Nanobodies Market By Application (Therapeutics, Diagnostics, Research Tools); By Therapeutic Area (Oncology, Autoimmune Diseases, Neurology, Infectious Diseases); By End User (Biopharma Companies, Academic Research Institutes, Diagnostic Labs, CDMOs); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global Nanobodies Market will witness a strong CAGR of 13.8%, valued at USD 1.4 billion in 2024 and expected to reach nearly USD 3.1 billion by 2030 , according to Strategic Market Research.

 

Nanobodies — also referred to as single-domain antibodies — are reshaping the biologics landscape. Sourced from camelids and engineered for human use, these miniature antibodies offer the specificity of monoclonal antibodies without the size-related limitations. In therapeutic settings, nanobodies are proving especially useful where conventional antibodies fall short: crossing the blood-brain barrier, binding hidden epitopes, and remaining stable in harsh biological conditions.

 

This market’s trajectory from niche to mainstream is no accident. The success of Caplacizumab , the first approved nanobody-based drug, validated the platform clinically and commercially. Since then, interest has surged in neurology, oncology, immunology, and infectious disease — both for nanobody therapies and diagnostics. Nanobodies are also entering CAR-T constructs and inhalable biologics, indicating a much broader utility than previously imagined.

 

From a technical standpoint, the advantages are hard to ignore. Nanobodies can be expressed in bacterial systems, lowering production costs and timelines. Their modularity makes them ideal candidates for multi-specific formats, bispecifics , and targeted payload delivery. These properties are attracting biotechs and large pharmas alike — not only for novel therapeutics but also as tools for imaging, neutralization, and even point-of-care diagnostics.

 

Investors are following suit. In the last three years, venture capital has poured into nanobody start-ups, especially those focused on immune-oncology and neurodegeneration. Several early-stage biotechs are also being acquired for their nanobody libraries or engineering IP — signaling a scramble to secure platform rights early.

 

From a policy lens, nanobody therapies are benefiting from accelerated regulatory pathways. Orphan drug designations, fast-track reviews, and growing interest in rare disease tools are pushing regulators to consider nanobody-based candidates with fewer bureaucratic hurdles.

 

This market also has a strong academic undercurrent. Many nanobody discovery platforms have spun out of university labs and continue to benefit from deep research pipelines. Strategic partnerships between academia and pharma are now standard — helping translate preclinical potential into commercial success faster than traditional antibody programs.

 

To be honest, nanobodies are no longer just the “small cousin” of monoclonals. They’re becoming their own class — functionally distinct, clinically powerful, and commercially scalable.

 

Market Segmentation And Forecast Scope

The nanobodies market cuts across a broad set of clinical and commercial dimensions. Unlike traditional antibody markets, segmentation here isn’t just about disease targets — it’s about modality, delivery format, use case, and production model. Based on inferred research patterns and current pipeline activity, the market can be segmented into four primary dimensions: by application , by therapeutic area , by end user , and by region .

By Application

Nanobodies are being deployed in both therapeutic and non-therapeutic formats. The most prominent application remains therapeutics, which accounted for an estimated 64% of market share in 2024. This includes anti-inflammatory agents, immune checkpoint inhibitors, and blood-clotting regulators. Diagnostics — both in vivo and in vitro — represent a fast-emerging secondary category. Here, nanobodies are used as imaging agents or biosensors, particularly in oncology and infectious disease. A third and growing application is research tools, where nanobodies are used to probe protein-protein interactions or as crystallography binders.

The fastest-growing application? Therapeutic nanobodies in neurodegenerative diseases. Their ability to cross the blood-brain barrier is opening doors that traditional antibodies could never access.

 

By Therapeutic Area

On the disease front, oncology remains the most commercially advanced segment. Nanobodies are being trialed for solid tumors , hematologic malignancies, and immune-oncology targets such as PD-L1 and CTLA-4. Autoimmune and inflammatory disorders are close behind, with nanobody constructs showing promise in conditions like rheumatoid arthritis, ulcerative colitis, and lupus.

What’s catching investor attention lately is the application in neurology — particularly Alzheimer’s, Parkinson’s, and multiple sclerosis. Nanobodies’ small size allows better brain penetration, which is a major hurdle for full-sized antibodies.

Infectious diseases also represent a growing target, with several nanobody candidates in development for COVID-19, RSV, influenza, and HIV. In fact, the pandemic fast-tracked global awareness of nanobodies’ potential in respiratory viral neutralization.

