Search Market Research Report
Cell And Gene Therapy CDMO Market Size, Share Global Analysis Report, 2025 – 2034
Cell And Gene Therapy CDMO Market Size, Share, Growth Analysis Report By Indication Types (Rare Diseases, Neurological Disorders, Infectious Diseases, Oncology, And Others), By Product Types (Cell Therapy, Gene-Modified Cell Therapy, And Gene Therapy), By Product Types (Clinical And Preclinical Stages), And By Region - Global Industry Insights, Overview, Comprehensive Analysis, Trends, Statistical Research, Market Intelligence, Historical Data and Forecast 2025 – 2034
Industry Insights
[221+ Pages Report] According to Facts & Factors, the global cell and gene therapy CDMO market size was valued at USD 6.24 billion in 2024 and is predicted to surpass USD 73.11 billion by the end of 2034. The cell and gene therapy CDMO industry is expected to grow by a CAGR of 27.90% between 2025 and 2034.
Cell and Gene Therapy CDMO Market: Overview
Cell and gene therapy CDMO refers to the service provider that helps biotechnology and pharmaceutical companies develop, manufacture, and market cell and gene therapies.
Cell therapy refers to transferring intact living cells into the human body to treat diseases. Gene therapy is modifying or replacing infected genes with correct genes using viral vectors to treat genetic disorders.
Key Insights
- As per the analysis shared by our research analyst, the global cell and gene therapy CDMO market size is estimated to grow annually at a CAGR of around 27.90% over the forecast period (2025-2034).
- In terms of revenue, the global cell and gene therapy CDMO market size was valued at around USD 6.24 billion in 2024 and is projected to reach USD 73.11 billion by 2034.
- Surge in clinical trials is driving the growth of the global cell and gene therapy CDMO market.
- Based on the indication types, the oncology segment is growing at a high rate and is projected to dominate the global market.
- Based on product types, the cell therapy segment is anticipated to grow with the highest CAGR in the global market.
- Based on the phase types, the clinical segment is projected to swipe the largest market share.
- Based on region, North America is expected to dominate the global market during the forecast period.
Cell and Gene Therapy CDMO Market: Growth Drivers
- Surge in clinical trials is driving the growth of the global market.
Increasing cell and gene therapy trials all across the globe are driving the growth of the global cell and gene therapy CDMO market. Biotech and pharma companies are taking the support of CDMOs to manage the development and production of CGT products.
Also, the rise in the incidence of cancer, rare diseases, and other genetic disorders is supporting the growth trajectory of the industry.
In addition, there is a surge in demand for personalized medicine, which is also propelling the market's growth. People no longer want 'one size fits all' therapies, and they’re willing to invest in customized therapies, which are further fostering demand for CDMOs in the market.
Technological advancements are another crucial factor fostering development in the market. The ongoing advancements in viral vector manufacturing, single-use bioreactors, etc., are making the market more efficient and faster.
However, such innovations help CDMOs make the entire process more affordable with less production time, which in turn is likely to contribute to the significant rise of the market's growth.
Many brands are coming up with more personalized cancer treatments for these therapies in small batches to treat a variety of genetic disorders. Viral vector is one of the innovations in gene therapy manufacturing that facilitates the delivery of genetic materials into the human body.
However, CDMO plays an important role in scaling the production of these viral vectors, which in turn also positively impacts the market's growth.
For instance, Cellino Biotech received funding of USD 80 million in 2022, which is expected to be used in the mass production of autologous and allogeneic cell therapies. The brand is a direct spin-out of Harvard University.
Cell and Gene Therapy CDMO Market: Restraints
- High manufacturing costs are likely to hinder the growth of the global market.
Cell and gene therapies are cost-intensive and need expertise & infrastructure, which hinders the growth of the global cell and gene therapy CDMO market.
Also, the requirement for specialist materials like bioreactors further adds to the overall cost. Furthermore, the cell and gene therapies are produced in small batches, creating limited economies of scale issues, thereby limiting the industry's growth.
Cell and Gene Therapy CDMO Market: Opportunities
- Regulatory support is expected to foster growth opportunities in the global market.
Authorities like the FDA, EMA, PMDA, etc., are revising their approval framework to fast-track the approval of cell and gene therapies. Governments are working on regulatory pathways to expedite the development process. CDMOs can help brands rapidly clear regulatory hurdles and facilitate easy marketing.
In addition, governments across the globe are working towards harmonizing standards for CGTs, which is also likely to revolutionize the cell and gene therapy CDMO industry in the coming years.
The complexities in manufacturing cell and gene therapies are beyond the capabilities of many small and medium-sized biotech and pharma companies, which is a major reason for outsourcing the production and manufacturing process to CDMOs.
Nowadays, companies only focus on therapy discovery and clinical development to develop innovative therapies in less time. Also, outsourcing helps companies avoid investments in production facilities, clean rooms, and skilled personnel, which further strengthens the demand for CDMOs in the market.
For instance, OmniaBio came up with the largest manufacturing facility in Canada in 2024. It is a 120,000 sq ft area to meet the requirements of cold chain logistics.
Cell and Gene Therapy CDMO Market: Challenges
- Supply chain and logistics are a big challenge in the global market.
The manufacturing of cell and gene therapies needs temperature-controlled storage rooms and transportation facilities, which is a big challenge in the cell and gene therapy CDMO industry.
Also, the complexity of supply chains in different locations creates various problems like transportation delays, potential damage during transit, and many others, which are further likely to negatively impact the industry growth.
Report Scope
Report Attribute |
Details |
Market Size in 2024 |
USD 6.24 Billion |
Projected Market Size in 2034 |
USD 73.11 Billion |
CAGR Growth Rate |
27.90% CAGR |
Base Year |
2024 |
Forecast Years |
2025-2034 |
Key Market Players |
Charles River Laboratories, OmniaBio, AGC Biologics, WuXi AppTec, Novartis AG, Thermo Fisher Scientific Inc., Samsung Biologics, Cytiva, Catalent Inc., Lonza, and others. |
Key Segment |
By Indication Types, By Product Types, By Product Types, and Region |
Major Regions Covered |
North America, Europe, Asia Pacific, Latin America, and the Middle East &, Africa |
Purchase Options |
Request customized purchase options to meet your research needs. Explore purchase options |
Cell and Gene Therapy CDMO Market: Segmentation
The global cell and gene therapy CDMO market can be segmented into indication types, product types, phase types, and regions.
On the basis of inclination types, the market can be segmented into rare diseases, neurological disorders, infectious diseases, oncology, and others. Oncology is the fastest-growing segment in the cell and gene therapy CDMO industry. The growing incidence of cancer all around the globe is likely to strengthen the demand for advanced and personalized treatments like TCR-T and CAR-T therapies. Solid tumors are becoming more common in humans, which is another important reason for the high growth rate of the segment.
Additionally, the need for customized patient-specific workflows and complex viral vector development poses a huge requirement for CDMO expertise, as they specialize in oncology assets. Pharma companies were undergoing strategic partnerships and mergers & acquisitions to fuel the cell therapy pipelines for oncology.
Also, biotech companies outsource their marketing activities so that they can focus on discovering advanced therapies. In addition, there is strong regulatory support for oncology therapies, which helps in faster approvals. The rising need for scalable and agile regulatory support is further expected to fuel the segment's growth.
On the basis of product types, the market can be segmented into cell therapy, gene-modified cell therapy, and gene therapy. The cell therapy segment is likely to dominate the global cell and gene therapy CDMO market during the forecast period.
The growing number of approvals of the therapies, particularly in the clinical trial pipeline, is a key factor contributing to the segment's growth. CDMOs are critical partners that help develop autonomous therapies.
Nowadays, the emergence of allogeneic cell therapies is also driving the demand for large-volume manufacturing services. Furthermore, technological advancements like automation, closed systems, and AI-enabled quality control are also likely to improve efficiency and reduce failure rates. High trial activities are increasing the outsourcing of certain activities, like process development, analytics, and GMP manufacturing.
