Adeno Associated Virus Vector Manufacturing Market Size, Share & Trends Analysis Report By Scale Of Operations (Clinical, Commercial), By Method, By Application, By Therapeutic Area, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global adeno associated virus vector manufacturing market size was valued at USD 767.7 million in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 22.5% from 2023 to 2030. Adeno Associated Virus (AAV) vectors have lucid structure, distinctive biology, dearth of disease correlation having a wide range of scope in the healthcare sector.The number of clinical trials and clinical trials evaluations of AAV vector-based therapies has increased over the last few years. For instance, a research article published in October 2020 stated that FDA-approved AAV vectors, Luxturna and Zolgensma, are administered in 250-300 clinical trials for treating a variety of human diseases. It showed good safety records and results in terms of AAV-mediated gene silencing, editing, and replacements.

This has had a positive impact on the globalmarket. Moreover, an increasing number of emerging players, the robust pipeline for gene therapies & vaccines, and technological advancements in gene therapies & vaccines drive the market. The industry is expected to witness lucrative growth during the forecast period. Technological advancement in the workflow by the players is likely to support applications with the process of AAV vector development and gene therapy operations. Many key players and emerging players are engaged in enhancing the R&D for the novel, safe, and effective gene delivery techniques. The AAV vectors are used to treat diseases, such as cystic fibrosis, DMD, retinitis pigmentosa, and various chronic diseases like cancer. The global industry has experienced an economic boost due to a rise in the demand for these vectors.

Researchers are working to develop gene-based therapies for various diseases. Although the number of patients receiving gene therapies is less, the future of gene therapy holds great promise as it is expected to revolutionize the treatment regime by targeting the genes responsible for disease pathogenesis. Various universities and institutes have a broad portfolio of gene therapy products in the pipeline, which is expected to boost the gene therapy market in the coming years. For example, the University of Massachusetts Medical School and the University of Utah are conducting a number of clinical trials that are aimed at developing and introducing new gene therapies in the market. A number of companies in the U.S. are adopting various strategic initiatives to broaden their product portfolio.

For instance, in October 2021, Merck KGaA opened its California-based viral vector manufacturing facility to expand its global footprint. This expansion would support industrial manufacturing and large-scale commercialization of viral gene therapy products.Moreover, the COVID-19 pandemic is estimated to have a positive impact on the market. This is attributed to the rising demand for the manufacturing and production of therapeutics by pharmaceutical and biotech companies. This creates opportunities to enhance R&D in therapeutic areas to develop new products for the development of viral vector-based vaccines and treatments. For instance, in September 2021, the University of Oxford and Ludwig Institute for Cancer Research manufactured a vaccine to cure cancer depending upon the successful creation of the Oxford-AstraZeneca vaccine used for the treatment of the SARS-CoV-2, COVID-19 virus.

The newly developed cancer vaccine, when used with immunotherapy, resulted in decreased tumor size by showing an anti-tumor immune response in In Vivo. This offered a greatopportunityfor adeno associated virus vector CDMO business expansion globally. On the other hand, there is a huge demand for AAV vectors under GMP conditions by the biomanufacturing facilities. The cost of AAV vector manufacturing at the laboratory scale is relatively high due to the costly downstream process, which is also time-consuming. This can be a restraining factor for the global market. However, AAV vector manufacturing is the safest and most effective method applied for emerging therapies. This will provide a lucrative growth opportunity for the market in the coming years.

Scale of Operations Insights

The commercial segment accounted for the major share of the overall industry in 2022 with a share of 57.50% of the overall revenue. The largest market share is attributed to high R&D investments by prominent industry players to cater to the growing demand for cell and gene therapy applications. In addition, the increasing risk of lifestyle-related chronic diseases is anticipated to drive the global industry, thus propelling the industry's growth over the forecast period. Moreover, the high demand for gene therapeutics in the healthcare industry leads to more demand for clinical trials. For instance, in April 2022, 4D Molecular Therapeutics announced 4D-710 for the treatment of cystic fibrosis, which is AAV-based genetic medicine. The first patient was given the dose of genetic medicine in its phase 1 and 2 clinical trials.

A consistent supply of funds and grants has led to the proliferation of advanced therapy clinical trials in the past years. In addition, noncommercial entities are offering sponsorships to accelerate clinical trials, which is one of the key industry drivers. Universities are some of the major noncommercial sponsors for ongoing advanced therapy clinical trials. The commercial segments are estimated to register the fastest CAGR between 2023 and 2030. The development in the manufacturing infrastructure for the production of commercial-scale AAV vectors by key players spurs industry growth. For instance, Applied Genetic Technologies Corp. has developed a manufacturing facility for commercial adeno associated virus vector-based gene therapy production. It involves phase 1 and 2 preclinical research facilities. Development in the R&D for clinical research drives the commercial scale of operation at the fastest growth rate.

Therapeutic Area Insights

The neurological disorders segmentdominated the industry in 2022 and accounted for the largest share of more than 28.00% of the total revenue. It is expected to grow further at a steady CAGR retaining its leading position over the forecast years. AAV vector has a wide range of applications in clinical research for neurological disorders, such as Parkinson’s disease, Alzheimer’s disease, spinal muscular atrophy, amyotrophic lateral sclerosis, and temporal lobe epilepsy. The genetic disorders segment is estimated to register the fastest CAGR between 2023 and 2030. Poor immunity, unhealthy lifestyle & eating habits, and heredity factors have increased the occurrence of genetic disorders. AAV vector-based therapies are used to treat these disorders.

