PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930127
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930127
The global cell and gene therapy market is poised for exceptional growth in the coming decade, driven by advancements in biotechnology, genomics, and molecular biology. According to Fortune Business Insights, the market was valued at USD 13.17 billion in 2025, with projections indicating growth to USD 17.54 billion in 2026 and a remarkable surge to USD 200.54 billion by 2034, reflecting a CAGR of 35.60% during the forecast period. In 2025, North America dominated the market with a 40.10% share, driven by cutting-edge research, established healthcare infrastructure, and strong regulatory support.
Cell and gene therapy focuses on personalized treatments for non-drug treatable diseases, including cancers, rare genetic disorders, and neurological conditions. These therapies involve modifying or replacing defective cells and genes, offering long-term and potentially curative benefits. Collaborations among industry leaders are accelerating product development, with companies such as Bayer AG and GSK plc investing heavily in R&D to expand their pipeline of therapies. For instance, in September 2024, Evotec SE partnered with Novo Nordisk A/s to develop off-the-shelf cell therapy products, highlighting the emphasis on innovation and global collaboration.
Market Dynamics
Drivers
The rising prevalence of cancer and rare genetic disorders is a major market driver. Cell and gene therapies correct genetic mutations or restore cell function in patients with limited treatment options. Advancements in genomic research and personalized medicine further enhance the development of targeted therapies. As per the World Health Organization (August 2025), approximately 7.74 million people globally were living with sickle cell disease in 2021, emphasizing the urgent need for innovative therapies.
Restraints
High manufacturing complexities and costs limit adoption. Personalized therapies require intricate production processes, specialized clinical studies, and rigorous quality control, which increase costs and reduce scalability. For example, Luxturna, a gene therapy for vision loss, costs approximately USD 425,000 per eye, creating financial barriers for patients and healthcare systems.
Opportunities
The development of new therapies for neurodegenerative disorders such as Alzheimer's, Parkinson's, and ALS represents significant growth potential. Companies are leveraging gene editing techniques to address underlying disease causes. In January 2025, Bayer AG and BlueRock Therapeutics LP initiated the bemdaneprocel Phase III trial, an investigational cell therapy for Parkinson's disease, signaling transformative opportunities in neurodegenerative treatment.
Challenges
The market faces a shortage of skilled professionals, including scientists, clinicians, and technical staff, required to develop and manufacture therapies. As per the International Society for Cell & Gene Therapy (ISCT, September 2025), only 35% of technical positions were adequately staffed, indicating a workforce gap that may impede growth.
Market Trends
A key trend is the increasing focus on CRISPR-based precision medicine. CRISPR enables precise gene editing, improving therapy efficacy and safety for genetic disorders. In May 2024, NIH-supported researchers developed a CRISPR-based therapy for carbamoyl phosphate synthetase 1 (CPS1) deficiency, demonstrating the technology's versatility for rare genetic diseases.
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Competitive Landscape
The market is consolidated, dominated by Novartis AG, Gilead Sciences, Inc., and Bayer AG, offering diverse CGT products and expanding globally through R&D and strategic collaborations. Other major players include Rocket Pharmaceuticals, Bristol-Myers Squibb, Krystal Biotech, Vertex Pharmaceuticals, and CRISPR Therapeutics. Key developments include FDA approvals for advanced therapies, new CAR-T cell therapies, and partnerships to strengthen onshore manufacturing.
Conclusion
The global cell and gene therapy market is projected to grow from USD 13.17 billion in 2025 to USD 200.54 billion by 2034, reflecting rapid adoption of targeted, personalized therapies for cancer, genetic, and neurodegenerative diseases. Despite challenges such as high costs and skilled workforce shortages, innovations in CRISPR-based therapies, cell engineering, and collaborative R&D are expected to drive unprecedented market expansion.
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