Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Workflow;
Upstream Processing (USP), Fermentation Technology, and Downstream Processing (DSP)By Product;
Bioreactors/Fermentors, Cell Culture Products, Filtration Assemblies, Bioreactors Accessories, Bags & Containers, and OthersBy Scale;
Industrial Scale (Over 50, 000L), and Small Scale (Less Than 50 and 000L)By Use Type;
In-House and OutsourcingBy Application;
Biopharmaceuticals, Specialty Industrial Chemicals, and Environmental AidsBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Introduction
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market (USD Million), 2021 - 2031
Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market was valued at USD 16,987.16 million in the year 2024. The size of this market is expected to increase to USD 42,116.46 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 13.9%.
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market Growth, Share, Size, Trends and Forecast
*Market size in USD million
CAGR 13.9 %
Study Period | 2025 - 2031 |
---|---|
Base Year | 2024 |
CAGR (%) | 13.9 % |
Market Size (2024) | USD 16,987.16 Million |
Market Size (2031) | USD 42,116.46 Million |
Market Concentration | Low |
Report Pages | 384 |
Major Players
- Merck KGaA
- Thermo Fisher Scientific, Inc
- GE healthcare
- Corning, Inc
- Sartorius AG
- CESCO BIOENGINEERING CO., LTD
- Bioprocess Control AB
- Eppendorf AG
- Applikon Biotechnology
- Lonza
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market
Fragmented - Highly competitive market without dominant players
The Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market is witnessing steady growth, fueled by the rising demand for biologic drugs and biosimilar therapies. Currently, more than 55% of manufacturing sites are designed to support both large- and small-scale production modes, underscoring the shift toward hybrid bioprocessing capabilities.
Shift Toward Single-Use Bioprocessing Solutions
The adoption of single-use bioprocessing systems is gaining momentum due to their flexibility and reduced contamination risks. These systems now power over 60% of small-scale operations and are increasingly used in larger facilities as well. Their role in cost optimization and ease of setup has made them integral to modern manufacturing strategies across the board.
Innovation Enhances Manufacturing Efficiency
Advancements in continuous bioprocessing, automated workflows, and real-time analytics are transforming biopharmaceutical production. Around 45% of facilities have deployed automation to streamline operations and maintain quality. These innovations are enabling manufacturers to meet increasing needs for tailored therapeutics and speed up production timelines.
Growing Popularity of Modular Bioproduction Plants
The market is also being shaped by the growth of modular and scalable manufacturing units, which offer rapid installation and operational flexibility. Nearly 40% of new manufacturing infrastructure now follows a modular format, facilitating swift response to changing production demands. This development benefits both major contract manufacturing organizations and niche biotech players.
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market Recent Developments
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In March 2023, Sartorius Stedim Biotech, a leading biopharmaceutical company, entered into an agreement to acquire Polyplus for more than USD 2.6 billion. Polyplus specializes in developing and manufacturing transfection and other DNA/RNA delivery reagents, along with GMP-grade plasmid DNA.
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In April 2022, Merck KGaA announced an investment of approximately USD 105 million to enhance its single-use manufacturing capabilities in China. Below are some key participants in the global large and small-scale bioprocessing market.
Segment Analysis
In this report, the Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market has been segmented by Workflow, Product, Scale, Use Type, Application, and Geography.
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, Segmentation by Workflow
The Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market has been segmented by Workflow into Upstream Processing (USP), Fermentation Technology, and Downstream Processing (DSP).
Upstream Processing (USP)
Upstream processing is a fundamental stage in biopharmaceutical manufacturing, focused on the cultivation of cells or microorganisms essential for producing biopharmaceuticals. It encompasses a variety of tasks such as media preparation, inoculation, and fermentation. This segment currently accounts for approximately 45% of the global bioprocessing market. Advancements in bioreactor technologies and automation are improving efficiency and scalability, making upstream processes more streamlined and cost-effective.
Fermentation Technology
Fermentation technology is crucial for large-scale biologics production. It uses microorganisms to create important biopharmaceutical products such as proteins, monoclonal antibodies, and vaccines. The fermentation technology market is growing at an annual rate of 15%, driven by improvements in bioreactor designs and the use of more sustainable methods. These advancements are accelerating fermentation processes in both large-scale and small-scale manufacturing.
Downstream Processing (DSP)
Downstream processing is essential for purifying and isolating biologics after fermentation or cell culture, ensuring the final product is safe and compliant with regulatory standards. This segment holds about 35% of the bioprocessing market share. Innovations in automation for chromatography, filtration, and centrifugation are improving the speed and accuracy of this process, leading to faster production cycles and lower operational costs.
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, Segmentation by Product
The Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market has been segmented by Product into Bioreactors/Fermentors, Cell Culture Products, Filtration Assemblies, Bioreactors Accessories, Bags & Containers, and Others.
Bioreactors/Fermentors
Bioreactors and fermentors are indispensable in biopharmaceutical manufacturing, providing the environment where essential biological processes such as cell culture and fermentation take place. These systems are vital for scaling up production while optimizing conditions for cell growth. The bioreactor and fermentor market is witnessing a growth rate of 12% annually, driven by increasing demand in both large- and small-scale biomanufacturing.
Cell Culture Products
Cell culture products, such as media, reagents, and culture vessels, are integral to cell growth in biomanufacturing. Used primarily in the upstream process, these products are essential for producing therapeutic proteins, monoclonal antibodies, and vaccines. The cell culture product market is expected to grow at an annual rate of 10-12%, fueled by increasing demand for biopharmaceuticals and advancements in culture technologies that improve yields and reduce manufacturing costs.
Filtration Assemblies
Filtration assemblies are critical in the purification process during both upstream and downstream bioprocessing. They remove contaminants, such as cell debris, microorganisms, and impurities, ensuring the final product is safe for use. The filtration assemblies market represents approximately 8% of the bioprocessing industry, driven by the growing demand for high-purity biologics and innovations in filtration technologies that ensure greater efficiency and product safety.
Bioreactors Accessories
Bioreactor accessories, including sensors, controllers, and mixing systems, enhance the functionality and efficiency of bioreactors and fermentors. These accessories are crucial in maintaining optimal environmental conditions during the production process. The market for bioreactor accessories is growing steadily, with an estimated annual growth rate of 7%, driven by the increasing complexity of biomanufacturing and the need for greater automation and process control.
Bags & Containers
Bags and containers are essential components in the biopharmaceutical supply chain, offering safe and flexible solutions for the storage, transport, and processing of biological materials. Their increasing use in single-use systems has driven significant market growth, with an expected annual growth rate of 14%. The shift toward disposable solutions in biomanufacturing contributes to this rise, as these systems minimize contamination risk and improve operational efficiency.
Others
The "Others" segment covers various smaller product categories, such as chromatography resins, labware, and sensors, that contribute to the smooth functioning of biopharmaceutical manufacturing. While these products represent a smaller share of the market, they still play a critical role in ensuring high-quality production. The market for these items is growing steadily at a rate of 5-6% per year, as ongoing innovations in materials and equipment continue to support bioprocessing needs.
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, Segmentation by Scale
The Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market has been segmented by Scale into Industrial Scale (Over 50, 000L), and Small Scale (Less Than 50 and 000L).
Industrial Scale
The industrial-scale segment, encompassing production volumes greater than 50,000L, is essential for the large-scale manufacturing of biologics, including vaccines, therapeutic proteins, and monoclonal antibodies. Industrial-scale production is vital for meeting the high-volume demand of global pharmaceutical markets. It offers significant cost efficiencies and ensures consistent product supply. The industrial-scale segment is expected to grow at a robust 10% annual rate, driven by technological innovations and the increasing demand for biopharmaceutical products across various therapeutic sectors.
Small Scale
Small-scale bioprocessing, which involves production volumes below 50,000L, is increasingly critical for the production of niche biologics, personalized medicines, and clinical trial batches. This segment provides flexibility, enabling manufacturers to quickly scale production and adjust to specific demands. The small-scale market is experiencing a growth rate of 8-10% per year, largely driven by advances in modular systems and the increasing need for specialized therapies and orphan drugs.
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, Segmentation by Use Type
The Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market has been segmented by Use Type into In-house, and Outsourcing.
In-house
In-house biopharmaceutical manufacturing refers to processes conducted within the company’s own facilities. This approach allows for complete control over production, ensuring high-quality standards and compliance with regulatory requirements. The in-house segment currently holds around 60% of the bioprocessing market and is expected to grow at an annual rate of 7-9%. Factors such as advances in production technology and the desire for greater oversight and customization are fueling this growth.
Outsourcing
Outsourcing biopharmaceutical manufacturing involves contracting with external manufacturers to handle specific production processes. This model offers cost-efficiency, flexibility, and the ability to scale quickly without heavy capital investment. The outsourcing segment is anticipated to grow at a rapid 10-12% annual rate, making up around 40% of the global bioprocessing market. The increasing demand for specialized services, faster time-to-market, and the trend toward flexible, on-demand manufacturing are all driving the growth of outsourcing in biopharmaceutical manufacturing.
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, Segmentation by Application
The Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market has been segmented by Application into Biopharmaceuticals, Specialty Industrial Chemicals, and Environmental Aids.
Biopharmaceuticals
Biopharmaceuticals are a dominant application within bioprocessing, covering the production of biologic drugs such as monoclonal antibodies, therapeutic proteins, and vaccines. This segment accounts for approximately 70% of the market share, fueled by the rising demand for biologics in the treatment of complex diseases like cancer and autoimmune disorders. The biopharmaceutical market is expected to grow at an annual rate of 9-11%, driven by innovations in drug development and personalized medicine.
Specialty Industrial Chemicals
Specialty industrial chemicals, including enzymes, amino acids, biofuels, and bioplastics, are increasingly produced through biotechnological processes. These chemicals find applications in industries ranging from food to agriculture to manufacturing. This application is growing rapidly at an annual rate of 7-9%, with bioprocessing accounting for approximately 15% of the market. The trend toward sustainable production methods is a key driver of growth in this segment.
Environmental
Bioprocessing applications in the environmental sector focus on using biological methods for waste management, water treatment, and pollution control. Bioremediation, in particular, leverages microorganisms to clean up contaminated sites, offering a more eco-friendly solution compared to traditional methods. The environmental bioprocessing market is projected to grow at 6-8% annually, accounting for about 10% of the total bioprocessing market. The rise in environmental concerns and stricter regulatory measures are propelling the growth of this segment.
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, Segmentation by Geography
In this report, the Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
Regions and Countries Analyzed in this Report
Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market Share (%), by Geographical Region, 2024
North America
North America, particularly the United States and Canada, is the largest market for biopharmaceutical manufacturing, contributing significantly to global bioprocessing revenues. The region’s advanced pharmaceutical sector, cutting-edge research facilities, and supportive regulatory environment drive a steady growth rate of 8-10% annually. The growing demand for biologics, vaccines, and personalized medicine continues to fuel North America’s dominance in the market.
Europe
Europe ranks second in the global bioprocessing market, with major pharmaceutical hubs in countries like Germany, the UK, and Switzerland. The market is growing at 7-9% annually, supported by increasing demand for biologics and robust healthcare systems. Additionally, Europe’s push for sustainable and green biomanufacturing practices is driving further demand for innovative biotechnological solutions.
Asia Pacific
Asia Pacific is emerging as the fastest-growing region in biopharmaceutical manufacturing, with a projected growth rate of 11-13% per year. Countries such as China, India, and Japan are playing an increasingly important role due to the rising demand for affordable healthcare, cost-effective manufacturing, and robust pharmaceutical industries. The region is also becoming a critical hub for clinical trials, further boosting the demand for biomanufacturing.
Middle East & Africa
The Middle East and Africa (MEA) market is experiencing steady growth, with an annual growth rate of 6-8%. Driven by improving healthcare infrastructure and increased government investments, the region is expanding its capabilities in biologic production. Countries like the UAE and Saudi Arabia are focusing on developing local biomanufacturing industries to reduce reliance on imports, while Africa benefits from growing healthcare access and infrastructure improvements.
Latin America
Latin America, including key markets such as Brazil and Mexico, is seeing moderate growth in biopharmaceutical manufacturing, projected at 5-7% annually. The rising demand for affordable biologics and expanding healthcare infrastructure are key drivers in the region. Latin America is becoming a competitive destination for contract manufacturing, offering lower production costs and growing biomanufacturing capabilities.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market. These factors include; Market Drivers, Restraints and Opportunities.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces—Drivers, Restraints, and Opportunities—affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential |
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Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development |
Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance |
Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances |
Drivers, Restraints and Opportunity
Drivers
- Biopharmaceutical Demand Growth
- Bioprocessing Technology Advancements
- Pharmaceutical R&D Investments
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Biopharmaceutical Pipeline Expansion - The continuous growth in the biopharmaceutical pipeline is significantly accelerating the expansion of the global bioprocessing market. The increasing demand for biologics, monoclonal antibodies, and cell and gene therapies has driven pharmaceutical firms to prioritize innovative manufacturing solutions. This trend is pushing the need for advanced bioprocessing technologies that can support both early-stage development and commercial-scale production.
As more drug candidates move through the development pipeline, manufacturers are compelled to enhance production efficiency, scalability, and quality control. The adoption of single-use systems and continuous processing has become widespread due to their flexibility and cost-effectiveness. These technologies allow quick adjustments across scales, enabling smoother progression from clinical trials to commercial launch.
Small-scale bioprocessing remains critical in early research, allowing rapid testing and refinement of new therapeutics. Its compatibility with modular setups supports agile development strategies. In contrast, large-scale bioprocessing infrastructure becomes essential during full-scale production, ensuring consistent output and compliance with global regulatory standards.
