developments in imaging technology are driving the growth of the Gene Therapy Market at a CAGR of 19.04% during the forecast period 2025 to 2035

Market Research Future (MRFR) has published a cooked research report on the “Global Gene Therapy Market” that contains the information from 2019 to 2035.

The Global Gene Therapy Market is estimated to register a CAGR of 19.04 % during the forecast period of 2025 to 2035.

MRFR recognizes the following companies as the key players in the Global Gene Therapy Market — Bristol-Myers Squibb Company, Lonza, UniQure N.V., Bluebird Bio, Inc., Orchard Therapeutics Plc, GenSight Biologics, Novartis AG, Amgen Inc., Sarepta Therapeutics Inc., Spark Therapeutics, Inc., and others.

The Global Gene Therapy Market accounted for registering a CAGR of 19.04% during the forecast period and is estimated to reach USD 46.91 billion by 2035.

The growing incidences of cancer and rare disorders are significantly fueling the global gene therapy market as the demand for innovative treatments escalates. As cancer rates rise and the prevalence of rare genetic disorders increases, traditional therapeutic options often fall short, creating a pressing need for advanced solutions. Gene therapy, with its potential to address the underlying genetic causes of these conditions, offers a promising alternative by targeting and modifying the specific genes involved. For instance, according to the International Agency for Research on Cancer, there were cancer cases of nearly 9,826,539 in Asia, 4,471,422 in Europe, 2,673 174 in Northern America, 1,551,060 in Latin America and the Caribbean, 1,185,216 in Africa, and 269 088 in Oceania cancer cases of both genders in 2022. 

Furthermore, India also reported increasing incidences of cancer, which is contributing to the growth of the global gene therapy market. As per the International Agency for Research on Cancer, there were 192,020 breast cancer cases, 143,759 lip, oral cavity, 127,526 cervix uteri, 81,748 lung, 70,637 oesophagus, 70,038 colorectum, and 727,588 cancer cases of others. These increased cases of cancer across India are increasing the demand for innovative drugs by healthcare providers and patients which leads to the frequent launches of drugs associated with gene therapy. For instance, in April 2024, the Indian Institute of Technology (IIT) Bombay and Tata Memorial Centre launched gene-based therapy, namely NexCAR19 CAR T-cell therapy. This product is India’s first therapy that is affordable, accessible, and low-cost. CAR T-cell therapy is a huge achievement for India and for Indian cancer patients. Moreover, as per the American Lung Association, there were about 30,000 people with cystic fibrosis in the US and nearly 70,000 people worldwide in 2022. Also, in April 2024, the Centers for Disease Control and Prevention reported that nearly 6,000 babies born with Down syndrome in the United States.

The escalating incidences of cancer and rare genetic disorders underscore a critical unmet need for gene therapy, driving substantial growth in the global market. As traditional treatments frequently fall short in addressing the complex genetic underpinnings of these conditions, gene therapy emerges as a transformative alternative. By targeting and correcting specific genetic mutations, gene therapy offers hope for more effective and personalized treatment options. The high number of cancer cases worldwide, including significant figures from regions like Asia and India, alongside the rising prevalence of rare disorders such as cystic fibrosis and Down syndrome, highlights the urgency for advanced therapies. Innovative solutions, exemplified by recent breakthroughs like the NexCAR19 CAR T-cell therapy in India, illustrate the growing demand for gene-based treatments. As the field of gene therapy evolves, its potential to meet the needs of patients with challenging conditions will continue to drive its expansion and impact on the healthcare landscape.

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Segmental Analysis

The Global Gene Therapy Market has been segmented based on by Vector Type, by Gene Type, by Application and by Delivery Method.

Based on Vector Type, this segment includes Viral Vector (Lentiviral Vectors (LVVs), Retrovirus Vectors, Adenoviral Vectors (AdVs) and Adeno-associated Viral Vectors (AAVs)) and Non-Viral Vector (Physical Vector, Chemical Vector). The Viral Vector segment dominated the global market in 2024, while the Non-Viral Vector is projected to be the fastest–growing segment during the forecast period. Among viral vectors, adeno-associated viruses (AAVs) and lentiviral vectors (LVVs) are widely used for their safety profiles and long-term gene expression. Non-viral vectors, including physical methods (like electroporation) and chemical carriers (like lipid nanoparticles), offer lower immunogenicity and easier large-scale manufacturing. The success of lipid nanoparticle-based mRNA vaccines during the COVID-19 pandemic has accelerated interest and innovation in non-viral delivery systems. Additionally, advancements in nanotechnology and material sciences are enhancing the efficiency and targeting capability of non-viral vectors, making them an attractive option for next-generation gene therapies and expanding their potential across various therapeutic areas.

Based on Gene Type, this segment includes Antigen, Cytokine, Tumor Suppressor, Suicide, Deficiency, Growth Factors, Receptors, and Others. The Antigen segment dominated the global market in 2024, while it is projected to be the fastest–growing segment during the forecast period. These therapies have shown remarkable clinical success and have received regulatory approvals, boosting market confidence. Additionally, antigen-based approaches are expanding into other areas such as infectious diseases and autoimmune disorders, supported by advancements in gene delivery technologies and personalized medicine. The segment benefits from a robust pipeline, significant investment, and favorable regulatory designations like orphan drug and breakthrough therapy status, which accelerate development and commercialization. Overall, the antigen segment's ability to deliver targeted, effective, and personalized treatments positions it as a key driver of innovation and growth in the gene therapy landscape.

