Remicade Biosimilars Market is forecasted to witness a thriving growth by 2026
Biosimilar
refers to biotherapeutic product that is similar in terms of quality,
efficacy, and safety to an existing licensed reference therapeutic
drug. Biological products are the fastest growing class of
therapeutic products, as they offer additional treatment options and
help in lowering healthcare costs. Biosimilars are almost identical
copies of the originally approved drugs and can be manufactured only
when the patent for the original innovator drug expires. These
products are highly sensitive to smallest changes in manufacturing
procedure, as these drugs possess high molecular complexity. Remicade
(Infliximab) refers to a chimeric monoclonal antibody biologic
licensed by U.S. FDA in 1998, as an innovative product indicated for
the treatment of Crohn’s disease in adults and children.
The monoclonal
antibody drug was first developed in partnership by Janssen Biotech,
Inc. and Merck & Co. The Remicade was later approved for its use
in the treatment of ulcerative colitis, plague psoriasis, rheumatic
arthritis, and spinal psoriatic arthritis in combination with
methotrexate. Later, various pharmaceutical manufacturers developed
biosimilars to infliximab, which lowered market share of Remicade due
to cost-effective prices.
Market Dynamics:
Increasing incidence
of autoimmune diseases such as plaque psoriasis and rheumatoid
arthritis are expected to drive growth of the Remicade biosimilar
market size. According to the American Autoimmune Related Disease
Association, around 50 million American suffered from autoimmune
diseases in the U.S. in 2017. Moreover, faster reaction rates of
these biosimilars due to their availability in the form of
intravenous mode of administration is further expected to increase
the adoption of Remicade biosimilar over the forecast period.
Furthermore, patent expiry of the branded versions is expected to
increase the number of biosimilars for its branded counterparts
thereby increasing the demand for Remicade biosimilar. However,
stringent regulatory guidelines for development of these biosimilars
as well as side effects of these drugs leading to risk of
hospitalization are expected to restrain growth of the global
Remicade biosimilar market.
Regional Insights
On the basis of
region, the global Remicade biosimilar market is segmented into North
America, Latin America, Europe, Asia Pacific, Middle East, and
Africa. Europe holds a dominant position in the global Remicade
biosimilar market and is expected to retain its dominance over the
forecast period, owing to the presence of top market players in the
region, rapid entry of biosimilars in the European market as well as
high adoption rate due low price of the biosimilars. For instance, in
2018, Sandoz, a Novartis division received European Commission (EC)
approval for Zessly (infliximab) a remicade biosimilar for use in
Europe. The successive research and speedy approvals by the U.S.
regulatory authorities for market entry of biosimilars in North
America is expected to drive growth of the market over the forecast
period. For instance, in December 2017, Pfizer, Inc. received the
U.S. FDA approval for second biosimilar, Ifixi to Janssen’s
blockbuster drug Remicade to treat rheumatoid arthritis.
Furthermore, Asia
Pacific is expected to witness significant growth in the market over
the forecast period, owing to developments in healthcare
infrastructure and U.S. FDA approval of Remicade (infliximab)
biosimilars by regional players to market the products
internationally. For instance, in April 2016, Celltrion- a South
Korea-based manufacturing company received the U.S. FDA approval for
intravenously administered version of the rheumatoid arthritis drug
sold under the name Infllectra. Moreover, major investments by
regional players for research and development of biosimilar
production is expected to drive growth of the market in Asia. For
instance, in October 2016, Cipla, Inc. invested US$ 8 million to set
up a manufacturing plant for biosimilars in South Africa.
Competitive
Landscape
Key players
operating in the global remicade biosimilar market include Janssen
Biotech, Inc., Merck and Company, Inc., Alvogen, Pfizer, Inc.,
Celltrion, Nippon Kayaku, Napp Pharmaceuticals, and others. Market
players are focused on introducing maximum number of biosimilar for
multiple indications to retain their position in the global market.
For instance, in July 2017, Merck & Company, Inc. in
collaboration with Samsung Bioepis introduced Renflexis
(infliximab-abda), a biosimilar to Remicade for the treatment of
moderate to severe Crohn’s disease, active ulcerative colitis,
rheumatoid arthritis, and other few disease indications.
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Market Taxonomy
On the basis of
disease indication, the global Remicade biosimilars market is
segmented into:
Ulcerative
Colitis
Rheumatoid
Arthritis
Ankylosing
Spondylitis
Crohn’s
Disease
Psoriatic
Arthritis
Plaque Psoriasis
On the basis of
geography, the global Remicade biosimilars market is segmented into:
North America
Latin America
Europe
Asia Pacific
Middle East
Africa
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