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Global Nanobody Market and Its Impact on Therapeutics and Diagnostics

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According to MRFR analysis, the global nanobody market size is expected to register a CAGR of 17.88% from 2023 to 2032 and hold a value of over USD 2.94 billion by 2032

In recent years, the field of biotechnology has witnessed a transformative breakthrough with the advent of nanobodies and Nanobody technology. Nanobodies, also known as VHH antibodies or single-domain antibodies, are small antigen-binding fragments derived from camelid heavy-chain antibodies. Their unique properties have positioned them as powerful tools in various applications, ranging from therapeutic drug development to diagnostics and imaging.

Nanobody technology harnesses the potential of these small, robust antibody fragments. Unlike traditional antibodies, nanobodies are compact, stable, and exhibit superior tissue penetration, making them ideal candidates for therapeutic interventions. Their single-domain structure allows for precise targeting of specific antigens, minimizing off-target effects and enhancing therapeutic efficacy.

One of the most promising areas of Nanobody technology lies in therapeutic drug development. Nanobodies have demonstrated remarkable success in treating various diseases, including cancer, autoimmune disorders, and infectious diseases. Their ability to selectively bind to disease-associated targets provides a level of precision previously unseen in the world of biologics.

Nanobodies have also carved a niche in diagnostics and imaging. Their small size allows for efficient labeling and imaging of target molecules, facilitating early disease detection and monitoring. This has significant implications in fields such as medical imaging, where conventional antibodies may face limitations.

The Nanobody market is experiencing rapid growth, driven by the increasing adoption of Nanobody technology across research, diagnostics, and therapeutics. Pharmaceutical companies and research institutions are investing heavily in the development of nanobody-based products, fueling innovation and expanding the market.

Major Key Players:

Some of the key nanobody Companies are Sanofi S.A. (France), Merck KGaA (Germany), Alphamab Oncology (China), Bristol Myers Squibb (US), Novartis AG (Switzerland), GenScript Biotech Corporation (US), Sensei Biotherapeutics (US), Beroni Group (Australia), DiosCURE Therapeutics SE (Germany), ExeVir Bio BV (Belgium), and Taisho Pharmaceutical Holdings Co., Ltd. (Japan).

Segment Analysis

The global nanobody market has been segmented into type, application, and end user.

Based on type, the market has been segmented into mono-specific and multi-specific. The mono-specific segment held a larger market share in 2021. The mono-specific nanobody available in the market incuded Cablivi (Caplacizumab) marketed by Sanofi S.A. (France). In addition, many pharmaceutical organizations are investing in R&D for the discovery and development of novel multi-specific nanobody drug candidates. Thus, many multi-specific nanobody drug candidates are in various phases of clinical trials for the treatment of cancer and other chronic diseases.

Based on application, the market has been segmented into therapeutic, diagnostic, and research.

The therapeutic segment is further segmented into cancer, neurodegenerative diseases, infectious diseases, and others.  The diagnostic segment is further segmented into the detection of proteins and microorganisms, detection of small molecules, and imaging.

Based on end user, the market has been segmented into pharmaceutical & biotechnology companies, research laboratories, and others. The pharmaceutical & biotechnology companies segment held the highest share in 2021, due to the rising investment in R&D activities for the development of nanobody-based new therapeutics for the treatment of chronic disorders such as neurodegenerative diseases, rheumatoid arthritis, osteoporosis, and other conditions.

Recent Development:

Nov 2023 A collaboration between Huma Therapeutics & Merck KGaA intends to inform and assist cancer patients in managing their course of therapy. Through the partnership, a Cross-Indication Disease Management Platform will be created using Huma's technology, providing patients receiving cancer treatments from Merck KGaA, Darmstadt, Germany, with access to a care pathway and educational resources. Launched in the UK in 2024, the Cross-Indication Disease Management Platform will assist patients suffering from urothelial carcinoma, a cancer that arises from urothelial cells lining the bladder, ureters, renal pelvis, and other organs. With US Food and Drug Administration (FDA) Class II 510(k) clearance and EU MDR Class IIb regulation, Huma will leverage its disease-agnostic Software as a Medical Device (SaMD) technology platform to enable the service.

Nov 2023 The monoclonal antibody Dupixent from Sanofi and Regeneron has achieved success in a second phase 3 study for chronic obstructive pulmonary disease (COPD), making it the first biologic to treat the lung illness and the initial breakthrough in the indication in over ten years. Dupixent will have access to yet another huge market if COPD is approved. Dupixent is already on a juggernaut trajectory as a treatment for asthma, atopic dermatitis, and several other inflammatory disorders. The drug brought in $3.1 billion in the third quarter, a 33% rise year over year. The drug's revenues for the first nine months were $8.4 billion after the third quarter's success.

Regional Analysis

North America is likely to dominate the nanobody market, owing to increasing investments in R&D by the key players & research institutes coupled with well developed healthcare infrastructure in the region. Furthermore, the presence of major industry players across the region, such as Thermo Fisher Scientific Inc. (US), Sensei Biotherapeutics, Inc. (US), Cusabio Technology LLC (US), and other players are further contributing to the regional growth.

Europe is likely to account for a significant share of the nanobody market due to the presence of a well-developed healthcare infrastructure and high healthcare expenditure. For instance, according to the Eurostat database, healthcare expenditure was 8.0% of GDP in 2020. Moreover, the rising product approvals from regulatory bodies is also expected to drive the growth of the global nanobody market in Europe during the forecast period. For instance, in September 2018, Cablivi (Caplacizumab) was granted marketing authorization by the European Commission for the treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP) in adults.

Asia-Pacific is projected to be the fastest-growing regional market during the forecast period due to factors like improved healthcare infrastructure and a high percentage of the geriatric population in the region demanding efficient therapeutics. Furthermore, initiatives undertaken by key players to expand operations in the region are also boosting the market growth.

Furthermore, the growth of the market in the Rest of the World is slower compared to the other regions due to the limited healthcare infrastructure and fewer research activities. However, increasing government initiatives for improving the healthcare sector and the rising prevalence of cancer and other chronic diseases are expected to drive the market over the forecast period.

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