The global gene therapy market was estimated at USD 5.54 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 18.88% from 2024 to 2030. Several factors contribute to this market growth, including the expanding field of advanced therapies, advancements in gene delivery technologies, and increasing competition among key players aiming to commercialize their therapies. Biotechnology companies are actively engaging in strategies such as acquisitions, mergers, collaborations, and partnerships to enhance their in-house expertise and strengthen their product pipelines.

However, the COVID-19 pandemic has adversely affected the growth of the gene therapy market. This sector faced significant disruptions due to the pandemic, leading to considerable challenges in the supply of materials, manufacturing processes, and logistics operations. For example, companies experienced prolonged delivery times for essential components. Additionally, they encountered shortages in clinical trial supplies when a partner contract manufacturing organization was forced to halt operations, revealing critical gaps in their supply chains.

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Vector Segmentation Insights

The AAV (adeno-associated virus) segment made a notable revenue contribution of 22% in 2023. Several biopharmaceutical companies are actively utilizing their viral vector platforms to develop AAV-based gene therapy products. For example, in September 2016, Lonza entered into an exclusive agreement with Massachusetts Eye and Ear to support its innovative Anc-AAV gene therapy platform, aimed at developing and commercializing next-generation gene therapies utilizing this AAV technology. Similarly, RegenxBio formed agreements with AveXis and Biogen in March 2014 and May 2016, respectively, allowing both companies to leverage RegenxBio’s AAV vector platform for the creation of gene therapy molecules.

Additionally, in May 2021, Biogen Inc. and Capsigen Inc. established a strategic research partnership focused on engineering novel AAV capsids capable of delivering transformative gene therapies. These therapies aim to address the underlying genetic causes of various neuromuscular and central nervous system disorders. In July 2021, a collaboration was announced involving the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST), the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), and the United States Pharmacopeia (USP). This partnership aims to evaluate analytical methods and develop standards for AAV. As part of this initiative, NIST and USP are conducting an interlaboratory study where multiple laboratories will assess critical quality attributes of AAV products, with their findings being compared and analyzed. This collaboration is expected to facilitate the development of new, promising gene therapies that could greatly enhance patient outcomes and quality of life.

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