Press release
Cell and Gene Therapy Market : Transforming the Future of Medicine
Cell and Gene Therapy Market
Cell and gene therapies (CGT) represent one of the most revolutionary shifts in modern healthcare, offering the potential to cure diseases at their genetic and cellular roots rather than simply managing symptoms. By repairing, replacing, or regenerating diseased cells and tissues, these therapies provide hope for conditions once considered incurable - from rare genetic disorders to cancers and degenerative diseases.
The global cell and gene therapy market is witnessing unprecedented growth, propelled by rapid scientific advancements, rising approvals of novel therapies, and increasing investments from pharmaceutical and biotechnology companies. With a surge in research pipelines and expanding manufacturing capabilities, the decade from 2024 to 2034 is expected to solidify cell and gene therapies as mainstream treatment options across multiple disease areas.
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Market Overview
• The global cell and gene therapy market size in 2024 is valued at USD 16.2 billion.
• It is projected to reach USD 56.8 billion by 2034, growing at a CAGR of 13.6 % during the forecast period.
• Growth is driven by the increasing number of regulatory approvals, expanding clinical trial pipelines, and strong demand for advanced therapies addressing unmet medical needs.
Key Market Drivers:
• Rising prevalence of genetic disorders and rare diseases.
• Increasing incidence of cancers and chronic illnesses.
• Expanding regulatory support and accelerated approval pathways.
• Growing collaborations between biotech startups, big pharma, and academic research institutions.
Key Challenges:
• High treatment costs limiting accessibility.
• Complex manufacturing and supply chain processes.
• Reimbursement and pricing pressures in developed and emerging markets.
• Ethical and safety considerations for gene editing technologies.
Leading Players:
Novartis AG, Gilead Sciences, Bluebird Bio, Bristol Myers Squibb, Spark Therapeutics, Pfizer Inc., Orchard Therapeutics, Sangamo Therapeutics, and CRISPR Therapeutics.
Segmentation Analysis
The cell and gene therapy market can be segmented as follows:
By Therapy Type
• Cell Therapy (Autologous, Allogeneic)
• Gene Therapy (Ex vivo, In vivo)
By Indication
• Oncology
• Rare Genetic Disorders
• Cardiovascular Diseases
• Neurological Disorders
• Ophthalmic Disorders
• Others
By Application
• Regenerative Medicine
• Immuno-oncology
• Genetic Disorder Treatment
• Others
By End-Use
• Hospitals & Clinics
• Biotechnology & Pharmaceutical Companies
• Academic & Research Institutes
By Technology
• Viral Vector-based
• Non-viral Vector-based
• CRISPR & Gene Editing Tools
• Cell Expansion & Engineering Platforms
Summary:
Gene therapies are gaining rapid momentum due to breakthrough approvals for rare diseases, while oncology continues to dominate as the leading therapeutic area. Cell-based therapies, particularly CAR-T cell therapies, are establishing a strong foothold in immuno-oncology. Hospitals and specialized clinics remain primary end users, supported by biotech and pharma companies scaling commercial production.
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Regional Analysis
North America
• Largest market, accounting for nearly 50 % of global revenues in 2024.
• Driven by strong clinical trial activity, regulatory support from the FDA, and leadership in CAR-T therapies.
• The U.S. dominates due to its advanced healthcare infrastructure and significant R&D funding.
Europe
• Strong presence of biotech clusters in Germany, the UK, France, and Switzerland.
• The European Medicines Agency (EMA) has created clear regulatory frameworks for ATMPs (advanced therapy medicinal products).
Asia-Pacific (APAC)
• Expected to record the fastest CAGR of ~15 % through 2034.
• China, Japan, and South Korea are heavily investing in CGT manufacturing and clinical trials.
• India is emerging as a competitive hub for affordable gene therapy development.
Middle East & Africa (MEA)
• Early adoption stage, but rising investments in advanced healthcare infrastructure in UAE and Saudi Arabia are opening opportunities.
Latin America
• Brazil and Mexico are at the forefront, with gradual adoption supported by international collaborations and clinical research.
Regional Summary:
North America and Europe dominate revenue generation, but Asia-Pacific will be the growth engine over the next decade, as governments push for innovation and local biotech ecosystems scale rapidly.
Market Dynamics
Growth Drivers
1. Increasing approvals of cell and gene therapies across multiple indications.
2. Rising demand for personalized medicine.
3. Expanding clinical trial pipelines and FDA/EMA fast-track designations.
4. Growing partnerships between pharma and biotech to scale production.
5. Strong funding inflows from venture capital and global health organizations.
Key Challenges
• High upfront costs (often exceeding USD 1 million per treatment).
• Manufacturing complexities and long development timelines.
• Limited patient access due to reimbursement restrictions.
• Safety concerns related to insertional mutagenesis and immune responses.
Latest Trends
• Development of allogeneic "off-the-shelf" CAR-T therapies to improve scalability.
• Integration of AI and big data to accelerate target discovery and trial design.
• Growth of next-generation viral and non-viral vectors with improved safety.
• Expansion of gene-editing tools like CRISPR for broader therapeutic use.
• Increasing focus on real-world evidence (RWE) to support reimbursement and regulatory decisions.
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Competitor Analysis
Major Players:
• Novartis AG (notable CAR-T therapies such as Kymriah)
• Gilead Sciences (Yescarta, Tecartus)
• Bristol Myers Squibb (Breyanzi, Abecma)
• Bluebird Bio (Zynteglo, Skysona)
• Spark Therapeutics (Luxturna)
• Pfizer Inc. (gene therapy pipeline in hemophilia and rare diseases)
• Orchard Therapeutics
• Sangamo Therapeutics
• CRISPR Therapeutics
• Fate Therapeutics
Competitive Summary:
The market is competitive yet collaborative. Established pharma companies are leveraging acquisitions and partnerships to secure advanced therapy pipelines, while smaller biotech firms focus on innovation in niche indications. Manufacturing capacity expansion and regulatory expertise are emerging as key differentiators in this rapidly evolving market.
Conclusion
The cell and gene therapy market is on a trajectory of transformative growth, projected to expand from USD 16.2 billion in 2024 to USD 56.8 billion by 2034, at a CAGR of 13.6 %.
This report is also available in the following languages : Japanese (細胞・遺伝子治療ファンダメンタル分析市場), Korean (세포 및 유전자 치료 기본 분석 시장), Chinese (细胞和基因治疗基本面分析市场), French (Analyse fondamentale du marché de la thérapie cellulaire et génique), German (Markt für Fundamentalanalysen zur Zell- und Gentherapie), and Italian (Analisi fondamentale del mercato della terapia cellulare e genica), etc.
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