Continuous bioprocessing market size was valued at USD 319.77 million in 2025 and is projected to hit the market valuation of USD 2,331.98 million by 2035 at a CAGR of 21.98% during the forecast period 2026–2035.
Continuous bioprocessing represents a fundamental paradigm shift from the traditional "stop-and-start" batch manufacturing model to an "always-on" continuous flow state. Unlike fed-batch systems, where raw materials are processed in discrete steps with pauses for holding and validation, continuous bioprocessing integrates upstream (cell culture) and downstream (purification) operations into a single, seamless loop. Materials flow constantly through the system, with raw materials continuously fed in and final drug substance continuously harvested.
The economic and operational implications of this shift in the continuous bioprocessing market are profound. By 2025, industry data indicates that continuous methods can achieve a 50% reduction in overall production costs per gram compared to legacy systems. This efficiency is driven by process intensification, where smaller equipment delivers massive outputs. For instance, Just-Evotec Biologics demonstrated a 10-fold higher productivity rate with their continuous platform. This transition is not merely technical; it is a strategic maneuver allowing manufacturers to reduce facility footprints by 51%, drastically lowering capital expenditures while accelerating time-to-market.
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While Monoclonal Antibodies (mAbs) remain the bedrock of the continuous bioprocessing market, the demand for continuous bioprocessing is increasingly driven by the need to produce complex, high-value modalities and cost-sensitive biosimilars. In the biosimilars sector, a record 18 approvals by the FDA in 2024 have placed manufacturers under immense pressure to lower the Cost of Goods Sold (COGS). Continuous processing is proving essential here, allowing for the high-volume, low-cost production required to compete in this crowded market.
Simultaneously, the industry is witnessing a surge in Antibody-Drug Conjugates (ADCs), highly potent complex therapies that require precise conjugation windows. Major players like WuXi Biologics reported managing 194 ADC projects in 2024, a volume that benefits significantly from the steady-state control offered by continuous conjugation.
Furthermore, bispecific antibodies are becoming a dominant pipeline feature. The complexity of these molecules often leads to lower yields in traditional batch modes, but continuous platforms are proving superior; currently, 151 bispecific projects are in development at major CDMOs, leveraging continuous purification to significantly improve recovery rates.
The transition to continuous operations in the continuous bioprocessing market relies on a specific suite of advanced technologies designed for extended endurance and high volumetric productivity. At the core of upstream processing are Perfusion Bioreactors, which allow for ultra-high cell densities by constantly removing waste and adding nutrients. This capability was demonstrated in 2025 when platforms like the WuXiUP achieved a staggering 110 g/L total output over a 24-day run, far stripping traditional fed-batch yields. Complementing this upstream efficiency are Continuous Chromatography Systems (SMB) in downstream processing, which utilize multiple small columns rather than one large vessel. This approach enables the substantial reuse of expensive Protein A resins; recent validation studies confirm that resins can now withstand 200 cycles while maintaining yields above 80%, drastically reducing consumable costs.
To support these long-duration campaigns in the continuous bioprocessing market, Single-Use Assemblies have become essential for avoiding cross-contamination. Their usage has been shown to reduce plastic waste by 57% compared to the water and energy-intensive cleaning requirements of stainless steel, aligning operations with sustainability goals. Finally, Process Analytical Technology (PAT) is facilitating "real-time release," which is widely considered the holy grail of continuous processing. New innovations, such as Thermo Fisher’s sterility testing kits, now offer a time-to-result of less than one day, effectively eliminating the bottlenecks traditionally associated with quality control.
Four key players dominate the landscape, providing the critical infrastructure that powers the continuous bioprocessing market.
The global landscape is concentrated in regions that combine technological innovation with massive capital deployment.
The continuous bioprocessing market is currently being shaped by a dual focus on sustainability and digital integration. Environmental responsibility is no longer optional; it is a business imperative. With 62% of biopharma executives citing sustainability as their top priority, the ability of continuous processes to reduce water usage by 50% and CO2 emissions by 54% is a massive driver of adoption. Amgen’s target to achieve carbon neutrality at their Ohio plant by 2027 exemplifies this trend.
Simultaneously, the industry is seeing a "digital revolution." Facilities are integrating digital twins and AI to manage the complexity of continuous runs. With 38.8% of companies evaluating automation, the trend is moving toward "lights-out" manufacturing, where human intervention is minimized, and process control is automated via advanced sensors.
Despite the optimism, significant hurdles remain. The most pressing is the talent gap. Running a continuous line requires a different skillset than traditional batch processing—specifically in automation and data analytics. Currently, 60,000 job vacancies remain unfilled in the US biopharma sector, creating a bottleneck for companies ready to deploy the technology.
Furthermore, regulatory complexity persists. While the FDA is supportive, harmonizing continuous manufacturing standards across global agencies (EMA, NMPA, FDA) remains difficult. Validating a process that never stops is inherently more complex than validating a discrete batch. Additionally, the capital cost of transition is high in the continuous bioprocessing market. While OpEx is lower, the upfront cost of replacing legacy stainless steel with advanced continuous disposable systems can be prohibitive for smaller players, slowing the democratization of the technology.
The consumables and reagents segment dominated the market in 2024, driven by the operational necessity of replacing single-use components to ensure sterility. The US single-use bioprocessing sector alone was valued at USD 9.65 billion in 2024, with single-use assemblies contributing USD 2.63 billion.
The dominance of the mAb segment is secured by historic commercial performance and regulatory throughput. In 2024, the FDA approved 13 novel monoclonal antibodies, the highest since 2015.
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The pharmaceutical and biotechnology segment remains the undisputed engine of the continuous bioprocessing market. Major players are not merely retrofitting; they are building greenfield "mega-sites" designed natively for continuous manufacturing.
| Company | Investment Amount | Location | Announcement/Action Date | Project Scope |
| AstraZeneca | USD 4.5 Billion | Virginia, USA | Oct-25 | Manufacturing campus construction. |
| Novo Nordisk | USD 4.1 Billion | Clayton, NC | Jun-24 | Fill-finish and manufacturing expansion. |
| Sanofi | EUR 1 Billion | Vitry-sur-Seine | May-24 | Doubling mAb production capacity. |
| Lonza | USD 1.2 Billion | Vacaville, CA | Oct-24 | Acquisition of Genentech’s massive site. |
| Amgen | USD 900 Million | Ohio, USA | Apr-25 | New facility targeting carbon neutrality. |
| Fujifilm Diosynth | USD 1.2 Billion | Holly Springs, NC | Apr-24 | Large-scale capacity expansion. |
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Holding a commanding 39% market share, North America remains the epicenter of continuous bioprocessing market in terms of innovation and adoption. This dominance is cemented by aggressive capital deployment, exemplified by Sanofi’s pledge of USD 20 billion for US manufacturing and R&D through 2030. Thermo Fisher Scientific reinforced this infrastructure backbone with a USD 2 billion investment in 2025, specifically targeting advanced production capabilities to support local demand. The region is not just building capacity but actively running it; the sector currently faces 60,000 unfilled manufacturing roles, reflecting intense operational activity that outpaces labor supply. Regulatory confidence also plays a vital role, as the FDA approved 48 novel drugs in 2024, encouraging manufacturers to adopt continuous lines for faster commercialization.
Shifting focus to scale, the Asia Pacific continuous bioprocessing market is rapidly converting Western R&D into commercial volume. Samsung Biologics is the primary engine here, with its "Plant 5" adding 180,000 liters of capacity in April 2025 to reach a site total of 784,000 liters. This massive infrastructure supports a client roster that now includes 17 of the top 20 global pharmaceutical companies. Meanwhile, WuXi Biologics in China has secured a USD 18.5 billion backlog, proving that global demand is flowing East. Lotte Biologics is further amplifying this regional dominance by targeting a combined capacity of 400,000 liters across its new mega-plants, establishing the region as the world’s factory for continuous biologics.
Europe continuous bioprocessing marketdistinguishes itself by combining deep engineering roots with stringent environmental mandates that favor continuous modes. Manufacturers here are driven by sustainability targets, leveraging continuous processes to achieve a validated 54% reduction in CO2 emissions and a 50% cut in water usage. Technology providers like Sartorius are anchoring this growth, having opened a center in 2024 to house 120 experts dedicated to process intensification. Furthermore, facilities like Just-Evotec’s J.POD are setting global standards for efficiency, proving that European innovation is critical for the hardware and protocols that power the global market.
Transitioning to continuous modes reduces production costs per gram by approximately 50% and facility footprints by 51%. Companies like Enzene Biosciences are leveraging this efficiency to target a production cost of USD 40 per gram in 2025, a critical advantage for competing in cost-sensitive biosimilar markets.
Yes. Amgen demonstrated that a 2,000L perfusion bioreactor matches the output of a 15,000L fed-batch vessel, producing 50 kilograms in just two weeks. With platforms like WuXiUP achieving 110 g/L yields, manufacturers can now deliver commercial-scale volume using significantly smaller infrastructure.
Absolutely. The steady-state control is ideal for fragile molecules like ADCs and bispecifics, minimizing degradation risks. This advantage drove the management of 194 ADC and 151 bispecific projects at WuXi Biologics in 2024, proving the model's superiority for high-complexity therapeutics.
It is a massive decarbonization lever, validated to reduce water usage by 50% and CO2 emissions by 54%. Even when using disposables, continuous bioprocessing marketreduce plastic waste by 57% compared to the resource-heavy cleaning cycles of stainless steel, directly enabling net-zero targets.
Yes. Innovations like rapid sterility testing now deliver results in <1 day, effectively unblocking real-time release. Supported by the FDA's approval of 48 novel drugs in 2024, regulatory bodies are actively validating these workflows when backed by robust Process Analytical Technology (PAT).
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