The cell and gene therapy infrastructure market is set for strong growth, with revenues expected to scale significantly from 2025 to 2034 as demand for advanced therapeutic development accelerates. This report, published by Towards Healthcare, a sister firm of Precedence Research, offers a concise and data-driven overview of the market’s evolving landscape.
Ottawa, Nov. 20, 2025 (GLOBE NEWSWIRE) — The cell and gene therapy infrastructure market is on an upward trajectory, poised to generate substantial revenue growth, potentially climbing into the hundreds of millions over the forecast years from 2025 to 2034. This market is surging because the escalating demand for advanced therapeutic development and manufacturing capacity is driving biopharma companies and CDMOs to invest heavily in facility build-outs, logistics, and delivery models.
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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, and delivery mechanisms (centralized, decentralized, or hybrid).
As the cell and gene therapy pipeline grows rapidly, biotechs and pharmaceutical players are increasing their manufacturing capacity, outsourcing to contract development and manufacturing organizations (CDMOs), and strengthening logistics to ensure safe, identity-preserved delivery to patients. These investments are contributing to enhanced maturity of both clinical and commercial aspects of the market.
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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 build-out of infrastructure and programs. Fast-track and breakthrough therapy designations minimize time to market, supporting significant investment in capability and manufacturing level.
- Technological Advancement & Digital Transformation: The introduction of artificial intelligence, predictive analytics, digital twins and automation in biomanufacturing not only improve operational efficiencies, but reduce batch failure, which leads to improvement in compliance.
- Supply Chain Complexity & Cold-Chain: The need for cell and gene therapies to have highly specialized logistics (cold chain, chain-of-identity), requires investment in specialized storage, transportation, and tracking capabilities.
- 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.
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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, concentration of leading CDMOs, and strong regulatory support. This region has a depth of venture capital investment, similar GMP-certified facilities, and established clinical trial infrastructure. In the U.S., the rapid growth of CDMOs, and large pharma companies building internal capacity, will propel the future demand for infrastructure. Lastly, the third-party logistics market for CGT in North America is healthy supported by cold-chain networks and stringent FDA regulations.
Asia-Pacific is anticipated to be the region growing fastest within the cell & gene therapy infrastructure market. A number of factors are driving rapid growth: Government investment and support for biotech infrastructure in China, India, Japan, and South Korea, established supporting policies and subsidies for advanced therapy, and CDMOs in this region offering cost-effective manufacturing support, all are all attractive to Western companies considering eventual outsourcing or global development of cell and gene-based therapies. Clinical development capabilities in Asia-Pacific region are also quickly growing, with the increasing number of cell and gene therapy trials occurring locally and subsequent demand for infrastructure.
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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 therapies.
Over 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 for their manufacturing needs to support their pipeline, clinical trials, and eventual commercial launch.
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.
Browse More Insights of Towards Healthcare:
The global cell and gene therapy CRO market is valued at US$ 4.90 billion in 2024, projected to reach US$ 5.39 billion in 2025 and surge to US$ 12.59 billion by 2034, expanding at a CAGR of 9.9% from 2025 to 2034.
The global cell and gene overexpression service market stands at US$ 771.40 million in 2024, increasing to US$ 805.73 million in 2025, and is expected to reach US$ 1,192.24 million by 2034, growing at a CAGR of 4.45% during the forecast period.
The global cell and gene therapy thawing equipment market, valued at US$ 0.96 billion in 2024, is set to grow to US$ 1.1 billion in 2025 and is projected to climb to US$ 3.56 billion by 2034, reflecting a strong CAGR of 14.24%.
The global cell and gene therapy cold chain logistics market is estimated at US$ 1.89 billion in 2024, rising to US$ 2.19 billion in 2025, with expectations to reach US$ 8.06 billion by 2034, registering a robust CAGR of 15.64%.
The global cell and gene therapy isolator market is valued at US$ 1.35 billion in 2024, projected to grow to US$ 1.52 billion in 2025 and further expand to US$ 4.47 billion by 2034, at a CAGR of 12.54% over the forecast period.
The global cell and gene therapy drug delivery devices market is on a growth trajectory, with revenues expected to rise significantly, reaching hundreds of millions of dollars between 2025 and 2034.
The global cell and gene therapy manufacturing market is projected to grow from US$ 5.08 billion in 2024 to a substantial US$ 22.88 billion by 2034, progressing at an impressive CAGR of 16.25% from 2025 to 2034.
The global cell and gene supply chain solutions market, valued at US$ 3.54 billion in 2024, is anticipated to increase to US$ 4.09 billion in 2025, and further reach US$ 14.95 billion by 2034, expanding at a strong CAGR of 15.54%.
The global cell and gene therapy tools and reagents market is expected to grow from US$ 10.04 billion in 2024 to US$ 11.12 billion in 2025, ultimately reaching US$ 27.3 billion by 2034, with a CAGR of 10.76% between 2025 and 2034.
The global cell and gene therapy manufacturing QC market, valued at US$ 2.66 billion in 2024, is projected to reach US$ 3.11 billion in 2025 and surge to US$ 12.35 billion by 2034, exhibiting a strong CAGR of 16.89% during the forecast period.
Recent 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
- Asia Pacific
- China
- Japan
- India
- South Korea
- Thailand
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
- Latin America
- Brazil
- Mexico
- Argentina
- Middle East and Africa (MEA)
- South Africa
- UAE
- Saudi Arabia
- Kuwait
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