Forecast Analysis
The high cost and utilization of biologic drugs, coupled to the growing need to curb pharmaceutical expenditure, provides considerable momentum to the emerging biosimilars market. With a biosimilar approval pathway in place in Europe and Japan, and imminently in the US, Datamonitor expects payer pressure to drive biosimilar uptake, particularly in Germany, the US, and the UK.
As the first to introduce guidelines for biosimilar drug approval, Europe has emerged as the testing ground for biosimilar drugs, with biosimilars for three biologics having entered the market to date human growth hormone, epoetin alpha, and filgrastim.
The size of the US market, combined with the voracious generic erosion that characterize it, make it an attractive prospect for would-be biosimilars makers, and as such, it represents the real prize, contingent on the creation of a biosimilars approval pathway.
Although guidance for biosimilar approval was issued in Japan in 2009, this market is unlikely to experience significant biosimilar incursion through the forecast period, contributing at most 1% to total seven major market volume sales in 2019.