This dual demand for scalable and integrated biomanufacturing reflects the industry's strategic focus on supporting long-term pipeline growth. Companies are investing heavily in flexible systems that can transition seamlessly across product lifecycles, positioning themselves to capitalize on the evolving biopharma landscape.
Restraints
- High Equipment and Facility Costs
- Manufacturing Process Complexity
- Regulatory Compliance Demands
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Small-Scale Bioprocessing Limitations - While small-scale bioprocessing systems offer advantages in early development stages, they come with significant capacity and scalability limitations. Their reduced throughput makes them unsuitable for high-volume production, limiting their utility in late-stage commercialization. These constraints often create bottlenecks in manufacturing and slow down time-to-market.
Transitioning from small-scale to large-scale production introduces challenges in maintaining product consistency, quality assurance, and regulatory compliance. The scale-up process can be complex and resource-intensive, discouraging companies that rely heavily on compact systems during early phases.
Many small-scale platforms lack advanced automation and real-time process monitoring, which are essential for ensuring consistent output and minimizing variability. The risk of contamination and batch failures is notably higher, particularly when producing high-value biologics.
While small-scale solutions remain important for discovery and trials, companies must adopt a hybrid approach that includes scalable, flexible infrastructure. Investing in versatile bioprocessing technologies enables smoother transitions and sustained productivity across all development stages.
Opportunities
- Emerging Markets Growth
- Single-Use Technology Development
- Automation and Control System Advances
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Contract Manufacturing Outsourcing - The rising shift toward outsourcing bioprocessing operations to contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) is unlocking major growth avenues. Pharmaceutical companies increasingly seek cost-effective, scalable, and efficient production strategies, making outsourcing a strategic move.
CMOs provide access to advanced technologies, including single-use bioreactors and integrated process analytics, without the need for large capital investments. This allows drug developers to maintain agility, reduce overhead, and focus on R&D, while outsourcing manufacturing and scale-up tasks to experienced third parties.
CDMOs offer value-added services like process optimization, regulatory support, and quality assurance, reducing development timelines and enhancing market readiness. Their experience in managing diverse biologics portfolios makes them invaluable for accelerating commercialization efforts.
As demand grows for both large-scale commercial output and small-batch personalized treatments, outsourcing is becoming essential for pharmaceutical success. The trend is prompting CDMOs to expand capacities and capabilities, fostering innovation and operational efficiency across the bioprocessing supply chain.
Competitive Landscape Analysis
Key players in Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market include:
- Merck KGaA
- Thermo Fisher Scientific Inc
- GE healthcare
- Corning Inc
- Sartorius AG
- CESCO BIOENGINEERING CO LTD
- Bioprocess Control AB
- Eppendorf AG
- Applikon Biotechnology
- Lonza
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Market Share Analysis
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Workflow
- Market Snapshot, By Product
- Market Snapshot, By Scale
- Market Snapshot, By Use Type
- Market Snapshot, By Application
- Market Snapshot, By Region
- Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Biopharmaceutical Demand Growth
- Bioprocessing Technology Advancements
- Pharmaceutical R&D Investments
- Biopharmaceutical Pipeline Expansion
- Restraints
- High Equipment and Facility Costs
- Manufacturing Process Complexity
- Regulatory Compliance Demands
- Small-Scale Bioprocessing Limitations
- Opportunities
- Emerging Markets Growth
- Single-Use Technology Development
- Automation and Control System Advances
- Contract Manufacturing Outsourcing
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, By Workflow, 2021 - 2031 (USD Million)
- Upstream Processing (USP)
- Fermentation Technology
- Downstream Processing (DSP)
- Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, By Product, 2021 - 2031 (USD Million)
- Bioreactors/Fermentors
- Cell Culture Products
- Filtration Assemblies
- Bioreactors Accessories
- Bags & Containers
- Others
- Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, By Scale, 2021 - 2031 (USD Million)
- Industrial Scale (Over 50,000L)
- Small Scale (Less Than 50,000L)
- Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, By Use Type, 2021 - 2031 (USD Million)
- In-House
- Outsourcing
- Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, By Application, 2021 - 2031 (USD Million)
- Biopharmaceuticals
- Specialty Industrial Chemicals
- Environmental Aids
- Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Large & Small-Scale Bioprocessing (Biopharmaceutical Manufacturing) Market, By Workflow, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Merck KGaA
- Thermo Fisher Scientific, Inc
- GE healthcare
- Corning, Inc
- Sartorius AG
- CESCO BIOENGINEERING CO., LTD
- Bioprocess Control AB
- Eppendorf AG
- Applikon Biotechnology
- Lonza
- Company Profiles
- Analyst Views
- Future Outlook of the Market