Single Domain Antibody Platforms Market Size, Share, and Growth Forecast from 2024 - 2031

Single Domain Antibody Platforms Market Size and Share Analysis

The global single domain antibody platforms market is projected to reach a size of US$ 32.7 Mn by 2024. It is estimated to witness a CAGR of 9.5% during the forecast period to reach a value of US$ 62.3 Mn by 2031. Rising prevalence of viral infections, immune disorders, and life-threatening diseases like cancer is facilitating the adoption of Single Domain Antibody (sdAb) platforms to improve treatment results.

According to the latest estimates released by the International Agency for Research on Cancer (IARC), there were a predicted 20 million new cancer cases in 2022 along with 9.7 million deaths in the same year.

Single domain antibody platform’s role in therapeutic development is anticipated to propel growth at a significant rate throughout the forecast period. SdAb platforms can improve the effectiveness of immune and antiviral therapies, thereby driving demand.

Rapid rise in drug development activities in emerging economies is facilitating expansion in these countries. Leading academic institutions across the globe are also supporting research in drug discovery and molecular biology through collaborations and partnerships, thereby fostering market expansion.

Key Highlights of the Market

• The ability of single domain antibodies to traverse the blood-brain barrier seamlessly is a key factor fostering their wide adoption.
• Innovations in technology have led to the development of unique single domain antibody platforms that provide improved functionality and better results.
• SdAb has superior stability and resilience in extreme conditions, which enables them to recognize epitopes that are otherwise inaccessible to traditional antibodies.
• Utility of new platforms is set to skyrocket due to their contribution to improving bioavailability in pharmaceutical applications.
• Single domain antibodies are highly versatile and adaptable, thereby making them an invaluable tool for medical research, disease detection and treatment, and innovations in biotechnology.
• In terms of animal source, the camelids category is projected to hold a share of 92.4% in 2024 as SdABs effectively penetrate tissues and bind to difficult-to-reach epitopes.
• By application, the therapeutic development segment is expected to account for a share of 46% in 2024 as sdAbs are ideal for large-scale production and low-cost therapeutic applications.
• Europe single domain antibody platforms market is estimated to hold a share of 27.4% in 2024 as the region is adopting sdAb in point-of-care diagnostic applications.
• The single domain antibody platforms market in North America is set to hold a value share of 38.3% in 2024 as biotechnology and pharmaceutical companies are partnering with research institutions to develop sdAb-based therapies.

Market Attributes	Key Insights
Single Domain Antibody Platforms Market Size (2024E)	US$ 32.7 Mn
Projected Market Value (2031F)	US$ 62.3 Mn
Global Market Growth Rate (CAGR 2024 to 2031)	9.5%
Historical Market Growth Rate (CAGR 2019 to 2023)	7.4%

SdAbs are Gaining Traction in Europe Owing to High Commercial Scalability

The single domain antibody platforms market in Europe is witnessing immense growth by holding a share of 27.4% in 2024. The platforms are progressively being adopted in point-of-care (POC) diagnostic applications. Their ability to seamlessly integrate into handheld diagnostic devices is estimated to enhance the speed and accessibility of medical diagnostics.

Single domain antibodies are gaining traction in the field of therapeutics and diagnostics across Europe owing to their commercial scalability in microbial systems. These help decrease costs and complexity associated with large-scale production. Countries in West Europe are emerging as prominent markets owing to the robust presence of biotech and pharmaceutical industries.

Northern Europe has a growing biotech sector with a high focus on unique drug discovery and diagnostics. Countries in Southern Europe, on the other hand, are still catching up with the adoption and innovations in the sdAb platform.

Federal Support through Funding Fostering Growth in North America

Rising number of immunotherapy candidates and clinical trials in North America are driving focus on immuno-oncology, where sdAbs show great promise. Their ability to conjugate with cytotoxic drugs or immune-modulating agents to create Antibody-Drug Conjugates (ADCs) is garnering attention in the cancer treatment space. For instance,

• The American Society of Clinical Oncology 2022 report found that federal funding provided for cancer research resulted in substantial growth in the diagnosis, treatment, and prevention of cancer. The Congress invested around US$ 1.25 Bn in funding for cancer research and development, further increasing the funding for National Institute of Health (NIH), including a US$ 120 Mn increase in National Cancer institute.

Biotechnology and pharmaceutical companies in North America are entering into partnerships with research institutions and biotech firms to develop sdAb based therapies. Such collaborations are predicted to accelerate the development and commercialization of SdAb products. The region is anticipated to dominate with a share of 38.3% in 2024.

Small Size and Superior Stability of Camelid SdAbs Makes them Reliable

Category	Market Share in 2024
Animal Source - Camelids	92.4%

Camelid animals are the primary biological source of sdAbs. They possess unique immune systems that produce heavy-chain antibodies. Small size of camelid-derived sdAbs enables them to effectively penetrate tissue and bind to difficult-to-reach epitopes, thereby making them beneficial to target complex diseases.

High stability of camelid sdAbs makes it reliable for use while also making them easier to handle, store, and transport. Camelid single domain antibodies are developed for several therapeutic indications and can be engineered in multiple forms of targeted therapeutics.

Their specificity and small size make camelid-derived single domain antibodies ideal for diagnostic applications. They are being already used in rapid testing for infectious diseases and as agents in medical imaging to improve detection of tumors.

Demand for Low-cost Therapeutic Applications to Create Opportunities

Category	Market Share in 2024
Application - Therapeutic Development	46%

Therapeutic development application is one of the key segments in the single domain antibody platforms market. SdAbs are being increasingly used in therapeutic development owing to their versatility that enables them to bind multiple targets simultaneously.

The platforms also enable cost-effective manufacturing, further facilitating cheap and swift production of sdAbs compared to traditional monoclonal antibodies. This further makes them an attractive option for large-scale production as well as low-cost therapeutic applications.

SdAbs are being used in Enzyme Replacement Therapy (ERT) to increase the efficiency of enzymes delivered to lysosomes and in vaccine development to enhance immune response. Gene therapy and neurological disorders are also exploring sdAbs because of their high penetration of blood-brain barrier and to deliver genetic material to specific cells or tissues.

Market Introduction and Trend Analysis

Growing demand for cost-effective biologics and biosimilars are raising sales of sdAbs. Biotech research and development is witnessing substantial investment as companies are entering the market to develop new sdAb-based products.

Rising demand for effective and precise treatments across several therapeutic areas are further augmenting expansion. Precision medicine is the prominent force shaping the healthcare industry. Increasing need for targeted therapies and personalized medicine is estimated to pose a demand for SdAbs owing to their ability to precisely target specific antigens and reduce off-target effects.

The steadily increasing demand for biologics in line with the shift in focus towards biotech-based drugs elevates the utility of sdAbs owing to their cost-effective production and functional versatility. This factor is leading to a rise in investments in sdAb development.

Regulatory bodies like the FDA, EMA, and Health Canada are supportive of biologics, including sdAb products. They have also expedited pathways for approval, especially in areas of higher unmet need, thereby accelerating the time-to-market for sdAb-based therapeutics and boosting their adoption.

Historical Growth and Course Ahead

The single domain antibody platforms market witnessed a CAGR of 7.4% during the historical period. SdAb platform has witnessed immense evolution over the past few years. This was attributed to innovations in high throughput screening, protein engineering, and enhanced understanding of antibody interactions.

The ability to produce single domain antibodies in higher specificity and affinity has played a key role in increasing their appeal in drug development. Development of synthetic sdAbs and camelid-derived sdAbs has further facilitated rapid discovery and production of sdAbs.

Single domain antibodies have over the course of time, found applications and uses in therapeutic, diagnostics, and research and development activities. The approval of the first sdAb-based therapeutic, Caplacizumab (Cablivi), in February 2019 by the FDA opened the door for broader adoption.

Market Growth Drivers

Increasing Collaborations and Strategic Expansions to Boost Demand

Single domain antibody companies are actively collaborating with research institutes, biopharmaceutical firms, and Clinical Research Organizations (CROs) to find novel applications and bring innovation in the market. There is an increasing focus on developing and upgrading key healthcare technologies along with the introduction of new products and services. For instance,

• In December 2020, GenScript ProBio’s Berkeley Lights Beacon platform was used by Initium Therapeutics to extend its antibody-drug pipelines and enhanced its distribution network.

Manufacturers are increasing investments in research and development to bolster innovation. They are prioritizing developing economies as these countries are showing fast growth in the single domain antibodies market share. The potential for outsourcing biotech projects has increased owing to the availability of skilled labor at affordable prices in developing nations such as China and India.

Development of Multivalent Antibody Types to Augment Sales

Small sizes of sdAbs enable the development of multivalent or bispecific antibody constructs, allowing them to simultaneously target two or more disease markers or epitopes. This ability opens new opportunities in targeted therapies, autoimmune diseases, and cancer immunotherapy where dual-target mechanism is able to provide improved therapeutic benefits.

Flexibility of single domain antibodies facilitates their utilization in combination with other biologic therapies like monoclonal antibodies or checkpoint inhibitors. This enables the creation of effective combination therapies in oncology and other areas.

Market Restraining Factors

Extended Approval Process to Emerge as a Prominent Restraint for Growth

As biologics progress through commercialization and clinical trials, regulatory requirements are likely to become more stringent. The approval of biological products in the U.S. requires a Biologics License Application (BLA). The product, as well as the process, must be validated and exclusively monitored against Critical Quality Attributes (CQAs) throughout the manufacturing process.

To gain approval, regulatory bodies must approve the end product as well as the process, CQAs, antibodies, consumable cell lines, and equipment that was used during production. The extended time associated with waiting for regulatory approvals is likely to be a prominent factor hampering growth of the global market.

It is necessary to use more than one animal as camelid species may not be readily available to all researchers due to animal husbandry because it necessitates specialized facilities. Analyzing the consistency of immunization processes like DNA immunization is also crucial to avoid the heterogeneity of immune responses. This can emerge as a key challenge to maintain process efficiency.

The handling of recombinant antibodies requires specialized laboratory training. Lack of experience in research laboratories and inadequate practice in handling recombinant antibodies are also set to hamper the single domain antibody platforms market growth.

Market Growth Opportunities

Rise of Innovative Drug Delivery Platforms to Create Significant Opportunities

SdAbs can be conjugated with several payloads like radioactive isotopes, gene-editing agents, and cytotoxic drugs. This is further anticipated to help create opportunities for the development of targeted drug delivery systems or nanomedicines. It can, in future, result in the development of precise and effective therapies while decreasing side effects.

Single domain antibodies have the potential to be used in oral formulations owing to their stability. This makes them extra patient friendly compared to injectable monoclonal antibodies, thereby presenting significant growth opportunities for oral biology.

Surging Prevalence of Infectious Diseases to Create Fresh Prospects

SbAds have shown promise in targeting several viruses, including HIV, influenza, SARS-CoV-2, and Ebola. They can bind to viral proteins with high specificity, potentially leading to the development of broad-spectrum antiviral therapies that can treat an array of viral infections.

Single domain antibody platform offers rapid response solutions for new and emerging infectious diseases owing to their quick production processes. Their stability and small size make them ideal for rapid deployment in response to pandemics or outbreaks.

SdAbs may be affordable and swift to generate compared to conventional monoclonal antibodies in preventive as well as therapeutic applications for viral infections. The requirement for antibody-based therapeutics is hence projected to rise across the globe.

Competitive Landscape for the Single Domain Antibody Platforms Market

Single domain antibody manufacturers are focused on innovative drug development along with product patenting to gain high market revenue. Leading manufacturers in the market are aiming to propel collaboration and accreditation to drive product demand and sales footprint.

Recent Industry Developments

• In March 2024, GenScript Biotech Corporation, based in the U.S., announced the expansion of its collaboration with Roche. Their partnership began in 2011 under a Laboratory Service Agreement. The expanded collaboration is aimed to further drive innovation across GenScript’s portfolio of life science research tools and services globally.
• In August 2024, Rockland Immunochemicals, based in the U.S., partnered with The Jackson Laboratory (JAX) and antibodies-online GmbH (ABO) to exclusively manufacture and distribute highly characterized Fc Neonatal Receptor (FcRn) antibodies.
• In January 2023, Kaneka Corporation, based in Tokyo, successfully increased its GMP manufacturing capacity for mRNA at Kaneka Eurogentec S.A., its wholly owned subsidiary in Liège, Belgium. The expansion, which began operations sequentially in late 2023, involved a capital investment of 2 billion JPY. It resulted in a production capacity approximately five times higher than the previous level.

Single Domain Antibody Platforms Market Report Scope

Attributes	Details
Forecast Period	2024 to 2031
Historical Data Available for	2019 to 2023
Market Analysis	US$ Million for Value
Key Regions Covered	North America Europe East Asia South Asia and Oceania Middle East and Africa Latin America
Key Market Segments Covered	Platform Type Animal Source Application End User Region
Key Companies Profiled in the Report	Creative BioLabs Synbio Technologies GenScript Biotech Corporation ProSci Incorporated BioCat GmbH Antibody Design Labs Rockland Immunochemicals, Inc. Hybrigenics Services NeoClone Biotechnology International LLC Kaneka Eurogentec S.A ProteoGenix
Report Coverage	Market Forecast and Trends Company Share Analysis Competitive Intelligence DROT Analysis Market Dynamics and Challenges Strategic Growth Initiatives
Customization and Pricing	Available upon request

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