On the basis of phase types, the market can be segmented into clinical and preclinical stages. The clinical segment accounts for the largest share of the cell and gene therapy CDMO industry. Fast-expanding clinical trial pipelines, majorly in phases 1 and 2, are fostering developments in the segment. There is a rise in the practice of first-in-human studies, particularly for rare diseases, which drives the segment's growth. Early-stage therapies need analytical validation, which is expertise-intensive. CDMOs present customizable platforms that can speed up the development of therapies.
Agencies like EMA, FDA, PMDA, etc. have come up with advanced therapies to expedite the development process, which in turn is boosting the requirement for clinical-grade materials in the factory. CDMOs offer turnkey services ranging from start-to-end support, which is also anticipated to widen the segment's growth. Small and mid-size biotechs, which lead the stage of innovation, outsource their tasks to CDMOs, which also support the segment's growth.
Cell and Gene Therapy CDMO Market: Regional Analysis
- North America to dominate the global market.
North America is projected to account for the largest share of the global cell and gene therapy CDMO market during the forecast period. The US is the leading market in North America because of the investments and favorable regulatory landscape.
Moreover, the fast-evolving biotech industry in the United States is likely to support the growth trajectory of the regional market. Canada is also likely to dominate the regional market because of the growing scope of challenging therapies in the region. Healthcare companies are increasing the clinical trials, which is also a driving factor in the regional market.
Regulatory agencies like the FDA have come up with new pathways to expedite the approval process of cell and gene therapies. In addition, ongoing technological advancements like CRISPR-Cas9 are likely to further revolutionize the regional market and facilitate a higher growth rate of the industry in North America.
Asia-Pacific is also anticipated to see significant developments in the cell and gene therapy CDMO industry because of numerous factors. China is leading the market in APAC because of the ongoing innovations in gene and cell processing technologies.
Furthermore, India is likely to see a substantial payout in the regional market because of the fast-expanding biotechnology sector in the region.
However, the growing demand for personalized medicine in APAC is also strengthening the demand for cell and gene solutions. The rising prevalence of chronic and genetic diseases in APAC is further expected to strengthen the demand in the region.
Therefore, such a landscape is anticipated to expedite the regional market's growth in the coming years. For instance, the American Society of Cell and Gene Therapy said that it has approved around 56 non-genetically modified cell therapies.
Cell and Gene Therapy CDMO Market: Competitive Analysis
The global cell and gene therapy CDMO market can be segmented into:
- Charles River Laboratories
- OmniaBio
- AGC Biologics
- WuXi AppTec
- Novartis AG
- Thermo Fisher Scientific Inc.
- Samsung Biologics
- Cytiva
- Catalent Inc.
- Lonza
For instance, SeCure Dx revealed that it got funding of USD 17.5 million to innovate gene therapeutics in 2021. The funding was done by RiverVest Venture Partners and Mass General Brigham Ventures.
The global cell and gene therapy CDMO market is segmented as follows:
By Indication Types Segment Analysis
- Rare Diseases
- Neurological Disorders
- Infectious Diseases
- Oncology
- Others
By Product Types Segment Analysis
- Cell Therapy
- Gene-Modified Cell Therapy
- Gene Therapy
By Product Types Segment Analysis
- Clinical
- Preclinical Stages
By Regional Segment Analysis
- North America
- The U.S.
- Canada
- Mexico
- Europe
- France
- The UK
- Spain
- Germany
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- Southeast Asia
- Rest of Asia Pacific
- The Middle East & Africa
- Saudi Arabia
- UAE
- Egypt
- Kuwait
- South Africa
- Rest of the Middle East & Africa
- Latin America
- Brazil
- Argentina
- Rest of Latin America
Table of Content
Industry Major Market Players
- Charles River Laboratories
- OmniaBio
- AGC Biologics
- WuXi AppTec
- Novartis AG
- Thermo Fisher Scientific Inc.
- Samsung Biologics
- Cytiva
- Catalent Inc.
- Lonza
Copyright © 2024 - 2025, All Rights Reserved, Facts and Factors