Adeno-associated virus (AAV) vectors have emerged as one of the most promising tools for gene delivery in both basic research and clinical gene therapy. Derived from the non-pathogenic AAV, these vectors offer several advantages, including low immunogenicity, the ability to infect both dividing and non-dividing cells, and long-term transgene expression in a variety of tissues.
The global AAV vector market estimated to grow from USD 2.2 billion in 2024 to 3.6 billion in 2025 and USD 6.0 billion by 2035, representing a CAGR of 5.3% during the forecast period.
The AAV vector genome comprises of inverted terminal repeats (ITRs) at both ends of the DNA strand and two open reading frames (ORFs), namely rep and cap. Each ITR sequence consists of 145 bases that have the ability to form a hairpin structure. These sequences are required for the primase-independent synthesis of a second DNA strand and the integration of the viral DNA into the host cell genome. Rep genes encode proteins that are required for the AAV life cycle and site-specific integration of the viral genome. Cap genes encode the capsid proteins, namely VP1, VP2 and VP3. Their versatility and safety profile have led to widespread use in treating genetic disorders, delivering therapeutic genes, and advancing precision medicine. Recent developments in AAV engineering have further enhanced tissue specificity and transduction efficiency, solidifying their role as a cornerstone in the field of gene therapy.
The adeno-associated virus was discovered more than 50 years ago and has evolved into one of the most extensively used gene delivery vectors for gene therapy applications. Further, owing to its unique biology, simple structure, and lack of disease correlation, adeno-associated viral vector is the most preferred vector for most medical related applications. In spite of these features, several challenges need to be addressed, such as amplifying immunogenicity and overcoming anti-AAV pre-existing immunity so as to improve the persistence of these vectors for longer periods. Moreover, innovating new capsid variants along with targeted evolution could increase transduction efficiency and minimize the immunogenicity. Further, optimized vector manufacturing and new adeno-associated viral variants are likely to evoke future regulatory approvals and advancements in patient’s health.
AAV vector-based therapies utilize adeno-associated virus vectors to deliver therapeutic genes safely and efficiently to targeted cells, enabling long-term gene expression with minimal immune response.
During research, it was identified ~635 adeno-associated viral vector-based therapies that are in different stages of development for the treatment of various diseases.
The AAV vector-based therapies domain is predominantly characterized by the presence of small companies, which account for more than 55% of all the developers active in this domain. The growing demand of AAV vector-based therapies has spurred the establishment of several small firms / start-ups in the last decade. Examples of the start-ups (in alphabetical order, established post-2020 and having an employee count of 2-10 employees) include Bloomsbury Genetic Therapies, Borea Therapeutics, NERVOSAVE THERAPEUTICS (a spin-off of INSERM), Opus Genetics (spin-out of Retinal Degeneration Fund), Ray Therapeutics and Seal Therapeutics (a spin-off of Biozentrum of the University of Basel).
In terms of the stage of development, most of the therapies (42%) are in preclinical stage of development, followed by those in clinical stage (30%). This indicates that adeno-associated viral vector based therapies are poised to experience high growth in the coming years driven by the large pipeline of therapies across various stages of development, reflecting strong innovation and increasing clinical validation potential. Further, it is worth mentioning that only eight adeno-associated viral vector based therapies have been commercialized till date, which constitutes only 1% of the overall AAV-based therapies that have either been commercialized or are under development. Of the eight marketed therapies, 38% have been developed for the treatment of hematological disorders. This is followed by therapies targeting neurological disorders (26%) and ophthalmic disorders (24%).
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