Single-use Bioprocessing Market to Reach US$ 25.40 Billion by 2031 at 18.93% CAGR; North America Leads with 39% Share - Key Players: Thermo Fisher Scientific, Danaher, Merck KGaA

The global Single-use Bioprocessing Market was valued at US$ 7.62 billion in 2021 and is estimated to reach US$ 25.40 billion by 2031, growing at a robust CAGR of 18.93% during the forecast period 2024-2031. The market is witnessing strong growth driven by the increasing demand for biologics and biosimilars, the need for flexible and cost-effective manufacturing solutions, and the rapid expansion of biopharmaceutical production capacities.

Single-use bioprocessing systems consist of disposable, plastic-based components that are sterilized using gamma irradiation and discarded after a single use, minimizing cross-contamination risks and reducing cleaning validation requirements. These systems are widely used across various stages of biopharmaceutical manufacturing, including upstream processing, mixing, filtration, purification, storage, and separation. Key product categories such as single-use bioreactors and fermenters, mixers, bags, bioprocess containers, and filtration systems dominate the market. Their ability to shorten setup times, lower capital investment, and enhance operational flexibility makes single-use bioprocessing an increasingly preferred choice for contract manufacturing organizations (CMOs), biopharma startups, and large-scale manufacturers alike.

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The Single-use Bioprocessing Market is the sector that provides disposable bioprocessing systems and components used in biopharmaceutical manufacturing to enhance efficiency, flexibility, and contamination control.

Key Developments
✅ October 2025: U.S. biopharmaceutical manufacturers expanded adoption of single-use bioprocessing systems to accelerate biologics and cell- and gene-therapy production while reducing contamination risk and cleaning validation time.

✅ September 2025: European bioprocessing facilities integrated advanced single-use bioreactors and filtration systems to improve process flexibility and support multiproduct manufacturing.

✅ August 2025: Asia-Pacific contract development and manufacturing organizations (CDMOs) scaled deployment of disposable bioprocessing technologies to meet rising demand for biosimilars and monoclonal antibodies.

✅ July 2025: Global suppliers enhanced single-use materials with improved film strength, extractables control, and sensor integration to ensure process reliability and regulatory compliance.

✅ May 2025: North American bioprocess technology providers advanced hybrid manufacturing models combining single-use and stainless-steel systems for large-scale biologics production.

✅ March 2025: Sustainability initiatives worldwide encouraged development of recyclable and lower-waste single-use bioprocessing components to address environmental concerns.

Mergers & Acquisitions
✅ November 2025: A U.S. life sciences equipment company acquired a single-use bioprocessing technology provider to expand its end-to-end biomanufacturing solutions portfolio.

✅ August 2025: A European bioprocessing supplier partnered with a CDMO to co-develop customized single-use manufacturing platforms for biologics and advanced therapies.

✅ June 2025: An Asia-Pacific single-use systems manufacturer was acquired by a global life sciences group to scale production capacity and strengthen regional market presence.

Key Players

Thermo Fisher Scientific Inc. | 3M Company | Applikon Biotechnology | Danaher Corporation | Merck KGaA | General Electric Company (GE) | PBS Biotech Inc. | Sartorius | Boehringer Ingelheim | NovoSep

Key Highlights

Thermo Fisher Scientific Inc. - Holds a share of 22.6%: Market leader in bioprocessing equipment and consumables, offering end-to-end solutions for upstream and downstream biologics manufacturing.

Danaher Corporation - Holds a share of 18.9%: Strong presence through brands such as Cytiva and Pall, delivering bioreactors, filtration, and purification technologies for biopharmaceutical production.

Merck KGaA - Holds a share of 15.4%: Provides bioprocessing reagents, single-use systems, and downstream purification solutions supporting biologics and advanced therapies.

Sartorius - Holds a share of 13.8%: Specializes in bioprocess solutions, including bioreactors, cell culture systems, and filtration technologies with strong adoption in cell and gene therapy manufacturing.

General Electric Company (GE) - Holds a share of 9.7%: Offers bioprocessing and digital manufacturing solutions, including single-use bioreactors and process analytics for biologics production.

Applikon Biotechnology - Holds a share of 6.4%: Known for laboratory and pilot-scale bioreactor systems supporting process development and scale-up.

PBS Biotech Inc. - Holds a share of 4.8%: Focuses on single-use bioreactors and scalable manufacturing platforms for biologics and cell-based therapies.

3M Company - Holds a share of 4.2%: Provides filtration, separation, and contamination control solutions critical to bioprocessing environments.

NovoSep - Holds a share of 2.9%: Specializes in continuous chromatography and downstream processing technologies for efficient biologics purification.

Boehringer Ingelheim - Holds a share of 1.3%: Operates as a major biopharmaceutical manufacturer with in-house bioprocessing expertise and contract manufacturing capabilities.

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Market Drivers
- Rising demand for biologics, biosimilars, vaccines, and cell and gene therapies.

- Need for faster manufacturing turnaround times and flexible production capabilities.

- Reduced risk of cross-contamination compared to traditional stainless-steel systems.

- Lower capital investment and operating costs, especially for small and mid-scale manufacturers.

- Growing adoption of modular and disposable manufacturing facilities.

- Increasing outsourcing to contract development and manufacturing organizations (CDMOs).

- Advancements in polymer materials improving performance, safety, and scalability.

Industry Developments
- Launch of advanced single-use bioreactors, mixers, filtration systems, and fluid management solutions.

- Expansion of single-use technologies into upstream and downstream bioprocessing applications.

- Growing partnerships between bioprocess equipment suppliers and biopharmaceutical manufacturers.

- Increased adoption of single-use systems for clinical-scale and commercial production.

- Integration of automation, sensors, and digital monitoring in disposable bioprocessing platforms.

- Rising investments and capacity expansions by leading single-use technology providers.

- Focus on sustainability initiatives including recyclable materials and waste reduction strategies.

Regional Insights
North America - 39% share: Driven by strong biopharmaceutical manufacturing base, high adoption of advanced bioprocess technologies, and presence of major suppliers.

Europe - 31% share: Supported by expanding biologics production, favorable regulatory environment, and increasing investments in biomanufacturing infrastructure.

Asia Pacific - 25% share: Fueled by rapid growth in biopharmaceutical manufacturing, CDMO expansion, and government support for life sciences.

Latin America - 3% share: Boosted by emerging biologics manufacturing capabilities and growing outsourcing activities.

Middle East & Africa - 2% share: Driven by gradual development of biomanufacturing facilities and increasing focus on local pharmaceutical production.

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Key Segments
By Product
Media bags and containers hold a significant share of the market due to their widespread use in bioprocessing for safe storage and transfer of culture media and buffers. Filtration assemblies are experiencing strong demand as biopharmaceutical manufacturers increasingly adopt single-use filtration solutions to improve process efficiency and reduce contamination risks. Disposable or single-use bioreactors represent one of the fastest-growing segments, driven by their flexibility, scalability, and reduced cleaning and validation requirements. Disposable mixers are gaining traction for efficient and contamination-free mixing of media and buffers in upstream and downstream processes. Other disposable products continue to support specialized and niche bioprocessing applications.

By Application
Filtration dominates the market as it is a critical step across multiple stages of bioprocessing, including clarification, sterilization, and purification. Storage applications account for a substantial share due to the growing use of single-use systems for holding media, buffers, and intermediates. Cell culture is a rapidly expanding segment, supported by rising biologics production and increasing adoption of disposable technologies in upstream processing. Mixing applications are witnessing steady growth with the increasing demand for efficient and flexible biomanufacturing workflows. Purification continues to gain importance as manufacturers focus on improving yield, product quality, and process consistency.

By End-Users
Biopharmaceutical manufacturers dominate the market owing to high adoption of disposable technologies to support large-scale biologics and vaccine production. Life science R&D companies hold a significant share, driven by extensive research activities and early-stage process development. Academic research institutes contribute steadily to market growth through ongoing research and training activities. Contract research organizations and contract manufacturing organizations (CROs & CMOs) are experiencing rapid growth as outsourcing of bioprocess development and manufacturing increases. Other end users, including diagnostic and specialty biotech firms, continue to support overall market demand.

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