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. Once approved in U.S., the company may plan to reap the maximum benefit out of it. Furthermore, the drug, Caplacizumab, is expected to have better efficiency compared to both the available treatment (i.e. plasma exchange therapy and immunosuppressant) for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). In Asia Pacific, Japan may take the lead as multiple products such as Caplacizumab, Vobarilizumab, and ALX- 0171 has successfully gone through initial phase of clinical development.

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.

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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.

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.

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Lucrative potential in the market has motivated leading biotechnology companies such as C.H. Boehringer Sohn AG & Ko. KG, MERCK KGaA, Merck & Co., Inc., AbbVie, Inc., Novo Nordisk A/S and Sanofi S.A. to collaborate or enter into a partnership agreement with the nanobodies manufacturer, Ablynx. In July 2017, Ablynx entered into a research collaboration and licensing agreement with Sanofi S.A. for the treatment of various immune-mediated inflammatory diseases. As per the agreement, Sanofi S.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. In January 2018, Sanofi S.A. made an offer to acquire Ablynx, and the offer was unanimously recommended by Ablynx board.

Nanobodies Market Restraint

Presently, there are no products in 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 the regulatory 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 is developing various products with leading biology companies such as Novo Nordisk A/S, Merck & Co., Inc., Merck KGaA, AbbVie, Inc., and C.H. Boehringer Sohn AG & Ko. KG.

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