Cell And Gene Therapy Market Size To Worth USD 232.22 Billion, Rising At 24% CAGR By 2035

Essential Highlights

• Cell and gene therapy industry poised to reach USD 33.5 billion by 2026.
• Forecasted to grow to USD 232.22 billion by 2035.
• Expected to maintain a CAGR of 24% from 2026 to 2035.
• The North American cell and gene therapy market is set to grow from US$ 11.34 billion in 2025 to US$ 79.01 billion by 2034 at a CAGR of 24.01%.
• Europe's cell and gene therapy market is $ 2.74 billion in 2024, $ 7.17 billion in 2025, and $ 48.96 billion by 2034, growing at 23.9% CAGR.
• APAC Cell and Gene Therapy Market to Grow from USD 4.59 billion in 2024 to USD 39.62 billion by 2034 at 24.04% CAGR
• The Middle East and Africa cell and gene therapy market is set to grow from USD 1.41 billion in 2025 to USD 9.75 billion by 2034 at a CAGR of 23.85%.
• The Latin American cell and gene therapy market is set to grow from US$ 1.15 billion in 2024 to nearly US$ 10.19 billion by 2034 at a 24.40% CAGR.
• It's expected to be worth billions of dollars in the coming years due to advancements in personalized medicine.
• Gene editing tools like CRISPR are revolutionizing treatment approaches.
• CAR-T cell therapy is proving highly effective for cancers like leukemia and lymphoma.
• Originally focused on rare genetic disorders and cancer, now expanding into neurological, cardiovascular, and autoimmune diseases.
• Growing interest in using gene therapy for conditions like sickle cell disease, blindness, and muscular dystrophy.
• Governments and regulatory bodies (FDA, EMA) are fast-tracking approvals for promising therapies.
• Big pharma and biotech companies are heavily investing, making this sector highly competitive.
• With more clinical trials, technological advancements, and investments, the future looks promising.

Executive Summary

The global cell & gene therapy market is fueled by a growing number of infectious disease and cancer cases, as well as enhancing technological advances, like gene editing tools. Many vital players are implementing robust clinical trials with a focus on personalized approaches, novel drug delivery systems, and faster regulatory approvals. However, the extensive companies are increasingly adopting AI and machine learning algorithms to analyse vast biological datasets, and are also exploring automation to streamline the production process.

Cell & Gene Therapy Market: Value Chain Analysis

Note: This part shall go with an infographic

1. R&D

This emphasises the use of genetic material, gene editing tools, and boosting discovery with AI, evolving new therapeutic vectors (e.g., AAV, lentiviruses), and overcoming limitations in scaling up complex manufacturing processes.

Key Players: Spark Therapeutics, Intellia Therapeutics, Bluebird Bio, etc.

2. Clinical Trials & Regulatory Approvals

Trials comprise a patient referral, eligibility screening, and informed consent, and then cell collection, a conditioning process to prepare the body, and then infusion of the modified cells, and finally follow the regulatory approvals process of the US FDA, EMA, or other bodies.

Key Players: IRCCS San Raffaele, Donald B. Kohn, M.D., David Williams, etc.

3. Patient Support & Services

They receive through insurance, financial assistance, patient education, care coordination, and psychosocial support.

Key Players: Cencora, Claritas Rx, Allucent, etc.

SWOT Analysis

Strength

• One of the significant strengths, gene therapies are immensely efficacious in curing different genetic diseases, such as sickle cell disease.
• Also, the advanced cell and gene therapies have potential in revolutionizing cancer treatments to develop precision CAR-T therapy by utilizing patients' own immune cells, with enhanced survival rates.
• Their emerging developments are involved in the treatment of inherited eye disorders, with other neurological concerns and boosted drug delivery systems.
• Also, the expanding collaborations among academic institutions, research organizations, and other industry companies are allowing access to expertise, resources, and patient populations, encouraging innovations.

Weakness

• A major restraint is the limitation in the collection, modification, and delivery of patient-specific cells, which may take weeks, resulting in increased manual work & expenditure of the overall process.
• Particularly, cell therapies have challenges in treating solid tumors, due to the immunosuppressive nature of solid tumors and physical barriers.

Opportunity

• A revolutionary opportunity is the progression of innovative next-generation gene editing tools, including prime and base editing, to facilitate accelerated precision and minimal off-target effects.
• For robust production, players can increasingly utilise automation and decentralised solutions to support streamlining the process, with lowered spending, and raised treatments accessibility to the patients.
• Additionally, the market will focus on groundbreaking reimbursement models, like outcome-based contracts, to make possible one-time treatments financially feasible for healthcare systems and patients.
  

Threats

• It is more difficult to explore the highly tailored nature of cell and gene therapy, which makes it inherently complex in scaling up from lab to large-scale production.
• Another is the need for maintenance of quality control during the manufacturing of living cells, as they carry an increased risk of contamination and complexities in quality and efficacy.

Latest Updates of Key Players in the Cell & Gene Therapy Market

Segmentation Analysis

Therapy Type Insights

Which Therapy Led the Cell & Gene Therapy Market in 2024?

In 2024, the cell therapy segment held the dominating share of the market. Its beneficial part is tissue regeneration and repair for chronic and degenerative diseases, including arthritis and heart disease, with a cure for particular issues, like sickle cell disease. In this era, many clinical trials are executing CAR-M (engineered macrophages) and natural killer (NK) cells for diverse blood cancers. In June 2025, more than 6,000 global interventional cell therapy trials were registered, as well as more than 2,154 of these being genetically modified cell therapies (like CAR-T).

Therapeutic Class Insights

Why did the Infectious Disease Segment Dominate the Market in 2024?

