Forecast Period | 2024-2028 |
Market Size (2022) | USD 6.01 Billion |
CAGR (2023-2028) | 9.26% |
Fastest Growing Segment | Non-viral vectors |
Largest Market | North America |
Market Overview
Global Gene Therapy Market has valued at USD 6.01 Billion in 2022 and is anticipated to project robust growth in the forecast period with a CAGR of 9.26% through 2028. The gene therapy is described as the treatment of an illness by changing, replacing, or supplementing a missing or defective genetic combination that is responsible for the disease. The gene therapy has become one of the most desirable research goals in the fight against degenerative illnesses. The need for gene therapy is being driven by an increase in the number of cases of cancer and other chronic diseases all across the world. The advancements in gene therapies are projected to be approved in the upcoming years, contributing to the gene therapy market’s growth during the forecast period.
Key Market Drivers
Advancements in Genetic Research
The increasing understanding of the genetic basis of diseases has enabled scientists to identify specific genes responsible for various disorders. This knowledge is crucial for designing targeted gene therapies that can correct or replace defective genes, addressing the root cause of diseases.
Rising Prevalence of Genetic Disorders
The increasing number of individuals diagnosed with genetic disorders highlights the unmet medical need for effective treatments. Conventional treatments for many genetic disorders often focus on managing symptoms rather than addressing the root cause. Gene therapy presents an opportunity to provide targeted and long-lasting solutions for these disorders.
Collaborations and Partnerships
Gene therapy involves a multidisciplinary approach, including molecular biology, genetics, biotechnology, clinical research, and regulatory affairs. Collaborations bring together experts from different fields, allowing them to share knowledge, insights, and best practices. This collective expertise fosters innovation and drives the development of more advanced and effective gene therapies.
Key Market Challenges
Technical Complexity
Developing effective gene therapies requires a deep understanding of genetics, molecular biology, and complex cellular processes. The technical complexity of designing therapies that accurately target and modify specific genes can lead to prolonged research and development timelines.
High Development Costs
Initial research to identify target genes, develop therapeutic constructs, and validate their efficacy in preclinical models can be expensive. This stage requires significant investment in laboratory resources, equipment, and skilled personnel.
Key Market Trends
Expanding Therapeutic Targets
Identifying new therapeutic targets means gene therapy can be applied to a wider range of medical conditions beyond traditional monogenic disorders. This diversity includes complex diseases like cancer, cardiovascular diseases, neurodegenerative disorders, and rare diseases, expanding the addressable patient population.
Growing CRISPR-Based Therapies
CRISPR-Cas9 technology allows researchers to edit genes with unparalleled precision. This precision is crucial for correcting or modifying specific genetic mutations that underlie various diseases. The ability to target and modify genes accurately enhances the effectiveness and safety of gene therapies.
Segmental Insights
Vector Type
Based on the Vector Type, the Non-Viral Vector segment is anticipated to witness substantial market growth throughout the forecast period. This growth can be attributed to multiple factors, such as Non-viral vectors typically have a lower risk of inducing immune responses compared to viral vectors. This enhanced safety profile reduces the likelihood of adverse effects and regulatory concerns, facilitating the development and approval of gene therapies. Non-viral vectors are less likely to integrate into the host genome, reducing the risk of insertional mutagenesis, a concern associated with certain viral vectors. This safety advantage supports long-term therapeutic applications. Non-viral vectors are less likely to provoke strong immune responses, enabling repeated administrations of gene therapies if necessary. This can be especially valuable for chronic conditions that require multiple treatments. Non-viral vectors often have simpler manufacturing processes than viral vectors, potentially reducing production costs and enabling more scalable manufacturing for clinical and commercial purposes. The safety advantages of non-viral vectors can lead to smoother regulatory pathways, facilitating faster approvals and reducing hurdles for clinical development and market entry. The emergence of non-viral vector technologies attracts a broader range of industry players, including biotechnology companies and academic institutions. This diversification drives competition, innovation, and market growth.
Delivery Method Insights
Based on the Delivery Method segment, the In-Vivo segment has been the dominant force in the market. In vivo gene therapy avoids the need for invasive procedures such as surgical implantation. This non-invasive nature makes it more acceptable to patients and reduces the risks associated with surgical interventions. In vivo gene therapy can be administered systemically, making it accessible to a broader range of patients. This approach is particularly beneficial for patients with diseases affecting multiple organs or tissues. In vivo gene therapy has the potential to affect multiple target cells or tissues throughout the body. This systemic effect is advantageous for conditions that involve widespread genetic abnormalities or diseases affecting multiple organs. Successful in vivo gene therapy can result in long-lasting effects, as the launched genetic material continues to express itself within the patient's body. In vivo gene therapy can address a wide range of therapeutic targets, from monogenic disorders to complex diseases like cancer, cardiovascular diseases, and neurodegenerative conditions. The non-invasive nature and systemic effect of in vivo gene therapy can positively influence patient acceptance, making clinical trial recruitment and market adoption smoother. The versatility of in vivo gene therapy allows for applications in a variety of medical fields, attracting a wider range of researchers, developers, and companies to the gene therapy market.
Regional Insights
North America, specifically the Gene Therapy Market, dominated the market in 2022, primarily due to North America, particularly the United States, has a robust research and innovation ecosystem that includes top universities, research institutions, and biotechnology companies. This environment fosters cutting-edge gene therapy research and development.
Recent Developments
- In June 2023, Sangamo Therapeutics Inc.entered into a licensed agreement with Voyager Therapeutics Inc. for thedevelopment of the epigenetic regulation treatment, a gene therapy, fortreating prion disease.
- In May 2023, Oxford BioMedica Plc launched the TetraVectaTM System whichis the 4th generation lentiviral vector delivery system. It is useful for genetherapy for delivering therapeutic genes into target cells.
- In December 2022, the collaboration between Cellectis SA and MayflowerBioventures resulted in the launch of Primera Therapeutics. The purpose was todevelop gene editing therapies for the treatment of mitochondrial disease.
- In June 2022, the alliance between Bristol-Myers Squibb Company andImmatics NV expanded for the development of multiple allogenic off the shelfTCR-T, and CAR-T programs. Both these are gene therapy programs that modify apatient’s T cells to target and attack cancer cells.
- In January 2022, Novartis AG collaborated with Alnylam to explore targettherapies for restoring liver function. In this collaboration, Novartisutilized Alnylam’s siRNA technology which is a gene therapy to develop atreatment for the regrowth of functional livers.
Key Market Players
- REGENXBIO Inc.
- Oxford Biomedica PLC.
- Voyager Therapeutics Inc.
- Human Stem Cells Institute
- Dimension Therapeutics, Inc.
- Bristol-Myers Squibb Company
- Sanofi-Aventis
- Applied genetic technologies corporation.
- F. Hoffmann-la roche ltd.
- Bluebird bio, inc.
- Novartis ag
- Uniqure n.v.
By Vector Type | By Delivery Method | By Indication | By Region |
Viral Vector Non-Viral Vector | In-Vivo Ex-Vivo | Rare Diseases Cancer Neurological Diseases Others | North America Europe Asia Pacific South America Middle East & Africa |