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Continuous Bioprocessing Market Set to Surpass Valuation of US$ 2,331.98 Million By 2035 | Astute Analytica

Continuous Bioprocessing Market Set to Surpass Valuation of US$ 2,331.98 Million By 2035 | Astute Analytica

The market is currently defined by a “capacity super-cycle,” where multi-billion dollar campus expansions are prioritizing flexibility and digital integration. Manufacturers are moving aggressively to secure supply chains and modernize infrastructure to rapidly scale novel modalities.

Chicago, Jan. 16, 2026 (GLOBE NEWSWIRE) — The global Continuous bioprocessing market size was valued at USD 319.77 million in 2025 and is anticipated to reach USD 2,331.98 million by 2035 at a CAGR of 21.98% during the forecast period 2026–2035.

The global continuous bioprocessing market is experiencing dynamic growth, fundamentally reshaped by the adoption of continuous bioprocessing and a strong emphasis on sustainability and efficiency. Driven by the increasing demand for biosimilars, complex modalities like ADCs, and biologics, manufacturers are pivoting from traditional fed-batch methods to advanced, integrated continuous workflows. This shift is not only improving cost-effectiveness, with potential reductions of 50% in production costs per gram, but also drastically enhancing sustainability. Facilities are shrinking by up to 51%, CO2 emissions are reduced by 54%, and water usage is cut by 50%.

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North America leads the continuous bioprocessing market with a 39% market share, fueled by significant capital investments and a robust regulatory environment that saw 48 novel drugs approved in 2024. Asia Pacific, particularly South Korea and China, is rapidly expanding its manufacturing capacity, becoming the global hub for high-volume production, as evidenced by Samsung Biologics’ massive infrastructure growth and WuXi Biologics’ substantial backlog. Europe leverages its engineering prowess and stringent sustainability mandates to drive technological adoption. Key enablers include perfusion bioreactors, continuous chromatography systems, and advanced PAT, facilitating “real-time release” and reducing production cycle times. Despite challenges like a significant talent gap and regulatory harmonization needs, the market’s trajectory is unequivocally towards intensified, digitized, and sustainable biomanufacturing practices.

Key Findings in Continuous Bioprocessing Market

  • By application type, the monoclonal antibodies segment led the market in 2025. 
  • By application type, the vaccine segment is expected to witness the highest growth during the forecast timeline. 
  • By product type, the consumables and reagents segment held the largest market share in 2025. 
  • By product type, the instruments segment is projected to register substantial growth at a remarkable CAGR over the forecast period. 
  • By end use, the CMOs and CROs segment is forecasted to expand at the fastest pace throughout the forecast period.
  • By end use, the pharmaceutical and biotechnology companies segment dominated the global continuous bioprocessing market in 2025. 
  • North America to accounts for 39% market share.

By Product Type, Consumables and Reagents Segment Capturing Dominant Market Share

The consumables and reagents segment anchored the industry in 2025, driven by the aggressive expansion of single-use manufacturing capacities globally. Suppliers are responding to the critical need for recurring inputs, highlighted by a major headquarters expansion in Aubagne, France, in June 2025 that added 9,000 square meters of cleanroom space. Such infrastructure is vital because the continuous bioprocessing market depends on a steady supply of disposable components to maintain sterile, closed-system operations. Filtration systems and consumables remain the largest revenue contributors due to their irreplaceable role in separation techniques.

Regional manufacturing hubs are further securing the supply chain for these essential products. Approximately USD 305 million was directed into South Korean operations to ramp up production in late 2024. Simultaneously, chromatography system manufacturing capacity in Bengaluru, India, was doubled throughout 2025. These localized investments ensure that biopharmaceutical manufacturers have immediate access to cell culture media and buffers, eliminating logistical bottlenecks. Operational expenditure on these disposables remains high, fueling segment growth. Consequently, the continuous bioprocessing market continues to rely on this segment as its primary revenue generator, supported by the recurring nature of consumable procurement.

By Application, Monoclonal Antibodies Application Securing Highest Market Share

The monoclonal antibodies segment commanded a significant portion of the market in 2025, bolstered by high-profile regulatory approvals and blockbuster sales performance. The FDA’s approval of Donanemab for Alzheimer’s disease on July 2, 2024, marked a pivotal moment, creating a new avenue for high-volume antibody production. Commercial success for existing therapies further validates the need for efficient manufacturing, with Opdivo generating USD 9.30 billion and the newer melanoma therapy Opdualag generating USD 928 million in 2024. These figures drive manufacturers to adopt continuous bioprocessing market technologies to improve titer yields and manage production costs effectively.

Investment in dedicated antibody manufacturing infrastructure is escalating to meet these commercial demands. Eli Lilly committed USD 4.5 billion in October 2024 to construct a “Medicine Foundry” in Indiana, a facility designed specifically to innovate drug production and support clinical supply. With the global prevalence of chronic conditions like cancer rising, the pressure to produce antibodies faster is intensifying. This operational urgency ensures that monoclonal antibodies remain the central application driving the adoption of the continuous bioprocessing market.

By End Use, Pharmaceutical and Biotechnology Segment Commanding the Market

The pharmaceutical and biotechnology segment dominated the global continuous bioprocessing market in 2025, evidenced by historic capital deployment from industry titans. Boehringer Ingelheim made headlines on December 19, 2025, by announcing a staggering USD 10 billion investment to expand U.S. operations through 2028. This move follows an earlier commitment of EUR 6.2 billion toward global R&D in 2024, underscoring the massive financial scale at which these companies operate. Eli Lilly has similarly reshaped the landscape, bringing its total investment in the LEAP District in Indiana to USD 13.5 billion as of late 2024. These mega-projects integrate continuous bioprocessing market principles from the ground up to ensure long-term competitiveness.

Capacity acquisition and acceleration are also key strategies defining this segment’s dominance. The acquisition of Catalent for USD 16.5 billion in 2024 was a strategic masterstroke to secure fill-finish capacity for obesity and diabetes portfolios. Meanwhile, Samsung Biologics accelerated its timeline, confirming that its massive Plant 5 became operational by April 2025 to handle surging client demand. Fujifilm Diosynth Biotechnologies also strengthened its footprint with a USD 1.2 billion expansion in North Carolina announced in April 2024. These figures prove that pharmaceutical and biotech companies are the primary architects of the continuous bioprocessing market growth trajectory.

Strategic Adoption Surges As Facilities Shift To Continuous Processing Models

Momentum within the Continuous bioprocessing market is accelerating rapidly as manufacturers pivot from static batch operations to dynamic, integrated workflows. Industry data from 2025 reveals that 38.8% of biomanufacturing facilities now explicitly plan to evaluate upstream continuous technologies. Active implementation is also rising, with 37.1% of global sites currently assessing upstream continuous methods, a notable increase from the previous year. Downstream operations are synchronizing with this shift, evidenced by a 33.9% adoption rate for continuous chromatography. Service providers are witnessing this demand firsthand. WuXi Biologics reported supporting 817 integrated client projects by late 2024, underscoring the scale of industry transition.

Operational metrics further validate the robust expansion of the Continuous bioprocessing market. Repligen reported a 15% sequential increase in CDMO orders during Q4 2024, signaling a strong rebound in outsourced manufacturing requirements. Consequently, orders outpaced sales by a distinct 6%, creating a healthy demand backlog. To support these advancing technical capabilities, 56% of biopharma companies confirmed active recruitment efforts for specialized manufacturing roles in late 2024. These figures collectively illustrate a sector moving decisively beyond experimental phases into widespread commercial readiness.

Yield Maximization and Cost Efficiency Redefine Biologics Production Standards

Productivity metrics in 2025 demonstrate that continuous methods now deliver exponentially higher output than traditional fed-batch systems. The Continuous bioprocessing market is being redefined by platforms like WuXiUP, which achieved a total output of 110 g/L over a 24-day run. Daily peak yields on such platforms have reached an impressive 7.6 g/L. Enzene Biosciences is matching this intensity, targeting 40 kg of drug substance per 1,000-liter batch with their EnzeneX 2.0 platform. Such high volumetric productivity allows for massive cost structures shifts. Enzene has set a production cost target of USD 40 per gram for 2025 using their fully connected models.

Financial efficiency is a primary driver for the Continuous bioprocessing market. Validated data from 2024 indicates that continuous manufacturing achieves a 50% reduction in overall production cost per gram compared to fed-batch approaches. Just-Evotec Biologics demonstrated a 10-fold higher productivity rate with their continuous platform versus legacy processes. Speed is equally critical, as demonstrated by Amgen. Their data shows that 50 kilograms of drug substance can be produced in just two weeks using a 2,000L perfusion bioreactor. That output effectively matches the production capability of a massive 15,000L fed-batch vessel, proving that smaller footprints can deliver commercial-scale volumes.

Infrastructure Scalability Explodes With High Throughput Facility Investments

Capital projects are reshaping global manufacturing capacity to accommodate next-generation processes. Samsung Biologics is leading this expansion within the Continuous bioprocessing market, with its “Plant 5” adding 180,000 liters of new capacity in April 2025. Upon completion, the total biomanufacturing capacity at the site will reach 784,000 liters. Long-term strategies are even more ambitious, targeting 1.324 million liters by 2032 to support hybrid continuous and batch demand. Lotte Biologics is similarly aggressive, aiming for a combined capacity of 400,000 liters across three new mega plants in South Korea by 2030.

Specific facility dimensions reflect the unique needs of the Continuous bioprocessing market. Lotte Biologics’ Plant 1 alone will offer 120,000 liters of capacity upon its Q1 2026 completion. In the United States, infrastructure is evolving to support final product handling. Amgen opened a digitally advanced packaging and assembly facility in Ohio spanning 270,000 square feet in 2024. Meanwhile, Enzene Biosciences launched its first US continuous manufacturing facility with a focused footprint of 54,000 square feet. These infrastructure developments confirm that the industry is building physical assets specifically designed for high-throughput, continuous operations.

Regulatory Approvals and Quality Standards Support Continuous Modalities

Regulatory momentum is clearing the path for widespread adoption of continuous bioprocessing techniques. The FDA’s Center for Drug Evaluation and Research approved 48 novel drugs in 2024, fostering a climate of innovation. A record 18 biosimilars were also approved in 2024, fueling the need for the cost-efficient production that the Continuous bioprocessing market offers. Total new drug approvals reached 55 in 2024, keeping pipelines robust. To meet these demands, 38.8% of facilities plan to evaluate automation specifically for continuous workflows in 2025.

Quality control technologies are advancing to support real-time release. Thermo Fisher Scientific launched “SteriSEQ” in 2025, a rapid sterility testing kit that delivers results in less than 1 day. Purity standards remain uncompromised even during extended continuous runs. Validation studies in 2025 showed that Host Cell Protein residuals were maintained below 1,000 ppm even after 200 continuous chromatography cycles. Furthermore, rProtein A shedding was strictly held to a 25 ppm limit after 200 cycles of resin reuse. These stringent quality metrics prove that the Continuous bioprocessing market can deliver safety profiles identical to or better than legacy batch methods.

Hardware Evolution Enables Extended Commercial Manufacturing Cycles

Equipment suppliers are launching purpose-built innovations to sustain long-duration campaigns. Thermo Fisher Scientific introduced the 5-liter “DynaDrive” Single-Use Bioreactor in 2025 to facilitate scalability studies. Durability of consumables is paramount in the Continuous bioprocessing market. Recent data confirms that chromatography resins can now withstand 200 cycles while maintaining yields above 80%. Even after 156 continuous cycles, resins retained 80% of their initial Dynamic Binding Capacity. For clinical supply, Enzene’s platform established 30 liters as the minimum scale for cGMP operations.

Innovation centers are expanding to train operators on these advanced systems. Sartorius opened a Center for Bioprocess Innovation in 2024 capable of accommodating 120 experts. Manufacturing density is also increasing. Fujifilm Diosynth announced that 20 bioreactors will be operational at their Holly Springs facility by the end of 2025. Supporting the speed of the Continuous bioprocessing market, rapid sterility testing now offers a 1 day turnaround time. These hardware and service advancements ensure that the physical supply chain is robust enough to handle the intensity of continuous production campaigns.

Massive Capital Expenditure Targeted At North American Capacity

Investment flows in 2024 and 2025 indicate a strategic reallocation of capital toward next-generation manufacturing hubs. Sanofi pledged a minimum of USD 20 billion for US manufacturing and R&D through 2030. Roche unveiled a similar strategy, earmarking USD 50 billion for US sites, contingent on policy environments. The Continuous bioprocessing market is a key beneficiary of these funds. Amgen alone invested USD 474 million into its Ohio final product assembly plant. Lotte Biologics committed USD 3 billion for its Korean continuous manufacturing plants while spending USD 160 million to acquire a Syracuse facility for US market entry.

Suppliers are matching these commitments to secure their positions in the Continuous bioprocessing market. Thermo Fisher Scientific invested USD 2 billion in 2025 to bolster its US manufacturing and R&D capabilities. Fujifilm Diosynth is pouring USD 1.2 billion into its Holly Springs facility to expand capacity. These multi-billion dollar figures confirm that the industry views continuous manufacturing not as a niche experiment, but as the foundation of future biopharmaceutical production.

Dominant Players Report Record Financials and Pipeline Volume

Leading CDMOs are capitalizing on the shift toward outsourced continuous manufacturing. WuXi Biologics reported a backlog of USD 18.5 billion as of December 31, 2024. Their portfolio depth is substantial, managing 16 commercial projects and 56 late-phase clinical projects. Complex modalities suited for the Continuous bioprocessing market are driving this volume, including 194 Antibody-Drug Conjugate projects and 151 bispecific antibody projects. Financially, WuXi achieved revenue of 18,675.4 million RMB in 2024, with non-COVID revenue growing by 13.1%. They also maintained a high talent retention rate of 95.8%.

Samsung Biologics posted equally impressive figures, reporting a full-year 2024 consolidated revenue of 4.55 trillion KRW. Their operational efficiency yielded an operating profit of 1.32 trillion KRW and a net profit of 1.08 trillion KRW. The forecast for 2025 anticipates revenue reaching 5.57 trillion KRW. Currently, 17 of the top 20 global pharmaceutical companies partner with Samsung. However, the broader market shows signs of correction; general biopharma job postings dropped 25% in mid-2024. This contraction suggests the industry is prioritizing efficiency and the Continuous bioprocessing market over general headcount growth.

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Continuous Bioprocessing Market Major Players:

  • 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

Key Market Segmentation:

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
  • Europe
  • Asia Pacific
  • Middle East and Africa
  • South America

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About Astute Analytica

Astute Analytica is a global market research and advisory firm providing data-driven insights across industries such as technology, healthcare, chemicals, semiconductors, FMCG, and more. We publish multiple reports daily, equipping businesses with the intelligence they need to navigate market trends, emerging opportunities, competitive landscapes, and technological advancements.

With a team of experienced business analysts, economists, and industry experts, we deliver accurate, in-depth, and actionable research tailored to meet the strategic needs of our clients. At Astute Analytica, our clients come first, and we are committed to delivering cost-effective, high-value research solutions that drive success in an evolving marketplace.

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Website: https://www.astuteanalytica.com/ 

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