Plasmapheresis Automation Equipment in 2025: Unveiling Breakthroughs, Market Expansion, and the Future of Automated Blood Plasma Collection. Explore How Innovation and Demand Are Shaping the Next Five Years.

• Executive Summary: Key Findings and 2025 Outlook
• Market Size and Growth Forecast (2025–2030): CAGR and Revenue Projections
• Technological Innovations: Automation, AI, and Next-Gen Devices
• Competitive Landscape: Leading Manufacturers and Strategic Moves
• Regulatory Environment and Compliance Trends
• End-User Analysis: Hospitals, Blood Banks, and Research Centers
• Regional Market Dynamics: North America, Europe, Asia-Pacific, and Beyond
• Drivers and Challenges: Demand, Supply Chain, and Cost Factors
• Emerging Applications and Future Opportunities
• Strategic Recommendations and Future Outlook
• Sources & References

Executive Summary: Key Findings and 2025 Outlook

The global market for plasmapheresis automation equipment is poised for significant growth in 2025, driven by rising demand for plasma-derived therapies, ongoing technological innovation, and expanding collection infrastructure. Plasmapheresis, the process of separating plasma from whole blood, is increasingly automated to improve efficiency, safety, and donor comfort. Automated systems are now the standard in major plasma collection centers, with leading manufacturers investing in next-generation devices that offer enhanced throughput, digital integration, and improved user interfaces.

Key industry players such as Fresenius Kabi, Terumo BCT, and Haemonetics Corporation continue to dominate the sector, each offering a portfolio of automated plasmapheresis devices. Fresenius Kabi’s COM.TEC and Aurora platforms, Terumo BCT’s Trima Accel, and Haemonetics Corporation’s NexSys PCS are widely adopted in both commercial and hospital-based plasma collection settings. These systems are designed to maximize plasma yield per donation, reduce procedure times, and ensure traceability through integrated software solutions.

In 2025, the sector is witnessing increased investment in digitalization and connectivity. Equipment manufacturers are rolling out cloud-based data management and remote monitoring features, enabling real-time oversight of collection operations and facilitating compliance with evolving regulatory standards. For example, Haemonetics Corporation has emphasized the integration of its NexLynk DMS software with its plasmapheresis devices, streamlining donor management and collection workflows.

The expansion of plasma collection networks, particularly in North America and Europe, is a key driver for equipment demand. Major plasma collection organizations, including Grifols and Octapharma, are scaling up their operations and investing in state-of-the-art automated equipment to meet the growing need for immunoglobulins, albumin, and other plasma-derived products. This trend is expected to continue through 2025 and beyond, as the global burden of immune and neurological disorders rises and new therapeutic indications for plasma products emerge.

Looking ahead, the outlook for plasmapheresis automation equipment remains robust. The sector is expected to benefit from ongoing R&D in device miniaturization, improved donor safety features, and enhanced data analytics capabilities. Strategic partnerships between equipment manufacturers and plasma collection organizations are likely to accelerate innovation and adoption. As regulatory requirements for traceability and quality tighten, automation and digital integration will become even more critical, positioning leading manufacturers for continued growth in the coming years.

Market Size and Growth Forecast (2025–2030): CAGR and Revenue Projections

The global market for plasmapheresis automation equipment is poised for robust growth from 2025 through 2030, driven by increasing demand for plasma-derived therapies, technological advancements, and expanding plasma collection networks. As of 2025, the market is estimated to be valued in the low billions (USD), with leading manufacturers reporting strong order books and capacity expansions. The compound annual growth rate (CAGR) for the sector is projected to range between 7% and 10% over the forecast period, reflecting both rising procedure volumes and ongoing equipment upgrades.

Key players in the plasmapheresis automation equipment market include Fresenius, Terumo BCT, and Haemonetics. These companies dominate the sector with advanced apheresis platforms, such as the Fresenius COM.TEC and Terumo BCT’s Spectra Optia, which are widely adopted in both standalone plasma collection centers and hospital-based settings. Haemonetics has reported continued investment in automation and digital integration, aiming to streamline donor management and improve throughput.

