2025 Market SizeUSD 1.30 BnBase year
2026 EstimateUSD 1.58 BnEstimated year
2034 ForecastUSD 7.52 BnForecast value
CAGR21.5%2026–2034
Largest RegionNorth America2025
Automated And Closed Cell Therapy Processing Systems Market Overview
The global automated and closed cell therapy processing systems market reached USD 1.30 billion in 2025 and is estimated at USD 1.58 billion for 2026. Revenue is projected to reach USD 7.52 billion in 2034, representing a 21.5% CAGR over 2026–2034.
150+Cocoon instruments installed through 2025Lonza 2025 annual report
2025FDA AMT designation for Ori IROOri Biotech
2025FDA AMT designation for Cellares Cell ShuttleCellares
2025Quantum integrated CAR-T protocol publishedTerumo BCT
Automated and closed cell therapy processing systems comprise specialized equipment, integrated platforms, single-use fluid paths and software supplied for controlled processing of therapeutic cells. The commercial boundary includes sales and leases of automated processing instruments and the directly associated proprietary consumables, maintenance and validated process software. It excludes the finished CAR-T or stem-cell medicine, unrelated general laboratory automation, contract manufacturing service revenue and non-automated standalone culture materials. This distinction prevents a drug sponsor’s therapy revenue from being counted again as equipment demand.
Lonza reported more than 150 installed Cocoon instruments and work with over 30 customers in its 2025 annual report. Its platform automates multiple cell-manufacturing stages using a single-use cassette, supporting decentralized manufacturing strategies. Thermo Fisher Scientific markets the CTS Rotea for separation, washing and concentration of cell products, while Terumo Blood and Cell Technologies has demonstrated integrated activation, transduction and expansion on its Quantum hollow-fiber systems. Such platforms reduce manual transfers that otherwise create contamination and process-variability risks.
In September 2025, Ori Biotech announced FDA Advanced Manufacturing Technology designation for its IRO platform. Lonza received the same type of designation for Cocoon in December 2025, while Cellares reported an AMT designation for Cell Shuttle in April 2025. These designations concern manufacturing technologies rather than approval of the therapies made on them. The companies continue to validate their platforms with therapeutic sponsors, whose quality systems must still establish product-specific comparability, process controls and regulatory compliance.
Commercial adoption spans integrated end-to-end systems and modular equipment dedicated to individual operations. Fresenius Kabi markets LOVO cell washing and concentration equipment, and its December 2024 collaboration with Ori Biotech demonstrated a connected workflow using IRO, Cue and LOVO. Cellares reported first patients infused with rese-cel produced on Cell Shuttle in April 2026. The distinction between validated clinical manufacturing and future commercial-scale deployment remains important when interpreting supplier orders, installations and capacity announcements.
Source: Lonza annual report; Ori Biotech AMT; Cellares clinical manufacturing.
Key Takeaways: Automated And Closed Cell Therapy Processing Systems Market
- Base-year market size: Equipment and directly associated processing revenues were valued at USD 1.30 billion in 2025.
- Forecast and CAGR: The 2034 outlook reaches USD 7.52 billion, with 21.5% annual growth from 2026.
- Leading type: Non-Stem Cell Therapy Systems represented an estimated ~90% of 2025 revenue, reflecting engineered T-cell manufacturing demand.
- Leading application: Industry represented an estimated ~66% of 2025 revenue as biopharma manufacturers and CDMOs adopted validated equipment.
- Largest region: North America accounted for an estimated ~41% of 2025 revenue, supported by U.S. CAR-T manufacturing and technology developers.
- Key growth drivers: FDA AMT designations, rising engineered-cell manufacturing complexity, disposable closed fluid paths and demand for repeatable batch records encourage equipment purchases.
- Competitive landscape: Lonza, Ori Biotech, Miltenyi Biotec, Cellares, Thermo Fisher, Terumo BCT and Fresenius Kabi compete across integrated and modular workflows.
- Report coverage: Revenue is tracked across Type, Application, End User and Processing Workflow, with five geographic regions and 2026–2034 forecasts.
Report Scope & Market Segmentation
Revenue covers functionally closed or fully closed automated instruments and associated disposable kits, licensed software and instrument maintenance for ex-vivo cell-therapy manufacturing; unrelated therapeutic drug sales and general bioprocessing lines are excluded.
| Report Attribute | Coverage |
|---|
| Base Year | 2025 |
| Estimated Year | 2026 |
| Forecast Period | 2026–2034 |
| Market Measurement | Revenue, USD million/billion |
| By Type | Stem Cell Therapy Systems; Non-Stem Cell Therapy Systems |
| By Application | Academia; Industry; Others |
| By End User | Biopharmaceutical Companies; Contract Development and Manufacturing Organizations; Research Institutes; Hospital Cell Processing Units |
| By Processing Workflow | Integrated End-to-End Platforms; Cell Selection and Washing; Cell Expansion; Harvesting and Formulation |
| By Region | North America; Europe; Asia-Pacific; Latin America; Middle East & Africa |
| Selected Countries | United States; Canada; Germany; Switzerland; United Kingdom; China; Japan; India; Brazil; Qatar |
| Key Market Players | Lonza Group AG; Ori Biotech Ltd; Cellares; Thermo Fisher Scientific Inc.; Terumo Blood and Cell Technologies; Fresenius Kabi; Miltenyi Biotec; Bio-Techne Corporation; Wilson Wolf Manufacturing Corporation; Multiply Labs; Sartorius AG; Cytiva (Danaher); Sony Corporation |
Market Definition & Revenue Boundaries
The Type axis follows the intended therapeutic cell population: stem-cell platforms process hematopoietic, mesenchymal or pluripotent-derived cells, whereas non-stem systems primarily process engineered T cells, NK cells and tumor-infiltrating lymphocytes. The Application axis identifies research or industrial use, while End User distinguishes purchasers such as biopharmaceutical sponsors and independent CDMOs. These axes describe the same revenue pool from different perspectives and must not be added together.
Only technology supplier receipts attributable to automated closed processing are counted. A CDMO purchasing an IRO, Cocoon or Quantum system creates one equipment sale; the subsequent CDMO service fee and the drug sponsor’s CAR-T medicine sale are excluded from the equipment total. Instrument-compatible consumables are included only when sold for these systems. Automated equipment used exclusively for conventional biologics, general blood banking or non-therapeutic cell analysis is excluded unless purchased for a qualifying therapy process.
Automated And Closed Cell Therapy Processing Systems Market Dynamics
Engineered T-cell manufacturing requires repeatable closed processing
FDA-approved CAR-T therapies are patient-specific biological products whose manufacturing requires cell selection, activation, genetic modification, expansion and final formulation. Ori Biotech says IRO automates labor-intensive manufacturing steps in a fully closed platform; Cellares reported that its Cell Shuttle performed enrichment through formulation with in-process controls. Closed transfers limit manual connections and can reduce opportunities for contamination, but developers still need therapy-specific process qualification and release testing. Growing use of autologous products creates recurring demand for sterile single-use sets and validated software alongside the initial instrument purchase.
FDA AMT designations encourage platform evaluation
Cellares reported FDA Advanced Manufacturing Technology designation for Cell Shuttle on April 1, 2025, and Ori Biotech received the designation for IRO in September 2025. Lonza announced Cocoon designation on December 11, 2025. These recognitions provide opportunities for earlier regulator engagement but do not constitute marketing authorization for a therapeutic product. Sponsors evaluating new manufacturing sites can incorporate automated platforms into comparability packages and regulatory discussions. Commercial purchases therefore depend on successful process transfer, quality evidence and capacity planning rather than the AMT designation alone.
Capital requirements constrain smaller production facilities
Integrated closed manufacturing instruments require capital expenditure, operator training, process development and consumable validation before clinical GMP use. Lonza has installed more than 150 Cocoon instruments, illustrating that adoption can involve multiple units across a distributed network. Small research groups may prefer modular washing or expansion equipment rather than an end-to-end platform. The need to validate every product-specific process makes replacement of an established manufacturing method costly, particularly when a sponsor has already submitted clinical or commercial quality documentation to regulators.
Consumable compatibility shapes lifetime equipment economics
Thermo Fisher Scientific states that the CTS Rotea system uses gamma-irradiated disposable kits and can perform separation, washing, concentration and buffer exchange. Fresenius Kabi’s LOVO uses a functionally closed disposable fluid path based on spinning-membrane filtration. Such kits create recurring supplier revenue while reducing the burden of cleaning reusable product-contact surfaces. However, platform-specific cartridges and reagents can increase switching costs, and sponsors must demonstrate material compatibility and sterility. A validated consumable supply chain becomes essential when therapy production shifts from small clinical batches to routine patient delivery.
Manufacturing services must remain outside equipment revenue
Cellares and Bristol Myers Squibb announced a worldwide manufacturing capacity agreement worth up to USD 380 million in upfront and milestone payments in April 2024. That agreement concerns manufacturing services and capacity, not USD 380 million of instrument sales. Lonza similarly operates a wider contract manufacturing business distinct from its Cocoon platform sales. Excluding outsourced production fees prevents double counting and keeps the equipment market comparable across direct-purchase, lease and instrument-service business models. Supplier disclosures that combine both activities require careful commercial attribution.
Sources: Lonza annual report; Cellares; Ori Biotech; Thermo Fisher Scientific; Fresenius Kabi; European Medicines Agency.
Market Trends & Growth Opportunities
Integrated manufacturing platforms link upstream and downstream steps
Lonza’s Cocoon combines cell selection, activation, transduction, expansion and harvest inside a cassette-based workflow. Ori Biotech’s IRO is designed to automate related operations while allowing process parameters to be tailored to a sponsor’s cells. Cellares’ Cell Shuttle integrates enrichment, selection, expansion and formulation, and its Cell Q platform addresses automated quality control. Integration reduces the number of open handling events and may support parallel patient batches. Adoption depends on the ability to reproduce the biological characteristics of the therapy when transferring a process from manual methods.
Modular equipment remains relevant for targeted unit operations
Thermo Fisher’s CTS Rotea can be inserted into different cell therapy workflows for washing and concentration without replacing every upstream operation. Fresenius Kabi’s LOVO provides a distinct filtration-based approach, and Terumo BCT’s Quantum Flex supports closed hollow-fiber cell expansion. Ori and Fresenius demonstrated combined IRO, Cue and LOVO processing in December 2024. Manufacturers with established upstream protocols can adopt automation incrementally, using existing quality documentation while validating new interfaces. The modular approach competes with end-to-end platforms on flexibility and implementation time.
Manufacturing automation extends beyond oncology CAR-T
Terumo BCT announced in November 2025 that University of Chicago researchers integrated TCR-T activation, transduction and expansion on Quantum Flex. Cellares and Seoul National University Hospital agreed in September 2026 to evaluate automated processing of gene-modified hematopoietic stem and progenitor cells. Ori and ImmuXell reported a first clinical patient dosed in May 2026 using an IRO-manufactured investigational TCR-T product. These projects broaden the types of therapeutic cells that equipment vendors must support while leaving clinical effectiveness and product approval to separate studies.
Digital batch records and process monitoring gain procurement weight
Ori Biotech describes its IRO system as a digitized platform intended to standardize manufacturing operations. Thermo Fisher lists CTS Rotea software features for process simulation, visual monitoring and audit-support functions. Multiply Labs markets robotic clusters with instrument orchestration and electronic manufacturing records. Sponsors seeking consistent release documentation can use these capabilities to reduce manual transcription and capture process deviations. However, software claims must be verified under the buyer’s own GMP procedures, and automated monitoring does not eliminate the need for independent product testing.
International capacity projects support localized equipment demand
Cellares has described manufacturing infrastructure in the United States, Europe and Japan, while its 2026 collaboration with Seoul National University Hospital extends technology evaluation into South Korea. Terumo BCT partnered with Japan’s CiRA Foundation to investigate closed automated production of induced pluripotent stem cells. Bio-Techne and Wilson Wolf supported an Indian CAR-T manufacturing project through a June 2025 G-Rex grant to Immuneel Therapeutics. These collaborations expand training and equipment evaluation outside established U.S. manufacturing clusters, although pilot installations do not guarantee recurring commercial revenue.
Automated And Closed Cell Therapy Processing Systems Market Segmentation by Type
Report SegmentationBy Type
Type divides equipment according to whether the processed therapeutic population is stem-cell based or non-stem-cell based. The division follows the intended product of the manufacturing run rather than the laboratory that owns the instrument.
Largest TypeNon-Stem Cell Therapy Systems
Non-stem-cell systems represented an estimated ~90% of 2025 revenue. Commercial CAR-T and clinical TCR-T development rely on engineered lymphocyte selection, transduction, expansion and harvest. Lonza Cocoon, Ori IRO and Cellares Cell Shuttle support T-cell workflows, while Terumo Quantum Flex demonstrated integrated CAR-T processing in 2025. Engineered T-cell production uses repeated patient-specific processing steps and validated sterile manufacturing systems, increasing equipment and disposable-kit demand. Lonza and Ori supply disposable cassettes for repeated patient-specific manufacturing runs, generating consumable demand after an instrument is installed.
Stem-Cell ProcessingStem Cell Therapy Systems
Stem-cell systems process hematopoietic progenitors, mesenchymal stem cells and pluripotent-derived populations. Terumo BCT has worked with Japan’s CiRA Foundation on automated induced pluripotent stem-cell manufacturing, while Cellares announced a 2026 Korean hospital collaboration involving gene-modified hematopoietic cells. Longer expansion cycles and different culture conditions require tailored bioreactor control. Stem-cell programs offer a distinct demand pool, but revenue is excluded when equipment is used solely for research cell banking without a therapeutic development purpose.
Future type mix depends on approvals and manufacturing scale in engineered immune cells and stem-cell therapies. A multipurpose platform is attributed to the therapy for which its installation or disposable kit is purchased, avoiding duplicate recognition of the same instrument in both type categories.
Automated And Closed Cell Therapy Processing Systems Market Segmentation by Application
Report SegmentationBy Application
Application separates industrial therapy manufacture, academic development and other qualifying clinical settings. The allocation is based on the manufacturing activity performed, not on whether a platform can technically serve several settings.
Leading ApplicationIndustry
Industry represented an estimated ~66% of 2025 market revenue. Biopharmaceutical companies and CDMOs procure GMP-compatible platforms for repeatable clinical and commercial manufacturing. Cellares announced its USD 380 million capacity agreement with Bristol Myers Squibb in 2024, and Lonza reported more than 30 Cocoon customers by 2025. That manufacturing-service agreement is excluded from equipment revenue, but the associated need for validated production capacity illustrates the industrial demand driver. Equipment manufacturers recognize qualifying hardware and disposable-kit sales separately from the CDMO manufacturing contracts that customers subsequently perform.
Development ApplicationAcademia
Academic centers use closed processing platforms for investigator-initiated trials, translational research and early GMP production. Seattle Children’s Research Institute joined Ori’s IRO evaluation network in November 2025, and the University of Chicago collaborated with Terumo on TCR-T process development. Research centers often begin with a small number of instruments and validate specific cell populations before expanding throughput. Equipment sales to these institutions are counted when intended for cell therapy development, while unrelated basic cell biology purchases remain outside scope.
Other Clinical UsesOthers
Other applications include hospital-based cellular processing programs that are neither industrial-scale CDMO services nor conventional academic research. Sidra Medicine in Qatar received a 2025 G-Rex grant to support a pediatric CAR-T production process. Such installations can support local clinical capacity but often have lower throughput than centralized industrial sites. The revenue allocation includes qualifying automated closed instruments and proprietary processing kits; it excludes hospital infusion fees and the price of the administered therapeutic dose.
Industrial procurement is expected to remain the largest application because clinical-stage programs must transition from laboratory protocols to controlled manufacturing before supplying larger patient populations.
Automated And Closed Cell Therapy Processing Systems Market Segmentation by End User
Report SegmentationBy End User
End User identifies the organization purchasing or leasing the equipment, distinguishing therapy sponsors, outsourced manufacturers, research institutes and hospital cell-processing units. This classification does not add to the separate Application axis.
Biopharmaceutical PurchasersBiopharmaceutical Companies
Biopharmaceutical developers acquire closed platforms to control process transfer, protect intellectual property and retain batch-record oversight. Multiply Labs describes robotic clusters owned and operated by the pharmaceutical buyer, which differs from outsourced CDMO service fees. Cellares has evaluated manufacturing processes with therapy developers including Cabaletta Bio and Kite. A sponsor may buy multiple systems for process development and clinical supply, but a single unit is allocated to its purchaser rather than to every therapy later produced on it.
Outsourced ManufacturersContract Development and Manufacturing Organizations
CDMOs operate systems for multiple client programs and emphasize rapid changeover, validated disposables and flexible workflows. Ori announced IRO customer deliveries to CDMOs in January 2025 and added Catalent’s Princeton facility to its partner network in October 2026. The CDMO equipment purchase is counted; its subsequent fee for manufacturing a client batch is not. Customer diversification can improve equipment utilization but also creates more process-specific validation work when switching between cell types and therapeutic sponsors.
Translational and Hospital BuyersResearch Institutes and Hospital Cell Processing Units
Research institutes and hospitals use automated systems for investigator-initiated studies and local clinical manufacturing. Seattle Children’s, University of Chicago and Sidra Medicine provide documented examples of process development or grant-supported adoption. Their procurement cycles can depend on institutional grants and trial recruitment rather than steady commercial patient volume. Revenue is assigned to the actual purchasing institution, with shared university-hospital programs classified according to the contracting buyer to prevent duplicate market allocations.
Purchaser segmentation supports supplier sales planning because a commercial sponsor, a CDMO and a university core laboratory differ in validation budgets, utilization and service requirements.
Automated And Closed Cell Therapy Processing Systems Market Segmentation by Processing Workflow
Report SegmentationBy Processing Workflow
Processing Workflow groups each instrument or consumable by its primary function: integrated processing, selection and washing, expansion, or harvesting and formulation. Multipurpose platforms are assigned once to the dominant purchased capability.
Integrated PlatformsIntegrated End-to-End Platforms
Lonza Cocoon, Ori IRO and Cellares Cell Shuttle combine several unit operations in a controlled manufacturing architecture. Lonza reports Cocoon installations across more than 30 customers, while Cellares achieved clinical manufacturing milestones with rese-cel in 2026. Integration can reduce the number of manual transfers and enable unified batch records, but sponsors must validate process performance against their existing method. Platform sales include the qualifying hardware and directly linked proprietary consumables rather than therapeutic output.
Upstream OperationsCell Selection and Washing
Thermo Fisher CTS Rotea and Fresenius Kabi LOVO provide modular processing for washing, concentration or buffer exchange. LOVO uses spinning-membrane filtration, while Rotea applies counterflow centrifugation and disposable processing sets. These systems can be added to existing GMP suites without replacing an entire manufacturing process. Their procurement depends on required cell recovery, acceptable shear exposure and compatibility with downstream transduction or expansion steps.
Expansion and FinalizationCell Expansion; Harvesting and Formulation
Terumo Quantum Flex supports functionally closed cell expansion, with 2025 research describing integrated activation, transduction and expansion for CAR-T manufacturing. Bio-Techne and Wilson Wolf provide G-Rex-associated manufacturing inputs and modular closed-process components. Harvesting and formulation systems concentrate final cell products and prepare them for cryopreservation or administration. Each item is allocated to its primary purchased operation, so consumables sold with an integrated system are not counted again under a separate workflow category.
Manufacturers increasingly connect separate equipment through validated closed tubing and electronic records, but product-specific process requirements continue to sustain demand for modular instruments.
Automated And Closed Cell Therapy Processing Systems Market Regional Analysis
North America leads the base-year market because U.S. therapy sponsors and platform developers have invested in GMP automation, while European suppliers and Asian translational programs support additional installations. North American purchasing is supported by documented U.S. cell-therapy manufacturing programs and equipment suppliers, while European and Asian research partnerships widen the installed base.
North America
Largest region - Estimated ~41% of 2025 revenueNorth America represented an estimated ~41% of 2025 revenue from automated closed cell-processing equipment. The United States hosts Cellares, Ori Biotech’s U.S. operations, Thermo Fisher manufacturing support and a concentration of CAR-T sponsors. Cellares received an FDA AMT designation for Cell Shuttle in April 2025 and reported its first two rese-cel patient doses manufactured on that platform in April 2026. Canadian programs can purchase the same equipment for research and clinical manufacture, while Canadian procurement is supported by a 2025 OmniaBio manufacturing expansion announcement. FDA designation is not equivalent to product approval, so supplier sales depend on actual instrument installations and consumable demand.
Priority country signals
United States
Selected market signalCellares reported April 2026 dosing of two Cabaletta Bio patients with rese-cel made on Cell Shuttle, following a January 2026 IND amendment clearance. Ori’s September 2025 AMT designation and Lonza’s December designation increase available regulatory engagement for qualifying platforms. U.S. facilities purchasing closed systems also need GMP validation, contamination controls and documented batch release procedures. These conditions favor vendors offering process support alongside equipment rather than instrument specifications alone.
Source: Cellares.
Canada
Selected market signalCanada announced support in March 2025 for OmniaBio’s Hamilton facility expansion, including AI- and robotics-enabled clinical and commercial cell and gene therapy manufacturing. The government described plans for greater manufacturing efficiency, not a disclosed sale of any named automated cell-processing system. Canadian equipment demand is limited to actual purchases of qualifying closed instruments and their consumables, while OmniaBio’s contract manufacturing service revenue remains outside the equipment boundary.
Source: Government of Canada.
Europe
Established supplier base - GMP-focused manufacturingEurope combines platform development, equipment manufacturing and advanced-therapy production. Swiss company Lonza reported more than 150 installed Cocoon instruments and over 30 customers in its 2025 annual report, while UK-founded Ori Biotech is commercializing the IRO platform. The European Medicines Agency describes specific GMP requirements for advanced therapy medicinal products, encouraging traceable closed processing and documented quality controls. European buyers include academic translational units and biopharma manufacturing facilities. Equipment suppliers compete on the ability to integrate validated consumables and transfer existing processes without changing therapeutic cell characteristics.
Priority country signals
Switzerland
Selected market signalLonza’s Cocoon platform uses a single-use cassette to automate cell selection, expansion and harvest for personalized therapies. In December 2025, the company reported FDA AMT designation for the platform, relevant to U.S. submissions by European and global customers. Lonza also reported an agreement to divest its Personalized Medicine business in its 2025 annual report, so supplier ownership and future sales attribution require attention when interpreting competitive positions.
Source: Lonza.
United Kingdom
Selected market signalOri Biotech has developed IRO as a closed, digitized manufacturing system and reported FDA AMT designation in September 2025. Its October 2026 partnership with Catalent adds a U.S. center of excellence, illustrating how a UK-origin technology developer can serve customers through international manufacturing networks. European procurement remains governed by product-specific validation, single-use kit availability and GMP requirements rather than by a platform’s home country alone.
Source: Ori Biotech.
Asia-Pacific
Expanding clinical infrastructure - Japan, China, India and KoreaAsia-Pacific demand is supported by local cell-therapy development and collaborations with international equipment suppliers. Terumo BCT partnered with Japan’s CiRA Foundation on automated induced pluripotent stem-cell production, using Quantum Flex technology. In China, Ori Biotech and ImmuXell reported a first patient dosed in May 2026 with an investigational TCR-T product manufactured on IRO. Cellares and Seoul National University Hospital announced a September 2026 project for gene-modified hematopoietic progenitor-cell manufacturing. These projects show active technology evaluation, although individual pilot collaborations cannot be converted directly into regional equipment sales.
Priority country signals
Japan
Selected market signalTerumo Blood and Cell Technologies worked with the CiRA Foundation to develop automated manufacturing processes for induced pluripotent stem cells on Quantum Flex. The project focuses on controlling expansion and differentiation of cells that require extended culture periods. Japanese manufacturers and research institutions can evaluate closed systems to limit manual transfers, but the market boundary includes purchased equipment and proprietary kits rather than the value of future stem-cell medicines.
Source: Terumo BCT.
India
Selected market signalBio-Techne, Wilson Wolf and CellReady awarded a USD 150,000 G-Rex grant to Immuneel Therapeutics in June 2025 to support CAR-T manufacturing process development. The award demonstrates a specific Indian clinical manufacturing initiative but is a grant rather than equipment sales revenue. Indian buyers face the additional requirements of local GMP training, sterile disposable sourcing and affordability for therapies that require patient-specific production.
Source: Bio-Techne.
Latin America
Emerging demand - Selective hospital and CDMO investmentLatin America has a smaller installed base of automated cell-processing systems than North America and Europe. Therapy developers and specialist hospitals may evaluate modular washing or expansion equipment before committing to fully integrated manufacturing lines. Thermo Fisher’s CTS Rotea supports several cell types and unit operations, allowing staged adoption where capital budgets are constrained. Regulatory differences and imported disposable supply can increase implementation costs. Commercial revenues are recognized in the purchasing country and not reassigned to the location of the instrument maker’s regional sales office.
Priority country signals
Brazil
Selected market signalBrazil’s Anvisa issued technical guidance in 2025 for cell-processing centers handling hematopoietic progenitor cells for transplantation and clinical research. This demonstrates a defined institutional quality-control context but does not establish sales of automated closed therapy-manufacturing instruments. Brazilian buyers may procure systems such as CTS Rotea or Quantum Flex for eligible workflows, with revenue attributed only when equipment and proprietary kits are actually purchased. Brazilian hospital transplant procedure fees and unrelated cell-processing services remain excluded from the equipment market.
Source: Anvisa.
Mexico
Selected market signalMexico’s National Autonomous University reported a 2024–2026 research project involving development of CAR-T cells alongside vaccines and antibodies. The project establishes domestic cell-engineering research but does not verify a specific automated closed-system purchase. Qualified equipment demand would arise when Mexican research or GMP facilities acquire validated processing platforms, with additional costs for sterile disposables, process qualification and operator training. The value of research grants and future therapeutic products is excluded from supplier equipment revenue.
Source: UNAM.
Middle East & Africa
Targeted institutional projects - Grant-supported technology adoptionMiddle East and Africa procurement is concentrated in specialist hospitals and selected research institutions. Bio-Techne reported that Sidra Medicine in Qatar received a USD 100,000 G-Rex grant in August 2025 to support a pediatric CAR-T manufacturing process. Such projects can create initial demand for closed processing components, training and validation services. The installed base is constrained by specialist staffing, facility requirements and the cost of imported sterile consumables. Purchases of qualifying equipment count as market revenue, while the value of research grants and hospital treatment fees is excluded from the equipment-sales total.
Priority country signals
Qatar
Selected market signalSidra Medicine received a USD 100,000 G-Rex grant in August 2025 for development and validation of a CAR-T manufacturing platform targeting pediatric oncology applications. The grant supports implementation of a closed or semi-automated process but is not equivalent to realized equipment revenue. Hospital teams must still demonstrate local GMP capability, sterile manufacturing procedures and therapy-specific product controls before any routine clinical production.
Source: Bio-Techne.
South Africa
Selected market signalSouth Africa opened Biovac’s new Cape Town development laboratory in November 2025 to advance vaccine manufacturing, according to its Department of Science, Technology and Innovation. The facility is not evidence of an automated cell-therapy processing installation and is excluded from this specialized market. Local therapy developers may eventually purchase closed cell-processing equipment, but qualifying revenue requires a documented instrument or consumable transaction. Regulatory validation and imported technical support would remain necessary for GMP cell-therapy operations.
Source: South African Department of Science.
Competitive Landscape
Competition spans fully integrated cell-manufacturing platforms, modular washing and expansion equipment, disposable processing sets and robotics-based automation. Lonza, Ori Biotech and Cellares compete for end-to-end process integration, while Thermo Fisher, Fresenius Kabi and Terumo BCT serve defined unit operations. Supplier revenues cannot be inferred from the number of clinical programs supported because equipment sales, consumables, CDMO service contracts and drug product revenues have different accounting boundaries.
Integrated PlatformLonza Cocoon
Lonza reported more than 150 Cocoon installations and over 30 customers in its 2025 annual report. The functionally closed system uses a single-use cassette for personalized cell therapy manufacturing.
Integrated PlatformOri IRO
Ori delivered its first four IRO instruments in December 2024 and reported FDA AMT designation in September 2025. IRO combines multiple cell-processing steps under software control, with early deployments to contract manufacturers and pharmaceutical developers.
Integrated PlatformCellares Cell Shuttle
Cellares reported FDA AMT designation in April 2025 and clinical rese-cel dosing in April 2026. Cellares also provides manufacturing services through its integrated development and manufacturing organization model, which are excluded from equipment receipts.
Modular ProcessingThermo Fisher, Terumo and Fresenius
CTS Rotea, Quantum Flex and LOVO address cell washing, expansion and concentration. Their products can connect with existing processes without replacing the entire manufacturing line.
Lonza’s 2025 annual report describes the Cocoon customer base and an agreement to divest Personalized Medicine, making ownership updates relevant for any later supplier ranking. Ori Biotech has disclosed early instrument deliveries and AMT designation, while Cellares has reported clinical validation of Cell Shuttle and a separate manufacturing capacity agreement with Bristol Myers Squibb. The latter agreement’s USD 380 million headline is a service-capacity transaction rather than disclosed hardware sales. Equipment suppliers compete separately for instrument installations, disposable sets, software and process-development support contracts.
Thermo Fisher Scientific differentiates CTS Rotea through counterflow centrifugation and disposable sterile processing kits. Fresenius Kabi offers LOVO spinning-membrane filtration and collaborated with Ori on a connected closed workflow. Terumo Blood and Cell Technologies reported integrated CAR-T activation, transduction and expansion on Quantum in 2025. These modular suppliers compete on process compatibility, throughput, cell recovery and maintenance support rather than solely on end-to-end automation claims.
Bio-Techne and Wilson Wolf support G-Rex-based closed and semi-automated manufacturing through equipment-compatible reagents and process-development programs. Their 2025 grants to Immuneel Therapeutics and Sidra Medicine demonstrate buyer engagement in India and Qatar. Cellares and Sony have separately described a collaboration to integrate automated cell sorting with Cell Shuttle. Multiply Labs supplies robotic clusters intended to automate existing GMP instruments, offering another architecture for laboratories unwilling to redesign validated manufacturing processes.
Equipment procurement depends on process comparability and commercial supply assurance. A therapy developer may favor a platform with strong documentation, while a CDMO may emphasize fast changeovers between sponsors and reliable disposable kit availability. FDA AMT designations can facilitate regulator interactions, but they do not guarantee therapeutic approvals or sales. Manufacturers with service teams capable of supporting installation qualification, operator training and electronic records can defend repeat purchasing relationships.
Key Companies Profiled
- Lonza Group AG
- Ori Biotech Ltd
- Cellares
- Thermo Fisher Scientific Inc.
- Terumo Blood and Cell Technologies
- Fresenius Kabi
- Miltenyi Biotec
- Bio-Techne Corporation
- Wilson Wolf Manufacturing Corporation
- Multiply Labs
- Sartorius AG
- Cytiva (Danaher)
- Sony Corporation
Recent Developments in the Automated And Closed Cell Therapy Processing Systems Market
October 2026: Ori Biotech announced that Catalent joined its Preferred Partner Network on October 6, 2026. Catalent’s Princeton facility is expected to become a Center of Excellence for the IRO platform, supporting development and GMP manufacturing workflows. The agreement broadens access to the automated system through an established CDMO but does not disclose instrument sales revenue. Source
September 2026: Cellares and Seoul National University Hospital announced a project on September 23, 2026 to evaluate automated manufacturing of gene-modified hematopoietic stem and progenitor cells. The collaboration concerns a prospective therapeutic process for paroxysmal nocturnal hemoglobinuria. Its commercial importance lies in adapting closed manufacturing to stem-cell modalities rather than reporting an approved product. Source
April 2026: Cellares announced on April 14, 2026 that the first two Cabaletta Bio patients received investigational rese-cel doses manufactured on Cell Shuttle. The products met release specifications and were used in the RESET clinical program. This was a clinical manufacturing milestone, not a commercial approval of rese-cel or a disclosure of Cell Shuttle instrument revenue. Source
December 2025: Lonza announced on December 11, 2025 that the FDA granted Advanced Manufacturing Technology designation to Cocoon. The functionally closed platform uses single-use cassettes and programmable protocols for personalized cell production. The designation can support early regulator engagement for users, while each cell-therapy sponsor remains responsible for demonstrating its own product quality and manufacturing control. Source
November 2025: Terumo Blood and Cell Technologies reported University of Chicago research demonstrating activation, transduction and expansion of TCR-T cells on a Quantum Flex bioreactor. The study expanded the platform’s documented applications beyond CAR-T manufacturing. The reported process is research evidence and does not represent authorization of a finished TCR-T therapy. Source
September 2025: Ori Biotech announced FDA Advanced Manufacturing Technology designation for its IRO platform on September 3, 2025. The company described IRO as a fully closed automated cell therapy system launched in 2024. The designation offers additional opportunities for regulatory engagement but does not establish product approval or the value of supplier sales. Source
Market Outlook, 2026–2034
The market is projected to increase from USD 1.58 billion in 2026 to USD 7.52 billion by 2034, equal to 21.5% CAGR. Forecast revenue is restricted to qualifying closed processing equipment, proprietary kits and related platform software.
| Forecast Variable | Observed Starting Point | Effect on 2026–2034 Demand |
|---|
| Integrated platforms | Cocoon 150+ installations through 2025 | More multi-operation platform orders and consumable purchases |
| Regulatory engagement | FDA AMT designations in 2025 | Greater opportunity to discuss platform-based manufacturing controls |
| Modular equipment | CTS Rotea, LOVO and Quantum Flex | Staged adoption without replacing complete validated workflows |
| Geographic expansion | India, Qatar and South Korea projects | Additional translational installations and supplier support demand |
In North America, sponsors seeking to scale CAR-T production can procure integrated equipment or connect modular instruments already validated in their facilities. The U.S. FDA’s Advanced Manufacturing Technology program offers a regulatory engagement mechanism for certain platforms, but therapy-specific comparability requirements remain. Cellares’ clinical rese-cel milestone in April 2026 provides a documented example of automated patient-dose manufacture. Repeat sales of sterile cassettes and kits are expected to rise with actual production volume rather than with the number of announced partnerships.
Europe is positioned to remain a supplier and engineering center through Lonza, Ori Biotech and associated technology partners. Lonza’s 2025 disclosure of more than 150 Cocoon installations shows an established installed base, while the company’s divestment agreement for Personalized Medicine could alter future supplier reporting. European GMP rules for advanced therapy medicinal products require robust quality control and validated manufacturing, favoring systems with documented process performance. Procurement will depend on integration costs, facility capacity and the availability of qualified consumables.
Asia-Pacific demand is linked to translational research and regional therapy manufacturing. Terumo BCT’s collaboration with the CiRA Foundation concerns automated iPS-cell manufacturing, and Cellares’ September 2026 Korean hospital partnership concerns gene-modified hematopoietic progenitor cells. In India, Bio-Techne and Wilson Wolf supported CAR-T process development at Immuneel Therapeutics. These programs can lead to instrument purchases and technical-service demand, but grants and investigational therapy values are excluded from the market total.
By 2034, integrated manufacturing, automated washing and expansion are expected to serve more therapeutic modalities than the 2025 base. Ori’s IRO platform and Terumo’s Quantum Flex have documented TCR-T applications, while Cellares is adapting Cell Shuttle for stem-cell processing. The revenue outlook remains sensitive to therapy approvals, manufacturing batch volumes, disposable kit prices and the pace at which sponsors can transfer validated processes. Manufacturers that provide reliable sterile supply chains and process documentation are better placed to retain recurring equipment customers.
Report Coverage
The coverage evaluates automated closed equipment procurement for cell therapy manufacturing across technologies, purchasers and regions.
Market sizing2025 base year, 2026 estimate, 2034 forecast and reconciled 2026–2034 CAGR.
TechnologyIntegrated systems and modular washing, expansion, harvesting and formulation.
Commercial boundaryEquipment and directly linked consumables, excluding finished therapies and CDMO fees.
Regional coverageNorth America, Europe, Asia-Pacific, Latin America and Middle East & Africa.
Frequently Asked Questions
What is the automated closed cell therapy processing systems market size?
Global equipment and directly associated processing revenue was **USD 1.30 billion in 2025**. The 2026 estimate is USD 1.58 billion. The boundary covers automated closed cell processing instruments, proprietary kits and directly linked platform software, excluding the sale of finished cell medicines and outsourced therapy manufacturing fees.
How fast will automated cell therapy processing systems grow?
The forecast is **21.5% CAGR from 2026 to 2034**, reaching USD 7.52 billion. Growth depends on validated manufacturing capacity, the number of therapeutic batches processed and repeat purchases of sterile disposable kits. Product-specific GMP qualification can slow adoption even when automated systems have received regulatory manufacturing-technology designations.
Which region leads closed cell therapy manufacturing equipment?
North America leads with an estimated ~41% of 2025 equipment revenue. U.S. therapy sponsors, contract manufacturers and platform developers support instrument installations and process development. Cellares and Ori Biotech have announced FDA Advanced Manufacturing Technology designations, while clinical manufacturing programs continue to require separate therapy-specific regulatory evidence.
What is the difference between open and closed cell processing?
Closed processing keeps therapeutic cells inside sterile fluid paths during defined manufacturing operations, reducing manual exposure. Thermo Fisher CTS Rotea uses disposable processing kits, and Fresenius Kabi LOVO uses a functionally closed filtration workflow. A closed platform does not remove the need for validated aseptic connections, contamination controls or release testing.
What are leading automated cell therapy processing platforms?
Lonza Cocoon, Ori IRO and Cellares Cell Shuttle integrate multiple manufacturing stages. Thermo Fisher CTS Rotea, Terumo Quantum Flex and Fresenius Kabi LOVO provide modular processing functions. Platform choice depends on cell type, required expansion capacity, existing GMP infrastructure, consumable compatibility and the sponsor’s process comparability obligations.
Does FDA AMT designation mean a cell therapy is approved?
No. Advanced Manufacturing Technology designation recognizes an eligible manufacturing technology and can facilitate regulatory interaction. Ori Biotech, Cellares and Lonza reported designations for IRO, Cell Shuttle and Cocoon during 2025. The FDA must still evaluate each finished cell therapy under its applicable regulatory pathway before the product can be marketed.
Are automated systems used for stem cell therapies?
Yes. Terumo BCT partnered with Japan’s CiRA Foundation to investigate automated induced pluripotent stem-cell manufacturing. Cellares and Seoul National University Hospital announced a 2026 collaboration on gene-modified hematopoietic stem and progenitor cells. Such applications require cell-specific expansion and quality controls distinct from engineered T-cell production.
Who buys closed cell processing equipment?
Biopharmaceutical sponsors, contract development and manufacturing organizations, academic research centers and hospital cell-processing units purchase qualifying platforms. Ori reported first IRO customer deliveries to CDMOs in early 2025, while Seattle Children’s joined its evaluation network later that year. Purchases are counted once at the technology supplier level, not again as manufacturing service revenue.
What are the largest cost challenges for automated cell processing?
Instrument purchase, process transfer, sterile disposable supply, validation work and operator training are important costs. A modular system can fit an established manufacturing suite, while an end-to-end platform may require a more extensive comparability exercise. Long-term consumable compatibility and reliable technical support influence the total cost of ownership.
How does automation support CAR-T manufacturing?
Automated platforms can combine cell selection, activation, transduction, expansion and harvesting under controlled conditions. Terumo BCT described a 2025 integrated Quantum CAR-T workflow, and Cellares reported clinical rese-cel doses manufactured on Cell Shuttle in April 2026. Such evidence supports process feasibility but does not replace product-specific potency and safety testing.
Which companies compete in closed cell therapy processing?
Suppliers include Lonza, Ori Biotech, Cellares, Thermo Fisher Scientific, Terumo Blood and Cell Technologies, Fresenius Kabi, Miltenyi Biotec, Bio-Techne, Wilson Wolf and Multiply Labs. Their offerings differ between integrated systems, modular instruments, reagents and robotics. Company-wide revenues cannot be treated as sales of this specialized equipment category.
Research Sources & Evidence Base
View research sources used for this overview
- Lonza. 2025 annual report: Specialized Modalities, 2026.
- Lonza. Cocoon FDA AMT designation, December 2025.
- Lonza. Cocoon T-cell processing collaboration, June 2025.
- Ori Biotech. IRO FDA AMT designation, September 2025.
- Ori Biotech. IRO first customer deliveries, January 2025.
- Ori Biotech. Catalent partner network, October 2026.
- Cellares. Cell Shuttle FDA AMT designation, April 2025.
- Cellares. First rese-cel patient dosing, April 2026.
- Cellares. Seoul National University Hospital partnership, September 2026.
- Cellares. Bristol Myers Squibb capacity agreement, April 2024.
- Thermo Fisher Scientific. CTS Rotea product and processing applications.
- Fresenius Kabi. IRO and LOVO modular workflow collaboration, December 2024.
- Terumo BCT. Quantum integrated CAR-T process, June 2025.
- Terumo BCT. University of Chicago Quantum TCR-T protocol, November 2025.
- Terumo BCT. CiRA iPS-cell automation collaboration, 2024.
- Bio-Techne. Immuneel G-Rex grant, June 2025.
- Bio-Techne. Sidra Medicine G-Rex grant, August 2025.
- European Medicines Agency. GMP guidelines for advanced therapies.
- Multiply Labs. Robotic closed manufacturing platform.
- Cellares. Cellares and Sony sorting integration, September 2024.
- Ori Biotech. IRO and ImmuXell clinical dosing, May 2026.
- Bio-Techne. G-Rex grant to Sonoma Biotherapeutics, November 2025.
- Miltenyi Bioindustry. CliniMACS Prodigy closed automated cell processing.
- Cytiva. Sefia cell therapy manufacturing platform.
- Sartorius. Ksep closed automated cell processing.
