Cell and Gene Therapy CDMO Market Size, Share and Trends 2025 to 2034

Cell and Gene Therapy CDMO Market Size and Forecast 2025 to 2034

The global cell and gene therapy CDMO market size was estimated at USD 6.31 billion in 2024 and is predicted to increase from USD 8.07 billion in 2025 to approximately USD 74.03 billion by 2034, expanding at a CAGR of 27.92% from 2025 to 2034. The rising demand to put specialized expertise, facilities, and regulatory knowledge into developing and manufacturing cell and gene therapy is fueling the CDMO market for cell and gene therapy.

Cell and Gene Therapy CDMO Market Key Takeaways

• North America dominated the global market with the largest share of 67% in 2024.
• Asia Pacific is expected to grow at a notable CAGR of 29.03% over the projected period.
• By phase, the pre-clinical segment has held a major market share of 67% in 2024.
• By phase, the clinical segment is projected to grow at a solid CAGR of 27.8% over the forecast period. 
• By product type, the cell therapy segment accounted for a considerable market share of 42% in 2024.
• By product type, the gene-modified cell therapy segment is anticipated to grow at a healthy CAGR of 29% during the studied years.  
• By indication, the oncology segment contributed the highest market share of 50% in 2024. 
• By indication, the rare diseases segment is projected to expand rapidly in the coming years.

How is Artificial Intelligence (AI) Changing the Cell and Gene Therapy CDMO Market?

Integration of artificial intelligence into the cell and gene therapy CDMO market has significantly enhanced the development and manufacturing process by optimizing cell selection, predicting treatment results, analyzing large datasets to identify potential issues, and improving overall efficiency with the help of automated decision-making. AI delivers a great level of efficiency in cell and gene therapy manufacturing and offers more patients to benefit from vital treatments. Furthermore, AI facilitates the development of novel therapies throughout the research and development value chain in various stages, including target identification, payload design, and many more.

• In October 2024, OmniaBio, a CDMO focused on cell and gene therapies, introduced a new manufacturing facility that claims to be the largest in Canada. The 120,000-square-foot site is designed to meet the needs of cold chain logistics as well as the production of cell and gene therapies with the help of artificial intelligence.

U.S. Cell and Gene Therapy CDMO Market Size and Growth 2025 to 2034

The U.S. cell and gene therapy CDMO market size was exhibited at USD 2.41 billion in 2024 and is projected to be worth around USD 28.73 billion by 2034, growing at a CAGR of 28.12% from 2025 to 2034.

North America accounted for the largest cell and gene therapy CDMO market share in 2024. The dominance of this region is experienced due to several factors, one of them is the expanding geographical reach. North America holds the largest market share due to its established healthcare infrastructure, high research and development investment, and supportive regulatory landscapes.

The region also has high adoption of cell and gene therapies, credited to its advanced technologies. The support from the regulatory environment in North America encourages innovation and development in cell and gene therapies.

Asia Pacific is projected to host the fastest-growing cell and gene therapy CDMO market in the coming years due to the rise in clinical trials for cell and gene therapies, driven by increasing patient needs for advanced treatment, growing government support, and an ascending ecosystem of innovation. This expansion is particularly observed in countries such as China with high cancer incidence, which leads to a strong push towards new treatment approaches. The government and regulatory support for CGT trials, in conjunction with increasing investment in products to get into the market.

Market Overview

Cell and gene therapy is a treatment that utilizes cells or genetic material to treat disease. CGT has the potential to treat the underlying cause of the disease, treat symptoms, and stop the progression of the disease. CDMO assists in providing specialized expertise and facilities to manufacture therapeutic products, which includes process development, clinical trial products, and scaling up to commercial manufacturing. This ensures high quality and adheres to strict regulatory compliance. 90% of biotech companies rely on contract development and manufacturer organization in the early stage and commercial launch of the product.

Cell and Gene Therapy CDMO Market Growth Factors

• Innovative technology: CDMOs are widely investing in cell and gene therapy technologies, with a large number of small- and medium-sized companies. The investment is largely observed for continuous manufacturing and artificial intelligence, which aids in improving the efficiency and scalability of the process. As cell and gene therapy is a complex technique, technological advancement is an essential need.
• Consolidation in the market: This trend is streamlining as larger players are acquiring smaller companies to expand their capabilities and geographic reach. This results in a more concentrated market with fewer major players, which allows for greater scale, wide service offerings, and improved efficiency.
• Geographical reach: The cell and gene therapy CDMO market is focused on territorial expansion, which will help meet the growing demand for cell and gene therapies. This is emerging in regions where the market is expected to grow significantly. Expansion refers to establishing healthcare infrastructure, high research and development investment, and supporting regulatory bodies.
• Regulatory landscape: The legal framework is evolving in cell and gene therapies, which ensures working closely with regulators to certify that the processes run by meeting the latest requirements. 

Market Scope

Market Dynamics

Drivers

Clinical trial for innovative Therapies

Cell and gene therapy (CGT) is rapidly expanding and evolving in healthcare through using living cells and genetic modification to treat disease. The cell and gene therapy CDMO market helps drug developers to successfully prepare for the execution of clinical trials in numerous ways. Presently, there are over 5,000 gene therapy trials listed in the National Institute of Health. The CDMO produces material for clinical trials, and if successful, it also assists in commercial manufacturing. Furthermore, CDMOs provide continuous monitoring and optimization of the manufacturing process, which ensures consistent product quality and meets the demands.

