The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor, an independent industry analyst company.
One of the key drivers for growth will be the loss of patent exclusivity for many branded products. More than 30 branded biologics with sales of $51 billion will lose patent exclusivity by 2015, according to a statement from Datamonitor, which will pave the way for biosimilars.
“With the market shares of first-generation biologic drugs stagnating or declining, biosimilar MAbs and second-generation biosimilars represent a high-value proposition for biosimilars manufacturers and key drivers for future growth,” Mark Hollis, healthcare analyst at Datamonitor, explained in the statement.
However, Hollis also warned that there a number of barriers to achieving commercial success with biosimilars in the developed markets, even though biosimilar approval pathways are now in place in Europe, Japan and the US. In 2009, Pharmaceutical Technology Europe discussed some of these issues in our August and September issues.
According to Datamonitor, existing biosimilars are well-positioned to take advantage of the predicted market growth because they already have an industry reputation, as well as relationships with key stakeholders. However, branded pharma companies may also be looking to leap into the biosimilars arena as a way of increasing sales. Partnerships and M&As are potential ways of achieving this.
Consequently, Datamonitor believes that the future biosimilars market will continue to be dominated by existing biosimilars players, with the addition of select, branded pharma companies. Companies in emerging markets may also make an appearance. Datamonitor adds: “Furthermore, emerging market biosimilars players are now looking to expand into global markets too, through partnerships with international pharma companies.”