ID: MRFR/HC/9539-HCR | 120 Pages | Author: Rahul Gotadki | May 2023
Nanobody Market is expected to USD 1.14 billion at a CAGR 24.2% during the forecast period 2022-2030.
The nanobody market size is projected to reach USD 1.14 billion by 2030 at 24.2% CAGR during the forecast period 2022 to 2030
Nanobodies are single-domain antibodies derived from mammalian heavy-chain antibodies, with unique properties such as nanosize, robust structure, stable & soluble behavior in aqueous solutions, and reversible protein refolding among others. Nanobodies have high affinity and can specifically target the antigens with low-off target accumulation due to their hydrophilic regions. They can also tolerate high temperature & pressure, chemical denaturants, and non-physiological pH.
The market of nanobody is expected to rise significantly in the forecast period, owing to factors such as the increasing prevalence of cancer and other chronic diseases, rising R&D activities, and the success of the clinical trials of nanobody products and their subsequent approvals expected to fuel the nanobody market growth. For instance, in February 2019, the United States Food and Drug Administration (FDA) approved Cablivi (caplacizumab-yhdp), the first nanobody-based medicine, for adults with Acquired Thrombotic Thrombocytopenic Purpura (aTTP). Furthermore, key players and various government medical research organizations such as the National Institutes of Health (NIH) among others are indulged in R&D activities for the advancement of nanobodies for therapeutical treatments. This is also expected to drive the growth of the global nanobody market over the forecast period. For instance, according to an article published in Nature Journal on December 21, 2020, researchers at the National Institutes of Health isolated a set of nanobodies against SARS-CoV-2. This nanobody is called NIH-CoVnb-112, which binds and blocks the variant form of the SARS-Cov-2 spike protein.
Due to the COVID-19 pandemic, drug development and research efforts have intensified, adding pressure on the healthcare industry. Although the initial impact of the pandemic was negative due to its impact on supply chains and workforces, the increase in R&D activities by research institutes for developing novel therapeutics has overall positively impacted the demand of the nanobody market. For instance, the Aitchison Lab of Seattle Children’s Hospital (US) is developing libraries of nanobodies specific to the novel coronavirus, derived from llamas immunized with SARS-CoV-2 spike and nucleocapsid proteins. Additionally, in July 2021, DiosCURE Therapeutics SE (Germany) signed a licensing agreement with the University of Bonn (Germany), University Hospital Bonn (Germany), Scripps Research (US), and Macrostruct Holding & Consulting AB (Sweden). Through this agreement, DiosCURE Therapeutics will be the worldwide licensor for the lead drug candidates DIOS-202, DIOS-203, and DIOS-301 for the treatment of COVID-19. Therefore, the increasing R&D activities by market players owing to the prevalence of COVID-19 are expected to drive the growth of the global nanobody market during the forecast period.
The rising prevalence of cancer and other chronic disorders such as neurodegenerative diseases, rheumatoid arthritis, osteoporosis, and other conditions demands nanobodies for their diagnosis & treatment, and it shows a huge potential in treating cancer and other chronic diseases. For instance, according to World Health Organization (WHO), cancer is the primary or second leading cause of death in 112 of 183 nations before the age of 70. Similarly, as per GLOBOCAN 2020 estimates of cancer incidence worldwide, an estimated 19.3 million new cancer cases in 2020.
The inherent properties of nanobodies such as small size, high solubility, high stability, and excellent tissue penetration in vivo make them advantageous for cancer applications. Their nanoscale dimensions enable deep penetration of tumors, and some nanobodies may cross the Blood-Brain Barrier (BBB). Nanobodies also retain high affinity and specificity for their target antigens with minimal off-target accumulation due to their hydrophilic regions. In addition, Nanobodies can be utilized in cancer therapy as allosteric inhibitors to control the enzymatic activity of their target proteins or as antagonists to prevent ligand binding and conformational changes that activate signaling cascades. Moreover, Nanobodies can also be conjugated with other cancer therapies, nanoparticles, viral vectors, and imaging agents for targeted tumor visualization. Thus, nanobody is highly used for the diagnosis and treatment of cancers. Hence, the rise in cancer and other chronic disorders drives the market growth.
A failure of clinical trials due to safety issues, noncompliance, and significant concerns such as complaints by a participant or any other party may hamper the market growth. For instance, according to ClinicalTrials.gov (US), the ALX-0651 molecule of Ablynx (Belgium) was in a Phase I study to determine whether it is safe and effective after single or multiple intravenous administrations to healthy male volunteers were terminated. This, in turn, has hampered the growth of the global nanobody market.
Moreover, the nanobodies are in the initial growth stage, which increases their risk of failure. Also, there is limited regulation for the standardization of products which further hampers the growth of the market.
Radiolabeled nanobodies are appealing probes for immune landscape profiling, as they display high stability, rapid targeting, higher specificity, and the ability to penetrate the tumor. In addition, nanobodies recognize an epitope, are non-competitive to a targeted unlabeled therapeutic compound and easily identified from ‘immune’ nanobody libraries. This enables it potential to combine conventional targeted medicines with radiolabeled nanobodies as adjuvant therapy. Thus, due to the exceptionally specific targeting capacity of radiolabeled nanobodies, nanobody-based Targeted Radionuclide Therapy (TRNT) can act as an add-on therapy to improve the outcome of patients that receive monoclonal antibodies (mAb) immunotherapy. Furthermore, nanobodies against all possible cellular targets are easily identified hence emphasizing their potential as generic theranostic tools in cancer. These aforementioned factors are anticipated to drive the market growth in the forthcoming years.
Value Chain Analysis
The global nanobody market is projected to exhibit significant growth over the forecast period, which can be attributed to factors such as a rise in the number of players working on launching novel nanobody products for different indications like psoriasis, rheumatoid arthritis, refractory lymphoma, and others. Moreover, other factors include the availability of research funding and the growing number of R&D activities for the advancement of nanobodies for therapeutical treatments. The value chain analysis for the nanobody industry comprises four major components, which start with the R&D, manufacturing of the products, distribution, and end with post-marketing surveillance.
Mono-specific nanobody is a protein construct comprising at least one nanobody, which is directed against a single immuno-oncology target. For instance, Caplacizumab—a product offered by Ablynx (Belgium)—is a mono-specific nanobody.
Multi-specific nanobody is a protein construct comprising one or more nanobodies, which is directed against two or more different immuno-oncology targets.
Nanobody approaches cover a wide range of therapeutic applications for the treatment of neurodegenerative diseases, cancer, viral infectious diseases, and others. In addition, the superior properties of nanobody such as small size, high stability, strong antigen-binding affinity, water solubility, and natural origin make them suitable for development into next-generation bio drugs. Moreover, the rising prevalence of cancer and neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, and others are expected to drive market growth. For instance, according to World Health Organization (WHO), dementia currently affects approximately 10 million people in Europe, with the prevalence expected to double by 2030. Furthermore, the therapeutic segment has been sub-segmented into cancer, neurodegenerative diseases, infectious diseases, and others.
Nanobodies are an attractive alternative to traditional antibody diagnostic tools as their small shape allows access to less-accessible epitopes. In addition, nanobodies can aid in early diagnosis and cancer prevention by detecting biomarkers and also improve current mAb-based diagnostic techniques due to their high specificity. Moreover, the diagnostic segment has been sub-segmented into the detection of proteins and microorganisms, the detection of small molecules, and imaging.
Nanobodies are being used as an exquisite research tool in structural, cell, and developmental biology. In addition, the strict monomeric state and easy tailoring of nanobodies are inspired many researchers to design innovative nanobody-based products. Moreover, increasing R&D activities by research institutes for developing nanobody-based treatments are anticipated to drive the research segment growth during the forecast period.
By End User
The pharmaceutical & biotechnology companies segment is expected to hold the largest market share in 2021 due to the rapid growth of the pharmaceutical & biotechnology industry across the globe. Nanobody molecules are supporting scientists to design new therapeutics, and develop medicines that could replace complex treatment regimens with single, multi-action drugs. Moreover, rising investment in R&D activities, along with the increase in the importance of nanobody molecules in drug discovery are boosting the market growth.
A nanobody is used in research laboratories for performing R&D activities for various therapeutic areas such as cancer, chronic kidney diseases, bone disorders, psoriasis, and others. The increasing number of research laboratories may contribute to the growth of this segment.
Other end users of nanobody are contract research organizations, research and academic institutes, and others.
Rising investment in the healthcare industry is driving the North American nanobody market
North America holds the largest nanobody market share in 2021, owing to the rising investment in the healthcare industry to bring new developments & inventions related to nanobody and the presence of major key players in the region such as Genscript Biotech Corporation (US), Sensei Biotherapeutics, Inc. (US), and Cusabio Technology LLC (US) among others. Moreover, the rising prevalence of chronic diseases such as cancer, bone disorders, and others in the region further fuels the growth of the market.
Rising focus on drug development is anticipated to drive the growth of the nanobody market
The European nanobody market is driven by the rising focus on developing nanobodies to strengthen therapeutic use and increasing government initiatives for R&D. For instance, in July 2021, scientists from Max Planck Institute for Biophysical Chemistry in Göttingen (Germany) and the University Medical Center Göttingen (Germany) has developed Single Variable Domain on a Heavy Chain (VHH) antibodies or nanobodies for the treatment of COVID-19. The drug has extreme stability & outstanding efficacy against the virus and its Alpha, Beta, Gamma, and Delta mutants.
Rising prevalence of cancer and developing healthcare infrastructure fueling the Asia-Pacific nanobody market
Asia-Pacific is estimated to be the fastest-growing market due to the developing healthcare infrastructure, establishment of research organizations and increase in R&D investments by the emerging markets such as China and India. Moreover, the rising prevalence of cancer and other chronic diseases is further driving the regional growth. For instance, according to the Australian Institute of Health and Welfare, In 2021, around 151,000 people are diagnosed with cancer (413 per day).
Rest of the World:
The Rest of the World is segmented into the Middle East, Africa, and Latin America. Government initiatives to increase medical expenditure and growing biologics & therapeutic research to investigate nanobodies and their interaction with other drug molecules are contributing to the growth of the nanobody market. Additionally, the growing burden of cancer, immune-mediated inflammatory diseases, and other diseases also affect market growth.
The nanobody market is profitable, both for existing players as well as new entrants. MRFR analysis revealed that the global nanobody market is expected to grow significantly in the coming years due to the increasing R&D activities by key drug manufacturers to bring novel drugs pertaining to nanobodies, and the increasing prevalence of cancer, viral infectious diseases, and others. In addition, the market players are adopting various strategies such as mergers & acquisitions, contractual agreements, and partnering with other players to expand their global footprint. Moreover, the vendors compete based on cost, product quality, reliability, and aftermarket services and try to bring a treatment to the public. It is crucial for the players to offer cost-efficient and high-quality nanobody-based products to succeed in the competitive market environment.
List of Key Companies Covered in this Report:
The study covers the existing short-term and long-term market effects, as well as helping decision-makers to draught short-term and long-term plans for businesses by region. The report covers major regions in North America, Europe, Asia-Pacific, and the Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porter's Five Forces, Value Chain, and impact of COVID-19 on the market.
Scope of the Report
The scope of the global nanobody market study includes the market size analysis and a detailed analysis of the manufacturer's products and strategies. The market has been segmented based on type, application, end user, and region
By End User
|Market Size||USD 1.14 Billion|
|Historical Data||2018 to 2020|
|Forecast Units||Value (USD Billion)|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, and Trends|
|Segments Covered||Type, Application, and End User|
|Geographies Covered||North America, Europe, Asia-Pacific, and the Rest of the World (RoW)|
|Key Vendors||• 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) • Taisho Pharmaceutical Holdings Co., Ltd. (Japan)|
|Key Market Opportunities||• Potential use of radiolabelled nanobodies as theranostic tools for cancer therapy|
|Key Market Drivers||• Increasing prevalence of cancer and other chronic diseases • Growing number of clinical trials of various nanobody products and their subsequent approval • Rising R&D activities by biopharmaceutical and pharmaceutical companies|
The market of nanobody is anticipated to reach USD 1.14 billion at 24.2% CAGR during the forecast period 2022 to 2030
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), Taisho Pharmaceutical Holdings Co., Ltd. (Japan) are the leading players in the market of nanobody
North America holds the largest market share due to rising investment in the healthcare industry
Increasing prevalence of cancer and other chronic diseases and Growing number of clinical trials of various nanobody products and their subsequent approval are the major market drivers
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