Biosimilar
is a biological product that resembles a reference product and is not
difference from the already approved reference product. These are
relatively cheaper than branded or approved products. Several
biologics for oncology have already lost their patents, and some are
in its period of expiry. As more products are expected to lose
patents, biosimilar is expected to gain popularity. Leading generic
players such as Mylan N.V., Teva Pharmaceutical Industries Ltd,
Allergan Plc, Sandoz (a Novartis International AG’s division) are
expected to capitalize on these patent expiries and may establish
themselves as dominating players in oncology biosimilars market.
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Rapid
approval of biosimilars for oncology is expected to be a major
driving factor for growth of the oncology biosimilars market over the
forecast period
There
was about a decade gap in approval of first biosimilars in two key
markets, Europe and the U.S. First biosimilar was approved in 2006 in
Europe, however, in the U.S. first product was approved in 2015. But
since approving the first biosimilar, the FDA has approved five
products in 2017. Out of these five biosimilars, two were approved
for oncology. First, oncology biosimilar Mvasi (bevacizumab-awwb)
received approval in September 2017, and second one, Ogivri
(trastuzumab) was approved in December 2017. In Europe, both of the
products have been approved, and Mvasi received approval from
European Commission in January 2018.
Moreover,
there are number of biosimilar application pending in the U.S. and
Europe. For Herceptin (trastuzumab) alone, there are around four
application pending in the FDA. These four application are from Amgen
and Allergan, Celltrion and Teva, Pfizer, and Samsung Bioepis. Recent
approval of products, and potential approval in next few years is
expected to boost the market growth over the forecast period.
North
America is expected to dominate the oncology biosimilars market over
the forecast period
On
the basis of region, oncology biosimilars market by Coherent Market
Insights is segmented into North America, Latin America, Europe, Asia
Pacific, Middle East, and Africa. North America is expected to be the
dominant market over the forecast period. U.S. FDA approved first
biosimilar in 2015, almost a decade later than first biosimilar
approval in Europe. However, since 2015, the number of approved
products has increased rapidly. This is expected to be factor for
growth of the market in North America. Moreover, currently there are
number of products in pipeline, which may receive approval from the
FDA over the forecast period. For instance, Pfizer Inc. — a
U.S.-based company — has three biosimilar products (i.e.
PF-05280014, PF-05280586 and PF-06439535) for oncology in Phase 3.
Key
players operating in the global oncology biosimilars market include
Amgen Inc., Allergan, Plc, Mylan N.V., Samsung Bioepis Co., Ltd.,
Teva Pharmaceutical Industries Ltd., Pfizer Inc., Celltrion
Healthcare, Novartis International AG, Biogen Idec, Inc., and Biocon
Limited.
Oncology
Biosimilars Market Taxonomy
By
Cancer Type:
-
Lung Cancer
-
Colorectal cancer
-
Cervical Cancer
-
Breast Cancer
-
Kidney cancer
-
Stomach cancer
-
Brain Cancer
-
Others
By
Product Type:
-
Monoclonal Antibody
-
Immunomodulators
-
Others
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