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The global AAV vector market (AAV based gene therapy and AAV manufacturing) is projected to grow from USD 1.9 billion in 2022 to USD 11.1 billion by 2035, exhibiting a CAGR of 14% during the forecast period. Given the potential of gene therapies in targeting the underlying cause of a disease at cellular level, the demand for such therapies has increased considerably over the past few years. Currently, more than 285 gene therapies are being evaluated in different phases of clinical development. Further, various gene therapy developers have raised more than USD 10 billion capital during the year 2021. With the growing interest in such therapies, the demand for novel delivery vectors has also increased. Among various gene delivery vectors available, adeno-associated viral vectors (AAV) have emerged as one of the most efficient viral vectors. Till now, there are six approved AAV based gene therapy, with five of them having received US FDA approval, the latest approval coming in June 2023. A number of adeno associated viral vector based therapies are also being evaluated in different clinical trials. In fact, it has been observed that clinical trials evaluating AAV based gene therapy have increased at a growth rate of ~30% over the last few years. Further, it is worth mentioning that over 50 clinical trials are expected to complete in the next three years. In order to cater to the demand, close to 100 companies, across the globe, have emerged for the development of AAV based gene therapy and AAV manufacturing. In fact, a number of these companies also offer advanced AAV technology platforms, enabling the processing of adeno-associated viral vectors and related therapies across different scales of operation from small scale to large scale. Looking at the adoption and acceptance of AAV vector as a safe delivery option for gene therapy, the market for AAV based gene therapy developers is likely to witness healthy market growth during the forecast period. This market growth will be driven by the support provided by AAV manufacturing companies and AAV technology providers.
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The Adeno-Associated Viral Vectors / AAV Vector Market: Focus on AAV Based Gene Therapy and AAV Manufacturing by Type of Therapy (Gene Augmentation, Immunotherapy and Others), Type of Gene Delivery Method Used (Ex vivo and In vivo), Target Therapeutic Area (Genetic Disorders, Haematological Disorders, Infectious Diseases, Metabolic Disorders, Muscle Disorders, Ophthalmic Disorders, Neurological Disorders and Others), Application Area (Gene Therapy, Cell Therapy and Vaccine), Scale of Operation (Preclinical, Clinical and Commercial) and Geographical Regions (North America, Europe, Asia Pacific, MENA, Latin America and Rest of the World): Industry Trends and Global Forecasts, 2022-2035 market report features an extensive study on the current market landscape, market size and future opportunities available to the AAV based gene therapy developers, AAV manufacturing companies and AAV technology providers. The market report offers an informed opinion on the likely evolution and underlines an in-depth analysis, highlighting the key drivers and the market trends related to this evolving segment of the pharmaceutical industry. Key takeaways of the AAV vector market are briefly discussed below.
Novartis Gene Therapies was the first company to receive EMA approval for an AAV based gene therapy in 2012, when Glybera received marketing authorization for treatment of inherited metabolic disorder lipoprotein lipase (LPL) deficiency (LPLD). The journey for the drug was short as it never received a go ahead from the FDA and was withdrawn from European market in 2017. Although the event questioned the development of AAV as a delivery vector for gene therapies, the pharmaceutical industry has seen six successful approvals since 2019. Zolgensma (Novartis Gene Therapies), Luxturna (Spark Therapeutics), Hemgenix (CSL Behring / UniQure), Roctavian (BioMarin Pharmaceuticals), Upstaza (PTC Therapeutics) and recently approved Elevidys (Sarepta Therapeutics) are six AAV based gene therapy available in either the US or EU markets for treatment of various indications. Zolgensma uses recombinant AAV9 vector for delivery of SMN1 gene to treat patients with spinal muscular atrophy. According to the financial information provided by Novartis Gene Therapies, Zolgensma generated net sales of USD 1,370 million in full year 2022 and is amongst the top 10 products in the company’s innovative medicines division. Presently, more than 550 AAV based gene therapy are being evaluated by drug developers worldwide, details of which have been captured in our market report.
Over the past years, more than 155 clinical trials evaluating AAV gene therapy have been registered across different regions of the world. We have identified more than 120 active clinical trials worldwide. More than 7,000 patients are enrolled in these clinical trials, geographical distribution for which is available in this market report. In November 2022, MeiraGTx started recruiting patients in a phase I clinical trial of its AAV gene therapy AAV-GAD for Parkinson’s disease. Parkinson’s disease is an indication in early stages of evaluation for treatment with AAV based gene therapy. In March 2023, Asklepios BioPharmaceutical, a subsidiary of Bayer AG, announced the presentation of clinical trial results from a phase 1b study of its AAV gene therapy AB-1005 at AD/PD™ 2023 Advances in Science & Therapy Conference in Sweden. The candidate is also being developed for the treatment of mild to moderate Parkinson’s disease. The evaluation of AAV based gene therapy for treatment of neurological disorders is expected to be a market driver in the long term.
