Cell And Gene Therapy CDMO Market By Service Type (Process Development, Manufacturing Services, Analytical & Quality Services, Fill-Finish & Packaging Services, Regulatory & Consulting Services), By Application (Oncology, Rare Genetic Disorders, Cardiovascular Diseases, Neurological Disorders, Infectious Diseases, Ophthalmology, Others), By Therapy Type (Cell Therapy CDMO, Gene Therapy CDMO), By Stages (Preclinical Development, Clinical Trials Manufacturing, Commercial Manufacturing, Lifecycle Management), and By End User (Biotechnology Companies, Pharmaceutical Companies, Academic & Research Institutes, Hospitals & Clinical Centers), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

---

What trends will shape Cell And Gene Therapy CDMO Market in the coming years?

The Cell And Gene Therapy CDMO Market accounted for USD 4.75 Billion in 2024 and USD 5.86 Billion in 2025 is expected to reach USD 47.44 Billion by 2035, growing at a CAGR of around 23.27% between 2025 and 2035. The cell and gene therapy CDMO market is a niche group of professional services that aid in drug development, cell manufacturing, and scaling of the cell and gene therapies to pharmaceutical and biotechnology companies. These CDMOs provide specialised knowledge in multifaceted procedures such as cell culturing, the generation of viral vectors, and gene editing, and they can speed up and streamline the process of therapy development. With the increasing popularity of cell and gene therapies to treat rare and complex diseases, the market in need of advanced capabilities in CDMOs has exploded. Such a market is important in assisting companies to be able to sail through technical and regulatory hurdles, shortening time-to-market and costs. Generally, it is an expanding market that is fuelled by the trends of innovation and personalised medicine.

What do industry experts say about the Cell And Gene Therapy CDMO market trends?

"The role of CDMOs in cell and gene therapy is mission-critical. They provide not only manufacturing capacity but also regulatory and technical expertise that accelerate the path from clinical development to commercial availability."

• Dr. Robert Preti, Chief Strategy Officer & Interim CEO, Minaris Regenerative Medicine (formerly Hitachi Chemical Advanced Therapeutics Solutions)

"As cell and gene therapies rapidly advance, the bottleneck is often not the science but the scalable and compliant manufacturing. CDMOs bridge this gap, making novel therapies accessible to patients faster."

• Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania; Co-inventor of CAR-T manufacturing platform

Which segments and geographies does the report analyze?

What are the key drivers and challenges shaping the Cell And Gene Therapy CDMO market?

How does increasing demand for personalized medicine accelerate market growth?

Increasing demand in personalised medicine is one of the biggest growth motivators in the cell and gene therapy CDMO market. Personalised medicine is based on the customisation of treatments according to the genome of an individual and needs a high level of specialisation and small-scale production, which is one of the core competencies of CDMOs. The FDA reported that in 2023, more than 35% of novel drug approvals were personalised medicines, a definite change in direction towards precision therapeutics.

The NIH and the National Human Genome Research Institute (NHGRI) have invested heavily in genomic research, and in 2022, the NHGRI budget includes over $620 million in support of efforts that form the basis of personalised therapies. The market grows swiftly with the need to adopt scalable, compliant, and specific manufacturing alliances with CDMOs as biotech companies are working on advanced treatment approaches such as CAR-T and gene editing.

Further, regulatory bodies are offering certain directions in the sphere of customised therapies with a greater sense of clarity, minimising the development risks and favouring creativity. Such regulatory transparency, coupled with technological developments, renders CDMOs key partners in the introduction of personalised therapies to the market in an efficient manner.

Can technological advancements in bioprocessing enhance production efficiency?

The cell and gene therapy CDMO market has been experiencing tremendous gains in production efficiency with the technological advancements in bioprocessing. Human error is being minimised through automation, real-time tracking, and single-use technologies, streamlining batch production and providing uniformity in products. To illustrate this point, the National Institutes of Health (NIH) points out that the current bioreactor systems, together with the advanced process control, can save up to 50% of the production time.

An article by the National Centre of Biotechnology Information (NCBI) observes that changing the conventional batch production to continuous perfusion systems has produced higher product yields due to a shift of about 0.1 g/L to more than 1 g/L in monoclonal antibody production, which applies to CGT processes. Moreover, higher education institutions such as MIT are also investing in modular and closed-system production methods to enhance scalability without breaking regulatory compliance. These innovations have a direct effect on saving on the cost and speeding up the delivery of therapies to patients.

Are limited skilled workforce challenges slowing manufacturing scale-up?

A shortage of a qualified workforce is a significant constraint that is slowing down the manufacturing scale-up of the cell and gene therapy CDMO market. Such treatments need skills of the highest order in aspects such as aseptic processing, vector production, and quality control, yet trained professionals are in severe short supply.

The U.S. Government Accountability Office (GAO) has cited endemic workforce shortages, especially biomanufacturing technicians and regulatory experts, because of insufficient training pipelines in the community colleges and universities (GAO-23-106030). Moreover, statistics provided by the U.S. Census Bureau also point out that manufacturing in general will encounter the problem of a shortage of labour, and millions of jobs could remain vacant as a result of skills being irrelevant to the jobs.

The International Society of Cell and Gene Therapy (ISCT) also notes that the current academic training is falling behind industry demands, and there is a threat of lagging in manufacturing and delivering advanced therapies. Such limitations cause workforce development to be an important bottleneck within the CGT CDMO space.

Will collaborations with pharma giants create new innovation avenues?

Partnerships between pharmaceutical companies and CDMOs are opening up new vistas of innovation in the Cell and Gene Therapy (CGT) sector through making available R&D capabilities and scalable manufacturing capabilities. The Bespoke Gene Therapy Consortium (BGTC) of the U.S. NIH – a collaboration between the FDA, NIH, and academic centres – is standardising gene therapy production and regulation pathways, facilitating the development of gene therapies for rare diseases. The NIH notes that this allows quicker and lower-cost clinical translation, which is a benefit to CDMOs engaged in viral vector production and 3A analytics.

Clinical hubs such as the University of Pennsylvania Gene Therapy Program engage pharma to commercialise CGT innovation. Such combined activities render CDMOs key points of innovation, being backed by social infrastructure and scientific rigour. The need to have personalised therapies increases; therefore, these partnerships assist in breaking technical bottlenecks during the process development. Government-supported consortia also curb duplications of efforts, which makes innovation more sustainable and more accessible.

Can automation integration reduce errors and boost process reproducibility?

Automation implementation in Cell and Gene Therapy (CGT) CDMO processes is crucial in reducing human error and batch reproducibility. Manual CGT manufacturing processes are intensely labour-intensive and prone to variability, especially when handling the cells and checking them and entering data.

The National Institutes of Health (NIH) study indicated that automated systems in biomanufacturing decreased the number of manual handling errors by more than 70% and produced more repeatable product results. Besides, a report by the National Centre of Biotechnology Information (NCBI) has highlighted that automation in the processes involved in T-cell therapy assured product uniformity across various sub-lots with less than 12% difference in key parameters.

Compliance with FDA Current Good Manufacturing Practice (cGMP) regulations that emphasise the regularity of control over production processes is also supported by automation. With increasing regulatory demands, CDMOs that use automation have a greater opportunity to provide scalable and predictable therapies that satisfy clinical and commercial needs.

What are the key market segments in the Cell And Gene Therapy CDMO industry?

Based on the Service Type, the Cell and Gene Therapy CDMO Market is classified into Process Development, Manufacturing Services, Analytical & Quality Services, Fill-Finish & Packaging Services, and Regulatory & Consulting Services. Manufacturing services are the most noticeable segment in the cell and gene therapy CDMO market. This is largely because of the complex and scalable nature of the production needs of cell and gene therapies, which warrant high levels of manufacturing capabilities to maintain the consistency of products, safety, as well as efficacy.

Critical manufacturing processes include cell expansion and viral vector production and purification, which are required to satisfy clinical and commercial supply requirements. This space requires high cost, technical know-how, and strict regulatory compliance to manufacture, and these factors dominate the segment, hence the backbone of the CDMO market.

Based on the application, the Cell and Gene Therapy CDMO Market is classified into Oncology, Rare Genetic Disorders, Cardiovascular Diseases, Neurological Disorders, Infectious Diseases, Ophthalmology, and Others. Oncology is the most visible application segment in the cell and gene therapy CDMO market. Such dominance is motivated by the fact that the prevalence and urgency of innovative cancer therapies are high, in particular CAR-T therapies and other personalised immunotherapies.

Applications in oncology require complicated, tailored production and strong supply chains, which stimulate extensive investment and progress in this direction. The need to develop effective cancer therapies has also increased the development and uptake of cell and gene therapies, and consequently, oncology is the driving force of demand in the CDMO market.

Which regions are leading the Cell And Gene Therapy CDMO market, and why?

The North American cell and gene therapy CDMO market is dominated by a number of factors. The area is well-established in terms of biotech and pharmaceutical firms that make innovations and introduce more advanced therapies. Strong government investments, favourable regulatory environments, and established research and commercialisation bases also boost development and commercialisation rates. Also, North America has a well-trained workforce and developed manufacturing capacities to support the efficient scale-up of complex cell and gene therapies. Increased incidence of chronic and rare diseases also drives up the need for personalised treatment.

All these helps to establish a conducive environment in which CDMOs can flourish, and North America is the most competitive market in this industry. The fact that large CDMO players and strategic alliances with research institutions are present enhances the leadership of the region even more. Overall, the capacity and influence of the region are also growing through the ongoing expansion of investment in cell and gene therapy manufacturing facilities.

The Asia Pacific cell and gene therapy CDMO market because of a number of factors. The high rate of development in the biotechnology infrastructure, the excellent support of the government, and excellent regulation policies have also resulted in a favourable innovation and growth environment. Moreover, there is a high number of skilled professionals in the region and relatively reduced production costs, which are favourable to global biopharma companies outsourcing their development and production requirements in the area.

Demand is further prompted by the growing number of chronic diseases and the growing investment in personalised medicine. The leading countries, such as China, Japan, and South Korea, capitalise on the latest technologies and have increased potential to supply the rising demand in the market. Altogether, the combination of technological advancement, cost-effectiveness, and strategic endeavours in the Asia Pacific makes it one of the major centres of cell and gene therapy CDMO.

What does the competitive landscape of the Cell And Gene Therapy CDMO market look like?

The cell and gene therapy CDMO market is very competitive, as it is overwhelmed with the need and urgency to obtain innovative and personalised therapies. The most popular firms, such as Lonza, WuXi Advanced Therapies, Thermo Fisher Scientific, and Catalent, have placed a lot of investment in increasing their manufacturing and technological capacities.

Lonza has been adding significant production capacity in the recent past to accommodate higher commercial volumes, and WuXi has also opened new platforms dedicated to CAR-T and gene-editing medicine. Further, AGC Biologics and Fujifilm Diosynth Biotechnologies are doing the same and concentrating on optimisation of their processes to shorten production schedules and lower production costs to provide them a competitive advantage.

Smaller but nimble players like OmniaBio are also on the rise as they deal with highly specialised services. These strategic actions indicate how the market is dynamic and speed, quality, and scalability are essential to the creation of the ever-increasing demand of biopharmaceutical innovators. With cell and gene therapies shifting from clinical trials and onto the commercial launch, the market will be dominated by CDMOs capable of showing flexibility and innovation.

Cell And Gene Therapy CDMO Market, Company Shares Analysis, 2024

To explore in-depth analysis in this report - Request Sample Report

Which recent mergers, acquisitions, or product launches are shaping the Cell And Gene Therapy CDMO industry?

• In June 2025, Cellex Cell Professionals announced major facility expansions and celebrated ten years of developing and manufacturing over 5,800 ATMP/CGT batches. These achievements reinforced its position as a trusted full-service CDMO in Europe. The expansions also increased its capacity to meet growing demand.
• In January 2025, Genenta Science strengthened its partnership with AGC Biologics by amending their Development and Master Services Agreement. The amendment established an exclusive GMP suite at AGC’s Cell & Gene Center of Excellence in Milan. This facility was set up to manufacture Genenta’s cell therapy product under cGMP standards, expanding AGC’s manufacturing capacity and reliability.

Report Coverage:

By Service Type

• Process Development
• Manufacturing Services
• Analytical & Quality Services
• Fill-Finish & Packaging Services
• Regulatory & Consulting Services

By Application

• Oncology
• Rare Genetic Disorders
• Cardiovascular Diseases
• Neurological Disorders
• Infectious Diseases
• Ophthalmology
• Others

By Therapy Type

• Cell Therapy CDMO
• Gene Therapy CDMO

By Stages

• Preclinical Development
• Clinical Trials Manufacturing
• Commercial Manufacturing
• Lifecycle Management

By End User

• Biotechnology Companies
• Pharmaceutical Companies
• Academic & Research Institutes
• Hospitals & Clinical Centers

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Lonza
• Catalent
• Wuxi Advanced Therapies
• Thermo Fisher Scientific
• Charles River Laboratories
• Novartis AG
• AGC Biologics
• OmniaBio
• Rentschler Biopharma SE
• Fujifilm Diosynth Biotechnologies
• Cytiva
• SK Pharmteco Inc.
• Evotec
• Merck KGaA
• BioNTech SE

Frequently Asked Questions (FAQs)