The global biosimilars market value is expected to
reach $20 billion by the end of 2015 and could hit $55 billion by 2020, with
growth primarily driven by a promising pipeline in active development and
government efforts to reduce healthcare spending, according to business intelligence
provider Publisher.
The company’s latest Pharma report states that
biologics currently account for between 17–20% of the pharmaceutical arena,
with a value of nearly $200 billion, and these products may replace 70% of
chemical drugs in the next two decades.
Senior Analyst, says the 30% to 50% reduction in
biosimilar prices compared with branded biologics could lead to considerable
savings in healthcare expenditure.
Senior Analyst comments: “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, meaning these two segments account for more than
half of the total trials.
“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.”
Publisher’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 harmonized.
Senior Analyst 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 finalized
guidelines for biosimilars in 2014 and approved its first biosimilar, Zarxio,
on March 6, 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 its European equivalent by value, but the uptake of biosimilars in
Europe is nearly four times higher, indicating the significant future potential
of biosimilars in the US.
Biosimilars – Regulatory Framework and Pipeline
Analysis report provides a regulatory overview and market outlook for
biosimilars, both globally and across the major markets of Europe, the US,
India, South Korea, Japan, and China. It includes market dynamics, analysis of
key players and an evaluation of the pipeline.
This report was built using data and information
sourced from proprietary databases, primary and secondary research, and
in-house analysis conducted by Publisher’s team of industry experts.
For further information on this report,
please visit- http://mrr.cm/4EU
Other Reports:
Contract Research
Organization Market - Global Deals and Operational Strategies - visit at: http://mrr.cm/4Ew
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