Single-use Bioprocessing Market

The global Single-use Bioprocessing Market is valued at USD 11.5 Billion in 2023 and is projected to reach a value of USD 57.35 Billion by 2032 at a CAGR (Compound Annual Growth Rate) of 19.6% between 2024 and 2032.

Key highlights of Single-use Bioprocessing Market

• The North American region dominated the market in 2023, obtaining the largest revenue share of 34.05%,
• The Asia Pacific region will witness remarkable growth with a CAGR during the forecast period,
• The Simple & Peripheral Elements segment dominated the Single-use Bioprocessing market with the largest market share of 48.9% in 2023,
• Upstream Bioprocessing segment dominated the market with a significant market share of 56.5% in 2023,
• Biopharmaceutical Manufacturers dominated the market with largest market share of 59.1% in 2023,
• The growing emphasis on cost-effectiveness, scalability, and operational efficiency in biopharmaceutical manufacturing further drives the Single-use Bioprocessing market.

Single-use Bioprocessing Market: Regional Overview

North America Dominated Sales with a 34.05% share in 2023. North America's Single-use Bioprocessing industry is fueled by significant investments in research and development, a well-defined regulatory environment, and the presence of key market players. The region's strong demand for biologics, competent workforce, and advanced healthcare infrastructure contribute to its leadership in single-use bioprocessing technology. Additionally, the need for single-use bioprocessing equipment is increased by the growing focus on vaccine development for combating diseases in the area. Disposable system adoption is accelerated by the existence of groups like the Bio-process System Alliance (BPSA), which boosts sales in North America. Additionally, the region's market is enlarging due to growing firm initiatives to build single-use bioprocessing facilities and provide novel products such as filter assemblies, bioreactors, and other consumables. For instance, Liquid single-use bioprocessing bags were introduced by ILC Dover Lp in May 2022 to handle and distribute sterile liquids for the biotherapeutics market. With the help of this launch, the business can set up the whole biotherapeutic and pharmaceutical manufacturing process, from handling and containing powder to handling sterile liquid and pre-filled powder and liquid bags.

U.S Single-use Bioprocessing Market Overview

The U.S Single-use Bioprocessing market, valued at USD 3.3 Billion in 2023 to USD 17.18 Billion in 2032, is anticipated to grow at a CAGR of 20.1% from 2024 to 2032. The rising demand for biopharmaceuticals, enhancements in single-use technologies, and increasing attention to flexibility and cost-effectiveness in biomanufacturing methods drive the growth of the U.S. Single-use Bioprocessing market. The advantages of decreased contamination risks, quicker turnaround times, and easier operations, in addition to the growing recognition of single-use systems by using biopharmaceutical manufacturers, especially for small-batch manufacturing and personalized medicine, are important elements propelling the market. In addition, the COVID-19 pandemic has highlighted the significance of flexible bioprocessing solutions even more, leading to increased investments in single-use technologies in the biopharmaceutical sector as businesses aim to improve their production capabilities and flexibility in response to changing market conditions.

Single-use Bioprocessing Market: Product Overview

In 2023, the Simple & Peripheral Elements segment dominated the market with the largest share of 48.9%. The Single-use Bioprocessing market, segmented by the Product, includes Simple & Peripheral Elements Tubing, Filters, Connectors, & Transfer Systems, Bags, Sampling Systems, Probes & Sensors: pH Sensor, Oxygen Sensor, Pressure Sensors, Temperature Sensors, Conductivity Sensors, Flow Sensors, Others, Others, Apparatus & Plants: Bioreactors: Upto 1000L, Above 1000L to 2000L, Above 2000L, Mixing, Storage, & Filling Systems, Filtration System, Chromatography Systems, Pumps, Others, Work Equipment: Cell Culture System, Syringes, Others. The Simple & Peripheral Elements segment plays pivotal roles across various stages of biopharmaceutical manufacturing, offering notable advantages such as flexibility, user-friendliness, and minimizing contamination risks. This segment's dominance underscores its indispensable role in enabling efficient, cost-effective, single-use bioprocessing solutions. Within the Simple & Peripheral Elements, tubing, filters, connectors, and transfer systems hold a majority share, facilitated by their widespread availability and compatibility with single-use bags, bioreactors, and other apparatus. For instance, Thermo Fisher Scientific, Inc. offers customization options, incorporating tubing and connectors into its bioprocessing container bags and equipment, further propelling the segment's momentum.

Single-use Bioprocessing Market: Workflow Overview

In 2023, significant revenue of 56.5% was generated by Single-use Bioprocessing for Upstream Bioprocessing. The Workflow segment is divided into Upstream Bioprocessing, Fermentation, and Downstream Bioprocessing. Upstream Bioprocessing, integral to the Single-use Bioprocessing market, involves nurturing cell cultures or microorganisms to yield desired therapeutic proteins, enzymes, or vaccines, making it pivotal for the biopharmaceutical production workflow. Its significant revenue contribution underscores its role in ensuring the quality and yield of the final product, which is heavily reliant on the efficiency and scalability of upstream processes. Factors such as advancements in cell culture technologies, escalating demand for biologics, and the adoption of single-use systems are driving the growth and prominence of Upstream Bioprocessing. Continuous developments in upstream bioprocessing technologies further augment this trend. For instance, innovative solutions like the Ambr 15 micro-bioreactor system by Sartorius AG offer high-throughput upstream process development, streamlined cell culture processing, and automated experimental setup and sampling, reducing operation time and fostering segment growth.

Single-use Bioprocessing Market: End Use Overview

In 2023, the Biopharmaceutical Manufacturers segment dominated the market with a most significant share of 59.1%. The Single-use Bioprocessing market, segmented by the End Use, is bifurcated Biopharmaceutical Manufacturers: CMOs & CROs, In-house Manufacturers, and Academic & Clinical Research Institutes. The market for Single-use Bioprocessing is dominated by the Biopharmaceutical Manufacturers sector, which indicates its significant contribution to developing, manufacturing, and marketing biopharmaceutical products such as cell therapy, monoclonal antibodies, and vaccines. Single-use bioprocessing technologies are widely used by companies to improve flexibility, accelerate production, and guarantee the quality and safety of their products. The need for scalable and affordable manufacturing solutions, growing demand for biologics, and increased investments in biopharmaceutical R&D are some of the factors contributing to the segment's importance. Furthermore, the market expansion is further propelled by the commercial success of biologics and the explosion in contract manufacturing and research services. Because of their benefits, including scalability, flexibility, lower infrastructure needs, and dedicated supply channels, CROs and CMOs are becoming increasingly popular, which will help the industry grow.

Key Trends

• There is a growing trend towards adopting Single-use systems in biopharmaceutical manufacturing due to their flexibility in adapting to varying production needs, mitigating the risk of cross-contamination between batches, and reducing upfront investment costs compared to traditional stainless-steel systems.
• There is an ongoing trend toward advancements in polymer science that led to the development of innovative materials that exhibit enhanced mechanical properties, such as improved strength, flexibility, and chemical resistance, ensuring durability and reliability in demanding manufacturing environments and minimizing the leaching of potentially harmful compounds into the biopharmaceutical product.
• There's a notable trend toward adopting pre-sterilized capsules and pods as single-use containers for biopharmaceutical manufacturing processes. By reducing the need for cleaning and sterilization procedures, these ready-to-use containers lower the risk of contamination and cut down on downtime between production runs. Furthermore, capsules and pods provide scalable and flexible manufacturing solutions, enabling quick scaling up or down of production capacity in response to changes in demand.

Premium Insights

The Single-use Bioprocessing market is propelled by several key drivers, such as the aging population, rising prevalence of chronic diseases, and advancements in biotechnology, creating a substantial market opportunity for single-use bioprocessing systems. The advantages of single-use technologies over conventional stainless-steel systems are growing, including a lower chance of cross-contamination, manufacturing flexibility, and quicker turnaround times. Additionally, the market is growing due to legislative initiatives supporting disposable technologies and the demand for quick and flexible manufacturing capabilities, which stimulate investment in cutting-edge single-use bioprocessing technologies and solutions.

