AAV Contract Development And Manufacturing Organizations Market Size, Share & Trends Analysis Report By Workflow, By Culture Type, By Application, By End-user, By Region, And Segment Forecasts, 2023 - 2035

Report Overview

The global AAV contract development and manufacturing organizations market was valued at USD 555.0 million in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 17.1% from 2023 to 2035. This growth can be attributed to the active evaluation of adeno-associated viral vectors for the development of various therapies for the treatment of infectious and chronic diseases, the rising number of AAV for vaccines and the rising number of corporate strategies such as expansion, mergers & acquisitions, product launches drive market growth.

The COVID-19 restrictions interrupted research-based operations and the progress of the healthcare industry. However, adeno-associated viral vector contract manufacturing market witnessed growth in 2020 and 2021. High market growth during the COVID-19 pandemic can be attributed to increased research activities seeking efficient treatment for the COVID-19 infection. The urgent need for vaccine research because of the pandemic impelled the market growth. Adeno-associated viral vector vaccines are comparatively easy to produce than live, attenuated, or recombinant vaccinations, as they do not require the same complicated methods. As these vaccines are relatively stable at room temperature, cold storage is not required for their transportation anywhere in the world.

Adeno-Associated Virus (AAV), adenovirus, or lentivirus vectors are currently used in most gene therapies in the market. For instance, in 2021, adeno-associated virus vector was used in more than 250 clinical trials and 82 gene therapy. Gene therapies that are directly administered to patients, by infusion or local administration (in vivo), commonly involve AAV and viral vectors, with AAV being the most preferred vector for applications other than cancer and vaccines.

Improving viral vector manufacturing for gene therapy applications is an important step in developing effective end products. In recent years, the biopharmaceutical industry has witnessed an activity spike, with service providers like Contract Development and Manufacturing Organizations (CDMOs) having invested in expansions of viral vector manufacturing capacity or viral vector development technologies. For instance, in August 2022, Merck KGaA launched its new, UpTempo Virtuos platform process for the CGMP manufacturing and development of adeno-associated viral (AAV) vectors. This platform would streamline & standardize various time-consuming steps in AAV manufacturing to reduce the timeline from gene to clinic and enable rapid first-in-human clinical evaluation.

Workflow Insights

The down-streaming process segment dominated the market and held the largest revenue share of 54.8% in 2022.  It is further subdivided into purification and fill finish. The process includes culture agitation, biomass separation, condensing collected materials, and other isolation and concentration procedures. The upstream process segment is expected to exhibit a 16.9% CAGR over the forecast period. The upstream viral production helps in the generation of cells that express the elements required to produce functional viral particles. This segment is further subdivided into vector amplification and expansion and vector recovery and harvesting.

Culture Type Insights

In terms of culture type, adherent culture accounted for the largest revenue share of 58.9% in 2022. Most of the viral vector products are manufactured using adherent cells. Using adherent human embryonic HEK293 cells is the most typical method of producing AAV and LVV vectors. HEK293-derived 293T cells or human embryonic HEK293 cells are often transfected with a vector construct (including GOI) and helper/packaging plasmids.

The suspension culture type segment is anticipated to register the fastest CAGR of 17.7% during the forecast period. The main driver is that it helps in the production of AAV vectors on a large scale utilizing suspension cell culture in standard bioreactors. The two main techniques used for this production are Spodoptera frugiperda (Sf9) insect cell infection utilizing the Baculovirus Expression Vector System and transient transfection of suspension-adapted mammalian HEK293 cells6-8 (BEVS).

Application Insights

Based on application, the cell and gene therapy development segment accounted for the largest revenue share of 38.3% in 2022 and is also anticipated to register the fastest CAGR of 18.1% during the forecast period. In 2020, pharmaceutical giants, including Novartis, Roche, and Bayer, acquired modest biotech firms focusing on gene therapies based on viral vectors for values close to or above 1 billion USD. This segment is receiving a significant amount of attention due to the potential to treat and possibly even cure diseases for which there are no current treatments.

The biopharmaceutical and pharmaceutical discovery register the second-fastest CAGR of 17.5% during the forecast period. Adeno-associated viral vectors are a significant area of pharmaceutical industry innovation. There are more than 270 established pharmaceutical companies and up-and-coming start-ups engaged in the development, spanning technology vendors, and application of AAV vectors. The key players include Voyager Therapeutics, Sanofi, F Hoffmann-La Roche, Genethon, GSK, Sangamo therapeutics, and Merck & Co.

