Home Healthcare IT United States Cell and Gene Therapy Manufacturing QC Market Size, Share And Growth Report By 2028

United States Cell and Gene Therapy Manufacturing QC Market Size & Outlook, 2025-2028

United States Cell and Gene Therapy Manufacturing QC Market Size

According to Straits Research analysis, the United States Cell and Gene Therapy Manufacturing QC Market was valued at USD 792.14 Million in 2024 and is projected to reach USD 1931.44 Million by 2028, expanding at a CAGR of 25% during the forecast period. The biopharmaceutical and medical research industries, particularly in innovative treatments like cancer immunotherapy and regenerative medicine, are primary catalysts for this growth. Advancements in molecular biology and genetic engineering are key drivers, especially in the agriculture and chemical sectors. Amidst the rise of green production and focus on sustainability, the market's impetus lies in low-carbon production technologies. Moreover, emerging trends like the use of AI/ML in quality control (QC) show promising export potential. As the U.S. continues to dominate in technology and scientific R&D, it strengthens its footprint in this essential biomedical market segment.

United States Cell and Gene Therapy Manufacturing QC Market Highlights

  • By 2024, Cell Therapy represented the largest share of the Therapy Type market size.
  • Gene Therapy is expected to remain the key growth driver within Therapy Type, registering the fastest CAGR during the forecast period.
  • As of 2024, United States held 35.43% of the global cell and gene therapy manufacturing qc market size.
  • By 2028, United States is anticipated to capture the largest share of the global cell and gene therapy manufacturing qc market.
  • In North America, United States is expected to lead the regional cell and gene therapy manufacturing qc market size by 2028.
  • Canada will remain the fastest-growing market in North America, reaching USD 24106 Million by 2028.
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Report Summary

Report Scope Details
Base Year for Study 2024
Study Period 2021-2028
Historical Period 2021-2023
Forecast Period 2025-2028
Market Size In 2024 USD 792.14 Million
Market Size In 2028 USD 1931.44 Million
Largest segment Cell Therapy
Fastest segment Gene Therapy
Units Revenue in USD Million
CAGR 25% (2025-2028)
Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends

United States Cell and Gene Therapy Manufacturing QC Market Share By Therapy Type

Segmentation Covered

Segments Sub Segments
Therapy Type
  1. Cell Therapy
  2. Gene Therapy
Cell Therapy
  1. CAR-T
  2. CAR-NK
  3. B-Cell
  4. Other
CAR-T
  1. Autologous CAR-T
  2. Allogeneic CAR-T
Gene Therapy
  1. Viral
  2. Non-Viral
Viral
  1. AAV
  2. Lentiviral vectors
  3. Other
Scale
  1. Pre commercial/ R&D Manufacturing
  2. Commercial Scale Manufacturing
Mode
  1. Contract Manufacturing
  2. In-house Manufacturing
Workflow
  1. Cell Processing
  2. Cell Banking
  3. Fill & Finish Operations
  4. Raw Material Testing
  5. Vector Production
  6. Other Workflows
Process
  1. Upstream Processes
  2. Downstream Processes
End User
  1. Pharmaceutical Companies
  2. Biopharmaceutical / Biotechnological Companies
  3. Contract Manufacturing Organizations
Pharmaceutical Companies
  1. Small Size
  2. Medium Size
  3. Large Size
Biopharmaceutical / Biotechnological Companies
  1. Small Size
  2. Medium Size
  3. Large Size
Contract Manufacturing Organizations
  1. Small Size
  2. Medium Size
  3. Large Size
Technology Type
  1. Fluorescence-Activated Cell Sorting (FACS)
  2. Enzyme-Linked Immunosorbent Assay (ELISA)
  3. Chromatography
  4. Next-Generation Sequencing (NGS)
  5. Polymerase Chain Reaction (PCR)
  6. Others 

Cell and Gene Therapy Manufacturing QC Market- Geographics


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