Biosimilars are complex biological products
made from living organism that include microorganisms such as bacteria and
yeast, humans, and animals. These biological products are similar biological
product also known as biological reference product, that have been approved by
the U.S. Food Drug and Administration (USFDA). Biosimilars are compared with
the biological reference products and licensed by the USFDA. Patent expiration
of biological reference product is the key factor leading to development of
biosimilars.
These are composed of complex molecules such as monoclonal
antibodies and human insulin. Advanced technologies are involved in the
development and manufacturing of biosimilars that include monoclonal antibody
(MAb) technology, nuclear magnetic resonance (NMR)technology, recombinant DNA
(r-DNA) technology, electrophoresis and bioassays. Monoclonal antibody
technology and bioassay are most significant technologies for the development
and validation of biosimilars. Most of the biologics, such as monoclonal
antibodies, anticoagulants, and vaccines are large molecules which need to be
administered parenterally to achieve the desired therapeutic effects. These
complex biosimilars are used in prevention and treatment of diabetes, multiple
sclerosis, cancer, rheumatoid arthritis, inflammatory bowel diseases, low white
blood cell count, anemia, infectious diseases, chronic kidney failure and other
health conditions and offers cost effective treatment than other synthetic and
biological drugs.
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Global Biosimilars
market has been witnessing growth driven by increasing prevalence of chronic
and autoimmune diseases, growing demand of cost-effective medicinal products
and growing aging population. According to World Cancer Research Fund
International, 14.1 million cancer cases were estimated in 2012 and is expected
to increase to 24 million by 2035. Elderly people are more prone to chronic
disease such as diabetes, rheumatoid arthritis chronic pain and other health
conditions.
As per United Nations Department of Economic and Social Affairs
(UNDESA) report on the global aging population, the population of people aged
60 years or above is growing at a high rate. The number of people aged 60 years
or over is projected to grow by 56.0 % globally, i.e. from 901 million in 2015
to 1.4 billion by 2030, and it is projected to more than double its size from
2015, to reach 2.1 billion by 2050. In addition, increasing research and
development investments, healthcare expenditures and technological advancement
also drive the growth of biosimilars market. However, Stringent regulations and
complex manufacturing process restricts the growth of biosimilars market. FDA
and EMA along with World Health Organisation are actively regulating the
development and validation of biosimilars. Countries such as Japan, South
Africa, Australia, Canada, Korea have crafted their own regulatory guidelines
for the development and validation of biosimilars.
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Geographically, Europe
is the largest market for biosimilars The European market for biosimilars is
driven by increasing prevalence of chronic diseases, and various initiatives taken
by the EMA and government to increase the awareness regarding new approaches
and use of biosimilars. North America is the second largest market for
biosimilars market, with the U.S. accounting for the largest revenue
contribution to the North American market. Some of the key factors driving the
revenue growth of the biosimilars market in North America include rise in the
number of chronic and lifestyle diseases, increasing research and development
investments and increasing healthcare expenditures. Private health insurance plays
an important role in U.S. healthcare system, provides primary healthcare
coverage to large population group leading to affordability of better
healthcare facilities. Asia-Pacific is expected to be the fastest growing
market for biosimilars due to a rise in the population, increased government
initiatives, availability of skilled labour, low manufacturing cost and growing
medical tourism in Singapore, Thailand, India and Malaysia.
In October 2016, Teva
Pharmaceuticals Industries Ltd. announced partnership with celltrion, Inc. and
Celltrion Healthcare for the commercialization of proposed Monoclonal Antibody
(MAb) biosimilars to Rituxan and Herceptin in the U.S. and Canada. Rituxan is
used in the treatment of rheumatoid arthritis, and chronic lymphatic leukemia
whereas Herceptin is used in the treatment of breast cancer.
In February 2016,
Sandoz, a Novartis company announced acquisition of rights for the development
and commercialization of PF06438179(biosimilar infliximab) in the European
Economic Area (EEA) from Pfizer. Infliximab is used in the treatment of
rheumatoid arthritis
MARKET SEGMENTAT
By Product
·
Monoclonal Antibodies
·
Human Growth Hormone
·
Insulin
·
Interferon
·
Erythropoietin
·
Granulocyte colony stimulating factor (G-CSF)
·
Peptides
·
Others
By Manufacturing type
·
Contract Manufacturing Organization
·
In-house Manufacturing
By Technology
·
Recombinant DNA Technology
·
Monoclonal Antibodies Technology
·
Nuclear Magnetic Resonance Technology
·
Chromatography
·
Bioassay
·
Others
By Application
·
Chronic autoimmune diseases
·
Oncology
·
Blood disorders
·
Growth Hormone Deficiency
·
Infectious Diseases
·
Other Applications
GEOGRAPHICAL SEGMENTATION
By Region
·
North America
o U.S.
o Canada
·
Europe
o U.K.
o Germany
o France
o Italy
o Rest of Europe
·
Asia-Pacific
o Japan
o China
o India
o Rest of Asia-Pacific
·
Latin America
o Brazil
o Mexico
o Rest of LATAM
o Middle East Africa
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