The market’s expansion is underpinned by the growing need for immunoglobulins, albumin, and other plasma-derived products, particularly in North America and Europe, where regulatory frameworks support large-scale plasma collection. The United States remains the largest single market, with ongoing investments in new collection centers and upgrades to existing infrastructure. For example, Fresenius and Terumo BCT have both announced partnerships with major plasma collection organizations to deploy next-generation automated systems, enhancing efficiency and donor safety.

Looking ahead, the market outlook remains positive, with revenue projections for 2030 expected to surpass USD 3 billion, assuming continued growth in plasma demand and further adoption of automation. The Asia-Pacific region is anticipated to see the fastest growth, as countries such as China and India expand their plasma collection infrastructure and adopt international standards for donor safety and product quality. Additionally, ongoing R&D by leading manufacturers is expected to yield more compact, user-friendly, and data-integrated devices, further accelerating market penetration.

In summary, the plasmapheresis automation equipment market is set for sustained expansion through 2030, supported by technological innovation, rising global plasma needs, and strategic investments by industry leaders such as Fresenius, Terumo BCT, and Haemonetics.

Technological Innovations: Automation, AI, and Next-Gen Devices

The landscape of plasmapheresis automation equipment is undergoing rapid transformation in 2025, driven by advances in automation, artificial intelligence (AI), and next-generation device engineering. Leading manufacturers are integrating sophisticated automation features to streamline plasma collection, enhance donor safety, and optimize operational efficiency. These innovations are particularly significant as global demand for plasma-derived therapies continues to rise, necessitating scalable and reliable collection technologies.

Key industry players such as Fresenius Kabi, Terumo BCT, and Haemonetics Corporation are at the forefront of this evolution. Their latest automated plasmapheresis systems feature real-time monitoring, touchless operation, and advanced data analytics. For example, Fresenius Kabi’s Alyx and Aurora platforms incorporate closed-loop automation, reducing manual intervention and minimizing contamination risks. Similarly, Terumo BCT’s Rika system leverages digital connectivity and user-friendly interfaces to improve both donor experience and staff workflow.

AI-driven enhancements are increasingly embedded in these devices. Predictive algorithms now assist in donor eligibility assessment, adverse event prediction, and personalized collection protocols. Haemonetics Corporation has introduced smart monitoring features that analyze donor vital signs and collection parameters in real time, enabling dynamic adjustments to ensure optimal plasma yield and donor safety. These AI capabilities are expected to become standard across new product lines by 2026, as regulatory bodies and plasma collection organizations emphasize data-driven quality assurance.

Connectivity and interoperability are also central to next-generation plasmapheresis equipment. Devices are being designed to seamlessly integrate with electronic health records (EHRs) and centralized data management systems, supporting compliance, traceability, and remote diagnostics. Fresenius Kabi and Terumo BCT have both announced partnerships with software providers to enable secure, cloud-based data exchange, which is expected to accelerate adoption in large-scale plasma collection centers.

Looking ahead, the outlook for plasmapheresis automation equipment is marked by continued investment in AI, robotics, and digital health integration. The next few years will likely see further miniaturization of devices, enhanced portability for mobile collection units, and expanded use of machine learning for predictive maintenance and process optimization. As the sector responds to both regulatory demands and the need for higher throughput, these technological innovations are poised to redefine standards in plasma collection worldwide.

Competitive Landscape: Leading Manufacturers and Strategic Moves

The competitive landscape for plasmapheresis automation equipment in 2025 is characterized by a concentrated group of global manufacturers, each leveraging technological innovation, strategic partnerships, and geographic expansion to strengthen their market positions. The sector is dominated by a handful of established players, with new entrants facing high barriers due to regulatory requirements, capital intensity, and the need for robust clinical validation.

Among the leading manufacturers, Fresenius stands out as a global leader in apheresis technology. Its automated plasmapheresis systems, such as the COM.TEC and Amicus platforms, are widely adopted in both therapeutic and donor plasma collection settings. The company continues to invest in R&D, focusing on improving automation, user interface, and safety features. In 2024 and 2025, Fresenius has announced collaborations with blood collection organizations to pilot next-generation devices with enhanced data connectivity and workflow integration.

Terumo BCT is another major player, recognized for its Spectra Optia Apheresis System, which is used globally for both therapeutic and collection applications. Terumo BCT has been expanding its manufacturing capacity and digital health capabilities, aiming to support the growing demand for plasma-derived therapies. The company’s recent strategic moves include partnerships with healthcare providers to implement remote monitoring and predictive maintenance for its equipment, enhancing uptime and operational efficiency.

Haemonetics is a key competitor, particularly in the North American market, with its NexSys PCS platform. The company has focused on automation, donor safety, and data analytics, integrating cloud-based solutions to optimize plasma collection center operations. In 2025, Haemonetics is expected to roll out software upgrades and new device configurations to address evolving regulatory standards and customer needs.

Other notable manufacturers include Kawasumi Laboratories, which supplies apheresis disposables and equipment, and B. Braun, which has a presence in select markets with its apheresis technologies. These companies are increasingly investing in automation and digital integration to remain competitive.

Looking ahead, the competitive landscape is likely to see further consolidation, with leading manufacturers pursuing mergers, acquisitions, and strategic alliances to expand their product portfolios and geographic reach. The integration of artificial intelligence, real-time data analytics, and remote service capabilities is expected to be a key differentiator, as manufacturers respond to the rising demand for efficiency, safety, and compliance in plasma collection and therapeutic apheresis.

Regulatory Environment and Compliance Trends

The regulatory environment for plasmapheresis automation equipment is evolving rapidly in 2025, reflecting both technological advancements and heightened global focus on blood safety and donor protection. Regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national authorities are intensifying oversight of automated plasmapheresis devices, emphasizing rigorous standards for device safety, efficacy, and data integrity.

In the United States, the FDA continues to require premarket approval (PMA) or 510(k) clearance for plasmapheresis automation systems, with a growing emphasis on cybersecurity, software validation, and real-time data monitoring. Recent guidance highlights the need for robust electronic records and traceability, especially as leading manufacturers like Fresenius Kabi and Terumo BCT integrate cloud connectivity and remote diagnostics into their devices. The FDA’s Center for Biologics Evaluation and Research (CBER) is also collaborating with industry to update standards for donor safety, including limits on collection frequency and volume, which directly impact equipment design and compliance requirements.

In Europe, the Medical Device Regulation (MDR) has fully replaced the previous Medical Device Directive, imposing stricter requirements for clinical evidence, post-market surveillance, and unique device identification (UDI). Companies such as Haemonetics Corporation and Fresenius Kabi are adapting their product documentation and quality management systems to meet these enhanced obligations. The MDR’s focus on transparency and traceability is driving the adoption of advanced automation features, such as integrated donor management and automated reporting, to facilitate compliance.

Globally, regulatory harmonization efforts are underway, with organizations like the International Society of Blood Transfusion (ISBT) and the World Health Organization (WHO) promoting best practices for automated plasmapheresis. These initiatives encourage manufacturers to align with international standards such as ISO 13485 for quality management and ISO 15189 for laboratory competence, further shaping equipment development and validation processes.

Looking ahead, the regulatory landscape is expected to become even more stringent as authorities respond to emerging risks, such as data privacy concerns and the integration of artificial intelligence in donor screening. Manufacturers are investing in compliance infrastructure and digital innovation to stay ahead of evolving requirements, ensuring that automated plasmapheresis equipment remains safe, effective, and fully aligned with global regulatory expectations through 2025 and beyond.

End-User Analysis: Hospitals, Blood Banks, and Research Centers

The adoption of plasmapheresis automation equipment is accelerating across key end-user segments—hospitals, blood banks, and research centers—driven by the need for efficiency, safety, and scalability in plasma collection and therapeutic procedures. In 2025, hospitals remain primary users, leveraging automated plasmapheresis systems for both therapeutic apheresis (e.g., treatment of autoimmune disorders, neurological conditions) and for supporting transfusion services. The integration of advanced automation is particularly notable in large tertiary care centers, where high patient throughput and stringent safety protocols necessitate reliable, user-friendly devices.

Blood banks represent the fastest-growing segment for plasmapheresis automation equipment. The global demand for plasma-derived therapies, such as immunoglobulins and clotting factors, continues to rise, prompting blood collection organizations to invest in high-throughput, automated systems. Leading manufacturers such as Fresenius Kabi and Terumo BCT have developed next-generation apheresis platforms that enable efficient plasma separation, minimize donor discomfort, and ensure traceability and compliance with regulatory standards. For example, Fresenius Kabi’s Amicus and Aurora systems are widely deployed in blood centers globally, offering customizable protocols and integrated data management to streamline operations.

Research centers, including academic institutions and biopharmaceutical R&D facilities, are increasingly utilizing automated plasmapheresis equipment to support clinical trials and translational research. These centers require flexible systems capable of handling variable volumes and specialized protocols. The ability to automate plasma collection and component separation is critical for studies involving cell therapies, immunology, and infectious diseases. Companies like Haemonetics Corporation and Terumo BCT provide modular platforms that can be adapted for research applications, supporting both routine and experimental workflows.

Looking ahead, the outlook for plasmapheresis automation equipment in these end-user segments is robust. Hospitals are expected to further integrate these systems with electronic health records and hospital information systems, enhancing traceability and patient safety. Blood banks will continue to prioritize automation to meet growing plasma collection targets, especially as new plasma-derived therapies enter the market. Research centers are anticipated to drive demand for highly customizable and data-rich platforms, supporting the next wave of clinical innovation. The ongoing development of user-centric interfaces, remote monitoring, and AI-driven analytics by industry leaders such as Fresenius Kabi, Terumo BCT, and Haemonetics Corporation will further shape adoption patterns through 2025 and beyond.

Regional Market Dynamics: North America, Europe, Asia-Pacific, and Beyond

The global market for plasmapheresis automation equipment is experiencing dynamic regional shifts as of 2025, driven by evolving healthcare infrastructure, regulatory landscapes, and the rising demand for plasma-derived therapies. North America remains the largest and most mature market, underpinned by robust investments in blood collection infrastructure, a high prevalence of plasma donation centers, and the presence of leading manufacturers. The United States, in particular, is home to major industry players such as Terumo BCT and Fresenius Kabi, both of which have expanded their automated plasmapheresis device portfolios to meet growing clinical and donor needs. The region’s regulatory environment, led by the U.S. Food and Drug Administration (FDA), continues to set stringent standards for device safety and efficacy, fostering innovation and adoption of next-generation automation systems.

In Europe, the market is characterized by a strong focus on quality and safety, with the European Medicines Agency (EMA) and national health authorities driving harmonized standards for blood and plasma collection. Countries such as Germany, France, and the United Kingdom are investing in modernizing their blood collection networks, with increasing adoption of automated plasmapheresis equipment from established suppliers like Haemonetics Corporation and Fresenius Kabi. The region is also witnessing collaborative efforts to address plasma self-sufficiency, which is expected to further stimulate demand for advanced automation technologies in the coming years.

The Asia-Pacific region is emerging as a high-growth market, propelled by expanding healthcare access, rising awareness of plasma therapies, and government initiatives to strengthen blood and plasma collection systems. Countries such as China, India, and Japan are rapidly scaling up their plasmapheresis infrastructure, with local and international manufacturers introducing automated solutions tailored to regional needs. Terumo BCT, with its strong presence in Japan and China, is actively collaborating with local healthcare providers to deploy its automated platforms. Additionally, domestic companies in China are beginning to enter the market, contributing to increased competition and innovation.

Beyond these core regions, Latin America and the Middle East are gradually adopting plasmapheresis automation, albeit at a slower pace due to infrastructural and regulatory challenges. However, international partnerships and technology transfer initiatives are expected to accelerate market development in these areas over the next few years. Overall, the outlook for plasmapheresis automation equipment is positive, with global demand projected to rise as healthcare systems prioritize efficiency, donor safety, and the growing need for plasma-derived medicinal products.

Drivers and Challenges: Demand, Supply Chain, and Cost Factors

The market for plasmapheresis automation equipment in 2025 is shaped by a complex interplay of demand drivers, supply chain dynamics, and cost considerations. The global demand for plasma-derived therapies—used in treating immunodeficiencies, neurological disorders, and bleeding conditions—continues to rise, directly fueling the need for efficient, high-throughput plasmapheresis systems. This demand is particularly acute in North America and Europe, where both voluntary plasma donation and contract plasma collection centers are expanding their capacities. Major industry players such as Fresenius, Terumo BCT, and Haemonetics are at the forefront, offering advanced automated plasmapheresis platforms that improve donor safety, reduce procedure times, and optimize plasma yield per session.

A key driver in 2025 is the ongoing innovation in automation and digital integration. Equipment now features real-time monitoring, remote diagnostics, and data connectivity, enabling plasma centers to streamline operations and comply with increasingly stringent regulatory requirements. For example, Haemonetics has introduced systems with enhanced user interfaces and integrated data management, while Terumo BCT emphasizes modularity and scalability in its devices to accommodate varying center sizes and throughput needs.

However, the supply chain for critical components—such as sterile disposables, sensors, and specialized pumps—remains vulnerable to disruptions. The COVID-19 pandemic exposed weaknesses in global logistics, and while some resilience has been built, manufacturers still face challenges in sourcing high-quality materials and maintaining just-in-time inventories. Companies like Fresenius and Haemonetics have responded by diversifying suppliers and investing in regional manufacturing hubs to mitigate risks.

Cost factors are another significant challenge. Automated plasmapheresis equipment represents a substantial capital investment for plasma collection centers, with ongoing expenses for consumables and maintenance. While automation reduces labor costs and increases throughput, the initial outlay can be prohibitive for smaller operators or those in emerging markets. To address this, leading manufacturers are exploring flexible financing models, leasing options, and service-based contracts to lower barriers to adoption.

Looking ahead, the outlook for 2025 and the following years suggests continued growth in demand, but also heightened competition and pressure to innovate. Regulatory scrutiny on donor safety and product quality is expected to intensify, pushing manufacturers to further enhance automation, traceability, and data integration. The ability of companies to balance cost, supply chain resilience, and technological advancement will be critical in shaping the future landscape of plasmapheresis automation equipment.

Emerging Applications and Future Opportunities

The landscape of plasmapheresis automation equipment is poised for significant transformation in 2025 and the coming years, driven by technological innovation, expanding clinical applications, and evolving global health priorities. Automated plasmapheresis systems, which separate plasma from whole blood with minimal manual intervention, are increasingly central to both therapeutic and donor plasma collection settings. The demand for plasma-derived therapies—such as immunoglobulins, albumin, and clotting factors—continues to rise, fueling the need for more efficient, scalable, and user-friendly automation solutions.

Key industry leaders, including Fresenius Kabi, Terumo BCT, and Haemonetics Corporation, are actively investing in next-generation plasmapheresis platforms. These companies are focusing on enhancing device connectivity, integrating real-time data analytics, and improving donor safety and comfort. For example, recent product lines emphasize features such as automated procedure optimization, wireless data transfer, and advanced monitoring of donor vital signs. Such innovations are expected to streamline workflow in plasma collection centers and hospitals, reduce operator error, and support compliance with increasingly stringent regulatory standards.

Emerging applications are also shaping the future of plasmapheresis automation. Beyond traditional uses in plasma donation and treatment of autoimmune diseases, there is growing interest in leveraging automated plasmapheresis for novel indications, such as the management of severe infectious diseases, neurological disorders, and even as adjunctive therapy in organ transplantation. The COVID-19 pandemic underscored the importance of rapid, high-throughput plasma collection for convalescent plasma therapies, accelerating investment in automation and digitalization across the sector.

Looking ahead, the integration of artificial intelligence (AI) and machine learning into plasmapheresis equipment is anticipated to further personalize procedures, optimize plasma yield, and predict adverse donor reactions. Companies are also exploring remote monitoring and telemedicine capabilities, enabling expert oversight of procedures in decentralized or resource-limited settings. Additionally, sustainability is emerging as a priority, with manufacturers developing equipment that reduces disposables, energy consumption, and environmental impact.

Geographically, the expansion of plasma collection infrastructure in Asia-Pacific and Latin America is expected to drive demand for automated systems tailored to diverse regulatory and operational environments. Strategic partnerships between equipment manufacturers and plasma fractionators are likely to accelerate technology adoption and support the global supply of plasma-derived medicines.

In summary, the next few years will see plasmapheresis automation equipment evolve rapidly, with a focus on digital integration, expanded clinical applications, and global accessibility—positioning the sector for robust growth and innovation.

Strategic Recommendations and Future Outlook

The landscape for plasmapheresis automation equipment is poised for significant evolution in 2025 and the following years, driven by technological innovation, regulatory shifts, and expanding global demand for plasma-derived therapies. Strategic recommendations for stakeholders in this sector should focus on several key areas to ensure competitiveness and sustainable growth.

• Invest in Next-Generation Automation: Leading manufacturers such as Fresenius Kabi and Terumo BCT are advancing automation capabilities, integrating features like real-time monitoring, enhanced donor safety, and data connectivity. Companies should prioritize R&D in artificial intelligence-driven process optimization, user-friendly interfaces, and remote diagnostics to meet the rising expectations of plasma collection centers and regulatory bodies.
• Expand Global Footprint: The demand for plasma-derived products is surging, particularly in Asia-Pacific and Latin America, where healthcare infrastructure is rapidly developing. Strategic partnerships with local healthcare providers and governments, as well as compliance with region-specific regulatory requirements, will be crucial for market penetration. Haemonetics Corporation and Fresenius Kabi have both announced expansion plans in emerging markets, reflecting this trend.
• Enhance Data Integration and Compliance: With increasing regulatory scrutiny, especially in the US and EU, equipment must support robust data management and traceability. Integration with electronic health records (EHR) and compliance with standards such as FDA’s 21 CFR Part 11 are becoming baseline requirements. Companies should invest in cybersecurity and interoperability to facilitate seamless data exchange and ensure donor privacy.
• Focus on Sustainability and Donor Experience: Environmental considerations are gaining prominence, with stakeholders seeking equipment that minimizes waste and energy consumption. Additionally, improving donor comfort and reducing procedure times can enhance donor retention rates, a critical factor given ongoing plasma shortages. Innovations in disposable sets and ergonomic design, as seen in recent product launches by Terumo BCT, are setting new industry benchmarks.

Looking ahead, the plasmapheresis automation equipment sector is expected to see continued consolidation, with major players acquiring niche technology firms to broaden their portfolios. The integration of digital health solutions and predictive analytics will further differentiate market leaders. Stakeholders who proactively address regulatory, technological, and market dynamics will be best positioned to capitalize on the robust growth forecast for 2025 and beyond.

Sources & References

• Fresenius Kabi
• Terumo BCT
• Haemonetics Corporation
• Grifols
• Octapharma
• Fresenius
• Kawasumi Laboratories
• B. Braun