Nanobodies Market RegionalAnalysis
Europe is expected to holddominant position in global NanobodiesMarket, owing to the first mover advantage. Marketing authorization application(MMA) to EMA for Caplacizumab was filed by Ablynx in February 2017, and thecompany expects to get approval in 2018. If approved, Europe will be the onlymarket to have nanobodies commercially available. However, North America isexpected to show rapid growth in this market, as the company is planning tofile for biologic license agreement for the same product to U.S. FDA in 2018,and expects to get approval from FDA by 2019. Once approved in U.S., thecompany may plan to reap the maximum benefit out of it. Furthermore, the drug,Caplacizumab, is expected to have better efficiency compared to both theavailable treatment (i.e. plasma exchange therapy and immunosuppressant) forthe treatment of acquired thrombotic thrombocytopenic purpura (aTTP). In AsiaPacific, Japan may take the lead as multiple products such as Caplacizumab,Vobarilizumab, and ALX- 0171 has successfully gone through initial phase ofclinical development.
Nanobodies are considered to beone of the best technology in the fields of research, diagnostics and therapyespecially in cancer research. These technology was developed from antigenbinding fragments, originating from Camelid heavy-chain antibodies. Thesemolecules do not have light chains, which is an essential part of antibodyfound in humans. Based on the above finding, nanobodies molecule containingsingle-domain only were developed, and these molecules contain functional andstructural properties similar to heavy chain antibodies.
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These molecules have severaladvantages as compared to the conventional antibodies such as small-size, nanoto picomolar affinities, and multiple route of administration. Ablynx, which isacquired by Sanofi S.A., is one of the leading company in this market.
Nanobodies Market Drivers
Currently, no products areavailable in the market, but there are multiple products in the pipelineincluding few in very late stage of clinical trials. For instance, marketing authorizationapplication for Caplacizumab for the treatment of acquired thromboticthrombocytopenic purpura (aTTP) has been submitted to European Medicine Agency(EMA) in February 2017. The product, Caplacizumab, is expected to be launchedin Europe in 2018. Moreover, the company, Ablynx, is expected to file forbiologic license agreement to the U.S. Food and Drug Administration (FDA) in2018, and is expected to launch this product in U.S. in 2019. Both, Europe andU.S. are the key markets for any biologics including monoclonal antibodies andare expected to be the high revenue generating market for nanobodies. Hence,approval by regulatory bodies in Europe and U.S. to Caplacizumab in very nearfuture (i.e. 2018, 2019) is expected to drive the growth of global nanobodiesmarket. As per the company, Ablynx, estimates the product has potential togenerate more than US$ 1 Bn. Furthermore, there are multiple products in earlystage of clinical development i.e. preclinical, phase 0, and phase 1. Ablynxalone had 8 products in clinical development phase (i.e. phase 0 to phase 3)and overall 45 products in pipeline as of March 2017.
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Lucrative potential in the markethas motivated leading biotechnology companies such as C.H. Boehringer Sohn AG& Ko. KG, MERCK KGaA, Merck & Co., Inc., AbbVie, Inc., Novo Nordisk A/Sand Sanofi S.A. to collaborate or enter into a partnership agreement with thenanobodies manufacturer, Ablynx. In July 2017, Ablynx entered into a researchcollaboration and licensing agreement with Sanofi S.A. for the treatment ofvarious immune-mediated inflammatory diseases. As per the agreement, SanofiS.A. will get access to Ablynx’s scientists and technology platforms, and also,to certain drugs in pipeline. Furthermore, in 2015, Ablynx and Merck & Co.,Inc. expanded their collaboration agreement focused on immuno-oncology. InJanuary 2018, Sanofi S.A. made an offer to acquire Ablynx, and the offer wasunanimously recommended by Ablynx board.
Nanobodies Market Restraint
Presently, there are no productsin market, and more than two-third products in very early phase of development,and these products have to go through various phases of clinical development.Failure in clinical trials for these products or slow approval by theregulatory bodies in the market may prove to be vital restraint in this market.
Nanobodies Market Key Players
Ablynx (now part of Sanofi S. A.)is the key player in the global nanobodies market. Moreover, the company isdeveloping various products with leading biology companies such as Novo NordiskA/S, Merck & Co., Inc., Merck KGaA, AbbVie, Inc., and C.H. Boehringer SohnAG & Ko. KG.
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