Single-Use Bioprocessing Market Size, Share, and Growth Forecast to 20

The global single-use bioprocessing market has emerged as a critical segment within the biopharmaceutical manufacturing industry, driven by the growing demand for flexible, scalable, and cost-efficient production solutions. Single-use bioprocessing systems, also known as disposable bioprocessing technologies, are designed for one-time use and eliminate the need for cleaning, sterilization, and validation processes associated with traditional stainless-steel systems.

The global single-use bioprocessing market size was USD 18.65 billion in 2023, which is estimated to be valued at USD 21.01 billion in 2024 and is projected to reach USD 54.40 billion by 2031, growing at a CAGR of 14.56% from 2024 to 2031. This robust growth reflects the rapid expansion of biologics, vaccines, cell and gene therapies, and biosimilars across global pharmaceutical pipelines.

Single-use technologies are increasingly preferred due to their ability to reduce capital expenditure, minimize contamination risks, accelerate production timelines, and enhance operational efficiency. As biopharmaceutical companies focus on agility and rapid response to market needs, disposable bioprocessing solutions are becoming a cornerstone of modern manufacturing strategies.

Single-Use Bioprocessing Market: Key Highlights

• Rapid adoption of biologics, monoclonal antibodies, vaccines, and advanced therapies is accelerating demand for single-use systems
• Cost savings through reduced cleaning validation, water usage, and downtime are driving industry adoption
• Increased use of modular and flexible manufacturing facilities supports market expansion
• Strong growth observed in cell and gene therapy manufacturing applications
• North America dominates the market, while Asia-Pacific is expected to witness the fastest growth
• Continuous innovation in materials, sensors, and automation is enhancing system performance

Market Drivers and Emerging Trends in Single-Use Bioprocessing

The global single-use bioprocessing market is being propelled by several powerful drivers linked to the evolution of biopharmaceutical production. One of the most significant drivers is the increasing demand for biologics, which require highly controlled, sterile, and flexible manufacturing environments. Single-use technologies enable faster scale-up and scale-down processes, making them ideal for clinical and commercial manufacturing.

Another major driver is the rising emphasis on cost optimization. Compared to traditional stainless-steel systems, single-use bioprocessing solutions significantly reduce upfront capital investment and operational expenses. Manufacturers can avoid costly cleaning, sterilization, and maintenance processes, resulting in improved productivity and reduced time-to-market.

The growing trend toward personalized medicine and small-batch production is further supporting market growth. Advanced therapies such as cell and gene therapies often require smaller production volumes with stringent contamination controls. Single-use systems provide the flexibility and sterility required for these specialized applications.

Emerging Trends

Technological advancements are shaping the future of single-use bioprocessing. Innovations in polymer materials are improving chemical compatibility, mechanical strength, and extractables and leachables (E&L) profiles. Additionally, the integration of sensors, automation, and digital monitoring tools is enhancing process control and real-time data visibility.

Hybrid manufacturing models that combine single-use and stainless-steel systems are also gaining popularity. These models allow manufacturers to leverage the advantages of both technologies, optimizing efficiency across different stages of production.

Sustainability is becoming an important trend, with manufacturers investing in recyclable materials and waste reduction strategies to address environmental concerns related to disposable systems.

Market Dynamics

Drivers

• Rising demand for biologics, vaccines, and biosimilars
• Reduced risk of cross-contamination
• Lower capital and operational costs
• Faster facility setup and process changeovers
• Increasing adoption of modular manufacturing facilities

Restraints

• Concerns regarding extractables and leachables
• Environmental impact of plastic waste
• Limited scalability for very large-volume production

Opportunities

• Expansion of cell and gene therapy manufacturing
• Growth in emerging biopharmaceutical markets
• Development of sustainable and recyclable single-use materials
• Increasing outsourcing to contract development and manufacturing organizations (CDMOs)

Global Single-Use Bioprocessing Market Segmentation

By Product Type

• Single-use bioreactors
• Disposable filtration systems
• Single-use mixers
• Disposable tubing assemblies
• Single-use sensors
• Other single-use accessories

Single-use bioreactors hold the largest market share due to their widespread adoption in upstream processing for cell culture and fermentation.

By Workflow

• Upstream processing
• Downstream processing

Upstream processing dominates the market, driven by extensive use of disposable bioreactors, bags, and media preparation systems.

By Application

• Monoclonal antibodies
• Vaccines
• Cell and gene therapies
• Biosimilars
• Other biologics

The cell and gene therapy segment is expected to witness the highest growth rate due to increasing clinical approvals and investments.

By End User

• Biopharmaceutical companies
• Contract development and manufacturing organizations (CDMOs)
• Research and academic institutes

CDMOs represent a rapidly growing segment as pharmaceutical companies increasingly outsource manufacturing activities.

Competitive Landscape of the Single-Use Bioprocessing Market

The global single-use bioprocessing market is moderately consolidated, with leading players focusing on product innovation, strategic partnerships, and geographic expansion. Companies are investing heavily in R&D to enhance product performance, ensure regulatory compliance, and address sustainability challenges.

Key Companies in the Market

• Thermo Fisher Scientific
• Sartorius AG
• Danaher Corporation
• Merck KGaA
• Avantor, Inc.
• Eppendorf SE
• Pall Corporation
• Lonza Group
• Corning Incorporated
• PBS Biotech

These companies are strengthening their market position through acquisitions, collaborations with biopharmaceutical manufacturers, and the development of next-generation single-use technologies.

Regional Analysis of the Single-Use Bioprocessing Market

North America

North America holds the largest share of the global single-use bioprocessing market due to the presence of a well-established biopharmaceutical industry, strong R&D investments, and rapid adoption of advanced manufacturing technologies. The United States leads the region, supported by a high concentration of biologics and cell therapy developers.

Europe

Europe represents a significant market, driven by increasing biologics production, favorable regulatory frameworks, and strong government support for biopharmaceutical innovation. Countries such as Germany, the United Kingdom, and France are key contributors to regional growth.

Asia-Pacific

Asia-Pacific is expected to witness the fastest CAGR during the forecast period. Rapid expansion of biopharmaceutical manufacturing in China, India, South Korea, and Japan, along with increasing investments in healthcare infrastructure, is fueling market growth.

Latin America

Latin America is experiencing steady growth due to rising healthcare investments and increasing demand for vaccines and biosimilars. Brazil and Mexico are leading markets in the region.

Middle East & Africa

The Middle East & Africa market is gradually expanding, supported by improving healthcare infrastructure and growing interest in local pharmaceutical manufacturing.

Future Outlook of the Single-Use Bioprocessing Market (2024–2031)

The future of the single-use bioprocessing market looks highly promising, with strong growth anticipated throughout the forecast period. The increasing complexity of biologics and advanced therapies will continue to drive demand for flexible, contamination-free manufacturing solutions.

Technological advancements in materials science, automation, and digital integration are expected to further enhance the efficiency and reliability of single-use systems. Additionally, sustainability initiatives aimed at reducing plastic waste and improving recyclability will play a crucial role in shaping market dynamics.

As biopharmaceutical companies focus on rapid innovation, cost control, and scalability, single-use bioprocessing technologies are set to become an integral part of next-generation manufacturing facilities worldwide.

Conclusion

The global single-use bioprocessing market is undergoing a significant transformation, driven by the rapid expansion of biologics, vaccines, and advanced therapies. With a projected market value of USD 54.40 billion by 2031 and a strong CAGR of 14.56%, the market offers substantial opportunities for technology providers, manufacturers, and investors.

The shift toward flexible, efficient, and contamination-free manufacturing solutions underscores the growing importance of single-use bioprocessing systems in the global biopharmaceutical landscape. Companies that invest in innovation, sustainability, and strategic collaborations will be well-positioned to capitalize on the market’s long-term growth potential.

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