Many research institutes are developing therapies and treatments for genetic disorders using adeno associated virus vectors. Moreover, key players are focusing on strategic collaborations to find novel solutions for genetic deformities treatment using adeno associated virus vectors. This has a positive impact on segment growth. For instance, in April 2020, Vertex Pharmaceuticals and Affinia Therapeutics entered into a strategic collaboration to develop AAV capsids to treat genetic therapies. AAV vector technology was used in an application with gene therapy to treat DMD, myotonic dystrophy type 1, and cystic fibrosis. AAV SmartLibrary helps the capsids with improved immunity, manufacturing capability, and tissue tropism.

Method Insights

On the basis of methods, the global industry has been further categorized into in vivo and in vitro methods. The in vivo method segment dominated the global industry in 2022. The segment accounted for the maximum share of more than 67.95% of the overall revenue. It is projected to expand further at a steady CAGR maintaining its leading position throughout the forecast period.

An increasing number of approvals for gene therapies has resulted in the rising demand for AAVs as gene therapy delivery devices. In the next few years, promising pipeline gene therapy candidates are expected to be launched in the market making it a potential revenue-generation advent. On the other hand, the in vitro method segment is expected to register the fastest growth rate during the estimated study period.

Application Insights

The vaccine application segment dominated the industry in 2022 and accounted for the maximum share of more than 51.90% of the total revenue. The segment is likely to maintain its dominance growing at a considerable CAGR during the forecast period. Vaccines play a vital role in the treatment of chronic viral infections. Many of the key players are investing and receiving funds for the treatment of diseases and the launch of novel solutions for the treatment of these diseases. For instance, in January 2021, Mass Eye and Ear, Boston released AAVCOVID an AAV vector-associated gene-based vaccine to treat COVID-19 virus infection.

CHAPTER 01It is a single-dose vaccine, which can be stored at room temperature for up to 1 month in animal models and further enter Phase I clinical trial. The vaccine program has received $2.1 million in funding from Bill & Melinda Gates Foundation for the further development of the vaccine. In addition, adeno associated virus vector-based vaccines are also used to treat diseases, such as HIV, Ebola, Zika virus, and influenza virus. Viral vectors show enhanced immune responses including cell-mediated immunity. The growing demand for the manufacturing of such vaccines spurs global industry growth. Gene therapy will be the fastest-growing segment during the forecast period. Over the recent years, R&D for advanced therapies, such as cell and gene therapies, has increased considerably.

This is owing to the high prevalence of genetic and chronic & terminal diseases, such as cancer, diabetes, and others. The market for such advanced therapies is still in the nascent stage and is constantly evolving. Owing to the high demand due to the COVID-19 pandemic, the AAV vector production market is expected to grow at a significant rate. Thus, global stakeholders are investing heavily in expanding their production capacities to fulfill the growing market demands. For instance, in June 2022, REGENXBIO Inc. opened AAV vector-based gene therapy facility for the manufacturing of NAV Technology-based AAV gene therapies at a 2000L scale. The company invested $65 million to open this state-of-art facility in Maryland.

Regional Insights

North America accounted for the largest share of more than 48.30% in 2022 due to the presence of well-established manufacturing facilities, supportive government funding programs, and an increase in R&D activities within the U.S.Asia Pacific is likely to emerge as the most lucrative region over the study period. This can be attributed to significant international businesses along with the growing focus of key companies to expand in emerging markets to increase their industry share. India's economic growth andheavy investments by international investors have madeIndia one of the most lucrative countries. Regional firms are expanding their influence in the market for AAV vector production.

Compared to big western markets, developing countries are seeing stronger growth, in terms of capacity expansion. Asian countries, especially China and India, have made advances in gene and cell therapy manufacturing. Global CDMOs are expanding their capacities in China owing to changing regulations that allow clinical and commercial manufacturing of advanced therapy products by third parties in the country. This has resulted in a significant flow of investment. On the other hand, India has well-established bio-manufacturing expertise and capacity for vaccine production. However, these countries are no immediate threat to dominating countries, such as the U.S. and some European countries.

Key Companies & Market Share Insights

The constant demand for AAV vector manufacturing for multiple applications has created numerous growth opportunities for major players to capitalize on. Companies are focusing on strategic initiatives, such as collaborations and acquisitions, to maximize their industry share. Some of the key players in the global adeno associated virus vector manufacturing market include:

• Roche

• BioMarin Pharmaceutical

• Oxford BioMedica

• WuXi AppTec

• YPOSKESI

• Sarepta Therapeutics

• Pfizer

• Audentes Therapeutics

• LifeSpan BioSciences, Inc.

• GenScript

Adeno Associated Virus Vector Manufacturing Market Report Scope

Global Adeno Associated Virus Vector Manufacturing Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global adeno associated virus vector manufacturing market report on the basis of scale of operations, therapeutic area, application, method, and region:

• Scale of Operations Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • Clinical

  • Preclinical

  • Commercial

• Therapeutic Area Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • Hematological Diseases

  • Infectious Diseases

  • Genetic Disorders

  • Neurological Disorders

  • Ophthalmic Disorders

  • Others

• Application Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • Cell Therapy

  • Gene Therapy

  • Vaccine

• Method Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • In Vitro

  • In Vivo

• Regional Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

  • U.S.

  • Canada

  • Europe

  • U.K.

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

  • Asia Pacific

  • Japan

  • China

  • India

  • South Korea

  • Australia

  • Thailand

  • Latin America

  • Brazil

  • Mexico

  • Argentina

  • Middle East & Africa

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait