North America Cell and Gene Therapy Manufacturing QC Market Size
According to Straits Research analysis The North America Cell and Gene Therapy Manufacturing QC Market was valued at USD 862.94 Million in 2024 and is projected to reach USD 2090.39 Million by 2028, expanding at a CAGR of 24.8% during the forecast period. The primary industries driving this demand include pharmacology, healthcare, and biotechnology. Key drivers involve the manufacture of advanced therapeutic medication, genetic diagnostics, and patient-specific treatment plans. Emerging trends include the introduction of GMP-certified laboratories and improved cell and gene therapy yield attributed to technological advancements. The industry also demonstrates tremendous export potential. With the increasing adoption of green production technologies and a strategic focus on sustainability, North America is effectively positioning itself as a leader in the global Cell and Gene Therapy Manufacturing QC Market.
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market Highlights
- By segment, Cell Therapy was the leading Therapy Type in terms of market size in 2024.
- Gene Therapy is expected to be the most lucrative Therapy Type segment, exhibiting the fastest growth throughout the forecast period.
- North America held 38.6% share of the global cell and gene therapy manufacturing qc market size in 2024.
- United States is expected to remain the largest contributor to the global market by 2028.
- By 2028, Canada is anticipated to record the highest growth in North America, with the market size expected to reach USD 24106 Million.
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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 862.94 Million |
| Market Size In 2028 |
USD 2090.39 Million |
| Largest segment |
Cell Therapy |
| Fastest segment |
Gene Therapy |
| Units |
Revenue in USD Million |
| CAGR |
24.8% (2025-2028) |
| Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends |
North America Cell and Gene Therapy Manufacturing QC Market Share By Therapy Type
Segmentation Covered
| Segments |
Sub Segments |
| Country |
- United States
- Canada
|
| Therapy Type |
- Cell Therapy
- Gene Therapy
|
| Cell Therapy |
- CAR-T
- CAR-NK
- B-Cell
- Other
|
| CAR-T |
- Autologous CAR-T
- Allogeneic CAR-T
|
| Gene Therapy |
- Viral
- Non-Viral
|
| Viral |
- AAV
- Lentiviral vectors
- Other
|
| Scale |
- Pre commercial/ R&D Manufacturing
- Commercial Scale Manufacturing
|
| Mode |
- Contract Manufacturing
- In-house Manufacturing
|
| Workflow |
- Cell Processing
- Cell Banking
- Fill & Finish Operations
- Raw Material Testing
- Vector Production
- Other Workflows
|
| Process |
- Upstream Processes
- Downstream Processes
|
| End User |
- Pharmaceutical Companies
- Biopharmaceutical / Biotechnological Companies
- Contract Manufacturing Organizations
|
| Pharmaceutical Companies |
- Small Size
- Medium Size
- Large Size
|
| Biopharmaceutical / Biotechnological Companies |
- Small Size
- Medium Size
- Large Size
|
| Contract Manufacturing Organizations |
- Small Size
- Medium Size
- Large Size
|
| Technology Type |
- Fluorescence-Activated Cell Sorting (FACS)
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Chromatography
- Next-Generation Sequencing (NGS)
- Polymerase Chain Reaction (PCR)
- OthersÂ
|
North America Cell and Gene Therapy Manufacturing QC Market By Country 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Therapy Type 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Cell Therapy 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By CAR-T 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Gene Therapy 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Viral 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Scale 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Mode 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Workflow 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Process 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By End User 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Pharmaceutical Companies 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Biopharmaceutical / Biotechnological Companies 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Contract Manufacturing Organizations 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.
North America Cell and Gene Therapy Manufacturing QC Market By Technology Type 2028
Source: Straits Research Analysis Company Publications, Primary Interviews.