Continuous Bioprocessing Market Size by Product (Chromatography, Filtration, Bioreactor, Media), Process (Upstream, Downstream), Scale of Operation (Commercial, Clinical), Application (mAbs, Vaccines, Cell & Gene Therapy), & End User - Global Forecast to 2028
The global size of continuous bioprocessing market in terms of revenue was estimated to be worth $218 million in 2023 and is poised to reach $599 million by 2028, growing at a CAGR of 22.4% from 2023 to 2028. The research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market.
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
|
Report Metric |
Details |
|
Market Revenue Size in 2023 |
$218 million |
|
Projected Revenue Size by 2028 |
$599 million |
|
Industry Growth Rate |
Poised to Grow at a CAGR of 22.4% |
|
Market Driver |
The emergence of integrated end-to-end continuous bioprocessing is projecting the market growth |
|
Market Opportunity |
PAT-enabled optimization of continuous bioprocesses |
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.
Frequently Asked Questions (FAQ):
What is the projected market revenue value of the global continuous bioprocessing market?
The global continuous bioprocessing market boasts a total revenue value of $599 million by 2028.
What is the estimated growth rate (CAGR) of the global continuous bioprocessing market?
The global continuous bioprocessing market has an estimated compound annual growth rate (CAGR) of 22.4% and a revenue size in the region of $218 million in 2023.
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This research study involved the extensive use of secondary sources, directories, and databases to identify and collect valuable information for the analysis of the global continuous bioprocessing market. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information and assess the growth prospects of the market. The global market size estimated through secondary research was then triangulated with inputs from primary research to arrive at the final market size.
Secondary Research
Secondary research was used mainly to identify and collect information for the extensive, technical, market-oriented, and commercial study of the continuous bioprocessing market. The secondary sources used for this study include World Health Organization (WHO), National Institutes of Health (NIH), United States Food and Drug Administration (US FDA), National Institute for Bioprocessing Research and Training (NIBRT), Society for Biological Engineering (SBE), Bio-Process Systems Alliance (BPSA), European Patent Office (EPO), India Brand Equity Foundation (IBEF), Biotechnology Innovation Organization (BIO), National Center for Biotechnology Information (NCBI), BioPharm International, EvaluatePharma, ScienceDirect, Eurostat, research journals; corporate filings such as annual reports, SEC filings, investor presentations, and financial statements; press releases; trade, business, professional associations and among others. These sources were also used to obtain key information about major players, market classification, and segmentation according to industry trends, regional/country-level markets, market developments, and technology perspectives.
Primary Research
Extensive primary research was conducted after acquiring basic knowledge about the global continuous bioprocessing market scenario through secondary research. Several primary interviews were conducted with market experts from the demand side, such as pharmaceutical and biopharmaceutical companies, CROs, CMOs, and academic & research institutes, and experts from the supply side, such as C-level and D-level executives, product managers, marketing & sales managers of key manufacturers, distributors, and channel partners. These interviews were conducted across five major regions, including the Asia Pacific, North America, Europe, Latin America, and the Middle East & Africa. Approximately 70% and 30% of the primary interviews were conducted with supply-side and demand-side participants, respectively. This primary data was collected through questionnaires, e-mails, online surveys, personal interviews, and telephonic interviews.
The following is a breakdown of the primary respondents:
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Market Size Estimation
Both top-down and bottom-up approaches were used to estimate and validate the total size of the continuous bioprocessing market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:
Bottom-up Approach
- The key players in the industry and market have been identified through extensive secondary research
- The revenues generated from the single-use assemblies business of leading players have been determined through primary and secondary research
- All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources
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Top-down Approach
After arriving at the overall market size from the market size estimation process, the total market was split into several segments and subsegments.
Data Triangulation
After arriving at the market size from the market size estimation process explained above, the total market was divided into several segmentsand subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.
Market Definition
Continuous bioprocessing is a method used in the biopharmaceutical industry for the production of biologically derived products, such as biopharmaceuticals, vaccines, and other biologics, through continuous and uninterrupted operations. In the context of continuous bioprocessing, perfusion refers to a method of cell culture and bioproduction where a constant flow of fresh culture media is supplied to a bioreactor, and a corresponding volume of spent media, cells, or bioproducts is continuously removed. This is in contrast to traditional batch bioprocessing, where the culture is grown in a single vessel and harvested at the end of the production cycle.
Stakeholders
- Continuous bioprocessing product manufacturers and distributors
- Pharmaceutical and biotechnology companies
- Healthcare service providers (including hospitals and clinics)
- R&D companies
- Academic institutes
- Government associations
- Market research and consulting firms
- Venture capitalists and investors
Report Objectives
- To define, describe, and forecast the global continuous bioprocessing market based on the product, scale of operation, process, application, end user and region
- To provide detailed information regarding the major factors influencing the growth of the market (such as drivers, restraints, opportunities and challenges)
- To strategically analyze micro-markets with respect to individual growth trends, future prospects, and contributions to the overall continuous bioprocessing market
- To analyze opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
- To forecast the size of the market segments with respect to five main regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa
- To strategically profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies
- To track and analyze competitive developments such as acquisitions, product launches, expansions, and R&D activities in the continuous bioprocessing market.
Available Customizations
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for this report:
Portfolio Assessment
- Product Matrix, which gives a detailed comparison of the product portfolios of the top three companies.
Company Information
- Detailed analysis and profiling of additional market players (up to three).
Geographical Analysis
- A further breakdown of the Rest of Asia Pacific continuous bioprocessing market into countries
- A further breakdown of the Rest of European continuous bioprocessing market into countries
- A further breakdown of the Rest of Latin American continuous bioprocessing market into countries
Growth opportunities and latent adjacency in Continuous Bioprocessing Market