U.S Cell and Gene Therapy CDMO Market Size, Share By Service Area (Cell Therapy, Plasmid DNA, Viral Vector, and Others), By Indication (Cancer, Cardiovascular Disease, Infectious Disease, Genetic Disorders, Neurological Disorders), By Phase (Phase 1, Phase 2, Phase 3, Phase 4) - Trends, Analysis and Forecast till 2034

U.S. Cell and Gene Therapy CDMO Market was valued at USD 2.37 Billion in 2024 and is expected to reach USD 27.7 Billion by 2034 growing at a CAGR of 28.90%

The Cell and Gene Therapy Contract Development and Manufacturing Organization (CDMO) market is leading the charge in transformative healthcare advancements, poised to revolutionize treatment methodologies for various diseases. With the rising demand for personalized medicine and the increasing recognition of cell and gene therapies' potential, the role of CDMOs is indispensable. These entities serve as vital intermediaries between research and commercialization, offering specialized knowledge and infrastructure for therapy development and manufacturing. Emphasizing scalability, quality control, and adherence to regulations, CDMOs enable biopharmaceutical firms to navigate the journey from concept to market efficiently and confidently. In this dynamic landscape of groundbreaking therapies and evolving regulatory landscapes, the Cell and Gene Therapy CDMO market stands as a hub of innovation, collaboration, and opportunity, primed to steer transformative healthcare advancements for years ahead.

Key Drivers of Target Market:

Prevalence of Genetic Disease

The increasing occurrence of genetic and rare diseases serves as a key catalyst driving the expansion of the Cell and Gene Therapy Contract Development and Manufacturing Organization (CDMO) market. With growing awareness of these conditions comes a heightened demand for innovative treatments capable of tackling their underlying genetic origins. Cell and gene therapies present promising avenues for intervention, targeting and rectifying genetic abnormalities at their core, potentially offering enduring or curative benefits to patients. In response to this demand surge, biopharmaceutical firms are increasingly seeking the specialized expertise of CDMOs in the development and manufacturing of these advanced therapies. CDMOs play an essential role in advancing the progress of cell and gene therapies, providing comprehensive services spanning process development, manufacturing, and quality assurance, thereby facilitating the efficient and effective delivery of these transformative treatments to patients in need.

High Investment

The high level of investment in the U.S. U.S. Cell and Gene Therapy CDMO Market is a significant driving factor for its growth. This substantial investment injects capital into research, development, and infrastructure, fostering innovation and advancement within the industry. As investors recognize the potential of cell and gene therapies to revolutionize healthcare, they are increasingly allocating funds to support the development and commercialization of these transformative treatments. This influx of capital enables CDMOs to expand their capabilities, invest in state-of-the-art technology, and enhance manufacturing processes to meet the growing demand for cell and gene therapy services. Consequently, the U.S. market benefits from a robust ecosystem of companies equipped to provide specialized expertise and services, driving forward the development and delivery of life-changing therapies to patients nationwide.

Restrains:

Limited Skilled Workforce

One significant challenge for the Cell and Gene Therapy Contract Development and Manufacturing Organization (CDMO) market is the scarcity of skilled workforce, which poses a notable constraint. Given the specialized nature of cell and gene therapy manufacturing, there's a demand for highly trained professionals proficient in fields like cell biology, molecular biology, and bioprocessing. However, there's a shortage of individuals with the requisite expertise to navigate the intricate manufacturing processes and regulatory landscape associated with these therapies. Consequently, CDMOs may encounter difficulties in recruiting and retaining qualified personnel, impacting their ability to scale operations, adhere to project timelines, and maintain consistent product quality. This scarcity could also lead to elevated labor costs and project delays, potentially limiting the competitiveness and expansion prospects of CDMOs in the cell and gene therapy market. Addressing this challenge through targeted training initiatives, partnerships with academic institutions, and talent development efforts is imperative for mitigating this restraint and realizing the full potential of the cell and gene therapy CDMO market.

The market is segmented based on Service Area, Indication, and Phase.

U.S. Cell and Gene Therapy CDMO Market Report Scope:

Segments Covered in the Report:

This report forecasts revenue growth at regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2023 to 2034. For the purpose of this study segmented the U.S. Cell and Gene Therapy CDMO Market report based on Service Area, Indication and Phases:

Segmentation:

By Service Area:

• Cell Therapy

• Plasmid DNA

• Viral Vector
• Others    

By Indication:

• Cancer
• Cardiovascular Disease
• Infectious Disease
• Genetic Disorders
• Neurological Disorders

By Phases:

• Phase 1
• Phase 2
• Phase 3
• Phase 4

The key players operating the U.S. Cell and Gene Therapy CDMO Market include Catalent Inc., LONZA GROUP, RECIPHARM AB, Wuxi Advanced Therapies, Pfizer CentreOne, Charles River Laboratories International Inc., PATHEON INC., Almac Group, FUJIFILM DIOSYNTH BIOTECHNOLOGIES, PCI Pharma Services.

• Catalent Inc.,. 
• LONZA GROUP
• RECIPHARM AB
• Wuxi Advanced Therapies
• Pfizer CentreOne
• Charles River Laboratories International Inc.
• PATHEON INC., INC.
• Almac Group
• FUJIFILM DIOSYNTH BIOTECHNOLOGIES
• PCI Pharma Services