Gene Therapy Market Demand Analysis in Advanced Biotechnology and Regulatory Approvals

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Gene Therapy Market- (By Type (Gene silencing, Cell replacement, Gene augmentation, Other therapies), By Vector (Viral vectors (Retroviral Vectors (Gamma Retroviral Vectors, Lentiviral Vectors), Adeno-Associated Viral Vectors, Other Viral Vectors), Non-Viral Vectors (Oligonucleotides, Other Non-Viral Vectors)), By Therapeutic area (Neurology, Oncology, Hepatology, Other therapeutic areas), By Delivery method (In Vivo, Ex Vivo), By Route Of Administration (Intravenous, Other routes of administration))), Trends, Industry Competition Analysis, Revenue and Forecast To 2034."

Gene Therapy Market Size is valued at USD 2.4 Bn in 2024 and is predicted to reach USD 13.6 Bn by the year 2034 at a 19.05% CAGR during the forecast period for 2025-2034

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Gene therapy is an advanced medical approach that involves modifying or replacing genetic material within a patient's cells to treat or prevent disease. Its primary objective is to correct or modulate gene functions that are defective or contribute to disease development. The global gene therapy market is experiencing strong growth, driven by continuous advancements in biotechnology that are facilitating the creation of innovative therapies for a wide range of genetic disorders.

Key factors supporting market expansion include increased research and development activities, favorable regulatory frameworks, and enhanced collaboration among pharmaceutical and biotechnology companies. North America and Europe currently lead the market, benefiting from established healthcare infrastructures, active clinical research programs, and significant investment in gene-editing technologies. As additional gene therapy candidates advance through clinical trials and secure regulatory approvals, the market is expected to continue expanding, providing new therapeutic options for patients with genetic conditions and contributing significantly to the evolution of the global healthcare sector.

List of Prominent Players in the gene therapy market:
• Novartis Ag
• Biogen Inc.
• Gilead Sciences, Inc.
• Bristol-Myers Squibb
• Alnylam Pharmaceuticals, Inc.
• Sarepta Therapeutics, Inc.
• Amgen, Inc.
• Orchard Therapeutics Plc
• F. Hoffmann-La Roche Ag
• Jazz Pharmaceuticals Plc
• Uniqure N.V.
• Johnson & Johnson
• Bluebird Bio, Inc.
• Biomarin Pharmaceutical Inc.
• Krystal Biotech, Inc.
• Shanghai Sunway Biotech Co. Ltd.
• Sibiono Genetech Co. Ltd.
• Ferring B.V.
• Vertex Pharmaceuticals Incorporated
• Pfizer, Inc.
• Sangamo Therapeutics, Inc.
• Regenxbio
• Ultragenyx Pharmaceutical Inc.
• Meiragtx Holdings Plc
• Anges, Inc.

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Market Dynamics
Drivers:
Gene therapy products undergo stringent regulatory evaluation prior to approval, and their capacity to target the underlying genetic causes of diseases provides therapeutic outcomes that are often more durable and effective than conventional treatments. This clinical advantage has contributed to a notable increase in regulatory authorizations, with the U.S. Food and Drug Administration (FDA) approving over ten gene therapy products between 2021 and 2023. Moreover, a substantial number of gene therapy candidates currently in clinical development are anticipated to receive approval in the coming years. These factors serve as primary drivers supporting the sustained growth of the global gene therapy market.

Challenges:
Despite its significant potential, the gene therapy market faces several challenges that may limit widespread adoption. High treatment costs restrict accessibility for many patients, while concerns regarding long-term safety, the need for post-treatment monitoring, and the potential for adverse effects necessitate careful oversight. Regulatory complexities, limited reimbursement frameworks, and challenges in achieving scalable and consistent manufacturing processes further constrain market growth. Additionally, ethical considerations and societal perceptions surrounding genetic modification remain areas of concern. Addressing these issues will be critical to ensuring continued market expansion and broader societal acceptance of gene therapy.

Regional Trends:
North America holds a leading position in the gene therapy market, driven by advanced biotechnological capabilities and a favorable regulatory environment. The presence of major industry players, coupled with significant investments in research and development, has reinforced the region's market leadership. The United States, in particular, serves as a key hub, hosting numerous clinical trials and achieving multiple product approvals. Collaborative initiatives between pharmaceutical companies and academic institutions are further accelerating innovation in the sector. North America is expected to maintain its dominant position, with ongoing efforts to expand therapeutic options for genetic disorders.

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Recent Developments:
• In May 2023, Novartis acquired a candidate gene therapy from Avrobio, a company experiencing financial challenges. Novartis made an unprecedented advance payment of $87.5 million for the clinical-phase asset, with no stipulations regarding future payments. The agreement encompassed AVR-RD-04, a hematopoietic stem cell gene therapy program under investigation designed to treat the uncommon genetic disorder cystinosis.
• In April 2023, Bristol-Myers Squibb expanded its global cell therapy manufacturing network. This expansion will enable in-house viral vector production via a manufacturing facility in the United States and its activities in Libertyville, Illinois. To make this happen, the business has signed an arrangement with Novartis. The facility and its operations could generate viral vectors for both of Bristol Myers Squibb's CAR T cell treatments. This advancement furthered the company's long-term goals in cell therapy.

Segmentation of Gene therapy market-
By Type
• Gene silencing
• Cell replacement
• Gene augmentation
• Other therapies
By Vector
• Viral vectors
o Retroviral Vectors
 Gamma Retroviral Vectors
 Lentiviral Vectors
o Adeno-Associated Viral Vectors
o Other Viral Vectors
• Non-Viral Vectors
o Oligonucleotides
o Other Non-Viral Vectors
By Therapeutic area
• Neurology
• Oncology
• Hepatology
• Other therapeutic areas
By Delivery method
• In Vivo
• Ex Vivo
By Route Of Administration
• Intravenous
• Other routes of administration
By Region-
North America-
• The US
• Canada
• Mexico
Europe-
• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe
Asia-Pacific-
• China
• Japan
• India
• South Korea
• South East Asia
• Rest of Asia Pacific
Latin America-
• Brazil
• Argentina
• Rest of Latin America
Middle East & Africa-
• GCC Countries
• South Africa
• Rest of Middle East and Africa

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This release was published on openPR.