They may replace 70% of chemical drugs in the next two decades
The global biosimilars market value is expected to reach US$20bn by the end of this year and could rise to $55bn by 2020, according to a new report from business intelligence provider GBI Research. Growth will mainly be driven by a promising pipeline in active development and government efforts to reduce healthcare spending.
The company’s latest CBR Pharma report, Biosimilars – Regulatory Framework and Pipeline Analysis, reveals that biologics currently account for between 17–20% of the pharmaceutical arena, worth nearly $200bn, and they may replace 70% of chemical drugs in the next two decades.
GBI Research Analyst Sumith Ladda says the 30–50% reduction in biosimilar prices compared with branded biologics could lead to considerable savings in healthcare expenditure.
Ladda says there are currently 642 biosimilar trials being conducted, with 146 unique molecules. Biosimilars are most focused on oncology therapy, with a 36% share, while immunology treatment comprises 21% of the pipeline; these two segments account for more than 50% of the total trials.
The focus has now shifted to complex monoclonal antibodies (mAbs), as there are numerous blockbuster mAbs going off-patent
Historically, simple proteins, such as filgastrim and epotien, were the prime targets of biosimilar development, but the focus has now shifted to complex monoclonal antibodies (mAbs), as there are numerous blockbuster mAbs going off-patent.
GBI Research’s report also states that while a regulatory framework for biosimilars has been established in all major markets, some aspects, such as interchangeability, naming conventions and extrapolation across indications, need to be harmonised.
Ladda continues: 'The European Medicines Agency has the most robust and longest-standing guidelines for biosimilars. Countries such as Japan, China, and South Korea have developed guidelines similar to these.
'The US Food and Drug Administration finalised guidelines for biosimilars in 2014 and approved its first biosimilar, Zarxio, on 6 March 2015. This marks the entry of biosimilars in the US, and has increased industry confidence in the country’s biosimilars market.'
The analyst adds that the US biologics space is twice the size of Europe by value, but the uptake of biosimilars in Europe is nearly four times higher, indicating the significant future potential of biosimilars in the US.