Based on Application, this segment includes Oncological Disorders, Rare Diseases, Cardiovascular Diseases, Neurological Disorders, Infectious Diseases, and Others. The Oncological Disorders segment dominated the global market in 2024, while it is projected to be the fastest–growing segment during the forecast period. This is primarily due to the rising global cancer burden and the increasing adoption of gene therapies like CAR-T cell therapy and oncolytic viruses, which offer targeted and effective treatment options. Advances in personalized medicine and immune-based gene therapies have shown significant success in treating hematologic and solid tumors, driving demand. Additionally, strong clinical pipelines, regulatory approvals, and substantial investments in cancer gene therapy research are fueling growth. The high unmet need for more effective cancer treatments and the ability of gene therapy to address previously untreatable cancers further strengthen this segment’s market position.

Based on the Delivery Method, this segment includes In Vivo Gene Therapy and Ex Vivo Gene Therapy. The In Vivo Gene Therapy segment dominated the global market in 2024, while it is projected to be the fastest–growing segment during the forecast period. This method involves directly delivering genetic material into a patient’s body, allowing for simpler, less invasive procedures compared to Ex Vivo approaches. In Vivo therapies are particularly effective for treating genetic and rare diseases, especially those affecting the liver, muscles, and central nervous system. The rise of adeno-associated viral (AAV) vectors and lipid nanoparticles has improved the safety and precision of in vivo delivery. Additionally, reduced complexity, lower treatment costs, and faster clinical translation are driving increased adoption. Growing research investments and successful clinical trials continue to accelerate development in this segment.

Regional Analysis

Geographically, the Global Gene Therapy Market has been segmented into North America, Europe, Asia-Pacific and Rest of the World.

Major demand factors driving the North America market are the growing incidences and prevalence of cancer and rare disorders and increasing approval for gene therapy products and favourable government support for gene therapy. Additionally, the availability of reimbursements and insurance coverage is making gene therapies more accessible to patients. Increased healthcare expenditure and investment in research and development are further fueling market expansion. Supportive regulatory frameworks and incentives are streamlining the approval process, while strategic partnerships and collaborations are accelerating innovation. The pipeline of gene therapy drugs includes a wide range of treatments for various genetic and acquired diseases, such as rare genetic disorders, cancer, and autoimmune diseases. The potential of these drugs to provide targeted and personalized treatments for patients with complex medical conditions has generated significant interest from biopharmaceutical companies, investors, and healthcare providers. The competitive landscape features established players who have adopted strategies such as acquisition, agreement, strategic alliance, collaboration, clinical trial, expansion, joint venture, new product development, and product approval to expand their product portfolio.

The Gene Therapy market in Europe is being propelled by several significant drivers. Strong infrastructure with renowned universities, research institutions and biotechnology hubs, and skilled workforce comprising scientists, clinicians, and industry professionals. The ongoing research and technological advancements in genomics and molecular biology are accelerating the development of innovative gene therapies. Improved understanding of gene functions, and disease mechanisms lead to more targeted and effective treatments. Increasing investments, by both public and private sectors, are transforming the market, providing significant funding, which supports clinical trials and the commercialization of gene therapies.

The Gene Therapy market in the Asia-Pacific region is driven by a combination of dynamic factors that contribute to its rapid growth. The APAC region has a high incidence of genetic and rare diseases, including inherited conditions like thalassemia and various cancers. This creates a strong demand for innovative treatments such as gene therapy. Additionally, Increased investments in healthcare infrastructure and biotechnology in countries like China, India, and Japan are supporting the development and adoption of advanced therapies, including gene therapy. Several APAC countries are implementing policies to promote biotech innovation and gene therapy research. Governments are offering grants, subsidies, and incentives to support clinical trials and commercialization of gene therapies. The region is becoming an important center for clinical trials due to lower costs, diverse patient populations, and regulatory environments that are becoming more beneficial to advanced therapies.

The Gene Therapy market in the Middle East and Africa is experiencing growth driven by several key factors. Rising disposable income and improved healthcare infrastructure across the region are driving demand for gene therapy. The growing R&D capabilities and the establishment of biotech hubs in countries like the UAE and Saudi Arabia are accelerating the development of gene therapies. Rising awareness and advocacy for rare diseases are creating a demand for new treatment options, including gene therapies.

Key Findings of the Study

• The Global Gene Therapy Market is expected to reach USD 46.91 billion by 2035, at a CAGR of 19.04% during the forecast period.


• The North America region accounted for the fastest-growing global market.


• Based on the Application, the Oncological Disorders segment was attributed to holding the largest market in 2024.


• Bristol-Myers Squibb Company, Lonza, UniQure N.V., Bluebird Bio, Inc., Orchard Therapeutics Plc, GenSight Biologics, Novartis AG, Amgen Inc., Sarepta Therapeutics Inc., Spark Therapeutics, Inc., and others are some of the players in the market.