End-user Insights

The pharmaceutical and biopharmaceutical companies segment accounted for the largest revenue share of 53.5% in 2022. Adeno-associated viral vectors are a significant area of pharmaceutical industry innovation. The first two gene therapy products approved by the FDA used AAV9 and AAV2 vectors for gene delivery. There are more than 270 companies established pharmaceutical companies, and upcoming start-ups engaged in the development, spanning technology vendors, and application of AAV vectors.

The academic and research institutes segment accounted for a CAGR of 15.3% during the forecast period. The increase in scientific communities' involvement in gene and cell therapy research has been a significant factor in this segment's revenue flow. This can be attributed to the high involvement of the global research community in the development of advanced therapies for the treatment of several genetic and acquired diseases that previously lacked an effective treatment paradigm.

Regional Insights

North America held the largest revenue share of 50.1% in 2022 due to the presence of established CMOs in the region providing adeno-associated virus manufacturing services, and a growing number of adeno-associated virus vaccines. Also, U.S. FDA is the body that governs the regulatory framework process on adeno-associated viruses in the U.S. region.

Asia Pacific is expected to expand at the fastest rate of 19.7% across the forecast period. This is due to the availability of a significant number of Food and Drug Administration (FDA), Therapeutic Goods Administration (TGA), and European Medicines Agency (EMA) approved facilities in the region that have improved contract manufacturing activities. Also, the low cost of manufacturing in the region is expected to increase the outsourcing of adeno-associated virus vector manufacturing services in the region.

Key Companies & Market Share Insights

Some of the key players in the global AAV CDMO market are Thermo Fischer Scientific, Inc., Charles River Laboratories International, Inc., Catalent, Inc., Danaher, Oxford Biomedica, Merck KGaA, Biovian Oy, GenScript, and Ask Bio. To remain competitive, market players are undertaking various strategic initiatives such as geographic expansion, mergers & acquisitions, and partnerships. For instance, in November 2022, Thermofisher Scientific Inc. launched the Gibco CTS AAV-MAX Helper-Free AAV Production System, a brand-new all-in-one tool developed to meet clinical and commercial needs for the economical and scalable development of adeno-associated virus (AAV)-based gene treatments. Some of the prominent players in the global AAV contract development and manufacturing organizations market include:

• Thermo Fischer Scientific, Inc.

• Creative Biogene

• Catalent Inc.

• Charles River Laboratories International, Inc.

• Danaher (Aldevron)

• Forge Biologics

• Genezen

• ViroCell Biologics

• Merck KGaA

• VIRALGEN

• Biovian Oy

• Esco Lifesciences (Esco Aster Pte. Ltd.)

• GenScript ProBio

• Porton Advanced Solution Ltd

• Ask Bio

• Showa Denko

• Takara Bio, Inc.

• ABL Manufacturing

• Oxford Biomedica

• Belief Biomed, Inc.

• Beijing Anlong Biomedicine Co., Ltd

• Forecyte Bio Limited

• Gene Pharma, Inc.

• Skyline Therapeutics

• TFBS Bioscience, Inc.

AAV Contract Development And Manufacturing Organizations Market Report Scope

Global AAV Contract Development And Manufacturing Organizations 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 2035. For this study, Grand View Research has segmented the global AAV contract development and manufacturing organizations market report based on workflow, culture type, application, end-user, and region:

• Workflow Outlook (Revenue, USD Million, 2018 - 2035)

  • Upstream Processing

    • Vector Amplification & Expansion

    • Vector Recovery & Harvesting

  • Downstream Processing

    • Purification

    • Fill Finish

• Culture Type Outlook (Revenue, USD Million, 2018 - 2035)

  • Adherent Culture

  • Suspension Culture

• Application Outlook (Revenue, USD Million, 2018 - 2035)

  • Cell & Gene Therapy Development

  • Vaccine Development

  • Biopharmaceutical & Pharmaceutical Discovery

  • Biomedical Research

• End-user Outlook (Revenue, USD Million, 2018 - 2035)

  • Pharmaceutical & Biopharmaceutical Companies

  • Academic & Research Institutes

• Regional Outlook (Revenue, USD Million, 2018 - 2035)

  • North America

    • U.S.                      

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

    • Belgium

    • Switzerland

    • Netherlands

    • Finland

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Singapore

    • Malaysia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait