Global Nanobodies Market - 20204-2031

Global Nanobodies Market - 20204-2031

The global nanobodies market reached US$ 502.60 million in 2023 and is expected to reach US$ 2,267.29 million by 2031, growing at a CAGR of 20.9% during the forecast period 2024-2031.

Nanobodies are also known as single-domain antibodies (sdAbs) or VHH antibodies. They are derived from the heavy-chain antibodies (HCAbs) found in camelids, such as alpacas, llamas, and camels. Unlike conventional antibodies that consist of both heavy and light chains, HCAbs are composed of heavy chains, which allows for the production of smaller antibody fragments.

The term ""VHH"" refers to the variable domain of the heavy chain, which is the part of the antibody responsible for binding to antigens. This domain is significantly smaller than the complete immunoglobulin G (IgG) antibody, with a molecular weight typically around 12-15 kDa, making it about one-tenth the size of conventional antibodies (which are approximately 150 kDa).

The versatility of nanobodies allows them to be utilized in both therapeutic and diagnostic applications. They are being employed in the treatment of cancer, neurodegenerative disorders, and infectious diseases, as well as in diagnostic applications for protein detection, imaging, and microorganism identification. This wide range of uses is significantly driving global nanobodies market expansion.

Market Dynamics: Drivers & Restraints

Advancements in precision medicine and personalized therapeutics

Advances in precision medicine and personalized therapeutics are significantly driving the growth of the global nanobodies market and are expected to drive throughout the market forecast period.

Advancements in precision medicine and personalized therapeutics are vital for the expansion of the global nanobodies market. This growth is driven by their ability to deliver customized treatments, improve targeting capabilities, minimize immunogenicity, facilitate rapid development, and support a wide range of applications across various diseases. Additionally, the integration of nanobodies into diagnostic tools enhances their significance in personalized medicine, positioning them as a promising avenue for improving patient outcomes through tailored therapeutic strategies.

Advancements in precision medicine and personalized therapeutics are demanding the global nanobodies market. These developments emphasize the customization of medical treatments to align with individual patient characteristics, such as genetic makeup, environmental influences, and lifestyle factors. Precision medicine seeks to tailor treatment strategies based on specific patient attributes rather than employing a generalized approach.

Nanobodies are particularly well-suited for this personalized strategy due to their unique properties, including high specificity and strong affinity for their targets. They can be engineered to bind selectively to disease-specific antigens, facilitating targeted therapies that reduce off-target effects and enhance therapeutic efficacy. All these factors demand the global nanobodies market.

Moreover, the rising increasing incidence of chronic diseases contributes to the global nanobodies market expansion.

High production costs

The high production costs are expected to hinder the global nanobodies market growth. The production of nanobodies involves complex biotechnological processes, including recombinant DNA technology and phage display, which necessitate specialized equipment and skilled personnel. These complexities contribute to significantly higher production costs compared to traditional monoclonal antibodies (mAbs).

For instance, according to the Kerafast custom nanobody production can reach prices as high as $18,000 for just 1 mg. Such costs may limit accessibility for smaller research institutions and hinder widespread adoption in clinical settings. Similarly, from the same source, the production of nanobodies is associated with high costs, with prices reaching up to $21,000 for just 1 mg in some cases. Thus, the above factors could be limiting the global nanobodies market's potential growth.

Segment Analysis

The global nanobodies market is segmented based on product type, application, end-user, and region.

Product Type:

Monovalent nanobodies segment is expected to dominate the global nanobodies market share

The monovalent nanobodies segment holds a major portion of the global nanobodies market share and is expected to continue to hold a significant portion of the global nanobodies market share during the forecast period.

Monovalent nanobodies are specifically designed to target a single antigen with high specificity. This design simplifies their application in diagnostics and research, making them valuable tools across various settings. Their selective binding capability enhances their effectiveness in identifying specific biomarkers, which is particularly important in the context of precision medicine.

There is a rising need for molecular probes utilized in research, diagnostics, and imaging applications. Monovalent nanobodies are particularly well-suited for these roles due to their small size and high affinity, enabling them to effectively target and visualize specific molecules within complex biological systems.

Furthermore, monovalent nanobodies have emerged as a promising alternative to conventional monoclonal antibodies in cancer therapy. These factors have solidified the segment's position in the nanobodies market. For instance, according to the NCBI research publication in January 2023, monovalent nanobodies exhibit superior abilities to target tumor-associated macrophages compared to bivalent nanobodies, particularly in tumor environments. Their enhanced diffusion and selective binding make them effective tools in cancer therapy.

Additionally, using bivalent nanobodies can help reduce peripheral antigenic sinks, thereby increasing the availability of monovalent nanobodies in tumors and optimizing their therapeutic effectiveness. This research provides valuable insights into how different formats of nanobodies can be strategically utilized to improve cancer treatment outcomes by enhancing the targeting of immune cells within tumors. These factors have solidified the segment's position in the nanobodies market.

Bispecific nanobodies segment is the fastest-growing segment in the global nanobodies market share

The bispecific nanobodies segment is the fastest-growing segment in the global nanobodies market share and is expected to hold the market share over the forecast period.

Bispecific nanobodies are specifically designed to bind to two different antigens or epitopes at the same time. This unique feature enables them to target multiple pathways, which can lead to better therapeutic outcomes, especially in complex diseases like cancer where various mechanisms are often involved.

The ability of bispecific nanobodies to simultaneously target tumor-associated antigens and immune checkpoints, such as PD-1 and CTLA-4, can significantly boost anti-tumor activity. Research has indicated that these bispecific nanobodies can effectively inhibit tumor growth by engaging T cells more efficiently than traditional monoclonal antibodies. For instance, the oncogene research study in May 2024, showed that bispecific nanobodies can enhance T-cell activation and improve overall anti-tumor responses, demonstrating their potential as powerful tools in cancer immunotherapy. These factors have solidified the segment's position in the nanobodies market.

Application :

Therapeutic segment is expected to dominate the global nanobodies market share

The therapeutic segment holds a major portion of the global nanobodies market share and is expected to continue to hold a significant portion of the nanobodies market share during the forecast period.

Therapeutic applications include cancer, neurodegenerative diseases, infectious diseases, inflammatory and autoimmune diseases, and others. Nanobodies are anticipated to have extensive potential in various aspects of infectious diseases, including the inhibition of viral replication and entry into cells, neutralization of viral toxins, stimulation of the human immune response, and elimination of virus-infected cells.

They are gaining increasing interest for their applications in preventing and treating bacterial toxins, as well as addressing traditional and acute infectious diseases. Recent clinical and experimental findings suggest that nanobodies, especially when formulated into multimeric and functionalized molecules, will play a significant role in future diagnostic and therapeutic tools, particularly for infectious diseases.

For instance, the epidermal growth factor receptor (EGFR) is frequently overexpressed in many tumors, making it a valuable target for cancer therapies. Nanobodies specifically designed to target EGFR have been developed and successfully utilized in diagnosing breast, ovarian, and prostate cancers.

Furthermore, key players in the nanobodies industry product launches and approvals that would drive this segment growth in the nanobodies market. For instance, in November 2021, Envafolimab received approval from the National Medical Products Administration (NMPA) in China for use in adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors.

This includes patients with advanced colorectal cancer who have experienced disease progression after treatment with standard chemotherapy regimens, such as fluoropyrimidine, oxaliplatin, and irinotecan. The approval signifies that Envafolimab can be used when no satisfactory alternative treatment options are available. These factors have solidified the segment's position in the nanobodies market.

Diagnostic segment is the fastest-growing segment in the global nanobodies market share

The diagnostic segment is the fastest-growing segment in the global nanobodies market share and is expected to hold the market share over the forecast period.

Diagnostic applications include the detection of proteins and microorganisms, detection of small molecules, and imaging techniques. Nanobodies are gaining significant attention in the field of diagnostics due to their unique characteristics and advantages over conventional monoclonal antibodies (mAbs). Ongoing research and development are focused on exploring various applications of nanobodies across different diagnostic methods.

Nanobody-based immunoassays are highly effective tools for detecting and identifying various targets, including foreign pathogens and toxins that are often difficult to detect using standard clinical methods. Additionally, nanobodies are employed in advanced molecular imaging techniques such as positron emission tomography (PET), single photon emission computed tomography (SPECT), near-infrared fluorescence (NIR), and ultrasound molecular imaging, enhancing disease diagnosis capabilities. These factors have solidified the segment's position in the nanobodies market.

Geographical Analysis

North America is expected to hold a significant position in the global nanobodies market share

North America holds a substantial position in the global nanobodies market and is expected to hold most of the market share.

The increasing incidence of chronic diseases, such as cancer and autoimmune disorders, is driving the need for effective nanobodies treatment solutions. There is an increasing inclination towards targeted therapies across various medical fields, especially in oncology. Nanobodies, recognized for their high specificity and ability to bind to intricate biomolecules, are considered ideal candidates for such targeted treatment options. Their distinct properties facilitate improved therapeutic outcomes while minimizing side effects compared to traditional monoclonal antibodies.

