The global single-use bioprocessing market size was estimated at USD 28.45 billion in 2023 and is projected to hit around USD 128.24 billion by 2033, growing at a CAGR of 16.25% during the forecast period from 2024 to 2033.
The single-use bioprocessing (SUB) market has revolutionized modern biopharmaceutical manufacturing by introducing cost-effective, flexible, and efficient production systems. Single-use technologies have replaced traditional stainless-steel systems, offering ease of use, rapid turnaround times, and significant cost savings in cleaning and validation processes. As the biopharmaceutical industry continues to expand driven by growing demand for monoclonal antibodies, vaccines, cell therapies, and gene therapies the need for scalable, customizable, and contamination-reducing solutions has fueled the adoption of single-use systems.
Historically, large-scale bioproduction relied heavily on reusable infrastructure. However, the limitations associated with cleaning, cross-contamination, and long setup times created opportunities for innovation. Single-use systems, by being pre-sterilized and disposable after use, minimize contamination risk and operational downtime, enabling more agile production environments. Particularly within clinical manufacturing and early-stage commercial production, SUB solutions have become critical to supporting fast-paced development cycles.
Moreover, increasing investments by biopharma giants in building modular and flexible manufacturing facilities are bolstering market growth. The global COVID-19 pandemic also showcased the advantages of single-use technologies, as they enabled rapid vaccine and therapeutic production under stringent timelines. Looking ahead, as biologics pipeline diversification continues, the single-use bioprocessing market is expected to maintain a robust growth trajectory.
Increased Adoption of Modular Facilities: Biopharma companies are increasingly designing modular plants equipped entirely with single-use systems, facilitating rapid scaling.
Integration of Automation and IoT: Smart single-use systems integrated with sensors and data analytics platforms are enhancing process monitoring and control.
Rising Popularity of Single-use Probes and Sensors: Demand for single-use sensors for real-time monitoring of critical parameters like pH, temperature, and oxygen is surging.
Growth in Cell and Gene Therapy Manufacturing: Single-use technologies are particularly suited for small-batch, high-value cell and gene therapies, fostering growth.
Sustainability Initiatives: Companies are investing in recycling programs and sustainable materials to address environmental concerns linked with disposability.
Collaborative Product Development: Increasing collaborations between biopharma companies and technology providers are leading to highly customized single-use solutions.
Expansion in Emerging Markets: Biopharma manufacturing facilities in Asia-Pacific and Latin America are increasingly adopting SUB systems.
Technological Innovations in Large-scale Single-use Bioreactors: Development of larger, robust bioreactors capable of handling volumes exceeding 2000 liters is gaining momentum.
Report Attribute | Details |
Market Size in 2024 | USD 33.07 Billion |
Market Size by 2033 | USD 128.24 Billion |
Growth Rate From 2024 to 2033 | CAGR of 16.25% |
Base Year | 2023 |
Forecast Period | 2024 to 2033 |
Segments Covered | Product, workflow, end-use, region |
Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
Key Companies Profiled | Sartorius AG; Danaher Corporation; Thermo Fisher Scientific, Inc.; Merck KGaA; Avantor, Inc; Eppendorf SE; Corning Incorporated; Lonza; PBS Biotech, Inc.; Meissner Filtration Products, Inc. |
The most compelling driver for the single-use bioprocessing market is the soaring demand for biopharmaceuticals. As monoclonal antibodies, vaccines, and gene therapies gain prominence in treating chronic and rare diseases, manufacturers are compelled to seek flexible, efficient production platforms. Single-use technologies perfectly align with this need, enabling faster production cycles, minimized risk of contamination, and adaptability to varying batch sizes.
For example, the rapid development and mass production of COVID-19 vaccines by companies like Moderna and Pfizer involved extensive use of single-use systems to streamline operations. Similarly, the surge in demand for biosimilars is pressuring manufacturers to adopt cost-effective technologies, further accelerating the uptake of SUB solutions across both clinical and commercial manufacturing pipelines.
While single-use technologies offer significant operational advantages, concerns regarding their environmental impact present a notable restraint. The disposable nature of these systems leads to substantial generation of plastic waste, raising questions about sustainability practices within the industry. Regulatory bodies and environmentally-conscious stakeholders are increasingly scrutinizing biopharma’s waste management strategies.
The lack of standardized recycling infrastructures for bioprocessing plastics exacerbates the issue. Moreover, high-temperature sterilization needs for contaminated waste pose additional challenges. Although companies are exploring biodegradable materials and recycling initiatives, achieving sustainable single-use operations at scale remains a complex hurdle that could influence purchasing decisions in the future.
A major growth opportunity lies in the increasing penetration of single-use bioprocessing technologies in emerging markets. Countries like China, India, Brazil, and South Korea are witnessing a biopharmaceutical boom fueled by government initiatives, local manufacturing incentives, and rising healthcare demands.
In these regions, new manufacturing facilities are often built from scratch, allowing for the direct adoption of the latest single-use technologies without the constraints of legacy stainless-steel infrastructures. For instance, India's "Make in India" initiative has attracted significant investments in biopharma manufacturing, creating fertile ground for SUB adoption. Similarly, China's aggressive push to dominate global biologics manufacturing is driving demand for flexible, scalable production systems, opening up new growth avenues for market players.
Among products, simple and peripheral elements dominated the single-use bioprocessing market in 2024, primarily due to their widespread applicability across different stages of biomanufacturing. Components like tubing, filters, and connectors are essential in almost every bioprocessing workflow, making them indispensable. Their comparatively lower cost and higher replacement frequency further boost recurring demand. Sampling systems, pH sensors, and oxygen sensors are increasingly deployed to ensure process control, sterility, and compliance with stringent regulatory standards. Manufacturers continually innovate these elements for enhanced durability and compatibility with evolving bioprocessing requirements.
On the other hand, the apparatus and plants segment is projected to grow at the fastest rate during the forecast period. Bioreactors, particularly those with capacities above 1000L, are increasingly engineered with robust single-use designs capable of supporting commercial production volumes. Companies like Sartorius AG and Thermo Fisher Scientific are pushing boundaries by introducing large-scale, modular, and automated SUB platforms. Mixing, storage, and filling systems are also undergoing innovation, allowing seamless scale-up and scalability in complex biomanufacturing environments.
In terms of workflow, upstream bioprocessing dominated the market in 2024. Single-use systems have significantly enhanced upstream processes, particularly cell culture and media preparation, by improving sterility assurance and operational flexibility. Disposable bioreactors, bags, and tubing systems simplify the setup of cell culture systems, enabling faster turnaround and higher productivity. Upstream applications, requiring stringent contamination control, have benefitted immensely from the shift towards single-use solutions.
However, downstream bioprocessing is expected to experience the fastest growth. Innovations in single-use chromatography systems and filtration units are making it possible to extend the advantages of disposability into purification processes. As biologics become more complex and diversified, flexible downstream platforms that minimize cross-contamination risks and allow rapid product changeovers are increasingly critical to manufacturing success.
Biopharmaceutical manufacturers represented the largest end-use segment in 2024. Within this group, in-house manufacturers have been the primary adopters, driven by the need for consistent quality control and proprietary manufacturing capabilities. Single-use systems allow these companies to develop tailored production lines for different biologics pipelines, maintaining operational efficiency and product integrity. Major pharma companies like Roche, Pfizer, and Amgen have fully embraced SUB technologies in new facility builds and expansions.
Meanwhile, Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) are forecasted to witness the fastest growth. As more biopharma companies outsource parts of their manufacturing and research to specialized service providers, CMOs and CROs are aggressively investing in single-use technologies to offer flexible, quick-to-market solutions. The ability to rapidly scale up or modify manufacturing lines to cater to different client needs makes SUB systems highly attractive for these players.
North America led the global single-use bioprocessing market in 2024, owing to the concentration of major biopharmaceutical companies, robust R&D activities, and a highly favorable regulatory environment. The U.S. holds the lion’s share, supported by extensive clinical trial activity and significant biologics manufacturing capabilities. The early adoption of advanced bioprocessing technologies, coupled with investments in modular and flexible facilities, cements North America's leading position.
Moreover, initiatives like the U.S. government's support for domestic biologics manufacturing under the "America COMPETES Act" further amplify opportunities for single-use systems. Companies like Thermo Fisher Scientific, Danaher Corporation, and Avantor are headquartered or have significant operations in the region, reinforcing the leadership position through continuous innovation and product launches.
Asia-Pacific is expected to exhibit the fastest growth over the forecast period. Biopharma markets in China, India, and South Korea are expanding rapidly, driven by government incentives, rising demand for biologics, and an increasing focus on healthcare infrastructure. China's "Made in China 2025" initiative prioritizes biopharmaceuticals as a strategic sector, with massive investments funneled into new production facilities heavily leveraging single-use systems.
In India, the booming biosimilars market and emergence of new biotechnology startups have created a thriving ecosystem favoring flexible and cost-effective manufacturing technologies. Additionally, global companies are increasingly outsourcing biomanufacturing to Asia-Pacific CMOs, further boosting the regional demand for SUB technologies.
February 2025: Sartorius launched the "BIOSTAT STR Plus," a new generation of single-use bioreactors designed for scalability beyond 2000L, targeting commercial biologics manufacturing.
January 2025: Thermo Fisher Scientific acquired a bioprocessing facility in Singapore to strengthen its single-use technology manufacturing capabilities in the Asia-Pacific region.
November 2024: Avantor, Inc. announced the launch of a new sustainable single-use platform incorporating recyclable materials, in response to increasing environmental concerns.
September 2024: Merck KGaA expanded its Mobius® single-use manufacturing site in Massachusetts, aiming to meet growing customer demand for integrated single-use systems.
The following are the leading companies in the single-use bioprocessing market. These companies collectively hold the largest market share and dictate industry trends. Financials, strategy maps & products of these single-use bioprocessing companies are analyzed to map the supply network.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Single-use Bioprocessing market.
By Product
By Workflow
By By End-use
By Region