Cell and Gene Therapy Market Size to Soar to USD 105.83 Billion with a 21.5% CAGR by 2033, Report by DataM Intelligence

The cell and gene therapy (CGT) market is rapidly emerging as one of the most transformative areas of modern medicine. These therapies offer innovative approaches to treating genetic disorders, rare diseases, and life-threatening conditions by addressing the root cause of disease rather than just managing symptoms. Cell therapies, such as CAR-T, harness the power of modified immune cells to target cancer, while gene therapies use vectors or editing technologies to correct faulty genes. As the life sciences industry embraces regenerative medicine and personalized healthcare, the adoption of CGT is accelerating across research, clinical development, and commercialization.

According to DataM Intelligence, the global cell and gene therapy market reached US$ 13.90 billion in 2024 and is projected to surge to US$ 105.83 billion by 2033, expanding at a remarkable CAGR of 21.5% during the forecast period 2025 to 2033. Growth is being driven by increasing regulatory approvals of novel therapies, rising investments in biotech R&D, and expanded indications in oncology, rare genetic disorders, and regenerative medicine. North America dominates the market, benefiting from FDA approvals and strong investment in biotech innovation, while Asia-Pacific particularly Japan and China is experiencing the fastest growth due to government support and advancements in gene-editing research.

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Key Highlights from the Report
➤ The global cell and gene therapy market was valued at US$ 13.90 billion in 2024 and will reach US$ 105.83 billion by 2033.
➤ The market will expand at a CAGR of 21.5% between 2025-2033, making it one of the fastest-growing healthcare sectors.
➤ Oncology applications dominate due to CAR-T and gene therapies for hematologic and solid tumors.
➤ North America leads the market, while Asia-Pacific is projected to grow fastest, with Japan pioneering regenerative medicine.
➤ Rapid increase in FDA and EMA approvals of advanced therapies is accelerating market adoption.
➤ Leading companies include Novartis, Gilead Sciences, Bluebird Bio, and Bristol Myers Squibb.

Market Segmentation

By Therapy Type
The market is segmented into cell therapy and gene therapy. Cell therapy involves the transplantation or modification of living cells to treat diseases, including CAR-T cells for cancer and stem cell therapies for regenerative medicine. Gene therapy focuses on introducing, altering, or deactivating genetic material within a patient's cells to correct genetic defects or modulate disease processes, often using viral vectors like AAV or lentivirus. While both are transformative, cell therapy currently holds a larger market share due to the commercial success of approved CAR-T products, though gene therapy is rapidly advancing with treatments for rare genetic disorders.

By Application
Key applications include oncology, musculoskeletal conditions, ophthalmology, blood disorders, immunodeficiency disorders, graft-versus-host disease (GVHD), rare diseases, and others. Oncology is the dominant segment, driven by the efficacy of CAR-T therapies in hematologic malignancies. Rare diseases, such as spinal muscular atrophy and inherited retinal dystrophies, are a major focus for gene therapy due to the high unmet need. Blood disorders (e.g., beta-thalassemia, hemophilia) and immunodeficiency disorders (e.g., SCID) are also significant, with gene therapies offering potential cures. Musculoskeletal and ophthalmology applications are emerging, leveraging regenerative approaches.

By End-User
Hospitals and specialized treatment centers are the primary end-users, administering advanced therapies like CAR-T infusions and gene replacements. Pharmaceutical and biotechnology companies drive R&D and commercialization. Research institutes and academic centers pioneer foundational science and clinical trials. Other end-users include contract manufacturing organizations (CMOs) and regulatory bodies ensuring safety and efficacy. The complexity of these therapies necessitates specialized facilities and expertise, concentrating initial adoption in major healthcare hubs, though outreach is expanding with evolving technology and infrastructure.

Regional Insights
North America dominates the cell and gene therapy market, with the U.S. leading global adoption. The FDA has accelerated approval pathways for advanced therapies, and significant investments are being made in CAR-T and gene-editing platforms. Several commercialized therapies, including Kymriah, Yescarta, and Zolgensma, originated in the U.S.

Europe holds the second-largest market share, with countries like Germany, the UK, and France advancing cell and gene therapy research. The EMA supports clinical trials, and several therapies have gained conditional approval under accelerated frameworks.

