Biosimilar Pipeline Analysis
Market – Dynamics
Biosimilar
Market is under the initial phase of development, they are used for the
treatment of various disorders such as autoimmune disease, cancer as per
National Institute of Health 2012 report, there were more than 23.5 million
people living with autoimmune disease in the U.S. and low pricing of biosimilar
drugs make them affordable for people. High prevalence of various types of
cancers and the need for affordable and effective treatment are the major
factors driving growth of the biosimilar pipeline analysis market. According to
the Centre for Disease Control (CDC), around 14.1 million people were diagnosed
with cancer in 2012, in the U.S., resulting in around 8.2 million fatalities.
Around 19.3 million new cases of cancer are projected to be diagnosed by 2025.
Similarly according to the data published by World Health Organization (WHO),
cancer accounted for 8.8 million of deaths worldwide in 2015.
Biosimilar is a type of
biological product that is almost identical to the original product, which has
undergone patent expiration. Development and validation of biosimilars are an
important part of the overall production process. Regulation for biosimilar
drugs plays an important role in maintaining the efficiency and balance between
original and biosimilar drugs. There are various authorities such as U.S. Food
and Drug Administration (FDA) and European Medicines Agency (EMA), which
regulate the development and commercialization of biosimilars. Biosimilar drugs
are available at relatively low prices as compared to patented drugs without compromising
on efficacy.
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Biosimilar has a complex
structure, multi-layer manufacturing and immunogenicity risk due to which they
require unique regulatory pathways for introduction in the market. Biosimilar
ensures treatment of diseases considered to be incurable such as cancer and
autoimmune disorders, they are developed independently and have same mechanism
of action as patented drugs for the specific disease. There are different
stages involved in the development of biosimilars such as product development,
process development, clinical trial and regulatory approval and review.
Rising approval of biosimilars is
expected to propel the market growth over the forecast period. As of January
2020, around 26 biosimilars has received U.S. Food and Drug Administration
(FDA) approvals. In December, 2019, Amgen Inc., received U.S. Food and Drug
Administration (FDA) approval for Avsola (infliximab-axxq) a biosimilar of
Remicade, indicated for the treatment of Crohn disease, ulcerative colitis,
rheumatoid arthritis and other conditions.
Various other companies such as
Pfizer Inc., Mylan, Merck, Amgen, Zydus Cadila are involved in the development
of biosimilars. Currently Amgen Inc. has 2 biosimilars at the clinical stage
pipeline which includes ABP 798, ABP 959 which will be used for the treatment
of non-Hodgkins Lymphoma, Paroxysmal nocturnal hemoglobinuria and rheumatoid
arthritis.
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There are various patented
biologics available in the market, but at a cost much higher that is
inaccessible to general population. This directed the need for biosimilars
market. There is a need for complex infrastructure in the development of
biosimilar and lengthy process of clinical trial and approval are the major
challenges faced by biosimilar pipeline analysis market.
Biosimilar Pipeline Analysis
Market – Regional Insights
Global biosimilar pipeline
analysis market is segmented into North America, Latin America, Europe, Asia
Pacific, Middle East and Africa. Europe is expected to dominate the biosimilar
pipeline analysis market due to technological advancements in healthcare
facilities and regulatory affiliation. Asia Pacific is expected to closely
follow Europe in terms of growth due to increased prevalence of autoimmune
disease, cancer, unmet clinical needs of people, and large price conscious population
of emerging economies.
North America market is expected
to grow significantly due to rising product approvals and high R&D
investments, which supports the growth of biosimilar pipeline analysis market
in near future. For instance, in June 2019, Pfizer Inc., received U.S. Food and
Drug Administration approval for ZIRABEV (bevacizumab-bvzr) it is the
biosimilar to Avastin, indicated for the treatment of metastatic colorectal
cancer, recurrent or metastatic non-squamous non-small cell lung cancer,
recurrent or metastatic cervical cancer.
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