 

By End User

The commercial distribution of nanobody-based products is still emerging. At present, biopharmaceutical companies dominate the usage landscape, especially those involved in rare disease and immunotherapy R&D. Academic and research institutes are major end users as well — particularly in structural biology, virology, and preclinical drug screening.

Contract research organizations (CROs) and CDMOs are playing a rising role in scaling nanobody manufacturing. These partners are being pulled into the market as biotech firms lacking in-house capabilities seek out scalable production solutions, especially for GMP-grade material.

 

By Region

Regionally, North America leads in terms of clinical trial activity, funding, and regulatory momentum. The U.S. alone hosts over 70% of nanobody clinical programs currently in Phase I or II. Europe follows closely, particularly Belgium and the Netherlands, which were early innovators in nanobody discovery.

Asia Pacific is moving from laggard to accelerator. China and South Korea have ramped up their biologics infrastructure, and several nanobody-focused biotech firms are emerging in Shanghai and Seoul. Latin America and Middle East & Africa remain largely untapped but may benefit from licensing models once first-wave nanobody products become commercialized.

In summary, the segmentation of this market is evolving from basic use cases to platform-based models. What was once a tool for rare disease now spans diagnostics, mainstream therapeutics, and modular bioconjugates. The commercial logic here is clear: nanobodies don’t just fit existing biologics categories — they create new ones.

 

Market Trends And Innovation Landscape

Nanobody innovation is no longer confined to academic curiosity — it’s now a full-blown industrial movement. From platform redesigns to multi-specific therapeutics, the market is being shaped by a new generation of bioengineers, biotechs , and pharma R&D teams. In many ways, nanobodies are forcing a rewrite of how we think about biologics — not just in size and specificity, but also in format, delivery, and function.

One of the biggest trends driving nanobody R&D is modular engineering. Nanobodies are now being stitched together into multi-domain therapeutics — trivalent, tetravalent, or even hybrid formats combining T-cell engagers, checkpoint inhibitors, and masking domains. These constructs promise not just better binding, but smarter pharmacokinetics and tunable immunogenicity.

 

Several oncology programs are now pairing nanobodies with cytotoxic payloads to build smaller, faster-clearing antibody-drug conjugates — ideal for solid tumor penetration where full-sized antibodies fall short.

 

Another frontier gaining traction is inhalable nanobody therapeutics. During the COVID-19 pandemic, early trials showed that nanobodies could be formulated into aerosols — allowing direct delivery to lung tissues. This is particularly relevant for respiratory viruses and inflammatory diseases like asthma or COPD. The implications are massive: biologics that don’t require injection, refrigeration, or infusion centers .

 

On the computational side, AI-guided antibody design is seeping into the nanobody space. Machine learning tools are being used to predict binding affinity, structural stability, and epitope coverage — shaving months off lead candidate optimization. Some startups are training models exclusively on nanobody scaffolds, creating databases that will drive the next wave of structure-based drug design.

 

Diagnostics are also seeing innovation. Nanobodies are being used to develop high-precision biosensors and PET imaging agents. Their small size and rapid clearance make them ideal for real-time imaging — especially in oncology and neurology. In Alzheimer’s research, nanobody-based tracers are being explored to visualize tau and beta-amyloid plaques with improved resolution compared to standard tracers.

 

There’s also momentum in nanobody-based CAR-T platforms . Replacing conventional scFvs with nanobody domains in CAR constructs is being tested to reduce tonic signaling and improve tumor infiltration. These are still early-stage programs, but they could reset the rules for adoptive cell therapy in solid tumors.

 

Perhaps the most under-the-radar trend? Microbiome-targeted nanobodies. A few research groups are developing oral nanobody therapies designed to act directly in the gut — binding bacterial virulence factors without being absorbed systemically. If successful, this could unlock a whole new class of local biologics.

 

Behind many of these breakthroughs are strategic partnerships. Pharma companies are quietly licensing nanobody libraries from academic labs. Venture-backed startups are co-developing therapeutics with CROs. And government grants — especially in Europe and Asia — are funding translational nanobody research in niche diseases.

 

To be honest, innovation in this market isn’t about doing what monoclonals do, only smaller. It’s about reimagining what biologics can be. Fast-acting. Low-cost. Self-administered. Combinable. And purpose-built for new biology.

