Global Adeno Associated Virus Vectors Manufacturing Market - 2023-2030

Global Adeno Associated Virus Vectors Manufacturing Market - 2023-2030

Global adeno-associated virus vectors manufacturing market reached US$ XX million in 2022 and is expected to reach US$ XX million by 2030, growing at a CAGR of XX% during the forecast period 2023-2030.

Adeno-associated viral (AAV) vectors are replication-defective, single-stranded DNA parvoviruses, which require a helper Ad for their replication. Site-specific or random AAV vector integration into the host cell genome, in the absence of a helper virus, results in long-term transgene expression. Additionally, adeno-associated viral vectors demonstrate high transduction efficiency in a broad range of quiescent and dividing target cells. In contrast to Ads, AAV vectors do not produce a significant immune response.

Moreover, adeno-associated viral vectors are more frequently used for gene therapy for genetic diseases and cancer. In addition, adeno-associated virus vector-mediated gene delivery is also approved for the treatment of inherited blindness and spinal muscular atrophy, long-term therapeutic effects and other rare diseases, including hemophilia and Duchenne muscular dystrophy. They are also considered in cell therapy and vaccine production to treat many diseases.

Market Dynamics: Drivers

Increasing adoption of adeno-associated viral vectors

The increasing adoption of adeno-associated viral vectors is expected to drive the market over the forecast period. The increasing adoption leads to an increasing focus on launching more manufacturing platforms. For instance, on May 16, 2023, AGC Biologics launched its BravoAAV and ProntoLVV viral vector platforms. Leveraging three decades of Lentiviral vector (LVV) and Adeno-Associated Viral vector (AAV) development, manufacturing and analytical experience, AGC Biologics’ new platforms offer fast, efficient and reproducible clinical and commercial GMP production and release.

Additionally, on October 10, 2022, Charles River Laboratories International, Inc. launched its nAAVigation Vector Platform (nAAVigation). Leveraging decades of Adeno-Associated Virus (AAV) vector contract development and manufacturing (CDMO) experience and biologics testing expertise, Charles River has established a platform that streamlines the pathway to GMP AAV vector manufacturing without the need for significant process development.

Moreover, the adeno-associated viral vectors are mostly used to treat many diseases, this further increases the adoption of adeno-associated virus vectors. For instance, on March 02, 2023, the first vector-delivered gene therapies to receive FDA approval for clinical use were Luxturna, Spark Therapeutics vision loss cure, and Zolgensma, Novartis’ spinal muscular atrophy treatment. In addition, they brought about a surge in demand for gene therapy delivery technologies. The surge is ongoing. Currently, it is stimulating innovation in vector design and manufacturing.

Furthermore, adeno-associated virus vectors are most commonly applicable for gene therapy, which also further increases the adoption. For instance, on March 9, 2023, Charles River Laboratories International, Inc. launched its off-the-shelf pHelper offering, which is designed to secure supply and streamline adeno-associated virus (AAV)-based gene therapy programs from early discovery through commercial manufacturing.

Further, the increasing prevalence of genetic, infectious, neurological, ophthalmic and other chronic disorders, rising FDA approvals, increasing clinical trials, increasing awareness and advancements in the development novel therapies and vaccines are the factors expected to drive the market over the forecast period.

Restraints

Factors such as high manufacturing costs, lack of skilled professionals and limited cloning capacity are expected to hamper the market.

Segment Analysis

The global adeno-associated virus vectors manufacturing market is segmented based on method, application, therapeutic area, end-user and region.

The gene therapy segment accounted for approximately 43.2% of the adeno-associated virus vectors manufacturing market share

The gene therapy segment is expected to hold the largest market share over the forecast period. Adeno-associated virus (AAV) vectors are the leading platform for gene delivery for the treatment of a variety of human diseases. Adeno-associated virus (AAV) vectors are currently among the most frequently used viral vectors for gene therapy. Many companies are focussing on adeno-associated virus vector manufacturing for gene therapy.

For instance, on February 23, 2021, SIRION Biotech GmbH, a world leader in viral vector-based gene delivery technologies for gene & cell therapy, signed a license and collaboration agreement with Sanofi, a global biopharmaceutical company, to develop improved tissue-selective adeno-associated virus (AAV) vectors to realize effective gene therapy treatments for disorders affecting major human organs.

Additionally, on August 1, 2023, Waters Corporation introduced the first in a new line of size exclusion chromatography (SEC) columns aimed at improving the analysis while lowering the cost of gene therapies, specifically adeno-associated viral (AAV) vectors. The new Waters XBridge Premier GTx BEH SEC columns double the speed of measuring the potency and safety of AAVs and optimize the manufacturing of these novel gene delivery vehicles.

