Nanobodies
are considered to be one of the best technology in the fields of
research, diagnostics and therapy especially in cancer research.
These technology was developed from antigen binding fragments,
originating from Camelid heavy-chain antibodies. These molecules do
not have light chains, which is an essential part of antibody found
in humans. Based on the above finding, nanobodies molecule containing
single-domain only were developed, and these molecules contain
functional and structural properties similar to heavy chain
antibodies. These molecules have several advantages as compared to
the conventional antibodies such as small-size, nano to picomolar
affinities, and multiple route of administration. Ablynx, which is
acquired by Sanofi S.A., is one of the leading company in this
market.
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Nanobodies
Market Drivers
Currently,
no products are available in the market, but there are multiple
products in the pipeline including few in very late stage of clinical
trials. For instance, marketing authorization application for
Caplacizumab for the treatment of acquired thrombotic
thrombocytopenic purpura (aTTP) has been submitted to European
Medicine Agency (EMA) in February 2017. The product, Caplacizumab, is
expected to be launched in Europe in 2018. Moreover, the company,
Ablynx, is expected to file for biologic license agreement to the
U.S. Food and Drug Administration (FDA) in 2018, and is expected to
launch this product in U.S. in 2019. Both, Europe and U.S. are the
key markets for any biologics including monoclonal antibodies and are
expected to be the high revenue generating market for nanobodies.
Hence, approval by regulatory bodies in Europe and U.S. to
Caplacizumab in very near future (i.e. 2018, 2019) is expected to
drive the growth of global nanobodies market. As per the company,
Ablynx, estimates the product has potential to generate more than US$
1 Bn. Furthermore, there are multiple products in early stage of
clinical development i.e. preclinical, phase 0, and phase 1. Ablynx
alone had 8 products in clinical development phase (i.e. phase 0 to
phase 3) and overall 45 products in pipeline as of March 2017.
Nanobodies
Market Regional Analysis
Europe
is expected to hold dominant position in global nanobodies market,
owing to the first mover advantage. Marketing authorization
application (MMA) to EMA for Caplacizumab was filed by Ablynx in
February 2017, and the company expects to get approval in 2018. If
approved, Europe will be the only market to have nanobodies
commercially available. However, North America is expected to show
rapid growth in this market, as the company is planning to file for
biologic license agreement for the same product to U.S. FDA in 2018,
and expects to get approval from FDA by 2019.
Nanobodies
Market Key Players
Ablynx
(now part of Sanofi S. A.) is the key player in the global nanobodies
market. Moreover, the company is developing various products with
leading biology companies such as
1.
Novo Nordisk A/S
2.
Merck & Co., Inc.
3.
Merck KGaA
4.
AbbVie, Inc.
5.
C.H. Boehringer Sohn AG & Ko. KG.
Nanobodies
Market Taxonomy:
The
global nanobodies market is segmented on the basis of product type,
indication, distribution channel, and region:
By
Product Type-
Mono-specific:
Monovalent, Multivalent, Bi-paratopic
Multi-specific
By
Indication - Acquired Thrombotic Thrombocytopenic Purpura (aTTP),
Respiratory Syncytial Virus (RSV) Infection, Rheumatoid Arthritis,
Systemic Lupus Erythematosus, Oncology, Immune?mediated Inflammatory
Diseases (IMID), Psoriasis, Chronic Kidney Diseases, Bone Disorders,
Others
By
Distribution Channel - Hospital Pharmacies, Retail Pharmacies,
Online Pharmacies
By
Geography- North America, Latin America, Europe, Asia Pacific,
Middle East, Africa
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