Biosimilars are undoubtedly a hot topic right now, with plenty of press coverage about new regulations, M&A activities, manufacturing, investments and projected market growth. We may not yet be seeing the exponential sales growth predicted by many, but analysts predict this market will exceed US$19.5bn by 2022.1
In the past year alone, the number of biosimilars in development has increased by 42%. While many of these products remain in preclinical development, a recent study suggests the number of biosimilars in clinical trials is increasing at a rate of 20% per year.2
As shown in Table 1, several leading biologics with annual revenues of more than $40bn are coming off patent in the next few years. This, combined with increasingly clear regulatory approval pathways in the US and EU, and a growing awareness of biosimilars in the medical community, is fuelling the growth in biosimilar development.
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