Cell And Gene Therapy Infrastructure Market Rising Opportunities - Towards Healthcare Insight
Ottawa, Nov. 20, 2025 (GLOBE NEWSWIRE) -- The cell and gene therapy infrastructure market
The Complete Study is Now Available for Immediate Access | Download the Sample Pages of this Report @Key Takeaways:
- By region, the North America segment was dominant in the cell and gene therapy infrastructure market in 2024. By region, the Asia Pacific segment is expected to be the fastest-growing over the forecast period, 2025 to 2034. By therapy type, the gene-modified cell therapy segment was dominant in 2024. By therapy type, the gene therapy segment is expected to be the fastest-growing over the forecast period, 2025 to 2034. By infrastructure component, the manufacturing facilities segment was dominant in 2024. By infrastructure component, the supply chain & logistics segment is expected to be the fastest-growing over the forecast period, 2025 to 2034. By delivery model, the centralized manufacturing & delivery segment was dominant in 2024. By delivery model, the hybrid models segment is expected to be the fastest-growing over the forecast period, 2025 to 2034. By end user, the biotech & pharmaceutical companies segment was dominant in the cell and gene therapy infrastructure market in 2024. By end user, the contract development and manufacturing organizations (CDMOs) segment is expected to be the fastest-growing over the forecast period, 2025 to 2034.
Market Overview:
What is contributing to the rapid growth of the cell & gene therapy infrastructure market?
The cell & gene therapy infrastructure market refers to the systems, facilities, and processes that are needed for the development, manufacturing, and delivery of advanced therapies like CAR-T and viral vector gene therapies, as well as other genetically modified cellular therapies. Infrastructure includes GMP-compliant manufacturing sites, cleanrooms, supply chain and cold-chain logistics As the cell and gene therapy pipeline grows rapidly, biotechs and pharmaceutical players are increasing their manufacturing capacity You can place an order or ask any questions, please feel free to contact us at ...Major Growth Drivers:
What is driving the market in the first place?
- Expanding Therapeutic Pipeline & Increased Outsourcing Demand: The rise of clinical-stage cell and gene therapy candidates is driving demand for scalable, GMP-compliant manufacturing for commercialization. Over 80% of developers are now using/connect with a third-party provider, a contract development and manufacturing organization (CDMO), thus abating their need to build proprietary infrastructure. Regulatory Backing & Fast-Track Approvals: There is an increase in positive regulatory agency engagement for both advanced therapy programs as well as expedited approval pathways - supporting investment in biotech Technological Advancement & Digital Transformation: The introduction of artificial intelligence, predictive analytics, digital twins and automation in biomanufacturing Supply Chain Complexity & Cold-Chain: The need for cell and gene therapies to have highly specialized logistics Geographic Expansion & Cost Arbitrage: Many companies are either investing in facilities or partnering with CDMO support in regions benefiting from lower cost of manufacturing and supportive government incentives for growth in areas such as Asia-Pacific.
Key Drifts:
What are the main trends defining the cell & gene therapy infrastructure landscape?
- Centralization to Hybrid Models Shift: The centralized manufacturing model is still dominant, but there is a notable uptick in hybrid delivery models, with combined centralized production with point-of-care (PoC) or decentralized manufacturing strategies. These hybrid delivery models alleviate the risk of transport and preserve product identity. Digital Supply Chain, Traceability Platforms: There is an increasing adoption of orchestration platforms that track every stage of the therapy, such as compliance, conformance, and schedules, through the manufacturing to patient infusion delivery pathway. Automation & Modular Manufacturing Facilities: Pharma and CDMOs are building modular, closed-system manufacturing suites (e.g. plug-and-play cleanrooms) that can quickly scale up and down according to demand.
Significant Challenge:
What is the most significant obstacle to growth?
To support cell and gene therapy, expanding the infrastructure requires considerable capital for GMP-grade manufacturing facilities which typically operate at high utilization rates. Companies in the market suggest capacity constraints are still present with many CDMOs reporting above 90% utilization and limited infrastructure is delaying developers that do not have their own manufacturing. The lack of excess capacity, combined with the capital cost of cleanrooms, viral-vector suites and quality-control systems presents a large barrier, particularly for more biotech.
Regional Analysis:
North America leads the cell & gene therapy infrastructure market due to an established biopharma ecosystem clinical trial infrastructure Asia-Pacific is anticipated to be the region growing fastest within the cell & gene therapy infrastructure market biotech infrastructure in China, India, Japan, and South Korea Get the latest insights on life science industry segmentation with our Annual Membership:Segmental Insights:
By Therapy Type
In 2024, the gene-modified cell therapy segment (e.g., CAR-T, TCR-T) accounted for the majority of share. This share was driven by the fast-paced clinical and commercial utilization of CAR-T products and marked investments in dedicated manufacturing suites, cleanrooms, and dedicated supply chain logistics targeted to living cell therapiesOver the forecasted period of 2025 to 2034, gene therapy segment (viral vector–based therapies, gene replacement) will carry the largest share and fastest growth as the pipeline continues to expand, more investigations achieve regulatory approvals, and the demand for viral vector production capability stimulates CDMOs and biopharma firms to scale-up manufacturing infrastructure.
By Infrastructure Component:
Manufacturing Facility (Majority of Share in 2024): Manufacturing facilities, particularly GMP-compliant facilities (e.g., cleanrooms, viral vector suites) comprised the majority share of component in 2024. These facilities are saturated with capital investments, but they ensure sterility, reproducibility, and compliance within both the clinical and commercial level.
The only component that will experience rapid growth during the forecast period is the supply chain and logistics infrastructure component. The complexity of transferring personalized therapies, temperature control, identity tracking, and orchestration platforms will take investments away from manufacturing goods into logistics, chain of identity systems and even real-time monitoring systems.
By Delivery Model
The predominant delivery model in 2024 was centralized manufacturing, therapies produced in centralized GMP production facilities on a large scale and shipped to end users before administering the therapy. This delivery model benefits from economies of scale and centralized quality governance.
Over the forecast period, hybrid delivery models (including centralized and decentralized/point-of-care manufacturing) are projected to grow fastest. A hybrid delivery setup reduces logistics risk, reduces delivery time, and preserves product identity - all attractive characteristics for clinical and commercial purposes.
By End User
Biotech and pharma companies were the dominant end-user of cell & gene therapy infrastructure during 2024. These companies are developing their own manufacturing capacities or partnering with CDMO companies
Contract Development & Manufacturing Organizations will grow the fastest relative to other end user segments. As the demand for outsourced manufacturing increases, CDMOs will get better infrastructure, bigger capacity, and innovative delivery models, so they can support more advanced therapy developers.
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The global cell and gene therapy manufacturing QC marketRecent Developments:
On Oct 2024, J&J is set to invest over US$ 2 billion in a new biologics and cell therapy manufacturing facility in Wilson, North Carolina. Once operational, this site will bolster J&J's capacity to supply advanced therapies for cancer, neurological, and immune-related diseases.
Cell and Gene Therapy Infrastructure Market Key Players List:
- BioLife Solutions TrakCel Vineti Cryoport Systems Be The Match BioTherapies Longevity BioImaging Ori Biotech Miltenyi Biotec Akron Biotech BioSpherix Cellino QuickSTAT Lonza Bioscience Marken SHL Medical
Segments Covered in the Report
By Therapy Type
- Gene-Modified Cell Therapy (e.g., CAR-T, TCR-T, NK cells) Gene Therapy (in-vivo and ex-vivo) Stem Cell Therapy Tissue Engineering
By Infrastructure Component
- Manufacturing Facilities (GMP-compliant facilities, clean rooms) Supply Chain & Logistics (cold chain, cryopreservation) Quality Control & Testing Laboratories IT & Data Management Platforms (supply chain orchestration, traceability) Automation & Robotics
By Delivery Model
- Centralized Manufacturing & Delivery Decentralized/Point-of-Care Manufacturing Hybrid Models
By End User
- Biotech & Pharmaceutical Companies Contract Development and Manufacturing Organizations (CDMOs) Research Institutes & Academic Hospitals Hospitals & Treatment Centers
By Region
- North America
- U.S. Canada
- China Japan India South Korea Thailand
- Germany UK France Italy Spain Sweden Denmark Norway
- Brazil Mexico Argentina
- South Africa UAE Saudi Arabia Kuwait
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