SINGLE-USE BIOPROCESSING SYSTEMS MARKET ANALYSIS

The global single-use bioprocessing systems market was valued US$ 35.19 Bn in 2024 and is expected to reach US$ 104.27 Bn by 2031 exhibiting a compound annual growth rate (CAGR) of 16.8% from 2024 to 2031.

The market is witnessing high growth owing to rising demand for cost-efficient and green bioprocessing equipment. With several pharmaceutical companies adopting single-use bioprocessing systems, the need for highly scalable and flexible technologies is growing. This shift can be attributed to advantages such as lowered capital investments, faster manufacturing cycles, and a reduced environmental footprint. Additionally, innovations in single-use products catering to large-scale manufacturing needs have boosted their adoption in biologics production. Rising demand for biopharmaceuticals and a growing preference for disposable technologies are likely to drive the global single-use bioprocessing systems market during the forecast period.  

Global Single-use Bioprocessing Systems Market - Regional Insights

• North America is expected to be the largest market for substance abuse treatment during the forecast period, accounting for over 43.7% of the market share in 2024. North America continues to dominate the global single-use bioprocessing systems market owing to the presence of large biopharmaceutical companies and growing adoption of single-use technologies in the region. The major market for single-use systems is the U.S., which is home to the majority of world's largest biopharma companies. These companies are actively investing in the development of novel biologics and biosimilars driving the need for single-use bioprocessing. Moreover, a supportive regulatory environment is also encouraging biopharma industries to incorporate single-use systems into their manufacturing operations to enhance flexibility and lower costs.
• Asia Pacific is expected to be the second-largest market for single-use bioprocessing systems, accounting for over 25.2% of the market share in 2024. Asia Pacific region has emerged as the fastest growing regional market for single-use bioprocessing systems globally. Countries like China, India, South Korea and Japan are witnessing the expansion of their domestic biopharmaceutical industries at an unprecedented rate over the past decade. Local biopharma companies in Asia Pacific have ramped up investments to cater to growing healthcare demands as well as expand their international footprint. This has bolstered the sales of single-use bioprocessing equipment in the region. Additionally, the presence of global biopharmaceutical companies establishing manufacturing facilities coupled with the availability of low-cost skilled workforce makes Asia Pacific a lucrative market for suppliers of single-use systems. The growth in imports of single-use bioprocessing systems from the U.S. and Europe by Asia Pacific countries highlights the increasing adoption of flexible single-use technologies.
• While North America has a strong biopharma industry base to leverage single-use systems, Asia Pacific provides immense opportunities for suppliers to tap rising investments in biomanufacturing sector and expand their geographical footprint. The pricing of single-use bioprocessing systems also varies across regions, with products available at competitive rates in Asia Pacific, helping boost its attractiveness as an emerging hotspot.

Figure 1. Global Single-use Bioprocessing Systems Market Share (%), By Region, 2024

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Analyst’s Views:

The global single-use bioprocessing systems market is experiencing strong growth driven by the rising adoption of disposable bioprocessing equipment across biopharmaceutical manufacturers. The flexibility and cost savings provided by single-use systems as compared to traditional stainless steel facilities are major factors boosting their popularity. Additionally, advances in single-use sensor technology that allow for real-time data monitoring are further expanding the capabilities of these systems. North America currently dominates the market due to presence of large biopharma companies and biotech startups rapidly replacing their conventional infrastructure with single-use options. In the coming years, the Asia Pacific region is expected to see the fastest gains in market share. This can be attributed to increasing research and development investments by emerging biologics manufacturers in China, India, and other Asian countries looking to rapidly develop biologic drugs. While the market shows promising growth opportunities, the replacement of traditional manufacturing assets poses a challenge to adoption. Additionally, concerns around reliability and extractability/recoverability of single-use components are key restraints that vendors must address through improved quality systems and extraction methods. Furthermore, a lack of globally recognized regulatory guidelines for these systems may slow widespread market acceptance. Overall, continued technological developments are expanding the applications of single-use bioprocessing beyond early and mid-scale

Overall, widespread societal issues, improving awareness, and increasing prioritization of mental health indicate healthy future growth prospects for the global single-use bioprocessing systems market.  