Restraint

High manufacturing complexities

The cell and gene therapy CDMO market faces a challenge with manufacturing complexities due to the inherent nature of therapies, which involve live cells, viral vectors, and individual treatment plans. The successful achievement of all this requires specialized expertise, stringent quality control, and adequate equipment. Manufacturing complexities contribute to increasing the production cost of approved gene therapy for patients.

Opportunity

Access to specialized facilities and technologies

The cell and gene therapy CDMO market is expected to receive hefty investment in the coming years for specialized facilities and technologies, which will be essential tools for the development and manufacturing of the therapies. Partnering with a CDMO can give access to several resources. The next five years are anticipated to be a critical period for the adoption of a combination of technological advances, strategic partnerships, and a major shift toward drug discovery. There will be noticeable capacity constraints, but despite that, the executives are expecting a lot more potential application for cell and gene therapies for relatively common conditions such as Parkinson’s disease, where CDMO creates larger development and manufacturing facilities.

Phase Insights

The pre-clinical segment held the largest share of the market in 2024. The major factor behind the dominance of the segment stands as the pre-clinical phase carries significant application in the research and development stage before the clinical trial. This stage is crucial for developing safe and effective treatment by addressing challenges such as vector design, delivery methods, cell manipulation, and potential side effects. The rising emphasis on investigational drug discoveries across the research sector is observed to sustain the segment’s position in the market.

The clinical segment is observed to grow at the fastest rate in the cell and gene therapy CDMO market during the forecast period. The growth of the segment is observed due to the evaluation conducted, which ensures the safety and efficacy of treating a specific disease. This also ensures that the regulatory standards for potential market approval are met. The clinical phase is a stage where the manufactured cell and gene therapy products are used in human clinical trials, consisting of all phases of testing – Phases 1, 2, and 3. The CDMO facilitates the production of high-grade therapy that is ready for administration to patients.

Product Type Insights

The cell therapy segment accounted for a considerable share of the cell and gene therapy CDMO market in 2024. Cell therapy is demanding as it offers a potential treatment option for diseases that have limited therapeutic options. This utilizes the body’s cells to repair damaged tissue, replace malfunctioning cells, and enhance the immune system. Some of the cells that may be utilized include hematopoietic (blood-forming) stem cells (HSC), mesenchymal stem cells, skeletal muscle stem cells, lymphocytes, pancreatic islet cells, and dendritic cells. Research is evolving with various cell types for the development of treatments as novel cell therapies and studies for potential application.

The gene-modified cell therapy segment is anticipated to grow with the highest CAGR during the studied years. Gene-modified cell therapy holds the potential to treat a wide range of diseases by directly manipulating a patient’s own cells to correct genetic defects. This approach aims towards fixing the faulty gene or replacing it with a healthy gene. It helps cure disease and makes the body better capable of fighting it. Car T-cell is an advancement towards cancer treatment by harnessing the patient’s own immune system to destroy cancer cells. 

Indication Insights

The oncology segment held a dominant presence in the cell and gene therapy CDMO market in 2024. The dominance is credited to the innovative program focusing on clinical evaluation to help expedite the development of transformative cancer therapies with modern technologies with curative potential. The therapeutic approach includes CAR-T cells, TCR-T cells, Tumor-Infiltrating lymphocytes, and Oncolytic virus therapy.

The rare diseases segment is expected to grow at the fastest rate over the forecast period of 2024 to 2034. The segment has a noticeable growth as it involves genetically modifying cells outside the body and then returning the cells back to the patient’s body. Diseases including blood disorders, inborn errors of immunity, and inherited blindness come under rare diseases. The Therapeutics for Rare and Neglected Diseases (TRND) is a program that helps develop treatments for rare diseases.

• Charles River is making a strategic expansion and partnership support into the rare disease gene therapy space. With their gene therapy expertise and offering continuous support towards therapeutic advancements for rare diseases.

Cell and Gene Therapy CDMO Market Top Market Companies

• Avid Bioservices
• Catalent
• Charles River Lobaoraties
• Curia
• Emergent BioSolutions
• Eurofins
• FUJIFILM Diosynth Biotechnologies
• Genscript
• Lonza
• Pfizer CentreOne
• Recipharm
• Syngene
• Thermo Fisher Scientific
• Wacker
• WuXi Biologics

Latest Announcements by Industry Leaders

• In September 2024, Dr. Frank Mathias, Chief Executive Officer of OXB, said, “The launch of our new brand identity reinforces OXB's significant transformation into a leading pure-play cell and gene therapy CDMO. This rebranding is more than just a new look – it reflects the global nature of our operations and our deep commitment to the success of our client’s drug development programs.”

Recent Developments

• In September 2024, Oxford Biomedical, a quality and innovation-led cell and gene therapy CDMO, launched its new corporate brand. The company is unveiling a more modern and recognizable visual identity that reinforces its transformation into a global-pure-play cell and gene therapy CDMO.
• In October 2024, Teijin Limited and Hilleman Laboratories, a biotechnology company based in Singapore, launched a signing of a memorandum of Understanding (MoU) for establishing a strategic international business partnership. This collaboration aims to expand contract development and manufacturing organization business in the field of cell and gene therapy.

Segments Covered in the Report

By Phase

• Pre-clinical
• Clinical

By Product Type

• Gene Therapy
  • Ex-vivo
  • In-vivo
• Gene-Modified Cell Therapy
  • CAR T-cell Therapies
  • CAR-NK Cell Therapy
  • TCR-T Cell Therapy Other
• Cell Therapy

By Indication

• Oncology
• Infectious Diseases
• Neurological Disorders
• Rare Diseases
• Others 

By Geography

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa