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The gene therapy market size is expected to reach USD 27,250.20 million by 2034, according to a new study by Polaris Market Research. The report "Gene Therapy Market Size, Share, Trends, Industry Analysis Report: By Therapeutic Area (Autoimmune Disorders, Cardiovascular Diseases, Dermatological Disorders, Hematological Disorders, Metabolic Disorders, Muscle-Related Diseases, Oncological Disorders, and Others), Vector Type, Approach, Route of Administration, and Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa) - Market Forecast, 2025-2034" gives a detailed insight into current market dynamics and provides analysis on future market growth.
Gene therapy involves modifying or replacing unhealthy genes within a patient's cells to treat or prevent disease. Rapid advancements in genetic engineering, along with an increasing understanding of molecular biology, have propelled gene therapy from experimental stages to real-world clinical applications. Researchers and biopharmaceutical companies are investing heavily in developing safe and effective therapies, while regulatory bodies are streamlining approval processes to accelerate gene therapy market expansion.
The demand for gene therapy has surged due to the increasing prevalence of genetic disorders such as Duchenne muscular dystrophy (DMD), sickle cell disease, hemophilia, and cystic fibrosis. Unlike traditional treatment methods that primarily focus on symptom management, gene therapy targets the underlying cause of these diseases at the genetic level. This targeted approach enhances treatment efficacy and offers the potential for long-term or even permanent relief. In recent years, significant breakthroughs in gene-editing technologies, such as CRISPR-Cas9 and zinc finger nucleases (ZFNs), have enabled more precise and efficient gene modifications.
The rising number of regulatory approvals for gene-based treatments is propelling the gene therapy market growth. Government agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recognized the transformative potential of these therapies. They are expediting the approval process for promising candidates. Therapies such as Zolgensma for spinal muscular atrophy (SMA) and Luxturna for inherited retinal disease have demonstrated remarkable clinical success, paving the way for broader adoption of gene-based therapies or treatments.
Based on therapeutic area, the oncological disorders segment leads the gene therapy market share in 2024 due to the prevalence of significant physical and psychological impacts of the disease and its treatment.
By vector type, the viral segment leads gene therapy market revenue share due to its effective and efficient delivering genes to the targeted cells for various cancers, monogenic and infectious diseases.
North America leads the gene therapy market due to its robust research infrastructure, advanced healthcare system, significant funding for clinical trials, and a supportive regulatory framework, particularly from the FDA, which allows for rapid development and approval of new gene therapies.
A few global key market players are Abeona Therapeutic, Novartis AG, Spark Therapeutics LLC, Gilead Sciences Inc., Bristol Myers Squibb, Adverum Biotechnologies, Alnylam Pharmaceuticals, American Gene Technologies, Applied Genetic Technologies Corporation, Biogen, and Ultragenyx.
Polaris Market Research has segmented the gene therapy market report on the basis of therapeutic area, vector type, approach, route of administration, and region: