Innovations in Genetic Engineering, Rising Prevalence of Chronic Diseases, and Regulatory Approvals Drive Market Expansion

AUSTIN, TX, UNITED STATES, February 27, 2025 /EINPresswire.com/ -- According to Research by SNS Insider, The Gene Therapy Market was estimated at USD 9.2 billion in 2023 and is expected to reach USD 54.39 billion by 2032, at a CAGR of 23.12% during the forecast period of 2024-2032.

The Gene Therapy Market is growing at a fast pace with advancements in genetic research, rising approvals of gene-based therapies, and growing incidence of genetic disorders. Advances in viral and non-viral vectors and growing applications in oncology and rare diseases are fueling market growth. Increased investments in biotechnology and favorable regulatory environments further boost the use of gene therapies, setting the market for substantial future growth.

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Market Segmentation Insights

By Vector Type, the adeno-associated virus (AAV) segment dominated the gene therapy market with a 22% market share in 2023.

The dominance is on account of its better safety profile, effective gene delivery, and long-term expression of genes. AAV vectors are most widely used for gene therapies owing to their non-pathogenic nature, low immunogenicity, and ability to transduce both dividing and non-dividing cells. Their capacity to offer long-lasting therapeutic benefits, particularly for rare genetic diseases, neurological disorders, and ophthalmic diseases, has contributed to their growing acceptance. Furthermore, continuous progress in AAV engineering has enhanced targeting specificity, minimizing the potential for off-target effects. The FDA approval of several AAV-based treatments and robust investment in AAV-based clinical trials has further solidified its leadership. Biotech companies and research centers continue to invest in AAV because of its scalability and clinical efficacy, enhancing its leadership in the gene therapy market.

By Route of Administration, the intravenous (IV) component segment dominated the gene therapy market in 2023 with the highest market share.

The dominance of the segment is because of its effectiveness in the systemic delivery of gene therapies to provide broad distribution to the cells of interest. Most of the approved gene therapies, such as SMA and hemophilia treatments, are based on IV administration since they enable the accurate and controlled delivery of viral vectors, including adeno-associated viruses (AAVs), directly into the bloodstream. This pathway is especially useful for disorders that involve extensive tissue or organ targeting. IV delivery is preferred due to its minimally invasive nature over surgical options, making it more patient-compliant and decreasing complications. Increasing numbers of gene therapies in clinical trials using IV infusion, as well as technological advances in vector engineering to maximize targeting efficiency, have cemented its market dominance.

By Indication, the spinal muscular atrophy (SMA) segment dominated the Gene Therapy Market with a 21% market share in 2023.

The spinal muscular atrophy dominance is owing to the widespread prevalence of the disease, high unmet medical needs, and success of commercially approved gene therapies such as Zolgensma. SMA is a rare, inherited genetic disorder with progressive muscle weakness and loss of movement primarily occurring in infants and young children. Gene therapy is an innovative treatment that provides a one-time cure that targets the very cause of the disease by substituting the defective SMN1 gene. The SMA segment's dominance is further fuelled by robust regulatory support, positive reimbursement policies, and large research funding. The presence of newborn screening programs has improved early detection, boosting the requirement for gene therapy treatment. With increasing progress and widening indications, SMA continues to be a prime application in the gene therapy market.

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North America dominated the Gene Therapy Market with a 31% market share in 2023.

The region’s dominance is due to its robust biotechnology industry, high R&D spending, and sophisticated healthcare infrastructure. The availability of top pharmaceutical firms, intense clinical trial activity, and supportive regulatory guidance from organizations such as the FDA have spurred gene therapy approvals. Moreover, a high incidence of genetic diseases and cancer, along with high funding from private and public sources, has fueled market growth. The region's highly established reimbursement policies also aid the widespread usage of gene therapies.

Key Players in Gene Therapy Market
• BioMarin.
• Amgen Inc.
• F. Hoffmann-La Roche
• Gilead Sciences Inc.
• Merck & Co.
• Legend Biotech.
• Bristol-Myers Squibb Company
• Sarepta Therapeutics Inc.
• Novartis AG
• uniQure N.V.

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