The infectious disease segment captured the biggest revenue share of the cell & gene therapy market in 2024. Market leaders have spurred numerous clinical trials for these diseases by using cell and gene therapies. Nowadays, researchers are exploring in vivo gene therapy for SARS-CoV-2 employing a soluble ACE2 decoy protein, which protects mice and macaques from infection. It is noted that HIV has been cured by using stem cell transplants from donors who have a natural genetic resistance to HIV (the CCR5 delta 32 mutation).

Oncology

During 2025-2034, the oncology segment is predicted to expand rapidly. Significant drivers are a rise in cases, R&D pipelines, clinical trials, and empowering alliances among pharmaceutical and biotech companies, and other organisations. Recent transformations include developments in CAR-T therapies, such as Carvykti for multiple myeloma

Diverse Types of Cancer Cases Around the Globe in 2024

Delivery Method Insights

In Vivo Therapy

In the coming era, the in vivo therapy segment is anticipated to expand rapidly in the market. Specifically, this type omits the time-consuming and expensive process of the extraction, modification, and re-infusion. Besides this, they are widely adopting developments in viral vectors, such as adeno-associated virus (AAV), to target specific tissues, like the brain, liver, and muscles, with increased efficacy and specificity. Recently, Luxturna for inherited retinal disease and Zolgensma for spinal muscular atrophy were approved.

End-Use Insights

What Made the Hospitals Segment Dominant in the Cell & Gene Therapy Market in 2024?

fostering cell and gene therapies through clinical trials

Trends in the Cell & Gene Therapy Market

1. Exploring Therapeutic Applications

Many strong players are shifting towards the use of these advanced therapies beyond oncology

2. Adoption of Integrated AI & Data Analytics

Manufacturers are fostering the emergence of AI and machine learning across the R&D and production lifecycle to improve manufacturing parameters, estimate outcomes, with simplify the approval process.

3. Stepping into Promising Investments

The era is promoting investments in ventures that demonstrate robust clinical data, clear commercial viability, and newer approaches to highlight recent bottlenecks.

Future Outlook in Cell & Gene Therapy Market

1. Complementary Efforts in pDNA & mRNA

The prospective period will implement steps in making available high-quality plasmid DNA (pDNA) and messenger RNA (mRNA) manufacturing capabilities that are facilitated by a significant market leader to allow gene editing platforms and therapeutic progression.

2. Substantial Developments in Allogeneic Therapies

Globe will bolster engineered T-cells, such as CAR-T therapies, which are being improved for allogeneic use, to allow rapid and more affordable treatments while lowering production restraints.

3. Emergence of Innovative Technologies

By upgrading the features of technologies used in manufacturing stages, including single-use bioreactors, automated manufacturing platforms, and advanced cryopreservation techniques, which boost robust production pipelines.

Leading Companies in Cell and Gene Therapy Market 2025

The cell and gene therapy market has experienced remarkable growth and progress in recent years, holding immense potential for transforming healthcare with personalized and targeted therapies

Some of the major market companies include Alnylam Pharmaceuticals Inc., Amgen Inc., Biogen Inc., CORESTEM Inc., Dendreon Pharmaceuticals LLC., Helixmith Co. Ltd., JCR Pharmaceuticals Co. Ltd., Kolon TissueGene Inc., Novartis AG, and Pfizer Inc.

Browse More Insights of Towards Healthcare:

The global cell and gene therapy (CGT) pharmaceuticals market

The global cell and gene therapy CRO market

The global cell and gene overexpression service market

The global cell and gene therapy thawing equipment market

The global cell and gene therapy cold chain logistics market

The global cell and gene therapy isolator market

The cell and gene therapy manufacturing market

The global cell and gene supply chain solutions market

The global cell and gene therapy tools and reagents market

The global cell and gene therapy manufacturing QC market

Segments Covered in the Report

By Therapy Type

• Cell Therapy
  
  • Stem Cells
  • T Cells
  • Dendritic Cells
  • NK Cells
  • Tumor Cells
• Gene Therapy
  

By Therapeutic Class

• Cardiovascular Disease
• Cancer
• Genetic Disorder
• Rare Diseases
• Oncology
• Hematology
• Ophthalmology
• Infectious Disease
• Neurological Disorders
  

By Delivery Method

• In Vivo
• Ex vivo

By End-Users

• Hospitals
• Cancer Care Centers
• Wound Care Centers
• Others

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• MEA
  

Immediate Delivery Available | Buy This Premium Research @

Access our exclusive, data-rich dashboard dedicated to the healthcare market - built specifically for decision-makers, strategists, and industry leaders. The dashboard features comprehensive statistical data, segment-wise market breakdowns, regional performance shares, detailed company profiles, annual updates, and much more. From market sizing to competitive intelligence, this powerful tool is one-stop solution to your gateway.

Access the Dashboard:

About Us

Towards Healthcare is a leading global provider of technological solutions, clinical research services, and advanced analytics, with a strong emphasis on life science research

You can place an order or ask any questions, please feel free to contact us at ...

Europe Region: +44 778 256 0738

North America Region: +1 8044 4193 44

APAC Region: +91 9356 9282 04

Web:

Our Trusted Data Partners

Precedence Research | Statifacts | Towards Packaging | Towards Automotive | Towards Food and Beverages | Towards Chemical and Materials | Towards Consumer Goods | Towards Dental | Towards EV Solutions | Nova One Advisor | Healthcare Webwire | Packaging Webwire | Automotive Webwire | Nutraceuticals Func Foods | Onco Quant | Sustainability Quant | Specialty Chemicals Analytics

Find us on social platforms: LinkedIn | Twitter | Instagram | Medium | Pinterest