Cell And Gene Therapy Manufacturing Market Size To Hit USD 106.03 BN By 2033
The global cell and gene therapy manufacturing market size was estimated at USD 9.95 billion in 2023 and is projected to hit around USD 106.03 billion by 2033, growing at a CAGR of 26.7% during the forecast period from 2024 to 2033.
The U.S. cell and gene therapy manufacturing market has witnessed a dramatic transformation over the last decade, becoming one of the most promising segments in the biotechnology and pharmaceutical industries. With rising incidences of chronic diseases, increasing FDA approvals for novel therapies, and rapid advancements in biotechnology platforms, this market is poised for robust growth. Cell and gene therapies represent a new frontier in personalized medicine, offering curative potential for conditions previously deemed untreatable.
Cell therapy involves the administration of living cells into a patient’s body to repair or replace damaged tissues or cells, while gene therapy entails the insertion or modification of genetic material to treat diseases at the molecular level. Manufacturing these therapies is complex and requires a highly specialized infrastructure, skilled workforce, rigorous quality control, and regulatory compliance.
The U.S. has emerged as a dominant force in this industry, not only due to its concentration of key players and biopharmaceutical innovators but also because of a conducive regulatory environment, government funding, and academic collaborations. The market continues to witness strategic mergers, technological innovations in automation and single-use bioprocessing systems, and a growing emphasis on decentralizing manufacturing capabilities to scale production.
The high cost and complexity of manufacturing pose challenges, but these are being progressively addressed through outsourcing to contract manufacturing organizations (CMOs), automation in cell processing, and standardization of production workflows. The evolution of CRISPR technologies, advancements in viral vector production, and digitization of quality control processes are driving efficiencies that enhance both scalability and affordability.
Increased adoption of single-use technologies to improve manufacturing flexibility, reduce contamination risks, and lower operational costs.
Growing strategic partnerships between biotech firms and contract manufacturers to meet the rising demand for large-scale production.
Acceleration in FDA approvals of advanced therapy medicinal products (ATMPs), boosting commercial-scale manufacturing activities.
Integration of artificial intelligence and machine learning in analytical and quality testing processes to optimize operations and reduce errors.
Expansion of in-house manufacturing capabilities by major biopharma players to strengthen intellectual property protection and gain operational control.
Emphasis on vector production innovations, including next-generation viral vectors and non-viral delivery platforms.
Development of closed and automated systems for cell processing to standardize quality and reduce manual intervention.
Investment in modular and decentralized facilities to facilitate rapid deployment and region-specific production scaling.
Cell And Gene Therapy Manufacturing Market Report Scope
| Report Attribute | Details |
| Market Size in 2024 | USD 12.60 Billion |
| Market Size by 2033 | USD 106.03 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 26.7% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Therapy type, scale, mode, workflow, region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Lonza; Bluebird Bio; Catalent Inc.; F. Hoffmann-La Roche Ltd.; Samsung Biologics; Boehringer Ingelheim; Cellular Therapeutics; Hitachi Chemical Co., Ltd.; Bluebird Bio Inc.; Takara Bio Inc.; Miltenyi Biotec; Thermo Fisher Scientific; F. Hoffmann-La Roche Ltd; Novartis AG; Merck KGaA; Wuxi Advanced Therapies |
A significant growth driver for the U.S. cell and gene therapy manufacturing market is the surge in FDA approvals of advanced therapies. The U.S. Food and Drug Administration has been actively accelerating the regulatory pathways for innovative cell and gene therapies under programs such as the Regenerative Medicine Advanced Therapy (RMAT) designation. Between 2019 and 2024, the FDA approved several transformative therapies, such as Zolgensma for spinal muscular atrophy and Abecma for multiple myeloma. These approvals have led to a rapid increase in demand for manufacturing capabilities, pushing companies to expand their production infrastructure and streamline processes to meet commercial demand. Furthermore, with more than 1,000 cell and gene therapy clinical trials currently underway in the U.S., this trend is expected to intensify, significantly contributing to the growth of manufacturing capabilities.
Despite its high potential, the market is hampered by the high cost and technical complexity associated with cell and gene therapy manufacturing. Unlike traditional pharmaceuticals, these therapies involve highly personalized, time-sensitive, and resource-intensive processes. Manufacturing requires specialized facilities compliant with Good Manufacturing Practices (GMP), skilled personnel, and complex logistics to maintain cell viability. Moreover, the scalability of autologous therapies which are patient-specific is particularly challenging. Each batch must be manufactured under unique parameters, making standardization and cost reduction difficult. For many biotech startups, the capital investment required to establish in-house capabilities is prohibitively high, creating a dependency on contract manufacturers and thereby increasing time-to-market and product pricing.
One of the most promising opportunities lies in the growing reliance on contract manufacturing services. With a surge in clinical pipelines and increasing commercialization of approved therapies, small and mid-sized biotech firms are turning to CMOs to avoid the high upfront costs of setting up GMP-compliant facilities. Leading CMOs in the U.S. have responded by expanding their capabilities, including cell banking, vector production, and fill-finish operations. They are also investing in automation and modular bioprocessing systems that enable flexibility and reduce turnaround times. As demand outpaces supply, CMOs that can offer end-to-end, scalable solutions are positioned to capture a substantial share of the market. The expansion of these services will play a pivotal role in accelerating innovation and democratizing access to life-saving therapies.
