In-Vivo Segment to Bolster Gene Therapy Market Growth During 2025-2031

According to our new research study on "Gene Therapy Market Forecast to 2031 - Global Analysis - by Vectors, Indication, and Delivery Mode," the market size is expected to grow from US$ 5.74 billion in 2024 to US$ 12.92 billion by 2031; the market is expected to register a CAGR of 14.5% during 2025-2031. The report highlights gene therapy market trends and drivers and restraints pertaining to the market growth.

Focus on Non-Coding RNAs and NGS-Based Diagnostics is Expanding the of Gene Therapy Market Size

Recent developments in genetic engineering include NGS techniques for identifying small RNA and long non-coding RNAs, characterizing their classes for therapeutic applications in gene regulation. In amyotrophic lateral sclerosis (ALS) research, miRNAs and lncRNAs have emerged as biomarkers for diagnosis and progression monitoring, with RNA therapy strategies advancing genetic insights. Market players are addressing the focus on non-coding RNAs (ncRNAs) and NGS-based diagnostics by developing sequencing panels that profile lncRNAs, miRNAs, and fusions alongside coding regions, enabling early detection and monitoring for gene therapy eligibility. This response integrates long-read NGS with bioinformatics to uncover ncRNA regulatory roles in cancer-related diseases, supporting precision diagnostics per NIH's genomic initiatives. Companies such as Illumina and Thermo Fisher are expanding panels for tumor-agnostic use, incorporating ncRNA biomarkers to guide CRISPR or RNA therapies.

The gene therapy market forecast involves the segmentation of the market based on the basis of type, species, diseases source, and route of administration, and geography.

The gene therapy market, based on vector, is divided into non-viral vectors and viral vectors. The viral vectors segment held a significant gene therapy market share in 2024 and is projected to register a higher CAGR during the forecast period.

the market based on indication, is categorized into neurological diseases, Duchenne muscular dystrophy, cancer, hepatological diseases, and other indications. The cancer segment held a significant gene therapy market share in 2024.

In terms of delivery mode, the market is bifurcated into in-vivo and ex-vivo. The in-vivo segment held a significant gene therapy market share in 2024 and is expected to register a higher CAGR during 2025-2031.

In terms of geography, the gene therapy market report is segmented into North America (US, Canada, and Mexico), Europe (UK, Germany, France, Italy, Spain, and Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and Rest of Asia Pacific), the Middle East & Africa (UAE, Saudi Arabia, Africa, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America). In terms of revenue, North America accounted for the largest gene therapy market share in 2024. The North America gene therapy market is segmented into the US, Canada, and Mexico. The US FDA approved nine cell and gene therapy products in 2024, targeting various types of cancers and genetic disorders such as hemophilia B and aromatic L-amino acid decarboxylase deficiency. In April 2025, the FDA approved Zevaskyn (prademagene zamikeracel), the first autologous, cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). This landmark approval represents a breakthrough for patients suffering from rare genetic skin conditions who lack functional Type VII collagen due to mutations in the COL7A1 gene.

Therefore, the robust industry activity in innovative therapeutics are reshaping treatment paradigms and driving the gene therapy market growth in the US.

Gene therapy market report includes company positioning and concentration to evaluate the performance of competitors/players in the market. Novartis AG; Astellas Pharma Inc; Bristol-Myers Squibb Co, Bluebird Bio Inc, Catalent Inc, Sanofi SA, Daiichi Sankyo Co Ltd, CSL Behring LLC, BioMarin Pharmaceutical Inc., and Vertex Pharmaceuticals Inc are among the key players in the market.

Companies profiled in the gene therapy market analysis adopt various organic and inorganic strategies. Organic strategies mainly include product launches and product approvals. Acquisitions, collaborations, and partnerships are among the inorganic growth strategies witnessed in the gene therapy market. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall market growth. Further, acquisition and partnership strategies help them strengthen their customer base and expand their product portfolios.

Contact Us
Phone: +1-646-491-9876
Email Id: sales@premiummarketinsights.com