Moreover, in this region, a major number of key player's presence, well-advanced healthcare infrastructure, strong investment in research and development, technological advancements and product launches & approvals help to propel the nanobodies market growth. For instance, in February 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (brand name CARVYKTI), an innovative nanobody-based CAR-T cell therapy developed by Legend Biotech in collaboration with Janssen Biotech, for the treatment of relapsed or refractory multiple myeloma in adults. Thus, the above factors are consolidating the region's position as a dominant force in the nanobodies market.

Asia Pacific is growing at the fastest pace in the global nanobodies market

Asia Pacific holds the fastest pace in the global nanobodies market and is expected to hold most of the market share.

The Asia-Pacific region is experiencing a significant increase in its elderly population, which is more vulnerable to chronic diseases such as cancer and autoimmune disorders. This d shift is driving the demand for innovative therapeutic options, including nanobodies.

Chronic diseases are becoming increasingly prevalent in the Asia-Pacific region, particularly cancer and infectious diseases. For instance, the National AIDS Control Organization (NACO) reported around 62,970 new HIV infections in India in 2021, this demands effective treatment solutions such as nanobodies. The increasing burden of such diseases is fueling the demand for targeted therapies like nanobodies.

The region is enhancing its research capabilities through increased investments in biotechnology and pharmaceutical research. Countries such as China and India are focusing on strengthening their healthcare systems and fostering research institutions specializing in nanobody technology. This commitment to developing advanced medical solutions is contributing significantly to nanobodies market growth.

Japan, China, and India are expected to hold the largest market share within the Asia-Pacific region due to their robust pharmaceutical industry, significant investments in biopharmaceutical research, and product launches & approvals. The country’s commitment to advancing healthcare technology positions it as a leader in the nanobodies market.

For instance, in September 2022, Ozoralizumab (Nanozora) is a novel therapeutic agent that was first approved in Japan for the treatment of rheumatoid arthritis (RA). Ozoralizumab is classified as a trivalent anti-tumor necrosis factor alpha (TNFα) nanobody compound. It is designed to inhibit the action of TNFα, a cytokine that plays a critical role in the inflammatory processes associated with rheumatoid arthritis. Thus, the above factors are consolidating the region's position as the fastest-growing force in the nanobodies market.

Competitive Landscape

The major global players in the nanobodies market include Sanofi, Biocytogen, Abnova Corporation., Proteintech Group, Inc., CUSABIO TECHNOLOGY LLC, Sino Biological, Inc., Capra Science, LubioScience GmbH, R&D Systems, Inc., ProteoGenix, and Kerafast among others.

Emerging Players

The emerging players in the global nanobodies market include GT Biopharma, Inc., MoonLake TX, Legend Biotech., and Rapid Novor, Inc. among others.

Key Developments
• In May 2024, MoonLake Immunotherapeutics, a clinical-stage biotechnology company focused on developing innovative therapies for inflammatory diseases, announced the initiation of its global Phase 3 clinical program called VELA. This program is designed to evaluate sonelokimab, an investigational nanobody, in patients suffering from moderate-to-severe hidradenitis suppurativa (HS).
• In March 2024, MoonLake Immunotherapeutics announced significant progress regarding its investigational nanobody, sonelokimab, in treating psoriatic arthritis (PsA). The company reported that continued treatment with sonelokimab led to substantial improvements in key clinical outcomes at the 24-week mark of the ARGO trial, a Phase 2 clinical trial specifically designed to evaluate the efficacy and safety of sonelokimab in patients with active PsA.
• In February 2023, Biocytogen Pharmaceuticals (Beijing) Co., Ltd. announced the launch of the “Nano 100 Project,” which aims to develop fully human nanobody drugs targeting over 100 different therapeutic targets. This initiative leverages Biocytogen’s proprietary RenNano mouse, a specially engineered model designed to produce fully human nanobodies, in conjunction with advanced high-throughput in vitro and in vivo antibody screening platforms.
• In December 2022, Taisho Pharmaceutical Co., Ltd. announced the launch of Nanozora 30 mg syringes for subcutaneous injection, which contains the active ingredient ozoralizumab, a genetically recombined TNFα inhibitor.

Why Purchase the Report?
• To visualize the global nanobodies market segmentation based on product type, application, end-user, and region and understand key commercial assets and players.
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• Excel data sheet with numerous data points of the nanobodies market with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in excel consisting of key products of all the major players.

The global nanobodies market report would provide approximately 65 tables, 56 figures, and 184 pages.

Target Audience 2023
• Manufacturers/ Buyers
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• Research Professionals
• Emerging Companies

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