2013-17 to drive growth in those markets.