The global Gene Therapy Market by Type (Gene silencing, Gene augmentation), Vector (Viral (Retroviral, AAV), Non-viral (Oligonucleotide)), Therapeutic Area (Neurology, Oncology), Delivery Method (In-vivo, Ex-vivo), RoA (Intravenous) - Global Forecast to 2028 ", is expected to reach USD 23.9 billion by 2028 from USD 9.0 billion in 2023, at a CAGR of 21.4% during the forecast period. The rising number of product approvals followed by growing focus on genomic research focused on development of novel therapeutics including gene therapies against critical indications, are the factors supporting market growth.

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Key Market Players

The market for gene therapy is consolidated, with key players strategizing to capture the market. Prominent players in the gene therapy market are Novartis AG (Switzerland), Biogen Inc. (US), Gilead Sciences, Inc. (US), Bristol-Myers Squibb (US), Alnylam Pharmaceuticals, Inc. (US), and Sarepta Therapeutics, Inc. (US)among others.

Driver: Increasing regulatory approvals for gene therapy products

Gene therapy products undergo rigorous regulatory scrutiny before approval. They act at the genetic level in order to generate therapeutic effects which are relatively effective and long term than traditional medicines. The number of approvals received for gene therapy products has been observed to increase due to this major advantage offered by these products. The US FDA has approved more than 10 products between 2021 and 2023. Additionally, there are significant number of products in the clinical pipeline expected to receive final approval during the forecast period. Thus, this is a major factor driving the growth of the market during the forecast period.

Restraint: High costs of gene therapy products

Research and development efforts are extensive for development of advanced therapies such as gene therapy. Thus, they demand a significant investment in terms of time and money. The costs include laboratory research, preclinical testing, clinical trials, and regulatory approval. Additionally, gene therapy products use of vectors which need to be produced and separately engineered as per requirement. This increases the complexity of the overall manufacturing process. The manufacturing processes are required to be highly controlled and adherence to stringent quality standards is required, adding to production costs. Besides, gene therapies are highly targeted therapies and are not produced in bulk. All these factors add to high costs of gene therapy products restraining its adoption especially in developing regions across the globe.

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Gene augmentation subsegment accounted is the fastest-growing of the gene therapy market by type

Among the type subsegments, the market is segmented gene silencing, cell replacement, gene augmentation, and other therapies. In 2022, the gene augmentation segment accounted for the highest growth rate of the gene therapy market by end user. Growth in this market segment can be attributed to factors such as growing number of clinical pipeline products employing gene augmentation mechanism and the favorable therapeutic effects generated among others.

Oncology is the fastest-growing segment of the gene therapy market by therapeutic area

Among the therapeutic area subsegment, the gene therapy market is segmented into oncology, neurology, hepatology, and other therapeutic areas. In 2023, oncology segment accounted for the fastest-growing share of the therapeutic area segment of gene therapy market. Growth in this market segment can be attributed to one of the major factors which is growth in the demand for targeted therapies including gene therapy.

Europe: The second-largest region in the gene therapy market.

The European market is the second-largest gene therapy market globally, mainly due to factors such as advancements in targeted therapy research and government support. Moreover, greater awareness among people about emerging area of treatments such as gene therapy, especially compared to developing regions is another factor supporting the growth of European gene therapy market.

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Recent Developments of Gene Therapy Industry:

  • In May 2022, Novartis AG (Switzerland) received US FDA approval for KYMRIAH (Tisagenlecleucel) for a third indication, including relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.
  • In May 2022, Biogen Inc. (US) partnered with Scribe Therapeutics (US) to develop a new neurological disease target in gene therapy using the company’s CRISPR technology. The deal size for this partnership was ~USD 15 million.

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