U.S. Large And Small-scale Bioprocessing Market (2025 - 2033) Size, Share & Trends Analysis Report By Scale, By Workflow, By Product (Bioreactors/Fermenters, Cell Culture Products), By Application, By Use-Type, By Mode, And Segment Forecasts

U.S. Large And Small-scale Bioprocessing Market Summary

The U.S. large and small-scale bioprocessing market size was estimated at USD 24.86 billion in 2024 and is projected to reach USD 67.34 billion by 2033, growing at a CAGR of 11.24% from 2025 to 2033. This growth is driven by the rising global demand for biologics, including monoclonal antibodies, vaccines, and cell and gene therapies. 

Biopharmaceutical companies are increasingly investing in flexible manufacturing solutions, such as single-use technologies and modular bioprocessing systems, to accelerate development timelines and reduce costs. 

Growing Adoption of Single-Use Technologies in U.S. Bioprocessing

The increasing implementation of single-use technology (SUT) is transforming the U.S. large- and small-scale bioprocessing market, enabling greater flexibility, operational efficiency, and cost-effectiveness in biologics manufacturing. Single-use systems, including bioreactors, bags, filters, connectors, and tubing, are increasingly favored over traditional stainless-steel setups, particularly for small-batch and multiproduct facilities. Their ability to reduce cleaning validation, lower the risk of cross-contamination, and minimize turnaround times makes them highly suitable for modern, fast-paced bioproduction environments. As the demand for personalized medicine and modular manufacturing grows, SUT adoption is accelerating across both clinical and commercial stages.

Biopharmaceutical companies and CDMOs are leveraging single-use technologies to streamline scale-up processes, shorten development timelines, and meet the increasing need for agile production. These systems are particularly valuable in early-stage manufacturing, where flexibility and speed are critical. The growth of cell and gene therapies, which often require small, high-value batches, is further driving the shift toward SUT-based infrastructure. Additionally, the rise of multiproduct facilities demands rapid changeovers, which are more efficiently supported by single-use components than traditional clean-in-place systems.

Manufacturers of bioprocessing equipment are continuously innovating within the SUT space to enhance performance, durability, and compatibility with complex biologics. Developments such as gamma-stable polymers, automation-integrated systems, and scalable single-use platforms are expanding the applicability of SUTs beyond early-stage production to include commercial-scale operations. Key industry players are also investing in hybrid bioprocessing models, combining single-use and stainless-steel systems, to balance cost, scale, and compliance. This trend reflects the evolving needs of manufacturers to customize production environments based on batch size, product type, and regulatory requirements.

Looking ahead, the growth trajectory of SUT in the U.S. bioprocessing market is supported by strong regulatory acceptance, increasing investment in flexible manufacturing facilities, and the expanding pipeline of biologics and advanced therapies. The technology’s ability to reduce capital expenditure, operational risk, and production downtime positions it as a core enabler of next-generation biomanufacturing. As the industry continues to prioritize speed, safety, and scalability, single-use systems are expected to play an even more central role in shaping the future of bioprocessing in the U.S.

Expanding Biologics Pipeline Accelerating U.S. Bioprocessing Growth

The rising demand for biologics is a major catalyst driving the expansion of the U.S. large- and small-scale bioprocessing market. Biologics, including monoclonal antibodies, vaccines, recombinant proteins, and advanced therapies, now represent a significant portion of the global drug pipeline. Their complex nature requires specialized manufacturing platforms with high precision, sterility, and scalability. As a result, biopharmaceutical companies are actively investing in cutting-edge bioprocessing technologies and flexible production systems to meet the evolving demands of biologic development and commercialization.

The U.S. large- and small-scale bioprocessing industry is particularly well-positioned, benefiting from strong R&D infrastructure, supportive regulatory pathways, and a high concentration of innovation-driven biotech and biopharma companies. The country’s leadership in biologics is further supported by a growing pipeline of complex therapies, including monoclonal antibodies, RNA-based drugs, and cell and gene therapies. Companies are increasingly investing in small-batch, modular, and single-use bioproduction systems to accommodate diverse product types and varying batch sizes. While firms like Sarepta Therapeutics continue to advance gene and RNA-based therapies for rare diseases, the broader industry trend reflects a shift toward highly targeted, personalized treatments requiring specialized bioprocessing capabilities.

Table 1 Sarepta Therapeutics pipeline as of 02/2025

Source: Sarepta Therapeutics, Industry Journals, Primary Interviews, Grand View Research

As the biologics market continues to expand, biopharma companies are increasingly turning to advanced upstream and downstream technologies, single-use systems, and contract development and manufacturing organizations (CDMOs) to scale efficiently and ensure regulatory compliance. The growing focus on personalized medicine, orphan drug development, and next-generation platforms like cell and gene therapy further intensifies the need for innovative and adaptive bioprocessing solutions. With a strong clinical pipeline and continued capital inflow, the U.S. bioprocessing industry is expected to remain at the forefront of biologics manufacturing, supporting both scientific breakthroughs and commercial scalability.

Market Concentration & Characteristics

The degree of innovation in the U.S. large and small-scale bioprocessing industry has significantly accelerated market growth, owing to the advancements in single-use technologies, continuous processing, and automation are streamlining production, reducing costs, and improving scalability. This innovation-driven landscape is enabling faster development of biologics and personalized therapies, attracting substantial investments from biopharma players and CDMOs.

The level of mergers and acquisitions activity in the market is steadily increasing, serving as a strategic lever for market consolidation and technological advancement. Key players are actively acquiring niche firms and technology providers to expand manufacturing capabilities, accelerate innovation, and strengthen integrated bioproduction platforms. This trend is reshaping the competitive landscape, fostering synergies, and driving end-to-end service models across upstream and downstream processes.

Regulations profoundly impact the U.S. large and small-scale bioprocessing market, acting both as a market driver and a barrier to entry. Stringent FDA guidelines ensure product safety and quality, driving the adoption of advanced technologies and standardized processes. At the same time, complex regulatory compliance increases operational costs and creates high entry barriers for emerging players, influencing investment strategies and partnerships across the sector.

Product expansion is a key growth driver for the U.S. large and small-scale bioprocessing industry as companies continuously broaden their portfolios to meet the rising demand for biologics, cell and gene therapies, and vaccines. The introduction of innovative bioprocessing solutions, such as advanced bioreactors, single-use systems, and modular facilities, enables greater flexibility, faster production cycles, and scalability, positioning manufacturers to address diverse therapeutic pipelines and evolving client needs.

Scale Insights

The industrial scale segment held the highest market share in 2024, driven by the growing demand for commercial-scale production of biologics, including monoclonal antibodies, vaccines, and cell and gene therapies. Large biopharmaceutical manufacturers are investing heavily in advanced bioprocessing infrastructure, including high-capacity bioreactors, continuous processing systems, and integrated downstream technologies, to support mass production with enhanced efficiency and cost-effectiveness. Additionally, the expansion of CDMO capabilities and the increasing number of FDA-approved biologics are fueling industrial-scale operations. The need for compliance with stringent regulatory standards and consistent product quality further reinforces the shift toward large-scale, automated, and standardized biomanufacturing environments.

The small-scale segment is expected to grow at the fastest CAGR of 11.95% over the forecast period. This is attributed to the rising number of emerging biotech startups, academic research initiatives, and early-phase drug development programs. The demand for flexible, cost-efficient, and modular bioprocessing systems, such as benchtop bioreactors and single-use technologies, is fueling adoption in small-scale settings. Additionally, increased funding for personalized medicine, rapid prototyping, and feasibility studies is boosting the need for scalable, small-volume production solutions that support innovation and accelerate time-to-clinic in the U.S. bioprocessing ecosystem.

Workflow Insights

The downstream processing segment is dominating the U.S. large and small-scale bioprocessing market with the highest market share of 46.85% in 2024. It is anticipated to grow at the fastest CAGR over the forecast period. The increasing need for efficient purification, separation, and concentration of high-value biologics such as monoclonal antibodies and recombinant proteins drives this. As biopharmaceutical pipelines expand, the demand for scalable, high-throughput downstream technologies, such as chromatography systems, filtration units, and centrifuges, continues to rise. Moreover, stringent regulatory requirements for product purity and consistency are pushing manufacturers to invest in advanced downstream solutions, positioning this segment as a critical component of commercial-scale bioproduction.

The fermentation segment is expected to grow at a significant CAGR over the forecast period. This is attributed to the increasing demand for microbial-based production of biologics, enzymes, and vaccines. Advancements in strain engineering, process optimization, and scalable fermentation technologies are enhancing yield and efficiency. Additionally, the rise of biosimilars and biopharmaceuticals relying on microbial expression systems, along with growing adoption of continuous fermentation processes, is further supporting segment expansion across both large- and small-scale bioprocessing operations in the U.S.

Product Insights

The bioreactors/fermenters segment is dominating the U.S. large and small-scale bioprocessing industry with the highest market share of 29.11% in 2024, driven by their central role in upstream bioproduction, supporting the cultivation of cells and microorganisms for biologics, vaccines, and cell therapies. Growing adoption of single-use bioreactors, demand for flexible and scalable production systems, and technological advancements in automation and control are further propelling segment growth. Additionally, the rise in contract manufacturing and expansion of high-throughput biologics pipelines are boosting the deployment of both stainless steel and disposable bioreactor systems across small biotech firms and large biopharma manufacturers.

The cell culture products segment is expected to grow at the fastest CAGR over the forecast period. This is attributed to the increasing demand for biologics, cell and gene therapies, and vaccine production. Advancements in media formulations, supplements, and reagents are supporting higher productivity and cell viability, fueling broader adoption across research and commercial manufacturing. Additionally, the shift toward animal-free and chemically defined media, along with expanding R&D activities, is further accelerating growth in this segment within the U.S. bioprocessing landscape.

Application Insights

The biopharmaceuticals segment dominated the U.S. large and small-scale bioprocessing market with the largest revenue share at 63.54% in 2024 and is anticipated to grow at the fastest CAGR over the forecast period. The rising demand for monoclonal antibodies, vaccines, recombinant proteins, and cell and gene therapies propels the growth. The surge in chronic and rare diseases, coupled with the expansion of targeted and personalized treatment options, has significantly increased biopharmaceutical production activities across the U.S. Advancements in bioprocessing technologies, increased R&D spending, and the growing presence of contract manufacturing partners have further supported the scalability and efficiency of biologics manufacturing. Additionally, favorable regulatory pathways and strong investment pipelines have reinforced the segment's dominance in both large- and small-scale operations.

The speciality industrial chemicals segment is expected to expand at a significant CAGR during the forecast period, due to increasing demand for high-purity chemicals in bioprocessing applications, including media preparation, buffer solutions, and cleaning processes. The shift toward continuous processing and single-use systems requires consistent chemical quality and performance, further driving adoption. Additionally, growth in contract manufacturing and stricter regulatory standards are boosting the need for specialized, compliant chemical solutions tailored to biopharmaceutical production.

Use-Type Insights

The multi-use segment dominated the U.S. large and small-scale bioprocessing market. It accounted for the highest revenue share in 2024. This dominance is attributed to its widespread adoption in large-scale commercial manufacturing, offering durability, cost-efficiency over long production cycles, and compatibility with complex biologics. Multi-use systems enable precise control, rigorous cleaning, and repeatable processes, making them ideal for high-throughput biologics production. Their established regulatory acceptance and integration into legacy infrastructure further support continued use across major biopharmaceutical facilities.

The single-use segment is expected to expand at the fastest CAGR during the forecast period, due to the growing demand for flexible, cost-effective, and contamination-free bioprocessing solutions. Increased adoption in small-scale and clinical manufacturing, faster batch turnaround times, and reduced cleaning validation requirements are driving its rapid uptake across the U.S. bioprocessing industry.

Mode Insights

The in-house segment dominated the U.S. large and small-scale bioprocessing industry with the highest revenue share in 2024. This dominance is attributed to large biopharmaceutical companies maintaining internal control over critical manufacturing processes to ensure product quality, regulatory compliance, and IP protection. In-house facilities offer greater oversight, customized production workflows, and faster response to process deviations or regulatory changes. Additionally, companies with established infrastructure are investing in advanced bioprocessing technologies to scale operations efficiently and reduce long-term costs. The growing pipeline of biologics and emphasis on end-to-end manufacturing integration further reinforce the preference for in-house production among key industry players.

The outsourced segment is anticipated to grow at the fastest CAGR throughout the forecast period, driven by the rising reliance on CDMOs for cost-effective, scalable, and specialized biomanufacturing solutions. Increasing complexity of biologics, need for regulatory compliance, and demand for rapid time-to-market are encouraging biopharma companies to outsource development and production, especially in early-stage and small-batch manufacturing environments.

Key U.S. Large And Small-Scale Bioprocessing Company Insights

The U.S. large- and small-scale bioprocessing market is characterized by the strong presence of established bioprocessing solution providers, CDMOs, and biopharmaceutical manufacturers. Leading players such as Thermo Fisher Scientific Inc.; Merck KGaA; Danaher Corporation; and Sartorius AG dominate the competitive landscape through their extensive product portfolios, global reach, and continued investments in innovation. These companies offer comprehensive bioprocessing solutions, including bioreactors, filtration systems, chromatography resins, and single-use technologies, enabling end-to-end manufacturing for biologics, vaccines, and cell and gene therapies. Strategic acquisitions, collaborative partnerships, and capacity expansions further support their market dominance.

A growing number of CDMOs and specialized service providers, such as Lonza Group, Fujifilm Diosynth Biotechnologies, Catalent Inc., and Samsung Biologics, are also gaining traction by offering scalable, outsourced solutions to biotech and pharma firms. These companies are investing in modular facilities, single-use technologies, and digital bioprocessing platforms to meet the rising demand for flexible and rapid manufacturing. Market share gains among CDMOs are driven by their ability to manage complex projects across early development to commercial-scale production while ensuring regulatory compliance. Emerging players and regional firms are focusing on niche areas like precision fermentation and cell therapy manufacturing, contributing to increased competition and innovation within the market.

The competitive landscape continues to evolve, with companies prioritizing technological differentiation, operational efficiency, and speed-to-market. Players are increasingly adopting integrated bioprocessing platforms, automation, and AI-enabled process optimization to gain a competitive edge. Moreover, the U.S. market is witnessing consolidation through mergers and acquisitions, allowing key companies to strengthen their capabilities, diversify service offerings, and expand geographically. As the pipeline for biologics and advanced therapies grows, market participants that can offer flexible, high-quality, and end-to-end biomanufacturing solutions are expected to maintain a dominant position and capture greater market share in the coming years.

Recent Developments

• In May 2025, Univercells Technologies in Belgium launched the scale‑X nitro controller to operate large‑scale (200 m² and 600 m²) fixed‑bed bioreactors, enabling cost‑effective, compact viral and advanced therapy manufacturing.

• In April 2025, Merck KGaA agreed to acquire U.S.-based SpringWorks Therapeutics in an all-cash deal valued at approximately USD 3.9 billion to strengthen its oncology and rare disease portfolio and expand its U.S. presence.

• In April 2025, Thermo Fisher Scientific unveiled enhanced integrated platform solutions, including its Accelerator platform and a high-yield CHO K‑1 cell line, reducing investigational new drug (IND) filing timelines from 13 to 9 months. These offerings deliver up to 8 g/L protein expression and stable production, streamlining biologics development from gene to patient.

U.S. Large And Small-Scale Bioprocessing Market Report Scope

U.S. Large And Small-Scale Bioprocessing Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this report, Grand View Research has segmented the U.S. large and small-scale bioprocessing market based on scale, workflow, product, application, use-type, and mode:

• Scale Outlook (Revenue, USD Million, 2021 - 2033)

  • Industrial Scale (Over 50,000 Liter)

  • Small Scale (Less Than 50,000 Liter)

• Workflow Outlook (Revenue, USD Million, 2021 - 2033)

  • Downstream Processing

  • Fermentation

  • Upstream Processing

• Product Outlook (Revenue, USD Million, 2021 - 2033)

  • Bioreactors/Fermenters

  • Cell Culture Products

  • Filtration Assemblies

  • Bioreactors Accessories

  • Bags & Containers

  • Others

• Application Outlook (Revenue, USD Million, 2021 - 2033)

  • Biopharmaceuticals

  • Speciality Industrial Chemicals

  • Environmental Aids

• Use-Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Multi-Use

  • Single-Use

• Mode Outlook (Revenue, USD Million, 2021 - 2033)

  • In-House

  • Outsourced