U.S. Large and Small-scale Bioprocessing Market (By Scale; By Workflow; By Product: Bioreactors/Fermenters, Cell Culture Products; By Application; By Use-Type; By Mode) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2025-2034

U.S. Large and Small-scale Bioprocessing Market Size and Top Companies 

The U.S. large and small-scale bioprocessing market size accounted for USD 24.88 billion in 2024 and it is projected to hit around USD 72.58 billion by 2034, growing at a CAGR of 11.3% from 2025 to 2034. The rising demand for biopharmaceuticals, growing chronic diseases, personalized medicine, technological advancements, and continuous bioprocessing, a growing focus on eco-friendly bioprocessing and manufacturing organizations, drive the market growth.

Key Pointers

• By scale, the industrial-scale segment is generated the maximum market share in 2024.
• By scale, the small-scale segment is predicted to grow at the remarkable CAGR of 11.96% during the forecast period.
• By workflow, the downstream processing segment is registered the maximum market share of 47% in 2024.
• By workflow, the fermentation segment is expected to grow at the notable CAGR from 2025 to 2034.
• By product, the bioreactors/fermenters segment is captured the maximum market share of 30% in 2024.
• By product, the cell culture products segment is estimated to expand the fastest CAGR during the forecast period. 
• By application, the biopharmaceuticals segment is held the largest market share of 64% in 2024.
• By use-type, the multi-use segment dominated the largest market share in 2024. 
• By mode, the in-house segment is held the largest revenue share in 2024. 

Market Overview 

The U.S. Large and Small-scale Bioprocessing Market

The U.S. large and small-scale bioprocessing market contains the use of living cells or their component, such as enzymes or microorganisms, to carry out laboratory or pilot plant-scale operations, where processes are conducted on a few liters. The large-scale bioprocesses are performed on a much larger scale, typically ranging from hundreds of liters to thousands of liters, and are designed to produce large quantities of the final product. The large-scale bioprocessing used in pharmaceutical production, such as monoclonal antibodies, vaccines, and insulin, as well as biofuel production and the food and beverage industry. The market growth is driven by the increasing prevalence of chronic diseases and the development of targeted therapies, increasing need for personalized medicine more investment in biotechnology research expands the potential for new bioprocessing applications, expansion of the market growth.

Report Scope of the U.S. Large and Small-scale Bioprocessing Market

Which Factor is Driving the U.S. Large and Small-scale Bioprocessing Market 

• The growing demand for biologics, rising chronic diseases and shift towards personalized medication, and increasing biopharmaceutical pipeline, and rising demand for bioprocessing at both large and small scales.
• In April 2025, the FDA's approval of Abeona Therapeutics' gene therapy, ZEVASKYN, highlights the expanding pipeline of complex therapies that require specialized bioprocessing capabilities. 
• The advancement in bioprocessing technologies, innovation in bioprocessing equipment, and methods are improving efficiency, scalability, and flexibility, driving adoption across the industry. The expansion of single-use technology, acquisition of biopharma businesses, and integration of AI and automation expansion of the market growth. 
• In May 2025, Waters Corporation introduced BioResolve Protein Affinity Columns to accelerate downstream bioprocessing with advanced analytics. (Source: Abeona Therapeutics Inc)

Market Trends

• The government initiatives and supporting programs, such as the U.S. government biomanufacturing initiatives and FDA fast-track pathways, are encouraging research, innovation, and domestic manufacturing, driving the market growth.
• In January 2025, the U.S. Department of Agriculture (USDA) is funding projects through this program to increase access to clean energy systems, including biofuels produced through fermentation. (Source: USDA)
• The increase in biotech startups and academic research initiatives is accelerating the adoption of smaller, more affordable bioprocessing platforms for research and development, adoption of AI and automation.
• In March 2025, Cytiva expanded its Xcellerex X-platform bioreactor portfolio with new single-use systems to support development from clinical to commercial stages.
• In May 2025, DuPont launched an AmberChrom™ TQ1 new agarose-based chromatography resin to support the purification of oligonucleotides and peptides. (Source: Cytivalifesciences)

Market Opportunity

• Biotech Week Boston / BioProcess International 

The key U.S. events for networking, exploring new technologies, and attending sessions on single-use systems and other innovations, they offer the best ecosystem for growing and supporting biotech companies, such as pharmaceutical and gene therapy, drug development in the bioprocessing industry, feature presentations and new product launches, and drive the market growth. (Source: Informaconnect)

• The Trend Towards Personalized Medicine 

The move toward tailoring treatments based on an individual's genetic profile is creating demand for flexible, small-scale bioprocessing equipment. This provides an important occasion for vendors who can produce innovative, modular platforms for small-batch and patient-specific treatments.

Market Challenge

High Investment and Operational Costs

The facilities required for establishing or expanding bioprocessing are a massive upfront investment in advanced equipment, cleanrooms, and automated systems. Beyond initial setup, bioprocessing involves substantial recurring expenses. These include the cost of raw materials, energy, quality control, maintenance, and, especially for large-scale operations, the regular replacement of disposable components hinders the market growth.

Segmental Insights

Scale Insights

How did the Industrial Scale Segment Dominate the U.S. Large and Small-scale Bioprocessing Market in 2024?

The industrial scale segment held the largest share of the market in 2024. The high demand for established biologics, the consistent and high-volume demand for commercial biologics, such as monoclonal antibodies and vaccines. The high-volume production of blockbuster drugs allows for significant economies of scale, which lowers the cost, high-output manufacturing. The increasing number of expiring patents for biologics has fueled the demand for cost-effective biosimilars. The strategic investment in large facilities and proven multi-use technology, and the rise of hybrid bioprocessing models, which combine the cost benefits of multi-use systems with the flexibility of single-use technologies, drive the market growth.

The small-scale segment is expected to grow at a notable rate during the predicted timeframe, owing to the rising focus of personalized medicine and advanced therapies, such as cell and gene require flexible, customized small-scale bioprocessing solutions. The increase in biotech startups and academic research drives demand for small-scale systems for early drug development and testing. Significant public and private investment supports biotechnology R&D, particularly for smaller, cost-effective systems. The technological advancement, including single-use and modular systems, improves efficiency and reduces contamination risk in small-scale operations.

Workflow Insights

Why does the Downstream Processing Segment Dominate the U.S. Large and Small-scale Bioprocessing Market by Platform?

The downstream processing segment held the largest share of the market in 2024, due to technological advancements and innovations in chromatography resins, and automated chromatography improved separation efficiency and capacity. The adoption of single-use components in downstream workflows increased flexibility, reduced contamination risk. The increasing pipeline of new biologics, biosimilars, and cell and gene therapies is driving demand for scalable and high-therapeutic downstream technologies. The strict regulatory requirements and focus on efficiency and intellectual property are expansion of the market growth.

The fermentation segment is expected to grow at a notable rate, as the fermentation process, which involves using microorganisms to produce valuable products, is widely used in various industries, including biopharmaceuticals and the production of specialty industrial chemicals. The rising demand for biosimilar and complex biopharmaceuticals relies deeply on fermentation technology to produce therapeutic proteins, monoclonal antibodies, and vaccines. The adoption of the continuous fermentation process allows for more efficient, sustainable, and cost-effective production compared to the traditional method. The increasing demand for flexible and scalable solutions and growth in single-use bioreactors boost the market growth.

Product Insights

How did the bioreactors/fermenters Segment Dominate the U.S. Large and Small-scale Bioprocessing Market in 2024?

The bioreactors/fermenters segment held the largest share of the market in 2024. The significant increase in the development and production of therapeutic proteins, monoclonal antibodies, and vaccines directly increased the need for bioreactors to cultivate the cells and microorganisms that produce these products. The rising demand for bioprocessing equipment, including bioreactors, and increasing emphasis on precision medicine, which involves tailoring treatments to individual patients, have spurred the need for advanced biomanufacturing processes that rely heavily on bioreactor technology.

The cell culture products segment is expected to grow at a notable rate during the predicted timeframe, owing to the increasing demand for cell and gene therapies rising demand for biologics, drugs, vaccines, and novel cell and gene therapies requires advanced cell culture. The rising need for precision and control, and increasing R&D in cell-based research. The media formulation offers improved consistency, reduced variability, and better regulatory compliance, particularly important for cell and gene therapy applications.

Application Insights

How did the Biopharmaceuticals Segment Dominate the U.S. Large and Small-scale Bioprocessing Market in 2024? 

The biopharmaceuticals segment held the largest share of the market in 2024. The expanding number of approvals and use of biologic drugs for chronic diseases drives the bioprocessing sector essential for their production. The expansion of treatment options, including vaccines and cell gene therapies increasingly crucial for treating chronic disease. The shift toward personalized medicine, especially in treating cancer and rare genetic disorders, drove demand for small-scale bioprocessing. The substantial investment in R&D is expanding the pipeline of complex biologic therapies, and integration in automation, real-time analysis, and artificial intelligence has improved the efficiency, precision, and scalability of bioprocessing.

The specialty industrial chemicals segment is expected to grow at a notable rate during the predicted timeframe, owing to the environmental concerns and sustainability goals intensifying. U.S. industries are turning toward bioprocessing as an eco-friendly alternative to conventional chemical manufacturing. The advancement of new drugs and therapies requires novel chemical inputs and process adjustments, and the expansion of bioprocessing drives the market growth. The bioprocess requires highly pure and precisely formulated chemicals for tasks, such as cell culture, fermentation, and downstream processing, especially indispensable chemicals.

Use-Type Insights

How did the Multi-Use Segment Dominate the U.S. Large and Small-scale Bioprocessing Market in 2024?

The multi-use segment holds a dominant share of the market in 2024. The multiuse system is are preferred choice for large-scale production due to its durability, cost efficiency over long production cycles, and ability to handle complex biologics. It offers precise control, enables rigorous cleaning, and facilitates repeatable processes, essential for high biological production. They support complex workflows and allow for customization, scalability, and control over every stage of the bioprocess. This system is preferred for large-scale commercial production, the expansion of market growth. 

The single-use segment is expected to grow at a notable rate during the predicted timeframe, due to single-use offers unparalleled flexibility, enabling biopharmaceutical companies to quickly adapt production processes to accommodate various product types and fluctuating batch sizes, from small-scale clinical trials to large-scale commercial manufacturing. The single-use technologies required a lower initial investment, reduced cleaning, sterilization, and validation needs translates to significant operational cost savings over the long term. The single-use minimizes contamination risk, and the growing demand for biologics and personalized medicine drives the market growth.

Mode Insights

How did the In-House Segment Dominate the U.S. Large and Small-scale Bioprocessing Market in 2024?

The in-house segment held the largest share of the market in 2024. The in-house segment maintains control and quality, and in-house production allows companies to protect their intellectual property and proprietary manufacturing processes, particularly relevant for advanced therapies with high value. The companies with existing infrastructure are investing in advanced bioprocessing technologies to scale operations effectively and manage costs over the long term. The rising demand for biologics and the need for end-to-end manufacturing integration further reinforce the preference for in-house production.

The outsourced segment is expected to grow at a notable rate during the predicted timeframe, owing to the companies' cloud outsourced manufacturing and focusing their resources on research, development, and innovation. The increasing growth in specialized biomanufacturing and a focus on accelerating time to market and regulatory compliance. The need for rapid development timelines and navigation of complex regulatory pathways encourages outsourcing. Many small and mid-sized firms chose to outsource their bioprocessing needs to contract development and manufacturing organizations and contract research organizations.

U.S. Large and Small-scale Bioprocessing Market – Value Chain Analysis

1. R&D
The U.S. large and small-scale bioprocessing market is expansion of commercial biologics, economies of scale, a hybrid system, and advanced downstream processing.

2. Patient Support and Services.
The U.S. large and small-scale bioprocessing market offers access and reimbursement support, adherence and education, side effect management, logistical coordination, and concierge services.

3. Clinical Trials and Regulatory Approvals.
Clinical trials are a crucial step in bioprocessing that evaluate a drug's safety and efficacy in humans. In the U.S., a company must file an Investigational New Drug (IND) application with the FDA before starting human trials. 

Recent Developments

• In May 2025, PeptiSystems partnered with Asahi Kasei Bioprocess America to offer customers a combined flow-through instrument and column technology for purification. (Source: Peptisystems)
• In April 2025, biotech company Manus announced a merger with technology company Inscripta to create an integrated platform for biomanufacturing. (Source: Manusbio)
• In March 2025, the Pow.Bio launched a new FDA-registered facility in California for precision fermentation, signaling increased investment in small-scale, continuous microbial processes. (Source: agfundernews)

U.S. Large and Small-scale Bioprocessing Market Top Companies

• Bio-Synthesis, Inc.
• Merck KGaA (MilliporeSigma)
• F. Hoffmann-La Roche Ltd
• Thermo Fisher Scientific, Inc.
• Distek, Inc.
• Danaher (Cytiva)
• Avantor, Inc.
• Corning Inc.
• Repligen Corporation
• Sartorius AG
• Saint-Gobain
• Lonza
• Entegris
• Eppendorf AG
• PBS Biotech, Inc.
  

Segment Covered in the Report

By Scale 

• Industrial Scale (Over 50,000 Liter)
• Small Scale (Less Than 50,000 Liter)

By Workflow 

• Downstream Processing
• Fermentation
• Upstream Processing

By Product 

• Bioreactors/Fermenters
• Cell Culture Products
• Filtration Assemblies
• Bioreactors Accessories
• Bags & Containers
• Others

By Application 

• Biopharmaceuticals
• Specialty Industrial Chemicals
• Environmental Aids

By Use-Type 

• Multi-Use
• Single-Use

By Mode 

• In-House
• Outsourced