 

Competitive Intelligence And Benchmarking

The nanobodies market is still young — but it’s already drawing clear battle lines between platform pioneers, agile biotechs , and large-cap pharmas trying to get a piece of the next-gen biologics pie. Unlike traditional monoclonal antibody markets, nanobody competition isn’t just about pipeline depth. It’s about platform defensibility, modularity, and clinical versatility.

Ablynx remains the category-defining player. Now a wholly owned subsidiary of Sanofi, Ablynx commercialized the world’s first nanobody therapeutic — Caplacizumab — and retains the broadest IP portfolio in the space. Their nanobody platform spans multiple indications including thrombosis, inflammation, and respiratory illness. What gives Ablynx its edge is both depth and duration — they’ve been building their scaffold libraries for over two decades.

 

Sanofi , leveraging Ablynx’s engine, is scaling up nanobody R&D across inflammation and oncology. Their clinical strategy includes standalone nanobody drugs and bispecifics combining nanobodies with traditional Fab regions. In doing so, Sanofi is hedging its biologics pipeline with modularity and speed-to-clinic advantages.

 

Berkeley Lights is positioning itself upstream — supplying discovery platforms that help biotech and pharma partners screen nanobody candidates with high-throughput single-cell workflows. While not a therapeutic developer itself, it plays a crucial enabling role and is deeply embedded in early-stage programs.

 

LaNova Medicines , a China-based biotech, is gaining visibility for its nanobody-based therapies targeting HER2 and PD-L1. Their programs combine nanobodies with proprietary linker technologies for improved tumor targeting. They’re part of a wave of Asian firms aiming to leapfrog into global clinical relevance by specializing in next-gen scaffolds.

 

Merck & Co. is a late but aggressive entrant. It recently announced nanobody development programs in immuno-oncology, leveraging external licensing deals rather than internal discovery. The move mirrors how Merck entered the mRNA space — by acquisition and collaboration rather than in-house R&D.

 

Other players worth noting include Teneobio (acquired by Amgen), Biolojic Design, and ExpreS2ion Biotechnologies. These firms are exploring niche applications of nanobodies: from immune engagers and multi-target constructs to vaccine scaffolds and enzyme inhibitors.

 

What separates frontrunners from followers in this space?

• Platform ownership vs. program licensing. Firms like Ablynx and Biolojic own their libraries and design engines. Others are licensing or white- labeling .

• Indication diversity. The more successful players are spreading across autoimmunity, oncology, and infectious disease — not putting all their bets in one clinical category.

• Manufacturing know-how. Since nanobodies can be produced in microbial systems, companies with optimized E. coli or yeast expression systems are pulling ahead on cost and scalability.
   

It’s also worth watching academic spinouts. Institutions like VIB (Belgium), UCSF, and the Karolinska Institute are patenting nanobody libraries with high-affinity scaffolds for niche indications. These spinouts often punch above their weight, especially in rare disease and neurodegeneration programs.

 

Unlike traditional biotech races that play out over decades, nanobody competition is compressing fast. IP stakes are being claimed, trials are moving faster due to lower toxicity profiles, and regulators are showing early willingness to evaluate nanobody-based biologics through expedited pathways.

 

To be honest, this isn’t a crowded market — it’s a focused one. But the companies that understand nanobodies aren’t just mini-antibodies — they’re designable therapeutic platforms — will lead the pack.

 

Regional Landscape And Adoption Outlook

The nanobodies market may be global in ambition, but regional adoption is playing out in very different ways — shaped by infrastructure, regulatory fluidity, academic investment, and biotech maturity. While North America and Europe are steering early innovation, Asia is fast becoming a strategic battleground for both development and manufacturing. Meanwhile, untapped white space exists in regions that haven’t traditionally prioritized next-gen biologics.

North America continues to lead the market in both R&D funding and clinical-stage nanobody programs. The United States, in particular, accounts for a significant share of active trials, driven by a dense cluster of biotech hubs in Boston, San Diego, and the Bay Area. The FDA’s responsiveness to novel biologics — especially with orphan and breakthrough therapy designations — has helped accelerate nanobody development.

Large-scale academic institutions like Stanford, Harvard, and the NIH are involved in nanobody discovery through structural biology and rare disease research programs. Several U.S. CROs have also upgraded capabilities to support nanobody-based IND submissions, which lowers the barrier for smaller biotechs entering the space.

Canada is making quieter but strategic moves, particularly in nanobody diagnostics. Universities in Toronto and Montreal have published early work on nanobody PET imaging tracers, some of which are now being spun into startup ventures.

 

Europe has deep roots in nanobody discovery — after all, the original concept emerged from labs in Belgium. Today, countries like Belgium, the Netherlands, and Germany remain core to the IP pipeline. The European Medicines Agency (EMA) has provided favorable regulatory feedback on early nanobody submissions, especially in rare disease.

What gives Europe an edge is its public-private innovation ecosystems . Programs like Horizon Europe and regional biotech clusters (e.g., BioValley in Switzerland, Medicon Valley in Denmark) are funding nanobody therapeutics and diagnostics through cross-border research consortia.

That said, some parts of Europe — particularly Southern and Eastern countries — still lag in commercial-scale nanobody manufacturing. These regions may become future licensees or distribution partners, but aren’t driving innovation directly.

 

Asia Pacific is shifting from follower to innovator. China, South Korea, and Japan are now home to emerging nanobody platforms — many of them backed by national biotech stimulus programs. China’s NMPA has begun fast-tracking clinical reviews for novel antibody formats, and several Chinese firms are developing PD-1 and HER2-targeting nanobody therapies.

South Korea is pushing ahead with inhalable nanobody therapeutics for respiratory diseases, supported by partnerships between Seoul-based hospitals and local biotechs . Japan, known for biologics manufacturing precision, is exploring nanobody-integrated biosensors and smart diagnostics — particularly for point-of-care infectious disease screening.

One notable development: Several CDMOs in South Korea and Singapore are marketing themselves as nanobody-specialized facilities — a shift that could position Asia as a contract manufacturing powerhouse for Western nanobody firms.

 

Latin America, Middle East, and Africa (LAMEA) remain underpenetrated, but this isn’t due to lack of relevance. Many countries in these regions face a high burden of infectious diseases, where nanobody-based diagnostics and antivirals could play a major role. The constraint is infrastructure — both regulatory and production.

That said, a few regional bright spots are emerging. Brazil has initiated nanobody-based research in universities like USP, and Saudi Arabia is investing in rare disease infrastructure that could open doors to nanobody-based orphan drugs.

NGO-driven innovation in Africa is also worth noting. Some global health organizations are evaluating nanobody diagnostics for diseases like tuberculosis and malaria — areas where traditional antibody tests have failed due to cost or stability issues.

In short, while North America and Europe dominate nanobody R&D today, Asia is rapidly catching up on both innovation and industrial scaling. LAMEA’s future may depend on accessibility and licensing strategies, not on original pipeline development.

To win globally, nanobody companies will need more than good science. They’ll need adaptable models — from licensing deals and regional trials to low-cost manufacturing strategies that fit local needs.

 

End-User Dynamics And Use Case

Unlike conventional biologics that are typically restricted to specialty hospitals or research institutions, nanobodies are starting to attract a broader set of end users. Their size, stability, and design flexibility allow them to fit into workflows that traditional monoclonal antibodies can’t. This flexibility is changing how — and where — nanobody-based solutions are being adopted.

Biopharmaceutical companies are the primary end users in the current landscape. These firms are investing in nanobody therapeutics across immuno-oncology, neurology, and autoimmune disease. What makes nanobodies attractive here isn’t just their therapeutic potential — it’s also their faster development timelines and easier manufacturability. Smaller companies are especially drawn to nanobodies because they can move from discovery to preclinical proof-of-concept with relatively limited infrastructure.

 

Academic research institutions are also major players. From probing intracellular targets to stabilizing protein structures for crystallography, nanobodies are being used as scientific tools in ways monoclonals never could. In fact, several Nobel Prize–winning structural biology studies have used nanobodies to stabilize GPCRs and other difficult-to-image proteins.

Then there are diagnostic labs and imaging centers , which are just beginning to tap into nanobody potential. Nanobodies labeled with radionuclides or fluorescent tags offer faster clearance from the bloodstream, higher contrast, and more precise targeting. These benefits make them ideal for PET scans in oncology and neurology. Early adopters are already integrating nanobody-based tracers into investigational imaging protocols.

 

Contract development and manufacturing organizations (CDMOs) are another important end user group — albeit more on the operational side. As demand grows for GMP-grade nanobodies, especially those that require bacterial expression systems, CDMOs are stepping in with microbial fermentation infrastructure and downstream purification expertise. Some are even launching nanobody-specific service lines for early-stage biotechs .

