Continuous Bioprocessing Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global continuous bioprocessing market, valued at US$201 million in 2022, is forecasted to grow at a robust CAGR of 22.4%, reaching US$218 million in 2023 and an impressive US$599 million by 2028. The growth of the market is largely driven by rising demand for biopharmaceuticals, advantages of continuous bioprocessing over batch/fed-batch mode, and emergence of integrated end-to-end continuous bioprocessing. On the other hand, high capital investment to limit entry for small players and stringent regulatory requirements are the major factors restraining the growth of this market.

Attractive Opportunities in the Continuous Bioprocessing Market

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Continuous Bioprocessing Market Dynamics

DRIVER: The emergence of integrated end-to-end continuous bioprocessing is projecting the market growth

End-to-end continuous bioprocessing is a process that integrates all of the steps involved in biopharmaceutical manufacturing into a single, continuous process. A growing number of companies are exploring continuous processing alongside intensification, which would lead to reduced production costs, real-time product releases, and predictive control. By chaining or combining serial steps in existing processes, continuous bioprocessing promises to transform biomanufacturing by reducing inter-campaign downtime, eliminating labor- and time-consuming steps, and reducing risk. Many companies are currently using continuous processes upstream, particularly in perfusion. Danaher Corporation (US), Sartorius AG (Germany), and Merck KGaA (Germany) are among the technology providers that have launched innovative automated perfusion systems and bioreactors.

RESTRAINT: High capital investment to limit entry for smaller players

Continuous bioprocessing often necessitates the use of sophisticated and specialized equipment, including bioreactors, chromatography systems, and automation technologies. Acquiring and maintaining these advanced systems requires a substantial initial capital outlay. End users must carefully evaluate their process and perform an economic analysis. In general, continuous manufacturing equipment has a higher capital investment because of the automation cost. The development and implementation of continuous biomanufacturing requires a substantial initial investment. Thus, the high capital investment needed for entry into the continuous bioprocessing market poses a significant challenge for smaller players.

OPPORTUNITY: PAT-enabled optimization of continuous bioprocesses

Process Analytical Technology (PAT) is a system of analytical tools that are used to monitor and control manufacturing processes. PAT can be used to optimize continuous bioprocessing by providing real-time data on the critical process parameters (CPPs) and critical quality attributes (CQAs) of the process. Process Analytical Technology (PAT) will play a key role in helping development scientists and manufacturing teams understand, control and optimize continuous bioprocesses. This real-time insight enables data-driven decision-making, allowing operators to make immediate adjustments when deviations or variations are detected.

CHALLENGE: Operational challenges

Process operational complexity in continuous bioprocessing presents multifaceted challenges that demand innovative solutions. Continuous manufacturing offers substantial benefits but also requires real-time monitoring and control of multiple critical parameters and quality attributes. Batch-fed processing has continued to increase in product titer as well as advances in a molecule's important quality properties as upstream and downstream continuous bioprocessing move towards greater scale and robustness. Batch techniques are still generally considered to be less complicated, less expensive, less risky, and less prone to failure than perfusion. With the advancement of relevant cell culture equipment, which now includes better pumps and controls, perfusion-purposed bioreactors, perfusion-tailored media, and general technological and operational advancements, alternating tangential flow (ATF) is starting to be produced relatively frequently.

Global Continuous Bioprocessing Ecosystem Analysis

The continuous bioprocessing market ecosystem comprises raw material suppliers, continuous bioprocessing product manufacturers, and end users such as pharmaceutical and biotechnology manufacturers, CROs, CDMOs, and academic & research institutes. Continuous bioprocessing products manufacturers provide chromatography systems and consumables, filtration systems and devices, bioreactors, cell culture media, cell lines, buffers and reagents, and other products.

Pharmaceutical & biotechnology companies held a dominant share in end user segment in continuous bioprocessing industry.

Based on end user, the continuous bioprocessing market is segmented into pharmaceutical & biotechnology companies, contract research organizations and contract manufacturing organizations (CROs & CMOs), and academic & research institutes. In 2022, the pharmaceutical & biotechnology companies segment accounted for the largest share of the market. The rising demand for biopharmaceuticals for the development of biosimilars in the treatment of chronic diseases is expected to be a key growth driver for this end-user segment. This has resulted in the growing focus of biopharmaceutical companies on the development of affordable biologics at lower costs. The adoption of continuous bioprocessing equipment is gradually increasing due to its wide applications in research & process development and the increasing manufacturing of biologics and biosimilars.

The filtration systems and devices segment of the continuous bioprocessing industry is expected to register fastest growth during the forecast period.

Based on product, the continuous bioprocessing market is segmented into chromatography systems & consumables; filtration systems & devices; bioreactors; cell culture media, cell lines, buffers, and reagents; and other products. The filtration systems & devices segment is estimated to grow at the highest CAGR during the forecast period. The high growth rate of this segment can be attributed to the increasing focus of mAbs in continuous bioprocessing, the growing clinical pipeline of mAbs awaiting regulatory approvals, and the advantages offered by monoclonal antibodies over other pharmaceutical drugs.

North America accounted for largest share in continuous bioprocessing industry in 2022.

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Geographically, the continuous bioprocessing market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is the largest market for continuous bioprocessing. Many players operating in the market, such as Danaher Corporation (US), Thermo Fisher Scientific, Inc. (US), and Repligen Corporation (US), have a strong presence in North America, with a wide customer base and established distribution channels. Similarly, an established biopharmaceutical industry in the region has also created a significant demand for continuous bioprocessing in this region. However, single use bioreactors associated issues such as leachables and extractables, and the presence of stringent regulations for disposable systems are expected to restrain the growth of the market in North America.

Key players in the global continuous bioprocessing market include Danaher Corporation (US), Sartorius AG (Germany), Thermo Fisher Scientific Inc. (US), Repligen Corporation (US), Merck KGaA (Germany), 3M Company (US), Getinge AB (Sweden), Eppendorf SE (Germany), Corning Incorporated (US), Entegris (US), FUJIFILM Holdings Corporation (Japan), Meissner filtration products, Inc. (US), Kühner AG (Switzerland), Esco Lifesciences Group (Singapore), SATAKE MultiMix Corporation (Japan), Bionet (Spain), Stobbe Group (Switzerland), bbi-biotech GmbH (Germany), OmniBRx Biotechnologies (India), Cell Culture Company, LLC (US), Pierre Guérin (France), Solida Biotech GmbH (Germany), Zellwerk GmbH (Germany), 3D Biotek, LLC (US), and FiberCell Systems Inc. (US).

Scope of the Continuous Bioprocessing Industry

This report categorizes the continuous bioprocessing market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Chromatography Systems and Consumables
• Filtration Systems and Devices
• Bioreactors
• Cell Culture Media, Cell Lines, Buffers and Reagents
• Other Products

By Scale of Operation

• Commercial Operations
• Clinical Operations

By Process

• Downstream Bioprocess
• Upstream Bioprocess

By Application

• Monoclonal Antibodies
• Vaccines
• Cell and Gene Therapy
• Other Applications

By End User

• Pharmaceutical and Biotechnology Companies
• Contract Research Organizations and Contract Manufacturing Organizations
• Academic and Research Institutes

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia Pacific (RoAPAC)
• Latin America
  • Brazil
  • Mexico
  • RoLATAM
• Middle East & Africa
  • Middle East
  • Africa

Recent Developments of Continuous Bioprocessing Industry:

• In August 2023, Sartorius collaborated with Repligen Corporation and launched the Integrated bioreactor system. This system incorporates Repligen XCell ATF upstream intensification technology into Sartorius’ Biostat STR bioreactor to simplify intensified seed train and N perfusion implementation for biopharmaceutical manufacturers.
• In July 2022, Cytiva expanded its operations with a new facility in Muskegon, Michigan. The new chromatography resins manufacturing site is part of Cytiva’s expansion investment.

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