According to Fortune Business Insights, the cell and gene therapy market size was valued at USD 12.21 billion in 2025. The market is projected to grow from USD 16.45 billion in 2026 to USD 143.55 billion by 2034, exhibiting a CAGR of 31.10% during the forecast period. North America dominated the cell and gene therapy market with a market share of 52.58% in 2025.
The cell and gene therapy market is witnessing rapid expansion due to increasing research and development activities, advancements in genetic engineering, rising adoption of personalized medicine, and growing interest in innovative therapeutic approaches for complex diseases.
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The cell and gene therapy market can be segmented based on therapy type, therapeutic area, end user, and geography. Based on therapy type, the market includes cell therapy and gene therapy. Cell therapy involves the use of living cells to repair, replace, or regenerate damaged tissues, while gene therapy focuses on modifying or introducing genetic material to address the underlying causes of diseases. Both approaches are becoming increasingly important in the development of advanced treatments. Based on therapeutic area, the market covers oncology, genetic disorders, neurological disorders, cardiovascular conditions, ophthalmic disorders, and other applications. Oncology represents an important area of application because researchers are increasingly investigating cell-based and gene-based approaches for difficult-to-treat cancers. Genetic disorders are also a major focus because gene therapy can potentially address disease mechanisms at their genetic source. Based on end user, the market includes hospitals, specialty clinics, research institutes, and other healthcare facilities. Hospitals and specialized treatment centers play an important role in the administration and monitoring of advanced therapies, while research institutes contribute substantially to clinical development and technological innovation.
The cell and gene therapy market is expanding rapidly as advances in biotechnology continue to improve the development of therapies designed to address complex and previously difficult-to-treat diseases. Increasing investment in research and development is encouraging pharmaceutical companies, biotechnology firms, academic institutions, and research organizations to explore new therapeutic approaches. The growing emphasis on personalized medicine is another important factor supporting market development. Cell and gene therapies can be designed around specific disease mechanisms and patient characteristics, creating opportunities for more targeted treatment strategies. Advances in gene editing technologies, viral and non-viral delivery systems, cell engineering, and manufacturing processes are improving the capabilities of developers and supporting the progression of innovative therapies. Increasing clinical research activity is also strengthening the pipeline of potential treatments across oncology, rare diseases, genetic disorders, and other therapeutic areas. The development of regenerative medicine is creating additional opportunities for cell-based approaches, particularly where conventional treatments may have limitations. At the same time, improvements in manufacturing technologies are helping companies address the complex requirements associated with producing personalized and genetically modified therapies. Pharmaceutical and biotechnology companies are also entering strategic collaborations, licensing agreements, and research partnerships to accelerate innovation and expand their therapeutic pipelines. Growing awareness of advanced treatment options among healthcare professionals and patients is supporting demand for innovative therapies. Regulatory agencies are also establishing frameworks to evaluate advanced therapeutic products, which can facilitate the development and commercialization of promising treatments. As scientific knowledge continues to improve, the cell and gene therapy market is expected to benefit from continued innovation, increasing clinical activity, and expanding applications across multiple disease categories.