The developed as useful class of biomolecules for research

The last
century saw tremendous growth in development of chemotherapy and antibiotics
based treatment of chronic inflammation, autoimmune diseases, cancer,
infectious diseases etc. They came with severe adverse effects, such as pain, insomnia,
fatigue, nausea, gastrointestinal conditions, and non-targeted actions, which
affect the quality of life of patients. Therefore, the need was to develop new
technologies for treatment of diseases.

 Here comes the role of
immunotherapy which target a disease by inducing, enhancing, or suppressing
patients own immune system, using immunomodulators including antibodies and
cytokines. Since the approval of first therapeutic mAb, Orthoclone OKT3;  FDA and EMA (European Medicine Agency) has given
approval to 68 mAbs, Fabs and scFV based immunotherapeutic drugs for treatment
of various diseases. The significance of the immunotherapy is evident from its
global market share, wherein   cancer
immunotherapy alone was valued at US$40.7 billion in year 2016 and expected to
reach US$124.88 billion by the end of year 2024. Increasing awareness about immunotherapeutic
coupled with the advantages it offers, technological advancement, rapid
adoption and increasing demand from emerging economies are driving the growth
for the market.

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Overwhelming
evidence in the literature suggests that camelid VHHs, have many additional
features that supersede those of conventional mAbs and antibody fragments (Fab
and scFv). Due to small size (15KDa MW), greater stability, they can be easily
reproduced in various expression systems and have been developed as useful
class of biomolecules for research and various medical diagnostic and
therapeutic applications over the last two decades. They have ability to
specifically recognize unique epitopes with sub-nanomolar affinity and were
given name “Nanobodies” by the developer Ablynx
in year 2013. It is expected that the first VHH-based drug (Caplacizumab; bivalent anti-vWF nanobody
for treating rare blood clotting disorders) will reach the market sometime in
2018

VHHs
are also well suited in the generation of bi- and multispecific antibodies. Bispecific
VHHs may be uniquely positioned for these applications given their simple
design and small size relative to other antibody fragments, which may result in
better solid tumor penetration rates, homogeneous production at high yield in
microbial systems, and ease of fusion to a heterodimerization motif. Thus, its
evident that nanobodies based immunotherapeutic drugs hold a strong future for
treatment of cancer, autoimmune diseases, inflammation and viral infections.

This
concise report contains IP filing trend analysis of patent applications filed
in 2017 in the domain of Nanobodies, and in-depth analysis of IP trend in this
technology. In addition, we highlight their potential for use in
various applications and the market value.