 

Hospitals and specialty clinics aren’t widespread adopters yet, but that’s changing — especially in regions where nanobody-based therapies like Caplacizumab have received approval. Once more nanobody drugs clear regulatory hurdles, frontline care providers will be central to delivery and monitoring. This is especially true in fields like hematology , where dosing needs to be rapid and reversible, and in neurology, where blood-brain barrier penetration is key.

 

One compelling use case is unfolding at a neurology center in Berlin. Faced with poor treatment responses in patients with progressive multiple sclerosis, clinicians began enrolling candidates into a compassionate-use program testing a nanobody-based therapeutic designed to target CNS-infiltrating B cells. Unlike traditional antibodies, the nanobody construct demonstrated consistent CNS bioavailability, leading to improved patient-reported outcomes and MRI markers within six months.

 

This isn’t just about better bioavailability — it’s about solving a real-world clinical bottleneck.

 

At the same time, veterinary clinics and animal health researchers are exploring nanobodies for livestock disease diagnostics and treatment. Because nanobodies are heat-stable and easy to produce, they offer a low-cost route for animal healthcare in remote or resource-constrained settings. This sub-segment isn’t mainstream yet, but it hints at future horizontal expansion.

 

To sum it up: Nanobody adoption is expanding far beyond just the lab bench or the pharma pipeline. Whether it’s a biotech firm seeking agility, a hospital looking for new treatment modalities, or a diagnostics center demanding faster scan results, nanobodies are meeting these end-user needs in ways most biologics can’t.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• Sanofi expanded its nanobody pipeline in 2024 by initiating Phase II trials for a next-generation nanobody immunotherapy in relapsed lymphoma, building on the Ablynx platform it acquired in 2018.

• Biolojic Design , an AI-driven biotech, announced successful preclinical results in 2023 for a conditionally active nanobody designed to activate only in disease microenvironments — a new concept in precision biologics.

• LaNova Medicines secured a strategic licensing agreement in early 2024 with a Korean CDMO to scale up manufacturing for its HER2-targeting nanobody therapeutic, marking one of the first East Asia–based commercial partnerships in this space.

• Karolinska Institute published a peer-reviewed study in 2023 showcasing a novel nanobody capable of crossing the blood-brain barrier and binding tau proteins — a potential game changer in Alzheimer’s imaging.

• ExpreS2ion Biotechnologies announced in 2024 the development of thermostable nanobody-based vaccine candidates for viral hemorrhagic fevers, using a yeast expression system suitable for LMIC deployment.

 

Opportunities

• Crossing the Blood-Brain Barrier (BBB) : Nanobodies are among the few biologics that consistently demonstrate BBB penetration, unlocking opportunities in neurodegenerative and rare CNS diseases.

• Inhalable Biologics : Inhaled delivery formats for nanobodies offer non-invasive therapeutic solutions, especially for pulmonary infections and chronic inflammatory conditions — a novel route with strong patient preference potential.

• AI-Powered Nanobody Design : Machine learning tools are accelerating nanobody scaffold optimization and epitope prediction, drastically reducing early-stage development timelines and de-risking preclinical failure.

 

Restraints

• Limited Commercial Approvals : Despite promising pipelines, the number of approved nanobody therapeutics remains low, which may slow adoption in hospital formularies and payer reimbursement systems.

• Manufacturing Know-How Gaps : While microbial systems make nanobodies cheaper to produce, scaling up without compromising quality requires specialized CDMO capabilities — a gap many smaller biotechs still face.
   

To be honest, the nanobody market isn’t constrained by biology — it’s constrained by infrastructure. The science is compelling. But without scale, partnerships, and more approvals, the market could struggle to break through.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 1.4 Billion
Revenue Forecast in 2030	USD 3.1 Billion
Overall Growth Rate	CAGR of 13.8% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Application, Therapeutic Area, End User, Region
By Application	Therapeutics, Diagnostics, Research Tools
By Therapeutic Area	Oncology, Autoimmune, Neurology, Infectious Diseases
By End User	Biopharma Companies, Academic Research Institutes, Diagnostic Labs, CDMOs
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., Canada, Germany, Belgium, China, Japan, South Korea, Brazil, Saudi Arabia
Market Drivers	- High-affinity targeting with low immunogenicity - Strong utility in crossing blood-brain barrier - Advancements in inhalable biologics and AI-driven scaffold design
Customization Option	Available upon request