Key highlights
- 1The US continuous bioprocessing market is expected to reach USD 1.2 billion by 2036, at a CAGR of 12.0% from 2026 to 2036, driven by process intensification, biologics demand, and regulatory support.
- 2Supply is concentrated. Four companies, Sartorius, Danaher through Cytiva, Thermo Fisher and Merck through MilliporeSigma, together held about 70-75% of the market in 2025.
- 3Regulation is supportive. ICH Q13 guidance on continuous manufacturing, adopted by the FDA, provides a clear regulatory framework, supporting adoption.
- 4Perfusion and intensification are becoming standard. Vendors build compatibility with Repligen's alternating-tangential-flow perfusion into single-use bioreactor lines, making intensification an option rather than an exception.
- 5Integration is advancing. Sartorius and Repligen introduced an integrated bioreactor combining XCell ATF upstream intensification with the Biostat STR bioreactor, connecting upstream and downstream.
- 6Investment is strong. Thermo Fisher committed USD 2 billion in 2025 to manufacturing and R&D, with bioreactors such as DynaDrive designed for perfusion.
- 7Key companies include Cytiva, Sartorius, MilliporeSigma, Thermo Fisher Scientific, and Repligen.
Report Overview
The US continuous bioprocessing market covers continuous and intensified biomanufacturing systems and consumables in the United States, spanning perfusion bioreactors, continuous chromatography and filtration, monitoring and control, and perfusion media and resins, for biopharmaceutical companies, CDMOs and research. Conventional batch and fed-batch systems are outside the scope except as the baseline. Continuous bioprocessing runs biomanufacturing continuously to raise productivity and reduce footprint. Demand is shaped by process intensification, biologics demand, facility flexibility, and regulatory support. This report examines the size, drivers, process stages, applications, end users, pricing, regions, competition, recent developments, and outlook of the market, and provides recommendations. Sizing is built bottom-up from continuous bioprocessing systems and consumables by process stage, application and end user in the United States, and reflects continuous and intensified bioprocessing.
Market dynamics
Drivers
- 01Process intensification for yield and cost is the primary driver as perfusion and continuous processing raise productivity per volume, reduce facility footprint and can lower cost, motivating adoption.
- 02Biologics demand is a strong driver as growing demand for monoclonal antibodies, recombinant proteins and other biologics drives biomanufacturing and interest in more productive processes.
- 03Facility flexibility is a driver as intensified and continuous processing enables smaller, more flexible facilities and single-use systems.
- 04Regulatory support is a driver as ICH Q13 guidance adopted by the FDA provides a clear framework for continuous manufacturing, giving companies confidence to adopt.
Opportunities
- 01Fully integrated continuous processing is a leading opportunity as connecting intensified upstream to continuous downstream, as in integrated bioreactor systems, moves beyond intensification toward end-to-end continuous manufacturing.
- 02Cell and gene therapy are an opportunity as new modalities adopt intensified and continuous processing.
- 03CDMO adoption is an opportunity as contract manufacturers add continuous and intensified capabilities to serve clients.
- 04Consumables and monitoring are an opportunity as perfusion media, resins and process-analytical-technology tools are recurring, high-value products.
Trends
- 01Perfusion and intensification becoming standard is a defining trend as vendors build perfusion compatibility into bioreactor lines and intensification becomes a common option.
- 02Integrated upstream-downstream systems are a trend as companies connect perfusion bioreactors with continuous chromatography and filtration.
- 03Strong investment is a trend as suppliers invest heavily in manufacturing, R&D and innovation centers.
- 04New tools and consumables are a trend as new resins, perfusion hardware and monitoring tools launch.
Report Summary
| Base Year | 2025 |
|---|---|
| Forecast Period | 2026-2036 |
| Market Size (2025) | USD 350 million |
| Market Size (2026) | USD 392 million |
| Market Size (2036) | USD 1.2 billion |
| CAGR (Value) | 12.0% (2026-2036) |
| Format | PDF & Excel |
| Segments Covered | By Process Stage: Downstream, Upstream, Monitoring & Media. By Application: mAbs, Recombinant Proteins & Vaccines, Cell & Gene Therapy. By End User; By Region. |
| Geographies Covered | United States (Northeast, West, South, Midwest) |
| Key Companies | Cytiva, Sartorius, MilliporeSigma, Thermo Fisher Scientific, Repligen, Pall Corporation, Bio-Rad Laboratories, Univercells, Other Companies |
Segmental analysis
By Process Stage
- Downstream holds the largest share at about 45% of the market in 2026, with upstream at about 40% and monitoring and media accounting for the remainder.
- Downstream including continuous chromatography and filtration systems, is the largest stage because continuous downstream processing, such as periodic counter-current chromatography, is high-value and central to continuous manufacturing.
- Upstream including perfusion bioreactors and intensification hardware such as alternating-tangential-flow systems, is a large stage as perfusion raises cell density and productivity.
- Monitoring and media including process-analytical-technology tools, perfusion media and resins, are a substantial and recurring segment.
The dominance of downstream reflects the value of continuous chromatography and filtration, while upstream perfusion is central to intensification.
By Application
- Monoclonal antibodies hold the largest share at about 50% of the market in 2026, with recombinant proteins and vaccines at about 30% and cell and gene therapy accounting for the remainder.
- Monoclonal antibodies are the largest application because they are the largest class of biologics and the main focus of intensified and continuous processing for productivity and cost.
- Recombinant proteins and vaccines are a significant application using continuous and intensified processing.
- Cell and gene therapy are a growing application adopting intensified processing for new modalities.
The dominance of monoclonal antibodies reflects their scale in biologics, while cell and gene therapy grows as a newer application.
By End User
- Biopharmaceutical companies hold the largest share at about 60% of the market in 2026, with CDMOs at about 30% and academic and research users accounting for the remainder.
- Biopharmaceutical companies which develop and manufacture biologics, are the largest end user because they adopt continuous and intensified processing for their products and facilities.
- CDMOs contract development and manufacturing organizations, are a significant and growing end user adding continuous capabilities to serve clients.
- Academic and research users use continuous bioprocessing for development.
The dominance of biopharmaceutical companies reflects their manufacturing role, while CDMOs grow as they build intensified capabilities.
Geographic analysis
Northeast and West
The Northeast and West are the largest regional markets within the United States, home to major biopharmaceutical clusters in Massachusetts, the broader Northeast, and California, with many biologics developers, CDMOs and research institutions adopting continuous and intensified processing. These clusters concentrate biomanufacturing and innovation. The Northeast and West lead the United States market through their biopharmaceutical clusters.
South
The South is a large and growing market with biomanufacturing in North Carolina's Research Triangle and other centers, CDMO capacity, and investment in biologics manufacturing. The region's growing biomanufacturing base supports adoption. The South is a significant and growing market with expanding biomanufacturing capacity.
Midwest
The Midwest is a substantial market with biopharmaceutical manufacturing, research, and biologics production in Illinois, Indiana and other states. The region's manufacturing and research support demand. The Midwest adds demand through its biopharmaceutical manufacturing and research base.
Pricing Analysis
Pricing in continuous bioprocessing reflects capital equipment, recurring consumables, and the total cost against batch processing. Continuous and intensified systems involve capital cost for perfusion bioreactors and continuous chromatography and filtration, and significant recurring cost for consumables, notably perfusion media, which perfusion consumes in large volumes, along with resins and single-use components, and the value case rests on higher productivity, smaller facilities and lower cost per gram against batch processing. Several factors set cost. The capital equipment for perfusion and continuous processing is a cost, though intensification can reduce facility scale. Consumables are a large recurring cost, and perfusion media consumption is a particular consideration, as continuous perfusion uses more media than batch. Resins, filters and single-use components add recurring cost. The productivity gain, smaller footprint and potential cost-per-gram reduction drive the value.
The trajectory of adoption depends on whether the productivity and facility savings outweigh the higher media and complexity costs for a given product, and the case is strong for high-demand products while less compelling for others, so adoption is selective.
Competitive landscape
The market is served by a concentrated group of bioprocessing suppliers. Cytiva, part of Danaher, offers continuous chromatography and filtration and bioprocessing systems. Sartorius offers perfusion bioreactors, membrane chromatography and integrated systems, and partners with Repligen. MilliporeSigma, the United States arm of Merck KGaA, offers continuous processing systems and consumables. Thermo Fisher Scientific offers bioreactors including perfusion-capable systems and has invested heavily. Repligen is a specialist in intensification, with alternating-tangential-flow perfusion, chromatography resins and monitoring tools. Pall Corporation, Bio-Rad and Univercells also serve the market.
Competition turns on technology and integration, productivity and reliability, consumables and support, and regulatory track record, and the market is concentrated, with four suppliers holding most of it. Process intensification and continuous manufacturing favour suppliers with proven, integrated systems and strong consumables and support, and Sartorius, Cytiva, Thermo Fisher and MilliporeSigma lead, with Repligen a key intensification specialist and partner. The field is concentrated and innovating, with integration and intensification advancing, and technology, integration and consumables shape competition, with the pace of adoption the key variable.
Voice of Customer
We adopt perfusion and intensification where the productivity gain and smaller facility footprint justify it, particularly for high-demand products, and ICH Q13 gives us a clear regulatory path. The recurring media cost of perfusion and the added process complexity are real considerations, so we intensify selectively rather than converting everything to continuous.
Process development lead, biopharmaceutical company (Northeast):
We are adding intensified and continuous capabilities to serve clients who want higher productivity and flexible facilities, and integrated upstream-downstream systems help us connect perfusion to continuous purification. The technology is maturing, but control, validation and operator expertise are where we focus, since running continuously demands more of our monitoring and process control.
Manufacturing engineer, CDMO (South):
We use perfusion and continuous processing in development to raise cell density and productivity, and the availability of perfusion-compatible bioreactors and monitoring tools makes it easier to work with. The benefits are clear in development, and the questions for manufacturing are about consistency, control and cost at scale.
Scientist, research institution (West):
Analyst perspective
The US continuous bioprocessing market is a steadily growing market at the leading edge of biomanufacturing, and one where intensification is becoming standard while fully continuous manufacturing advances more gradually. Continuous and intensified bioprocessing, through perfusion bioreactors, continuous chromatography and filtration, and integrated systems, raises productivity, reduces facility footprint and can lower cost, and demand is driven by process intensification, biologics demand, facility flexibility, and regulatory support through ICH Q13, adopted by the FDA. The market is served by a concentrated group of suppliers, with four companies holding most of it, and intensification is becoming a standard option as vendors build perfusion into bioreactor lines and integrate upstream with downstream, supported by strong investment such as Thermo Fisher's USD 2 billion commitment.
The honest considerations are the pace of adoption, complexity and cost, and the persistence of batch. The market's reality is that most commercial biomanufacturing remains batch or fed-batch, and the transition is largely intensification, adding perfusion and continuous steps, rather than wholesale conversion to fully continuous manufacturing, so growth is real but gradual and selective rather than a rapid replacement of batch. Continuous processing adds complexity in control, validation and operation, and requires expertise, which slows adoption. The cost case is product-specific, as perfusion consumes large volumes of media and adds complexity, so the productivity and facility savings outweigh the costs for high-demand products but less so for others. The supplier base is concentrated, supporting the leaders but limiting choice. The market should be assessed on the pace and selectivity of adoption, the product-specific cost case, and the progress toward integration rather than on the productivity promise alone, and intensification, biologics demand and regulatory support drive steady growth, with adoption pace, complexity and cost, and the persistence of batch the key variables.
Key Strategic Developments
- 2023: Sartorius and Repligen introduced an integrated bioreactor system combining Repligen's XCell ATF upstream intensification with Sartorius' Biostat STR bioreactor, connecting upstream and downstream.
- 2024: Sartorius opened a Center for Bioprocess Innovation, with an integrated platform connecting perfusion bioreactors with membrane chromatography.
- 2025: Thermo Fisher committed USD 2 billion to manufacturing and R&D, with perfusion-capable bioreactors such as DynaDrive scaling from 50 L to 5,000 L.
- 2025: Repligen launched CTech SoloVPE PLUS for rapid at-line concentration measurement and AVIPure HiPer AAV9 chromatography resin for viral-vector purification.
- 2024-2026: ICH Q13 guidance on continuous manufacturing, adopted by the FDA, provided a clear regulatory framework supporting adoption.
Strategic Recommendations
For bioprocessing suppliers
The priority is to advance integrated, intensified and continuous systems and to support adoption with consumables, monitoring and expertise, because intensification is becoming standard while full continuous manufacturing advances gradually, and integration, reliability and support decide adoption. Companies should offer perfusion-compatible and integrated upstream-downstream systems, develop consumables and process-analytical tools, reduce media and complexity costs, and support customers through validation and operation. Building on the clear ICH Q13 framework and demonstrating product-specific value strengthen the position.
For biopharmaceutical companies and CDMOs
The recommendation is to adopt intensification and continuous processing selectively where the product-specific productivity and facility case is strong, invest in control and expertise, and use the ICH Q13 framework. For investors, this is a steadily growing market to evaluate on the pace and selectivity of adoption, the product-specific cost case, and progress toward integration rather than on the productivity promise alone, recognising that intensification, biologics demand and regulatory support drive steady growth while adoption pace, complexity and cost, and the persistence of batch are the key variables.
Sustainability impact
Smaller Footprint and Resource Efficiency
Continuous and intensified bioprocessing enables smaller facilities and can improve resource efficiency per unit of product.These systems support efficient manufacturing.
By raising productivity per volume and reducing facility footprint, continuous and intensified bioprocessing can lower the space, energy and resources needed per unit of biologic, improving the efficiency of biomanufacturing where adopted.
Consumables and Media Use
Perfusion and continuous processing consume large volumes of media and single-use consumables, a sustainability consideration. These systems involve consumable trade-offs.
By using large volumes of perfusion media and single-use components, continuous processing has a consumables footprint that offsets some efficiency gains, so media efficiency, single-use waste management and recycling are part of the sustainability picture.
Reliable Supply of Biologics
Efficient biomanufacturing supports reliable supply of important biologic medicines. These systems support healthcare supply.
By improving productivity and enabling flexible facilities, continuous bioprocessing can support more reliable and responsive supply of biologic medicines, contributing to healthcare through efficient manufacturing.
Selective, Product-Specific Benefit
The sustainability benefit of continuous bioprocessing depends on the product and process fit. These systems deliver benefit where well matched.
By delivering efficiency where productivity and facility savings outweigh consumable and complexity costs, continuous bioprocessing provides its benefit for well-matched products, so the sustainability value is realised selectively rather than universally.
Table of contents
14 chapters · 163 pages · click to expandFrequently asked questions
The US continuous bioprocessing market was valued at USD 350 million in 2025 and is projected to reach USD 1.2 billion by 2036, growing from USD 392 million in 2026, at a CAGR of 12.0% from 2026 to 2036, driven by process intensification, biologics demand, and regulatory support.