Moreover, adeno-associated virus vectors helps researchers for developing gene therapies to treat many serious disorders. For instance, in November 2022, PerkinElmer, Inc., a global leader committed to innovating for a healthier world, launched ready-to-use Adeno-associated Virus Vectors (AAV) Detection Kits to support researchers working on gene therapies for a variety of serious diseases. The high-throughput viral assays are designed to help researchers quickly and easily characterize viral vector particles being produced to enable decision-making for safe and efficient gene transfer.

Geographical Analysis

North America accounted for approximately 40.3% of the market share

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing research activities. North America especially the United States is known for its strong presence of major players such as biotechnology companies and pharmaceutical companies. The presence of major players actively focussing on manufacturing more advanced adeno-associated virus vectors by offering advantages such as cost-effectiveness.

For instance, on November 16, 2022, Thermo Fisher Scientific, the world leader in serving science, introduced the Gibco CTS AAV-MAX Helper-Free AAV Production System, a new all-in-one solution designed to help meet clinical and commercial demands for cost-effective and scalable development of adeno-associated virus (AAV)-based gene therapies. It is the only product of its kind that is manufactured under cGMP conditions to enable large-scale applications.

Furthermore, increasing research activities in the region helps to manufacture more advanced virus vectors which are more advantageous for gene therapy. As research activities increase, gene therapies are developed more precisely by offering wide treatment options for many diseases, which results in better patient outcomes.

For instance, on February 15, 2022, Repligen Corporation, a life sciences company focused on bioprocessing technology leadership, launched three advanced affinity chromatography resins for use in gene therapy manufacturing workflows. The resins AVIPure - AAV9, AVIPure - AAV8, and AVIPure - AAV2 – were developed by Avitide LLC, a Repligen company, and are specific to the major adeno-associated virus (AAV) gene therapy vectors.

Competitive Landscape

The major global players in the adeno-associated virus vectors manufacturing market include Thermo Fisher Scientific Inc., Oxford Biomedica PLC, Lonza Ltd, uniQure N.V., FUJIFILM Diosynth Biotechnologies, SIRION Biotech GmbH, Curigin Inc., Pfizer Inc., Genscript Biotech Corp and Vector Biolabs among others.

Key Developments
• On March 27, 2023, Avirmax CMC Inc. a cGMP-licensed contract development and manufacturing organization (CDMO), implemented its newly developed Sf rhabdovirus-free cell lines (under the generic trademark of Sf-RVF) developed for producing recombinant adeno-associated viral vectors (rAAV).
• On August 30, 2023, Quest Diagnostics granted FDA breakthrough designation for its adeno-associated virus (AAV) test, AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Breakthrough Device Designation is an FDA process designed to expedite the development and review of certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
• On June 15, 2022, Exothera SA collaborated with LogicBio Therapeutics and Polyplus-transfection SA. for the development of a highly scalable AAV manufacturing platform with a capacity from 200 L to 2,000 L.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global adeno-associated virus vectors manufacturing market. The pandemic has created a surge in demand for adeno-associated viral vectors, particularly in the development and production of COVID-19 vaccines. The urgent need for large-scale manufacturing of these vectors to support vaccine development has led to increased demand.

For instance, according to the National Institute of Health (NIH), 2022, based on the study, they developed a type 9 adeno-associated virus vectored vaccine candidate expressing a dimeric receptor binding domain (RBD) of the SARS-CoV-2 spike protein (S protein) and evaluated its immunogenicity in a murine model. The vaccine candidate, named AAV9-RBD virus, was constructed by inserting a signal peptide to the N-terminus of two copies of RBD, spaced by a linker, into the genome of a type 9 adeno-associated virus.

Market Segmentation

By Method
• In Vivo
• In Vitro

By Application
• Gene Therapy
• Cell Therapy
• Vaccine Production
• Others

By Therapeutic Area
• Genetic Disorders
• Infectious Diseases
• Neurological Disorders
• Hematological Diseases
• Ophthalmic Disorders
• Others

By End-User
• Pharmaceutical Companies
• Biotechnology Companies
• Academic and Research Institutes
• Others

By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
Australia
Rest of Asia-Pacific
• Middle East and Africa

Why Purchase the Report?
• To visualize the global adeno-associated virus vectors manufacturing market segmentation based on method, application, therapeutic area, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of adeno-associated virus vectors manufacturing market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global adeno-associated virus vectors manufacturing market report would provide approximately 69 tables, 71 figures, and 188 Pages.

Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies