According to latest report, the U.S. cell and gene therapy CDMO market size was valued at USD 3.19 billion in 2024 and is projected to hit around USD 33.24 billion by 2034, growing at a compound annual growth rate (CAGR) of 27.11% over the forecast period 2025 to 2034.
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Cell And Gene Therapy CDMO Market Report Highlights
- The pre-clinical segment accounted for the largest share of 60.2% in 2024. The increasing pipeline of cell and gene therapeutics is one of the major factors supporting the segment’s growth
- Based on the product type, the cell therapy segment accounted for the largest share of 35.6% in 2024. Cell therapy services are vital in advancing regenerative medicine & personalized medicine
- Rare diseases are anticipated to witness the highest CAGR of 28.5% across the analysis period. The growing prevalence of several rare diseases has led to a surge in R&D activities in cell and gene therapies, thus supporting segmental growth
Research Demand for Therapeutics to Manage Chronic Conditions Bolsters Growth
A surge in cases of cancers, cardiovascular diseases, diabetes, and chronic illnesses in the United States has intensified the urgency for developing effective gene therapies. The increasing focus on personalized medicine, which tailors treatments to the genetic profiles of individual patients, is significantly driving the demand for precise gene therapy analyses. Additionally, gene therapy aids in pinpointing drug targets for developing targeted therapies and contributes to public health initiatives by tracking and monitoring the spread of infectious diseases. Gene therapy and cell therapy represent a groundbreaking approach to treating various illnesses by modifying, replacing, or supplementing defective or absent genes that contribute to disease onset. The U.S. cell and gene therapy CDMO market is seeing significant growth due to the demand for cells across applications such as biopharmaceutical production, drug discovery, and development since cell lines help to develop new therapies, vaccines, and immunotherapy.
The mechanisms of gene therapy are primarily centered around the manipulation of genetic material. Advancements in genomic technologies, particularly cell manipulation, are leading to remarkable enhancements in gene expression analysis, making it increasingly efficient, accurate, and cost-effective. The advancement in biomaterials will improve the cell’s biocompatibility and mechanical properties to create effective tissue scaffolds. The creation of 3D bioprinting has given perfect control over cell placement and will also create extracellular matrix components. Cell therapies hold immense scope for cell-based therapies, and regenerative medicines are curing opportunities for diabetes and Parkinson’s. Strategies include inactivating problematic genes that contribute to disease or replacing them with healthy copies capable of restoring normal function. Gene therapy analysis plays a pivotal role in this regard, providing critical insights that are fundamental for developing advanced diagnostic tools and treatment strategies.
Support from governmental initiatives promoting genomics research has also catalyzed the growth of the U.S. cell and gene therapy CDMO market, encouraging further investment and innovation. The new innovative treatment has emerged as a focal point of research, particularly in the battle against degenerative diseases that afflict millions worldwide. The gene and cell therapy analyses are essential for identifying specific biomarkers and therapeutic targets that can lead to more effective treatment options. Moreover, the surging prevalence of chronic diseases—including various types of cancer, cardiovascular conditions, and neurological disorders—highlights the urgent need for innovative diagnostic and therapeutic solutions.
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U.S. Cell And Gene Therapy CDMO Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 3.83 billion |
|
Revenue Forecast in 2030 |
USD 33.25 billion |
|
Growth rate |
CAGR of 27.11% from 2025 to 2034 |
|
Base year for estimation |
2024 |
|
Actual estimates/Historical data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD million/billion and CAGR from 2024 to 2034 |
|
Report Coverage |
Revenue forecast, company share, competitive landscape, growth factors and trends |
|
Segments Covered |
Phase, product type, indication, region |
|
Key companies profiled |
Lonza; Catalent, Inc; Cytiva; Samsung Biologics; Thermo Fisher Scientific Inc.; Novartis AG; WuXi AppTec; AGC Biologics; OmniaBio; Rentschler Biopharma SE; Charles River Laboratories |
Integration of AI in the U.S. Cell and Gene Therapy CDMO Market
Several factors facilitate the expansion of the gene therapy market. AI can seamlessly integrate gene expression data with other types of information, such as clinical records, to offer a comprehensive understanding of diseases and their responses to treatments. AI-driven tools facilitate the identification of novel gene candidates while assessing their stability and efficacy for therapeutic applications. By streamlining the sequencing process, AI reduces both the time and costs typically associated with sequencing efforts. In addition, Artificial intelligence (AI) plays a pivotal role in the evolution of gene therapy by analyzing extensive genomic and molecular datasets to pinpoint potential gene therapy targets and validate their therapeutic relevance. The drug discovery process is also being expedited by AI, as it can identify potential drug targets through gene expression data and help predict the efficiency and safety of new drug candidates. AI technologies support the real-time monitoring of patient data, allowing for adaptive therapy approaches based on gene expression profiles, clinical parameters, and individual treatment responses.
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U.S. Cell and Gene Therapy Contract Development and Manufacturing Organisations:
This table below ranks cell and gene therapy contract manufacturers based on their total revenue derived from contract services in 2024. Note: this is revenue from across their business, not specifically for cell and gene therapy.
|
Company Name |
HQ Country |
Contract Revenue (US$m) |
Total Number of Facilities |
|
1. Catalent |
United States |
4,563 |
28 |
|
2. Thermo Fisher Scientific |
United States |
1,986.70 |
57 |
|
3. Pfizer CentreOne |
United States |
1,510 |
37 |
|
4. Charles River Laboratories |
United States |
729.44 |
20 |
|
5. Curia |
United States |
476 |
22 |
|
6 Avid Bioservices |
United States |
169.27 |
3 |
|
7. FUJIFILM Diosynth Biotechnologies |
United States |
127.6 |
6 |
|
8. Emergent BioSolutions |
United States |
119.3 |
9 |
|
9. Cytovance Biologics |
United States |
117.43 |
2 |
|
10. BioReliance |
United States |
84.4 |
4 |
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U.S. Cell And Gene Therapy CDMO Market Trends
• Growth in Different Fields: The increasing presence of chronic diseases, cancer treatment, the aging population, and the shortage of orange donors pave the path for the alternative market. Next-generation sequencing (NGS), automation, and powerful analytical technologies will contribute to the market growth. This shift is propelled by significant advancements in gene therapy technologies, coupled with a more profound understanding of the genetic underpinnings of complex diseases.
• Market Access: Increasing investments in the healthcare industry and government initiatives are funding the research of the market. Integration of advanced genetic engineering techniques to improve cell stability, productivity, predictability, and viability will boost the market growth. This also includes providing clearer guidance for developers to navigate the regulatory landscape and fostering a more efficient pathway for bringing these innovative therapies to market, thus accelerating their availability to patients in need.
• Improvement in Vector Engineering: Adoption of automation solutions as they enhance speed accuracy and prevent human errors. The upcoming innovative trends, such as microfluidic-chip–based single-cell cloning, will reduce the number of clones that must be expanded and inspected while increasing the percentage of finding a cell line that makes high titers of manufacturable products. This entails the meticulous modification of viral capsids to enhance their ability to target specific cell types, which is critical in reducing unintended immune responses.
• Gene Editing: Technological advancements and integration of AI boost the research and growth rate of the market. The adoption of CRISPR/Cas9, a technologically advanced method that enables modification of cell lines, will drive market growth. These cutting-edge tools are not only revolutionizing the treatment of hereditary genetic disorders, such as cystic fibrosis and sickle cell anemia, but they are also being rigorously investigated in clinical trials for a wide range of applications, including viral infections and tumor suppressor genes in cancer therapy.
• AI Integration: By integrating data from a variety of sources, AI provides a holistic view of biological processes, enhancing our understanding of complex systems. Advanced methodologies, including artificial intelligence and machine learning, are becoming pivotal in the analysis and interpretation of gene expression datasets. These innovations are guiding researchers toward novel insights and discoveries, ultimately improving our understanding of complex biological systems. Moreover, AI can handle and analyze massive genomic data sets, enabling large-scale population studies and research protection.
U.S. Cell And Gene Therapy CDMO Market Segment Insights
Phase Insights
In the U.S. cell and gene therapy CDMO market, the pre-clinical segment stands out as dominant. This prominence is primarily attributed to the pivotal role the pre-clinical phase plays in the research and development landscape before entering clinical trials. This stage is essential for establishing safe and efficacious treatments, as it tackles a range of challenges such as vector design, innovative delivery mechanisms, cell manipulation, and the identification of potential side effects.
By refining these elements, researchers can lay a solid groundwork for future therapeutic strategies. Conversely, the clinical segment is recognized as the fastest-growing area within the U.S. cell and gene therapy CDMO market. This growth can be linked to thorough evaluations that assess the safety and effectiveness of therapies aimed at specific diseases. These evaluations not only help in meeting rigorous regulatory standards required for market approval but also enhance the prospects of successful treatment.
Product Type Insights
The segment dedicated to cell therapy leads the U.S. cell and gene therapy CDMO market. Cell therapy is increasingly in demand due to its transformative potential for treating conditions that currently offer few therapeutic alternatives. This innovative approach harnesses the body’s cells to repair or regenerate damaged tissues, replace malfunctioning cells, and bolster the immune system, thereby providing a promising avenue for recovery.
On the other hand, gene-modified cell therapy has emerged as the fastest-growing segment in the market. This cutting-edge technique involves the direct modification of a patient's cells to rectify genetic defects. By either repairing faulty genes or substituting them with healthy versions, gene-modified cell therapies aim to correct the underlying genetic causes of a broad spectrum of diseases, offering hope for the development of future treatments.
Indication Insights
In the context of indications, the oncology segment occupies the leading position within the U.S. cell and gene therapy CDMO market. This dominance is largely attributed to the innovative clinical evaluation programs that expedite the development of transformative therapies for cancer. These programs leverage modern technologies that hold significant curative potential, aiming to revolutionize cancer treatment and improve patient outcomes.
Meanwhile, the segment addressing rare diseases is identified as the fastest-growing niche in the market. This rapid expansion is due in part to advanced techniques that involve the genetic modification of cells outside the patient's body, followed by reinfusion of these cells back into the patient. Such approaches can be particularly effective for rare genetic disorders, where tailored treatments can significantly enhance the quality of life for affected individuals.
Recent Developments
• In November 2024, GHO Capital Partners and Ampersand Capital Partners put out a bid to buy CDMO Avid Bioservices for US$ 1.1 billion. The deal is one of many ventures by PE to increase its presence in the biotechnology manufacturing space. GHO currently fields CDMOs Alacami, RoslinCT, Ardena, and Sterling Pharma Solutions in its life sciences portfolio.
• In May 2024, Catalent was set to tap into its Baltimore facility to develop Universal AAV immuno-gene therapy, Siren’s AAV vector-based therapeutic candidate. Siren’s focus lies in integrating AAV gene therapy and cytokine immunotherapy into a single treatment aimed at fighting numerous types of solid tumors.
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U.S. Cell And Gene Therapy CDMO Market Top Key Companies:
• Lonza
• Catalent, Inc
• Cytiva
• Samsung Biologics
• Thermo Fisher Scientific Inc.
• Novartis AG
• WuXi AppTec
• AGC Biologics
• OmniaBio
• Rentschler Biopharma SE
• Charles River Laboratories
U.S. Cell And Gene Therapy CDMO Market Report Segmentation
This report forecasts revenue growth at, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Statifacts has segmented the global U.S. Cell And Gene Therapy CDMO Market
By Phase
• Pre-clinical
• Clinical
By Product Type
• Gene Therapy
o Ex-vivo
o In-vivo
• Gene-Modified Cell Therapy
o CAR T-cell Therapies
o CAR-NK Cell Therapy
o TCR-T Cell Therapy
o Other
• Cell Therapy
By Indication
• Oncology
• Infectious Diseases
• Neurological Disorders
• Rare Diseases
• Others
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