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 Which Application Areas Are Fueling the Surge in Demand?

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.

What Are the Most Prominent Products Enabling This Shift?

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.

Who Are the Titans Leading the Market and What Do They Offer?

Four key players dominate the landscape, providing the critical infrastructure that powers the continuous bioprocessing market.

1. Thermo Fisher Scientific: A giant in the space, Thermo Fisher committed USD 2 billion in 2025 to bolster its manufacturing and R&D capabilities. Their key offering includes the "DynaDrive" Single-Use Bioreactor, which scales from 50L to 5,000L, explicitly designed to handle the high agitation and mass transfer rates required in continuous perfusion.
2. Sartorius: Focusing heavily on the intersection of automation and processing, Sartorius launched a new Center for Bioprocess Innovation in 2024 accommodating 120 experts. Their integrated platform connects perfusion bioreactors with membrane chromatography, offering a "process-in-a-box" solution that simplifies the adoption curve for smaller biotechs.
3. Danaher (Cytiva/Pall): Cytiva remains a leader in end-to-end continuous solutions. Their offerings focus on closing the loop between upstream and downstream. Their automated continuous chromatography systems are industry standards, supporting the 33.9% adoption rate seen in downstream facilities today.
4. Merck KGaA (MilliporeSigma): Their BioContinuum™ Platform is pivotal for facilities aiming for "Process 4.0." They specialize in connected software and hardware that allow for the orchestration of the entire continuous line, addressing the 38.8% of facilities planning to evaluate automation in 2025.

Which Nations Hold the Strongest Position in Production and Consumption Across the Global Continuous Bioprocessing Market?

The global landscape is concentrated in regions that combine technological innovation with massive capital deployment.

1. United States: The US remains the undisputed leader in both innovation and consumption. Driven by investments like Sanofi’s USD 20 billion pledge and Roche’s USD 50 billion strategy, the US market is characterized by early adoption of cutting-edge technologies. The vacancy rate of 8% for skilled biomanufacturing roles highlights the intense operational activity here.
2. South Korea: Rapidly emerging as the world's factory for biologics, South Korea is home to massive continuous capacity. Samsung Biologics alone reported a revenue of 4.55 trillion KRW in 2024. With Lotte Biologics aiming for 400,000 liters of capacity, the nation is aggressively pivoting toward continuous manufacturing to serve global clients.
3. Germany: As the engineering hub of Europe continuous bioprocessing market, Germany is central to the production of the hardware itself (Sartorius, Merck). It is a key exporter of continuous technology and maintains a robust domestic manufacturing sector focused on high-quality complex biologics.
4. China: dominated by CDMO giants like WuXi Biologics (which holds an USD 18.5 billion backlog), China is the engine of volume. The region is moving fast from "me-too" batch manufacturing to sophisticated continuous workflows to service global clients, employing over 4,383 scientists at WuXi alone to drive this evolution.

What Recent Trends Are Shaping Market Dynamics?

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.

What Challenges are Negatively Affecting Continuous Bioprocessing Market Growth?

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.

Segmental Analysis 

Recurring Revenue from Single Use Consumables Dominating Biomanufacturing Workflows

The consumables and reagents segment dominated the market in 2025, functioning as the recurring revenue engine for the entire industry. Leading suppliers are aggressively expanding portfolios to maintain this momentum, exemplified by Repligen Corporation launching three high-performance chromatography resins, including AVIPure HiPer AAV9, in December 2025. For instance, Thermo Fisher Scientific simultaneously strengthened its position by introducing plant-based, lower-carbon films for single-use container lines in December 2024. These innovations are critical because the continuous bioprocessing market relies on disposable technologies to ensure sterility without time-consuming cleaning cycles. Production capacity for these essential inputs is scaling rapidly, with Thermo Fisher Scientific dedicating USD 40 million to expand its single-use technology manufacturing site in Pennsylvania. MilliporeSigma also bolstered the supply chain by investing in a new bioprocessing production center in Daejeon, South Korea, in April 2024.

Commercial scale operations are driving unprecedented volume consumption of these materials. Takara Bio integrated Thermo Fisher’s DynaDrive bioreactors for large-scale viral vector manufacturing in May 2024, creating a sustained demand for compatible consumables. ABEC followed this trend by introducing its single-use Advanced Therapy Bioreactor in March 2025 to streamline cell expansion workflows. Financially, the U.S. single-use bioprocessing sector alone was valued at USD 9.65 billion in 2024, underscoring the segment's immense economic footprint. Merck KGaA contributed to this growth by releasing new resins in 2024 that significantly reduce purification time. Furthermore, WuXi Biologics’ massive 430,000-liter capacity expansion post-2024 necessitates a constant stream of media and buffers to function. The segment’s vitality is effectively summarized by the single-use assemblies sector, which generated USD 2.63 billion in 2024. Ultimately, consumables serve as the operational backbone of the continuous bioprocessing market.

Blockbuster Monoclonal Antibody Revenues Driving Manufacturing Intensification

The monoclonal antibodies (mAbs) segment dominated the market in 2025, propelled by a historic surge in regulatory successes and commercial performance. The FDA approved 13 novel monoclonal antibodies in 2024, marking the highest count for this modality since 2015. Commercial success for established therapies remains a primary accelerator, with Keytruda generating USD 29.48 billion in revenue during 2024. Dupixent achieved USD 13.61 billion in sales, while Skyrizi reached USD 11.71 billion in the same period. These massive revenue streams incentivize manufacturers to adopt continuous bioprocessing market solutions to maximize titer yields and reduce cost of goods. The pipeline for future therapies is equally robust, with over 1,400 investigational antibody candidates currently in development globally. As of December 2024, regulatory bodies were reviewing 30 new investigational antibody therapeutics, ensuring a steady demand for advanced manufacturing capacity.

Underlying this demand is the rising global burden of chronic diseases that mAbs effectively treat. New estimates for 2024 indicate lung cancer cases reached 2.5 million globally, while breast cancer diagnoses hit 2.3 million. To address such prevalence, companies are accelerating production, evidenced by the FDA’s approval of Marstacimab for hemophilia on October 11, 2024. Contract manufacturing organizations are pivoting to meet this need, with WuXi Biologics supporting 66 Phase III mAb projects in 2024 alone. Specialized entities like WuXi XDC reported revenues of RMB 4.05 billion in 2024, driven largely by antibody-related projects. Consequently, the continuous bioprocessing market is indispensable for sustaining the monoclonal antibody revolution. The dominance of this application segment is secured by the dual forces of high clinical need and exceptional commercial viability.

Pharmaceutical Giants Investing Billions in Next Generation Facilities

The pharmaceutical and biotechnology segment dominated the global continuous bioprocessing market in 2025, as major players committed billions to next-generation manufacturing infrastructure. Sanofi exemplifies this trend, announcing a EUR 1 billion investment in May 2024 to double its monoclonal antibody production capacity at Vitry-sur-Seine. Amgen has been particularly active, revealing a USD 650 million expansion in Puerto Rico in September 2025 to integrate advanced technologies. This followed Amgen's opening of a USD 1 billion manufacturing facility in North Carolina in late 2024. Such massive capital projects drive the adoption of the continuous bioprocessing market technologies by embedding them into the foundation of new sites. Amgen further solidified its commitment with a USD 900 million expansion in Ohio announced in April 2025.

Strategic acquisitions and greenfield investments highlight the sector's aggressive growth trajectory. Lonza acquired Genentech’s large-scale manufacturing site in Vacaville for USD 1.2 billion in October 2024 to upgrade its capabilities. Meanwhile, AstraZeneca broke ground on a massive USD 4.5 billion manufacturing campus in Virginia in October 2025. Fujifilm Diosynth Biotechnologies is also a key contributor, investing USD 1.2 billion to expand its Holly Springs, North Carolina facility in April 2024. Novo Nordisk joined the expansion wave with a USD 4.1 billion investment in Clayton, North Carolina, announced in June 2024. Contract research demand supports this activity, with WuXi Biologics reporting 817 integrated client projects as of December 2024. Thermo Fisher Scientific pledged USD 2 billion to U.S. manufacturing in April 2025 to support these biopharma needs. These unprecedented investments prove that pharmaceutical and biotech companies are the undisputed engines of the continuous bioprocessing market.

 Regional Analysis 

North America Controls Dominant Market Share Through Massive Infrastructure And Innovation Investments

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.

Asia Pacific Rapidly Expands As The Global Engine For High Volume Production

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 Leverages Engineering Expertise And Sustainability Mandates To Drive Technology Adoption

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.

Top 5 Recent Developments in Continuous Bioprocessing Market 

• Transcenta Therapeutics announced a strategic collaboration with EirGenix on December 28, 2025, licensing its Highly Intensified Continuous Bioprocessing (HiCB) platform, including continuous perfusion and hybrid purification technologies, to boost biologics efficiency and affordability.​
• Samsung Biologics revealed plans to introduce N-1 perfusion technology to 1 kL bioreactors starting May 2025, enabling up to 10-fold higher cell densities, over 98% viability, and 30% shorter production times via Alternating Tangential Flow systems.​
• Asahi Kasei Life Science announced on July 29, 2025, a new spinning plant for Planova™ virus removal filters in Japan, set to start operations in 2030, enhancing bioprocess supply for biologics amid surging demand.​
• Ecolab launched a new bioprocessing purification resin on June 16, 2025, at BIO 2025, designed to optimize antibody manufacturing operations in continuous workflows.​
• Enzene unveiled its EnzeneX fully connected continuous manufacturing platform in early 2025, promising 10x productivity gains, 50% cost reductions, and smaller footprints for complex biotherapeutics.

Top Companies in the Continuous Bioprocessing Market

• FUJIFILM HOLDINGS CORPORATION
• Shimadzu Corporation
• Bionet
• Danaher Corporation
• Eppendorf SE
• Merck KGaA
• Repligen Corporation
• Sartorius AG
• Thermo Fisher Scientific Inc.
• WuXi Biologics
• Other Prominent Players

Market Segmentation Overview

By Product

• Instruments
  • Bioreactors
  • Filtration Systems
  • Chromatography Systems
  • Process Analytical Technologies
  • Others
• Consumables & Reagents
  • Media & Buffers
  • Filters & Membranes
  • Resin
  • Tubing & Bags
  • Others

By Application

• Monoclonal antibodies
• Vaccines
• Cell and gene therapy
• Research & Development
• Other applications

By End Use

• Pharmaceutical and biotechnology companies
• CMOs and CROs
• Research and academic institutes

By Region

• North America
  • The US
  • Canada
  • Mexico
• Europe
  • Western Europe
    • The UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Rest of Eastern Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia and New Zealand
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of MEA
• South America
  • Argentina
  • Brazil
  • Rest of South America