The U.S. cell and gene therapy (CGT) bioanalytical testing services market is poised for significant growth over the next decade, with projections indicating an expansion from $181.73 million in 2025 to $349.29 million by 2034, according to a new research report. This represents a compound annual growth rate (CAGR) of 7.53%, driven by increasing research activities, investments in healthcare infrastructure, and technological advancements.
Market Segmentation and Growth Drivers
The bioavailability and bioequivalence studies segment currently leads the market with a 33.4% share as of 2024 and is expected to maintain the highest growth rate through the forecast period. The pharmacokinetic segment follows closely, projected to grow at a 7.6% CAGR.
In terms of development stages, the non-clinical segment dominates with a 62.2% market share and is forecasted to grow at a 7.6% CAGR. Meanwhile, the clinical segment is expected to expand at a slightly slower pace of 7.1% CAGR.
Among product types, cell therapy currently holds the largest share at 39.1%, while gene-modified cell therapy is anticipated to be the fastest-growing segment with a 7.8% CAGR. The oncology indication segment leads with a substantial 49.0% market share, though the rare diseases segment is expected to demonstrate the highest growth rate in the coming years.
"Bioanalytical testing services are essential for the production of cell and gene therapies by facilitating the manipulation of cells throughout the manufacturing process," noted a market analyst familiar with the report. "These services are critical for stimulating various cellular functions, such as proliferation, differentiation, and survival—each of which is crucial for developing effective therapies."
Technological Advancements Driving Innovation
The market is experiencing significant technological evolution, with breakthroughs in gene editing technologies propelling expansion. Advanced analytical techniques including enzyme-linked immunosorbent assays (ELISA), flow cytometry, quantitative polymerase chain reaction (qPCR), and mass spectrometry are becoming increasingly important for measuring growth factor levels and activity.
Artificial intelligence (AI) integration is poised to transform the bioanalytical testing services landscape. Other notable technological advancements include next-generation sequencing and machine learning techniques, which enhance the accuracy, efficiency, and throughput of bioanalytical testing.
Dr. Sarah Johnson, Director of Cell Therapy Research at a leading biotech firm, commented, "The integration of AI and machine learning with bioanalytical testing is revolutionizing how we approach cell and gene therapy development. These technologies allow us to process complex datasets more efficiently and identify patterns that might otherwise be missed, ultimately accelerating the path to clinical applications."
Market Trends and Regulatory Environment
Several key trends are shaping the U.S. cell and gene therapy bioanalytical testing services market:
-
Growth of the CGT Sector: The expansion is significantly influenced by the rising number of clinical trials and commercial product approvals, necessitating extensive bioanalytical testing to ensure product safety and efficacy.
-
Emphasis on Personalized Medicine: The customization of therapies to meet unique genetic and physiological needs of individual patients is driving demand for highly specific and sensitive bioanalytical assays.
-
Regulatory Scrutiny: Heightened oversight from governing bodies is mandating more thorough characterization of CGT products, propelling demand for specialized bioanalytical services.
The regulatory landscape continues to evolve, with agencies such as the FDA establishing stringent guidelines to govern the development and approval of cell and gene therapies. This increased scrutiny underscores the critical importance of comprehensive testing to mitigate risks and ensure patient safety.
Competitive Landscape
The market features several key players, including:
- BioAgilytix Labs
- KCAS Bioanalytical Services
- IQVIA, Inc.
- Laboratory Corporation of America Holdings
- Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific Inc.)
- Prolytix
- Pharmaron
- Charles River Laboratories
- Syneos Health
- SGS SA
- Intertek Group Plc
Recent developments in the space include Miltenyi Biotec's launch of the Cell & Gene Therapy Center of Excellence in Hyderabad, India, in February 2025, and KCAS Bio's May 2024 partnership with Australia-based Crux Biolabs to provide harmonized spectral flow cytometry across multiple continents.
Future Outlook
The future of the U.S. cell and gene therapy bioanalytical testing services market appears promising, with continued growth expected due to increasing prevalence of life-threatening and rare diseases, rising research and development investments from pharmaceutical and biopharmaceutical companies, and ongoing technological innovations.
Industry experts anticipate that the integration of advanced technologies and the expansion of personalized medicine approaches will further accelerate market growth. Additionally, the development of novel testing methodologies and increased collaboration between industry stakeholders are expected to drive innovation in the space.
"As cell and gene therapies continue to demonstrate remarkable clinical outcomes, particularly in oncology and rare diseases, the demand for sophisticated bioanalytical testing services will only increase," explained Dr. Michael Chen, a biotechnology analyst. "Companies that can provide comprehensive, accurate, and efficient testing solutions will be well-positioned to capitalize on this growing market."
