United States Cell Therapy Manufacturing Market By Therapy (T-Cell Therapies, Dendritic Cell Therapies, Tumor Cell Therapies, Stem Cell Therapies), By Source of Cell (Autologous v/s Allogenic), By Scale of Operation (Preclinical, Clinical, Commercial), By Source (In-House v/s Contract Manufacturing), By Application (Oncology, Cardiovascular Diseases, Orthopedic Diseases, Others), By End User (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes, Others), By Region, Competition Forecast & Opportunities, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.51 Billion
CAGR (2026-2031)	13.16%
Fastest Growing Segment	Preclinical
Largest Market	Midwest
Market Size (2031)	USD 3.17 Billion

Market Overview

The United States Cell Therapy Manufacturing Market will grow from USD 1.51 Billion in 2025 to USD 3.17 Billion by 2031 at a 13.16% CAGR. Cell therapy manufacturing entails the highly regulated bioprocessing of living cells, involving their isolation, genetic engineering, expansion, and preservation for use in autologous or allogeneic therapeutic applications. The United States market is primarily propelled by the increasing prevalence of chronic and rare diseases, alongside foundational advancements in biopharmaceutical infrastructure that facilitate precise genetic modifications. This growth is further reinforced by robust regulatory pathways and sustained investment aimed at translating clinical pipelines into commercial realities. According to the International Society for Cell & Gene Therapy, the sector achieved a significant milestone with seven cell and gene therapy products receiving FDA approval in 2024, underscoring the rapid commercial maturation of these modalities.

Despite this progress, market expansion is significantly impeded by the high cost of goods sold and inherent scalability limitations. The intricate logistics required to maintain the viability of living cellular products, coupled with labor-intensive production methods, create substantial financial bottlenecks that restrict broader patient accessibility and strain healthcare budgets. Consequently, the inability to efficiently scale manufacturing processes remains a critical hurdle that stakeholders must overcome to ensure long-term commercial sustainability.

Key Market Drivers

Strategic Expansion of Biopharmaceutical Manufacturing Infrastructure is a primary catalyst propelling the United States Cell Therapy Manufacturing Market, as stakeholders race to resolve scalability bottlenecks and vein-to-vein logistics challenges. To meet the technical demands of producing autologous and allogeneic therapies, major industry players are heavily investing in localized, current Good Manufacturing Practice (cGMP) compliant facilities that integrate process development with commercial production. A prime example of this capacity fortification occurred when, according to Thermo Fisher Scientific, April 2025, in the 'Advanced Therapies Collaboration Center Grand Opening' announcement, the company inaugurated a new facility in Carlsbad, California, specifically designed to accelerate clinical and commercial manufacturing workflows for cell-based immunotherapies. This expansion exemplifies the sector's shift toward specialized infrastructure capable of supporting the rapid transition of complex therapeutics from the laboratory to the patient.

Complementing this physical expansion is the Robust Influx of Public and Private Research Funding, which provides the essential capital required to navigate the high costs of clinical translation and manufacturing process optimization. Sustained financial backing allows developers to adopt automated solutions and secure partnerships with Contract Development and Manufacturing Organizations (CDMOs), thereby de-risking the commercialization pathway. According to the Alliance for Regenerative Medicine, March 2025, in the 'State of the Industry Briefing', the cell and gene therapy sector attracted $15.2 billion in investment in 2024, representing a 30% increase compared to the prior year. This surging capital flow is further evidenced by the financial performance of key manufacturing partners; according to Lonza Group, July 2025, in the 'Half-Year Report 2025', the company's contract development and manufacturing division reported sales of CHF 3.1 billion, underscoring the massive commercial scale of the bioprocessing market supporting these advanced modalities.

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Key Market Challenges

The high cost of goods sold and inherent scalability limitations fundamentally restrict the expansion of the United States cell therapy manufacturing market. The production of these living drugs relies heavily on labor-intensive manual processes that are difficult to automate or scale efficiently. This complexity drives up operational expenses to unsustainable levels and makes the final therapies prohibitively expensive for widespread reimbursement and adoption. As a result manufacturers struggle to increase output volume without incurring exponential cost increases which creates a severe financial bottleneck in the supply chain.

This inability to scale production directly hampers the capacity of the market to service the rapidly growing development pipeline. The current infrastructure is ill-equipped to handle the surge in demand for clinical and commercial-grade materials. According to the Alliance for Regenerative Medicine, in 2024, the regenerative medicine sector supported nearly 2,000 active clinical trials globally. This massive volume of therapeutic candidates places immense pressure on United States manufacturing facilities that lack the necessary industrial efficiency to meet such demand. Without the ability to lower production costs and drastically increase throughput the market faces a critical barrier where commercial viability lags behind scientific progress.

Key Market Trends

The adoption of automated closed-system manufacturing technologies is fundamentally reshaping the production landscape by addressing the critical bottleneck of labor-intensive manual workflows. Manufacturers are increasingly implementing modular, "factory-in-a-box" platforms that integrate robotics and real-time monitoring to ensure consistent product quality while minimizing contamination risks associated with open processing. This technological shift allows for high-throughput parallel processing in a reduced footprint, directly countering the scalability limitations of traditional methods. According to Fierce Pharma, March 2024, in the 'Cellares hits manufacturing milestone for its cell therapy factory-in-a-box' article, the company’s newly validated Cell Shuttle platform can yield 10 times more cell therapy batches per year than conventional manual methods with a comparable workforce, demonstrating the massive efficiency gains available through advanced automation.

Simultaneously, the market is undergoing a decisive transition toward allogeneic "off-the-shelf" cell therapy platforms to overcome the high costs and logistical complexities of autologous treatments. By utilizing donor-derived cells that can be manufactured in large batches and cryopreserved for immediate use, this modality eliminates the vein-to-vein lag time that critically impacts patient care in rapidly progressing indications. This strategic pivot is attracting substantial industrial commitment as major pharmaceutical entities seek to secure scalable, universal therapeutic assets. According to Roche, November 2024, in the 'Roche enters into a definitive agreement to acquire Poseida Therapeutics' announcement, the company agreed to acquire Poseida for a total equity value of approximately $1.5 billion to advance donor-derived off-the-shelf CAR-T therapies, validating the commercial imperative behind this manufacturing paradigm shift.

Segmental Insights

The preclinical segment represents the fastest-growing area within the United States cell therapy manufacturing market, driven by a surge in early-stage research and development activities. This expansion results from increased investment by biopharmaceutical companies seeking to identify viable therapeutic candidates. Additionally, a rising volume of Investigational New Drug applications submitted to the U.S. Food and Drug Administration creates significant demand for manufacturing services to support mandatory safety and toxicology studies. Consequently, developers are prioritizing consistent production standards during these initial phases to ensure successful progression into human clinical trials.

Regional Insights

The Midwest US stands as the leading region in the United States Cell Therapy Manufacturing Market, primarily due to its strategic central geographic location which optimizes logistics for time-critical autologous treatments. This area provides essential proximity to major air cargo transportation hubs, ensuring the rapid turnaround times required for transporting patient-specific cells nationwide. Furthermore, the region offers scalable industrial space and lower operational costs relative to coastal research centers, attracting a dense concentration of Contract Development and Manufacturing Organizations (CDMOs). These factors enable the Midwest to support high-volume commercial production efficiently, fulfilling the rigorous supply chain demands associated with FDA-approved cell therapies.

Recent Developments

• In April 2025, Thermo Fisher Scientific opened its first United States Advanced Therapies Collaboration Center in Carlsbad, California. The 6,000-square-foot facility was established to assist biotech and pharmaceutical companies in transitioning cell therapy programs from research to commercial manufacturing. By providing access to current good manufacturing practices (cGMP) capabilities and end-to-end workflow solutions, the center aimed to resolve critical development challenges. This investment in manufacturing infrastructure allowed developers to leverage specialized expertise and advanced instrumentation, ultimately accelerating the timeline for bringing novel cell-based immunotherapies to the market and improving patient access to these complex treatments.
• In May 2024, Cytiva introduced the Sefia cell therapy manufacturing platform, which was developed in collaboration with Kite, a Gilead Company. This innovative system was designed to automate labor-intensive steps such as cell isolation, activation, and harvest, addressing common bottlenecks in autologous cell therapy production. By replacing manual processes with automated technology, the platform aimed to reduce the risk of batch failures and increase production capacity by up to 50% per year. This launch provided United States manufacturers with a scalable solution to meet the rising demand for personalized cancer treatments while potentially lowering production costs.
• In April 2024, Bristol Myers Squibb entered into a worldwide capacity reservation and supply agreement valued at up to $380 million with Cellares, an integrated development and manufacturing organization. This collaboration focused on deploying Cellares’ automated manufacturing platform, the Cell Shuttle, to produce chimeric antigen receptor T cell (CAR-T) therapies. The agreement provided the pharmaceutical company with exclusive access to smart factories in the United States, Europe, and Japan. This strategic move aimed to expand manufacturing capacity, improve scalability, and accelerate the delivery of transformative treatments to patients by addressing the operational complexities associated with cell therapy production.
• In January 2024, Kite, a Gilead Company, obtained approval from the U.S. Food and Drug Administration (FDA) for a manufacturing process change related to its CAR T-cell therapy, Yescarta. This regulatory authorization enabled the company to shorten the median turnaround time for the product in the United States from 16 days to 14 days. By optimizing the manufacturing steps involving the preparation of patient-specific T cells, the organization aimed to expedite the delivery of these life-saving treatments. This development highlighted the industry's focus on enhancing manufacturing efficiency to better support patients battling aggressive forms of large B-cell lymphoma.

Key Market Players

• Thermo Fisher Scientific
• Lonza Group
• GE HealthCare
• Catalent Inc.
• Parexel International
• WuXi Advanced Therapies
• Sartorius AG
• Miltenyi Biotec
• Charles River Laboratories
• Fujifilm Cellular Dynamics

By Therapy	By Source of Cell	By Scale of Operation	By Source	By Application	By End User	By Region
T-Cell Therapies Dendritic Cell Therapies Tumor Cell Therapies Stem Cell Therapies	Autologous v/s Allogenic	Preclinical Clinical Commercial	In-House v/s Contract Manufacturing	Oncology Cardiovascular Diseases Orthopedic Diseases Others	Pharmaceutical & Biotechnology Companies Academic & Research Institutes Others	Northeast Midwest South West

Report Scope:

In this report, the United States Cell Therapy Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Cell Therapy Manufacturing Market, By Therapy:

• T-Cell Therapies
• Dendritic Cell Therapies
• Tumor Cell Therapies
• Stem Cell Therapies

• United States Cell Therapy Manufacturing Market, By Source of Cell:

• Autologous v/s Allogenic

• United States Cell Therapy Manufacturing Market, By Scale of Operation:

• Preclinical
• Clinical
• Commercial

• United States Cell Therapy Manufacturing Market, By Source:

• In-House v/s Contract Manufacturing

• United States Cell Therapy Manufacturing Market, By Application:

• Oncology
• Cardiovascular Diseases
• Orthopedic Diseases
• Others

• United States Cell Therapy Manufacturing Market, By End User:

• Pharmaceutical & Biotechnology Companies
• Academic & Research Institutes
• Others

• United States Cell Therapy Manufacturing Market, By Region:

• Northeast
• Midwest
• South
• West