The United States Nanobodies Market is estimated to be valued at USD 109.87 Mn in 2024 and is expected to reach USD 334.97 Mn by 2031, growing at a compound annual growth rate (CAGR) of 17.3% from 2024 to 2031.

Factors such as increasing investment in research and development for production of nanobodies for various therapeutic applications, rising demand for nanobodies due to their high specificity and ability to target complex epitopes are driving the market growth.

Market Driver – Increasing Adoption of Next Generation Diagnostics and Therapeutics

The field of diagnostics and therapeutics in the United States is currently undergoing a revolution with the adoption of next generation technologies. Nanobodies hold tremendous potential in this area due to their unique properties like small size, stability, and ability to target specific disease markers. Nanobodies have shown great promise as diagnostic tools that can detect biomarkers with high sensitivity and specificity. For example, recent research has demonstrated the utility of nanobodies in developing rapid and low-cost at-home test kits for infectious diseases like COVID-19 (World Health Organization, 2022). This could significantly improve testing rates and enable timely medical intervention.

On the therapeutics front as well, nanobodies are being extensively researched for their ability to precisely deliver drugs inside the body. Pharmaceutical companies are actively developing nanobody-based therapies for various oncological, immunological, infectious and rare genetic disorders. For example, researchers in the U.S. have designed nanobodies that can transport gene editing machinery like CRISPR-Cas9 into cells to correct genetic mutation.

Market Driver – Increasing Awareness About Early Diagnosis of Diseases

Over the past few years, there has been a significant emphasis on early detection and diagnosis of disease as this can greatly improve patient outcomes and survival rates. Healthcare providers and advocacy groups across the US have launched various awareness campaigns to educate the general public about the importance of regular screenings and checkups, even if no symptoms are present. This has led to an increase in the number of people getting tested proactively. However, traditional diagnostic methods are often invasive, can delay results, and cause discomfort. Nanobodies present a promising alternative as they can enable minimally invasive and highly sensitive detection directly in a patient sample. Their small size allows them to quickly penetrate tissues and detect even minute biomarkers. Leading organizations are working on developing nanobody-based tests that can be performed at home or point-of-care to improve accessibility and turnaround times.

The focus on early diagnosis is well supported by data. For example, according to American Cancer Society breast cancer reports from 2021, the 5-year relative survival rate for women diagnosed with localized breast cancer is 99%.

Market Challenge – Higher Production Cost & Limitations

Higher production costs and technical limitations are significantly restraining the growth of the United States nanobodies market. Producing nanobodies involves complex biotechnological processes such as recombinant monoclonal antibody technology and phage display to derive therapeutic monoclonal antibodies from camelidae animals like camels, llamas and alpacas. These state-of-the-art antibody engineering methods require specialized laboratory equipment, highly skilled biotechnicians and sustained investments in research and development. As a result, the manufacturing costs of nanobodies are substantially high compared to traditional monoclonal antibodies produced in mammalian cell lines.

The high capital intensiveness of nanobody production means any inefficiency or technical snag along the complex production workflow acts as a major hurdle. It drastically increases the per unit costs, making nanobodies less competitive and uneconomical for widespread clinical and commercial applications. For example, according to the data published by the United States Department of Agriculture in 2021, the equipment costs for setting up a medical biotech production facility adhering to cGMP standards ranges from $50-100 million.

Market Opportunity – Strong Focus on Research and Development

A significant area of opportunity in the US nanobodies market lies in ramping up research and development efforts. Nanobodies have immense potential to transform various fields like diagnostics, therapeutics and bioimaging due to their small size and high stability. However, more research is required to fully unlock this potential. Directing greater funding and resources towards basic research from both public and private sources could explore new applications of nanobodies. This may include developing nanobodies that can target complex diseases, enhance drug delivery capabilities or enable earlier disease detection among others.

Intensifying R&D collaborations between leading research institutes and biotech companies could also fast-track innovations. Several new discoveries in the past few years related to customizable nanobody design and production have laid the foundation for future advancements. However, these need to be scaled up from conceptualization to product development. Sustained government grants for collaborative projects involving universities and small biotech start-ups through agencies like the National Institutes of Health can help shorten this timeline. It will also help build expertise in this niche area within the country.

Insights, By Product Type: Multifunctional Capabilities Drive Growth of Bivalent Nanobodies

Bivalent nanobodies sub-segment contribute 54.9% to the US nanobodies market owing to their unique ability to target two different epitopes or antigens simultaneously. By linking two nanobody domains, bivalent nanobodies can bind to two separate binding sites on a target molecule or connect two different targets. This bifunctional design allows bivalent nanobodies to elicit stronger biological effects compared to monovalent nanobodies. Their increased avidity and affinity enable bivalent nanobodies to more effectively cross-link or cluster cell surface receptors and ligands. This multifunctional mechanism of action makes bivalent nanobodies highly effective for various therapeutic applications.

In oncology, bivalent nanobodies that concurrently bind tumor cells and immune cells help boost anti-tumor immune responses. The dual targeting ability facilitates immune cell clustering and activation at tumor sites. Bivalent nanobodies are also being explored for delivering two different payloads like drugs and imaging agents to tumors for enhanced therapeutic indices and diagnostics. In inflammatory diseases, bivalent nanobodies can bind soluble cytokines and their receptors to simultaneously block inflammatory signaling pathways. Such multi-epitope engagement enables bivalent nanobodies to more potently neutralize disease mediators compared to monoclonal therapies. Overall, the unique dual-targeting feature addresses complex disease biology through multifunctional mechanisms, positioning bivalent nanobodies as a promising platform technology.

Insights, By Therapeutic Area:

Inflammatory and autoimmune diseases sub-segment contribute XX% to the US nanobodies market driven by significant unmet needs. These chronic conditions involve an imbalance of immune system activation leading to tissue and organ damage over time. Current treatment options are often associated with severe side effects from long-term systemic immunosuppression. Nanobodies provide a precise and well-tolerated alternative for modulating immune responses in inflammatory diseases. Their small size allows deep tissue penetration for effective delivery to sites of inflammation while minimizing off-target effects.

Notably, nanobodies show promise for neutralizing pro-inflammatory cytokines central to many autoimmune diseases. Given as biologics, nanobodies can selectively inhibit excess cytokine activity to reduce inflammation. As cytokine pathways often involve both soluble mediators and cell surface receptors, bispecific nanobodies offer advantages through their dual targeting capabilities. Nanobodies are also being developed to deplete only pathogenic immune cell subsets instead of broadly suppressing whole immune pathways. Such selective targeting enables nanobodies to achieve stronger clinical responses against autoimmune diseases with improved safety profiles versus existing drugs. As the immune etiology of many chronic diseases is still being elucidated, nanobodies also enable exploring new disease targets and pathways to address unmet needs.

The major players operating in the United States Nanobodies Market include Merck KGaA, Sanofi, GenScript, Numab Therapeutics, CUSABIO TECHNOLOGY LLC, Proteintech Group, Inc., GT Biopharma, Inc., Confo Therapeutics, QVQ, and MoonLake.

• On June 20, 2023, Alamar Biosciences, a privately held life sciences company, and Frazier Life Sciences, a venture capital fund, announced the launch of Attovia Therapeutics, a new company that focuses on developing biotherapeutics for immune-mediated illness and cancer. The firm which is built on Attobody, Alamar's innovative patented biparatopic nanobody platform, completed a US$ 60 million Series A funding led by Frazier and joined by venBio and Illumina Ventures.
• In October 2020, the Government Royapettah Hospital (GRH) in Chennai, India, organized an awareness program on breast cancer in India. This campaign helped in early detection, diagnosis, and availability of advanced technologies to improve survival rate of patients.
• In June 2021, Sensei Biotherapeutics, a clinical-stage biotechnology company, announced the reprioritization of next-generation multi-antigenic immunophage platform, monoclonal antibody, and nanobody programs
• In January 2021, Sanofi, a multinational pharmaceutical and healthcare company, announced the acquisition of Kymab, a pharmaceutical company, to add KY1005 to its pipeline. KY1005 is a human monoclonal antibody targeting key immune system regulator OX40L.
• In October 2020, Proteintech, a biotechnology company that manufactures antibodies, announced the acquisition of ChromoTek, a manufacturer of Camelid, single-domain antibodies called as nanobodies.

• By Product Type
  • Monovalent Nanobodies
  • Bivalent Nanobodies
  • Bispecific Nanobodies
  • Biparatopic Nanobodies
  • Multivalent Nanobodies
  • Fusion Nanobodies
• By Therapeutic Area
  • Oncology
  • Infectious Diseases
  • Inflammatory and Autoimmune Diseases
  • Neurological Disorders
  • Others