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Market Dynamics

Biopharmaceuticals, including vaccines, monoclonal antibodies, and cell therapies, are gaining prominence in the healthcare sector due to their specificity, efficacy, and potential for personalized medicine

The market for biopharmaceuticals is driven worldwide by rising chronic disease cases and growing biotechnology developments. Single-use bioprocessing systems offer advantages such as reduced risk of cross-contamination, shorter setup times, and increased flexibility, making them preferred choices for biopharmaceutical manufacturing. This driver fuels the expansion of the Single-Use Bioprocessing market, attracting investments, fostering innovation, and driving technological advancements in disposable bioprocessing technologies.

Leachables and extractables are compounds that can migrate from single-use bioprocessing components into biopharmaceutical products, posing potential risks to product quality, safety, and regulatory compliance

Concerns regarding leachables and extractables arise from using various materials in disposable bioprocessing systems, such as plastics, films, and adhesives, which may contain compounds that can leach into the process fluids. Addressing these issues requires rigorous testing, characterization, and qualification of single-use components to ensure that leachables and extractables remain within acceptable limits and do not adversely affect product quality or patient safety.

Single-use bioprocessing systems generate a significant amount of waste that is challenging to dispose of properly

Single-use bioprocessing systems wastes, including disposable bags, tubing, filters, and connectors, must be disposed of properly to mitigate environmental impact. The environmental sustainability of traditional disposal techniques, like landfilling or incineration, may need to be improved owing to worries about plastic pollution, greenhouse gas emissions, and resource depletion. Recycle, composting, or sterilizing for reuse are types of sustainable waste management techniques that are vital to reducing the environmental impact of single-use bioprocessing and guaranteeing resource stewardship.

Competitive Landscape

The competitive landscape of the Single-use Bioprocessing market is characterized by a wide range of key players ranging from well-established industry giants to innovative startups. Key players such as Thermo Fisher Scientific, Danaher Corporation, and Sartorius AG dominate with their comprehensive product portfolios and global presence, leveraging their extensive R&D capabilities and strategic acquisitions. However, niche players like Merck KGaA and Eppendorf AG carve out their space with specialized offerings, focusing on technological advancements and tailored solutions. Moreover, the market witnesses a continuous influx of new entrants driven by advancements in biotechnology and growing demand for flexible manufacturing solutions, intensifying competition and fostering innovation across the sector.

The key players in the global Single-use Bioprocessing market include - Thermo Fisher Scientific Inc. (U.S.), Merck KGaA (Germany), Avantor Inc. (U.S.), Eppendorf SE (Germany), Sartorius AG (Germany), Lonza Group AG (Switzerland), PBS Biotech Inc. (U.S.), Meissner Filtration Products Inc. (U.S.), Danaher Corp. (U.S.), Corning Inc. (U.S.) among others.

Recent Market Developments

AGC Biologics Expands Pharmaceutical Manufacturing Capabilities in Japan to Meet Global Demand

• In January 2024, CDMO AGC Biologics announced a growth strategy to develop pharmaceutical manufacturing capabilities in Asia by expanding its mammalian cell culture, mRNA, and cell therapy facility in Japan. This development aims to support the global demand for biologics and advanced therapy medicinal products.

Getinge Launches AppliFlex ST GMP, a Single-Use Bioreactor for mRNA and Cell Therapies

• In September 2023, Getinge launched a single-use bioreactor named the AppliFlex ST GMP. The new product is available in different sizes and provides a comprehensive cGMP manufacturing solution for mRNA production and cell and gene therapies.

Other Recent Developments

• In April 2023, Merck KGaA launched Ultimus, a single-use process container film, to provide superior strength & leak resistance for single-use assemblies.
• In April 2023, Cytiva introduced the X-platform bioreactors that simplify the upstream bioprocessing operations for producing monoclonal antibodies (mAbs), protein-based drugs, and cell and gene therapies.

The global Single-use Bioprocessing market can be categorized as Product, Workflow, End Use, and Region.