More than 80 companies across the globe have the required capabilities to manufacture adeno-associated viral vectors. At present, majority of the companies have preclinical and clinical batch manufacturing capabilities. Of the identified AAV manufacturing companies 43% also have capability to cater to large scale commercial manufacturing demand. Companies like Thermo Fisher Scientific are also developing AAV manufacturing technologies that can help the drug developers to scale production from small research scale to large scale commercial production. Catering to the growing demand for AAV vectors, Thermo Fisher Scientific launched Gibco AAV-MAX Helper-Free AAV Production System in November 2022. Another company, Charles River Laboratories launched a nAAVigation platform to support AAV manufacturing in October 2022. Charles River Laboratories platform claims to reduce the time from process development to large scale GMP manufacturing by 55%. Many more AAV manufacturing CMO and CDMO are developing AAV technology platforms for efficient manufacturing. Such technological developments will support market growth during the forecast period.
Multiple partnerships and collaborations have been established between the stakeholders in order to enhance development activity in this growing segment of the pharmaceutical industry. For AAV based gene therapy developers, product development and commercialization agreements are the most popular engagement model. However, as the AAV gene therapies move from preclinical to clinical and commercial stages of development, there has been an increase in the demand for service of AAV manufacturing companies. Such companies are engaging in partnerships and collaborations, not only with the AAV based gene therapy developers but also with other manufacturers to enhance their service portfolio. In May 2023, Forge Biologics collaborated with LabCorp to provide access to good manufacturing practice (GMP) scale manufacturing capabilities, drug development services and scientific expertise to their clients in the AAV market.
The growing interest in AAV vector market is also evident from the patents filed for protection of intellectual property related to AAV technology. Close to 4,400 patents related to adeno-associated viral vectors have been analyzed in our market report. On the basis of patents analysis, Baxalta, Biomarin, Genzyme, Regenxbio, Spark Therapeutics and Voyager Therapeutics are the most popular AAV based gene therapy drug developers from the pharmaceutical industry. Considering the prevalent trends and projected opportunity associated with the overall adeno-associated viral vectors industry, we believe that the AAV vector market is anticipated to grow at a health CAGR during the forecast period.
The global AAV vectors market was estimated to be USD 1.9 billion in 2022. In 2023 alone, there have been three key approvals. Another drug, Hemgenix from CSL Behring, which received FDA approval for treatment of hemophilia B in November 2022, witnessed its first sale in June 2023. Driven by the launch of new AAV based gene therapy candidates and a strong late stage pipeline, the AAV vectors market size is estimated to reach USD 11.1 billion by 2035, exhibiting a CAGR of 14% during forecast period. North America currently holds the largest market share, essentially owing to the approval of majority AAV based gene therapy candidates in the US. Additionally, the North American market has also witnessed adoption of this gene therapy segment by the patients. We expect the market in North America to continue to hold the largest market share during the forecast period of the report.
Examples of key players engaged in adeno-associated viral vectors industry / AAV vector market (which have also been profiled in this report) include (in alphabetical order), Abeona Therapeutics, Aldevron (acquired by Danaher), Oxford BioMedica, Sanofi (CEPiA, Sanofi Pasteur, Genzyme), WuXi AppTec, and YPOSKESI. This market report includes an easily searchable, excel database of all AAV based gene therapy developers, AAV manufacturing companies and AAV technology providers worldwide.
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Several recent developments have taken place in the field of adeno-associated viral vectors. We’ve outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that we’ve outlined in our analysis.
The market research report presents an in-depth analysis of the various AAV based gene therapy developers, AAV manufacturing companies and AAV technology providers engaged in the AAV vector market, across different segments, as defined in the table below:
Key Report Attributes | Details | |
Base Year |
2021 |
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Forecast Period |
2022 – 2035 |
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Market Size (2022) |
$1.95 billion |
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Market Size (2035) |
$11.3 billion |
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CAGR |
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Type of Therapy |
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Type of Gene Delivery Method Used |
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Target Therapeutic Area |
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Scale of Operation |
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Application Area |
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Geographical Regions |
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The market report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry. Amongst other elements, the market research report includes:
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One of the key objectives of this market report was to evaluate the current market size and the future opportunity associated with the adeno-associated viral vectors / AAV vector market, over the forecast period. Based on various parameters, such as the likely increase in number of clinical trials, anticipated growth in target patient population, existing price variations across different types of vectors, and the anticipated success of gene therapy products (considering both approved and late-stage clinical candidates), we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. In order to provide a detailed future outlook, our projections have been segmented on the basis of type of therapy (gene augmentation, immunotherapy and others), type of gene delivery method used (ex vivo and in vivo), target therapeutic area (genetic disorders, hematological disorders, infectious diseases, metabolic disorders, ophthalmic disorders, muscle disorders, neurological disorders and others), application area (gene therapy, cell therapy and vaccine), scale of operation (preclinical, clinical and commercial), and geographical region (North America, Europe, Asia Pacific, MENA, Latin America and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s market growth.
The opinions and insights presented in this study were also influenced by discussions held with senior stakeholders in the industry. The market report features detailed transcripts of interviews held with the following industry and non-industry players:
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this research report are in USD, unless otherwise specified.