Strategic Growth Outlook, Trends, and Competitive Analysis (2024–2035)
The Cell and Gene Therapy Contract Development and Manufacturing Organization (CDMO) Market is projected to grow exponentially—from USD 6.3 billion in 2024 to a remarkable USD 75.0 billion by 2035, expanding at a CAGR of 28.0%. This impressive growth is fueled by increased investments in advanced biologics, the expanding pipeline of cell and gene therapies, and the increasing trend among biotech firms to outsource manufacturing services to specialized CDMOs.
As clinical trials surge and regulatory approvals accelerate, CDMOs have emerged as indispensable partners for biopharmaceutical companies seeking scalable, compliant, and cost-effective solutions for complex therapies.
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Cell and Gene Therapy CDMO Market Segmentation Overview
By Product Type:
Gene Therapy:
Ex-Vivo: Involves genetic modification of cells outside the body, including applications in hematologic and immune disorders.
In-Vivo: Direct delivery of genetic material into the patient’s body, gaining traction for conditions like hemophilia and retinal diseases.
Cell Therapy:
CAR T-Cell Therapy
CAR-NK Cell Therapy
TCR-T Cell Therapy
Others: Includes stem cell therapy and dendritic cell therapy.
By Services:
Contract Development: Pre-clinical research, vector design, cell line development, assay development, and analytical support.
Contract Manufacturing: cGMP production of viral vectors, plasmids, and engineered cells for clinical and commercial use.
By Phase:
Pre-Clinical
Clinical: Phase I to Phase III manufacturing support and regulatory services.
By Application:
Oncology (dominant)
Immunology
Neurology
Cardiovascular
Others
By End-User:
Biopharmaceutical Companies
Academic Institutions
Hospitals
Others: CROs and cell banks
Regional Insights
North America holds the largest market share due to favorable regulatory support, strong funding ecosystem, and increasing FDA approvals of gene and cell therapies.
Europe is advancing rapidly with investments in GMP manufacturing infrastructure and regional funding programs for rare disease research.
Asia-Pacific is the fastest-growing region, driven by booming biotech sectors in China, India, and South Korea, alongside rising demand for localized manufacturing.
Latin America and Middle East & Africa are emerging regions showing interest in regenerative medicine and establishing early-stage CDMO partnerships.
Cell and Gene Therapy CDMO Market Players
Major companies contributing to innovation and scale in the global Cell and Gene Therapy CDMO Market include:
FUJIFILM Diosynth Biotechnologies
WuXi AppTec
Lonza
Thermo Fisher Scientific Inc.
Charles River Laboratories
Novartis AG
AGC Biologics
OmniaBio
Catalent, Inc
Evotec
Cytiva
Rentschler Biopharma SE
SK pharmteco Inc.
These players are expanding their capabilities across vector development, viral vector manufacturing, and regulatory compliance to serve a growing base of cell and gene therapy developers.
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Recent Industry Developments
1. Lonza and Vertex Expand Partnership on Gene Editing Therapies
In early 2025, Lonza and Vertex Pharmaceuticals announced the expansion of their long-term manufacturing collaboration for CRISPR-based gene editing therapies, focusing on sickle cell disease and beta-thalassemia. This collaboration includes large-scale GMP manufacturing at Lonza’s facility in Portsmouth, New Hampshire.
2. Catalent Launches Commercial Cell Therapy Facility in Belgium
Catalent announced the opening of its new European commercial-scale cell therapy manufacturing facility in 2025. Located in Gosselies, Belgium, the site is designed to meet demand for CAR T-cell and stem cell manufacturing services across Europe.
3. OmniaBio Secures Canadian Government Funding
OmniaBio, a subsidiary of Centre for Commercialization of Regenerative Medicine (CCRM), secured over CAD 40 million in government grants in 2025 to expand viral vector manufacturing capacity and support local biotech startups focused on gene therapy.
4. SK pharmteco Expands into Plasmid DNA Manufacturing
In a move to vertically integrate their services, SK pharmteco announced its acquisition of a plasmid DNA specialist to support upstream production for gene therapy clients globally.
Cell and Gene Therapy CDMO Market Opportunities and Challenges
Opportunities:
Increasing FDA and EMA approvals of cell & gene therapy drugs
Surge in rare disease-focused biotech startups requiring specialized CDMO services
Growing demand for allogeneic therapies that require scalable manufacturing models
Investment in modular and flexible GMP facilities to speed time-to-market
Challenges:
High capital investment required for viral vector and plasmid production
Global shortage of skilled labor and process development scientists
Complex regulatory frameworks across multiple markets
Manufacturing bottlenecks due to raw material supply chain constraints
Conclusion
The Cell and Gene Therapy CDMO Market is poised to be a foundational pillar of the next generation of personalized medicine. As therapy developers seek experienced partners to navigate complex regulatory pathways, scale manufacturing, and ensure quality assurance, the role of CDMOs will become increasingly strategic. The market offers significant growth opportunities for both established players and innovative entrants that can meet evolving client demands with flexibility, speed, and GMP compliance.
Authored by:
Riya B. More, Research Associate at Prophecy Market Insights
This analysis is based on primary interviews, expert consultations, and detailed secondary research, delivering key insights into the CDMO segment of the cell and gene therapy industry.