Global Single-use Bioprocessing Systems Market- Drivers

• Increased Use of Single-Use Systems for Vaccine and Therapeutics Manufacturing: The COVID-19 pandemic has highlighted the importance of rapid and scalable vaccine and therapeutic drug production capabilities. Single-use bioprocessing systems offer significant advantages in responding quickly to public health crises by enabling faster production timelines and flexible manufacturing capacities compared to traditional stainless-steel facilities. The pandemic response involved unprecedented investments and collaborations to develop and distribute vaccines in record time using single-use technologies. Many drug makers who previously used conventional facilities have now adopted single-use options to produce COVID vaccines and treatments on a massive scale. They recognize that single-use systems allow for faster scale-up of operations without lengthy and expensive construction of new cleanrooms. Regulatory approvals are also faster since these systems present lower risks of cross-contamination. Going forward, regulatory agencies and governments are likely to emphasize the development of rapid vaccine production capabilities to prepare for future pandemics. This will further drive investments in single-use technologies that facilitate quicker responses versus traditional stainless steel equipment with rigid capacities. The pandemic has showcased the advantages of single-use systems to the broader healthcare industry as well, raising awareness of their benefits for manufacturing other drugs and biologics outside of pandemic settings. Overall adoption is expected to continue increasing as biopharma firms recognize the flexibility, speed, and regulatory advantages that these systems provide for vaccine and therapeutics production.
• Increased Bioproduction of Complex and Novel Biologic Therapies: The biopharmaceutical industry is witnessing rapid development and approval of complex novel biologic therapies such as monoclonal antibodies, gene therapies, and cell therapies to treat cancer, autoimmune diseases, and other serious medical conditions. Production of these complex biologics requires advanced manufacturing capabilities and highly controlled environments compared to traditional small molecule drugs. Single-use bioprocessing systems are particularly well-suited for manufacturing such sensitive therapies since they eliminate issues like leachables, particles and bioburden associated with the reuse and cleaning of stainless-steel equipment. Their disposable and pre-sterilized nature also makes the transfer and injection of high-value biologics safer while reducing contamination risks. As the pipeline of novel biologic drugs grows, especially those involving regenerative medicine and gene/cell therapy approaches, demand is increasing for specialized single-use technologies fitted with sensors and controllers that can carefully regulate critical manufacturing parameters.

Global Single-use Bioprocessing Systems Market- Opportunities

• Growing Bio Pharmaceutical Industry: Biologics have become the fastest-growing segment of the pharmaceutical market. This rapid growth of biologics drives the demand for single-use technologies that provide the benefits of flexible operations, easy scale-up, and lower initial capital investments. Emerging markets also present major opportunities owing to increasing R&D investments from governments and rising biotech

Global Single-use Bioprocessing Systems Market – Trends

• Increasing outsourcing of bioproduction: The growing trend of outsourcing bioproduction processes to contract development and manufacturing organizations (CDMOs) has significantly impacted the global single-use bioprocessing systems market in recent years. More pharmaceutical and biotech companies are outsourcing their biomanufacturing needs to specialized CDMOs that offer flexible, cost-effective single-use technologies. This allows product developers to focus on their core competencies in R&D and reduces their capital investment in manufacturing infrastructure. CDMOs are increasingly adopting standardized, pre-validated single-use platforms that offer speed, flexibility, and aseptic safety. They can easily customize the processes as per client requirements and handle fluctuating production demands. This has enabled even small biotech startups and mid-sized firms to access large-scale biomanufacturing capabilities. For instance, many COVID-19 vaccine developers that lacked production facilities leveraged CDMOs to quickly scale-up using ready-to-use single-use systems. According to a 2021 report by the International Federation of Pharmaceutical Manufacturers & Associations, CDMOs accounted for 41% of the global vaccine production during the COVID-19 pandemic. As more biopharma companies opt to outsource, the demand for robust commercial-scale single-use solutions at CDMOs has surged significantly. Major elements of single-use bioprocessing infrastructure like bioreactors, mixers, tangential flow filtration devices, storage bags, and connectors are being rapidly added at several CDMO facilities. For example, Chinese CDMO WuXi Biologics has invested US$600 million since 2018 to expand its aseptic drug substance manufacturing capacity based on standardized perfusion-based single-use bioprocessing technologies, as stated on their corporate website. This has propelled overall sales of single-use systems among leading suppliers.

Global Single-use Bioprocessing Systems Market - Restraints

• High costs associated with single-use components: The high costs associated with single-use components are one of the major factors restraining the growth of the global single-use bioprocessing systems market. Single-use technologies require single-use bags, tubing, connectors, sample bags, and other components that need to be replaced for every new process run. This makes the overall production process quite expensive as compared to traditional stainless steel based systems, which can be reused for multiple batches. The per-use nature of these single-use components means that pharmaceutical companies have to regularly procure fresh components and dispose-off the used ones after each manufacturing cycle. This drives up their recurring expenditure on consumables. Additionally, single-use systems also require capital investment in terms of their installation and validation, which adds to their overall cost. The high costs associated with procuring single-use bags, assemblies, sensors, etc. on a periodic basis negatively impacts the profit margins of pharmaceutical manufacturers, especially for large volume production. Manufacturers also have to factor in the costs of proper waste disposal of the used single-use components as per environmental guidelines, which further adds to their expenses. The bioprocessing waste generated from single-use systems contains microbiological contaminants and other hazardous materials that require incineration at high temperatures or autoclaving before safe disposal. This regulated waste management is costly for companies. The high costs of components and operations have discouraged certain pharmaceutical manufacturers, especially those involved in large volume drug production, from fully adopting single-use bioprocessing technologies. According to the data from the World Bank, the global average annual healthcare expenditure per capita increased from US$957 in 2015 to US $1,23 in 2020. This shows the rising healthcare costs worldwide, which impact the profitability of pharmaceutical manufacturers. The high costs of single-use technologies thus act as a deterrent for the greater adoption of these systems by all drug manufacturers.

Counterbalance – Despite the high initial costs and recurring expenses associated with single-use bioprocessing components, their adoption offers significant advantages in terms of flexibility, scalability, and reduced risk of cross-contamination. Additionally, advancements in technology and increasing demand for personalized medicine are driving innovations to mitigate costs and enhance the cost-effectiveness of single-use systems over time.

Figure 2. Global Single-use Bioprocessing Systems Market Share (%), By End User, 2024

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Global Single-use Bioprocessing Systems Market- Recent Developments

Product Launch & Product Approval

• On September 15, 2024, Getinge, one of the leading medtech companies, announced the launch of AppliFlex ST GMP, a single-use bioreactor system designed for clinical production in cell and gene therapy as well as mRNA production.
• On May 2, 2024, DuPont, a chemical company, showcased DuPon Liveo single-use biopharma processing solutions for critical fluid transport applications at BioProcess International Europe, which was held on May 9-12, 2024.

Acquisition and Partnership

• On May 31, 2024, Getinge announced an agreement to acquire 100% of the shares in High Purity New England, Inc., one of the leading U.S.-based companies in the area of custom single-use solutions for bioprocessing applications.
• In December 2020, Pall Corporation, one of the global leaders in filtration, separation, and purification, announced a strategic partnership with Single Use Support GmbH, one of the leading providers and end-to-end solutions for safe handling of biologics, from bulk manufacturing to fill finishing to distribute, which protects single-use bags and contains drug substances during freezing, thawing, storage, and shipping.

Top Companies in the Global Single-use Bioprocessing Systems Market

• Merck KGaA
• Thermo Fisher Scientific Inc.
• Liquidyne
• Corning Incorporated
• Foxx Life Sciences.
• PARKER HANNIFIN CORP
• Danaher Corporation.
• Sartorius
• GE Healthcare
• Eppendorf
• Getinge AB
• PBS Biotech
• Esco Bioengineering
• Distek
• Bionet
• Other Prominent Players

Definition: Single-use bioprocessing systems are disposable equipment used in biopharmaceutical manufacturing, comprising flexible plastic bags, tubing, connectors, and filters. They provide a sterile, cost-effective, and efficient alternative to traditional stainless-steel equipment, minimizing cross-contamination risks and setup time.