Asia-Pacific is expected to grow at the highest CAGR. Japan stands out, with government initiatives under its Regenerative Medicine Act supporting clinical adoption of CGT. China is making rapid progress with a growing pipeline of CAR-T therapies and gene-editing trials, supported by massive biotech investments. India, South Korea, and Singapore are also expanding their regenerative medicine capabilities.

Latin America and Middle East & Africa are gradually entering the CGT space, with Brazil and the UAE emerging as early adopters through collaborations with global biotech companies.

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Market Dynamics

Market Drivers
The cell and gene therapy market is fueled by several key factors. One of the strongest drivers is the growing number of regulatory approvals from agencies such as the FDA and EMA, which has accelerated commercialization of advanced therapies and boosted investor confidence. Breakthroughs in CAR-T cell therapy and gene-editing platforms, such as CRISPR-Cas9, are enabling treatments for cancers, rare genetic conditions, and other complex diseases that previously had limited or no therapeutic options. Rising biotech and pharmaceutical R&D investments in regenerative medicine further support innovation and expansion of the pipeline. Moreover, the increasing demand for curative therapies in oncology and rare disorders continues to fuel adoption, as patients and providers seek long-term, life-changing treatment solutions rather than symptomatic management.

Market Restraints
Despite rapid progress, the industry faces several hurdles. High treatment costs, often reaching several hundred thousand dollars per patient, remain a major barrier to widespread access and affordability. In addition, manufacturing challenges, including limited scalability and complex supply chain requirements for viral vectors, constrain production capacity. Regulatory complexities related to ensuring long-term safety and efficacy also slow down clinical approvals, while reimbursement challenges create uncertainty for healthcare providers and patients. Together, these factors hinder broader adoption and limit market penetration, particularly in cost-sensitive regions.

Market Opportunities
Looking ahead, the market presents significant growth opportunities. Expanding gene therapies into common chronic diseases such as diabetes, cardiovascular disorders, and neurodegenerative conditions could dramatically increase the patient base. The development of allogeneic ("off-the-shelf") cell therapies, which eliminate the need for individualized cell sourcing, has the potential to improve scalability, reduce costs, and simplify logistics. Furthermore, advancements in next-generation CRISPR and gene-editing technologies are opening new possibilities for precise, safe, and durable treatments. Emerging markets in Asia-Pacific, Latin America, and the Middle East also present untapped potential as governments invest in advanced healthcare infrastructure and biotech innovation.

Reasons to Buy the Report
✔ Accurate market forecasts and CAGR projections through 2033.
✔ In-depth segmentation by therapy type, indication, and vector platform.
✔ Regional insights highlighting North America's dominance and Japan's leadership in regenerative medicine.
✔ Profiles of major companies and updates on clinical trial pipelines.
✔ Identification of growth opportunities in oncology, rare diseases, and next-gen gene-editing platforms.

Frequently Asked Questions (FAQs)
◆ How big is the global cell and gene therapy market in 2024, and what is the forecast for 2033?
◆ Which therapy type dominates the cell and gene therapy market?
◆ What is the projected CAGR of the cell and gene therapy market during 2025-2033?
◆ Which region leads in the global cell and gene therapy industry?
◆ Who are the major players in the cell and gene therapy market?

Company Insights
Key players in the cell and gene therapy market include:
» Amgen, Inc.
» Bluebird Bio, Inc.
» Bristol Myers Squibb Company
» CSL Behring LLC
» Gilead Sciences, Inc.
» Krystal Biotech, Inc.
» Novartis AG
» Orchard Therapeutics group
» Sarepta Therapeutics, Inc.
» Vertex Pharmaceuticals Incorporated

Recent Developments

✦In 2024, Bluebird Bio received FDA approval for its gene therapy for sickle cell disease, marking a milestone in genetic disorder treatments.

✦In 2023, Novartis announced expanded indications for its CAR-T therapy Kymriah in treating additional forms of lymphoma.

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Conclusion
The cell and gene therapy market is entering a period of exponential growth, projected to rise from US$ 13.90 billion in 2024 to US$ 105.83 billion by 2033, at a CAGR of 21.5%. With oncology and rare genetic diseases leading adoption, and advancements in CAR-T, AAV, and CRISPR technology driving innovation, CGT represents the future of medicine. North America currently dominates, but Asia-Pacific led by Japan and China will be the fastest-growing region. Despite high costs and regulatory complexities, the market holds immense potential to revolutionize healthcare with curative therapies over the next decade.

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