Cell and Gene Therapy CDMO Services Market: By Therapy Type (Cell Therapy (Allogeneic, Autologous, Viral Vector), Gene Therapy (Viral Vectors, Non-viral Vectors)), By Application (Clinical Manufacturing, Commercial Manufacturing), By Therapeutic Area (Oncology, Orthopedics, Infectious Disease, Cardiovascular Disease, Others), By End User (Pharmaceutical & Biotechnology Companies, Academics & Research Institutes, Others), and Geography (North America, Europe, Asia Pacific, Latin America, and MEA)

Cell and Gene Therapy CDMO Services Market was valued at USD 5,193.7 million in 2022 and is expected to grow at a 17.5% CAGR from 2023 to 2029. Cell and gene therapy plays an important role in modern healthcare to treat many disorders and diseases. The cell and gene therapy CDMO are used for the development of new modalities like cell therapy, gene therapy, and other innovative vaccines necessitating a massive investment in new production facilities for viral vectors, nucleic acid, cell manipulation, and lipid-based formulations. As CDMOs can adaptably alter their manufacturing lines to meet the mounting demand of smaller and diverse projects is expected to drive market growth. The increasing prevalence of chronic diseases such as genetic disorders, cancer, and autoimmune diseases is expected to increase the demand for cell and gene therapies and expected to drive market growth over the forecast period. For instance, more than 2 million cancer cases were diagnosed in US in 2021.

In addition, the development and commercialization of advanced modern gene editing technologies such as CRISPR/Cas9, TALEN, and personalized therapies such as chimeric antigen receptor T-cell are expected to boost the growth of cell and gene therapy CDMO services market. However, high cost of therapy, and complex manufacturing process involved in the production of cell and gene therapy are expected to restrain the growth of cell and gene therapy CDMO services market over the forecast period. Moreover, the factors like improving healthcare infrastructures in emerging countries, the development of novel cell and gene therapies, and growing collaboration and partnerships between biopharmaceutical companies and CDMOs are anticipated to provide opportunity to market players in the growth of cell and gene therapy CDMO services market over the forecast period. Geographically, North America region held the major market share in 2022 and is expected to dominate the global cell and gene therapy CDMO services market in the forecasted years.

Cell and Gene Therapy CDMO Services Market Key Developments:

Fujifilm Diosynth Biotechnologies

In October 2022, Fujifilm Diosynth Biotechnologies commenced the construction of a $300-million expansion project at its biomanufacturing campus located in College Station, Texas. This endeavor aims to significantly increase the company's capacity for manufacturing advanced therapies and vaccines in the United States. The expansion plan entails the establishment of a new cGMP production facility and the addition of approximately 138,000 square feet to the existing 300,000-square-foot campus.

In January 2022, Fujifilm has successfully acquired a cell-therapy manufacturing facility located in Thousand Oaks, California from Atara Biotherapeutics, a biopharmaceutical company based in South San Francisco, California. This acquisition was made for a sum of $100 million. The newly acquired facility possesses the capability to produce both clinical and commercial cell therapies, including allogeneic T-cell and CAR T immunotherapies.

In addition to the acquisition, Fujifilm Diosynth is also expanding its offerings in viral-vector and gene-therapy in Darlington, UK. As part of this expansion, the company has established process development laboratories and manufacturing capabilities specifically designed for early-stage gene therapies. The process development laboratories are already operational, and the manufacturing services commenced in the spring of 2022.

In December 2021, Fujifilm has unveiled its intention to invest £400 million ($533 million) in expanding its facility in Billingham, Teesside, UK. The expansion project will involve the establishment of a viral gene-therapy facility as well as a mammalian cell-culture facility. It is projected that these new facilities will become operational by late 2023. This investment is part of a larger global capital investment package totaling JPY 90 billion ($797 million), which was initially announced by the company in June 2021.

uBriGene

In 2023, uBriGene, a cell and gene contract development and manufacturing organization (CDMO) is expanding into the US market with the acquisition of a manufacturing facility from Mustang Bio.

AGC Biologics

In May 2023, AGC Biologics announced the launch of its BravoAAV and ProntoLVV viral vector platforms offering flexible and accelerated vector development and manufacturing for cell and gene therapy programs. AGC Biologics' new platforms capitalize on their extensive expertise in Lentiviral vector (LVV) and Adeno-Associated Viral vector (AAV) development, manufacturing, and analytical experience spanning three decades. These platforms provide rapid, effective, and consistent clinical and commercial GMP production and release capabilities.

In 2022, AGC Biologics expands cell and gene therapy CDMO Capacity at its U.S. site. In order to meet strong demand, AGC Biologics will increase the capacity of its virus vector manufacturing facility at its Longmont, Colorado, U.S. site.

Samsung Biologics

In January 2022, Samsung Biologics has announced its plans to begin the construction of a new manufacturing facility. This facility will be specifically designed for the production of multi-modal products, including cell and gene therapies, as well as vaccines utilizing mRNA, plasmid DNA, and viral vectors. This new facility will complement the existing mRNA vaccine drug-substance manufacturing suite that Samsung Biologics recently added to its facility in Songdo, South Korea.

Thermo Fisher Scientific

In August 2022, Thermo Fisher Scientific has recently opened a cutting-edge viral vector manufacturing facility in Plainville, Massachusetts, covering an impressive area of 300,000 square feet. This new facility marks a significant expansion of the company's capacity for clinical and commercial viral vector production. With this addition, Thermo Fisher Scientific now operates a total of six sites dedicated to viral vector manufacturing, strategically located across the United States and Europe.

In 2022, The company expanded its cell-therapy network with a 44,000-square-foot facility at UCSF's Mission Bay campus, as part of a strategic partnership. Additionally, they opened a 67,000-square-foot plasmid manufacturing facility in Carlsbad, California.

In 2021, Thermo Fisher Scientific strengthened its contract viral vector manufacturing services through the acquisition of Henogen S.A., the viral vector manufacturing business of Novasep in Belgium. The acquisition, valued at EUR 725 million ($875 million), expands Thermo Fisher's capabilities in the field of viral vector manufacturing.

GC Corporation

In April 2022, GC Corporation announced that it has signed a definitive agreement to acquire 100% of the shares of BioCentriq, Inc., a pioneering US-based contract development and manufacturing organization (CDMO) that designs and develops scalable cell and gene technologies. This cross-border acquisition broadens GC companies’ capabilities in scaling CDMO platforms.

eureKare

In 2022, eureKARE announced the successful IPO on Euronext Paris (Professional Segment) of eureKING, the first European SPAC1 in healthcare dedicated to biomanufacturing that has been co-founded by eureKARE. eureKING intends to target companies specializing in three highly innovative, fast-growing segments: the production of biological products, cell and gene therapies and live biotherapeutics.