| 【英語タイトル】Global Adeno Associated Virus Vectors Manufacturing Market - 2023-2030
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 | ・商品コード：DATAM671EM881
・発行会社（調査会社）：DataM Intelligence
・発行日：2023年11月
・ページ数：100
・レポート言語：英語
・レポート形式：PDF
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・調査対象地域：グローバル
・産業分野：医療・バイオ
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❖ レポートの概要 ❖
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
1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Method
3.2. Snippet by Application
3.3. Snippet by Therapeutic Area
3.4. Snippet by End-User
3.5. Snippet by Region
4. Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. Increasing Adoption of Adeno-Associated Viral Vectors
4.1.2. Restraints
4.1.2.1. High Manufacturing Costs
4.1.3. Opportunity
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter’s Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Pipeline Analysis
5.6. Unmet Needs
5.7. Patent Analysis
5.8. DMI Opinion
6. COVID-19 Analysis
6.1. Analysis of COVID-19
6.1.1. Scenario Before COVID
6.1.2. Scenario During COVID
6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During the Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion
7. By Method
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Method
7.1.2. Market Attractiveness Index, By Method
7.2. In Vivo*
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. In Vitro
8. By Application
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
8.1.2. Market Attractiveness Index, By Application
8.2. Gene Therapy*
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Cell Therapy
8.4. Vaccine Production
8.5. Others
9. By Therapeutic Area
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
9.1.2. Market Attractiveness Index, By Therapeutic Area
9.2. Genetic Disorders*
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Infectious Diseases
9.4. Neurological Disorders
9.5. Hematological Diseases
9.6. Ophthalmic Disorders
9.7. Others
10. By End-User
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
10.1.2. Market Attractiveness Index, By End-User
10.2. Pharmaceutical Companies*
10.2.1. Introduction
10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Biotechnology Companies
10.4. Academic and Research Institutes
10.5. Others
11. By Region
11.1. Introduction
11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
11.1.2. Market Attractiveness Index, By Region
11.2. North America
11.2.1. Introduction
11.2.2. Key Region-Specific Dynamics
11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Method
11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.2.7.1. U.S.
11.2.7.2. Canada
11.2.7.3. Mexico
11.3. Europe
11.3.1. Introduction
11.3.2. Key Region-Specific Dynamics
11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Method
11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.3.7.1. Germany
11.3.7.2. UK
11.3.7.3. France
11.3.7.4. Italy
11.3.7.5. Spain
11.3.7.6. Rest of Europe
11.4. South America
11.4.1. Introduction
11.4.2. Key Region-Specific Dynamics
11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Method
11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.4.7.1. Brazil
11.4.7.2. Argentina
11.4.7.3. Rest of South America
11.5. Asia-Pacific
11.5.1. Introduction
11.5.2. Key Region-Specific Dynamics
11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Method
11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.5.7.1. China
11.5.7.2. India
11.5.7.3. Japan
11.5.7.4. Australia
11.5.7.5. Rest of Asia-Pacific
11.6. Middle East and Africa
11.6.1. Introduction
11.6.2. Key Region-Specific Dynamics
11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Method
11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
12. Competitive Landscape
12.1. Competitive Scenario
12.2. Market Positioning/Share Analysis
12.3. Mergers and Acquisitions Analysis
13. Company Profiles
13.1. Thermo Fisher Scientific Inc.*
13.1.1. Company Overview
13.1.2. Product Portfolio and Description
13.1.3. Financial Overview
13.1.4. Key Developments
13.2. Oxford Biomedica PLC
13.3. Lonza Ltd
13.4. uniQure N.V.
13.5. FUJIFILM Diosynth Biotechnologies
13.6. SIRION Biotech GmbH
13.7. Curigin Inc.
13.8. Pfizer Inc.
13.9. Genscript Biotech Corp
13.10. Vector Biolabs
LIST NOT EXHAUSTIVE
14. Appendix
14.1. About Us and Services
14.2. Contact Us