Cell therapy manufacturing dominated the U.S. cell and gene therapy manufacturing market in 2024, owing to the high number of approved and pipeline therapies involving stem cells and immune cell treatments like CAR-T. Stem cell therapy, in particular, has gained traction due to its applications in regenerative medicine, neurological conditions, and autoimmune diseases. Prominent examples include FDA-approved therapies such as Provenge and the ongoing development of mesenchymal stem cell therapies. Non-stem cell therapies—such as CAR-T cell therapy—have also witnessed massive investments from companies like Novartis and Gilead Sciences for their success in treating cancers like lymphoma and leukemia.
On the other hand, gene therapy manufacturing is the fastest-growing segment, attributed to the increasing focus on precision medicine and genome editing technologies. The growing use of viral vectors (e.g., AAV, lentivirus) to deliver therapeutic genes, especially in monogenic disorders, is a key factor fueling this growth. Therapies like Luxturna and Zolgensma are prime examples of commercial successes in this space. Moreover, ongoing advancements in CRISPR/Cas9 technology and synthetic biology are expanding gene therapy applications beyond rare diseases into chronic conditions, accelerating the need for scalable and reliable gene therapy manufacturing solutions.
Pre-commercial/R&D scale manufacturing currently dominates the market, primarily because the majority of therapies are still in early-stage or clinical development. This scale is critical for establishing proof-of-concept, optimizing dosing, and ensuring safety and efficacy before entering large-scale production. Biopharmaceutical companies are heavily investing in pilot-scale plants and technology transfer systems that facilitate smooth transitions from research to commercialization. Additionally, government funding and academic research collaborations have led to the establishment of innovation hubs that support early-stage production.
However, commercial scale manufacturing is growing at the fastest pace, driven by an increase in therapy approvals and demand for wider market access. As products move beyond clinical trials, companies are investing in GMP-compliant commercial facilities or outsourcing to large-scale CMOs. The scalability of operations, coupled with demand for supply chain resilience, is fostering innovations in automation, real-time analytics, and continuous processing systems that facilitate high-volume and consistent product output.
Contract manufacturing leads the U.S. market in 2024, especially among emerging biotech companies that lack in-house infrastructure. CMOs provide expertise, scalability, and access to specialized technologies, making them vital partners in expediting time-to-market. Several prominent U.S.-based CMOs, such as Catalent, Thermo Fisher Scientific, and Lonza, have significantly expanded their service portfolios to cover upstream and downstream manufacturing, analytical testing, and regulatory support.
Nonetheless, in-house manufacturing is gaining traction, particularly among established biopharmaceutical companies that seek greater control over their intellectual property, quality standards, and supply chain operations. For instance, Pfizer and Novartis have recently invested in in-house facilities for vector production and cell processing. These facilities enhance operational agility, allow companies to customize workflows, and are better suited to the long-term management of autologous therapies.
Cell processing remains the dominant workflow segment, as it is the core operation in both autologous and allogeneic therapies. This step involves the collection, activation, expansion, and modification of cells—a complex process requiring stringent control to ensure viability and potency. Innovations in closed systems, robotic handling, and cryopreservation are revolutionizing this workflow, enabling higher efficiency and reproducibility. Companies are also focusing on standardizing these processes to support broader commercial use.
Vector production is the fastest-growing segment, driven by the surge in gene therapy applications that require viral or non-viral vectors for gene delivery. The shortage of high-quality viral vectors has emerged as a bottleneck, pushing both CMOs and in-house facilities to expand capacity and adopt scalable technologies. Companies like Oxford Biomedica and Thermo Fisher Scientific are heavily investing in advanced vector platforms, aiming to streamline production and reduce batch variability. Furthermore, innovations in producer cell lines and transfection technologies are expected to further propel growth in this area.
The key entities in the market are undertaking several strategic initiatives such as licensing, partnership, and mergers and acquisitions to expand their market presence. Over the last few years, the market witnessed various remarkable mergers and acquisitions. For instance, in January 2022, Thermo Fisher acquired PeproTech, a manufacturer of recombinant proteins such as growth factors and cytokines, for USD 1.85 billion:
In March 2024, Thermo Fisher Scientific announced the opening of a new $200 million commercial-scale cell therapy manufacturing site in Plainville, Massachusetts, aimed at boosting capacity for viral vector production and cell therapy processing.
In January 2024, Catalent entered a multi-year manufacturing agreement with Sarepta Therapeutics for its gene therapy pipeline, signaling an expansion of Catalent’s services in vector development and analytical testing.
In December 2023, Lonza revealed its plans to invest over $300 million in expanding its U.S.-based facilities for viral vector production, including a new site in Maryland to support growing customer demand.
In November 2023, Bristol Myers Squibb completed its expansion of a state-of-the-art cell therapy manufacturing facility in Bothell, Washington, intended to support commercial production of CAR-T therapies.
In September 2023, WuXi AppTec acquired a U.S.-based GMP-compliant cell therapy contract manufacturer to strengthen its presence in the American market and expand service offerings for local clients.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Cell And Gene Therapy Manufacturing market.
By Therapy Type
By Scale
By Mode
By Workflow
By Region
Cross-segment Market Size and Analysis for Mentioned Segments
Additional Company Profiles
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Additional Countries (Apart
From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers