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.
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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.
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.
The
increasing prevalence of rare cancer in patients owing to oncological
diseases segment to dominate in the orphan drugs market
The
global orphan drugs market is segmented on the basis of disease, by
product type and by region
On
the basis of disease type,
-
Hematologic and Immunologic diseases
-
Infectious diseases
-
Metabolic diseases
-
Neurologic diseases
-
Oncologic diseases
-
Other orphan diseases
On
the basis of product type,
-
Biological orphan drugs
-
Non-biological orphan drugs
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