Cell and Gene Therapy Market Size to Reach US$ 105.83 Billion by 2033 | 21.5% CAGR | CAR-T, CRISPR & Gene Editing Drive Global Growth

Cell and Gene Therapy Market reached US$ 13.90 Billion in 2024 and is expected to reach US$ 105.83 Billion by 2033, growing at a CAGR of 21.5% during the forecast period of 2025 to 2033. The market is witnessing rapid growth driven by increasing prevalence of genetic and chronic diseases, rising investments in advanced therapies, and growing adoption of personalized medicine. Technological advancements in CAR-T cell therapies, gene editing (CRISPR/Cas9), viral and non-viral vectors, and ex vivo and in vivo delivery methods, along with expanding clinical trials and regulatory approvals, are further accelerating commercialization and adoption across hospitals, specialty clinics, and research institutions globally.

The global Cell and Gene Therapy market is expanding rapidly, driven by CAR-T and TCR therapies, gene editing, and regenerative medicine. Rising clinical research, regulatory approvals, and scalable manufacturing innovations are accelerating adoption. Precision medicine and technological advancements are expected to sustain long-term growth worldwide.

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✅ Key Developments in the Cell and Gene Therapy Market
🔹February 2026: In the United States, accelerated FDA approvals of next‐generation cell and gene therapies-spanning CAR‐T, gene‐edited hematopoietic stem cells, and AAV‐based in vivo gene therapies-are expanding treatment options for oncology, rare genetic disorders, and hematological conditions.

🔹January 2026: In Europe, regulatory pathways are being streamlined for regenerative medicine products under the EU's Advanced Therapy Medicinal Products (ATMP) framework, enabling faster clinical translation and market access for innovative cell and gene therapies.

🔹December 2025: In Japan, revised revision of the Pharmaceuticals and Medical Devices Act (PMD Act) and conditional early approval systems are facilitating earlier introduction of gene therapies targeting neuromuscular and metabolic diseases, supported by post‐marketing safety data collection.

🔹November 2025: In China, domestic biotech companies are advancing expansive pipelines in CAR‐T and viral vector‐based gene therapies, leveraging scale and growing manufacturing capabilities to reduce development costs and improve accessibility.

✅ Key Players
Novartis AG | Gilead Sciences Inc. | Bristol Myers Squibb Company | Vertex Pharmaceuticals Incorporated | Sarepta Therapeutics Inc. | CSL Behring LLC | Amgen Inc. | Orchard Therapeutics group | Krystal Biotech Inc. | bluebird bio Inc.

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✅ Market Drivers
Rapid advancements in cell and gene therapy technologies are driving the development of novel treatments for genetic disorders, cancers, and rare diseases.

Growing prevalence of rare and inherited disorders is increasing demand for personalized therapies that provide long-term or curative outcomes.

Strong investment in research and development, coupled with expanding clinical trial pipelines, is accelerating commercialization of innovative therapies.

Regulatory support, including expedited approval pathways and orphan drug incentives, is encouraging companies to develop cell and gene-based solutions.

Rising adoption of personalized medicine and precision therapies is promoting integration of cell and gene therapy into standard treatment protocols.

✅ Industry Developments
Launch of CAR-T therapies, gene-editing technologies like CRISPR, and ex vivo/in vivo gene therapies targeting oncology, hematology, and metabolic disorders.

Strategic collaborations between biotech firms, academic institutions, and pharmaceutical companies to co-develop scalable and clinically validated therapies.

Expansion of manufacturing facilities for viral vectors, cell processing, and gene delivery platforms to meet global demand.

Development of next-generation therapies with improved safety profiles, reduced immune reactions, and enhanced efficacy.

Increasing integration of digital tools, AI, and bioinformatics for patient selection, treatment monitoring, and optimization of therapy outcomes.


✅ Regional Analysis:
North America - Holds 44% share: Driven by advanced biotechnology research, high adoption of innovative therapies, strong presence of leading companies like Novartis and Gilead Sciences, and robust regulatory support for cell and gene therapy approvals.

Europe - Holds 26% share: Supported by growing clinical trial activity, favorable reimbursement policies, expanding precision medicine initiatives, and increasing government funding for advanced therapies.

Asia Pacific - Holds 22% share: Fueled by rising investments in biotech infrastructure, increasing prevalence of genetic disorders, growing R&D collaborations, and improving access to advanced therapeutics in China, Japan, and South Korea.

Latin America - Holds 5% share: Growth backed by emerging biotech facilities, increasing awareness of gene therapy options, and gradual adoption of innovative treatments.

Middle East & Africa - Holds 3% share: Expansion driven by improving healthcare infrastructure, growing rare disease awareness, and gradual introduction of advanced cell and gene therapies.

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✅ Key Segments
By Therapy Type
Gene therapy holds a dominant share in the cell and gene therapy market driven by its ability to treat genetic disorders at the molecular level, including rare inherited diseases and monogenic disorders. Cell therapy represents a significant segment supported by growing adoption of stem cell-based treatments, regenerative medicine applications, and immune cell therapies such as CAR-T for oncology. Combination therapies that integrate cell and gene approaches are gaining traction due to synergistic therapeutic effects and enhanced clinical outcomes. RNA-based therapies and other advanced nucleic acid treatments are emerging rapidly as innovation expands in precision medicine.

By Application
Oncology accounts for the largest share of the market owing to high prevalence of cancers, increasing approval of CAR-T therapies, and adoption of gene-modified immune cell therapies. Genetic and rare diseases represent a rapidly growing segment supported by advancements in gene-editing technologies, targeted delivery systems, and orphan drug incentives. Cardiovascular applications are expanding steadily with gene and cell therapy approaches aimed at tissue regeneration and heart disease management. Neurological disorders, including Parkinson's and spinal cord injuries, are gaining traction as regenerative and gene-based interventions evolve. Other applications, including autoimmune diseases and ophthalmic disorders, continue to emerge as research and clinical development advance.

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